The citizens of The United States have made Medical Malpractice Legal!

COVID-19 PREP Act Declarations

The PREP ACT suggests that somebody who has zero legal authority,
who does not work for the legal branch of government

is legally bound to interfere with another branch of government.
Not only that, but THE PREP ACT gives their
secretary
this authority. NONE of these people are voted for; they are all appointed.
The Secretary’s Secretary
is, in no way,
an elected person!
“…the Secretary of the Department of Health and Human Services (Secretary)”

The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of the Department of Health and Human Services (Secretary) to issue a PREP Act declaration. The declaration provides immunity from liability (except for willful misconduct) for claims:

Who is the Secretary to the Secretary of the Department of Health and Human Services?

of loss caused, arising out of, relating to, or resulting from administration or use of countermeasures to diseases, threats and conditions 

determined by the Secretary to constitute a present, or credible risk of a

future public health emergency 

to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of such countermeasures 

A PREP Act declaration is specifically for the purpose of providing immunity from liability, and is different from, and not dependent on, other emergency declarations.

COVID-19 PREP Act Declarations and Amendments:

Advisory Opinion 20-03 on the Public Readiness and Emergency Preparedness Act and the Secretary’s Declaration under the Act October 22, 2020, as Modified on October 23, 2020

Advisory Opinions on the Legal Effect of the Secretary’s March 10, 2020 PREP Act Declaration

Download the Guidance Document

Final

Issued by: Office of the General Counsel (OGC)

Issue Date: October 23, 2020

HHS is committed to making its websites and documents accessible to the widest possible audience, including individuals with disabilities. We are in the process of retroactively making some documents accessible. If you need assistance accessing an accessible version of this document, please reach out to the guidance@hhs.gov.

DISCLAIMER: The contents of this database lack the force and effect of law, except as authorized by law (including Medicare Advantage Rate Announcements and Advance Notices) or as specifically incorporated into a contract. The Department may not cite, use, or rely on any guidance that is not posted on the guidance repository, except to establish historical facts.

Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 (March 17, 2020):

DEPARTMENT OF HEALTH & HUMAN SERVICES Office of the Secretary

---

The General Counsel
Washington, D.C. 20201
1
ADVISORY OPINION 20-02 ON THE PUBLIC READINESS AND EMERGENCY PREPAREDNESS ACT
AND THE SECRETARY’S DECLARATION UNDER THE ACT
MAY 19, 2020
We have received requests from pharmacists, pharmacies, and one trade association asking the
Office of the General Counsel (OGC) whether the Public Readiness and Emergency Preparedness
(PREP) Act preempts state licensing laws that restrict the ability of pharmacists to order and administer COVID-19 diagnostic tests where the Department of Health and Human Services (HHS) has
expressly authorized pharmacists, under the PREP Act, to order and administer those tests. For the
reasons and subject to the limitations set forth below, we conclude that the PREP Act, in conjunction
with the Secretary’s March 10, 2020 declaration, preempts any state or local requirement that prohibits
or effectively prohibits a pharmacist from ordering and administering a COVID-19 diagnostic test
that the Food and Drug Administration (FDA) has authorized.
BACKGROUND
On April 8, 2020, the Office of the Assistant Secretary for Health (OASH) issued guidance
“authorizing licensed pharmacists to order and administer COVID-19 tests, including serology tests,
that the Food and Drug Administration (FDA) has authorized.”1
OASH did so as an Authority Having Jurisdiction pursuant to the Secretary’s March 10, 2020 declaration under the PREP Act. See 85
Fed. Reg. 15,198, 15,202 (March 17, 2020); 85 Fed. Reg. 21,012 (April 15, 2020) (amending the March
10, 2020 declaration); see also Pub. L. No. 109-148, Public Health Service Act §§ 319F-3, 319F-4, 42
U.S.C. §§ 247d-6d, 247d-6e.
Secretary Alex M. Azar II explained the need for the authorization, as follows:
Giving pharmacists the authorization to order and administer
COVID-19 tests to their patients means easier access to testing for
Americans who need it. Pharmacists play a vital role in delivering convenient access to important public health services and information.
The Trump Administration is pleased to give pharmacists the chance
to play a bigger role in the COVID-19 response, alongside all of America’s heroic healthcare workers.2
Assistant Secretary for Health Brett P. Giroir, M.D. further stressed the need for the authorization:
In an effort to expand testing capabilities, we are authorizing licensed
pharmacists to order and administer COVID-19 tests to their patients.
The accessibility and distribution of retail and independent community-based pharmacies make pharmacists the first point of contact with
a healthcare professional for many Americans. This will further expand testing for Americans, particularly our healthcare workers and
1 https://www.hhs.gov/sites/default/files/authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.pdf 2 https://www.hhs.gov/about/news/2020/04/08/hhs-statements-on-authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.html
2
first responders who are working around the clock to provide care,
compassion and safety to others.3
Consistent with that authorization, numerous states have made clear that licensed pharmacists
may order and administer FDA-authorized COVID-19 tests.4
Some of those states—including
Alaska, New Mexico, and Virginia—relied on the HHS guidance when authorizing their licensed pharmacists to order and administer FDA-authorized COVID-19 tests.5
On April 14, 2020, OGC issued an Advisory Opinion on the PREP Act discussing, among
other things, the OASH guidance.
6
The opinion explained (at 6-7) that licensed pharmacists “are
covered as qualified persons (and hence as covered persons) even if they may not be licensed or authorized by the State to prescribe the tests pursuant to § 247d-6d(i)(8)(A), because they fit within the
alternative definition of ‘qualified persons’ pursuant to § 247d-6d(i)(8)(B), as provided by the Secretary
in the declaration.”
Since then, OGC has been asked whether, under the PREP Act, licensed pharmacists may
order and administer COVID-19 tests even in states that prohibit licensed pharmacists from ordering
and administering those tests.
This Advisory Opinion addresses that question and sets forth the current views of OGC.
7
It
is not a final agency action or a final order. Nor does it bind HHS or the federal courts. It does not
have the force or effect of law.
SUMMARY OF CONCLUSIONS
Under the PREP Act, state and local authorities may not prohibit or effectively prohibit “qualified persons” from ordering and administering covered countermeasures for three reasons.
3 Id. 4 See https://naspa.us/resource/covid-19-testing/; see also, e.g., https://www.nacds.org/news/california-urged-to-remove-remaining-covid-19-testing-barriers-on-pharmacists-to-advance-testing-rampup-and-re-opening-of-state/ (noting on April 23, 2020, that “[n]ineteen other states have put into
place policies consistent with the HHS guidance … that authorizes pharmacists to order and conduct
testing for COVID-19 that the [FDA] has authorized”).
5 See, e.g., https://alaskapharmacy.org/wp-content/uploads/2020/03/4-16-20-AK-BOP-COVID-19-
Tests-Ordering-Administering.pdf; https://www.dhp.virginia.gov/Pharmacy/news/COVIDTestingGuidance.pdf; http://www.rld.state.nm.us/uploads/FileLinks/ad6770c244f74bdaaeaa53842023b4c7/Pharmacist_Ordering_and_Administering_COVID_19_Testing.pdf. 6 https://www.hhs.gov/sites/default/files/prep-act-advisory-opinion-april-14-2020.pdf. 7 See Air Brake Sys., Inc. v. Mineta, 357 F.3d 632, 647-48 (6th Cir. 2004) (holding that the Chief Counsel
of the National Highway Traffic Safety Administration had delegated authority to issue advisory opinions to regulated entities in fulfillment of a congressional directive to promote regulatory compliance);
5 U.S.C. § 301 (“The head of an executive department … may prescribe regulations for the government
of his department, the conduct of its employees, [and] the distribution and performance of its business[.]”).
3
First, through his PREP Act declaration, the Secretary can designate a “qualified person” to
use and administer a covered countermeasure even when that person is not authorized to do so under
state law. See § 247d-6d(i)(8)(A)–(B). In his declaration, the Secretary designated licensed pharmacists
as qualified persons for purposes of administering FDA-authorized COVID-19 tests independent of
state licensing laws.
Second, the PREP Act expressly preempts any state or local legal requirement that prohibits or
effectively prohibits a qualified person from ordering and administering a covered countermeasure
pursuant to the Secretary’s declaration.
Third, states and localities cannot challenge in court the Secretary’s designation of persons
authorized to order and administer covered countermeasures. Under the PREP Act, “No court of
the United States, or of any State, shall have subject matter jurisdiction to review, whether by mandamus or otherwise, any action by the Secretary” pursuant to his declaration under § 247d-6d(b).
By including those broad and robust provisions, Congress made clear that states and localities
may not “establish, enforce, or continue in effect” any legal requirement that prohibits or effectively
prohibits licensed pharmacists from ordering and administering FDA-authorized COVID-19 tests.
LEGAL FRAMEWORK
The PREP Act lists five categories of “covered person[s]” who are eligible for PREP Act
immunity when administering or using a “covered countermeasure”—(1) a manufacturer of the countermeasure; (2) a distributor of the countermeasure; (3) a program planner of such countermeasure;
(4) a qualified person who prescribed, administered, or dispensed the countermeasure; and (5) an
official, agent, or employee of a person or entity described in the four categories above. See 42 U.S.C.
§ 247d-6d(i)(2).
There are two categories of “qualified person.” See 42 U.S.C. § 247d-6d(i)(8).8

The first category includes those who are authorized under state law to take the relevant actions with respect to a covered countermeasure—namely, someone who is “a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed.” 42 U.S.C. § 247d-6d(i)(8)(A).
The second category includes “a person within a category of persons so identified in a declaration by the Secretary under subsection (b).” 42 U.S.C. § 247d-6d(i)(8)(B).
By including that second category, the PREP act makes clear that the Secretary may designate
someone as a “qualified person” even if that person is not authorized to prescribe, administer, or
dispense such countermeasures under state law when that person prescribes, administers, or dispenses the coun-
8 There is only one provision of the PREP Act that discusses those authorized under state law to
prescribe, administer, or dispense a covered countermeasure. And that is the definition of “qualified
person” under § 247d-6d(i)(8).
4
termeasures in that State. Because the definition of “covered person” makes someone’s status as a “qualified person” relevant only to the extent that the person performs one of those three acts, it necessarily
applies to those who act without state authorization.
If the definition of “qualified person” were limited to persons already authorized under state
law to prescribe, administer, or dispense a covered countermeasure, then § 247d-6d(i)(8)(B) would be
superfluous in light of § 247d-6d(i)(8)(A), which automatically includes those who are authorized under state law to do those very things. The Secretary would never have occasion to immunize someone
under § 247d-6d(i)(8)(B) if states and localities could prohibit those persons from prescribing, administering, or dispensing the covered countermeasures in the first place. See TRW Inc. v. Andrews, 534
U.S. 19, 31 (2001) (“It is ‘a cardinal principle of statutory construction’ that ‘a statute ought, upon the
whole, to be so construed that, if it can be prevented, no clause, sentence, or word shall be superfluous,
void, or insignificant.’” (Citations omitted)).
To further effectuate the PREP Act, including § 247d-6d(i)(8)(B), Congress included an express-preemption provision in the PREP Act to preclude state and local governments from establishing or enforcing such prohibitions when they would serve to prohibit “qualified persons” from administering countermeasures recommended by a PREP Act declaration:
During the effective period of [the] declaration …, or at any time with
respect to conduct undertaken in accordance with such declaration, no
State or political subdivision of a State may establish, enforce, or continue in effect with respect to a covered countermeasure any provision
of law or legal requirement that … is different from, or is in conflict
with, any requirement applicable under this section; and relates to the
… prescribing, dispensing, or administration by qualified persons of
the covered countermeasure.
42 U.S.C. § 247d-6d(b)(8).
OGC has not located published federal case law discussing the breadth of the “different from,
or is in conflict with” preemption language. But see, e.g., Casabiana v. Mount Sinai Med. Ctr., 2014 WL
10413521, *2 (N.Y. Sup. Ct. Dec. 2, 2014); Parker v. St. Lawrence Cty. Pub. Health Dep’t, 102 A.D.3d
140, 143-44 (N.Y. Sup. Ct. App. Div. 2012). But courts have broadly interpreted similar preemption
clauses, including those that preempt state or local laws that are “‘different from, or in addition to’”
federal legal requirements. See, e.g., Wolicki-Gables v. Arrow Int’l., Inc., 634 F.3d 1296, 1300 (11th Cir.
2011) (quoting Riegel v. Medtronic, Inc., 552 U.S. 312, 321 (2008)). According to the Supreme Court,
that preemption language “sweeps widely” and preempts any language that “deviates from [requirements] imposed by federal law.” Nat’l Meat Ass’n. v. Harris, 565 U.S. 452, 459, 461 (2012). A state or
local legal requirement is “different from, or in addition to” federal requirements if it is not “genuinely
equivalent” to the federal requirements. Wolicki-Gables, 634 F.3d at 1300 (quoting McMullen v. Medtronic, Inc., 421 F.3d 482, 489 (7th Cir. 2005)).
The PREP Act is distinct from the provision above in that it preempts any state or local legal
requirement that is “different from, or is in conflict with”—instead of “in addition to”—PREP Act
requirements. (Emphasis added). But that difference is immaterial here. The plain meaning of “different” is “not the same” or “having at least one property not possessed by another.” WEBSTER’S
THIRD NEW INTERNATIONAL DICTIONARY 630 (1961). Those definitions of “different” encompass
5
“not genuinely equivalent” and “deviat[ions] from.” So the PREP Act’s preemption clause has a
sufficiently broad sweep to encompass state requirements that would prohibit or effectively prohibit
pharmacists from administering FDA-approved COVID-19 tests.
And at a minimum, that sweep is broad enough to preempt a state or local legal requirement
that prohibits or effectively prohibits activity by qualified persons whom the Secretary has authorized
to perform those activities through his declaration, which is a requirement under the PREP Act. Such
prohibitions are plainly “not genuinely equivalent” to PREP Act requirements. If anything, they are
directly “in conflict with” those requirements.
LICENSED PHARMACISTS AND COVID-19 TESTING
As explained in the April 14, 2020 Advisory Opinion (at 6-7), the Secretary has designated
licensed pharmacists as “qualified persons” under his declaration. And by designating licensed pharmacists as “qualified persons,” the Secretary has also authorized licensed pharmacists to order and
administer FDA-authorized COVID-19 tests in states where the licensed pharmacists are not authorized to do so.
Because of that authorization, “no State or political subdivision of a State may establish, enforce, or continue in effect with respect to [FDA-authorized COVID-19 tests] any provision of law
or legal requirement that is different from, or is in conflict with, any requirement applicable under this
section” and that “relates to … the prescribing, dispensing, or administration by qualified persons of
the covered countermeasure.” 42 U.S.C. § 247d-6d(b)(8)(A).9

As explained above, any state or local law or legal requirement that prohibits or effectively
prohibits licensed pharmacists from ordering and administering FDA-authorized COVID-19 tests are
different from or in conflict with the declaration—and therefore, a legal requirement under the PREP
Act. So during the effective period of the PREP Act declaration, a state or locality cannot establish,
enforce, or continue any such legal requirements under the PREP Act’s preemption provision.
10
It is important to note that the PREP Act does not preempt all state and local legal requirements. Not all legal requirements that regulate the pharmacy profession differ from or conflict with
the PREP Act or any declaration issued under that Act with respect to COVID-19 tests.
9 The Secretary’s declaration under § 247d-6d(b) is a requirement for PREP Act immunity under
§§ 247d-6d(a)(1), (i)(8)(B). The declaration’s designations of covered countermeasures and qualified
persons are also requirements to establish PREP Act immunity under §§ 247d-6d(a)(1), (i)(8)(B).
10 When Congress intends to exempt state-licensing laws from its preemption provisions, Congress
explicitly says so. See, e.g., 42 U.S.C. § 1395w-26(b)(3) (“The standards established under this part shall
supersede any State law or regulation (other than State licensing laws or State laws relating to plan solvency)” (emphasis added)); 8 U.S.C. § 1324a(h)(2) (“The provisions of this section preempt any State
or local law imposing civil or criminal sanctions (other than through licensing and similar laws)” (emphasis
added)). Congress did not do so in the PREP Act. Instead, Congress gave the Secretary virtually
unreviewable authority to immunize and designate a “qualified person” to use a “covered countered
measure.”
6
LIMITATIONS
This Advisory Opinion may be supplemented or changed. It is intended to minimize the need
for individual advisory opinions.
Persons seeking PREP Act immunity are responsible for determining whether their products
are covered countermeasures, whether a person or entity is a covered person, whether reasonable
precautions have been taken to facilitate the safe use of covered countermeasures, and in general,
whether immunity applies to them and their activities.
Robert P. Charrow
General Counsel
May 19, 2020

First Amendment to Declaration under the PREP Act for Medical Countermeasures against COVID-19 (April 15, 2020):

DEPARTMENT OF HEALTH & HUMAN SERVICES Office of the Secretary

---

The General Counsel
Washington, D.C. 20201
1
ADVISORY OPINION ON THE PUBLIC READINESS AND EMERGENCY PREPAREDNESS ACT AND
THE MARCH 10, 2020 DECLARATION UNDER THE ACT
APRIL 17, 2020, AS MODIFIED ON MAY 19, 2020
Purpose of this Advisory Opinion
On March 10, 2020, the Secretary of Health and Human Services (Secretary) issued a
Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act), effective
February 4, 2020, for certain medical products to be used against COVID-19. See 85 Fed. Reg. 15,198,
15,202 (March 17, 2020); see also Pub. L. No. 109-148, Public Health Service Act § 319F-3, 42 U.S.C.
§ 247d-6d and 42 U.S.C. § 247d-6e.
We have received requests for advisory opinions, especially from those donating goods and
services, on whether various activities qualify for PREP Act immunity. The Office of the General
Counsel will make every effort to respond to each request. But we have limited resources, especially
in this time of national emergency. To minimize the need to request an advisory opinion, we issue
this omnibus advisory opinion that should address most questions and concerns about the scope of
PREP Act immunity during the Coronavirus disease 2019 (COVID-19) pandemic.
This advisory opinion sets forth the current views of the Office of the General Counsel.1
It
is not a final agency action or a final order. Nor does it bind HHS or the federal courts. It does not
have the force or effect of law.
The PREP Act
PREP Act immunity applies to any “covered person” with respect to all “claims for loss”
caused by, arising out of, relating to, or resulting from the “administration” or the “use” of a “covered
countermeasure” if a declaration has been issued with respect to that countermeasure. 42 U.S.C.
§ 247d-6d(a)(1). We often receive questions about whether a medical product is a covered
countermeasure, whether a person is a covered person, and whether a specific activity qualifies as use
or administration of a covered countermeasure.
Therefore, this advisory opinion
• provides a list of covered countermeasures subject to an Emergency
Use Authorization (EUA);
2
1 See Air Brake Sys., Inc. v. Mineta, 357 F.3d 632, 647-48 (6th Cir. 2004) (holding that the Chief
Counsel of the National Highway Traffic Safety Administration had delegated authority to issue
advisory opinions to regulated entities in fulfillment of a congressional directive to promote regulatory
compliance); 5 U.S.C. § 301 (“The head of an executive department … may prescribe regulations for
the government of his department, the conduct of its employees, [and] the distribution and
performance of its business[.]”).
2 See Appendix A, https://www.fda.gov/media/136702/download Appendix B,
https://www.fda.gov/media/136832/download .
2
• advises that an entity or individual who complies with all other
requirements of the PREP Act and the conditions of the Secretary’s
declaration will not lose PREP Act immunity—even if the medical
product at issue is not a covered countermeasure—if that entity or
individual reasonably could have believed that the product was a
covered countermeasure;
• advises that a person who complies with all other requirements of the
PREP Act and the conditions of the Secretary’s declaration will not
lose PREP Act immunity—even if the person at issue is not a covered
person—if the entity or individual reasonably could have believed that
the person was a covered person; and
• sets forth HHS’s view that covered persons should take, and
document, reasonable precautions under the current emergent
circumstances to facilitate the safe use or administration of covered
countermeasures and to make those documents publicly and easily
available.
If all requirements of the PREP Act and the declaration are met, immunity covers claims for
loss sounding in tort or contract, as well as claims for loss relating to compliance with local,3 state, or
federal laws, regulations, or other legal requirements. Immunity applies when a covered person
engages in activities related to an agreement or arrangement with the federal government, or when a
covered person acts according to an Authority Having Jurisdiction to respond to a declared
emergency. We interpret these two conditions broadly to include (1) any arrangement with the federal
government, or (2) any activity that is part of an authorized emergency response at the federal,
regional, state, or local level. Such activities can be authorized through, among other things, guidance,
requests for assistance, agreements, or other arrangements. Because the Secretary issued a Public
Health Emergency declaration on January 31, 2020, effective as of January 27, 2020, the immunity
granted by the PREP Act under this declaration applies regardless of whether state or local authorities
have declared states of emergencies.
A few caveats about PREP Act immunity: First, PREP Act immunity is not absolute. For
example, the PREP Act does not provide immunity against federal enforcement actions brought by
the federal government—whether civil, criminal, or administrative. Nor does the PREP Act provide
immunity against suit and liability for claims under federal law for equitable relief. PREP Act immunity
(exempting preemption) is also limited to claims for personal injury or damage to property. Second,
the PREP Act replaces certain damages claims that would normally be brought in court with a nofault compensation system outlined at 42 C.F.R. pt. 110. Third, PREP Act immunity must be read in
light of the PREP Act’s broad, express-preemption provision. 4
3 While PREP Act immunity does not expressly extend to local laws, the Act expressly preempts
any State and local law that “is different from, or is in conflict with, any requirement applicable under
[the PREP Act].” 42 U.S.C. § 247d-6d(b)(8).
4 Under § 247d-6d(b)(8)(A), (1) “no State or political subdivision of a State may establish,
enforce, or continue in effect with respect to a covered countermeasure any provision of law or legal
requirement that is different from, or is in conflict with, any requirement applicable under this section”
3
Covered Countermeasures
The PREP Act authorizes the Secretary to issue a declaration to provide liability immunity to
certain individuals and entities (covered persons) against any claim of loss caused by, arising out of,
relating to, or resulting from the manufacture, distribution, administration, or use of medical
countermeasures (covered countermeasures). Under the March 10, 2020 declaration, covered
countermeasures are any
antiviral, any other drug, any biologic, any diagnostic, any other device,
or any vaccine, used to treat, diagnose, cure, prevent, or mitigate
COVID–19, or the transmission of SARS-CoV–2 or a virus mutating
therefrom, or any device used in the administration of any such
product, and all components and constituent materials of any such
product.
85 Fed. Reg. 15,198, 15,202 (March 17, 2020).
Any drug, device, or biological product that is approved, cleared, or licensed by the FDA and
is used to diagnose, mitigate, prevent, treat, cure, or limit the harm of COVID-19 is a covered
countermeasure. The Coronavirus Aid, Relief, and Economic Security (CARES) Act § 3103, Pub. L.
No. 116-136 (March 27, 2020), amended the PREP Act to add respiratory protective devices to the
list of covered countermeasures so long as they are NIOSH approved and determined by the Secretary
to be a priority for use during a public health emergency declared by the Secretary under section 319
of the Public Health Service Act.5
See 42 U.S.C. § § 247d, 247d-6d(i)(1)(D). Any drug, device, or
biological product authorized for emergency use with respect to COVID-19 under an EUA, described
in Emergency Use Instructions (EUI) issued by the CDC, or being researched under certain
investigational provisions (i.e., IND, IDE) to treat COVID-19 is a covered countermeasure. See 21
C.F.R. pts. 312 and 812. In addition, as noted above, the CARES Act amended the PREP Act to
include certain respiratory protective devices. These requirements apply equally to products held in
the public and private sectors.
Covered countermeasures include, among other things, a “qualified pandemic or epidemic
product.” See 42 U.S.C. § 247d-6d(i)(1)(A). The term “qualified pandemic or epidemic product”
means
a drug … biological product … or device [as] defined … [in] the
Federal Food, Drug, and Cosmetic Act … that is
(A) (i) a product manufactured, used, designed, developed, modified,
licensed, or procured— (I) to diagnose, mitigate, prevent, treat, or
cure a pandemic or epidemic; or (II) to limit the harm such
pandemic or epidemic might otherwise cause;

and (2) relates to, among other things, use or administration of the covered countermeasure.
(Emphasis added).
5 The Secretary issued an amendment to the Declaration effective March 27, 2020 to address
this statutory change. 85 Fed. Reg. 21,012 (April 15, 2020).
4
(ii) a product manufactured, used, designed, developed, modified,
licensed, or procured to diagnose, mitigate, prevent, treat, or cure
a serious or life-threatening disease or condition caused by a
product described in clause (i); or
(iii) a product or technology intended to enhance the use or effect
of a drug, biological product, or device described in clause (i) or
(ii); and
(B) (i) approved or cleared under chapter V of the Federal Food, Drug,
and Cosmetic Act [21 U.S.C. § 351 et seq.] or licensed under section
262 of this title;
(ii) the object of research for possible use as described by
subparagraph (A) and is the subject of an exemption under section
505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act [21
U.S.C. §§ 355(i), 360j(g)]; or
(iii) authorized for emergency use in accordance with section 564,
564A, or 564B of the Federal Food, Drug, and Cosmetic Act [21
U.S.C. §§ 360bbb–3, 360bbb–3a, 360bbb–3b].
42 U.S.C. § 247d-6d(i)(7).
Thus, in order to meet the definition of a qualified pandemic or epidemic product, a product
(1) must be used for COVID-19; and
(2) must be
(a) approved, licensed, or cleared by FDA;
(b) authorized under an EUA;
(c) described in an EUI; or
(d) used under either an Investigational New Drug (IND)
application or an Investigational Device Exemption (IDE). 6
The number of products used for COVID-19 that are approved, licensed, or cleared are too
numerous to list. But we have found that industry has often sought clarity regarding whether certain
products, including diagnostic tests and personal protective equipment (PPE), are covered by EUAs.
Footnote 2, above, links to a list those products that are covered by EUAs. We hope that this list
proves helpful. HHS will use its best efforts to regularly update that list, although there may be a lag
between the actual issuance of the EUA by FDA and the product’s appearance on the list.
Given the broad scope of PREP Act immunity, Congress did not intend to impose a strictliability standard on covered persons for determining whether a product is a covered countermeasure.
Instead, we believe that a person or entity that otherwise meets the requirements for PREP Act
immunity will not lose that immunity—even if the product is not a covered countermeasure—if that
person or entity reasonably could have believed that the product was a covered countermeasure. See,
e.g., 42 U.S.C. § 247d-6d(a)(4)(B) (applying the “reasonably-could-have-believed” standard to predicate
6 While certain information about products under an IND or IDE is confidential commercial
information and not subject to disclosure, some information is available to the public on
clinicaltrials.gov.
5
requirements for PREP Act immunity not involving the actual use and administration of covered
countermeasures).
For example, FDA has issued EUAs for certain COVID-19 tests and PPE. A covered person
purchases 500,000 tests or respirators that appear to be authorized under an EUA. The covered
person has taken reasonable steps—under the current, emergent circumstances—to substantiate the
authenticity of the products. But it turns out that some or all of the products are counterfeit. Under
those circumstances, we believe that the person would be immune against a claim arising out of the
use of a counterfeit test or respirator.
Covered Person
The PREP Act provides immunity to a “covered person” for certain activities (e.g.,
manufacturing, distributing, using, or administering) involving a “covered countermeasure,” as
defined in the PREP Act and delineated in a PREP Act declaration issued by the Secretary. The term
“covered person,”
when used with respect to the administration or use of a covered
countermeasure, means—
(A) the United States; or
(B) a person or entity that is—
(i) a manufacturer of such countermeasure;
(ii) a distributor of such countermeasure;
(iii) a program planner of such countermeasure;
(iv) a qualified person who prescribed, administered, or
dispensed such countermeasure; or
(v) an official, agent, or employee of a person or entity
described in clause (i), (ii), (iii), or (iv).
42 U.S.C. § 247d-6d(i)(2). We have received questions about the meaning of “program planner” and
“qualified person.”
The term “program planner” means
a State or local government, including an Indian tribe, a person
employed by the State or local government, or other person who
supervised or administered a program with respect to the
administration, dispensing, distribution, provision, or use of a security
countermeasure or a qualified pandemic or epidemic product,
including a person who has established requirements, provided policy
guidance, or supplied technical or scientific advice or assistance or
provides a facility to administer or use a covered countermeasure in
accordance with [the Secretary’s declaration].
42 U.S.C. § 247d-6d(i)(6).
6
Under the Secretary’s declaration, “[A] private sector employer or community group or other
‘person’ can be a program planner when it carries out the described activities.” 85 Fed. Reg. at 15,202.
The term “qualified person,” when used
with respect to the administration or use of a covered countermeasure,
means— (A) a licensed health professional or other individual who is
authorized to prescribe, administer, or dispense such countermeasures
under the law of the State in which the countermeasure was prescribed,
administered, or dispensed; or (B) a person within a category of
persons so identified in a declaration by the Secretary.
42 U.S.C. § 247d-6d(i)(8).
With respect to that second category, the Secretary, through Section V of his declaration, has
determined that qualified persons also include
[a]ny person authorized in accordance with the public health and
medical emergency response of the Authority Having Jurisdiction, as
described in Section VII below, to prescribe, administer, deliver,
distribute or dispense the Covered Countermeasures, and their
officials, agents, employees, contractors and volunteers, following a
Declaration of an emergency[.]
85 Fed. Reg. at 15,202.
Therefore, an Authority Having Jurisdiction has broad powers to extend PREP Act immunity
to additional individuals as part of a public health and medical emergency response. The Authority
Having Jurisdiction does so by authorizing “any person” to “prescribe, administer, deliver, distribute
or dispense the Covered Countermeasures.” Section VII of the declaration explains that “[t]he
Authority Having Jurisdiction means the public agency or its delegate that has legal responsibility and
authority for responding to an incident, based on political or geographical (e.g., city, county, tribal,
state, or federal boundary lines) or functional (e.g., law enforcement, public health) range or sphere of
authority.” Id. As the lead federal public-health agency that has legal responsibility and authority for
responding to the COVID-19 emergency, HHS is an Authority Having Jurisdiction, but it is not the
only Authority Having Jurisdiction to respond to the COVID-19 emergency.
The following is an example of a qualified person under Sections V and VII of the declaration.
In response to the COVID-19 emergency, the HHS Office of the Assistant Secretary for Health
(OASH) issued guidance for licensed pharmacists to order and administer COVID-19 tests, including
serology tests, that the FDA has authorized. Such tests are covered countermeasures under the
declaration. Thus, under Sections V and VII of the declaration, such pharmacists are covered persons.
Specifically, they are qualified persons, as they are acting in accordance with guidance from HHS—an
Authority Having Jurisdiction to respond—following a declared emergency by the Secretary. The
pharmacists are covered as qualified persons (and hence as covered persons) even if they may not be
7
licensed or authorized by the State to prescribe the tests pursuant to § 247d-6d(i)(8)(A)), because they
fit within the alternative definition of “qualified persons” pursuant to paragraph § 247d-6d(i)(8)(B), as
provided by the Secretary in the declaration.
As with covered countermeasures, an entity or person that otherwise meets the requirements
for PREP Act immunity will not lose that immunity—even if the entity or person is not a covered
person—if that entity or person reasonably could have believed, under the current, emergent
circumstances, that the person was a covered person. See, e.g., 42 U.S.C. § 247d-6d(a)(4)(B).
For example, a pharmacy allows its licensed pharmacists to order FDA-authorized, self-swab
COVID-19 tests pursuant to the OASH guidance. Notwithstanding the pharmacy’s reasonablecompliance measures to ensure current licensure, it turns out that one of the pharmacists had
inadvertently allowed his license to expire. Under those circumstances, the pharmacy would still be
immune against a lawsuit relating to the COVID-19 test prescribed by that pharmacist.
Reasonable Precautions
Under the PREP Act, immunity is broad. As a general matter, a covered person is immune
from liability for all claims for loss except for willful misconduct that proximately caused death or
serious injury. 42 U.S.C. § 247d-6d(c)(3). Suits alleging an exception to immunity for covered persons
can only be brought before a three-judge court in the United States District Court for the District of
Columbia. 42 U.S.C. § 247d-6d(e)(1), (5). And to prevail, a plaintiff must establish, by clear and
convincing evidence, that the willful misconduct proximately caused death or serious injury. 42 U.S.C.
§ 247d-6d(c)(3).
But even then, certain acts or omissions remain immune from suit. For example, under 42
U.S.C. § 247d-6d(c)(4),
Notwithstanding any other provision of law, a program planner or
qualified person shall not have engaged in “willful misconduct” as a
matter of law where such program planner or qualified person acted
consistent with applicable directions, guidelines, or recommendations
by the Secretary regarding the administration or use of a covered
countermeasure that is specified in the declaration under subsection
(b), provided either the Secretary, or a State or local health authority,
was provided with notice of information regarding serious physical
injury or death from the administration or use of a covered
countermeasure that is material to the plaintiff’s alleged loss within 7
days of the actual discovery of such information by such program
planner or qualified person.
And under 42 U.S.C. § 247d-6d(c)(5), certain acts or omissions by a manufacturer or distributor and
“subject to regulation by this chapter or by the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301
et seq.]” will not constitute willful misconduct if (1) “neither the Secretary nor the Attorney General
has initiated an enforcement action with respect to such act or omission” or (2) “such an enforcement
action has been initiated and the action has been terminated or finally resolved without a covered
remedy.”
8
Nevertheless, HHS encourages all covered persons using or administering covered
countermeasures to document the reasonable precautions they have taken to safely use the covered
countermeasures.
For example, consider a distributor of medical products that sources PPE from a new supplier
abroad in a good-faith attempt to quickly deliver PPE to American communities affected by COVID19. Among other things, that distributor assesses the supplier’s facility to confirm that the supplier
actually manufactures the PPE. The distributor also confirms that the supplier has quality-control
processes in place.
Under those circumstances, the distributor may wish to make available to the purchaser
information about the reasonable efforts that the distributor had taken to safely use the covered
countermeasures. Purchasers such as hospitals would then be able to make more informed decisions
about how best to use the PPE. Overall, this would provide greater transparency in implementing the
PREP Act.
Compensation for Injuries
The PREP Act, like workers’ compensation or the National Vaccine Injury Compensation
Program, substitutes a no-fault, speedy compensation system in place of expensive and uncertain
litigation. Those who have been seriously injured or died as the direct result of a covered
countermeasure administered or used under a declaration may seek compensation from the Covered
Countermeasures Process Fund. Requests for benefits must be made to the Health Resources and
Services Administration’s Countermeasures Injury Compensation Program (CICP). Compensation
for serious injuries may be available to eligible requesters under CICP.
A serious injury generally means a physical injury that warranted hospitalization (whether or
not the person was actually hospitalized) or that led to a significant loss of function or disability. 42
C.F.R. § 110.3(z). CICP pays reasonable and necessary medical benefits. CICP also pays lost wages
to eligible recipients. Death benefits may also be available to certain survivors of eligible individuals
who died as a direct result of the administration or use of a covered countermeasure. CICP is payer
of last resort. So benefits are reduced by the amounts payable by other public and private third-party
payers (such as health insurance and workers’ compensation). The regulations implementing the CICP
are at 42 C.F.R. pt. 110.
Compensation for injuries is more limited than the liability immunity afforded under the PREP
Act. As described above, the PREP Act provides immunity for all claims for loss. But CICP will
provide compensation only for eligible claims of serious physical injury or death. CICP will not
compensate claims related to emotional injury, fear of injury, business losses, or other types of claims
for which immunity is provided. Information about this program can be found at
https://www.hrsa.gov/cicp/about/index.html or by calling 855-266-2427.
Limitations
This Advisory Opinion may be supplemented or modified. It is intended to minimize the
need for individual advisory opinions.
9
Persons seeking PREP Act immunity are responsible for determining whether their products
are covered countermeasures, whether a person or entity is a covered person, whether reasonable
precautions have been taken to facilitate the safe use of covered countermeasures, and in general,
whether immunity applies to them and their activities.
Robert P. Charrow
General Counsel
May 19, 2020

:Second Amendment to Declaration under the PREP Act for Medical Countermeasures against COVID-19 (June 8, 2020) :

ACTION:

Notice of amendment.

SUMMARY:

The Secretary issues this amendment pursuant to section 319F-3 of the Public Health Service Act to expand the authority for certain Qualified Persons authorized to prescribe, dispense, and administer seasonal influenza vaccines under section VI of this Declaration.

DATES:

This amendment is effective as of January 7, 2022.

FOR FURTHER INFORMATION CONTACT:

L. Paige Ezernack, Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue SW, Washington, DC 20201; 202-260-0365, paige.ezernack@hhs.gov.

SUPPLEMENTARY INFORMATION:

The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to issue a Declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (Covered Countermeasures), except for claims involving “willful misconduct” as defined in the PREP Act. Under the PREP Act, a Declaration may be amended as circumstances warrant.

The PREP Act was enacted on December 30, 2005, as Public Law 109-148, Division C, § 2. It amended the Public Health Service (PHS) Act, adding section 319F-3, which addresses liability immunity, and section 319F-4, which creates a compensation program. These sections are codified at 42 U.S.C. 247d-6d and 42 U.S.C. 247d-6e, respectively. Section 319F-3 of the PHS Act has been amended by the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, enacted on March 13, 2013, and the Coronavirus Aid, Relief, and Economic Security (CARES) Act, Public Law 116-136, enacted on March 27, 2020, to expand Covered Countermeasures under the PREP Act.

On January 31, 2020, the former Secretary, Alex M. Azar II, declared a public health emergency pursuant to section 319 of the PHS Act, 42 U.S.C. 247d, effective January 27, 2020, for the entire United States to aid in the response of the nation’s health care community to the COVID-19 outbreak. Pursuant to section 319 of the PHS Act, the Secretary renewed that declaration effective on April 26, 2020, July 25, 2020, October 23, 2020, January 21, 2021, April 21, 2021, July 20, 2021, and October 15, 2021.

On March 10, 2020, former Secretary Azar issued a Declaration under the PREP Act for medical countermeasures against COVID-19 (85 FR 15198, Mar. 17, 2020) (the Declaration). On April 10, the former Secretary amended the Declaration under the PREP Act to extend liability immunity to covered countermeasures authorized under the CARES Act (85 FR 21012, Apr. 15, 2020). On June 4, the former Secretary amended the Declaration to clarify that covered countermeasures under the Declaration include qualified countermeasures that limit the harm COVID-19 might otherwise cause. (85 FR 35100, June 8, 2020). On August 19, the former Secretary amended the declaration to add additional categories of Qualified Persons and amend the category of disease, health condition, or threat for which he recommended the administration or use of the Covered Countermeasures. (85 FR 52136, Aug. 24, 2020). On December 3, 2020, the former Secretary amended the declaration to incorporate Advisory Opinions of the General Counsel interpreting the PREP Act and the Secretary’s Declaration and authorizations issued by the Department’s Office of the Assistant Secretary for Health as an Authority Having Jurisdiction to respond; added an additional category of qualified persons under Section V of the Declaration; made explicit that the Declaration covers all qualified pandemic and epidemic products as defined under the PREP Act; added a third method of distribution to provide liability protections for, among other things, private distribution channels; made explicit that there can be situations where not administering a covered countermeasure to a particular individual can fall within the PREP Act and the Declaration’s liability protections; made explicit that there are substantive federal legal and policy issues and interests in having a unified whole-of-nation response to the COVID-19 pandemic among federal, state, local, and private-sector entities; revised the effective time period of the Declaration; and republished the declaration in full. (85 FR 79190, Dec. 9, 2020). On February 2, 2021, the Acting Secretary Norris Cochran amended the Declaration to add additional categories of Qualified Persons authorized to prescribe, dispense, and administer COVID-19 vaccines that are covered countermeasures under the Declaration (86 FR 7872, Feb. 2, 2021). On February 16, 2021, the Acting Secretary amended the Declaration to add additional categories of Qualified Persons authorized to prescribe, dispense, and administer COVID-19 vaccines that are covered countermeasures under the Declaration (86 FR 9516, Feb. 16, 2021) and on February 22, 2021, the Department filed a notice of correction to the February 2 and February 16 notices correcting effective dates stated in the Declaration, and correcting the description of qualified persons added by the February 16, 2021 amendment. (86 FR 10588, Feb. 22, 2021). On March 11, 2021, the Acting Secretary amended the Declaration to add additional Qualified Persons authorized to prescribe, dispense, and administer covered countermeasures under the Declaration. (86 FR 14462, Mar. 16, 2021). On August 4, 2021, Secretary Xavier Becerra amended the Declaration to clarify categories of Qualified Persons and to expand the scope of authority for certain Qualified Persons to administer seasonal influenza vaccines to adults. (86 FR 41977, Aug. 4, 2021). On September 14, 2021, Secretary Becerra amended the Declaration to expand the scope of authority for certain Qualified Persons to administer COVID-19 therapeutics subcutaneously, intramuscularly, or orally (86 FR 51160, Sept. 14, 2021) and on September 30, 2021, the Department filed a notice of correction to the September 14 notice clarifying the terms “ACIP recommendations” and “ACIP’s standard immunization schedules.” (86 FR 54696, Oct. 4, 2021).

Secretary Xavier Becerra now amends section V of the Declaration to add subsection (j) to expand the scope of authority for licensed pharmacists to order and administer and qualified pharmacy interns to administer seasonal influenza vaccines.

Accordingly, subsection V(j) authorizes:

(j) Any pharmacist who holds an active license or certification permitting the person to prescribe, dispense, or administer vaccines under the law of any State or who is authorized under Section V(d) of this Declaration who prescribes, dispenses, or administers seasonal influenza vaccines, or a pharmacy intern as authorized under the section V(d) of this Declaration who administers seasonal influenza vaccines, in any jurisdiction where the PREP Act applies, other than the State in which the license or certification is held, so long as the license or certification of the pharmacist or pharmacy intern has not been suspended or restricted by any licensing authority, surrendered while under suspension, discipline or investigation by a licensing authority or surrendered following an arrest, and the individual is not on the List of Excluded Individuals/Entities maintained by the Office of Inspector General;

Description of This Amendment by Section

Section V. Covered Persons

Under the PREP Act and the Declaration, a “qualified person” is a “covered person.” Subject to certain limitations, a covered person is immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration or use of a covered countermeasure if a declaration under the PREP Act has been issued with respect to such countermeasure. “Qualified person” includes (A) a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed; or (B) “a person within a category of persons so identified in a declaration by the Secretary” under subsection (b) of the PREP Act. 42 U.S.C. 247d-6d(i)(8)

The Secretary anticipates that there will be a need to increase the available pool of providers able to order and administer seasonal influenza vaccines. Seasonal influenza has the potential to inflict significant burden and strain on the U.S. healthcare system in its own right; and in conjunction with the ongoing COVID-19 pandemic, a spike in influenza cases could overwhelm healthcare providers. The health care system capacity and the vaccination workforce are likely to become increasingly strained throughout the nation. Allowing pharmacists and pharmacy interns to administer both COVID-19 vaccines and seasonal influenza vaccines in jurisdictions where the need is greatest would allow states maximum flexibility in limiting potential impacts of both illnesses. Pharmacists and pharmacy interns are well positioned to increase access to seasonal influenza vaccines and have played a critical role in this pandemic in overseeing COVID-19 testing and vaccine administration. Given their skill set and training, as well as looming provider shortages, pharmacists and pharmacy interns would require minimal, if any, additional training to administer and would not place any undue training burden on providers.

By this amendment to the Declaration, the Secretary expands the authorization for an additional category of persons who are qualified persons under section 247d-6d(i)(8)(B). First, the amendment expands the authorization for a pharmacist who holds an active license or certification permitting the person to prescribe, dispense, or administer vaccines under the law of any State or who is authorized under Section V(d) of this Declaration who prescribes, dispenses, or administers seasonal influenza vaccines, or a pharmacy intern as authorized under the section V(d) of this Declaration who administers seasonal influenza vaccines, in any jurisdiction where the PREP Act applies, other than the State in which the license or certification is held.

As qualified persons, these licensed pharmacists and interns will be afforded liability protections in accordance with the PREP Act and the terms of this amended Declaration. Second, to the extent that any State law that would otherwise prohibit these healthcare professionals who are a “qualified person” from prescribing, dispensing, or administering seasonal influenza vaccines or other Covered Countermeasures, such law is preempted. On May 19, 2020, the Office of the General Counsel issued an advisory opinion concluding that, because licensed pharmacists are “qualified persons” under this declaration, the PREP Act preempts state law that would otherwise prohibit such pharmacists from ordering and administering authorized COVID-19 diagnostic tests.^[1] The opinion relied in part on the fact that the Congressional delegation of authority to the Secretary under the PREP Act to specify a class of persons, beyond those who are authorized to administer a covered countermeasure under State law, as “qualified persons” would be rendered a nullity in the absence of such preemption. This opinion is incorporated by reference into this declaration. Based on the reasoning set forth in the May 19, 2020 advisory opinion, any State law that would otherwise prohibit a member of any of the classes of “qualified persons” specified in this declaration from administering a covered countermeasure is likewise preempted. In accordance with section 319F-3(i)(8)(A) of the Public Health Service Act, a State remains free to expand the universe of individuals authorized to administer covered countermeasures within its jurisdiction under State law.

The plain language of the PREP Act makes clear that there is preemption of state law as described above. Furthermore, preemption of State law is justified to respond to the nation-wide public health emergency caused by COVID-19 as it will enable States to quickly expand the vaccination, treatment and prevention workforces with additional qualified healthcare professionals where State or local requirements might otherwise inhibit or delay allowing these healthcare professionals to participate in the COVID-19 countermeasure program.

Amendments to Declaration

Amended Declaration for Public Readiness and Emergency Preparedness Act Coverage for medical countermeasures against COVID-19.

Section V of the March 10, 2020 Declaration under the PREP Act for medical countermeasures against COVID-19, as amended April 10, 2020, June 4, 2020, August 19, 2020, as amended and republished on December 3, 2020, as amended on February 2, 2021, as amended March 11, 2021, as amended on August 4, 2021, and as amended on September 14, 2021, is further amended pursuant to section 319F-3(b)(4) of the PHS Act as described below. All other sections of the Declaration remain in effect as republished at 85 FR 79190 (Dec. 9, 2020).

1. Covered Persons, section V, delete in full and replace with:

V. Covered Persons

42 U.S.C. 247d-6d(i)(2), (3), (4), (6), (8)(A) and (B)

Covered Persons who are afforded liability immunity under this Declaration are “manufacturers,” “distributors,” “program planners,” “qualified persons,” and their officials, agents, and employees, as those terms are defined in the PREP Act, and the United States. “Order” as used herein and in guidance issued by the Office of the Assistant Secretary for Health ^[2] means a provider medication order, which includes prescribing of vaccines, or a laboratory order, which includes prescribing laboratory orders, if required. In addition, I have determined that the following additional persons are qualified persons:

(a) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction, as described in Section VII below, to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a Declaration of an Emergency, as that term is defined in Section VII of this Declaration; ^[3]

(b) Any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with Section 564 of the FD&C Act.

(c) Any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the FD&C Act.

(d) A State-licensed pharmacist who orders and administers, and pharmacy interns and qualified pharmacy technicians who administer (if the pharmacy intern or technician acts under the supervision of such pharmacist and the pharmacy intern or technician is licensed or registered by his or her State board of pharmacy),^[4] (1) vaccines that the Centers for Disease Control and Prevention (CDC)/Advisory Committee on Immunization Practices (ACIP) recommend ^[5] to persons ages three through 18 according to CDC’s/ACIP’s standard immunization schedule or (2) seasonal influenza vaccine administered by qualified pharmacy technicians and interns that the CDC/ACIP recommends to persons aged 19 and older according to CDC’s/ACIP’s standard immunization schedule; or (3) FDA authorized or FDA licensed COVID-19 vaccines to persons ages three or older. Such State-licensed pharmacists and the State-licensed or registered interns or technicians under their supervision are qualified persons only if the following requirements are met:

i. The vaccine must be authorized, approved, or licensed by the FDA.

ii. In the case of a COVID-19 vaccine, the vaccination must be ordered and administered according to CDC’s/ACIP’s COVID-19 vaccine recommendation(s).

iii. In the case of a childhood vaccine, the vaccination must be ordered and administered according to CDC’s/ACIP’s standard immunization schedule.

iv. In the case of seasonal influenza vaccine administered by qualified pharmacy technicians and interns, the vaccination must be ordered and administered according to CDC’s/ACIP’s standard immunization schedule.

v. In the case of pharmacy technicians, the supervising pharmacist must be readily and immediately available to the immunizing qualified pharmacy technician.

vi. The licensed pharmacist must have completed the immunization training that the licensing State requires for pharmacists to order and administer vaccines. If the State does not specify training requirements for the licensed pharmacist to order and administer vaccines, the licensed pharmacist must complete a vaccination training program of at least 20 hours that is approved by the ACPE to order and administer vaccines. Such a training program must include hands on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.

vii. The licensed or registered pharmacy intern and qualified pharmacy technician must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.

viii. The licensed pharmacist, licensed or registered pharmacy intern and qualified pharmacy technician must have a current certificate in basic cardiopulmonary resuscitation; ^[6]

ix. The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period.

x. The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient’s primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine;

xi. The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregiver accompanying the child of the importance of a well-child visit with a pediatrician or other licensed primary care provider and refer patients as appropriate; and

xii. The licensed pharmacist, the licensed or registered pharmacy intern and the qualified pharmacy technician must comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention (CDC) COVID-19 vaccination provider agreement and any other federal requirements that apply to the administration of COVID-19 vaccine(s).

(e) Healthcare personnel using telehealth to order or administer Covered Countermeasures for patients in a state other than the state where the healthcare personnel are licensed or otherwise permitted to practice. When ordering and administering Covered Countermeasures by means of telehealth to patients in a state where the healthcare personnel are not already permitted to practice, the healthcare personnel must comply with all requirements for ordering and administering Covered Countermeasures to patients by means of telehealth in the state where the healthcare personnel are permitted to practice. Any state law that prohibits or effectively prohibits such a qualified person from ordering and administering Covered Countermeasures by means of telehealth is preempted.^[7] Nothing in this Declaration shall preempt state laws that permit additional persons to deliver telehealth services.

(f) Any healthcare professional or other individual who holds an active license or certification permitting the person to prescribe, dispense, or administer vaccines under the law of any State as of the effective date of this amendment, or a pharmacist or pharmacy intern as authorized under the section V(d) of this Declaration, who prescribes, dispenses, or administers COVID-19 vaccines that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies, other than the State in which the license or certification is held, in association with a COVID-19 vaccination effort by a federal, State, local Tribal or territorial authority or by an institution in the State in which the COVID-19 vaccine covered countermeasure is administered, so long as the license or certification of the healthcare professional has not been suspended or restricted by any licensing authority, surrendered while under suspension, discipline or investigation by a licensing authority or surrendered following an arrest, and the individual is not on the List of Excluded Individuals/Entities maintained by the Office of Inspector General, subject to: (i) Documentation of completion of the Centers for Disease Control and Prevention COVID-19 (CDC) Vaccine Training Modules ^[8] and, for healthcare providers who are not currently practicing, documentation of an observation period by a currently practicing healthcare professional experienced in administering intramuscular injections, and for whom administering intramuscular injections is in their ordinary scope of practice, who confirms competency of the healthcare provider in preparation and administration of the COVID-19 vaccine(s) to be administered;

(g) Any member of a uniformed service (including members of the National Guard in a Title 32 duty status) (hereafter in this paragraph “service member”) or Federal government, employee, contractor, or volunteer who prescribes, administers, delivers, distributes or dispenses a Covered Countermeasure. Such Federal government service members, employees, contractors, or volunteers are qualified persons if the following requirement is met: The executive department or agency by or for which the Federal service member, employee, contractor, or volunteer is employed, contracts, or volunteers has authorized or could authorize that service member, employee, contractor, or volunteer to prescribe, administer, deliver, distribute, or dispense the Covered Countermeasure as any part of the duties or responsibilities of that service member, employee, contractor, or volunteer, even if those authorized duties or responsibilities ordinarily would not extend to members of the public or otherwise would be more limited in scope than the activities such service member, employees, contractors, or volunteers are authorized to carry out under this declaration; and

(h) The following healthcare professionals and students in a healthcare profession training program subject to the requirements of this paragraph:

1. Any midwife, paramedic, advanced or intermediate emergency medical technician (EMT), physician assistant, respiratory therapist, dentist, podiatrist, optometrist or veterinarian licensed or certified to practice under the law of any state who prescribes, dispenses, or administers COVID-19 vaccines that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a COVID-19 vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the COVID-19 vaccine covered countermeasure is administered;

2. Any physician, advanced practice registered nurse, registered nurse, practical nurse, pharmacist, pharmacy intern, midwife, paramedic, advanced or intermediate EMT, respiratory therapist, dentist, physician assistant, podiatrist, optometrist, or veterinarian who has held an active license or certification under the law of any State within the last five years, which is inactive, expired or lapsed, who prescribes, dispenses, or administers COVID-19 vaccines that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a COVID-19 vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the COVID-19 vaccine covered countermeasure is administered, so long as the license or certification was active and in good standing prior to the date it went inactive, expired or lapsed and was not revoked by the licensing authority, surrendered while under suspension, discipline or investigation by a licensing authority or surrendered following an arrest, and the individual is not on the List of Excluded Individuals/Entities maintained by the Office of Inspector General;

3. Any medical, nursing, pharmacy, pharmacy intern, midwife, paramedic, advanced or intermediate EMT, physician assistant, respiratory therapy, dental, podiatry, optometry or veterinary student with appropriate training in administering vaccines as determined by his or her school or training program and supervision by a currently practicing healthcare professional experienced in administering intramuscular injections who administers COVID-19 vaccines that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a COVID-19 vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the COVID-19 vaccine covered countermeasure is administered;

Subject to the following requirements:

i. The vaccine must be authorized, approved, or licensed by the FDA.

ii. Vaccination must be ordered and administered according to CDC’s/ACIP’s COVID-19 vaccine recommendation(s);

iii. The healthcare professionals and students must have documentation of completion of the Centers for Disease Control and Prevention COVID-19 Vaccine Training Modules and, if applicable, such additional training as may be required by the State, territory, locality, or Tribal area in which they are prescribing, dispensing, or administering COVID-19 vaccines;

iv. The healthcare professionals and students must have documentation of an observation period by a currently practicing healthcare professional experienced in administering intramuscular injections, and for whom administering vaccinations is in their ordinary scope of practice, who confirms competency of the healthcare provider or student in preparation and administration of the COVID-19 vaccine(s) to be administered and, if applicable, such additional training as may be required by the State, territory, locality, or Tribal area in which they are prescribing, dispensing, or administering COVID-19 vaccines;

v. The healthcare professionals and students must have a current certificate in basic cardiopulmonary resuscitation; ^[9]

vi. The healthcare professionals and students must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient’s primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine; and

vii. The healthcare professionals and students comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention (CDC) COVID-19 vaccination provider agreement and any other federal requirements that apply to the administration of COVID-19 vaccine(s).

(i) A State-licensed pharmacist who orders and administers, and pharmacy interns and qualified pharmacy technicians who administer (if the pharmacy intern or technician acts under the supervision of such pharmacist and the pharmacy intern or technician is licensed or registered by his or her State board of pharmacy) ^[10] FDA authorized, approved, or licensed COVID-19 therapeutics. Such State-licensed pharmacists and the State-licensed or registered interns or technicians under their supervision are qualified persons only if the following requirements are met:

i. The COVID-19 therapeutic must be authorized, approved, or licensed by the FDA.

ii. In the case of a licensed pharmacist ordering a COVID-19 therapeutic, the therapeutic must be ordered for subcutaneous, intramuscular, or oral administration and in accordance with the FDA approval, authorization, or licensing.

iii. In the case of licensed pharmacists, qualified pharmacy technicians, and licensed or registered pharmacy interns administering the COVID-19 therapeutic, the therapeutic must be administered subcutaneously, intramuscularly, or orally in accordance with the FDA approval, authorization, or licensing.

iv. In the case of qualified pharmacy technicians, the supervising pharmacist must be readily and immediately available to the qualified pharmacy technician.

v. In the case of COVID-19 therapeutics administered through intramuscular or subcutaneous injections, the licensed pharmacist, licensed or registered pharmacy intern and qualified pharmacy technician must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of COVID-19 therapeutics, the recognition and treatment of emergency reactions to COVID-19 therapeutics, and any additional training required in the FDA approval, authorization, or licensing.

vi. The licensed pharmacist, licensed or registered pharmacy intern and qualified pharmacy technician must have a current certificate in basic cardiopulmonary resuscitation; ^[11]

vii. The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers COVID-19 therapeutics, including informing the patient’s primary-care provider when available and complying with requirements with respect to reporting adverse events.

viii. The licensed pharmacist, the licensed or registered pharmacy intern and the qualified pharmacy technician must comply with any applicable requirements (or conditions of use) that apply to the administration of COVID-19 therapeutics.

(j) Any pharmacist who holds an active license or certification permitting the person to prescribe, dispense, or administer vaccines under the law of any State or who is authorized under Section V(d) of this Declaration who prescribes, dispenses, or administers seasonal influenza vaccines, or a pharmacy intern as authorized under the section V(d) of this Declaration who administers seasonal influenza vaccines, in any jurisdiction where the PREP Act applies, other than the State in which the license or certification is held, so long as the license or certification of the pharmacist or pharmacy intern has not been suspended or restricted by any licensing authority, surrendered while under suspension, discipline or investigation by a licensing authority or surrendered following an arrest, and the individual is not on the List of Excluded Individuals/Entities maintained by the Office of Inspector General.

Nothing in this Declaration shall be construed to affect the National Vaccine Injury Compensation Program, including an injured party’s ability to obtain compensation under that program. Covered countermeasures that are subject to the National Vaccine Injury Compensation Program authorized under 42 U.S.C. 300aa-10 et seq. are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program. All other terms and conditions of the Declaration apply to such covered countermeasures.

2. Effective Time Period, section XII, delete in full and replace with:

Liability protections for any respiratory protective device approved by NIOSH under 42 CFR part 84, or any successor regulations, through the means of distribution identified in Section VII(a) of this Declaration, begin on March 27, 2020 and extend through October 1, 2024.

Liability protections for all other Covered Countermeasures identified in Section VI of this Declaration, through means of distribution identified in Section VII(a) of this Declaration, begin on February 4, 2020 and extend through October 1, 2024.

Liability protections for all Covered Countermeasures administered and used in accordance with the public health and medical response of the Authority Having Jurisdiction, as identified in Section VII(b) of this Declaration, begin with a Declaration of Emergency as that term is defined in Section VII (except that, with respect to qualified persons who order or administer a routine childhood vaccination that CDC/ACIP recommends to persons ages three through 18 according to CDC’s/ACIP’s standard immunization schedule, liability protections began on August 24, 2020), and last through (a) the final day the Declaration of Emergency is in effect, or (b) October 1, 2024, whichever occurs first.

Liability protections for all Covered Countermeasures identified in Section VII(c) of this Declaration begin on December 9, 2020 and last through (a) the final day the Declaration of Emergency is in effect or (b) October 1, 2024 whichever occurs first.

Liability protections for Qualified Persons under section V(d) of the Declaration who are qualified pharmacy technicians and interns to seasonal influenza vaccine to persons aged 19 and older begin on August 4, 2021.

Liability protections for Qualified Persons under section V(f) of the Declaration begin on February 2, 2021, and last through October 1, 2024.

Liability protections for Qualified Persons under section V(g) of the Declaration begin on February 16, 2021, and last through October 1, 2024.

Liability protections for Qualified Persons who are physicians, advanced practice registered nurses, registered nurses, or practical nurses under section V(h) of the Declaration begins on February 2, 2021 and last through October 1, 2024, with additional conditions effective as of March 11, 2021and liability protections for all other Qualified persons under section V(h) begins on March 11, 2021 and last through October 1, 2024.

Liability protections for Qualified Persons under section V(i) of the Declaration who are licensed pharmacists to order and administer and qualified pharmacy technicians and licensed or registered pharmacy interns to administer COVID-19 therapeutics begin on September 9, 2021.

Liability protections for Qualified Persons under section V(j) of the Declaration begin on December 30, 2021.

Authority: 42 U.S.C. 247d-6d.

Dated: January 4, 2022.

Xavier Becerra,

Secretary, U.S. Department of Health and Human Services.

Footnotes

1.  Department of Health and Human Services General Counsel Advisory Opinion on the Public Readiness and Emergency Preparedness Act, May 19, 2020, available at: https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​prep-act-advisory-opinion-hhs-ogc.pdf/​ (last visited Jan. 24, 2021). See also, Department of Justice Office of Legal Counsel Advisory Opinion for Robert P. Charrow, General Counsel of the Department of Health and Human Services, January 12, 2021, available at: https://www.justice.gov/​sites/​default/​files/​opinions/​attachments/​2021/​01/​19/​2021-01-19-prep-act-preemption.pdf (last visited Jan. 24, 2021). Back to Citation

2.  See Guidance for Licensed Pharmacists, COVID-19 Testing, and Immunity Under the PREP Act, OASH, Apr. 8, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.pdf (last visited Jan. 24, 2021); Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act, OASH, Sept. 3, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf (last visited Jan. 24, 2021). Back to Citation

3.  See, e.g., Guidance for Licensed Pharmacists, COVID-19 Testing, and Immunity Under the PREP Act, OASH, Apr. 8, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.pdf (last visited Jan. 24, 2021); Guidance for PREP Act Coverage for COVID-19 Screening Tests at Nursing Homes, Assisted-Living Facilities, Long-Term-Care Facilities, and other Congregate Facilities, OASH, Aug. 31, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​prep-act-coverage-for-screening-in-congregate-settings.pdf (last visited Jan. 24, 2021); Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act, OASH, Sept. 3, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf (last visited Jan. 24, 2021); Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH, Oct. 20, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/prep-act-guidance.pdf (last visited Jan. 24, 2021); PREP Act Authorization for Pharmacies Distributing and Administering Certain Covered Countermeasures, Oct. 29, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/prep-act-authorization-pharmacies-administering-covered-countermeasures.pdf (last visited Jan. 24, 2021) (collectively, OASH PREP Act Authorizations). Nothing herein shall suggest that, for purposes of the Declaration, the foregoing are the only persons authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction. Back to Citation

4.  Some states do not require pharmacy interns to be licensed or registered by the state board of pharmacy. As used herein, “State-licensed or registered intern” (or equivalent phrases) refers to pharmacy interns authorized by the state or board of pharmacy in the state in which the practical pharmacy internship occurs. The authorization can, but need not, take the form of a license from, or registration with, the State board of pharmacy. Similarly, states vary on licensure and registration requirements for pharmacy technicians. Some states require certain education, training, and/or certification for licensure or registration; others either have no prerequisites for licensure or registration or do not require licensure or registration at all. As used herein, to be a “qualified pharmacy technician,” pharmacy technicians working in states with licensure and/or registration requirements must be licensed and/or registered in accordance with state requirements; pharmacy technicians working in states without licensure and/or registration requirements must have a CPhT certification from either the Pharmacy Technician Certification Board or National Healthcareer Association. See Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH, Oct. 20, 2020 at 2, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/prep-act-guidance.pdf (last visited Jan. 24, 2021). Back to Citation

5.  Where the term CDC/ACIP recommendations, standard immunization schedules, or similar language is used, this includes both direct CDC recommendations as well as recommendations adopted by the CDC Director after recommendation by ACIP, which are commonly referred to as ACIP recommendations or schedules. Back to Citation

6.  This requirement is satisfied by, among other things, a certification in basic cardiopulmonary resuscitation by an online program that has received accreditation from the American Nurses Credentialing Center, the ACPE, or the Accreditation Council for Continuing Medical Education. The phrase “current certificate in basic cardiopulmonary resuscitation,” when used in the September 3, 2020 or October 20, 2020 OASH authorizations, shall be interpreted the same way. See Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act, OASH, Sept. 3, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf (last visited Jan. 24, 2021); Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH, Oct. 20, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/prep-act-guidance.pdf (last visited Jan. 24, 2021). Back to Citation

7.  See, e.g., Advisory Opinion 20-02 on the Public Readiness and Emergency Preparedness Act and the Secretary’s Declaration under the Act, May 19, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​advisory-opinion-20-02-hhs-ogc-prep-act.pdf (last visited Jan. 24, 2021). Back to Citation

8.  See COVID-19 Vaccine Training Modules, available at https://www.cdc.gov/​vaccines/​covid-19/​training.html. Back to Citation

9.  This requirement is satisfied by, among other things, a certification in basic cardiopulmonary resuscitation by an online program that has received accreditation from the American Nurses Credentialing Center, the ACPE, or the Accreditation Council for Continuing Medical Education. The phrase “current certificate in basic cardiopulmonary resuscitation,” when used in the September 3, 2020 or October 20, 2020 OASH authorizations, shall be interpreted the same way. See Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act, OASH, Sept. 3, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf (last visited Jan. 24, 2021); Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH, Oct. 20, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/prep-act-guidance.pdf (last visited Jan. 24, 2021). Back to Citation

10.  Some states do not require pharmacy interns to be licensed or registered by the state board of pharmacy. As used herein, “State-licensed or registered intern” (or equivalent phrases) refers to pharmacy interns authorized by the state or board of pharmacy in the state in which the practical pharmacy internship occurs. The authorization can, but need not, take the form of a license from, or registration with, the State board of pharmacy. Similarly, states vary on licensure and registration requirements for pharmacy technicians. Some states require certain education, training, and/or certification for licensure or registration; others either have no prerequisites for licensure or registration or do not require licensure or registration at all. As used herein, to be a “qualified pharmacy technician,” pharmacy technicians working in states with licensure and/or registration requirements must be licensed and/or registered in accordance with state requirements; pharmacy technicians working in states without licensure and/or registration requirements must have a CPhT certification from either the Pharmacy Technician Certification Board or National Healthcareer Association. See Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH, Oct. 20, 2020 at 2, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/prep-act-guidance.pdf (last visited Jan. 24, 2021). Back to Citation

11.  This requirement is satisfied by, among other things, a certification in basic cardiopulmonary resuscitation by an online program that has received accreditation from the American Nurses Credentialing Center, the ACPE, or the Accreditation Council for Continuing Medical Education. The phrase “current certificate in basic cardiopulmonary resuscitation,” when used in the September 3, 2020 or October 20, 2020 OASH authorizations, shall be interpreted the same way. See Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act, OASH Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act, OASH, Sept. 3, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf (last visited Jan. 24, 2021); Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH, Oct. 20, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/prep-act-guidance.pdf (last visited Jan. 24, 2021). Back to Citation

[FR Doc. 2022-00151 Filed 1-5-22; 11:15 am]

BILLING CODE P

Third Amendment to Declaration under the PREP Act for Medical Countermeasures Against COVID–19 (August 24, 2020) :

ACTION:

Notice, correction.

SUMMARY:

This document clarifies a term that appeared in the “Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19,” including in the final notice published in the Federal Register on September 14, 2021, entitled “Ninth Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19.” Specifically, this document supplements the references to the Advisory Committee on Immunization Practices (ACIP) with references to the Centers for Disease Control and Prevention (CDC). This change is being made to clarify that what are commonly referred to as “ACIP recommendations” and “ACIP standard immunization schedules” are in fact recommendations and schedules made by the CDC after consultation with ACIP. The addition of “CDC” is also intended to recognize coverage of recommendations issued directly by the CDC. This clarification also applies to related guidance and opinions.

DATES:

This correction is applicable September 30, 2021.

FOR FURTHER INFORMATION CONTACT:

L. Paige Ezernack, Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue SW, Washington, DC 20201; 202-260-0365, paige.ezernack@hhs.gov.

Corrections

Corrections to technical errors that appeared in sections V(d) and (h) and XII of the final notice published in the Federal Register on September 14, 2021 at 86 FR 51160 entitled “Ninth Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19. These corrections are made to clarify that when the term Advisory Committee on Immunization Practices (ACIP) schedule or recommendation is used in the declaration, that refers to recommendations made to the Centers for Disease Control and Prevention (CDC) by the ACIP in its advisory role under the Federal Advisory Committee Act. Such recommendations are taken into consideration when the CDC issues its recommendations, as adopted by the CDC Director. These have historically been published in CDC’s Morbidity and Mortality Weekly Report under the title “ACIP recommendations.” The term “CDC” is added throughout the declaration whenever referring to ACIP recommendations or schedules to also recognizes coverage of recommendations issued directly by the CDC. Subsection V(d) is clarified to read:

(d) A State-licensed pharmacist who orders and administers, and pharmacy interns and qualified pharmacy technicians who administer (if the pharmacy intern or technician acts under the supervision of such pharmacist and the pharmacy intern or technician is licensed or registered by his or her State board of pharmacy),^[1] (1) Vaccines that the CDC/ACIP recommend ^[2] to persons ages three through 18 according to CDC’s/ACIP’s standard immunization schedule or (2) seasonal influenza vaccine administered by qualified pharmacy technicians and interns that the CDC/ACIP recommend to persons aged 19 and older according to CDC’s/ACIP’s standard immunization schedule; or (3) FDA authorized or FDA licensed COVID-19 vaccines to persons ages three or older. Such State-licensed pharmacists and the State-licensed or registered interns or technicians under their supervision are qualified persons only if the following requirements are met:

i. The vaccine must be authorized, approved, or licensed by the FDA;

ii. In the case of a COVID-19 vaccine, the vaccination must be ordered and administered according to CDC’s/ACIP’s COVID-19 vaccine recommendation(s);

iii. In the case of a childhood vaccine, the vaccination must be ordered and administered according to CDC’s/ACIP’s standard immunization schedule;

iv. In the case of seasonal influenza vaccine administered by qualified pharmacy technicians and interns, the vaccination must be ordered and administered according to CDC’s/ACIP’s standard immunization schedule;

v. In the case of pharmacy technicians, the supervising pharmacist must be readily and immediately available to the immunizing qualified pharmacy technician;

vi. The licensed pharmacist must have completed the immunization training that the licensing State requires for pharmacists to order and administer vaccines. If the State does not specify training requirements for the licensed pharmacist to order and administer vaccines, the licensed pharmacist must complete a vaccination training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE) to order and administer vaccines. Such a training program must include hands on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines;

vii. The licensed or registered pharmacy intern and qualified pharmacy technician must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines;

viii. The licensed pharmacist, licensed or registered pharmacy intern and qualified pharmacy technician must have a current certificate in basic cardiopulmonary resuscitation; ^[3]

ix. The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period;

x. The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient’s primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine;

xi. The licensed pharmacist must inform his or her childhood vaccination patients and the adult caregiver accompanying the child of the importance of a well-child visit with a pediatrician or other licensed primary care provider and refer patients as appropriate; and

xii. The licensed pharmacist, the licensed or registered pharmacy intern and the qualified pharmacy technician must comply with any applicable requirements (or conditions of use) as set forth in the CDC COVID-19 vaccination provider agreement and any other federal requirements that apply to the administration of COVID-19 vaccine(s).

Section V(h) is clarified to read:

(h) The following healthcare professionals and students in a healthcare profession training program subject to the requirements of this paragraph:

1. Any midwife, paramedic, advanced or intermediate emergency medical technician (EMT), physician assistant, respiratory therapist, dentist, podiatrist, optometrist or veterinarian licensed or certified to practice under the law of any state who prescribes, dispenses, or administers COVID-19 vaccines that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a COVID-19 vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the COVID-19 vaccine covered countermeasure is administered;

2. Any physician, advanced practice registered nurse, registered nurse, practical nurse, pharmacist, pharmacy intern, midwife, paramedic, advanced or intermediate EMT, respiratory therapist, dentist, physician assistant, podiatrist, optometrist, or veterinarian who has held an active license or certification under the law of any State within the last five years, which is inactive, expired or lapsed, who prescribes, dispenses, or administers COVID-19 vaccines that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a COVID-19 vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the COVID-19 vaccine covered countermeasure is administered, so long as the license or certification was active and in good standing prior to the date it went inactive, expired or lapsed and was not revoked by the licensing authority, surrendered while under suspension, discipline or investigation by a licensing authority or surrendered following an arrest, and the individual is not on the List of Excluded Individuals/Entities maintained by the Office of Inspector General;

3. Any medical, nursing, pharmacy, pharmacy intern, midwife, paramedic, advanced or intermediate EMT, physician assistant, respiratory therapy, dental, podiatry, optometry or veterinary student with appropriate training in administering vaccines as determined by his or her school or training program and supervision by a currently practicing healthcare professional experienced in administering intramuscular injections who administers COVID-19 vaccines that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a COVID-19 vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the COVID-19 vaccine covered countermeasure is administered;

Subject to the following requirements:

i. The vaccine must be authorized, approved, or licensed by the FDA;

ii. Vaccination must be ordered and administered according to CDC’s/ACIP’s COVID-19 vaccine recommendation(s);

iii. The healthcare professionals and students must have documentation of completion of the CDC COVID-19 Vaccine Training Modules and, if applicable, such additional training as may be required by the State, territory, locality, or Tribal area in which they are prescribing, dispensing, or administering COVID-19 vaccines;

iv. The healthcare professionals and students must have documentation of an observation period by a currently practicing healthcare professional experienced in administering intramuscular injections, and for whom administering vaccinations is in their ordinary scope of practice, who confirms competency of the healthcare provider or student in preparation and administration of the COVID-19 vaccine(s) to be administered and, if applicable, such additional training as may be required by the State, territory, locality, or Tribal area in which they are prescribing, dispensing, or administering COVID-19 vaccines;

v. The healthcare professionals and students must have a current certificate in basic cardiopulmonary resuscitation; ^[4]

vi. The healthcare professionals and students must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient’s primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine; and

vii. The healthcare professionals and students comply with any applicable requirements (or conditions of use) as set forth in the CDC COVID-19 vaccination provider agreement and any other federal requirements that apply to the administration of COVID-19 vaccine(s).

Section XII is clarified to read:

“Liability protections for all Covered Countermeasures administered and used in accordance with the public health and medical response of the Authority Having Jurisdiction, as identified in Section VII(b) of this Declaration, begin with a Declaration of Emergency as that term is defined in Section VII (except that, with respect to qualified persons who order or administer a routine childhood vaccination that CDC/ACIP recommends to persons ages three through 18 according to CDC’s/ACIP’s standard immunization schedule, liability protections began on August 24, 2020), and last through (a) the final day the Declaration of Emergency is in effect, or (b) October l, 2024, whichever occurs first.” This amendment does not change effective dates under Section XII.

Karuna Seshasai,

Executive Secretary to the Department, U.S. Department of Health and Human Services.

Footnotes

1.  Some states do not require pharmacy interns to be licensed or registered by the state board of pharmacy. As used herein, “State-licensed or registered intern” (or equivalent phrases) refers to pharmacy interns authorized by the state or board of pharmacy in the state in which the practical pharmacy internship occurs. The authorization can, but need not, take the form of a license from, or registration with, the State board of pharmacy. Similarly, states vary on licensure and registration requirements for pharmacy technicians. Some states require certain education, training, and/or certification for licensure or registration; others either have no prerequisites for licensure or registration or do not require licensure or registration at all. As used herein, to be a “qualified pharmacy technician,” pharmacy technicians working in states with licensure and/or registration requirements must be licensed and/or registered in accordance with state requirements; pharmacy technicians working in states without licensure and/or registration requirements must have a CPhT certification from either the Pharmacy Technician Certification Board or National Healthcareer Association. See Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH, Oct. 20, 2020 at 2, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/prep-act-guidance.pdf (last visited Jan. 24, 2021). Back to Citation

2.  Where the term CDC/ACIP recommendations, standard immunization schedules, or similar language is used, this includes both direct CDC recommendations as well as recommendations adopted by the CDC Director after recommendation by ACIP, which are commonly referred to as ACIP recommendations or schedules. Back to Citation

3.  This requirement is satisfied by, among other things, a certification in basic cardiopulmonary resuscitation by an online program that has received accreditation from the American Nurses Credentialing Center, the ACPE, or the Accreditation Council for Continuing Medical Education. The phrase “current certificate in basic cardiopulmonary resuscitation,” when used in the September 3, 2020 or October 20, 2020 OASH authorizations, shall be interpreted the same way. See Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act, OASH, Sept. 3, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf (last visited Jan. 24, 2021); Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH, Oct. 20, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/prep-act-guidance.pdf (last visited Jan. 24, 2021). Back to Citation

4.  This requirement is satisfied by, among other things, a certification in basic cardiopulmonary resuscitation by an online program that has received accreditation from the American Nurses Credentialing Center, the ACPE, or the Accreditation Council for Continuing Medical Education. The phrase “current certificate in basic cardiopulmonary resuscitation,” when used in the September 3, 2020 or October 20, 2020 OASH authorizations, shall be interpreted the same way. See Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act, OASH, Sept. 3, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf (last visited Jan. 24, 2021); Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH, Oct. 20, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/prep-act-guidance.pdf (last visited Jan. 24, 2021). Back to Citation

[FR Doc. 2021-21652 Filed 9-30-21; 4:15 pm]

BILLING CODE 4150-37-P

Fourth Amendment to Declaration under the PREP Act for Medical Countermeasures Against COVID–19 (December 3, 2020):

ACTION:

Notice of amendment.

SUMMARY:

The Secretary issues this amendment pursuant to section 319F-3 of the Public Health Service Act to expand the authority for certain Qualified Persons authorized to prescribe, dispense, and administer COVID-19 therapeutics that are covered countermeasures under section VI of this Declaration.

DATE:

This amendment is effective as of September 14, 2021.

FOR FURTHER INFORMATION CONTACT:

L. Paige Ezernack, Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue SW, Washington, DC 20201; 202-260-0365, paige.ezernack@hhs.gov.

SUPPLEMENTARY INFORMATION:

The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to issue a Declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (Covered Countermeasures), except for claims involving “willful misconduct” as defined in the PREP Act. Under the PREP Act, a Declaration may be amended as circumstances warrant.

The PREP Act was enacted on December 30, 2005, as Public Law 109-148, Division C, § 2. It amended the Public Health Service (PHS) Act, adding section 319F-3, which addresses liability immunity, and section 319F-4, which creates a compensation program. These sections are codified at 42 U.S.C. 247d-6d and 42 U.S.C. 247d-6e, respectively. Section 319F-3 of the PHS Act has been amended by the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, enacted on March 13, 2013, and the Coronavirus Aid, Relief, and Economic Security (CARES) Act, Public Law 116-136, enacted on March 27, 2020, to expand Covered Countermeasures under the PREP Act.

after ‘‘medical’’;
(iii) in subparagraph (B), by striking ‘‘Medical
evacuation and fatality management’’ and inserting
‘‘Fatality management’

https://www.govinfo.gov/content/pkg/PLAW-113publ5/pdf/PLAW-113publ5.pdf

‘‘(8) ensure that public health and medical information
distributed by the Department of Health and Human Services
during a public health emergency is delivered in a manner
that takes into account the range of communication needs of
the intended recipients, including at-risk individuals.’’

https://www.govinfo.gov/content/pkg/PLAW-113publ5/pdf/PLAW-113publ5.pdf

On January 31, 2020, the former Secretary, Alex M. Azar II, declared a public health emergency pursuant to section 319 of the PHS Act, 42 U.S.C. 247d, effective January 27, 2020, for the entire United States to aid in the response of the nation’s health care community to the COVID-19 outbreak. Pursuant to section 319 of the PHS Act, the Secretary renewed that declaration effective on April 26, 2020, July 25, 2020, October 23, 2020, January 21, 2021, April 21, 2021 and July 20, 2021.

On March 10, 2020, former Secretary Azar issued a Declaration under the PREP Act for medical countermeasures against COVID-19 (85 FR 15198, Mar. 17, 2020) (the Declaration). On April 10, the former Secretary amended the Declaration under the PREP Act to extend liability immunity to covered countermeasures authorized under the CARES Act (85 FR 21012, Apr. 15, 2020). On June 4, the former Secretary amended the Declaration to clarify that covered countermeasures under the Declaration include qualified countermeasures that limit the harm COVID-19 might otherwise cause. (85 FR 35100, June 8, 2020). On August 19, the former Secretary amended the declaration to add additional categories of Qualified Persons and amend the category of disease, health condition, or threat for which he recommended the administration or use of the Covered Countermeasures. (85 FR 52136, Aug. 24, 2020). On December 3, 2020, the former Secretary amended the declaration to incorporate Advisory Opinions of the General Counsel interpreting the PREP Act and the Secretary’s Declaration and authorizations issued by the Department’s Office of the Assistant Secretary for Health as an Authority Having Jurisdiction to respond; added an additional category of qualified persons under Section V of the Declaration; made explicit that the Declaration covers all qualified pandemic and epidemic products as defined under the PREP Act; added a third method of distribution to provide liability protections for, among other things, private distribution channels; made explicit that there can be situations where not administering a covered countermeasure to a particular individual can fall within the PREP Act and the Declaration’s liability protections; made explicit that there are substantive federal legal and policy issues and interests in having a unified whole-of-nation response to the COVID-19 pandemic among federal, state, local, and private-sector entities; revised the effective time period of the Declaration; and republished the declaration in full. (85 FR 79190, Dec. 9, 2020). On February 2, 2021, the Acting Secretary Norris Cochran amended the Declaration to add additional categories of Qualified Persons authorized to prescribe, dispense, and administer COVID-19 vaccines that are covered countermeasures under the Declaration (86 FR 7872, Feb. 2, 2021). On February 16, 2021, the Acting Secretary amended the Declaration to add additional categories of Qualified Persons authorized to prescribe, dispense, and administer COVID-19 vaccines that are covered countermeasures under the Declaration (86 FR 9516, Feb. 16, 2021) and on February 22, 2021, the Department filed a notice of correction to the February 2 and February 16 notices correcting effective dates stated in the Declaration, and correcting the description of qualified persons added by the February 16, 2021 amendment. (86 FR 10588, Feb. 22, 2021). On March 11, 2021, the Acting Secretary amended the Declaration to add additional Qualified Persons authorized to prescribe, dispense, and administer covered countermeasures under the Declaration. (86 FR 14462, Mar. 16, 2021). On August 4, 2021, Secretary Xavier Becerra amended the Declaration to clarify categories of Qualified Persons and to expand the scope of authority for certain Qualified Persons to administer seasonal influenza vaccines to adults. (86 FR 41977, Aug. 4, 2021).

Secretary Xavier Becerra now amends section V of the Declaration to add subsection (i) to expand the scope of authority for licensed pharmacists to order and administer and qualified pharmacy technicians and pharmacy interns to administer COVID-19 therapeutics subcutaneously, intramuscularly, or orally as authorized, approved, or licensed by the U.S. Food and Drug Administration (FDA).

Accordingly, subsection V(i) authorizes:

(i) A State-licensed pharmacist who orders and administers, and pharmacy interns and qualified pharmacy technicians who administer (if the pharmacy intern or technician acts under the supervision of such pharmacist and the pharmacy intern or technician is licensed or registered by his or her State board of pharmacy) ^[1] FDA authorized, approved, or licensed COVID-19 therapeutics. Such State-licensed pharmacists and the State-licensed or registered interns or technicians under their supervision are qualified persons only if the following requirements are met:

i. The COVID-19 therapeutic must be authorized, approved, or licensed by the FDA;

ii. In the case of a licensed pharmacist ordering a COVID-19 therapeutic, the therapeutic must be ordered for subcutaneous, intramuscular, or oral administration and in accordance with the FDA approval, authorization, or licensing;

iii. In the case of licensed pharmacists, qualified pharmacy technicians, and licensed or registered pharmacy interns administering the COVID-19 therapeutic, the therapeutic must be administered subcutaneously, intramuscularly, or orally in accordance with the FDA approval, authorization, or licensing;

iv. In the case of qualified pharmacy technicians, the supervising pharmacist must be readily and immediately available to the qualified pharmacy technician;

v. In the case of COVID-19 therapeutics administered through intramuscular or subcutaneous injections, the licensed pharmacist, licensed or registered pharmacy intern and qualified pharmacy technician must complete a practical training program that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of COVID-19 therapeutics, the recognition and treatment of emergency reactions to COVID-19 therapeutics, and any additional training required in the FDA approval, authorization, or licensing;

vi. The licensed pharmacist, licensed or registered pharmacy intern and qualified pharmacy technician must have a current certificate in basic cardiopulmonary resuscitation; ^[2]

vii. The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers COVID-19 therapeutics, including informing the patient’s primary-care provider when available and complying with requirements with respect to reporting adverse events;

viii. The licensed pharmacist, the licensed or registered pharmacy intern and the qualified pharmacy technician must comply with any applicable requirements (or conditions of use) that apply to the administration of COVID-19 therapeutics.

Description of This Amendment by Section

Section V. Covered Persons

Under the PREP Act and the Declaration, a “qualified person” is a “covered person.” Subject to certain limitations, a covered person is immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration or use of a covered countermeasure if a declaration under the PREP Act has been issued with respect to such countermeasure. “Qualified person” includes (A) a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed; or (B) “a person within a category of persons so identified in a declaration by the Secretary” under subsection (b) of the PREP Act. 42 U.S.C. 247d-6d(i)(8).

By this amendment to the Declaration, the Secretary clarifies and expands the authorization for a category of persons who are qualified persons under section 247d-6d(i)(8)(B). First, the amendment clarifies that licensed pharmacists are authorized to order and administer and licensed or registered pharmacy interns and qualified pharmacy technicians are authorized to administer COVID-19 therapeutics that are Covered Countermeasures under section VI of this Declaration. The Secretary anticipates that there will be a need to increase the available pool of providers able to order and administer COVID-19 therapeutics to address rising COVID-19 cases, to expand patient access to these critical therapies, and to keep as many patients out of the hospital as possible. Rising COVID-19 cases, largely attributable to the Delta variant, is a public health threat caused by COVID-19, placing additional strains on our healthcare system. Pharmacists, pharmacy technicians, and pharmacy interns are well positioned to increase access to therapeutics and have played a critical role in this pandemic in overseeing COVID-19 testing and vaccine administration. Given their skill set and training, as well as looming provider shortages, pharmacists, pharmacy technicians, and pharmacy interns will quickly expand access to COVID-19 therapeutics.

COVID-19 therapeutics may be administered as intramuscular injections, subcutaneous injections, or orally and would require minimal, if any, additional training to administer beyond training pharmacists, pharmacy technicians, and pharmacy interns have already received for vaccine administration, and would not place any undue training burden on providers.

As qualified persons, these licensed pharmacists, qualified pharmacy technicians and interns will be afforded liability protections in accordance with the PREP Act and the terms of this amended Declaration. Second, to the extent that any State law that would otherwise prohibit these healthcare professionals who are a “qualified person” from prescribing, dispensing, or administering COVID-19 therapeutics or other Covered Countermeasures, such law is preempted. On May 19, 2020, the Office of the General Counsel issued an advisory opinion concluding that, because licensed pharmacists are “qualified persons” under this declaration, the PREP Act preempts state law that would otherwise prohibit such pharmacists from ordering and administering authorized COVID-19 diagnostic tests.^[3] The opinion relied in part on the fact that the Congressional delegation of authority to the Secretary under the PREP Act to specify a class of persons, beyond those who are authorized to administer a covered countermeasure under State law, as “qualified persons” would be rendered a nullity in the absence of such preemption. This opinion is incorporated by reference into this declaration. Based on the reasoning set forth in the May 19, 2020 advisory opinion, any State law that would otherwise prohibit a member of any of the classes of “qualified persons” specified in this declaration from administering a covered countermeasure is likewise preempted. In accordance with section 319F-3(i)(8)(A) of the Public Health Service Act, a State remains free to expand the universe of individuals authorized to administer covered countermeasures within its jurisdiction under State law.

The plain language of the PREP Act makes clear that there is preemption of state law as described above. Furthermore, preemption of State law is justified to respond to the nation-wide public health emergency caused by COVID-19 as it will enable States to quickly expand the vaccination, treatment and prevention workforces with additional qualified healthcare professionals where State or local requirements might otherwise inhibit or delay allowing these healthcare professionals to participate in the COVID-19 countermeasure program.

Amendments to Declaration

Amended Declaration for Public Readiness and Emergency Preparedness Act Coverage for medical countermeasures against COVID-19.

Section V of the March 10, 2020 Declaration under the PREP Act for medical countermeasures against COVID-19, as amended April 10, 2020, June 4, 2020, August 19, 2020, as amended and republished on December 3, 2020, as amended on February 2, 2021, as amended March 11, 2021, and as amended on August 4, 2021, is further amended pursuant to section 319F-3(b)(4) of the PHS Act as described below. All other sections of the Declaration remain in effect as republished at 85 FR 79190 (Dec. 9, 2020).

1. Covered Persons, section V, delete in full and replace with:

V. Covered Persons

42 U.S.C. 247d-6d(i)(2), (3), (4), (6), (8)(A) and (B)

Covered Persons who are afforded liability immunity under this Declaration are “manufacturers,” “distributors,” “program planners,” “qualified persons,” and their officials, agents, and employees, as those terms are defined in the PREP Act, and the United States. “Order” as used herein and in guidance issued by the Office of the Assistant Secretary for Health ^[4] means a provider medication order, which includes prescribing of vaccines, or a laboratory order, which includes prescribing laboratory orders, if required. In addition, I have determined that the following additional persons are qualified persons:

(a) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction, as described in Section VII below, to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a Declaration of an Emergency, as that term is defined in Section VII of this Declaration;^[5]

(b) Any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with Section 564 of the FD&C Act;

(c) Any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the FD&C Act;

(d) A State-licensed pharmacist who orders and administers, and pharmacy interns and qualified pharmacy technicians who administer (if the pharmacy intern or technician acts under the supervision of such pharmacist and the pharmacy intern or technician is licensed or registered by his or her State board of pharmacy),^[6] (1) vaccines that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP’s standard immunization schedule or (2) seasonal influenza vaccine administered by qualified pharmacy technicians and interns that the ACIP recommends to persons aged 19 and older according to ACIP’s standard immunization schedule; or (3) FDA authorized or FDA licensed COVID-19 vaccines to persons ages three or older. Such State-licensed pharmacists and the State-licensed or registered interns or technicians under their supervision are qualified persons only if the following requirements are met:

i. The vaccine must be authorized, approved, or licensed by the FDA;

ii. In the case of a COVID-19 vaccine, the vaccination must be ordered and administered according to ACIP’s COVID-19 vaccine recommendation(s);

iii. In the case of a childhood vaccine, the vaccination must be ordered and administered according to ACIP’s standard immunization schedule;

iv. In the case of seasonal influenza vaccine administered by qualified pharmacy technicians and interns, the vaccination must be ordered and administered according to ACIP’s standard immunization schedule;

v. In the case of pharmacy technicians, the supervising pharmacist must be readily and immediately available to the immunizing qualified pharmacy technician;

vi. The licensed pharmacist must have completed the immunization training that the licensing State requires for pharmacists to order and administer vaccines. If the State does not specify training requirements for the licensed pharmacist to order and administer vaccines, the licensed pharmacist must complete a vaccination training program of at least 20 hours that is approved by the ACPE to order and administer vaccines. Such a training program must include hands on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines;

vii. The licensed or registered pharmacy intern and qualified pharmacy technician must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines;

viii. The licensed pharmacist, licensed or registered pharmacy intern and qualified pharmacy technician must have a current certificate in basic cardiopulmonary resuscitation; ^[7]

ix. The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period;

x. The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient’s primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine;

xi. The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregiver accompanying the child of the importance of a well-child visit with a pediatrician or other licensed primary care provider and refer patients as appropriate; and

xii. The licensed pharmacist, the licensed or registered pharmacy intern and the qualified pharmacy technician must comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention (CDC) COVID-19 vaccination provider agreement and any other federal requirements that apply to the administration of COVID- 19 vaccine(s).

(e) Healthcare personnel using telehealth to order or administer Covered Countermeasures for patients in a state other than the state where the healthcare personnel are licensed or otherwise permitted to practice. When ordering and administering Covered Countermeasures by means of telehealth to patients in a state where the healthcare personnel are not already permitted to practice, the healthcare personnel must comply with all requirements for ordering and administering Covered Countermeasures to patients by means of telehealth in the state where the healthcare personnel are permitted to practice. Any state law that prohibits or effectively prohibits such a qualified person from ordering and administering Covered Countermeasures by means of telehealth is preempted.^[8] Nothing in this Declaration shall preempt state laws that permit additional persons to deliver telehealth services;

(f) Any healthcare professional or other individual who holds an active license or certification permitting the person to prescribe, dispense, or administer vaccines under the law of any State as of the effective date of this amendment, or a pharmacist or pharmacy intern as authorized under the section V(d) of this Declaration, who prescribes, dispenses, or administers COVID-19 vaccines that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies, other than the State in which the license or certification is held, in association with a COVID-19 vaccination effort by a federal, State, local Tribal or territorial authority or by an institution in the State in which the COVID-19 vaccine covered countermeasure is administered, so long as the license or certification of the healthcare professional has not been suspended or restricted by any licensing authority, surrendered while under suspension, discipline or investigation by a licensing authority or surrendered following an arrest, and the individual is not on the List of Excluded Individuals/Entities maintained by the Office of Inspector General, subject to: (i) Documentation of completion of the Centers for Disease Control and Prevention COVID-19 (CDC) Vaccine Training Modules ^[9] and, for healthcare providers who are not currently practicing, documentation of an observation period by a currently practicing healthcare professional experienced in administering intramuscular injections, and for whom administering intramuscular injections is in their ordinary scope of practice, who confirms competency of the healthcare provider in preparation and administration of the COVID-19 vaccine(s) to be administered;

(g) Any member of a uniformed service (including members of the National Guard in a Title 32 duty status) (hereafter in this paragraph “service member”) or Federal government, employee, contractor, or volunteer who prescribes, administers, delivers, distributes or dispenses a Covered Countermeasure. Such Federal government service members, employees, contractors, or volunteers are qualified persons if the following requirement is met: The executive department or agency by or for which the Federal service member, employee, contractor, or volunteer is employed, contracts, or volunteers has authorized or could authorize that service member, employee, contractor, or volunteer to prescribe, administer, deliver, distribute, or dispense the Covered Countermeasure as any part of the duties or responsibilities of that service member, employee, contractor, or volunteer, even if those authorized duties or responsibilities ordinarily would not extend to members of the public or otherwise would be more limited in scope than the activities such service member, employees, contractors, or volunteers are authorized to carry out under this declaration; and

(h) The following healthcare professionals and students in a healthcare profession training program subject to the requirements of this paragraph:

1. Any midwife, paramedic, advanced or intermediate emergency medical technician (EMT), physician assistant, respiratory therapist, dentist, podiatrist, optometrist or veterinarian licensed or certified to practice under the law of any state who prescribes, dispenses, or administers COVID-19 vaccines that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a COVID-19 vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the COVID-19 vaccine covered countermeasure is administered;

2. Any physician, advanced practice registered nurse, registered nurse, practical nurse, pharmacist, pharmacy intern, midwife, paramedic, advanced or intermediate EMT, respiratory therapist, dentist, physician assistant, podiatrist, optometrist, or veterinarian who has held an active license or certification under the law of any State within the last five years, which is inactive, expired or lapsed, who prescribes, dispenses, or administers COVID-19 vaccines that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a COVID-19 vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the COVID-19 vaccine covered countermeasure is administered, so long as the license or certification was active and in good standing prior to the date it went inactive, expired or lapsed and was not revoked by the licensing authority, surrendered while under suspension, discipline or investigation by a licensing authority or surrendered following an arrest, and the individual is not on the List of Excluded Individuals/Entities maintained by the Office of Inspector General;

3. Any medical, nursing, pharmacy, pharmacy intern, midwife, paramedic, advanced or intermediate EMT, physician assistant, respiratory therapy, dental, podiatry, optometry or veterinary student with appropriate training in administering vaccines as determined by his or her school or training program and supervision by a currently practicing healthcare professional experienced in administering intramuscular injections who administers COVID-19 vaccines that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a COVID-19 vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the COVID-19 vaccine covered countermeasure is administered;

Subject to the following requirements:

i. The vaccine must be authorized, approved, or licensed by the FDA;

ii. Vaccination must be ordered and administered according to ACIP’s COVID-19 vaccine recommendation(s);

iii. The healthcare professionals and students must have documentation of completion of the Centers for Disease Control and Prevention COVID-19 Vaccine Training Modules and, if applicable, such additional training as may be required by the State, territory, locality, or Tribal area in which they are prescribing, dispensing, or administering COVID-19 vaccines;

iv. The healthcare professionals and students must have documentation of an observation period by a currently practicing healthcare professional experienced in administering intramuscular injections, and for whom administering vaccinations is in their ordinary scope of practice, who confirms competency of the healthcare provider or student in preparation and administration of the COVID-19 vaccine(s) to be administered and, if applicable, such additional training as may be required by the State, territory, locality, or Tribal area in which they are prescribing, dispensing, or administering COVID-19 vaccines;

v. The healthcare professionals and students must have a current certificate in basic cardiopulmonary resuscitation; ^[10]

vi. The healthcare professionals and students must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient’s primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine; and

vii. The healthcare professionals and students comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention (CDC) COVID-19 vaccination provider agreement and any other federal requirements that apply to the administration of COVID-19 vaccine(s).

(i) A State-licensed pharmacist who orders and administers, and pharmacy interns and qualified pharmacy technicians who administer (if the pharmacy intern or technician acts under the supervision of such pharmacist and the pharmacy intern or technician is licensed or registered by his or her State board of pharmacy) ^[11] FDA authorized, approved, or licensed COVID-19 therapeutics. Such State-licensed pharmacists and the State-licensed or registered interns or technicians under their supervision are qualified persons only if the following requirements are met:

ix. The COVID-19 therapeutic must be authorized, approved, or licensed by the FDA;

x. In the case of a licensed pharmacist ordering a COVID-19 therapeutic, the therapeutic must be ordered for subcutaneous, intramuscular, or oral administration and in accordance with the FDA approval, authorization, or licensing;

xi. In the case of licensed pharmacists, qualified pharmacy technicians, and licensed or registered pharmacy interns administering the COVID-19 therapeutic, the therapeutic must be administered subcutaneously, intramuscularly, or orally in accordance with the FDA approval, authorization, or licensing;

xii. In the case of qualified pharmacy technicians, the supervising pharmacist must be readily and immediately available to the qualified pharmacy technician;

xiii. In the case of COVID-19 therapeutics administered through intramuscular or subcutaneous injections, the licensed pharmacist, licensed or registered pharmacy intern and qualified pharmacy technician must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of COVID-19 therapeutics, the recognition and treatment of emergency reactions to COVID-19 therapeutics, and any additional training required in the FDA approval, authorization, or licensing;

xiv. The licensed pharmacist, licensed or registered pharmacy intern and qualified pharmacy technician must have a current certificate in basic cardiopulmonary resuscitation; ^[12]

xv. The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers COVID-19 therapeutics, including informing the patient’s primary-care provider when available and complying with requirements with respect to reporting adverse events;

xvi. The licensed pharmacist, the licensed or registered pharmacy intern and the qualified pharmacy technician must comply with any applicable requirements (or conditions of use) that apply to the administration of COVID-19 therapeutics.

Nothing in this Declaration shall be construed to affect the National Vaccine Injury Compensation Program, including an injured party’s ability to obtain compensation under that program. Covered countermeasures that are subject to the National Vaccine Injury Compensation Program authorized under 42 U.S.C. 300aa-10 et seq. are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program. All other terms and conditions of the Declaration apply to such covered countermeasures.

2. Effective Time Period, section XII, delete in full and replace with:

Liability protections for any respiratory protective device approved by NIOSH under 42 CFR part 84, or any successor regulations, through the means of distribution identified in Section VII(a) of this Declaration, begin on March 27, 2020 and extend through October 1, 2024.

Liability protections for all other Covered Countermeasures identified in Section VI of this Declaration, through means of distribution identified in Section VII(a) of this Declaration, begin on February 4, 2020 and extend through October 1, 2024.

Liability protections for all Covered Countermeasures administered and used in accordance with the public health and medical response of the Authority Having Jurisdiction, as identified in Section VII(b) of this Declaration, begin with a Declaration of Emergency as that term is defined in Section VII (except that, with respect to qualified persons who order or administer a routine childhood vaccination that ACIP recommends to persons ages three through 18 according to ACIP’s standard immunization schedule, liability protections began on August 24, 2020), and last through (a) the final day the Declaration of Emergency is in effect, or (b) October 1, 2024, whichever occurs first.

Liability protections for all Covered Countermeasures identified in Section VII(c) of this Declaration begin on December 9, 2020 and last through (a) the final day the Declaration of Emergency is in effect or (b) October 1, 2024 whichever occurs first.

Liability protections for Qualified Persons under section V(d) of the Declaration who are qualified pharmacy technicians and interns to seasonal influenza vaccine to persons aged 19 and older begin on August 4, 2021.

Liability protections for Qualified Persons under section V(f) of the Declaration begin on February 2, 2021, and last through October 1, 2024.

Liability protections for Qualified Persons under section V(g) of the Declaration begin on February 16, 2021, and last through October 1, 2024.

Liability protections for Qualified Persons who are physicians, advanced practice registered nurses, registered nurses, or practical nurses under section V(h) of the Declaration begins on February 2, 2021 and last through October 1, 2024, with additional conditions effective as of March 11, 2021and liability protections for all other Qualified persons under section V(h) begins on March 11, 2021 and last through October 1, 2024.

Liability protections for Qualified Persons under section V(i) of the Declaration who are licensed pharmacists to order and administer and qualified pharmacy technicians and licensed or registered pharmacy interns to administer COVID-19 therapeutics begin on September 9, 2021.

Authority: 42 U.S.C. 247d-6d.

Dated: September 9, 2021.

Xavier Becerra,

Secretary, U.S. Department of Health and Human Services.

Footnotes

1.  Some states do not require pharmacy interns to be licensed or registered by the state board of pharmacy. As used herein, “State-licensed or registered intern” (or equivalent phrases) refers to pharmacy interns authorized by the state or board of pharmacy in the state in which the practical pharmacy internship occurs. The authorization can, but need not, take the form of a license from, or registration with, the State board of pharmacy. Similarly, states vary on licensure and registration requirements for pharmacy technicians. Some states require certain education, training, and/or certification for licensure or registration; others either have no prerequisites for licensure or registration or do not require licensure or registration at all. As used herein, to be a “qualified pharmacy technician,” pharmacy technicians working in states with licensure and/or registration requirements must be licensed and/or registered in accordance with state requirements; pharmacy technicians working in states without licensure and/or registration requirements must have a Certified Pharmacy Technician (CPhT) certification from either the Pharmacy Technician Certification Board or National Healthcareer Association. See Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH, Oct. 20, 2020 at 2, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/prep-act-guidance.pdf (last visited Jan. 24, 2021). Back to Citation

2.  This requirement is satisfied by, among other things, a certification in basic cardiopulmonary resuscitation by an online program that has received accreditation from the American Nurses Credentialing Center, the ACPE, or the Accreditation Council for Continuing Medical Education. The phrase “current certificate in basic cardiopulmonary resuscitation,” when used in the September 3, 2020 or October 20, 2020 OASH authorizations, shall be interpreted the same way. See Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act, OASH, Sept. 3, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf (last visited Jan. 24, 2021); Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH, Oct. 20, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/prep-act-guidance.pdf (last visited Jan. 24, 2021). Back to Citation

3.  Department of Health and Human Services General Counsel Advisory Opinion on the Public Readiness and Emergency Preparedness Act, May 19, 2020, available at: https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​prep-act-advisory-opinion-hhs-ogc.pdf/​ (last visited Jan. 24, 2021). See also, Department of Justice Office of Legal Counsel Advisory Opinion for Robert P. Charrow, General Counsel of the Department of Health and Human Services, January 12, 2021, available at: https://www.justice.gov/​sites/​default/​files/​opinions/​attachments/​2021/​01/​19/​2021-01-19-prep-act-preemption.pdf (last visited Jan. 24, 2021). Back to Citation

4.  See Guidance for Licensed Pharmacists, COVID-19 Testing, and Immunity Under the PREP Act, OASH, Apr. 8, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.pdf (last visited Jan. 24, 2021); Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act, OASH, Sept. 3, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf (last visited Jan. 24, 2021). Back to Citation

5.  See, e.g., Guidance for Licensed Pharmacists, COVID-19 Testing, and Immunity Under the PREP Act, OASH, Apr. 8, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.pdf (last visited Jan. 24, 2021); Guidance for PREP Act Coverage for COVID-19 Screening Tests at Nursing Homes, Assisted-Living Facilities, Long-Term-Care Facilities, and other Congregate Facilities, OASH, Aug. 31, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​prep-act-coverage-for-screening-in-congregate-settings.pdf (last visited Jan. 24, 2021); Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act, OASH, Sept. 3, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf (last visited Jan. 24, 2021); Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH, Oct. 20, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/prep-act-guidance.pdf (last visited Jan. 24, 2021); PREP Act Authorization for Pharmacies Distributing and Administering Certain Covered Countermeasures, Oct. 29, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/prep-act-authorization-pharmacies-administering-covered-countermeasures.pdf (last visited Jan. 24, 2021) (collectively, OASH PREP Act Authorizations). Nothing herein shall suggest that, for purposes of the Declaration, the foregoing are the only persons authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction. Back to Citation

6.  Some states do not require pharmacy interns to be licensed or registered by the state board of pharmacy. As used herein, “State-licensed or registered intern” (or equivalent phrases) refers to pharmacy interns authorized by the state or board of pharmacy in the state in which the practical pharmacy internship occurs. The authorization can, but need not, take the form of a license from, or registration with, the State board of pharmacy. Similarly, states vary on licensure and registration requirements for pharmacy technicians. Some states require certain education, training, and/or certification for licensure or registration; others either have no prerequisites for licensure or registration or do not require licensure or registration at all. As used herein, to be a “qualified pharmacy technician,” pharmacy technicians working in states with licensure and/or registration requirements must be licensed and/or registered in accordance with state requirements; pharmacy technicians working in states without licensure and/or registration requirements must have a CPhT certification from either the Pharmacy Technician Certification Board or National Healthcareer Association. See Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH, Oct. 20, 2020 at 2, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/prep-act-guidance.pdf (last visited Jan. 24, 2021). Back to Citation

7.  This requirement is satisfied by, among other things, a certification in basic cardiopulmonary resuscitation by an online program that has received accreditation from the American Nurses Credentialing Center, the ACPE, or the Accreditation Council for Continuing Medical Education. The phrase “current certificate in basic cardiopulmonary resuscitation,” when used in the September 3, 2020 or October 20, 2020 OASH authorizations, shall be interpreted the same way. See Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act, OASH, Sept. 3, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf (last visited Jan. 24, 2021); Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH, Oct. 20, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/prep-act-guidance.pdf (last visited Jan. 24, 2021). Back to Citation

8.  See, e.g., Advisory Opinion 20-02 on the Public Readiness and Emergency Preparedness Act and the Secretary’s Declaration under the Act, May 19, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​advisory-opinion-20-02-hhs-ogc-prep-act.pdf (last visited Jan. 24, 2021). Back to Citation

9.  See COVID-19 Vaccine Training Modules, available at https://www.cdc.gov/​vaccines/​covid-19/​training.html. Back to Citation

10.  This requirement is satisfied by, among other things, a certification in basic cardiopulmonary resuscitation by an online program that has received accreditation from the American Nurses Credentialing Center, the ACPE, or the Accreditation Council for Continuing Medical Education. The phrase “current certificate in basic cardiopulmonary resuscitation,” when used in the September 3, 2020 or October 20, 2020 OASH authorizations, shall be interpreted the same way. See Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act, OASH, Sept. 3, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf (last visited Jan. 24, 2021); Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH, Oct. 20, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/prep-act-guidance.pdf (last visited Jan. 24, 2021). Back to Citation

11.  Some states do not require pharmacy interns to be licensed or registered by the state board of pharmacy. As used herein, “State-licensed or registered intern” (or equivalent phrases) refers to pharmacy interns authorized by the state or board of pharmacy in the state in which the practical pharmacy internship occurs. The authorization can, but need not, take the form of a license from, or registration with, the State board of pharmacy. Similarly, states vary on licensure and registration requirements for pharmacy technicians. Some states require certain education, training, and/or certification for licensure or registration; others either have no prerequisites for licensure or registration or do not require licensure or registration at all. As used herein, to be a “qualified pharmacy technician,” pharmacy technicians working in states with licensure and/or registration requirements must be licensed and/or registered in accordance with state requirements; pharmacy technicians working in states without licensure and/or registration requirements must have a CPhT certification from either the Pharmacy Technician Certification Board or National Healthcareer Association. See Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH, Oct. 20, 2020 at 2, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/prep-act-guidance.pdf (last visited Jan. 24, 2021). Back to Citation

12.  This requirement is satisfied by, among other things, a certification in basic cardiopulmonary resuscitation by an online program that has received accreditation from the American Nurses Credentialing Center, the ACPE, or the Accreditation Council for Continuing Medical Education. The phrase “current certificate in basic cardiopulmonary resuscitation,” when used in the September 3, 2020 or October 20, 2020 OASH authorizations, shall be interpreted the same way. See Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act, OASH Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act, OASH, Sept. 3, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf (last visited Jan. 24, 2021); Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH, Oct. 20, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/prep-act-guidance.pdf (last visited Jan. 24, 2021). Back to Citation

[FR Doc. 2021-19790 Filed 9-9-21; 4:15 pm]

BILLING CODE 4150-28-P

Fifth Amendment to Declaration under the PREP Act for Medical Countermeasures Against COVID–19 (February 2, 2021):

ACTION:

Notice of amendment.

SUMMARY:

The Secretary issues this amendment pursuant to section 319F-3 of the Public Health Service Act to clarify and expand the authority for certain Qualified Persons authorized to prescribe, dispense, and administer covered countermeasures under section VI of this Declaration.

DATES:

This amendment is effective as of August 4, 2021.

FOR FURTHER INFORMATION CONTACT:

L. Paige Ezernack, Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue SW, Washington, DC 20201; 202-260-0365, paige.ezernack@hhs.gov.

SUPPLEMENTARY INFORMATION:

The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to issue a Declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (Covered Countermeasures), except for claims involving “willful misconduct” as defined in the PREP Act. Under the PREP Act, a Declaration may be amended as circumstances warrant.

The PREP Act was enacted on December 30, 2005, as Public Law 109-148, Division C, § 2. It amended the Public Health Service (PHS) Act, adding section 319F-3, which addresses liability immunity, and section 319F-4, which creates a compensation program. These sections are codified at 42 U.S.C. 247d-6d and 42 U.S.C. 247d-6e, respectively. Section 319F-3 of the PHS Act has been amended by the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, enacted on March 13, 2013, and the Coronavirus Aid, Relief, and Economic Security (CARES) Act, Public Law 116-136, enacted on March 27, 2020, to expand Covered Countermeasures under the PREP Act.

On January 31, 2020, the former Secretary, Alex M. Azar II, declared a public health emergency pursuant to section 319 of the PHS Act, 42 U.S.C. 247d, effective January 27, 2020, for the entire United States to aid in the response of the nation’s health care community to the COVID-19 outbreak. Pursuant to section 319 of the PHS Act, the Secretary renewed that declaration effective on April 26, 2020, July 25, 2020, October 23, 2020, January 21, 2021, April 21, 2021 and July 20, 2021.

On March 10, 2020, former Secretary Azar issued a Declaration under the PREP Act for medical countermeasures against COVID-19 (85 FR 15198, Mar. 17, 2020) (the Declaration). On April 10, the former Secretary amended the Declaration under the PREP Act to extend liability immunity to covered countermeasures authorized under the CARES Act (85 FR 21012, Apr. 15, 2020). On June 4, the former Secretary amended the Declaration to clarify that covered countermeasures under the Declaration include qualified countermeasures that limit the harm COVID-19 might otherwise cause. (85 FR 35100, June 8, 2020). On August 19, the former Secretary amended the declaration to add additional categories of Qualified Persons and amend the category of disease, health condition, or threat for which he recommended the administration or use of the Covered Countermeasures. (85 FR 52136, August 24, 2020). On December 3, 2020, the former Secretary amended the declaration to incorporate Advisory Opinions of the General Counsel interpreting the PREP Act and the Secretary’s Declaration and authorizations issued by the Department’s Office of the Assistant Secretary for Health as an Authority Having Jurisdiction to respond; added an additional category of qualified persons under Section V of the Declaration; made explicit that the Declaration covers all qualified pandemic and epidemic products as defined under the PREP Act; added a third method of distribution to provide liability protections for, among other things, private distribution channels; made explicit that there can be situations where not administering a covered countermeasure to a particular individual can fall within the PREP Act and the Declaration’s liability protections; made explicit that there are substantive federal legal and policy issues and interests in having a unified whole-of-nation response to the COVID-19 pandemic among federal, state, local, and private-sector entities; revised the effective time period of the Declaration; and republished the declaration in full. (85 FR 79190, December 9, 2020). On February 2, 2021, the Acting Secretary Norris Cochran amended the Declaration to add additional categories of Qualified Persons authorized to prescribe, dispense, and administer COVID-19 vaccines that are covered countermeasures under the Declaration (86 FR 7872, February 2, 2021). On February 16, 2021, the Acting Secretary amended the Declaration to add additional categories of Qualified Persons authorized to prescribe, dispense, and administer COVID-19 vaccines that are covered countermeasures under the Declaration (86 FR 9516, February 16, 2021) and on February 22, 2021, the Department filed a notice of correction to the February 2 and February 16 notices correcting effective dates stated in the Declaration, and correcting the description of qualified persons added by the February 16, 2021 amendment. (86 FR 10588, February 22, 2021). On March 11, 2021, the Acting Secretary amended the Declaration to add additional Qualified Persons authorized to prescribe, dispense, and administer covered countermeasures under the Declaration. (86 FR 14462 March 16, 2021).

Secretary Xavier Becerra now amends section V of the Declaration to revise subsections (d) and (f) to clarify that qualified pharmacy technicians are Qualified Persons covered by the Declaration, and to expand the scope of authority for qualified pharmacy technicians to administer seasonal influenza vaccines to adults within the state where they are authorized to practice and for interns to administer seasonal influenza vaccines to adults consistent with other terms and conditions of the Declaration.

Accordingly, subsection V(d) authorizes:

(d) A State-licensed pharmacist who orders and administers, and pharmacy interns and qualified pharmacy technicians who administer (if the pharmacy intern or technician acts under the supervision of such pharmacist and the pharmacy intern or technician is licensed or registered by his or her State board of pharmacy),^[1] (1) vaccines that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP’s standard immunization schedule or (2) seasonal influenza vaccine administered by qualified pharmacy technicians and interns that the ACIP recommends to persons aged 19 and older according to ACIP’s standard immunization schedule; or (3) FDA authorized or FDA licensed COVID -19 vaccines to persons ages three or older. Such State-licensed pharmacists and the State-licensed or registered interns or technicians under their supervision are qualified persons only if the following requirements are met:

i. The vaccine must be authorized, approved, or licensed by the FDA;

ii. In the case of a COVID-19 vaccine, the vaccination must be ordered and administered according to ACIP’s COVID-19 vaccine recommendation(s);

iii. In the case of a childhood vaccine, the vaccination must be ordered and administered according to ACIP’s standard immunization schedule;

iv. In the case of seasonal influenza vaccine administered by qualified pharmacy technicians and interns, the vaccination must be ordered and administered according to ACIP’s standard immunization schedule;

v. In the case of pharmacy technicians, the supervising pharmacist must be readily and immediately available to the immunizing qualified pharmacy technician;

vi. The licensed pharmacist must have completed the immunization training that the licensing State requires for pharmacists to order and administer vaccines. If the State does not specify training requirements for the licensed pharmacist to order and administer vaccines, the licensed pharmacist must complete a vaccination training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE) to order and administer vaccines. Such a training program must include hands on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines;

vii. The licensed or registered pharmacy intern and qualified pharmacy technician must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines;

viii. The licensed pharmacist, licensed or registered pharmacy intern and qualified pharmacy technician must have a current certificate in basic cardiopulmonary resuscitation; ^[2]

ix. The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period;

x. The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient’s primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine;

xi. The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregiver accompanying the child of the importance of a well-child visit with a pediatrician or other licensed primary care provider and refer patients as appropriate; and

xii. The licensed pharmacist, the licensed or registered pharmacy intern and the qualified pharmacy technician must comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention (CDC) COVID-19 vaccination provider agreement and any other federal requirements that apply to the administration of COVID-19 vaccine(s).

Further, the initial phrase of subsection V(f) is revised to state authorize “Any healthcare professional or other individual who holds an active license or certification permitting the person to prescribe, dispense, or administer vaccines under the law of any State as of the effective date of this amendment, or a pharmacist or pharmacy intern as authorized under the section V(d) of this Declaration. . . .”

Description of This Amendment by Section

Section V. Covered Persons

Under the PREP Act and the Declaration, a “qualified person” is a “covered person.” Subject to certain limitations, a covered person is immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration or use of a covered countermeasure if a declaration under the PREP Act has been issued with respect to such countermeasure. “Qualified person” includes (A) a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed; or (B) “a person within a category of persons so identified in a declaration by the Secretary” under subsection (b) of the PREP Act. 42 U.S.C. 247d-6d(i)(8)

By this amendment to the Declaration, the Secretary clarifies and expands the authorization for a category of persons who are qualified persons under section 247d-6d(i)(8)(B). First, the amendment clarifies that qualified pharmacy technicians are authorized to administer Childhood vaccinations and COVID-19 vaccinations that are Covered Countermeasures under section VI of this Declaration. The Department has authorized qualified pharmacy technicians to administer these vaccines under section V(a) of the Declaration through Guidance issued by the Assistant Secretary for Health.^[3] This amendment adds qualified pharmacy technicians to section V(d) of the Declaration, to clarify that these healthcare professionals are authorized subject to the conditions stated in that subsection. In addition, the amendment expands the authorization for qualified pharmacy technicians and interns to administer seasonal influenza vaccines under the supervision of a pharmacist to persons aged 19 and older consistent with ACIP recommendations. The Secretary anticipates that there will be a need for the adult population to receive both COVID-19 and seasonal influenza vaccines throughout the 2021-2022 influenza season. Health risks may increase for individuals who contract seasonal influenza concurrently with COVID-19, thus expanding the scope of authorized vaccinators for seasonal influenza lessens the harm otherwise caused by COVID-19.

While influenza incidence was lower than anticipated last fall and winter, the same cannot be assumed for the 2021-2022 flu season, as states have largely lifted the community mitigation measures previously in place at the height of the COVID-19 pandemic. Seasonal influenza has the potential to inflict significant burden and strain on the U.S. healthcare system in its own right; and in conjunction with the ongoing COVID-19 pandemic, a spike in influenza cases could overwhelm healthcare providers. Like the vaccination against COVID-19, the vaccination against influenza requires many people to be vaccinated within a short period of time, potentially creating a surge on the system. Concern also remains regarding the emergence of SARS-CoV-2 variants and their potential to cause disease both among vaccinated and unvaccinated populations. It is yet to be determined if COVID-19 vaccine boosters will be recommended; however, if boosters become necessary, allowing pharmacy interns and technicians to administer both COVID-19 vaccines and influenza vaccines would allow states maximum flexibility in limiting potential impacts of both illnesses. ACIP also recently voted unanimously in favor of COVID-19 and influenza vaccine co-administration.^[4 5] Like COVID-19 vaccines, influenza vaccines are administered as intramuscular (IM) injections, and would require minimal, if any, additional training to administer, and would not place any undue training burden on providers.

As qualified persons, these qualified pharmacy technicians and interns will be afforded liability protections in accordance with the PREP Act and the terms of this amended Declaration. Second, to the extent that any State law that would otherwise prohibit these healthcare professionals who are a “qualified person” from prescribing, dispensing, or administering COVID-19 vaccines or other Covered Countermeasures, such law is preempted. On May 19, 2020, the Office of the General Counsel issued an advisory opinion concluding that, because licensed pharmacists are “qualified persons” under this declaration, the PREP Act preempts state law that would otherwise prohibit such pharmacists from ordering and administering authorized COVID-19 diagnostic tests.^[6] The opinion relied in part on the fact that the Congressional delegation of authority to the Secretary under the PREP Act to specify a class of persons, beyond those who are authorized to administer a covered countermeasure under State law, as “qualified persons” would be rendered a nullity in the absence of such preemption. This opinion is incorporated by reference into this declaration. Based on the reasoning set forth in the May 19, 2020 advisory opinion, any State law that would otherwise prohibit a member of any of the classes of “qualified persons” specified in this declaration from administering a covered countermeasure is likewise preempted. In accordance with section 319F-3(i)(8)(A) of the Public Health Service Act, a State remains free to expand the universe of individuals authorized to administer covered countermeasures within its jurisdiction under State law.

The plain language of the PREP Act makes clear that there is preemption of state law as described above. Furthermore, preemption of State law is justified to respond to the nation-wide public health emergency caused by COVID-19 as it will enable States to quickly expand the vaccination workforce with additional qualified healthcare professionals where State or local requirements might otherwise inhibit or delay allowing these healthcare professionals to participate in the COVID-19 countermeasure program.

Amendments to Declaration

Amended Declaration for Public Readiness and Emergency Preparedness Act Coverage for medical countermeasures against COVID-19.

Section V of the March 10, 2020 Declaration under the PREP Act for medical countermeasures against COVID-19, as amended April 10, 2020, June 4, 2020, August 19, 2020, as amended and republished on December 3, 2020, and as amended on February 2, 2021, and as amended March 11, 2021, is further amended pursuant to section 319F-3(b)(4) of the PHS Act as described below. All other sections of the Declaration remain in effect as republished at 85 FR 79190 (December 9, 2020).

1. Covered Persons, section V, delete in full and replace with:

V. Covered Persons

42 U.S.C. 247d-6d(i)(2), (3), (4), (6), (8)(A) and (B)

Covered Persons who are afforded liability immunity under this Declaration are “manufacturers,” “distributors,” “program planners,” “qualified persons,” and their officials, agents, and employees, as those terms are defined in the PREP Act, and the United States. “Order” as used herein and in guidance issued by the Office of the Assistant Secretary for Health ^[7] means a provider medication order, which includes prescribing of vaccines, or a laboratory order, which includes prescribing laboratory orders, if required. In addition, I have determined that the following additional persons are qualified persons:

(a) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction, as described in Section VII below, to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a Declaration of an Emergency, as that term is defined in Section VII of this Declaration; ^[8]

(b) Any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with Section 564 of the FD&C Act;

(c) Any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the FD&C Act;

(d) A State-licensed pharmacist who orders and administers, and pharmacy interns and qualified pharmacy technicians who administer (if the pharmacy intern or technician acts under the supervision of such pharmacist and the pharmacy intern or technician is licensed or registered by his or her State board of pharmacy),^[9] (1) vaccines that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP’s standard immunization schedule or (2) seasonal influenza vaccine administered by qualified pharmacy technicians and interns that the ACIP recommends to persons aged 19 and older according to ACIP’s standard immunization schedule; or (3) FDA authorized or FDA licensed COVID -19 vaccines to persons ages three or older. Such State-licensed pharmacists and the State-licensed or registered interns or technicians under their supervision are qualified persons only if the following requirements are met:

i. The vaccine must be authorized, approved, or licensed by the FDA;

ii. In the case of a COVID-19 vaccine, the vaccination must be ordered and administered according to ACIP’s COVID-19 vaccine recommendation(s);

iii. In the case of a childhood vaccine, the vaccination must be ordered and administered according to ACIP’s standard immunization schedule;

iv. In the case of seasonal influenza vaccine administered by qualified pharmacy technicians and interns, the vaccination must be ordered and administered according to ACIP’s standard immunization schedule;

v. In the case of pharmacy technicians, the supervising pharmacist must be readily and immediately available to the immunizing qualified pharmacy technician;

vi. The licensed pharmacist must have completed the immunization training that the licensing State requires for pharmacists to order and administer vaccines. If the State does not specify training requirements for the licensed pharmacist to order and administer vaccines, the licensed pharmacist must complete a vaccination training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE) to order and administer vaccines. Such a training program must include hands on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines;

vii. The licensed or registered pharmacy intern and qualified pharmacy technician must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines;

viii. The licensed pharmacist, licensed or registered pharmacy intern and qualified pharmacy technician must have a current certificate in basic cardiopulmonary resuscitation; ^[10]

ix. The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period;

x. The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient’s primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine;

xi. The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregiver accompanying the child of the importance of a well-child visit with a pediatrician or other licensed primary care provider and refer patients as appropriate; and

xii. The licensed pharmacist, the licensed or registered pharmacy intern and the qualified pharmacy technician must comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention (CDC) COVID-19 vaccination provider agreement and any other federal requirements that apply to the administration of COVID-19 vaccine(s).

(e) Healthcare personnel using telehealth to order or administer Covered Countermeasures for patients in a state other than the state where the healthcare personnel are licensed or otherwise permitted to practice. When ordering and administering Covered Countermeasures by means of telehealth to patients in a state where the healthcare personnel are not already permitted to practice, the healthcare personnel must comply with all requirements for ordering and administering Covered Countermeasures to patients by means of telehealth in the state where the healthcare personnel are permitted to practice. Any state law that prohibits or effectively prohibits such a qualified person from ordering and administering Covered Countermeasures by means of telehealth is preempted.^[11] Nothing in this Declaration shall preempt state laws that permit additional persons to deliver telehealth services;

(f) Any healthcare professional or other individual who holds an active license or certification permitting the person to prescribe, dispense, or administer vaccines under the law of any State as of the effective date of this amendment, or a pharmacist or pharmacy intern as authorized under the section V(d) of this Declaration, who prescribes, dispenses, or administers COVID-19 vaccines that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies, other than the State in which the license or certification is held, in association with a COVID-19 vaccination effort by a federal, State, local Tribal or territorial authority or by an institution in the State in which the COVID-19 vaccine covered countermeasure is administered, so long as the license or certification of the healthcare professional has not been suspended or restricted by any licensing authority, surrendered while under suspension, discipline or investigation by a licensing authority or surrendered following an arrest, and the individual is not on the List of Excluded Individuals/Entities maintained by the Office of Inspector General, subject to: (i) Documentation of completion of the Centers for Disease Control and Prevention COVID-19 (CDC) Vaccine Training Modules ^[12] and, for healthcare providers who are not currently practicing, documentation of an observation period by a currently practicing healthcare professional experienced in administering intramuscular injections, and for whom administering intramuscular injections is in their ordinary scope of practice, who confirms competency of the healthcare provider in preparation and administration of the COVID-19 vaccine(s) to be administered;

(g) Any member of a uniformed service (including members of the National Guard in a Title 32 duty status) (hereafter in this paragraph “service member”) or Federal government, employee, contractor, or volunteer who prescribes, administers, delivers, distributes or dispenses a Covered Countermeasure. Such Federal government service members, employees, contractors, or volunteers are qualified persons if the following requirement is met: The executive department or agency by or for which the Federal service member, employee, contractor, or volunteer is employed, contracts, or volunteers has authorized or could authorize that service member, employee, contractor, or volunteer to prescribe, administer, deliver, distribute, or dispense the Covered Countermeasure as any part of the duties or responsibilities of that service member, employee, contractor, or volunteer, even if those authorized duties or responsibilities ordinarily would not extend to members of the public or otherwise would be more limited in scope than the activities such service member, employees, contractors, or volunteers are authorized to carry out under this declaration; and

(h) The following healthcare professionals and students in a healthcare profession training program subject to the requirements of this paragraph:

1. Any midwife, paramedic, advanced or intermediate emergency medical technician (EMT), physician assistant, respiratory therapist, dentist, podiatrist, optometrist or veterinarian licensed or certified to practice under the law of any state who prescribes, dispenses, or administers COVID-19 vaccines that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a COVID-19 vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the COVID-19 vaccine covered countermeasure is administered;

2. Any physician, advanced practice registered nurse, registered nurse, practical nurse, pharmacist, pharmacy intern, midwife, paramedic, advanced or intermediate EMT, respiratory therapist, dentist, physician assistant, podiatrist, optometrist, or veterinarian who has held an active license or certification under the law of any State within the last five years, which is inactive, expired or lapsed, who prescribes, dispenses, or administers COVID-19 vaccines that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a COVID-19 vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the COVID-19 vaccine covered countermeasure is administered, so long as the license or certification was active and in good standing prior to the date it went inactive, expired or lapsed and was not revoked by the licensing authority, surrendered while under suspension, discipline or investigation by a licensing authority or surrendered following an arrest, and the individual is not on the List of Excluded Individuals/Entities maintained by the Office of Inspector General;

3. Any medical, nursing, pharmacy, pharmacy intern, midwife, paramedic, advanced or intermediate EMT, physician assistant, respiratory therapy, dental, podiatry, optometry or veterinary student with appropriate training in administering vaccines as determined by his or her school or training program and supervision by a currently practicing healthcare professional experienced in administering intramuscular injections who administers COVID-19 vaccines that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a COVID-19 vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the COVID-19 vaccine covered countermeasure is administered;

Subject to the following requirements:

i. The vaccine must be authorized, approved, or licensed by the FDA;

ii. Vaccination must be ordered and administered according to ACIP’s COVID-19 vaccine recommendation(s);

iii. The healthcare professionals and students must have documentation of completion of the Centers for Disease Control and Prevention COVID-19 Vaccine Training Modules and, if applicable, such additional training as may be required by the State, territory, locality, or Tribal area in which they are prescribing, dispensing, or administering COVID-19 vaccines;

iv. The healthcare professionals and students must have documentation of an observation period by a currently practicing healthcare professional experienced in administering intramuscular injections, and for whom administering vaccinations is in their ordinary scope of practice, who confirms competency of the healthcare provider or student in preparation and administration of the COVID-19 vaccine(s) to be administered and, if applicable, such additional training as may be required by the State, territory, locality, or Tribal area in which they are prescribing, dispensing, or administering COVID-19 vaccines;

v. The healthcare professionals and students must have a current certificate in basic cardiopulmonary resuscitation; ^[13]

vi. The healthcare professionals and students must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient’s primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine; and

vii. The healthcare professionals and students comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention (CDC) COVID-19 vaccination provider agreement and any other federal requirements that apply to the administration of COVID-19 vaccine(s).

Nothing in this Declaration shall be construed to affect the National Vaccine Injury Compensation Program, including an injured party’s ability to obtain compensation under that program. Covered countermeasures that are subject to the National Vaccine Injury Compensation Program authorized under 42 U.S.C. 300aa-10 et seq. are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program. All other terms and conditions of the Declaration apply to such covered countermeasures.

2. Effective Time Period, section XII, delete in full and replace with:

Liability protections for any respiratory protective device approved by NIOSH under 42 CFR part 84, or any successor regulations, through the means of distribution identified in Section VII(a) of this Declaration, begin on March 27, 2020 and extend through October 1, 2024.

Liability protections for all other Covered Countermeasures identified in Section VI of this Declaration, through means of distribution identified in Section VII(a) of this Declaration, begin on February 4, 2020 and extend through October 1, 2024.

Liability protections for all Covered Countermeasures administered and used in accordance with the public health and medical response of the Authority Having Jurisdiction, as identified in Section VII(b) of this Declaration, begin with a Declaration of Emergency as that term is defined in Section VII (except that, with respect to qualified persons who order or administer a routine childhood vaccination that ACIP recommends to persons ages three through 18 according to ACIP’s standard immunization schedule, liability protections began on August 24, 2020), and last through (a) the final day the Declaration of Emergency is in effect, or (b) October 1, 2024, whichever occurs first.

Liability protections for all Covered Countermeasures identified in Section VII(c) of this Declaration begin on December 9, 2020 and last through (a) the final day the Declaration of Emergency is in effect. or (b) October 1, 2024. whichever occurs first.

Liability protections for Qualified Persons under section V(d) of the Declaration who are qualified pharmacy technicians and interns to administer seasonal influenza vaccine to persons aged 19 and older begin on August 4, 2021.

Liability protections for Qualified Persons under section V(f) of the Declaration begin on February 2, 2021, and last through October 1, 2024.

Liability protections for Qualified Persons under section V(g) of the Declaration begin on February 16, 2021, and last through October 1, 2024.

Liability protections for Qualified Persons who are physicians, advanced practice registered nurses, registered nurses, or practical nurses under section V(h) of the Declaration begins on February 2, 2021 and last through October 1, 2024, with additional conditions effective as of March 11, 2021and liability protections for all other Qualified persons under section V(h) begins on March 11, 2021 and last through October 1, 2024.

Authority: 42 U.S.C. 247d-6d.

Dated: July 30, 2021.

Xavier Becerra,

Secretary, Department of Health and Human Services.

Footnotes

1.  Some states do not require pharmacy interns to be licensed or registered by the state board of pharmacy. As used herein, “State-licensed or registered intern” (or equivalent phrases) refers to pharmacy interns authorized by the state or board of pharmacy in the state in which the practical pharmacy internship occurs. The authorization can, but need not, take the form of a license from, or registration with, the State board of pharmacy. Similarly, states vary on licensure and registration requirements for pharmacy technicians. Some states require certain education, training, and/or certification for licensure or registration; others either have no prerequisites for licensure or registration or do not require licensure or registration at all. As used herein, to be a “qualified pharmacy technician,” pharmacy technicians working in states with licensure and/or registration requirements must be licensed and/or registered in accordance with state requirements; pharmacy technicians working in states without licensure and/or registration requirements must have a Certified Pharmacy Technician (CPhT) certification from either the Pharmacy Technician Certification Board or National Healthcareer Association. See Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH, Oct. 20, 2020 at 2, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/prep-act-guidance.pdf (last visited Jan. 24, 2021). Back to Citation

2.  This requirement is satisfied by, among other things, a certification in basic cardiopulmonary resuscitation by an online program that has received accreditation from the American Nurses Credentialing Center, the ACPE, or the Accreditation Council for Continuing Medical Education. The phrase “current certificate in basic cardiopulmonary resuscitation,” when used in the September 3, 2020 or October 20, 2020 OASH authorizations, shall be interpreted the same way. See Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act, OASH, Sept. 3, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf (last visited Jan. 24, 2021); Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH, Oct. 20, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/prep-act-guidance.pdf (last visited Jan. 24, 2021). Back to Citation

3.  Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH, Oct. 20, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/prep-act-guidance.pdf (last visited June 17, 2021). Back to Citation

4.  https://www.medpagetoday.com/​meetingcoverage/​acip/​93283.

5.  https://www.aappublications.org/​news/​2021/​06/​24/​acip-flu-rabies-dengue-062421. Back to Citation

6.  Department of Health and Human Services General Counsel Advisory Opinion on the Public Readiness and Emergency Preparedness Act, May 19, 2020, available at: https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​prep-act-advisory-opinion-hhs-ogc.pdf/​ (last visited Jan. 24, 2021). See also, Department of Justice Office of Legal Counsel Advisory Opinion for Robert P. Charrow, General Counsel of the Department of Health and Human Services, January 12, 2021, available at: https://www.justice.gov/​sites/​default/​files/​opinions/​attachments/​2021/​01/​19/​2021-01-19-prep-act-preemption.pdf (last visited Jan. 24, 2021). Back to Citation

7.  See Guidance for Licensed Pharmacists, COVID-19 Testing, and Immunity Under the PREP Act, OASH, Apr. 8, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.pdf (last visited Jan. 24, 2021); Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act, OASH, Sept. 3, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf (last visited Jan. 24, 2021). Back to Citation

8.  See, e.g., Guidance for Licensed Pharmacists, COVID-19 Testing, and Immunity Under the PREP Act, OASH, Apr. 8, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.pdf (last visited Jan. 24, 2021); Guidance for PREP Act Coverage for COVID-19 Screening Tests at Nursing Homes, Assisted-Living Facilities, Long-Term-Care Facilities, and other Congregate Facilities, OASH, Aug. 31, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​prep-act-coverage-for-screening-in-congregate-settings.pdf (last visited Jan. 24, 2021); Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act, OASH, Sept. 3, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf (last visited Jan. 24, 2021); Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH, Oct. 20, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/prep-act-guidance.pdf (last visited Jan. 24, 2021); PREP Act Authorization for Pharmacies Distributing and Administering Certain Covered Countermeasures, Oct. 29, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/prep-act-authorization-pharmacies-administering-covered-countermeasures.pdf (last visited Jan. 24, 2021) (collectively, OASH PREP Act Authorizations). Nothing herein shall suggest that, for purposes of the Declaration, the foregoing are the only persons authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction. Back to Citation

9.  Some states do not require pharmacy interns to be licensed or registered by the state board of pharmacy. As used herein, “State-licensed or registered intern” (or equivalent phrases) refers to pharmacy interns authorized by the state or board of pharmacy in the state in which the practical pharmacy internship occurs. The authorization can, but need not, take the form of a license from, or registration with, the State board of pharmacy. Similarly, states vary on licensure and registration requirements for pharmacy technicians. Some states require certain education, training, and/or certification for licensure or registration; others either have no prerequisites for licensure or registration or do not require licensure or registration at all. As used herein, to be a “qualified pharmacy technician,” pharmacy technicians working in states with licensure and/or registration requirements must be licensed and/or registered in accordance with state requirements; pharmacy technicians working in states without licensure and/or registration requirements must have a Certified Pharmacy Technician (CPhT) certification from either the Pharmacy Technician Certification Board or National Healthcareer Association. See Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH, Oct. 20, 2020 at 2, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/prep-act-guidance.pdf (last visited Jan. 24, 2021). Back to Citation

10.  This requirement is satisfied by, among other things, a certification in basic cardiopulmonary resuscitation by an online program that has received accreditation from the American Nurses Credentialing Center, the ACPE, or the Accreditation Council for Continuing Medical Education. The phrase “current certificate in basic cardiopulmonary resuscitation,” when used in the September 3, 2020 or October 20, 2020 OASH authorizations, shall be interpreted the same way. See Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act, OASH, Sept. 3, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf (last visited Jan. 24, 2021); Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH, Oct. 20, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/prep-act-guidance.pdf (last visited Jan. 24, 2021). Back to Citation

11.  See, e.g., Advisory Opinion 20-02 on the Public Readiness and Emergency Preparedness Act and the Secretary’s Declaration under the Act, May 19, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​advisory-opinion-20-02-hhs-ogc-prep-act.pdf (last visited Jan. 24, 2021). Back to Citation

12.  See COVID-19 Vaccine Training Modules, available at https://www.cdc.gov/​vaccines/​covid-19/​training.html. Back to Citation

13.  This requirement is satisfied by, among other things, a certification in basic cardiopulmonary resuscitation by an online program that has received accreditation from the American Nurses Credentialing Center, the ACPE, or the Accreditation Council for Continuing Medical Education. The phrase “current certificate in basic cardiopulmonary resuscitation,” when used in the September 3, 2020 or October 20, 2020 OASH authorizations, shall be interpreted the same way. See Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act, OASH, Sept. 3, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf (last visited Jan. 24, 2021); Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH, Oct. 20, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/prep-act-guidance.pdf (last visited Jan. 24, 2021). Back to Citation

[FR Doc. 2021-16681 Filed 8-2-21; 11:15 am]

BILLING CODE P

Sixth Amendment to Declaration under the PREP Act for Medical Countermeasures Against COVID–19 (February 16, 2021) :

14462 Federal Register / Vol. 86, No. 49 / Tuesday, March 16, 2021 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Voluntary Partner Surveys To Implement Executive Order 12862 in the Health Resources and Services Administration AGENCY: Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. SUMMARY: In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA’s ICR only after the 30 day comment period for this notice has closed. DATES: Comments on this ICR should be received no later than April 15, 2021. ADDRESSES: Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/ PRAMain. Find this particular information collection by selecting ‘‘Currently under Review—Open for Public Comments’’ or by using the search function. FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance requests submitted to OMB for review, email Lisa Wright-Solomon, the HRSA Information Collection Clearance Officer at paperwork@hrsa.gov or call (301) 443– 1984. SUPPLEMENTARY INFORMATION: Information Collection Request Title: Voluntary Partner Surveys to Implement Executive Order 12862 in the Health Resources and Services Administration, OMB No. 0915–0212—Extension. Abstract: In response to Executive Order 12862, HRSA is proposing to conduct voluntary customer surveys of its partners to assess strengths and weaknesses in program services and processes. HRSA partners are typically state or local governments, health care facilities, health care consortia, health care providers, and researchers. HRSA is requesting continued approval of a generic clearance from OMB to conduct the partner surveys. Partner surveys to be conducted by HRSA might include, for example, mail, electronic, and/or telephone surveys of grantees to determine satisfaction with grant processes or technical assistance provided by a contractor, or in-class or virtual evaluation forms completed by providers who receive training from HRSA grantees to measure satisfaction with the training experience. Results of these surveys will be used to plan and redirect resources and efforts as needed to improve services and processes. Focus groups may also be used to gain partner input that will inform the design of mail, electronic and/or telephone surveys. Focus groups, in-class evaluation forms, mail surveys, electronic surveys, and telephone surveys are expected to be the preferred data collection methods for this information collection. A generic approval allows HRSA to conduct a limited number of partner surveys without a full-scale OMB review of each survey. If this generic information collection request receives continued approval, information on each individual partner survey will not be published in the Federal Register. A 60-day notice published in the Federal Register on December 15, 2020, vol. 85, No. 241; pp. 81210–11. There were no public comments. Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose, or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below. TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS Form name Number of respondents Number of responses per respondent Total responses Average burden per response (in hours) Total burden hours In-class evaluations ……………………………………………………. 40,000 1 40,000 .05 2,000 Mail/Telephone surveys ………………………………………………. 12,000 1 12,000 .25 3,000 Focus groups …………………………………………………………….. 250 1 250 1.50 375 Total …………………………………………………………………… 52,250 …………………… 52,250 …………………… 5,375 HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency’s functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Maria G. Button, Director, Executive Secretariat. [FR Doc. 2021–05349 Filed 3–15–21; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Seventh Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID–19 ACTION: Notice of amendment. VerDate Sep<11>2014 16:52 Mar 15, 2021 Jkt 253001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\16MRN1.SGM 16MRN1 jbell on DSKJLSW7X2PROD with NOTICES Federal Register / Vol. 86, No. 49 / Tuesday, March 16, 2021 / Notices 14463 SUMMARY: The Acting Secretary issues this amendment pursuant to section 319F–3 of the Public Health Service Act to add additional categories of Qualified Persons authorized to prescribe, dispense, and administer covered countermeasures under section VI of this Declaration. DATES: This amendment to the Declaration is effective as of March 11, 2021. FOR FURTHER INFORMATION CONTACT: L. Paige Ezernack, Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue SW, Washington, DC 20201; 202–260– 0365, paige.ezernack@hhs.gov. SUPPLEMENTARY INFORMATION: The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to issue a Declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (Covered Countermeasures), except for claims involving ‘‘willful misconduct’’ as defined in the PREP Act. Under the PREP Act, a Declaration may be amended as circumstances warrant. The PREP Act was enacted on December 30, 2005, as Public Law 109– 148, Division C, section 2. It amended the Public Health Service (PHS) Act, adding section 319F–3, which addresses liability immunity, and section 319F–4, which creates a compensation program. These sections are codified at 42 U.S.C. 247d–6d and 42 U.S.C. 247d–6e, respectively. Section 319F–3 of the PHS Act has been amended by the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113–5, enacted on March 13, 2013 and the Coronavirus Aid, Relief, and Economic Security (CARES) Act, Public Law 116–136, enacted on March 27, 2020, to expand Covered Countermeasures under the PREP Act. On January 31, 2020, the former Secretary, Alex M. Azar II, declared a public health emergency pursuant to section 319 of the PHS Act, 42 U.S.C. 247d, effective January 27, 2020, for the entire United States to aid in the response of the nation’s health care community to the COVID–19 outbreak. Pursuant to section 319 of the PHS Act, the Secretary renewed that declaration effective on April 26, 2020, July 25, 2020, October 23, 2020, and January 21, 2021. On March 10, 2020, former Secretary Azar issued a Declaration under the PREP Act for medical countermeasures against COVID–19 (85 FR 15198, Mar. 17, 2020) (the Declaration). On April 10, the former Secretary amended the Declaration under the PREP Act to extend liability immunity to covered countermeasures authorized under the CARES Act (85 FR 21012, Apr. 15, 2020). On June 4, the former Secretary amended the Declaration to clarify that covered countermeasures under the Declaration include qualified countermeasures that limit the harm COVID–19 might otherwise cause. (85 FR 35100, June 8, 2020). On August 19, the former Secretary amended the declaration to add additional categories of Qualified Persons and amend the category of disease, health condition, or threat for which he recommended the administration or use of the Covered Countermeasures. (85 FR 52136, August 24, 2020). On December 3, 2020, the former Secretary amended the declaration to incorporate Advisory Opinions of the General Counsel interpreting the PREP Act and the Secretary’s Declaration and authorizations issued by the Department’s Office of the Assistant Secretary for Health as an Authority Having Jurisdiction to respond; added an additional category of qualified persons under Section V of the Declaration; made explicit that the Declaration covers all qualified pandemic and epidemic products as defined under the PREP Act; added a third method of distribution to provide liability protections for, among other things, private distribution channels; made explicit that there can be situations where not administering a covered countermeasure to a particular individual can fall within the PREP Act and the Declaration’s liability protections; made explicit that there are substantive Federal legal and policy issues and interests in having a unified whole-of-nation response to the COVID– 19 pandemic among Federal, state, local, and private-sector entities; revised the effective time period of the Declaration; and republished the declaration in full. (85 FR 79190, December 9, 2020). On February 2, 2021, the Acting Secretary Norris Cochran amended the Declaration to add additional categories of Qualified Persons authorized to prescribe, dispense, and administer COVID–19 vaccines that are covered countermeasures under the Declaration (86 FR 7872, February 2, 2021). On February 16, 2021, the Acting Secretary amended the Declaration to add additional categories of Qualified Persons authorized to prescribe, dispense, and administer COVID–19 vaccines that are covered countermeasures under the Declaration (86 FR 9516, February 16, 2021) and on February 22, 2021, the Department filed a notice of correction to the February 2 and February 16 notices correcting effective dates stated in the Declaration, and correcting the description of qualified persons added by the February 16, 2021 amendment. (86 FR 10588, February 22, 2021). The Acting Secretary now amends section V of the Declaration to revise subsection (f) to clarify that observers should be experienced in administering intramuscular injections; delete subsection (g), change the prior subsection (h) to subsection (g) and add a new subsection (h) to add additional categories of qualified persons covered under the PREP Act, and thus authorizes: (h) The following healthcare professionals and students in a healthcare profession training program subject to the requirements of this paragraph: 1. Any midwife, paramedic, advanced or intermediate emergency medical technician (EMT), physician assistant, respiratory therapist, dentist, podiatrist, optometrist or veterinarian licensed or certified to practice under the law of any state who prescribes, dispenses, or administers COVID–19 vaccines that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a COVID–19 vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the COVID–19 vaccine covered countermeasure is administered; 2. Any physician, advanced practice registered nurse, registered nurse, practical nurse, pharmacist, pharmacy intern, midwife, paramedic, advanced or intermediate EMT, respiratory therapist, dentist, physician assistant, podiatrist, optometrist, or veterinarian who has held an active license or certification under the law of any State within the last five years, which is inactive, expired or lapsed, who prescribes, dispenses, or administers COVID–19 vaccines that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a COVID–19 vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the COVID–19 vaccine covered countermeasure is VerDate Sep<11>2014 16:52 Mar 15, 2021 Jkt 253001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 E:\FR\FM\16MRN1.SGM 16MRN1 jbell on DSKJLSW7X2PROD with NOTICES 14464 Federal Register / Vol. 86, No. 49 / Tuesday, March 16, 2021 / Notices 1This requirement is satisfied by, among other things, a certification in basic cardiopulmonary resuscitation by an online program that has received accreditation from the American Nurses Credentialing Center, the ACPE, or the Accreditation Council for Continuing Medical Education. The phrase ‘‘current certificate in basic cardiopulmonary resuscitation,’’ when used in the September 3, 2020 or October 20, 2020 OASH authorizations, shall be interpreted the same way. See Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID–19 Vaccines and Immunity under the PREP Act, OASH, Sept. 3, 2020, available at https://www.hhs.gov/guidance/ sites/default/files/hhs-guidance-documents// licensed-pharmacists-and-pharmacy-internsregarding-covid-19-vaccines-immunity.pdf (last visited Jan. 24, 2021); Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID–19 Vaccines, and COVID–19 Testing, OASH, Oct. 20, 2020, available at https:// www.hhs.gov/guidance/sites/default/files/hhsguidance-documents//prep-act-guidance.pdf (last visited Jan. 24, 2021). administered, so long as the license or certification was active and in good standing prior to the date it went inactive, expired or lapsed and was not revoked by the licensing authority, surrendered while under suspension, discipline or investigation by a licensing authority or surrendered following an arrest, and the individual is not on the List of Excluded Individuals/Entities maintained by the Office of Inspector General; 3. Any medical, nursing, pharmacy, pharmacy intern, midwife, paramedic, advanced or intermediate EMT, physician assistant, respiratory therapy, dental, podiatry, optometry or veterinary student with appropriate training in administering vaccines as determined by his or her school or training program and supervision by a currently practicing healthcare professional experienced in administering intramuscular injections who administers COVID–19 vaccines that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a COVID–19 vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the COVID–19 vaccine covered countermeasure is administered; Subject to the following requirements: i. The vaccine must be authorized, approved, or licensed by the FDA; ii. Vaccination must be ordered and administered according to ACIP’s COVID–19 vaccine recommendation(s); iii. The healthcare professionals and students must have documentation of completion of the Centers for Disease Control and Prevention COVID–19 Vaccine Training Modules and, if applicable, such additional training as may be required by the State, territory, locality, or Tribal area in which they are prescribing, dispensing, or administering COVID–19 vaccines; iv. The healthcare professionals and students must have documentation of an observation period by a currently practicing healthcare professional experienced in administering intramuscular injections, and for whom administering intramuscular injections is in their ordinary scope of practice, who confirms competency of the healthcare provider or student in preparation and administration of the COVID–19 vaccine(s) to be administered and, if applicable, such additional training as may be required by the State, territory, locality, or Tribal area in which they are prescribing, dispensing, or administering COVID–19 vaccines; v. The healthcare professionals and students must have a current certificate in basic cardiopulmonary resuscitation; 1 vi. The healthcare professionals and students must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient’s primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine; and vii. The healthcare professionals and students comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention (CDC) COVID– 19 vaccination provider agreement and any other federal requirements that apply to the administration of COVID– 19 vaccine(s). Description of This Amendment by Section Section V. Covered Persons Under the PREP Act and the Declaration, a ‘‘qualified person’’ is a ‘‘covered person.’’ Subject to certain limitations, a covered person is immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration or use of a covered countermeasure if a declaration under the PREP Act has been issued with respect to such countermeasure. ‘‘Qualified person’’ includes (A) a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed; or (B) ‘‘a person within a category of persons so identified in a declaration by the Secretary’’ under subsection (b) of the PREP Act. 42 U.S.C. 247d–6d(i)(8). By this amendment to the Declaration, the Acting Secretary identifies an additional categories of persons who are qualified persons under section 247d– 6d(i)(8)(B): licensed healthcare professionals who may not ordinarily prescribe, dispense or administer vaccines, additional healthcare providers with recently expired licenses, and students in a healthcare profession training program, subject to appropriate training, supervision, and other specified requirements. The Acting Secretary anticipates that significantly more vaccines will be available to the public in the spring and summer of 2021, and wants to ensure that states have the greatest flexibility in mobilizing the workforce they will need to engage in the largest vaccination effort in our Nation’s history. This amendment thus expands the pool of vaccinators to individuals who have or can obtain training and the capability to administer vaccines even if prescribing, dispensing and administering vaccines is not within the scope of their license or usual responsibilities, allowing States, Territories, local areas and Tribes to use these individuals in their vaccination programs. The Acting Secretary has determined that there is an urgent need to expand the pool of available COVID–19 vaccinators in order to respond effectively to the pandemic. As vaccine supply is made more widely available over the coming months, health care system capacity and the vaccination workforce are likely to become increasingly strained throughout the Nation. As qualified persons, these healthcare professionals and students in healthcare profession training programs will be afforded liability protections in accordance with the PREP Act and the terms of this amended Declaration. Second, to the extent that any State law that would otherwise prohibit the healthcare professionals and students in healthcare profession training programs who are a ‘‘qualified person’’ from prescribing, dispensing, or administering COVID–19 vaccines or other Covered Countermeasures, such law is preempted. On May 19, 2020, the Office of the General Counsel issued an advisory opinion concluding that, because licensed pharmacists are VerDate Sep<11>2014 16:52 Mar 15, 2021 Jkt 253001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\16MRN1.SGM 16MRN1 jbell on DSKJLSW7X2PROD with NOTICES Federal Register / Vol. 86, No. 49 / Tuesday, March 16, 2021 / Notices 14465 2 Department of Health and Human Services General Counsel Advisory Opinion on the Public Readiness and Emergency Preparedness Act, May 19, 2020, available at: https://www.hhs.gov/ guidance/sites/default/files/hhs-guidancedocuments/prep-act-advisory-opinion-hhs-ogc.pdf/ (last visited Jan. 24, 2021). See also, Department of Justice Office of Legal Counsel Advisory Opinion for Robert P. Charrow, General Counsel of the Department of Health and Human Services, January 12, 2021, available at: https://www.justice.gov/sites/ default/files/opinions/attachments/2021/01/19/ 2021-01-19-prep-act-preemption.pdf (last visited Jan. 24, 2021). 3See Guidance for Licensed Pharmacists, COVID– 19 Testing, and Immunity Under the PREP Act, OASH, Apr. 8, 2020, available at https:// www.hhs.gov/guidance/sites/default/files/hhsguidance-documents//authorizing-licensedpharmacists-to-order-and-administer-covid-19- tests.pdf (last visited Jan. 24, 2021); Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID–19 Vaccines and Immunity under the PREP Act, OASH, Sept. 3, 2020, available at https://www.hhs.gov/guidance/sites/default/files/ hhs-guidance-documents//licensed-pharmacistsand-pharmacy-interns-regarding-covid-19-vaccinesimmunity.pdf (last visited Jan. 24, 2021). 4See, e.g., Guidance for Licensed Pharmacists, COVID–19 Testing, and Immunity Under the PREP Act, OASH, Apr. 8, 2020, available at https:// www.hhs.gov/guidance/sites/default/files/hhsguidance-documents//authorizing-licensedpharmacists-to-order-and-administer-covid-19- tests.pdf (last visited Jan. 24, 2021); Guidance for PREP Act Coverage for COVID–19 Screening Tests at Nursing Homes, Assisted-Living Facilities, LongTerm-Care Facilities, and other Congregate Facilities, OASH, Aug. 31, 2020, available at https://www.hhs.gov/guidance/sites/default/files/ hhs-guidance-documents/prep-act-coverage-forscreening-in-congregate-settings.pdf (last visited Jan. 24, 2021); Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID–19 Vaccines and Immunity under the PREP Act, OASH, Sept. 3, 2020, available at https:// www.hhs.gov/guidance/sites/default/files/hhsguidance-documents//licensed-pharmacists-andpharmacy-interns-regarding-covid-19-vaccinesimmunity.pdf (last visited Jan. 24, 2021); Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID–19 Vaccines, and COVID–19 Testing, OASH, Oct. 20, 2020, available at https://www.hhs.gov/guidance/ sites/default/files/hhs-guidance-documents//prepact-guidance.pdf (last visited Jan. 24, 2021); PREP Act Authorization for Pharmacies Distributing and Administering Certain Covered Countermeasures, Oct. 29, 2020, available at https://www.hhs.gov/ guidance/sites/default/files/hhs-guidancedocuments//prep-act-authorization-pharmaciesadministering-covered-countermeasures.pdf (last visited Jan. 24, 2021) (collectively, OASH PREP Act Authorizations). Nothing herein shall suggest that, for purposes of the Declaration, the foregoing are the only persons authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction. 5Some states do not require pharmacy interns to be licensed or registered by the state board of pharmacy. As used herein, ‘‘State-licensed or registered intern’’ (or equivalent phrases) refers to pharmacy interns authorized by the state or board of pharmacy in the state in which the practical pharmacy internship occurs. The authorization can, but need not, take the form of a license from, or registration with, the State board of pharmacy. See Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID– 19 Vaccines, and COVID–19 Testing, OASH, Oct. 20, 2020 at 2, available at https://www.hhs.gov/ guidance/sites/default/files/hhs-guidancedocuments//prep-act-guidance.pdf (last visited Jan. 24, 2021). ‘‘qualified persons’’ under this declaration, the PREP Act preempts state law that would otherwise prohibit such pharmacists from ordering and administering authorized COVID–19 diagnostic tests.2 The opinion relied in part on the fact that the Congressional delegation of authority to the Secretary under the PREP Act to specify a class of persons, beyond those who are authorized to administer a covered countermeasure under State law, as ‘‘qualified persons’’ would be rendered a nullity in the absence of such preemption. This opinion is incorporated by reference into this declaration. Based on the reasoning set forth in the May 19, 2020 advisory opinion, any State law that would otherwise prohibit a member of any of the classes of ‘‘qualified persons’’ specified in this declaration from administering a covered countermeasure is likewise preempted. In accordance with section 319F–3(i)(8)(A) of the Public Health Service Act, a State remains free to expand the universe of individuals authorized to administer covered countermeasures within its jurisdiction under State law. The plain language of the PREP Act makes clear that there is preemption of state law as described above. Furthermore, preemption of State law is justified to respond to the nation-wide public health emergency caused by COVID–19 as it will enable States to quickly expand the vaccination workforce with additional qualified healthcare professionals where State or local requirements might otherwise inhibit or delay allowing these healthcare professionals to participate in the COVID–19 vaccination program. Amendments to Declaration Amended Declaration for Public Readiness and Emergency Preparedness Act Coverage for medical countermeasures against COVID–19. Section V of the March 10, 2020 Declaration under the PREP Act for medical countermeasures against COVID–19, as amended April 10, 2020, June 4, 2020, August 19, 2020, as amended and republished on December 3, 2020, and as amended on February 2, 2021, is further amended pursuant to section 319F–3(b)(4) of the PHS Act as described below. All other sections of the Declaration remain in effect as republished at 85 FR 79190 (December 9, 2020). 1. Covered Persons, section V, delete in full and replace with: V. Covered Persons 42 U.S.C. 247d–6d(i)(2), (3), (4), (6), (8)(A) and (B) Covered Persons who are afforded liability immunity under this Declaration are ‘‘manufacturers,’’ ‘‘distributors,’’ ‘‘program planners,’’ ‘‘qualified persons,’’ and their officials, agents, and employees, as those terms are defined in the PREP Act, and the United States. ‘‘Order’’ as used herein and in guidance issued by the Office of the Assistant Secretary for Health 3 means a provider medication order, which includes prescribing of vaccines, or a laboratory order, which includes prescribing laboratory orders, if required. In addition, I have determined that the following additional persons are qualified persons: (a) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction, as described in Section VII below, to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a Declaration of an Emergency, as that term is defined in Section VII of this Declaration; 4 (b) Any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with Section 564 of the FD&C Act; (c) Any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the FD&C Act; (d) A State-licensed pharmacist who orders and administers, and pharmacy interns who administer (if the pharmacy intern acts under the supervision of such pharmacist and the pharmacy intern is licensed or registered by his or her State board of pharmacy),5 (1) vaccines that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP’s standard immunization schedule or (2) FDA authorized or FDA licensed COVID–19 vaccines to persons ages three or older. Such State-licensed pharmacists and the State-licensed or registered interns under their supervision are qualified persons only if the following requirements are met: i. The vaccine must be authorized, approved, or licensed by the FDA; ii. In the case of a COVID–19 vaccine, the vaccination must be ordered and administered according to ACIP’s COVID–19 vaccine recommendation(s); VerDate Sep<11>2014 16:52 Mar 15, 2021 Jkt 253001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\16MRN1.SGM 16MRN1 jbell on DSKJLSW7X2PROD with NOTICES 14466 Federal Register / Vol. 86, No. 49 / Tuesday, March 16, 2021 / Notices 6This requirement is satisfied by, among other things, a certification in basic cardiopulmonary resuscitation by an online program that has received accreditation from the American Nurses Credentialing Center, the ACPE, or the Accreditation Council for Continuing Medical Education. The phrase ‘‘current certificate in basic cardiopulmonary resuscitation,’’ when used in the September 3, 2020 or October 20, 2020 OASH authorizations, shall be interpreted the same way. See Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID–19 Vaccines and Immunity under the PREP Act, OASH, Sept. 3, 2020, available at https://www.hhs.gov/guidance/ sites/default/files/hhs-guidance-documents// licensed-pharmacists-and-pharmacy-internsregarding-covid-19-vaccines-immunity.pdf (last visited Jan. 24, 2021); Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID–19 Vaccines, and COVID–19 Testing, OASH, Oct. 20, 2020, available at https:// www.hhs.gov/guidance/sites/default/files/hhsguidance-documents//prep-act-guidance.pdf (last visited Jan. 24, 2021). 7See, e.g., Advisory Opinion 20–02 on the Public Readiness and Emergency Preparedness Act and the Secretary’s Declaration under the Act, May 19, 2020, available at https://www.hhs.gov/guidance/ sites/default/files/hhs-guidance-documents/ advisory-opinion-20-02-hhs-ogc-prep-act.pdf (last visited Jan. 24, 2021). 8See COVID–19 Vaccine Training Modules, available at https://www.cdc.gov/vaccines/covid-19/ training.html. iii. In the case of a childhood vaccine, the vaccination must be ordered and administered according to ACIP’s standard immunization schedule; iv. The licensed pharmacist must have completed the immunization training that the licensing State requires for pharmacists to order and administer vaccines. If the State does not specify training requirements for the licensed pharmacist to order and administer vaccines, the licensed pharmacist must complete a vaccination training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE) to order and administer vaccines. Such a training program must include hands on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines; v. The licensed or registered pharmacy intern must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines; vi. The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation; 6 vii. The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period; viii. The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient’s primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine; ix. The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregiver accompanying the child of the importance of a well-child visit with a pediatrician or other licensed primary care provider and refer patients as appropriate; and x. The licensed pharmacist and the licensed or registered pharmacy intern must comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention (CDC) COVID– 19 vaccination provider agreement and any other federal requirements that apply to the administration of COVID– 19 vaccine(s). (e) Healthcare personnel using telehealth to order or administer Covered Countermeasures for patients in a state other than the state where the healthcare personnel are licensed or otherwise permitted to practice. When ordering and administering Covered Countermeasures by means of telehealth to patients in a state where the healthcare personnel are not already permitted to practice, the healthcare personnel must comply with all requirements for ordering and administering Covered Countermeasures to patients by means of telehealth in the state where the healthcare personnel are permitted to practice. Any state law that prohibits or effectively prohibits such a qualified person from ordering and administering Covered Countermeasures by means of telehealth is preempted.7 Nothing in this Declaration shall preempt state laws that permit additional persons to deliver telehealth services; (f) Any healthcare professional or other individual who holds an active license or certification permitting the person to prescribe, dispense, or administer vaccines under the law of any State as of the effective date of this amendment, or as authorized under the section V(d) of this Declaration, who prescribes, dispenses, or administers COVID–19 vaccines that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies, other than the State in which the license or certification is held, in association with a COVID–19 vaccination effort by a federal, State, local Tribal or territorial authority or by an institution in the State in which the COVID–19 vaccine covered countermeasure is administered, so long as the license or certification of the healthcare professional has not been suspended or restricted by any licensing authority, surrendered while under suspension, discipline or investigation by a licensing authority or surrendered following an arrest, and the individual is not on the List of Excluded Individuals/Entities maintained by the Office of Inspector General, subject to: (i) Documentation of completion of the Centers for Disease Control and Prevention COVID–19 (CDC) Vaccine Training Modules 8 and, for healthcare providers who are not currently practicing, documentation of an observation period by a currently practicing healthcare professional experienced in administering intramuscular injections, and for whom administering intramuscular injections is in their ordinary scope of practice, who confirms competency of the healthcare provider in preparation and administration of the COVID–19 vaccine(s) to be administered; (g) Any member of a uniformed service (including members of the National Guard in a Title 32 duty status) (hereafter in this paragraph ‘‘service member’’) or Federal government, employee, contractor, or volunteer who prescribes, administers, delivers, distributes or dispenses a Covered Countermeasure. Such Federal government service members, employees, contractors, or volunteers are qualified persons if the following requirement is met: the executive department or agency by or for which the Federal service member, employee, contractor, or volunteer is employed, contracts, or volunteers has authorized or could authorize that service member, employee, contractor, or volunteer to prescribe, administer, deliver, distribute, or dispense the Covered Countermeasure as any part of the duties or responsibilities of that service member, employee, contractor, or volunteer, even if those authorized duties or responsibilities ordinarily would not extend to members of the VerDate Sep<11>2014 16:52 Mar 15, 2021 Jkt 253001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 E:\FR\FM\16MRN1.SGM 16MRN1 jbell on DSKJLSW7X2PROD with NOTICES Federal Register / Vol. 86, No. 49 / Tuesday, March 16, 2021 / Notices 14467 9This requirement is satisfied by, among other things, a certification in basic cardiopulmonary resuscitation by an online program that has received accreditation from the American Nurses Credentialing Center, the ACPE, or the Accreditation Council for Continuing Medical Education. The phrase ‘‘current certificate in basic cardiopulmonary resuscitation,’’ when used in the September 3, 2020 or October 20, 2020 OASH authorizations, shall be interpreted the same way. See Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID–19 Vaccines and Immunity under the PREP Act, OASH, Sept. 3, 2020, available at https://www.hhs.gov/guidance/ sites/default/files/hhs-guidance-documents// licensed-pharmacists-and-pharmacy-internsregarding-covid-19-vaccines-immunity.pdf (last visited Jan. 24, 2021); Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID–19 Vaccines, and COVID–19 Testing, OASH, Oct. 20, 2020, available at https:// www.hhs.gov/guidance/sites/default/files/hhsguidance-documents//prep-act-guidance.pdf (last visited Jan. 24, 2021). public or otherwise would be more limited in scope than the activities such service member, employees, contractors, or volunteers are authorized to carry out under this declaration; and (h) The following healthcare professionals and students in a healthcare profession training program subject to the requirements of this paragraph: 1. Any midwife, paramedic, advanced or intermediate emergency medical technician (EMT), physician assistant, respiratory therapist, dentist, podiatrist, optometrist or veterinarian licensed or certified to practice under the law of any state who prescribes, dispenses, or administers COVID–19 vaccines that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a COVID–19 vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the COVID–19 vaccine covered countermeasure is administered; 2. Any physician, advanced practice registered nurse, registered nurse, practical nurse, pharmacist, pharmacy intern, midwife, paramedic, advanced or intermediate EMT, respiratory therapist, dentist, physician assistant, podiatrist, optometrist, or veterinarian who has held an active license or certification under the law of any State within the last five years, which is inactive, expired or lapsed, who prescribes, dispenses, or administers COVID–19 vaccines that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a COVID–19 vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the COVID–19 vaccine covered countermeasure is administered, so long as the license or certification was active and in good standing prior to the date it went inactive, expired or lapsed and was not revoked by the licensing authority, surrendered while under suspension, discipline or investigation by a licensing authority or surrendered following an arrest, and the individual is not on the List of Excluded Individuals/Entities maintained by the Office of Inspector General; 3. Any medical, nursing, pharmacy, pharmacy intern, midwife, paramedic, advanced or intermediate EMT, physician assistant, respiratory therapy, dental, podiatry, optometry or veterinary student with appropriate training in administering vaccines as determined by his or her school or training program and supervision by a currently practicing healthcare professional experienced in administering intramuscular injections who administers COVID–19 vaccines that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a COVID–19 vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the COVID–19 vaccine covered countermeasure is administered; Subject to the following requirements: i. The vaccine must be authorized, approved, or licensed by the FDA; ii. Vaccination must be ordered and administered according to ACIP’s COVID–19 vaccine recommendation(s); iii. The healthcare professionals and students must have documentation of completion of the Centers for Disease Control and Prevention COVID–19 Vaccine Training Modules and, if applicable, such additional training as may be required by the State, territory, locality, or Tribal area in which they are prescribing, dispensing, or administering COVID–19 vaccines; iv. The healthcare professionals and students must have documentation of an observation period by a currently practicing healthcare professional experienced in administering intramuscular injections, and for whom administering vaccinations is in their ordinary scope of practice, who confirms competency of the healthcare provider or student in preparation and administration of the COVID–19 vaccine(s) to be administered and, if applicable, such additional training as may be required by the State, territory, locality, or Tribal area in which they are prescribing, dispensing, or administering COVID–19 vaccines; v. The healthcare professionals and students must have a current certificate in basic cardiopulmonary resuscitation; 9 vi. The healthcare professionals and students must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient’s primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine; and vii. The healthcare professionals and students comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention (CDC) COVID– 19 vaccination provider agreement and any other federal requirements that apply to the administration of COVID– 19 vaccine(s). Nothing in this Declaration shall be construed to affect the National Vaccine Injury Compensation Program, including an injured party’s ability to obtain compensation under that program. Covered countermeasures that are subject to the National Vaccine Injury Compensation Program authorized under 42 U.S.C. 300aa–10 et seq. are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program. All other terms and conditions of the Declaration apply to such covered countermeasures. 2. Effective Time Period, section XII, delete in full and replace with: Liability protections for any respiratory protective device approved by NIOSH under 42 CFR part 84, or any successor regulations, through the means of distribution identified in Section VII(a) of this Declaration, begin on March 27, 2020 and extend through October l, 2024. Liability protections for all other Covered Countermeasures identified in Section VI of this Declaration, through means of distribution identified in Section VII(a) of this Declaration, begin on February 4, 2020 and extend through October l, 2024. Liability protections for all Covered Countermeasures administered and used in accordance with the public health and medical response of the Authority Having Jurisdiction, as VerDate Sep<11>2014 16:52 Mar 15, 2021 Jkt 253001 PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 E:\FR\FM\16MRN1.SGM 16MRN1 jbell on DSKJLSW7X2PROD with NOTICES 14468 Federal Register / Vol. 86, No. 49 / Tuesday, March 16, 2021 / Notices identified in Section VII(b) of this Declaration, begin with a Declaration of Emergency as that term is defined in Section VII (except that, with respect to qualified persons who order or administer a routine childhood vaccination that ACIP recommends to persons ages three through 18 according to ACIP’s standard immunization schedule, liability protections began on August 24, 2020), and last through (a) the final day the Declaration of Emergency is in effect, or (b) October l, 2024, whichever occurs first. Liability protections for all Covered Countermeasures identified in Section VII(c) of this Declaration begin on December 9, 2020 and last through (a) the final day the Declaration of Emergency is in effect, or (b) October l, 2024, whichever occurs first. Liability protections for Qualified Persons under section V(f) of the declaration begin on February 2, 2021, and last through October 1, 2024. Liability protections for Qualified Persons under section V(g) of the declaration begin on February 16, 2021, and last through October 1, 2024. Liability protections for Qualified Persons who are physicians, advanced practice registered nurses, registered nurses, or practical nurses under section V(h) of the declaration begins on February 2, 2021 and last through October 1, 2024, with additional conditions effective as of March 11, 2021 and liability protections for all other Qualified persons under section V(h) begins on March 11, 2021 and last through October 1, 2024. Authority: 42 U.S.C. 247d–6d. Norris Cochran, Acting Secretary, Department of Health and Human Services. [FR Doc. 2021–05401 Filed 3–11–21; 4:15 pm] BILLING CODE 4150–37–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Dental & Craniofacial Research; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Board of Scientific Counselors, National Institute of Dental and Craniofacial Research. The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Board of Scientific Counselors, National Institute of Dental and Craniofacial Research. Date: May 18–19, 2021. Time: 9:00 a.m. to 4:15 p.m. Agenda: To review and evaluate personnel qualifications and performance, and competence of individual investigators. Place: National Institutes of Health, 6701 Democracy Blvd., Bethesda, MD 20892 (Virtual Meeting). Contact Person: Alicia J. Dombroski, Ph.D., Director, Division of Extramural Activities, Natl Inst of Dental and Craniofacial Research, National Institutes of Health, Bethesda, MD 20892. (Catalogue of Federal Domestic Assistance Program No. 93.121, Oral Diseases and Disorders Research, National Institutes of Health, HHS) Dated: March 10, 2021. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–05351 Filed 3–15–21; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services [OMB Control Number 1615–0046] Agency Information Collection Activities; Extension, Without Change, of a Currently Approved Collection: Interagency Alien Witness and Informant Record AGENCY: U.S. Citizenship and Immigration Services, Department of Homeland Security. ACTION: 60-day notice. SUMMARY: The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) invites the general public and other Federal agencies to comment upon this proposed extension of a currently approved collection of information. In accordance with the Paperwork Reduction Act (PRA) of 1995, the information collection notice is published in the Federal Register to obtain comments regarding the nature of the information collection, the categories of respondents, the estimated burden (i.e., the time, effort, and resources used by the respondents to respond), the estimated cost to the respondent, and the actual information collection instruments. DATES: Comments are encouraged and will be accepted for 60 days until May 17, 2021. ADDRESSES: All submissions received must include the OMB Control Number 1615–0046 in the body of the letter, the agency name and Docket ID USCIS– 2006–0062. Submit comments via the Federal eRulemaking Portal website at https://www.regulations.gov under eDocket ID number USCIS–2006–0062. USCIS is limiting communications for this Notice as a result of USCIS’ COVID– 19 response actions. FOR FURTHER INFORMATION CONTACT: USCIS, Office of Policy and Strategy, Regulatory Coordination Division, Samantha Deshommes, Chief, telephone number (240) 721–3000 (This is not a toll-free number. Comments are not accepted via telephone message). Please note contact information provided here is solely for questions regarding this notice. It is not for individual case status inquiries. Applicants seeking information about the status of their individual cases can check Case Status Online, available at the USCIS website at https://www.uscis.gov, or call the USCIS Contact Center at 800–375–5283 (TTY 800–767–1833). SUPPLEMENTARY INFORMATION: Comments You may access the information collection instrument with instructions or additional information by visiting the Federal eRulemaking Portal site at: https://www.regulations.gov and entering USCIS–2006–0062 in the search box. All submissions will be posted, without change, to the Federal eRulemaking Portal at https:// www.regulations.gov, and will include any personal information you provide. Therefore, submitting this information makes it public. You may wish to consider limiting the amount of personal information that you provide in any voluntary submission you make to DHS. DHS may withhold information provided in comments from public viewing that it determines may impact the privacy of an individual or is offensive. For additional information, please read the Privacy Act notice that is available via the link in the footer of https://www.regulations.gov. Written comments and suggestions from the public and affected agencies should address one or more of t

Technical Correction to Fifth and Sixth Amendments to the Declaration under the PREP Act for Medical Countermeasures Against COVID-19 (February 22, 2021):

AGENCY:

Office of the Secretary, Department of Health and Human Services.

ACTION:

Notice, correction.

SUMMARY:

This document corrects one technical error that appeared in the final notice published in the Federal Register on February 2, 2021 entitled “Fifth Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19” and two technical errors that appeared in the final notice published in the Federal Register on Tuesday, February 16, 2021, entitled “Sixth Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19.”

DATES:

The correction to the final notice entitled “Fifth Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19” is effective February 2, 2021 and the corrections to the final notice entitled “Sixth Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19” are effective February 16, 2021.

FOR FURTHER INFORMATION CONTACT:

L. Paige Ezernack, Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue SW, Washington, DC 20201; 202-260-0365, paige.ezernack@hhs.gov.

Corrections

1. Correction to final notice published in the Federal Register on February 2, 2021 entitled “Fifth Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19.

Amendments to the Declaration, section 2, Effective Time Period, section XII; the sentence is corrected to read: “add to the end of the section: Liability protections for Qualified Persons under sections V(f) and V(g) of the declaration begin on February 2, 2021, and last through October 1, 2024.

2. Corrections to final notice published in the Federal Register on Tuesday, February 16, 2021, entitled “Sixth Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19.

Amendments to the Declaration, section 1, subsection V(h) is amended to read:

(h) Any member of a uniformed service (including members of the National Guard in a Title 32 duty status) (hereafter in this paragraph “service member”) or Federal government, employee, contractor, or volunteer who prescribes, administers, delivers, distributes or dispenses a Covered Countermeasure. Such Federal government service members, employees, contractors, or volunteers are qualified persons if the following requirement is met: The executive department or agency by or for which the Federal service member, employee, contractor, or volunteer is employed, contracts, or volunteers has authorized or could authorize that service member, employee, contractor, or volunteer to prescribe, administer, deliver, distribute, or dispense the Covered Countermeasure as any part of the duties or responsibilities of that service member, employee, contractor, or volunteer, even if those authorized duties or responsibilities ordinarily would not extend to members of the public or otherwise would be more limited in scope than the activities such service member, employees, contractors, or volunteers are authorized to carry out under this declaration.

Amendments to the Declaration, section 2, Effective Time Period, section XII; the sentence is corrected to read: “add to the end of the section: Liability protections for Qualified Persons under section V(h) of the declaration begin on February 16, 2021, and last through October 1, 2024.

Wilma Robinson,

Deputy Executive Secretary, U.S. Department of Health and Human Services.

[FR Doc. 2021-03526 Filed 2-19-21; 8:45 am]

BILLING CODE 4150-37-P

Seventh Amendment to Declaration under the PREP Act for Medical Countermeasures Against COVID–19 (March 11,  2021):

ACTION:

Notice of amendment.

SUMMARY:

The Acting Secretary issues this amendment pursuant to section 319F-3 of the Public Health Service Act to add additional categories of Qualified Persons authorized to prescribe, dispense, and administer covered countermeasures under section VI of this Declaration.

DATES:

This amendment to the Declaration is effective as of February 16, 2021.

FOR FURTHER INFORMATION CONTACT:

L. Paige Ezernack, Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue SW, Washington, DC 20201; 202-260-0365, paige.ezernack@hhs.gov.

SUPPLEMENTARY INFORMATION:

The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to issue a Declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (Covered Countermeasures), except for claims involving “willful misconduct” as defined in the PREP Act. Under the PREP Act, a Declaration may be amended as circumstances warrant.

The PREP Act was enacted on December 30, 2005, as Public Law 109-148, Division C, section 2. It amended the Public Health Service (PHS) Act, adding section 319F-3, which addresses liability immunity, and section 319F-4, which creates a compensation program. These sections are codified at 42 U.S.C. 247d-6d and 42 U.S.C. 247d-6e, respectively. Section 319F-3 of the PHS Act has been amended by the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, enacted on March 13, 2013 and the Coronavirus Aid, Relief, and Economic Security (CARES) Act, Public Law 116-136, enacted on March 27, 2020, to expand Countermeasures under the PREP Act.

On January 31, 2020, former Secretary, Alex M. Azar II, declared a public health emergency pursuant to section 319 of the PHS Act, 42 U.S.C. 247d, effective January 27, 2020, for the entire United States to aid in the response of the nation’s health care community to the COVID-19 outbreak. Pursuant to section 319 of the PHS Act, the Secretary renewed that declaration effective on April 26, 2020, July 25, 2020, October 23, 2020, and January 21, 2021.

On March 10, 2020, former Secretary Azar issued a Declaration under the PREP Act for medical countermeasures against COVID-19 (85 FR 15198, Mar. 17, 2020) (the Declaration). On April 10, the former Secretary amended the Declaration under the PREP Act to extend liability immunity to covered countermeasures authorized under the CARES Act (85 FR 21012, Apr. 15, 2020). On June 4, the former Secretary amended the Declaration to clarify that covered countermeasures under the Declaration include qualified countermeasures that limit the harm COVID-19 might otherwise cause. (85 FR 35100, June 8, 2020). On August 19, the former Secretary amended the declaration to add additional categories of Qualified Persons and amend the category of disease, health condition, or threat for which he recommended the administration or use of the Covered Countermeasures. (85 FR 52136, August 24, 2020). On December 3, 2020, the former Secretary amended the declaration to incorporate Advisory Opinions of the General Counsel interpreting the PREP Act and the Secretary’s Declaration and authorizations issued by the Department’s Office of the Assistant Secretary for Health as an Authority Having Jurisdiction to respond; added an additional category of qualified persons under Section V of the Declaration; made explicit that the Declaration covers all qualified pandemic and epidemic products as defined under the PREP Act; added a third method of distribution to provide liability protections for, among other things, private distribution channels; made explicit that there can be situations where not administering a covered countermeasure to a particular individual can fall within the PREP Act and the Declaration’s liability protections; made explicit that there are substantive federal legal and policy issues and interests in having a unified whole-of-nation response to the COVID-19 pandemic among federal, state, local, and private-sector entities; revised the effective time period of the Declaration; and republished the declaration in full. (85 FR 79190 December 9, 2020). On January 28, 2021, the Acting Secretary amended the Declaration to add additional categories of Qualified Persons authorized to prescribe, dispense, and administer COVID-19 vaccines that are covered countermeasures under the Declaration (86 FR 7872, February 2, 2021).

The Acting Secretary now amends section V of the Declaration to add a new subsection (h) to add an additional category of qualified persons covered under the PREP Act, and thus authorizes:

(h) Any Federal government employee, contractor, or volunteer who prescribes, administers, delivers, distributes or dispenses a Covered Countermeasure. Such Federal government employees, contractors, or volunteers are qualified persons if the following requirement is met: The executive department or agency by or for which the Federal employee, contractor, or volunteer is employed, contracts, or volunteers has authorized or could authorize that employee, contractor, or volunteer to prescribe, administer, deliver, distribute, or dispense the Covered Countermeasure as any part of the duties or responsibilities of that employee, contractor, or volunteer, even if those authorized duties or responsibilities ordinarily would not extend to members of the public or otherwise would be more limited in scope than the activities such employees, contractors, or volunteers are authorized to carry out under this declaration.

Description of This Amendment by Section

Section V. Covered Persons

Under the PREP Act and the Declaration, a “qualified person” is a “covered person.” Subject to certain limitations, a covered person is immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration or use of a covered countermeasure if a declaration under the PREP Act has been issued with respect to such countermeasure. “Qualified person” includes (A) a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed; or (B) “a person within a category of persons so identified in a declaration by the Secretary” under subsection (b) of the PREP Act. 42 U.S.C. 247d-6d(i)(8)

By this amendment to the Declaration, the Acting Secretary identifies an additional category of persons who are qualified persons under section 247d-6d(i)(8)(B): Federal employees, contractors and volunteers authorized by their Department or agency to prescribe, administer, deliver, distribute, or dispense the Covered Countermeasure as any part of their duties or responsibilities.

The Acting Secretary has determined that there is an urgent need to expand the pool of available COVID-19 vaccinators in order to respond effectively to the pandemic. As vaccine supply is made more widely available over the coming months, health care system capacity and the vaccination workforce are likely to become increasingly strained throughout the Nation. The United States is deploying federal personnel, contractors and volunteers to assist in the national COVID-19 vaccination program. While the United States is a covered person under the PREP Act and the Declaration, this amendment clarifies that federal employees, contractors and volunteers are also qualified persons authorized by the Secretary to prescribe, dispense, or administer covered countermeasures, consistent with the terms and conditions of the Declaration.

As qualified persons, these employees, contractors and volunteers will be afforded liability protections in accordance with the PREP Act and the terms of this amended Declaration in addition to the protection that is afforded to the United States as a covered person. Second, to the extent that any State law that would otherwise prohibit the employees, contractors, or volunteers who are a “qualified person” from prescribing, dispensing, or administering COVID-19 vaccines or other Covered Countermeasures, such law is preempted. On May 19, 2020, the Office of the General Counsel issued an advisory opinion concluding that, because licensed pharmacists are “qualified persons” under this declaration, the PREP Act preempts state law that would otherwise prohibit such pharmacists from ordering and administering authorized COVID-19 diagnostic tests.^[1] The opinion relied in part on the fact that the Congressional delegation of authority to the Secretary under the PREP Act to specify a class of persons, beyond those who are authorized to administer a covered countermeasure under State law, as “qualified persons” would be rendered a nullity in the absence of such preemption. This opinion is incorporated by reference into this declaration. Based on the reasoning set forth in the May 19, 2020 advisory opinion, any State law that would otherwise prohibit a member of any of the classes of “qualified persons” specified in this declaration from administering a covered countermeasure is likewise preempted. In accordance with section 319F-3(i)(8)(A) of the Public Health Service Act, a State remains free to expand the universe of individuals authorized to administer covered countermeasures within its jurisdiction under State law.

The plain language of the PREP Act makes clear that there is preemption of state law as described above. Furthermore, preemption of State law is justified to respond to the nation-wide public health emergency caused by COVID-19 as it will enable States to quickly expand the vaccination workforce with additional qualified healthcare professionals where State or local requirements might otherwise inhibit or delay allowing these healthcare professionals to participate in the COVID-19 vaccination program.

Amendments to Declaration

Amended Declaration for Public Readiness and Emergency Preparedness Act Coverage for medical countermeasures against COVID-19.

Section V of the March 10, 2020 Declaration under the PREP Act for medical countermeasures against COVID-19, as amended April 10, 2020, June 4, 2020, August 19, 2020, as amended and republished on December 3, 2020, and as amended on February 2, 2021, is further amended pursuant to section 319F-3(b)(4) of the PHS Act as described below. All other sections of the Declaration remain in effect as republished at 85 FR 79190 (December 9, 2020).

1. Covered Persons, section V, delete in full and replace with:

V. Covered Persons

42 U.S.C. 247d-6d(i)(2), (3), (4), (6), (8)(A) and (B)

Covered Persons who are afforded liability immunity under this Declaration are “manufacturers,” “distributors,” “program planners,” “qualified persons,” and their officials, agents, and employees, as those terms are defined in the PREP Act, and the United States. “Order” as used herein and in guidance issued by the Office of the Assistant Secretary for Health ^[2] means a provider medication order, which includes prescribing of vaccines, or a laboratory order, which includes prescribing laboratory orders, if required. In addition, I have determined that the following additional persons are qualified persons:

(a) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction, as described in Section VII below, to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a Declaration of an Emergency, as that term is defined in Section VII of this Declaration; ^[3]

(b) Any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with Section 564 of the FD&C Act;

(c) Any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the FD&C Act;

(d) A State-licensed pharmacist who orders and administers, and pharmacy interns who administer (if the pharmacy intern acts under the supervision of such pharmacist and the pharmacy intern is licensed or registered by his or her State board of pharmacy),^[4] (1) vaccines that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP’s standard immunization schedule or (2) FDA authorized or FDA licensed COVID -19 vaccines to persons ages three or older. Such State-licensed pharmacists and the State-licensed or registered interns under their supervision are qualified persons only if the following requirements are met:

i. The vaccine must be authorized, approved, or licensed by the FDA;

ii. In the case of a COVID-19 vaccine, the vaccination must be ordered and administered according to ACIP’s COVID-19 vaccine recommendation(s).

iii. In the case of a childhood vaccine, the vaccination must be ordered and administered according to ACIP’s standard immunization schedule;

iv. The licensed pharmacist must have completed the immunization training that the licensing State requires in order for pharmacists to order and administer vaccines. If the State does not specify training requirements for the licensed pharmacist to order and administer vaccines, the licensed pharmacist must complete a vaccination training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE) to order and administer vaccines. Such a training program must include hands on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines;

v. The licensed or registered pharmacy intern must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines;

vi. The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation; ^[5]

vii. The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period;

viii. The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient’s primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine;

ix. The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregiver accompanying the child of the importance of a well-child visit with a pediatrician or other licensed primary care provider and refer patients as appropriate; and

x. The licensed pharmacist and the licensed or registered pharmacy intern must comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention (CDC) COVID-19 vaccination provider agreement and any other federal requirements that apply to the administration of COVID-19 vaccine(s).

(e) Healthcare personnel using telehealth to order or administer Covered Countermeasures for patients in a state other than the state where the healthcare personnel are licensed or otherwise permitted to practice. When ordering and administering Covered Countermeasures by means of telehealth to patients in a state where the healthcare personnel are not already permitted to practice, the healthcare personnel must comply with all requirements for ordering and administering Covered Countermeasures to patients by means of telehealth in the state where the healthcare personnel are permitted to practice. Any state law that prohibits or effectively prohibits such a qualified person from ordering and administering Covered Countermeasures by means of telehealth is preempted.^[6] Nothing in this Declaration shall preempt state laws that permit additional persons to deliver telehealth services.

(f) Any healthcare professional or other individual who holds an active license or certification permitting the person to prescribe, dispense, or administer vaccines under the law of any State as of the effective date of this amendment, or as authorized under the section V(d) of this Declaration, who prescribes, dispenses, or administers COVID-19 vaccines that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies, other than the State in which the license or certification is held, in association with a COVID-19 vaccination effort by a federal, State, local Tribal or territorial authority or by an institution in the State in which the COVID-19 vaccine covered countermeasure is administered, so long as the license or certification of the healthcare professional has not been suspended or restricted by any licensing authority, surrendered while under suspension, discipline or investigation by a licensing authority or surrendered following an arrest, and the individual is not on the List of Excluded Individuals/Entities maintained by the Office of Inspector General, subject to: (i) Documentation of completion of the Centers for Disease Control and Prevention COVID-19 (CDC) Vaccine Training Modules ^[7] and, for healthcare providers who are not currently practicing, documentation of an observation period by a currently practicing healthcare professional adequately experienced in vaccination who confirms competency of the healthcare provider in preparation and administration of the particular COVID-19 vaccine(s) to be administered; and

(g) Any physician, advanced practice registered nurse, registered nurse, or practical nurse who has held an active license or certification to prescribe, dispense, or administer vaccines under the law of any State within the last five years, which is inactive, expired or lapsed, who prescribes, dispenses, or administers COVID-19 vaccines that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a COVID-19 vaccination effort by a federal, State, local, Tribal or territorial authority or by an institution in which the COVID-19 vaccine covered countermeasure is administered, so long as the license or certification was active and in good standing prior to the date it went inactive, expired or lapsed and was not revoked by the licensing authority, surrendered while under suspension, discipline or investigation by a licensing authority or surrendered following an arrest, and the individual is not on the List of Excluded Individuals/Entities maintained by the Office of Inspector General, subject to (i) documentation of completion of the Centers for Disease Control and Prevention COVID-19 Vaccine Training Modules and (ii) documentation of an observation period by a currently practicing healthcare professional adequately experienced in vaccination who confirms competency of the healthcare provider in preparation and administration of the particular COVID-19 vaccine(s) to be administered.

(h) Any Federal government employee, contractor, or volunteer who prescribes, administers, delivers, distributes or dispenses a Covered Countermeasure. Such Federal government employees, contractors, or volunteers are qualified persons if the following requirement is met: The executive department or agency by or for which the Federal employee, contractor, or volunteer is employed, contracts, or volunteers has authorized or could authorize that employee, contractor, or volunteer to prescribe, administer, deliver, distribute, or dispense the Covered Countermeasure as any part of the duties or responsibilities of that employee, contractor, or volunteer, even if those authorized duties or responsibilities ordinarily would not extend to members of the public or otherwise would be more limited ien scope than the activities such employees, contractors, or volunteers are authorized to carry out under this declaration.

Nothing in this Declaration shall be construed to affect the National Vaccine Injury Compensation Program, including an injured party’s ability to obtain compensation under that program. Covered countermeasures that are subject to the National Vaccine Injury Compensation Program authorized under 42 U.S.C. 300aa-10 et seq. are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program. All other terms and conditions of the Declaration apply to such covered countermeasures.

2. Effective Time Period, Section XII, Add to the End of the Section:

Liability protections for Qualified Persons under sections V(f) and V(d) of the declaration begin on February 8, 2021 and last through October 1, 2024.

Authority: 42 U.S.C. 247d-6d.

Norris Cochran,

Acting Secretary, Department of Health and Human Services.

Footnotes

1.  Department of Health and Human Services General Counsel Advisory Opinion on the Public Readiness and Emergency Preparedness Act, May 19, 2020, available at: https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​prep-act-advisory-opinion-hhs-ogc.pdf/​ (last visited Jan. 24, 2021). See also, Department of Justice Office of Legal Counsel Advisory Opinion for Robert P. Charrow, General Counsel of the Department of Health and Human Services, January 12, 2020, available at: https://www.justice.gov/​sites/​default/​files/​opinions/​attachments/​2021/​01/​19/​2021-01-19-prep-act-preemption.pdf (last visited Jan. 24, 2021). Back to Citation

2.  See Guidance for Licensed Pharmacists, COVID-19 Testing, and Immunity Under the PREP Act, OASH, Apr. 8, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.pdf (last visited Jan. 24, 2021); Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act, OASH, Sept. 3, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf (last visited Jan. 24, 2021). Back to Citation

3.  See, e.g., Guidance for Licensed Pharmacists, COVID-19 Testing, and Immunity Under the PREP Act, OASH, Apr. 8, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.pdf (last visited Jan. 24, 2021); Guidance for PREP Act Coverage for COVID-19 Screening Tests at Nursing Homes, Assisted-Living Facilities, Long-Term-Care Facilities, and other Congregate Facilities, OASH, Aug. 31, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​prep-act-coverage-for-screening-in-congregate-settings.pdf (last visited Jan. 24, 2021); Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act, OASH, Sept. 3, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf (last visited Jan. 24, 2021); Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH, Oct. 20, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/prep-act-guidance.pdf (last visited Jan. 24, 2021); PREP Act Authorization for Pharmacies Distributing and Administering Certain Covered Countermeasures, Oct. 29, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/prep-act-authorization-pharmacies-administering-covered-countermeasures.pdf (last visited Jan. 24, 2021) (collectively, OASH PREP Act Authorizations). Nothing herein shall suggest that, for purposes of the Declaration, the foregoing are the only persons authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction. Back to Citation

4.  Some states do not require pharmacy interns to be licensed or registered by the state board of pharmacy. As used herein, “State-licensed or registered intern” (or equivalent phrases) refers to pharmacy interns authorized by the state or board of pharmacy in the state in which the practical pharmacy internship occurs. The authorization can, but need not, take the form of a license from, or registration with, the State board of pharmacy. See Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH, Oct. 20, 2020 at 2, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/prep-act-guidance.pdf (last visited Jan. 24, 2021). Back to Citation

5.  This requirement is satisfied by, among other things, a certification in basic cardiopulmonary resuscitation by an online program that has received accreditation from the American Nurses Credentialing Center, the ACPE, or the Accreditation Council for Continuing Medical Education. The phrase “current certificate in basic cardiopulmonary resuscitation,” when used in the September 3, 2020 or October 20, 2020 OASH authorizations, shall be interpreted the same way. See Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act, OASH, Sept. 3, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf (last visited Jan. 24, 2021); Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH, Oct. 20, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/prep-act-guidance.pdf (last visited Jan. 24, 2021). Back to Citation

6.  See, e.g., Advisory Opinion 20-02 on the Public Readiness and Emergency Preparedness Act and the Secretary’s Declaration under the Act, May 19, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​advisory-opinion-20-02-hhs-ogc-prep-act.pdf (last visited Jan. 24, 2021). Back to Citation

7.  See COVID-19 Vaccine Training Modules, available at https://www.cdc.gov/​vaccines/​covid-19/​training.html. Back to Citation

[FR Doc. 2021-03106 Filed 2-11-21; 4:15 pm]

BILLING CODE 4150-37-P

Eighth Amendment to Declaration Under the PREP Act for Medical Countermeasures Against COVID–19 (August 4, 2021):

7872 Federal Register / Vol. 86, No. 20 / Tuesday, February 2, 2021 / Notices Agenda: To review and evaluate grant applications. For Further Information Contact: Jaya Raman, Ph.D., Scientific Review Officer, National Center for Chronic Disease Prevention and Health Promotion, CDC, 4770 Buford Highway, Mailstop S107–8, Atlanta, Georgia 30341, Telephone (770) 488–6511, JRaman@cdc.gov. The Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Kalwant Smagh, Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention. [FR Doc. 2021–02164 Filed 2–1–21; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended, and the Determination of the Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, CDC, pursuant to Public Law 92–463. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP)— SIP21–003, Evaluating Alternative Delivery Models for ArthritisAppropriate Evidence-Based Physical Activity and Self-Management Interventions. Date: April 29, 2021. Time: 11:00 a.m.–6:00 p.m., EDT. Place: Teleconference. Agenda: To review and evaluate grant applications. For Further Information Contact: Jaya Raman, Ph.D., Scientific Review Officer, National Center for Chronic Disease Prevention and Health Promotion, CDC, 4770 Buford Highway, Mailstop S107–8, Atlanta, Georgia 30341, Telephone (770) 488–6511, JRaman@cdc.gov. The Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Kalwant Smagh, Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention. [FR Doc. 2021–02160 Filed 2–1–21; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Fifth Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID–19 ACTION: Notice of amendment. SUMMARY: The Acting Secretary issues this amendment pursuant to section 319F–3 of the Public Health Service Act to add additional categories of Qualified Persons authorized to prescribe, dispense, and administer COVID–19 vaccines that are covered countermeasures under section VI of this Declaration. DATES: This amendment to the Declaration is effective as of February 2, 2021. FOR FURTHER INFORMATION CONTACT: L. Paige Ezernack, Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue SW, Washington, DC 20201; Telephone: 202–260–0365; paige.ezernack@hhs.gov. SUPPLEMENTARY INFORMATION: The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to issue a Declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (Covered Countermeasures), except for claims involving ‘‘willful misconduct’’ as defined in the PREP Act. Under the PREP Act, a Declaration may be amended as circumstances warrant. The PREP Act was enacted on December 30, 2005, as Public Law 109– 148, Division C, section 2. It amended the Public Health Service (PHS) Act, adding section 319F–3, which addresses liability immunity, and section 319F–4, which creates a compensation program. These sections are codified at 42 U.S.C. 247d–6d and 42 U.S.C. 247d–6e, respectively. Section 319F–3 of the PHS Act has been amended by the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113–5, enacted on March 13, 2013 and the Coronavirus Aid, Relief, and Economic Security (CARES) Act, Public Law 116–136, enacted on March 27, 2020, to expand Countermeasures under the PREP Act. On January 31, 2020, former Secretary Alex M. Azar II declared a public health emergency pursuant to section 319 of the PHS Act, 42 U.S.C. 247d, effective January 27, 2020, for the entire United States to aid in the response of the nation’s health care community to the COVID–19 outbreak. Pursuant to section 319 of the PHS Act, the Secretary renewed that declaration effective on April 26, 2020, July 25, 2020, October 23, 2020, and January 21, 2121. On March 10, 2020, former Secretary Azar issued a Declaration under the PREP Act for medical countermeasures against COVID–19 (85 FR 15198, Mar. 17, 2020) (the Declaration). On April 10, the former Secretary amended the Declaration under the PREP Act to extend liability immunity to covered countermeasures authorized under the CARES Act (85 FR 21012, Apr. 15, 2020). On June 4, the former Secretary amended the Declaration to clarify that covered countermeasures under the Declaration include qualified countermeasures that limit the harm COVID–19 might otherwise cause. (85 FR 35100, June 8, 2020) On August 19, the former Secretary amended the declaration to add additional categories of Qualified Persons and amend the category of disease, health condition, or threat for which he recommended the administration or use of the Covered Countermeasures. (85 FR 51236, August 24, 2020). On December 3, 2020, the former Secretary amended the declaration to incorporate Advisory Opinions of the General Counsel interpreting the PREP Act and the VerDate Sep<11>2014 19:08 Feb 01, 2021 Jkt 253001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\FR\FM\02FEN1.SGM 02FEN1 jbell on DSKJLSW7X2PROD with NOTICES Federal Register / Vol. 86, No. 20 / Tuesday, February 2, 2021 / Notices 7873 1See COVID–19 Vaccine Training Modules, available at https://www.cdc.gov/vaccines/covid-19/ training.html. Secretary’s Declaration and authorizations issued by the Department’s Office of the Assistant Secretary for Health as an Authority Having Jurisdiction to respond; added an additional category of qualified persons under Section V of the Declaration; made explicit that the Declaration covers all qualified pandemic and epidemic products as defined under the PREP Act; added a third method of distribution to provide liability protections for, among other things, private distribution channels; made explicit that there can be situations where not administering a covered countermeasure to a particular individual can fall within the PREP Act and the Declaration’s liability protections; made explicit that there are substantive Federal legal and policy issues and interests in having a unified whole-of-nation response to the COVID– 19 pandemic among Federal, state, local, and private-sector entities; revised the effective time period of the Declaration; and republished the declaration in full. (85 FR 79190 December 9, 2020). The Acting Secretary now amends section V of the Declaration to add additional categories of qualified persons covered under the PREP Act, and thus authorizes: (f) Any healthcare professional or other individual who holds an active license or certification permitting the person to prescribe, dispense, or administer vaccines under the law of any State as of the effective date of this amendment, or as authorized under section V(d) of this Declaration, who prescribes, dispenses, or administers COVID–19 vaccines that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies, other than the State in which the license or certification is held, in association with a COVID–19 vaccination effort by a federal, State, local, Tribal, or territorial authority or by an institution in the State in which the COVID–19 vaccine covered countermeasure is administered, so long as the license or certification of the healthcare professional has not been suspended or restricted by any licensing authority, surrendered while under suspension, discipline or investigation by a licensing authority or surrendered following an arrest, and the individual is not on the List of Excluded Individuals/Entities maintained by the Office of Inspector General, subject to: (i) Documentation of completion of the Centers for Disease Control and Prevention COVID–19 (CDC) Vaccine Training Modules 1 and, for healthcare providers who are not currently practicing, documentation of an observation period by a currently practicing healthcare professional adequately experienced in vaccination who confirms competency of the healthcare provider in preparation and administration of the particular COVID– 19 vaccine(s) to be administered; and (g) Any physician, advanced practice registered nurse, registered nurse, or practical nurse who has held an active license or certification to prescribe, dispense, or administer vaccines under the law of any State within the last five years, which is inactive, expired or lapsed, who prescribes, dispenses, or administers COVID–19 vaccines that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a COVID–19 vaccination effort by a federal, State, local, tribal or territorial authority or by an institution in which the COVID–19 vaccine covered countermeasure is administered, so long as the license or certification was active and in good standing prior to the date it went inactive, expired or lapsed and was not revoked by the licensing authority, surrendered while under suspension, discipline, or investigation by a licensing authority or surrendered following an arrest, and the individual is not on the List of Excluded Individuals/Entities maintained by the Office of Inspector General, subject to (i) documentation of completion of the Centers for Disease Control and Prevention COVID–19 Vaccine Training Modules and (ii) documentation of an observation period by a currently practicing healthcare professional adequately experienced in vaccination who confirms competency of the healthcare provider in preparation and administration of the particular COVID– 19 vaccine(s) to be administered. Description of This Amendment by Section Section V. Covered Persons Under the PREP Act and the Declaration, a ‘‘qualified person’’ is a ‘‘covered person.’’ Subject to certain limitations, a covered person is immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration or use of a covered countermeasure if a declaration under the PREP Act has been issued with respect to such countermeasure. ‘‘Qualified person’’ includes (A) a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed; or (B) ‘‘a person within a category of persons so identified in a declaration by the Secretary’’ under subsection (b) of the PREP Act. 42 U.S.C. 247d–6d(i)(8). By this amendment to the Declaration, the Acting Secretary identifies two additional categories of persons who are qualified persons under section 247d– 6d(i)(8)(B), allowing healthcare providers who are licensed in a State to prescribe, dispense, and/or administer COVID–19 vaccines in any State or jurisdiction where the PREP Act applies, and allowing physicians, registered nurses, and practical nurses whose licenses expired within the past five years to prescribe, dispense, and/or administer COVID–19 vaccines in any State. The Acting Secretary has determined that there is an urgent need to expand the pool of available COVID–19 vaccinators in order to respond effectively to the pandemic. As vaccine supply is made more widely available over the coming months, health care system capacity and the vaccination workforce are likely to become increasingly strained throughout the Nation. Permitting Physicians, registered nurses, and practical nurses who have recently expired licenses also significantly expands the vaccination workforce. There are approximately 160,000 inactive physicians and 350,000 inactive registered nurses and practical nurses in the United States. These healthcare professionals can safely administer COVID–19 vaccines because they all have training in performing injections and observing for side effects and will be required to document completion of the Centers for Disease Control and Prevention (CDC) COVID–19 Vaccine Training Modules. Including these healthcare professionals as Qualified Persons under this amended Declaration achieves two purposes. First, the healthcare professionals will be afforded liability protections in accordance with the PREP Act and the terms of this amended Declaration. Second, any State law that would otherwise prohibit the healthcare professionals who are a ‘‘qualified person’’ from prescribing, dispensing, or administering COVID–19 vaccines is preempted. On May 19, 2020, the Office of the General Counsel issued an advisory opinion concluding that, because licensed pharmacists are VerDate Sep<11>2014 19:08 Feb 01, 2021 Jkt 253001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\02FEN1.SGM 02FEN1 jbell on DSKJLSW7X2PROD with NOTICES 7874 Federal Register / Vol. 86, No. 20 / Tuesday, February 2, 2021 / Notices 2 Department of Health and Human Services General Counsel Advisory Opinion on the Public Readiness and Emergency Preparedness Act, May 19, 2020, available at: https://www.hhs.gov/ guidance/sites/default/files/hhs-guidancedocuments/prep-act-advisory-opinion-hhs-ogc.pdf/ (last visited Jan. 24, 2021). See also, Department of Justice Office of Legal Counsel Advisory Opinion for Robert P. Charrow, General Counsel of the Department of Health and Human Services, January 12, 2020, available at: https://www.justice.gov/sites/ default/files/opinions/attachments/2021/01/19/ 2021-01-19-prep-act-preemption.pdf (last visited Jan. 24, 2021). 3See Guidance for Licensed Pharmacists, COVID– 19 Testing, and Immunity Under the PREP Act, OASH, Apr. 8, 2020, available at https:// www.hhs.gov/guidance/sites/default/files/hhsguidance-documents//authorizing-licensedpharmacists-to-order-and-administer-covid-19- tests.pdf (last visited Jan. 24, 2021); Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID–19 Vaccines and Immunity under the PREP Act, OASH, Sept. 3, 2020, available at https://www.hhs.gov/guidance/sites/default/files/ hhs-guidance-documents//licensed-pharmacistsand-pharmacy-interns-regarding-covid-19-vaccinesimmunity.pdf (last visited Jan. 24, 2021). 4See, e.g., Guidance for Licensed Pharmacists, COVID–19 Testing, and Immunity Under the PREP Act, OASH, Apr. 8, 2020, available at https:// www.hhs.gov/guidance/sites/default/files/hhsguidance-documents//authorizing-licensedpharmacists-to-order-and-administer-covid-19- tests.pdf (last visited Jan. 24, 2021); Guidance for PREP Act Coverage for COVID–19 Screening Tests at Nursing Homes, Assisted-Living Facilities, LongTerm-Care Facilities, and other Congregate Facilities, OASH, Aug. 31, 2020, available at https://www.hhs.gov/guidance/sites/default/files/ hhs-guidance-documents//prep-act-coverage-forscreening-in-congregate-settings.pdf (last visited Jan. 24, 2021); Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID–19 Vaccines and Immunity under the PREP Act, OASH, Sept. 3, 2020, available at https:// www.hhs.gov/guidance/sites/default/files/hhsguidance-documents//licensed-pharmacists-andpharmacy-interns-regarding-covid-19-vaccinesimmunity.pdf (last visited Jan. 24, 2021); Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID–19 Vaccines, and COVID–19 Testing, OASH, Oct. 20, 2020, available at https://www.hhs.gov/guidance/ sites/default/files/hhs-guidance-documents//prepact-guidance.pdf (last visited Jan. 24, 2021); PREP Act Authorization for Pharmacies Distributing and Administering Certain Covered Countermeasures, Oct. 29, 2020, available at https://www.hhs.gov/ guidance/sites/default/files/hhs-guidancedocuments//prep-act-authorization-pharmaciesadministering-covered-countermeasures.pdf (last visited Jan. 24, 2021) (collectively, OASH PREP Act Authorizations). Nothing herein shall suggest that, for purposes of the Declaration, the foregoing are the only persons authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction. 5Some states do not require pharmacy interns to be licensed or registered by the state board of pharmacy. As used herein, ‘‘State-licensed or registered intern’’ (or equivalent phrases) refers to pharmacy interns authorized by the state or board of pharmacy in the state in which the practical pharmacy internship occurs. The authorization can, but need not, take the form of a license from, or registration with, the State board of pharmacy. See Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID– 19 Vaccines, and COVID–19 Testing, OASH, Oct. 20, 2020 at 2, available at https://www.hhs.gov/ guidance/sites/default/files/hhs-guidancedocuments//prep-act-guidance.pdf (last visited Jan. 24, 2021). ‘‘qualified persons’’ under this declaration, the PREP Act preempts state law that would otherwise prohibit such pharmacists from ordering and administering authorized COVID–19 diagnostic tests.2 The opinion relied in part on the fact that the Congressional delegation of authority to the Secretary under the PREP Act to specify a class of persons, beyond those who are authorized to administer a covered countermeasure under State law, as ‘‘qualified persons’’ would be rendered a nullity in the absence of such preemption. This opinion is incorporated by reference into this declaration. Based on the reasoning set forth in the May 19, 2020 advisory opinion, any State law that would otherwise prohibit a member of any of the classes of ‘‘qualified persons’’ specified in this declaration from administering a covered countermeasure is likewise preempted. In accordance with section 319F–3(i)(8)(A) of the Public Health Service Act, a State remains free to expand the universe of individuals authorized to administer covered countermeasures within its jurisdiction under State law. The plain language of the PREP Act makes clear that there is complete preemption of state law as described above. Furthermore, preemption of State law is justified to respond to the nationwide public health emergency caused by COVID–19 as it will enable States to quickly expand the vaccination workforce with additional qualified healthcare professionals where State or local requirements might otherwise inhibit or delay allowing these healthcare professionals to participate in the COVID–19 vaccination program. Amendments to Declaration Amended Declaration for Public Readiness and Emergency Preparedness Act Coverage for medical countermeasures against COVID–19. Section V of the March 10, 2020 Declaration under the PREP Act for medical countermeasures against COVID–19, as amended April 10, 2020, June 4, 2020, and August 19, 2020 and amended and republished on December 3, 2020 is further amended pursuant to section 319F–3(b)(4) of the PHS Act as described below. All other sections of the Declaration remain in effect as republished at 85 FR 79190 (December 9, 2020). 1. Covered Persons, section V, delete in full and replace with: V. Covered Persons 42 U.S.C. 247d–6d(i)(2), (3), (4), (6), (8)(A) and (B) Covered Persons who are afforded liability immunity under this Declaration are ‘‘manufacturers,’’ ‘‘distributors,’’ ‘‘program planners,’’ ‘‘qualified persons,’’ and their officials, agents, and employees, as those terms are defined in the PREP Act, and the United States. ‘‘Order’’ as used herein and in guidance issued by the Office of the Assistant Secretary for Health 3 means a provider medication order, which includes prescribing of vaccines, or a laboratory order, which includes prescribing laboratory orders, if required. In addition, I have determined that the following additional persons are qualified persons: (a) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction, as described in Section VII below, to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a Declaration of an Emergency, as that term is defined in Section VII of this Declaration; 4 (b) Any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with Section 564 of the FD&C Act; (c) Any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the FD&C Act; (d) A State-licensed pharmacist who orders and administers, and pharmacy interns who administer (if the pharmacy intern acts under the supervision of such pharmacist and the pharmacy intern is licensed or registered by his or her State board of pharmacy),5 (1) vaccines that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP’s standard immunization schedule or (2) FDA authorized or FDA licensed COVID –19 vaccines to persons ages three or older. Such State-licensed pharmacists and the State-licensed or registered interns under their supervision are qualified persons only if the following requirements are met: i. The vaccine must be authorized, approved, or licensed by the FDA; ii. In the case of a COVID–19 vaccine, the vaccination must be ordered and administered according to ACIP’s COVID–19 vaccine recommendation(s). VerDate Sep<11>2014 19:08 Feb 01, 2021 Jkt 253001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\02FEN1.SGM 02FEN1 jbell on DSKJLSW7X2PROD with NOTICES Federal Register / Vol. 86, No. 20 / Tuesday, February 2, 2021 / Notices 7875 6This requirement is satisfied by, among other things, a certification in basic cardiopulmonary resuscitation by an online program that has received accreditation from the American Nurses Credentialing Center, the ACPE, or the Accreditation Council for Continuing Medical Education. The phrase ‘‘current certificate in basic cardiopulmonary resuscitation,’’ when used in the September 3, 2020 or October 20, 2020 OASH authorizations, shall be interpreted the same way. See Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID–19 Vaccines and Immunity under the PREP Act, OASH, Sept. 3, 2020, available at https://www.hhs.gov/guidance/ sites/default/files/hhs-guidance-documents// licensed-pharmacists-and-pharmacy-internsregarding-covid-19-vaccines-immunity.pdf (last visited Jan. 24, 2021); Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID–19 Vaccines, and COVID–19 Testing, OASH, Oct. 20, 2020, available at https:// www.hhs.gov/guidance/sites/default/files/hhsguidance-documents//prep-act-guidance.pdf (last visited Jan. 24, 2021). 7See, e.g., Advisory Opinion 20–02 on the Public Readiness and Emergency Preparedness Act and the Secretary’s Declaration under the Act, May 19, 2020, available at https://www.hhs.gov/guidance/ sites/default/files/hhs-guidance-documents/ advisory-opinion-20-02-hhs-ogc-prep-act.pdf (last visited Jan. 24, 2021). 8See COVID–19 Vaccine Training Modules, available at https://www2.cdc.gov/vaccines/ed/ covid19/index.asp (last visited Jan. 23, 2021) https://www.cdc.gov/vaccines/covid-19/ training.html. iii. In the case of a childhood vaccine, the vaccination must be ordered and administered according to ACIP’s standard immunization schedule; iv. The licensed pharmacist must have completed the immunization training that the licensing State requires in order for pharmacists to order and administer vaccines. If the State does not specify training requirements for the licensed pharmacist to order and administer vaccines, the licensed pharmacist must complete a vaccination training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE) to order and administer vaccines. Such a training program must include hands on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines; v. The licensed or registered pharmacy intern must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines; vi. The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation; 6 vii. The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period; viii. The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient’s primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine; ix. The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregiver accompanying the child of the importance of a well-child visit with a pediatrician or other licensed primary care provider and refer patients as appropriate; and x. The licensed pharmacist and the licensed or registered pharmacy intern must comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention (CDC) COVID– 19 vaccination provider agreement and any other federal requirements that apply to the administration of COVID– 19 vaccine(s). (e) Healthcare personnel using telehealth to order or administer Covered Countermeasures for patients in a state other than the state where the healthcare personnel are licensed or otherwise permitted to practice. When ordering and administering Covered Countermeasures by means of telehealth to patients in a state where the healthcare personnel are not already permitted to practice, the healthcare personnel must comply with all requirements for ordering and administering Covered Countermeasures to patients by means of telehealth in the state where the healthcare personnel are permitted to practice. Any state law that prohibits or effectively prohibits such a qualified person from ordering and administering Covered Countermeasures by means of telehealth is preempted.7 Nothing in this Declaration shall preempt state laws that permit additional persons to deliver telehealth services. (f) Any healthcare professional or other individual who holds an active license or certification permitting the person to prescribe, dispense, or administer vaccines under the law of any State as of the effective date of this amendment, or as authorized under the section V(d) of this Declaration, who prescribes, dispenses, or administers COVID–19 vaccines that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies, other than the State in which the license or certification is held, in association with a COVID–19 vaccination effort by a federal, State, local Tribal or territorial authority or by an institution in the State in which the COVID–19 vaccine covered countermeasure is administered, so long as the license or certification of the healthcare professional has not been suspended or restricted by any licensing authority, surrendered while under suspension, discipline or investigation by a licensing authority or surrendered following an arrest, and the individual is not on the List of Excluded Individuals/Entities maintained by the Office of Inspector General, subject to: (i) Documentation of completion of the Centers for Disease Control and Prevention COVID–19 (CDC) Vaccine Training Modules 8 and, for healthcare providers who are not currently practicing, documentation of an observation period by a currently practicing healthcare professional adequately experienced in vaccination who confirms competency of the healthcare provider in preparation and administration of the particular COVID– 19 vaccine(s) to be administered; and (g) Any physician, advanced practice registered nurse, registered nurse, or practical nurse who has held an active license or certification to prescribe, dispense, or administer vaccines under the law of any State within the last five years, which is inactive, expired or lapsed, who prescribes, dispenses, or administers COVID–19 vaccines that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a COVID–19 vaccination effort by a federal, State, local, Tribal or territorial authority or by an institution in which the COVID–19 vaccine covered countermeasure is administered, so long as the license or certification was active and in good standing prior to the date it went inactive, expired or lapsed and was not revoked by the licensing authority, surrendered while under suspension, discipline or investigation by a licensing authority or surrendered following an arrest, and the individual is not on the List of Excluded Individuals/Entities maintained by the Office of Inspector VerDate Sep<11>2014 19:08 Feb 01, 2021 Jkt 253001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\02FEN1.SGM 02FEN1 jbell on DSKJLSW7X2PROD with NOTICES 7876 Federal Register / Vol. 86, No. 20 / Tuesday, February 2, 2021 / Notices General, subject to (i) documentation of completion of the Centers for Disease Control and Prevention COVID–19 Vaccine Training Modules and (ii) documentation of an observation period by a currently practicing healthcare professional adequately experienced in vaccination who confirms competency of the healthcare provider in preparation and administration of the particular COVID–19 vaccine(s) to be administered. Nothing in this Declaration shall be construed to affect the National Vaccine Injury Compensation Program, including an injured party’s ability to obtain compensation under that program. Covered countermeasures that are subject to the National Vaccine Injury Compensation Program authorized under 42 U.S.C. 300aa–10 et seq. are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program. All other terms and conditions of the Declaration apply to such covered countermeasures. 2. Effective Time Period, section XII, add to the end of the section: Liability protections for Qualified Persons under sections V(f) and V(d) of the declaration begin on January 28, 2021, and last through October 1, 2024. Authority: 42 U.S.C. 247d–6d. Norris Cochran, Acting Secretary, Department of Health and Human Services. [FR Doc. 2021–02174 Filed 1–29–21; 4:15 pm] BILLING CODE 4150–37–P INTERNATIONAL TRADE COMMISSION [Investigation Nos. 701–TA–663–664 and 731–TA–1555–1556 (Preliminary)] Granular Polytetrafluoroethylene (PTFE) Resin From India and Russia; Institution of Anti-Dumping and Countervailing Duty Investigations and Scheduling of Preliminary Phase Investigations AGENCY: United States International Trade Commission. ACTION: Notice. SUMMARY: The Commission hereby gives notice of the institution of investigations and commencement of preliminary phase antidumping and countervailing duty investigation Nos. 701–TA–663– 664 and 731–TA–1555–1556 (Preliminary) pursuant to the Tariff Act of 1930 (‘‘the Act’’) to determine whether there is a reasonable indication that an industry in the United States is materially injured or threatened with material injury, or the establishment of an industry in the United States is materially retarded, by reason of imports of granular polytetrafluoroethylene (PTFE) resin from India and Russia, provided for in subheading 3904.61.00 of the Harmonized Tariff Schedule of the United States, that are alleged to be sold in the United States at less than fair value and alleged to be subsidized by the Governments of India and Russia. Unless the Department of Commerce (‘‘Commerce’’) extends the time for initiation, the Commission must reach a preliminary determination in antidumping and countervailing duty investigations in 45 days, or in this case by March 15, 2021. The Commission’s views must be transmitted to Commerce within five business days thereafter, or by March 22, 2021. DATES: January 27, 2021. FOR FURTHER INFORMATION CONTACT: Keysha Martinez ((202) 205–2136), Office of Investigations, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting the Commission’s TDD terminal on 202– 205–1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202–205–2000. General information concerning the Commission may also be obtained by accessing its internet server (https:// www.usitc.gov). The public record for these investigations may be viewed on the Commission’s electronic docket (EDIS) at https://edis.usitc.gov. SUPPLEMENTARY INFORMATION: Background.—These investigations are being instituted, pursuant to sections 703(a) and 733(a) of the Tariff Act of 1930 (19 U.S.C. 1671b(a) and 1673b(a)), in response to a petition filed on January 27, 2021, by Daikin America, Inc., Orangeburg, New York. For further information concerning the conduct of these investigations and rules of general application, consult the Commission’s Rules of Practice and Procedure, part 201, subparts A and B (19 CFR part 201), and part 207, subparts A and B (19 CFR part 207). Participation in the investigations and public service list.—Persons (other than petitioners) wishing to participate in the investigations as parties must file an entry of appearance with the Secretary to the Commission, as provided in §§ 201.11 and 207.10 of the Commission’s rules, not later than seven days after publication of this notice in the Federal Register. Industrial users and (if the merchandise under investigation is sold at the retail level) representative consumer organizations have the right to appear as parties in Commission antidumping duty and countervailing duty investigations. The Secretary will prepare a public service list containing the names and addresses of all persons, or their representatives, who are parties to these investigations upon the expiration of the period for filing entries of appearance. Limited disclosure of business proprietary information (BPI) under an administrative protective order (APO) and BPI service list.—Pursuant to § 207.7(a) of the Commission’s rules, the Secretary will make BPI gathered in these investigations available to authorized applicants representing interested parties (as defined in 19 U.S.C. 1677(9)) who are parties to the investigations under the APO issued in the investigations, provided that the application is made not later than seven days after the publication of this notice in the Federal Register. A separate service list will be maintained by the Secretary for those parties authorized to receive BPI under the APO. Conference.— In light of the restrictions on access to the Commission building due to the COVID–19 pandemic, the Commission is conducting the staff conference through video conferencing on February 17, 2021. Requests to appear at the conference should be emailed to preliminaryconferences@usitc.gov (DO NOT FILE ON EDIS) on or before February 12, 2021. Please provide an email address for each conference participant in the email. Information on conference procedures will be provided separately and guidance on joining the video conference will be available on the Commission’s Daily Calendar. A nonparty who has testimony that may aid the Commission’s deliberations may request permission to participate by submitting a short statement. Please note the Secretary’s Office will accept only electronic filings during this time. Filings must be made through the Commission’s Electronic Document Information System (EDIS, https:// edis.usitc.gov). No in-person paperbased filings or paper copies of any electronic filings will be accepted until further notice. Written submissions.—As provided in §§ 201.8 and 207.15 of the Commission’s rules, any person may submit to the Commission on or before February 22, 2021, a written brief containing information and arguments pertinent to the subject matter of the investigations. Parties shall file written

Ninth Amendment to Declaration Under the PREP Act for Medical Countermeasures Against COVID–19 (Fact Sheet | PDF Presentation):

ACTION:

Notice of Amendment and Republished Declaration.

SUMMARY:

The Secretary issues this amendment pursuant to section 319F-3 of the Public Health Service Act to amend his March 10, 2020 Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19.

DATES:

The amendments to the Declaration are applicable as of February 4, 2020, except as otherwise specified in Section XII.

FOR FURTHER INFORMATION CONTACT:

Robert P. Kadlec, MD, MTM&H, MS, Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue SW, Washington, DC 20201; Telephone: 202-205-2882.

SUPPLEMENTARY INFORMATION:

The Public Readiness and Emergency Preparedness (PREP) Act, 42 U.S.C. 247d-6d et. seq., authorizes the Secretary of Health and Human Services (the Secretary) to issue a declaration to provide liability protections to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from, the manufacture, distribution, administration, or use of certain medical countermeasures (Covered Countermeasures), except for claims involving “willful misconduct,” as defined in the PREP Act. Such declarations are subject to amendment as circumstances warrant.

The PREP Act was enacted on December 30, 2005, as Public Law 109-148, Division C, Section 2. It amended the Public Health Service (PHS) Act, adding Section 319F-3, which addresses liability immunity, and Section 319F-4, which creates a compensation program. These sections are codified at 42 U.S.C. 247d-6d and 42 U.S.C. 247d-6e, respectively. Section 319F-3 of the PHS Act has been amended by the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, enacted on March 13, 2013, and the Coronavirus Aid, Relief, and Economic Security (CARES) Act, Public Law 116-136, enacted on March 27, 2020, to expand Covered Countermeasures under the PREP Act.

On January 31, 2020, the Secretary declared a public health emergency pursuant to section 319 of the PHS Act, 42 U.S.C. 247d, effective January 27, 2020, for the entire United States to aid in the response to the Coronavirus Disease 2019 (COVID-19) outbreak, which subsequently became a global pandemic. Pursuant to section 319 of the PHS Act, the Secretary renewed that declaration on April 21, 2020, July 23, 2020, and October 2, 2020. On March 10, 2020, the Secretary issued a declaration under the PREP Act for medical countermeasures against COVID-19.^[1] On April 10, the Secretary amended the Declaration to extend liability protections to Covered Countermeasures authorized under the CARES Act.^[2] On June 4, the Secretary amended the Declaration to clarify that Covered Countermeasures under the Declaration include qualified pandemic and epidemic products that limit the harm that COVID-19 might otherwise cause.^[3] On August 19, the Secretary amended the Declaration to add additional categories of Qualified Persons and to amend the category of disease, health condition, or threat for which he recommends the administration or use of Covered Countermeasures.^[4]

The Secretary now further amends the Declaration pursuant to section 319F-3 of the Public Health Service Act. This Fourth Amendment to the Declaration:

(a) Clarifies that the Declaration must be construed in accordance with the Department of Health and Human Services (HHS) Office of the General Counsel (OGC) Advisory Opinions on the Public Readiness and Emergency Preparedness Act and the Declaration (Advisory Opinions).^[5] The Declaration incorporates the Advisory Opinions for that purpose.

(b) Incorporates authorizations that the HHS Office of the Assistant Secretary for Health (OASH) has issued as an Authority Having Jurisdiction.^[6]

(c) Adds an additional category of Qualified Persons under Section V of the Declaration and 42 U.S.C. 247d-6d(i)(8)(B), i.e., healthcare personnel using telehealth to order or administer Covered Countermeasures for patients in a state other than the state where the healthcare personnel are permitted to practice.^[7]

(d) Modifies and clarifies the training requirements for certain licensed pharmacists and pharmacy interns to administer certain routine childhood or COVID-19 vaccinations.

(e) Makes explicit that Section VI covers all qualified pandemic and epidemic products under the PREP Act.

(f) Adds a third method of distribution under Section VII of the Declaration and 42 U.S.C. 247d-6d(a)(5) that would provide liability protections for, among other things, additional private-distribution channels.

(g) Makes explicit in Section IX that there can be situations where not administering a covered countermeasure to a particular individual can fall within the PREP Act and this Declaration’s liability protections.

(h) Makes explicit in Section XI that there are substantial federal legal and policy issues, and substantial federal legal and policy interests, in having a unified, whole-of-nation response to the COVID-19 pandemic among federal, state, local, and private-sector entities. The world is facing an unprecedented pandemic. To effectively respond, there must be a more consistent pathway for Covered Persons to manufacture, distribute, administer or use Covered Countermeasures across the nation and the world.

(i) Revises the effective time period of the Declaration in light of the amendments to the Declaration.^[8]

The Secretary republishes the Declaration, as amended, in full. Unless otherwise noted, all statutory citations are to the U.S. Code.

Description of This Amendment

Declaration

The Declaration has fifteen sections describing PREP Act coverage for medical countermeasures against COVID-19. OGC has issued Advisory Opinions interpreting the PREP Act and reflecting the Secretary’s interpretation of the Declaration.^[9] The Secretary now amends the Declaration to clarify that the Declaration must be construed in accordance with the Advisory Opinions. The Secretary expressly incorporates the Advisory Opinions for that purpose.

Section V. Covered Persons

Section V of the Declaration describes Covered Persons, including additional qualified persons identified by the Secretary, as required under the PREP Act. The Secretary amends Section V to specify an additional category of qualified persons. Specifically, healthcare personnel who are permitted to order and administer a Covered Countermeasure through telehealth in a state may do so for patients in another state so long as the healthcare personnel comply with the legal requirements of the state in which the healthcare personnel are permitted to order and administer the Covered Countermeasure by means of telehealth.

Telehealth is widely recognized as a valuable tool to promote public health during this pandemic. According to the Centers for Disease Control and Prevention (CDC),

Telehealth services can facilitate public health mitigation strategies during this pandemic by increasing social distancing. These services can be a safer option for [healthcare personnel (HCP)] and patients by reducing potential infectious exposures. They can reduce the strain on healthcare systems by minimizing the surge of patient demand on facilities and reduce the use of [personal protective equipment (PPE)] by healthcare providers.

Maintaining continuity of care to the extent possible can avoid additional negative consequences from delayed preventive, chronic, or routine care. Remote access to healthcare services may increase participation for those who are medically or socially vulnerable or who do not have ready access to providers. Remote access can also help preserve the patient-provider relationship at times when an in-person visit is not practical or feasible. Telehealth services can be used to:

• Screen patients who may have symptoms of COVID-19 and refer as appropriate
• Provide low-risk urgent care for non-COVID-19 conditions, identify those persons who may need additional medical consultation or assessment, and refer as appropriate
• Access primary care providers and specialists, including mental and behavioral health, for chronic health conditions and medication management
• Provide coaching and support for patients managing chronic health conditions, including weight management and nutrition counseling
• Participate in physical therapy, occupational therapy, and other modalities as a hybrid approach to in-person care for optimal health
• Monitor clinical signs of certain chronic medical conditions (e.g., blood pressure, blood glucose, other remote assessments)
• Engage in case management for patients who have difficulty accessing care (e.g., those who live in very rural settings, older adults, those with limited mobility)
• Follow up with patients after hospitalization
• Deliver advance care planning and counseling to patients and caregivers to document preferences if a life-threatening event or medical crisis occurs
• Provide non-emergent care to residents in long-term care facilities
• Provide education and training for HCP through peer-to-peer professional medical consultations (inpatient or outpatient) that are not locally available, particularly in rural areas.^[10]

Similarly, CMS has stressed the importance of telehealth during this pandemic:

Telehealth, telemedicine, and related terms generally refer to the exchange of medical information from one site to another through electronic communication to improve a patient’s health. Innovative uses of this kind of technology in the provision of healthcare is increasing. And with the emergence of the virus causing the disease COVID-19, there is an urgency to expand the use of technology to help people who need routine care, and keep vulnerable beneficiaries and beneficiaries with mild symptoms in their homes while maintaining access to the care they need. Limiting community spread of the virus, as well as limiting the exposure to other patients and staff members will slow viral spread.^[11]

Accordingly, CMS and other HHS components has substantially expanded the scope of services paid under Medicare when furnished using telehealth technologies during this pandemic.

Other HHS components have also taken steps to expand the use of telehealth during the pandemic.^[12]

Moreover, to expand the use of telehealth during this pandemic, the Office for Civil Rights (OCR) at HHS is exercising enforcement discretion and will not impose penalties for noncompliance with the regulatory requirements under the Health Insurance Portability and Accountability Act (HIPAA) Rules against covered healthcare providers that serve patients through everyday communications technologies during the COVID-19 nationwide public health emergency.^[13] This exercise of discretion applies to widely available communications apps, such as FaceTime or Skype, when used in good faith for any telehealth treatment or diagnostic purpose, regardless of whether the telehealth service is directly related to COVID-19.^[14]

Many states have authorized out-of-state healthcare personnel to deliver telehealth services to in-state patients, either generally or in the context of COVID-19.^[15]

To help maximize the utility of telehealth, the Secretary declares that the term “qualified person” under 42 U.S.C. 247d-6d(i)(8)(B) includes healthcare personnel using telehealth to order or administer Covered Countermeasures for patients in a state other than the state where the healthcare personnel are permitted to practice. When ordering and administering Covered Countermeasures through telehealth to patients in a state where the healthcare personnel are not already permitted to do so, the healthcare personnel must comply with all requirements for ordering and administering Covered Countermeasures to patients through telehealth in the state where the healthcare personnel are licensed or otherwise permitted to practice. Any state law that prohibits or effectively prohibits such a qualified person from ordering and administering Covered Countermeasures through telehealth is preempted.^[16] Nothing in this Declaration shall preempt state laws that permit additional persons to deliver telehealth services.

The Secretary also amends Section V to include several examples of Covered Persons who are Qualified Persons, because they are authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures. Those examples include certain pharmacists, pharmacy interns, and pharmacy technicians who order or administer certain COVID-19 tests and certain vaccines.^[17] These examples are not an exclusive or exhaustive list of persons who are qualified persons identified by the Secretary in Section V.

The Secretary also amends Section V to make explicit that the requirement in that section for certain qualified persons to have a current certificate in basic cardiopulmonary resuscitation is satisfied by, among other things, a certification in basic cardiopulmonary resuscitation by an online program that has received accreditation from the American Nurses Credentialing Center, the Accreditation Council for Pharmacy Education (ACPE), or the Accreditation Council for Continuing Medical Education.

The Secretary also amends Section V’s training requirements for licensed pharmacists to order and administer certain childhood or COVID-19 vaccines. To order and administer vaccines, the licensed pharmacist must have completed the immunization training that the licensing State requires in order for pharmacists to administer vaccines. If the State does not specify training requirements for the licensed pharmacist to order and administer vaccines, the licensed pharmacist must complete a vaccination training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE) to order and administer vaccines. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.

Other than the basic cardiopulmonary resuscitation requirement and the practical training program requirement, this Amendment does not change the requirements for a pharmacist, pharmacy intern, or pharmacy technician to be a “qualified person” under 42 U.S.C. 247d-6d(i)(8)(B) who can order or administer childhood or COVID-19 vaccines pursuant to the Declaration.

Section VI. Covered Countermeasures

The Secretary amends Section VI to make explicit that Section VI covers all qualified pandemic and epidemic products under the PREP Act.

Section VII. Limitations on Distribution

The Secretary may specify that liability protections are in effect only for Covered Countermeasures obtained through a particular means of distribution. The Declaration previously stated that liability immunity is afforded to Covered Persons only for Recommended Activities related to (a) present or future federal contracts, cooperative agreements, grants, other transactions, interagency agreements, or memoranda of understanding or other federal agreements; or (b) activities authorized in accordance with the public health and medical response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute, or dispense the Covered Countermeasures following a declaration of an emergency.

COVID-19 is an unprecedented global challenge that requires a whole-of-nation response that utilizes federal-, state-, and local- distribution channels as well as private-distribution channels. Given the broad scale of this pandemic, the Secretary amends the Declaration to extend PREP Act coverage to additional private-distribution channels, as set forth below.

The amended Section VII adds that PREP Act liability protections also extend to Covered Persons for Recommended Activities that are related to any Covered Countermeasure that is:

(a) Licensed, approved, cleared, or authorized by the Food and Drug Administration (FDA) (or that is permitted to be used under an Investigational New Drug Application or an Investigational Device Exemption) under the Federal Food, Drug, and Cosmetic (FD&C) Act or Public Health Service (PHS) Act to treat, diagnose, cure, prevent, mitigate or limit the harm from COVID-19, or the transmission of SARS-CoV-2 or a virus mutating therefrom; or

(b) a respiratory protective device approved by the National Institute for Occupational Safety and Health (NIOSH) under 42 CFR part 84, or any successor regulations, that the Secretary determines to be a priority for use during a public health emergency declared under section 319 of the PHS Act to prevent, mitigate, or limit the harm from, COVID-19, or the transmission of SARS-CoV-2 or a virus mutating therefrom.

To qualify for this third distribution channel (but not necessarily to qualify for the other distribution channels), a Covered Person must manufacture, test, develop, distribute, administer, or use the Covered Countermeasure pursuant to the FDA licensure, approval, clearance, or authorization (or pursuant to an Investigational New Drug Application or Investigational Device Exemption), or the NIOSH approval.

This third distribution channel may extend PREP Act coverage when there is no federal agreement or authorization in accordance with the public health and medical response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures following a declaration of an emergency. For example, a manufacturer, distributor, program planner, or qualified person engages in manufacturing, testing, development, distribution, administration, or use of a COVID-19 test pursuant to an FDA Emergency Use Authorization for that COVID-19 test. If the Covered Person satisfies all other requirements of the PREP Act and Declaration, there will be PREP Act coverage even if there is no federal agreement to cover those activities and those activities are not part of the authorized activity of an Authority Having Jurisdiction.

Section IX. Administration of Covered Countermeasures

The Secretary amends Section IX to make explicit that there can be situations where not administering a covered countermeasure to a particular individual can fall within the PREP Act and this Declaration’s liability protections.

Section XI. Geographic Area

The Secretary makes explicit in Section XI that there are substantial federal legal and policy issues, and substantial federal legal and policy interests within the meaning of Grable & Sons Metal Products, Inc. v. Darue Eng’g. & Mf’g., 545 U.S. 308 (2005), in having a unified, whole-of-nation response to the COVID-19 pandemic among federal, state, local, and private-sector entities. The world is facing an unprecedented global pandemic. To effectively respond, there must be a more consistent pathway for Covered Persons to manufacture, distribute, administer or use Covered Countermeasures across the nation and the world. Thus, there are substantial federal legal and policy issues, and substantial federal legal and policy interests within the meaning of Grable & Sons Metal Products, Inc. v. Darue Eng’g. & Mf’g., 545 U.S. 308 (2005), in having a uniform interpretation of the PREP Act. Under the PREP Act, the sole exception to the immunity from suit and liability of covered persons is an exclusive Federal cause of action against a Covered Person for death or serious physical injury proximately caused by willful misconduct by such Covered Person. In all other cases, an injured party’s exclusive remedy is an administrative remedy under section 319F-4 of the PHS Act. Through the PREP Act, Congress delegated to me the authority to strike the appropriate Federal-state balance with respect to particular Covered Countermeasures through PREP Act declarations.

Section XII. Effective Time Period

The Secretary amends Section XII to provide that liability protections for all Covered Countermeasures administered and used in accordance with the public health and medical response of the Authority Having Jurisdiction, as identified in Section VII(b) of this Declaration, begins with a “Declaration of Emergency,” as defined in Section VII (except that, with respect to qualified persons who order or administer a routine childhood vaccination that ACIP recommends to persons ages three through 18 according to ACIP’s standard immunization schedule, PREP Act coverage began on August 24, 2020), and lasts through (a) the final day the Declaration of Emergency is in effect, or (b) October 1, 2024, whichever occurs first. This change is to conform the text of the Declaration to the Third Amendment.^[18]

The Secretary also amends Section XII to provide that liability protections for all Covered Countermeasures identified in Section VII(c) of this Declaration begins on the date of this amended Declaration and lasts through (a) the final day the Declaration of Emergency is in effect, or (b) October 1, 2024, whichever occurs first. Because the Secretary is adding Section VII(c) to the Declaration in this Amendment, Section XII provides that Section VII(c) is effective as of the date this amended Declaration is published.

Additional Amendments

The Secretary also makes other, non-substantive amendments.

Declaration, as Amended, for Public Readiness and Emergency Preparedness Act Coverage for Medical Countermeasures Against COVID-19

To the extent any term previously in the Declaration, including its amendments, is inconsistent with any provision of this Republished Declaration, the terms of this Republished Declaration are controlling. This Declaration must be construed in accordance with the Advisory Opinions of the Office of the General Counsel (Advisory Opinions). I incorporate those Advisory Opinions as part of this Declaration.^[19] This Declaration is a “requirement” under the PREP Act.

I. Determination of Public Health Emergency

42 U.S.C. 247d-6d(b)(1)

I have determined that the spread of SARS-CoV-2 or a virus mutating therefrom and the resulting disease COVID-19 constitutes a public health emergency. I further determine that use of any respiratory protective device approved by NIOSH under 42 CFR part 84, or any successor regulations, is a priority for use during the public health emergency that I declared on January 31, 2020 under section 319 of the PHS Act for the entire United States to aid in the response of the nation’s healthcare community to the COVID-19 outbreak.

II. Factors Considered

42 U.S.C. 247d-6d(b)(6)

I have considered the desirability of encouraging the design, development, clinical testing, or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, and use of the Covered Countermeasures.

III. Recommended Activities

42 U.S.C. 247d-6d(b)(1)

I recommend, under the conditions stated in this Declaration, the manufacture, testing, development, distribution, administration, and use of the Covered Countermeasures.

IV. Liability Protections

42 U.S.C. 247d-6d(a), 247d-6d(b)(1)

Liability protections as prescribed in the PREP Act and conditions stated in this Declaration are in effect for the Recommended Activities described in Section III.

V. Covered Persons

42 U.S.C. 247d-6d(i)(2), (3), (4), (6), (8)(A) and (B)

Covered Persons who are afforded liability protections under this Declaration are “manufacturers,” “distributors,” “program planners,” and “qualified persons,” as those terms are defined in the PREP Act; their officials, agents, and employees; and the United States.

In addition, I have determined that the following additional persons are qualified persons:

(a) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction, as described in Section VII below, to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a Declaration of Emergency, as that term is defined in Section VII of this Declaration; ^[20]

(b) any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with Section 564 of the FD&C Act;

(c) any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the FD&C Act;

(d) a State-licensed pharmacist who orders and administers, and pharmacy interns who administer (if the pharmacy intern acts under the supervision of such pharmacist and the pharmacy intern is licensed or registered by his or her State board of pharmacy), ^[21] (1) vaccines that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP’s standard immunization schedule or (2) FDA-authorized or FDA-licensed COVID-19 vaccines to persons ages three or older. Such State-licensed pharmacists and the State-licensed or registered interns under their supervision are qualified persons only if the following requirements are met:

i. The vaccine must be authorized, approved, or licensed by the FDA;

ii. In the case of a COVID-19 vaccine, the vaccination must be ordered and administered according to ACIP’s COVID-19 vaccine recommendation(s).

iii. In the case of a childhood vaccine, the vaccination must be ordered and administered according to ACIP’s standard immunization schedule;

iv. The licensed pharmacist must have completed the immunization training that the licensing State requires in order for pharmacists to order and administer vaccines. If the State does not specify training requirements for the licensed pharmacist to order and administer vaccines, the licensed pharmacist must complete a vaccination training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE) to order and administer vaccines. Such a training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines;

v. The licensed or registered pharmacy intern must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines;

vi. The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation; ^[22]

vii. The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period;

viii. The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient’s primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine; and

ix. The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregiver accompanying the child of the importance of a well-child visit with a pediatrician or other licensed primary care provider and refer patients as appropriate.

x. The licensed pharmacist and the licensed or registered pharmacy intern must comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention (CDC) COVID-19 vaccination provider agreement and any other federal requirements that apply to the administration of COVID-19 vaccine(s).

(e) Healthcare personnel using telehealth to order or administer Covered Countermeasures for patients in a state other than the state where the healthcare personnel are licensed or otherwise permitted to practice. When ordering and administering Covered Countermeasures by means of telehealth to patients in a state where the healthcare personnel are not already permitted to practice, the healthcare personnel must comply with all requirements for ordering and administering Covered Countermeasures to patients by means of telehealth in the state where the healthcare personnel are permitted to practice. Any state law that prohibits or effectively prohibits such a qualified person from ordering and administering Covered Countermeasures by means of telehealth is preempted.^[23] Nothing in this Declaration shall preempt state laws that permit additional persons to deliver telehealth services.

Nothing in this Declaration shall be construed to affect the National Vaccine Injury Compensation Program, including an injured party’s ability to obtain compensation under that program. Covered Countermeasures that are subject to the National Vaccine Injury Compensation Program authorized under 42 U.S.C. 300aa-10 et seq. are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program. All other terms and conditions of the Declaration apply to such Covered Countermeasures.

VI. Covered Countermeasures

42 U.S.C. 247d-6b(c)(1)(B), 42 U.S.C. 247d-6d(i)(1) and (7)

Covered Countermeasures are:

(a) Any antiviral, any drug, any biologic, any diagnostic, any other device, any respiratory protective device, or any vaccine manufactured, used, designed, developed, modified, licensed, or procured:

i. To diagnose, mitigate, prevent, treat, or cure COVID-19, or the transmission of SARS-CoV-2 or a virus mutating therefrom; or

ii. to limit the harm that COVID-19, or the transmission of SARS-CoV-2 or a virus mutating therefrom, might otherwise cause;

(b) a product manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a serious or life-threatening disease or condition caused by a product described in paragraph (a) above;

(c) a product or technology intended to enhance the use or effect of a product described in paragraph (a) or (b) above; or

(d) any device used in the administration of any such product, and all components and constituent materials of any such product.

To be a Covered Countermeasure under the Declaration, a product must also meet 42 U.S.C. 247d-6d(i)(1)‘s definition of “Covered Countermeasure.”

VII. Limitations on Distribution

42 U.S.C. 247d-6d(a)(5) and (b)(2)(E)

I have determined that liability protections are afforded to Covered Persons only for Recommended Activities involving:

(a) Covered Countermeasures that are related to present or future federal contracts, cooperative agreements, grants, other transactions, interagency agreements, memoranda of understanding, or other federal agreements;

(b) Covered Countermeasures that are related to activities authorized in accordance with the public health and medical response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures following a Declaration of Emergency; or

(c) Covered Countermeasures that are:

i. Licensed, approved, cleared, or authorized by the FDA (or that are permitted to be used under an Investigational New Drug Application or an Investigational Device Exemption) under the FD&C Act or PHS Act to treat, diagnose, cure, prevent, mitigate, or limit the harm from COVID-19, or the transmission of SARS-CoV-2 or a virus mutating therefrom; or

ii. a respiratory protective device approved by NIOSH under 42 CFR part 84, or any successor regulations, that the Secretary determines to be a priority for use during a public health emergency declared under section 319 of the PHS Act to prevent, mitigate, or limit the harm from COVID-19, or the transmission of SARS-CoV-2 or a virus mutating therefrom.

To qualify for this third distribution channel, a Covered Person must manufacture, test, develop, distribute, administer, or use the Covered Countermeasure pursuant to the FDA licensure, approval, clearance, or authorization (or pursuant to an Investigational New Drug Application or Investigational Device Exemption), or the NIOSH approval.

As used in this Declaration, the terms “Authority Having Jurisdiction” and “Declaration of Emergency” have the following meanings:

(a) The Authority Having Jurisdiction means the public agency or its delegate that has legal responsibility and authority for responding to an incident, based on political or geographical (e.g., city, county, tribal, state, or federal boundary lines) or functional (e.g., law enforcement, public health) range or sphere of authority.

(b) A Declaration of Emergency means any declaration by any authorized local, regional, state, or federal official of an emergency specific to events that indicate an immediate need to administer and use the Covered Countermeasures, with the exception of a federal declaration in support of an Emergency Use Authorization under Section 564 of the FD&C Act unless such declaration specifies otherwise.

I have also determined that, for governmental program planners only, liability protections are afforded only to the extent such program planners obtain Covered Countermeasures through voluntary means, such as (a) donation; (b) commercial sale; (c) deployment of Covered Countermeasures from federal stockpiles; or (d) deployment of donated, purchased, or otherwise voluntarily obtained Covered Countermeasures from state, local, or private stockpiles.

VIII. Category of Disease, Health Condition, or Threat

42 U.S.C. 247d-6d(b)(2)(A)

The category of disease, health condition, or threat for which I recommend the administration or use of the Covered Countermeasures is not only COVID-19 caused by SARS-CoV-2, or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID-19, SARS-CoV-2, or a virus mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases.

IX. Administration of Covered Countermeasures

42 U.S.C. 247d-6d(a)(2)(B)

Administration of the Covered Countermeasure means physical provision of the countermeasures to recipients, or activities and decisions directly relating to public and private delivery, distribution and dispensing of the countermeasures to recipients, management and operation of countermeasure programs, or management and operation of locations for the purpose of distributing and dispensing countermeasures.

Where there are limited Covered Countermeasures, not administering a Covered Countermeasure to one individual in order to administer it to another individual can constitute “relating to . . . the administration to . . . an individual” under 42 U.S.C. 247d-6d. For example, consider a situation where there is only one dose ^[24] of a COVID-19 vaccine, and a person in a vulnerable population and a person in a less vulnerable population both request it from a healthcare professional. In that situation, the healthcare professional administers the one dose to the person who is more vulnerable to COVID-19. In that circumstance, the failure to administer the COVID-19 vaccine to the person in a less-vulnerable population “relat[es] to . . . the administration to” the person in a vulnerable population. The person in the vulnerable population was able to receive the vaccine only because it was not administered to the person in the less-vulnerable population. Prioritization or purposeful allocation of a Covered Countermeasure, particularly if done in accordance with a public health authority’s directive, can fall within the PREP Act and this Declaration’s liability protections.

X. Population

42 U.S.C. 247d-6d(a)(4), 247d-6d(b)(2)(C)

The populations of individuals to whom the liability protections of this Declaration extend include any individual who uses or is administered the Covered Countermeasures in accordance with this Declaration.

Liability protections are afforded to manufacturers and distributors without regard to whether the countermeasure is used by or administered to this population; liability protections are afforded to program planners and qualified persons when the countermeasure is used by or administered to this population, or the program planner or qualified person reasonably could have believed the recipient was in this population.

XI. Geographic Area

42 U.S.C. 247d-6d(a)(4), 247d-6d(b)(2)(D)

Liability protections are afforded for the administration or use of a Covered Countermeasure without geographic limitation.

Liability protections are afforded to manufacturers and distributors without regard to whether the Covered Countermeasure is used by or administered in any designated geographic area; liability protections are afforded to program planners and qualified persons when the countermeasure is used by or administered in any designated geographic area, or the program planner or qualified person reasonably could have believed the recipient was in that geographic area.

COVID-19 is a global challenge that requires a whole-of-nation response. There are substantial federal legal and policy issues, and substantial federal legal and policy interests within the meaning of Grable & Sons Metal Products, Inc. v. Darue Eng’g. & Mf’g., 545 U.S. 308 (2005), in having a unified, whole-of-nation response to the COVID-19 pandemic among federal, state, local, and private-sector entities. The world is facing an unprecedented pandemic. To effectively respond, there must be a more consistent pathway for Covered Persons to manufacture, distribute, administer or use Covered Countermeasures across the nation and the world. Thus, there are substantial federal legal and policy issues, and substantial federal legal and policy interests within the meaning of Grable & Sons Metal Products, Inc. v. Darue Eng’g. & Mf’g., 545 U.S. 308 (2005), in having a uniform interpretation of the PREP Act. Under the PREP Act, the sole exception to the immunity from suit and liability of covered persons under the PREP Act is an exclusive Federal cause of action against a covered person for death or serious physical injury proximately caused by willful misconduct by such covered person. In all other cases, an injured party’s exclusive remedy is an administrative remedy under section 319F-4 of the PHS Act. Through the PREP Act, Congress delegated to me the authority to strike the appropriate Federal-state balance with respect to particular Covered Countermeasures through PREP Act declarations.^[25]

XII. Effective Time Period

42 U.S.C. 247d-6d(b)(2)(B)

Liability protections for any respiratory protective device approved by NIOSH under 42 CFR part 84, or any successor regulations, through the means of distribution identified in Section VII(a) of this Declaration, begin on March 27, 2020 and extend through October 1, 2024.

Liability protections for all other Covered Countermeasures identified in Section VI of this Declaration, through means of distribution identified in Section VII(a) of this Declaration, begin on February 4, 2020 and extend through October 1, 2024.

Liability protections for all Covered Countermeasures administered and used in accordance with the public health and medical response of the Authority Having Jurisdiction, as identified in Section VII(b) of this Declaration, begin with a Declaration of Emergency as that term is defined in Section VII (except that, with respect to qualified persons who order or administer a routine childhood vaccination that ACIP recommends to persons ages three through 18 according to ACIP’s standard immunization schedule, liability protections began on August 24, 2020), and last through (a) the final day the Declaration of Emergency is in effect, or (b) October 1, 2024, whichever occurs first.

Liability protections for all Covered Countermeasures identified in Section VII(c) of this Declaration begin on the date of this amended Declaration and last through (a) the final day the Declaration of Emergency is in effect, or (b) October 1, 2024, whichever occurs first.

XIII. Additional Time Period of Coverage

42 U.S.C. 247d-6d(b)(3)(B) and (C)

I have determined that an additional 12 months of liability protection is reasonable to allow for the manufacturer(s) to arrange for disposition of the Covered Countermeasure, including return of the Covered Countermeasures to the manufacturer, and for Covered Persons to take such other actions as are appropriate to limit the administration or use of the Covered Countermeasures.

Covered Countermeasures obtained for the SNS during the effective period of this Declaration are covered through the date of administration or use pursuant to a distribution or release from the SNS.

XIV. Countermeasures Injury Compensation Program

42 U.S.C 247d-6e

The PREP Act authorizes the Countermeasures Injury Compensation Program (CICP) to provide benefits to certain individuals or estates of individuals who sustain a covered serious physical injury as the direct result of the administration or use of the Covered Countermeasures, and benefits to certain survivors of individuals who die as a direct result of the administration or use of the Covered Countermeasures. The causal connection between the countermeasure and the serious physical injury must be supported by compelling, reliable, valid, medical and scientific evidence in order for the individual to be considered for compensation. The CICP is administered by the Health Resources and Services Administration, within the Department of Health and Human Services. Information about the CICP is available at the toll-free number 1-855-266-2427 or http://www.hrsa.gov/​cicp/​.

XV. Amendments

42 U.S.C. 247d-6d(b)(4)

Amendments to this Declaration will be published in the Federal Register, as warranted.

Authority: 42 U.S.C. 247d-6d.

Dated: December 3, 2020.

Alex M. Azar II,

Secretary of Health and Human Services.

Footnotes

1.  85 FR 15198 (Mar. 17, 2020). Back to Citation

2.  85 FR 21012 (Apr. 15, 2020). Back to Citation

3.  85 FR 35100 (June 8, 2020). Back to Citation

4.  85 FR 52136 (Aug. 24, 2020). Back to Citation

5.  See, e.g., Advisory Opinion on the Public Readiness and Emergency Preparedness Act and the March 10, 2020 Declaration under the Act, Apr. 17, 2020, as Modified on May 19, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​prep-act-advisory-opinion-hhs-ogc.pdf (last visited Dec. 1, 2020); Advisory Opinion 20-02 on the Public Readiness and Emergency Preparedness Act and the Secretary’s Declaration under the Act, May 19, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​advisory-opinion-20-02-hhs-ogc-prep-act.pdf (last visited Dec. 1, 2020); Advisory Opinion 20-03 on the Public Readiness and Emergency Preparedness Act and the Secretary’s Declaration under the Act, Oct. 22, 2020, as Modified on Oct. 23, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​AO3.1.2_​Updated_​FINAL_​SIGNED_​10.23.20.pdf (last visited Dec. 1, 2020); Advisory Opinion 20-04 on the Public Readiness and Emergency Preparedness Act and the Secretary’s Declaration under the Act, Oct. 22, 2020, as Modified on Oct. 23, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​AO%204.2_​Updated_​FINAL_​SIGNED_​10.23.20.pdf (last visited Dec. 1, 2020). Back to Citation

6.  See, e.g., Guidance for Licensed Pharmacists, COVID-19 Testing, and Immunity Under the PREP Act, OASH, Apr. 8, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.pdf (last visited Dec. 1, 2020); Guidance for PREP Act Coverage for COVID-19 Screening Tests at Nursing Homes, Assisted-Living Facilities, Long-Term-Care Facilities, and other Congregate Facilities, OASH, Aug. 31, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/prep-act-coverage-for-screening-in-congregate-settings.pdf (last visited Dec. 1, 2020); Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act, OASH, Sept. 3, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf (last visited Dec. 1, 2020); Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH, Oct. 20, 2020, available at https://www.hhs.gov/​sites/​default/​files/​prep-act-guidance.pdf (last visited Dec. 1, 2020); PREP Act Authorization for Pharmacies Distributing and Administering Certain Covered Countermeasures, Oct. 29, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/prep-act-authorization-pharmacies-administering-covered-countermeasures.pdf (last visited Dec. 1, 2020) (collectively, OASH PREP Act Authorizations). Back to Citation

7.  “Telehealth, telemedicine, and related terms generally refer to the exchange of medical information from one site to another through electronic communication to improve a patient’s health.” Medicare Telemedicine Health Care Provider Fact Sheet, Mar. 17, 2020, available at https://www.cms.gov/​newsroom/​fact-sheets/​medicare-telemedicine-health-care-provider-fact-sheet (last visited on Dec. 2, 2020). For the Declaration and the Fourth Amendment, the term “telehealth” includes telehealth, telemedicine, and related terms as described by the Centers for Medicare & Medicaid (CMS). Back to Citation

8.  In addition, the Fourth Amendment makes certain non-substantive changes. Those should not be interpreted to change any substantive provisions. Back to Citation

9.  See, e.g., Advisory Opinion on the Public Readiness and Emergency Preparedness Act and the March 10, 2020 Declaration under the Act, Apr. 17, 2020, as Modified on May 19, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​prep-act-advisory-opinion-hhs-ogc.pdf (last visited Dec. 1, 2020); Advisory Opinion 20-02 on the Public Readiness and Emergency Preparedness Act and the Secretary’s Declaration under the Act, May 19, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​advisory-opinion-20-02-hhs-ogc-prep-act.pdf (last visited Dec. 1, 2020); Advisory Opinion 20-03 on the Public Readiness and Emergency Preparedness Act and the Secretary’s Declaration under the Act, Oct. 22, 2020, as Modified on Oct. 23, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​AO3.1.2_​Updated_​FINAL_​SIGNED_​10.23.20.pdf (last visited Dec. 1, 2020); Advisory Opinion 20-04 on the Public Readiness and Emergency Preparedness Act and the Secretary’s Declaration under the Act, Oct. 22, 2020, as Modified on Oct. 23, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​AO%204.2_​Updated_​FINAL_​SIGNED_​10.23.20.pdf (last visited Dec. 1, 2020). Back to Citation

10.  Using Telehealth to Expand Access to Essential Health Services during the COVID-19 Pandemic, CDC, updated June 10, 2020, available at https://www.cdc.gov/​coronavirus/​2019-ncov/​hcp/​telehealth.html (last visited Dec. 1, 2020). Back to Citation

11.  Medicare Telemedicine Health Care Provider Fact Sheet, Mar. 17, 2020, available at https://www.cms.gov/​newsroom/​fact-sheets/​medicare-telemedicine-health-care-provider-fact-sheet (last visited Dec. 1, 2020). Back to Citation

12.  See, e.g., Trump Administration Drives Telehealth Services in Medicaid and Medicare, CMS, Oct. 14, 2020, available at https://www.cms.gov/​newsroom/​press-releases/​trump-administration-drives-telehealth-services-medicaid-and-medicare (last visited Dec. 1, 2020); Secretary Azar Announces Historic Expansion of Telehealth Access to Combat COVID-19, Mar. 17, 2020, available at https://www.hhs.gov/​about/​news/​2020/​03/​17/​secretary-azar-announces-historic-expansion-of-telehealth-access-to-combat-covid-19.html (last visited Nov. 30, 2020); OIG Policy Statement Regarding Physicians and Other Practitioners That Reduce or Waive Amounts Owed by Federal Health Care Program Beneficiaries for Telehealth Services During the 2019 Novel Coronavirus (COVID-19) Outbreak, Mar. 17, 2020, available at https://oig.hhs.gov/​fraud/​docs/​alertsandbulletins/​2020/​policy-telehealth-2020.pdf (last visited Nov. 30, 2020). Back to Citation

13.  OCR Announces Notification of Enforcement Discretion for Telehealth Remote Communications During the COVID-19 Nationwide Public Health Emergency, Mar. 17, 2020, available at https://www.hhs.gov/​about/​news/​2020/​03/​17/​ocr-announces-notification-of-enforcement-discretion-for-telehealth-remote-communications-during-the-covid-19.html (last visited Dec. 1, 2020). The PREP Act does not provide immunity against federal enforcement actions brought by the federal government. We refer to this exercise of enforcement discretion as another example of the Department’s desire to support the expanded use of telehealth during this pandemic. Back to Citation

14.  Id. Back to Citation

15.  See, e.g., 2020 Alaska Laws Ch. 10 (S.B. 241) Sec. 7 (healthcare provider can perform telehealth if, among other things, “the health care provider is licensed, permitted, or certified to provide healthcare services in another jurisdiction and is in good standing in the jurisdiction that issued the license, permit, or certification”); CT Exec. Order No. 7G, Sec. 5(b), Mar. 19, 2020, available at https://portal.ct.gov/​-/​media/​Office-of-the-Governor/​Executive-Orders/​Lamont-Executive-Orders/​Executive-Order-No-7G.pdf (last visited Dec. 1, 2020) (“Subsection (a)(12)’s requirements for the licensure, certification or registration of telehealth providers shall be suspended for such telehealth providers that are Medicaid enrolled providers or in-network providers for commercial fully insured health insurance providing telehealth services to patients”); Fl. Emerg. Order, DOH No. 20-002, In Re: Suspension of Statutes, Rules, and Orders, Made Necessary by COVID-19, Mar. 16, 2020, available at http://www.flhealthsource.gov/​pdf/​emergencyorder-20-002.pdf?​inf_​contact_​key=​c1be7c474d297aa416752a23d2694901680f8914173f9191b1c0223e68310bb1 (last visited Dec. 1, 2020) (“For purposes of preparing for, responding to, and mitigating any effect of COVID-19, health care professionals not licensed in this state may provide health care services to a patient licensed in this state using telehealth, notwithstanding the requirements of section 456.47(4)(a) through (c), (h), and (i), Florida Statutes . . . . This exemption shall apply only to the following out of state health care professionals holding a valid, clear, and unrestricted license in another state or territory in the United States who are not currently under investigation or prosecution in any disciplinary proceeding in any of the states in which they hold a license: physicians, osteopathic physicians, physician assistants, and advanced practice registered nurses.”); IA Emer. Dec., Sec. 39 (Nov. 10, 2020), available at https://governor.iowa.gov/​sites/​default/​files/​documents/​Public%20Health%20Proclamation%20-%202020.11.10.pdf (last visited Dec. 1, 2020) (temporarily suspending any statute or rule defining a doctor or medical staff as “requiring all doctors and medical staff be licensed to practice in this state, to the extent that individual is licensed to practice in another state”); NH Emer. Order # 15 Pursuant to Exec. Order 2020-4, Sec. 1, Mar. 23, 2020, available at https://www.governor.nh.gov/​sites/​g/​files/​ehbemt336/​files/​documents/​emergency-order-15.pdf (last visited Dec. 1, 2020) (“any out-of-state medical provider whose profession is licensed within this State shall be allowed to perform any medically necessary service as if the medical provider were licensed to perform such service within the state of New Hampshire subject to,” among other things, the medical provider being “licensed and in good standing in another United States jurisdiction”). Back to Citation

16.  Advisory Opinion 20-02 on the Public Readiness and Emergency Preparedness Act and the Secretary’s Declaration under the Act, May 19, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​advisory-opinion-20-02-hhs-ogc-prep-act.pdf (last visited Dec. 1, 2020). Back to Citation

17.  See, e.g., Guidance for Licensed Pharmacists, COVID-19 Testing, and Immunity Under the PREP Act, OASH, Apr. 8, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.pdf (last visited Dec. 1, 2020); Guidance for PREP Act Coverage for COVID-19 Screening Tests at Nursing Homes, Assisted-Living Facilities, Long-Term-Care Facilities, and other Congregate Facilities, OASH, Aug. 31, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/prep-act-coverage-for-screening-in-congregate-settings.pdf (last visited Dec. 1, 2020); Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act, OASH, Sept. 3, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf (last visited Dec. 1, 2020); Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH, Oct. 20, 2020, available at https://www.hhs.gov/​sites/​default/​files/​prep-act-guidance.pdf (last visited Dec. 1, 2020); PREP Act Authorization for Pharmacies Distributing and Administering Certain Covered Countermeasures, Oct. 29, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/prep-act-authorization-pharmacies-administering-covered-countermeasures.pdf (last visited Dec. 1, 2020). Back to Citation

18.  See 85 FR 52136 (Aug. 24, 2020). Back to Citation

19.  See, e.g., Advisory Opinion on the Public Readiness and Emergency Preparedness Act and the March 10, 2020 Declaration under the Act, Apr. 17, 2020, as Modified on May 19, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​prep-act-advisory-opinion-hhs-ogc.pdf (last visited Dec. 1, 2020); Advisory Opinion 20-02 on the Public Readiness and Emergency Preparedness Act and the Secretary’s Declaration under the Act, May 19, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​advisory-opinion-20-02-hhs-ogc-prep-act.pdf (last visited Dec. 1, 2020); Advisory Opinion 20-03 on the Public Readiness and Emergency Preparedness Act and the Secretary’s Declaration under the Act, Oct. 22, 2020, as Modified on Oct. 23, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​AO3.1.2_​Updated_​FINAL_​SIGNED_​10.23.20.pdf (last visited Dec. 1, 2020); Advisory Opinion 20-04 on the Public Readiness and Emergency Preparedness Act and the Secretary’s Declaration under the Act, Oct. 22, 2020, as Modified on Oct. 23, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​AO%204.2_​Updated_​FINAL_​SIGNED_​10.23.20.pdf (last visited Dec. 1, 2020). This is not to suggest that other PREP Act declarations should be construed in a manner contrary to the interpretation provided in the Advisory Opinions. Back to Citation

20.  See, e.g., Guidance for Licensed Pharmacists, COVID-19 Testing, and Immunity Under the PREP Act, OASH, Apr. 8, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.pdf (last visited Dec. 1, 2020); Guidance for PREP Act Coverage for COVID-19 Screening Tests at Nursing Homes, Assisted-Living Facilities, Long-Term-Care Facilities, and other Congregate Facilities, OASH, Aug. 31, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/prep-act-coverage-for-screening-in-congregate-settings.pdf (last visited Dec. 1, 2020); Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act, OASH, Sept. 3, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf (last visited Dec. 1, 2020); Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH, Oct. 20, 2020, available at https://www.hhs.gov/​sites/​default/​files/​prep-act-guidance.pdf (last visited Dec. 1, 2020); PREP Act Authorization for Pharmacies Distributing and Administering Certain Covered Countermeasures, Oct. 29, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/prep-act-authorization-pharmacies-administering-covered-countermeasures.pdf (last visited Dec. 1, 2020) (collectively, OASH PREP Act Authorizations). Nothing herein shall suggest that, for purposes of the Declaration, the foregoing are the only persons authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction. Back to Citation

21.  Some states do not require pharmacy interns to be licensed or registered by the state board of pharmacy. As used herein, “State-licensed or registered intern” (or equivalent phrases) refers to pharmacy interns authorized by the state or board of pharmacy in the state in which the practical pharmacy internship occurs. The authorization can, but need not, take the form of a license from, or registration with, the State board of pharmacy. See Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH, Oct. 20, 2020 at 2, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/prep-act-guidance.pdf (last visited Dec. 1, 2020). Back to Citation

22.  This requirement is satisfied by, among other things, a certification in basic cardiopulmonary resuscitation by an online program that has received accreditation from the American Nurses Credentialing Center, the ACPE, or the Accreditation Council for Continuing Medical Education. The phrase “current certificate in basic cardiopulmonary resuscitation,” when used in the September 3, 2020 or October 20, 2020 OASH authorizations, shall be interpreted the same way. See Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act, OASH, Sept. 3, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​/licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf (last visited Dec. 1, 2020); Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH, Oct. 20, 2020, available at https://www.hhs.gov/​sites/​default/​files/​prep-act-guidance.pdf (last visited Dec. 1, 2020). Back to Citation

23.  See, e.g., Advisory Opinion 20-02 on the Public Readiness and Emergency Preparedness Act and the Secretary’s Declaration under the Act, May 19, 2020, available at https://www.hhs.gov/​guidance/​sites/​default/​files/​hhs-guidance-documents/​advisory-opinion-20-02-hhs-ogc-prep-act.pdf (last visited Dec. 1, 2020). Back to Citation

24.  For simplicity, this example assumes a patient only requires one dose of the vaccine. Back to Citation

25.  42 U.S.C. 247d-6d(b)(7) provides that “[n]o court of the United States, or of any State, shall have subject matter jurisdiction to review, whether by mandamus or otherwise, any action by the Secretary under this subsection.” Back to Citation

[FR Doc. 2020-26977 Filed 12-8-20; 8:45 am]

BILLING CODE 4150-37-P

Technical Correction to Ninth Amendment to the Declaration under the PREP Act for Medical Countermeasures Against COVID-19 (October 4, 2021):

52136 Federal Register / Vol. 85, No. 164 / Monday, August 24, 2020 / Notices • Drawing the program link between outreach and education, promoting consumer understanding of health care coverage choices, and facilitating consumer selection/enrollment, which in turn support the overarching goal of improved access to quality care, including prevention services, envisioned under the Affordable Care Act. The current members of the Panel as of February 28, 2020 are: E. Lorraine Bell, Chief Officer, Population Health, Catholic Charities USA; Nazleen Bharmal, Medical Director of Community Partnerships, Cleveland Clinic; Angie Boddie, Director of Health Programs, National Caucus and Center on Black Aging, Inc.; Julie Carter, Senior Federal Policy Associate, Medicare Rights Center; Scott Ferguson, Director of Care Transitions and Population Health, Mount Sinai St. Luke’s Hospital; Leslie Fried, Senior Director, Center for Benefits Access, National Council on Aging; David Goldberg, President and CEO of Mon Health System; JeanVenable Robertson Goode, Professor, Department of Pharmacotherapy and Outcomes Science, School of Pharmacy, Virginia Commonwealth University; Ted Henson, Director of Health Center Performance and Innovation, National Association of Community Health Centers; Joan Ilardo, Director of Research Initiatives, Michigan State University, College of Human Medicine; Cheri Lattimer, Executive Director, National Transitions of Care Coalition; Cori McMahon, Vice President, Tridiuum; Alan Meade, Director of Rehab Services, Holston Medical group; Michael Minor, National Director, H.O.P.E. HHS Partnership, National Baptist Convention USA, Incorporated; Jina Ragland, Associate State Director of Advocacy and Outreach, AARP Nebraska; Morgan Reed, Executive Director, Association for Competitive Technology; Margot Savoy, Chair, Department of Family and Community Medicine, Temple University Physicians; Congresswoman Allyson Schwartz, President and CEO, Better Medicare Alliance; and; Tia Whitaker, Statewide Director, Outreach and Enrollment, Pennsylvania Association of Community Health Centers. II. Provisions of This Notice In accordance with section 10(a) of the FACA, this notice announces a meeting of the APOE. The agenda for the September 23, 2020 meeting will include the following: • Welcome and listening session with CMS leadership • Recap of the previous (June 25, 2020) meeting • CMS programs, initiatives, and priorities • An opportunity for public comment • Meeting summary, review of recommendations, and next steps Individuals or organizations that wish to make a 5-minute oral presentation on an agenda topic should submit a written copy of the oral presentation to the DFO at the address listed in the ADDRESSES section of this notice by the date listed in the DATES section of this notice. The number of oral presentations may be limited by the time available. Individuals not wishing to make an oral presentation may submit written comments to the DFO at the address listed in the ADDRESSES section of this notice by the date listed in the DATES section of this notice. III. Meeting Participation The meeting is open to the public, but attendance is limited to registered participants. Persons wishing to attend this meeting must register at the website https://www.eventbrite.com/e/apoeseptember-23-2020-virtual-meetingtickets-114295017474 or contact the DFO at the address or number listed in the FOR FURTHER INFORMATION CONTACT section of this notice by the date specified in the DATES section of this notice. This meeting will be held virtually. Individuals who are not registered in advance will be unable to attend the meeting. IV. Collection of Information This document does not impose information collection requirements, that is, reporting, recordkeeping, or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). The Administrator of the Centers for Medicare & Medicaid Services (CMS), Seema Verma, having reviewed and approved this document, authorizes Lynette Wilson, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the Federal Register. Authority: Sec. 1114(f) of the Social Security Act (42 U.S.C. 1314(f)), sec. 222 of the Public Health Service Act (42 U.S.C. 217a), and sec. 10(a) of Pub. L. 92–463 (5 U.S.C. App. 2, sec. 10(a) and 41 CFR part 102–3). Dated: August 17, 2020. Lynette Wilson, Federal Register Liaison, Department of Health and Human Services. [FR Doc. 2020–18535 Filed 8–21–20; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Third Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID–19 ACTION: Notice of amendment. SUMMARY: The Secretary issues this amendment pursuant to section 319F–3 of the Public Health Service Act to add additional categories of Qualified Persons and amend the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures. DATES: This amendment to the Declaration published on March 17, 2020 (85 FR 15198) is effective as of August 24, 2020. FOR FURTHER INFORMATION CONTACT: Robert P. Kadlec, MD, MTM&H, MS, Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue SW, Washington, DC 20201; Telephone: 202–205–2882. SUPPLEMENTARY INFORMATION: The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to issue a Declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (Covered Countermeasures), except for claims involving ‘‘willful misconduct’’ as defined in the PREP Act. Under the PREP Act, a Declaration may be amended as circumstances warrant. The PREP Act was enacted on December 30, 2005, as Public Law 109– 148, Division C, § 2. It amended the Public Health Service (PHS) Act, adding section 319F–3, which addresses liability immunity, and section 319F–4, which creates a compensation program. These sections are codified at 42 U.S.C. 247d–6d and 42 U.S.C. 247d–6e, respectively. Section 319F–3 of the PHS Act has been amended by the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113–5, enacted on March 13, 2013 and the Coronavirus Aid, Relief, and Economic Security (CARES) Act, Public Law 116–136, enacted on March 27, VerDate Sep<11>2014 16:31 Aug 21, 2020 Jkt 250001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\24AUN1.SGM 24AUN1 jbell on DSKJLSW7X2PROD with NOTICES Federal Register / Vol. 85, No. 164 / Monday, August 24, 2020 / Notices 52137 1The only vaccines that ACIP has recommended are authorized or approved by the Food and Drug Administration (FDA). PREP Act coverage here is limited to covered persons ordering and administering FDA-authorized or FDA-approved vaccines. 2See Advisory Opinion on the Public Readiness and Emergency Preparedness Act and the March 10, 2020 Declaration under the Act, 5–6 (May 19, 2020), https://www.hhs.gov/sites/default/files/prep-actadvisory-opinion-hhs-ogc.pdf (last visited Aug. 5, 2020). 3See Advisory Opinion 20–02 on the Public Readiness and Emergency Preparedness Act and the Secretary’s Declaration under the Act, 3–5 (May 19, 2020), https://www.hhs.gov/sites/default/files/ advisory-opinion-20-02-hhs-ogc-prep-act.pdf (setting forth PREP Act’s legal framework for identifying a ‘‘qualified person’’ and preemption of state law that is different from, or is in conflict with, that designation). 4 Jeanne M. Santoli et al., Effects of the COVID– 19 Pandemic on Routine Pediatric Vaccine Ordering and Administration—United States, 2020, 69 MMWR 591, 592 (2020), https://www.cdc.gov/ mmwr/volumes/69/wr/pdfs/mm6919e2-H.pdf. (last visited July 15, 2020); see also Melissa Jenco, AAP urges vaccination as rates drop due to COVID–19, AAP News (May 8, 2020), https:// www.aappublications.org/news/2020/05/08/ covid19vaccinations050820 (last visited July 15, 2020). 5 Jeanne M. Santoli et al., Effects of the COVID– 19 Pandemic on Routine Pediatric Vaccine Ordering and Administration—United States, 2020, 69 MMWR 591, 592 (2020), https://www.cdc.gov/ mmwr/volumes/69/wr/pdfs/mm6919e2-H.pdf (last visited July 15, 2020). 6Tara M. Vogt, Provision of Pediatric Immunization Services During the COVID–19 Pandemic: an Assessment of Capacity Among Pediatric Immunization Providers Participating in the Vaccines for Children Program—United States, May 2020, 69 MMWR 859, 859–61, https:// www.cdc.gov/mmwr/volumes/69/wr/pdfs/ mm6927a2-H.pdf (last visited July 15, 2020). 7Routine Vaccination During the COVID–19 Outbreak, CDC, https://www.cdc.gov/vaccines/ parents/visit/vaccination-during-COVID-19.html (last visited July 14, 2020). 2020, to expand Covered Countermeasures under the PREP Act. On January 31, 2020, the Secretary declared a public health emergency pursuant to section 319 of the PHS Act, 42 U.S.C. 247d, effective January 27, 2020, for the entire United States to aid in the response of the nation’s health care community to the COVID–19 outbreak. Pursuant to section 319 of the PHS Act, the Secretary renewed that declaration on April 26, 2020, and July 25, 2020. On March 10, 2020, the Secretary issued a Declaration under the PREP Act for medical countermeasures against COVID–19 (85 FR 15198, Mar. 17, 2020) (the Declaration). On April 10, the Secretary amended the Declaration under the PREP Act to extend liability immunity to covered countermeasures authorized under the CARES Act (85 FR 21012, Apr. 15, 2020). On June 4, the Secretary amended the Declaration to clarify that covered countermeasures under the Declaration include qualified countermeasures that limit the harm COVID–19 might otherwise cause. The Secretary now amends section V of the Declaration to identify as qualified persons covered under the PREP Act, and thus authorizes, certain State-licensed pharmacists to order and administer, and pharmacy interns (who are licensed or registered by their State board of pharmacy and acting under the supervision of a State-licensed pharmacist) to administer, any vaccine that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP’s standard immunization schedule (ACIPrecommended vaccines).1 The Secretary also amends section VIII of the Declaration to clarify that the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures includes not only COVID–19 caused by SARS–CoV–2 or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID– 19, SARS–CoV–2, or a virus mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases. Description of This Amendment by Section Section V. Covered Persons Under the PREP Act and the Declaration, a ‘‘qualified person’’ is a ‘‘covered person.’’ Subject to certain limitations, a covered person is immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration or use of a covered countermeasure if a declaration under subsection (b) has been issued with respect to such countermeasure. ‘‘Qualified person’’ includes (A) a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed; or (B) ‘‘a person within a category of persons so identified in a declaration by the Secretary’’ under subsection (b) of the PREP Act. 42 U.S.C. 247d–6d(i)(8).2 By this amendment to the Declaration, the Secretary identifies an additional category of persons who are qualified persons under section 247d–6d(i)(8)(B).3 On May 8, 2020, CDC reported, ‘‘The identified declines in routine pediatric vaccine ordering and doses administered might indicate that U.S. children and their communities face increased risks for outbreaks of vaccinepreventable diseases,’’ and suggested that a decrease in rates of routine childhood vaccinations were due to changes in healthcare access, social distancing, and other COVID–19 mitigation strategies.4 The report also stated that ‘‘[p]arental concerns about potentially exposing their children to COVID–19 during well child visits might contribute to the declines observed.’’ 5 On July 10, 2020, CDC reported its findings of a May survey it conducted to assess the capacity of pediatric health care practices to provide immunization services to children during the COVID– 19 pandemic. The survey, which was limited to practices participating in the Vaccines for Children program, found that, as of mid-May, 15 percent of Northeast pediatric practices were closed, 12.5 percent of Midwest practices were closed, 6.2 percent of practices in the South were closed, and 10 percent of practices in the West were closed. Most practices had reduced office hours for in-person visits. When asked whether their practices would likely be able to accommodate new patients for immunization services through August, 418 practices (21.3 percent) either responded that this was not likely or the practice was permanently closed or not resuming immunization services for all patients, and 380 (19.6 percent) responded that they were unsure. Urban practices and those in the Northeast were less likely to be able to accommodate new patients compared with rural practices and those in the South, Midwest, or West.6 In response to these troubling developments, CDC and the American Academy of Pediatrics have stressed, ‘‘Well-child visits and vaccinations are essential services and help make sure children are protected.’’ 7 The Secretary re-emphasizes that important recommendation to parents and legal guardians here: If your child is due for a well-child visit, contact your pediatrician’s or other primary-care provider’s office and ask about ways that the office safely offers well-child visits and vaccinations. Many medical offices are taking extra steps to make sure that well-child visits can occur safely during the COVID–19 pandemic, including: • Scheduling sick visits and wellchild visits during different times of the VerDate Sep<11>2014 16:31 Aug 21, 2020 Jkt 250001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\24AUN1.SGM 24AUN1 jbell on DSKJLSW7X2PROD with NOTICES 52138 Federal Register / Vol. 85, No. 164 / Monday, August 24, 2020 / Notices 8For purposes of this amendment, ‘‘State’’ shall have the same meaning ascribed to it in 42 U.S.C. 201(f). Under section 201(f), ‘‘State’’ includes the several States, the District of Columbia, Guam, the Commonwealth of Puerto Rico, the Northern Mariana Islands, the Virgin Islands, American Samoa, and the Trust Territory of the Pacific Islands. 9See, e.g., Ala. Code § 34–23–1(5), (21) (2020); Ala. Admin. Code r. 680–X–2–.14(1) (2000); Alaska Stat. Ann. § 08.80.168(a) (West 2020); Cal. Bus. & Prof. Code § 4052(a)(11) (West 2020); Colo. Code Regs. § 719–1:19.00.00 (West 2020); Ga. Code Ann. § 43–34–26.1 (West 2020); Idaho Code Ann. § 54– 1704 (West 2020); Idaho Code Ann. § 37–201 (West 2020); Ind. Code Ann. § 25–26–13–31.2(a) (West 2020); Iowa Admin. Code § 657–39.10(6) (2020); La. Admin. Code tit. 46, Pt. LIII, § 521 (2020); Mich. Comp. Laws Ann. § 333.9204 (2020); Miss. Code Ann. § 73–21–73(a), (dd) (West 2000); MO 20 CSR 2220–6.040; MO 20 CSR 2220–6.050; Neb. Rev. Stat. Ann. §§ 38–2806, 38–2837 (West 2000); 175 Neb. Admin. Code. § 8.003.01A(3)(m)(4)(a) (2020); N.H. Rev. Stat. § 318:16–b (2020); Nev. Admin. Code § 639.2971 (2020); N.M. Stat. Ann. § 61–11–2(A), (G), (CC) (West 2020); Okla. Stat. Ann. tit. 59, § 353.30 (West 2020); Or. Rev. Stat. § 689.645 (West 2020); https://www.oregon.gov/oha/PH/ PREVENTIONWELLNESS/VACCINES IMMUNIZATION/IMMUNIZATIONPROVIDER RESOURCES/Pages/pharmacy.aspx#:∼:text= Immunization%20Resources%20for%20Oregon %20Pharmacists,a%20patient%20of%20any %20age (last visited Aug. 13, 2020); S.C. Code Ann. § 40–43–190 (2020); S.D. Codified Laws § 36–11–2, S.D. Codified Laws § 36–11–19.1; Tenn. Code Ann. § 63–10–204(1), 39(A) (West 2020); Tex. Occ. Code Ann. § 551.003(33) (2020); 22 Tex. Admin. Code § 295.15(e) (2020); Utah Code Ann. § 58–17b– 102(1), (57) (West 2020); Utah Admin. Code R156– 17b–621(5) (2020); Va. Code Ann. § 54.1–3408(I) (2020); Wash. Rev. Code Ann. § 18.64.011(1), (28) (West 2020); Wis. Stat. Ann. § 450.035 (West 2020). While these states allow pharmacists to administer vaccines to children of any age, some impose additional requirements. See, e.g., Cal. Bus. & Prof. Code §§ 4052(a)(11), 4052.8 (permitting pharmacists to administer any vaccine listed on the routine immunization schedules recommended by the Advisory Committee on Immunization Practices to persons three years of age and older, but requiring the pharmacist to administer immunizations to persons under three years of age only pursuant to a protocol with a prescriber); Colo. Code Regs. § 719–1:19.00.00 (West 2020) (requiring that pharmacists administer vaccines and immunizations ‘‘per authorization of a physician’’). 10See, e.g., Ariz. Rev. Stat. Ann. § 32–1974(B) (2020); Ark. Code Ann. § 17–92–101 (2020); D.C. Mun. Reg Tit. 17 sec. 6512.10 (2012); Haw. Rev. Stat. § 461–11.4 (West 2019); 225 Ill. Comp. Stat. Ann. 85/3(d) (West 2020); Kan. Stat. Ann. § 65– 1635a (2020); Ky. Rev. Stat. Ann. § 315.010(22) (West 2020); Me. Rev. Stat. Ann. tit. 32, § 13831 (West 2020); Md. Code Ann., Health Occ. § 12–508 (2020); 247 Mass. Code Regs. 16.03 (2020); Minn. Stat. Ann. § 151.01 (West 2020); Mont. Code Ann. § 37–7–105 (West 2019); N.J. Stat. Ann. § 45:14–63 (West 2020); N.Y. Comp. Codes R. & Regs. tit. 8, § 63.9 (2020); N.C. Gen. Stat. Ann. § 90–85.15B (West 2020); N.D. Cent. Code Ann. § 43–15–01 (West 2020); Ohio Rev. Code Ann. § 4729.41 (West 2020); 63 Pa. Cons. Stat. § 390–9.2 (West 2020); P.R. Laws tit. 20, § 410c (2018); 5 R.I. Gen. Laws Ann. § 5–19.1–31 (West 2020); W.Va. Code Ann. § 30–5– 7 (West 2020); Wyo Stat. Ann. § 33–24–157 (2020). 11See, e.g., Conn. Gen. Stat. § 20–633(a) (West 2012); 24 Del. Code Ann. § 2502(23)(h) (West 2020); Fla. Stat. Ann. § 465.189(1) (West 2020); Vt. Admin. R. of Board of Pharm. § 10.35 (West 2020). 12See, e.g., Or. Admin. R. 855–019–0270 (2020) (‘‘[A]n intern who is appropriately trained and qualified in accordance with Section (3) of this rule may perform the same duties as a pharmacist, provided that the intern is supervised by an appropriately trained and qualified pharmacist.’’). 13See, e.g., Guidance for Pharmacists and Pharmacy Technicians in Community Pharmacies during the COVID–19 Response, CDC, https:// www.cdc.gov/coronavirus/2019-ncov/hcp/ pharmacies.html (last updated June 28, 2020) (‘‘As a vital part of the healthcare system, pharmacies play an important role in providing medicines, therapeutics, vaccines, and critical health services to the public.’’); Kimberly McKeirnan & Gregory Sarchet, Implementing Immunizing Pharmacy Technicians in a Federal Healthcare Facility, 7 Pharmacy 1, 7 (2019), https://www.mdpi.com/2226- 4787/7/4/152/htm (last visited Aug. 5, 2020) (HHS Indian Health Service study demonstrating ‘‘the effective implementation of immunization-trained pharmacy technicians and the positive impact utilization of pharmacy support personnel can create’’ on childhood vaccination rates in medically underserved populations). 14 Get to Know Your Pharmacist, CDC, https:// www.cdc.gov/features/pharmacist-month/ index.html (last visited July 14, 2020). 15Early-Season Flu Vaccination Coverage— United States, November 2018, CDC, https:// www.cdc.gov/flu/fluvaxview/nifs-estimatesnov2018.htm (last visited July 14, 2020). 16See Immunization Schedules: For Health Care Providers, CDC, https://www.cdc.gov/vaccines/ schedules/hcp/index.html (last visited July 14, 2020). The immunization schedule recommends that certain vaccines be administered only to children of a certain age. For example, the second dose of both the measles, mumps, and rubella vaccine, as well as the varicella vaccine, should not be administered until a child is between four and six years old. See Recommended Child and Adolescent Immunization Schedule for ages 18 years or younger, United States, 2020, CDC (Jan. 29, 2020), https://www.cdc.gov/vaccines/schedules/ downloads/child/0-18yrs-child-combinedschedule.pdf (last visited Aug. 5, 2020). day or days of the week, or at different locations. • Asking patients to remain outside until it is time for their appointments to reduce the number of people in waiting rooms. • Adhering to recommended social (physical) distancing and other infection-control practices, such as the use of masks. The decrease in childhoodvaccination rates is a public health threat and a collateral harm caused by COVID–19. Together, the United States must turn to available medical professionals to limit the harm and public health threats that may result from decreased immunization rates. We must quickly do so to avoid preventable infections in children, additional strains on our healthcare system, and any further increase in avoidable adverse health consequences—particularly if such complications coincide with additional resurgence of COVID–19. Together with pediatricians and other healthcare professionals, pharmacists are positioned to expand access to childhood vaccinations. Many States already allow pharmacists to administer vaccines to children of any age.8 9 Other States permit pharmacists to administer vaccines to children depending on the age—for example, 2, 3, 5, 6, 7, 9, 10, 11, or 12 years of age and older.10 Few States restrict pharmacist-administered vaccinations to only adults.11 Many States also allow properly trained individuals under the supervision of a trained pharmacist to administer those vaccines.12 Pharmacists are well positioned to increase access to vaccinations, particularly in certain areas or for certain populations that have too few pediatricians and other primary-care providers, or that are otherwise medically underserved.13 As of 2018, nearly 90 percent of Americans lived within five miles of a community pharmacy.14 Pharmacies often offer extended hours and added convenience. What is more, pharmacists are trusted healthcare professionals with established relationships with their patients. Pharmacists also have strong relationships with local medical providers and hospitals to refer patients as appropriate. For example, pharmacists already play a significant role in annual influenza vaccination. In the early 2018–19 season, they administered the influenza vaccine to nearly a third of all adults who received the vaccine.15 Given the potential danger of serious influenza and continuing COVID–19 outbreaks this autumn and the impact that such concurrent outbreaks may have on our population, our healthcare system, and our whole-of-nation response to the COVID–19 pandemic, we must quickly expand access to influenza vaccinations. Allowing more qualified pharmacists to administer the influenza vaccine to children will make vaccinations more accessible. Therefore, the Secretary amends the Declaration to identify State-licensed pharmacists (and pharmacy interns acting under their supervision if the pharmacy intern is licensed or registered by his or her State board of pharmacy) as qualified persons under section 247d–6d(i)(8)(B) when the pharmacist orders and either the pharmacist or the supervised pharmacy intern administers vaccines to individuals ages three through 18 pursuant to the following requirements: • The vaccine must be FDAauthorized or FDA-approved. • The vaccination must be ordered and administered according to ACIP’s standard immunization schedule.16 • The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training VerDate Sep<11>2014 16:31 Aug 21, 2020 Jkt 250001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\24AUN1.SGM 24AUN1 jbell on DSKJLSW7X2PROD with NOTICES Federal Register / Vol. 85, No. 164 / Monday, August 24, 2020 / Notices 52139 17Cf., e.g., Cal. Bus. & Prof. Code § 4052.8; 3 Colo. Code Regs. § 719–1:19.00.00; 856 Ind. Admin. Code 4–1–1; 46 La. Admin. Code tit. 46Part LIII, § 521; Nev. Admin. Code § 639.2973; 22 Tex. Admin. Code § 295.15(c). 18Cf., e.g., Ark. Admin. Code § 070.00.9–09–00– 0002; 3 Colo. Code Regs. § 719–1:19.00.00; Nev. Admin. Code § 639.2973; N.H. Rev. Stat. § 318:16– d; Ohio Rev. Code Ann. § 4729.41(B); Or. Admin. R. 855–019–0270 (2020); S.C. Code Ann. §§ 40–43– 190(B)(1), (4); Utah Admin. Code r. 156R–17b– 621(5); Vt. Admin. Code 20–4–1400:10.35. 19Cf., e.g., Ariz. Admin. Code § R4–23–411(D(3); Conn. Gen. Stat. § 20–633(b); D.C. Mun. Regs. tit. 17, § 6512.3; 856 Ind. Admin. Code 4–1–1(c); Iowa Admin. Code r. 657–39.10(2)(A); Kan. Stat. Ann. § 65–1635a(a); La. Admin. Code tit. 46 Part LIII, § 521(D); Me. Rev. Stat. Ann. tit. 32, § 13832; Md. Code Ann., Health Occ. § 12–508(b)(2)(ii); Mont. Code Ann. § 37–7–101(24)(b); N.J. Admin. Code § 13:39–4.21(b)(2); N.D. Cent. Code Ann. § 43–15– 31.5; Or. Admin. R. 855–019–0270 (2020); 63 Pa. Stat. Ann. § 390–9.2;(a)(2) 216 R.I. Code R. § 40–15– 1.11; S.C. Code Ann. §§ 40–43–190(B)(4); S.D. Admin. R. 20:51:28:02; W. Va. Code St. R. § 15–12– 4; Wyo. Admin. Code 059.0001.16 § 7. 20Cf., e.g., AR ADC § 070.00.9–09–00–0002; 3 Colo. Code Regs. § 719–1:19.00.00; N.J. Stat. Ann. § 13:39–4.21; S.C. Code Ann. §§ 40–43–190(B)(1), (5); 22 Tex. Admin. Code § 295.15(c); Utah Admin. Code r. 156–17b–621(5); 59–0001–16 Wyo. Code R. § 7. 21Cf., e.g., Ala. Admin. Code. r. 680–X–2.14; Ariz. Admin. Code § R4–23–411(E); AR ADC § 070.00.9–09–00–0002; Cal. Code Regs. tit. 16, § 1746.4; Conn. Gen. Stat. § 20–633(b); 225 Ill. Comp. Stat. Ann. 85/3(d)(4); Kan. Stat. Ann. § 65– 1635a(a); Mont. Admin. R. 24.174.503; Nev. Rev. Stat. Ann. § 454.213(s); N.H. Rev. Stat. § 318:16–d; N.J. Stat. Ann. § 45:14–63; N.Y. Comp. Codes R. & Regs. tit. 8, § 63.9; N.D. Cent. Code Ann. § 43–15– 31.5; Or. Admin. r. 855–019–0280; 216–40; R.I. Code R. § 15–1.11; S.C. Code Ann. §§ 40–43– 190(B)(1), (5); S.D. Admin. R. 20:51:28:04; Tenn. Code Ann. § 53–10–211; 22 Tex. Admin. Code § 295.15(c); 04–230 Vt. Code R. § 10.35; Va. Code Ann. § 54.1–3408; Wis. Stat. Ann. § 450.035. 22See, e.g., Letter from Kathleen E. Toomey, M.D., M.P.H., Comm’r and State Health Officer, Ga. Dep’t of Pub. Health, available at https://www.gpha.org/ immunization/ (last visited July 15, 2020). 23See, e.g., AL ST § 34–23–53; 12 AAC 52.992; Cal. Bus. & Prof. Code § 4052; Cal. Bus. & Prof. Code § 4052.8(b); 3 Colo. Code Regs. § 719–1:19.00.00; Ga. Code Ann., § 43–34–26.1; 856 IAC 4–1–1; Iowa Code § 39.10(2)(a); N.M. Admin. Code 16.19.26; Okla. Admin. Code 535:10–11–5; Code 1976 § 40– 43–190 (South Carolina). 24 Vaccine Recommendations and Guidelines of the ACIP, https://www.cdc.gov/vaccines/hcp/aciprecs/general-recs/administration.html (last visited July 29, 2020). 25 Id. 26 Id.; Nicole E. Omecene, et al., Implementation of pharmacist-administered pediatric vaccines in the United States: major barriers and potential solutions for the outpatient setting, https:// www.ncbi.nlm.nih.gov/pmc/articles/PMC6594428/ (last visited July 29, 2020). 27Preschool and Kindergarten Enrollment, https://nces.ed.gov/programs/coe/indicator_cfa.asp (last visited July 29, 2020). 28State School Immunization Requirements and Vaccine Exemption Laws, https://www.cdc.gov/ phlp/docs/school-vaccinations.pdf, (last visited July 29, 2020). 29Nothing herein shall affect federal law requirements in 42 CFR part 455, subpart E regarding screening and enrollment of Medicare and Medicaid providers. Moreover, nothing herein shall preempt State laws that permit additional individuals to administer vaccines that ACIP recommends to persons age 18 or younger according to ACIP’s standard immunization schedule. For example, Idaho permits pharmacy technicians who meet certain requirements to administer vaccines under the supervision of an immunizing pharmacist. Such technicians can still administer vaccines to the extent they would have been able to absent publication of this amendment. Moreover, pharmacists and pharmacy interns may still order or administer vaccines to individuals ages two or younger to the extent authorized under State law. 30 42 U.S.C. 247d–d6(i)(7)(A); 85 FR 35–100, 35– 102. program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.17 • The licensed or registered pharmacy intern must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.18 • The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation.19 • The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period.20 • The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient’s primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine.21 • The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregivers accompanying the children of the importance of a well-child visit with a pediatrician or other licensed primarycare provider and refer patients as appropriate.22 These requirements are consistent with those in many States that permit licensed pharmacists to order and administer vaccines to children and permit licensed or registered pharmacy interns acting under their supervision to administer vaccines to children.23 Administering vaccinations to children age three and older is less complicated and requires less training and resources than administering vaccinations to younger children. That is because ACIP generally recommends administering intramuscular injections in the deltoid muscle for individuals age three and older.24 For individuals less than three years of age, ACIP generally recommends administering intramuscular injections in the anterolateral aspect of the thigh muscle.25 Administering injections in the thigh muscle often presents additional complexities and requires additional training and resources including additional personnel to safely position the child while another healthcare professional injects the vaccine.26 Moreover, as of 2018, 40% of threeyear-olds were enrolled in preprimary programs (i.e. preschool or kindergarten programs).27 Preprimary programs are beginning in the coming weeks or months, so the Secretary has concluded that it is particularly important for individuals ages three through 18 to receive ACIP-recommended vaccines according to ACIP’s standard immunization schedule. All States require children to be vaccinated against certain communicable diseases as a condition of school attendance. These laws often apply to both public and private schools with identical immunization and exemption provisions.28 As nurseries, preschools, kindergartens, and schools reopen, increased access to childhood vaccinations is essential to ensuring children can return. Notwithstanding any State or local scope-of-practice legal requirements, (1) qualified licensed pharmacists are identified as qualified persons to order and administer ACIP-recommended vaccines and (2) qualified State-licensed or registered pharmacy interns are identified as qualified persons to administer the ACIP-recommended vaccines ordered by their supervising qualified licensed pharmacist.29 Both the PREP Act and the June 4, 2020 Second Amendment to the Declaration define ‘‘covered countermeasures’’ to include qualified pandemic and epidemic products that ‘‘limit the harm such pandemic or epidemic might otherwise cause.’’ 30 The troubling decrease in ACIPrecommended childhood vaccinations and the resulting increased risk of associated diseases, adverse health conditions, and other threats are categories of harms otherwise caused by VerDate Sep<11>2014 16:31 Aug 21, 2020 Jkt 250001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\24AUN1.SGM 24AUN1 jbell on DSKJLSW7X2PROD with NOTICES 52140 Federal Register / Vol. 85, No. 164 / Monday, August 24, 2020 / Notices 31 Jeanne M. Santoli et al., Effects of the COVID– 19 Pandemic on Routine Pediatric Vaccine Ordering and Administration—United States, 2020, 69 MMWR No. 19, at 591–93 (May 15, 2020), https://www.cdc.gov/mmwr/volumes/69/wr/ mm6919e2.htm; Cristi A. Bramer et al., Decline in Child Vaccination Coverage During the COVID–19 Pandemic—Michigan Care Improvement Registry, May 2016–May 2020, 69 MMWR No. 20, at 630–31 (May 22, 2020), https://www.cdc.gov/mmwr/ volumes/69/wr/mm6920e1.htm. COVID–19 as set forth in Sections VI and VIII of this Declaration.31 Hence, such vaccinations are ‘‘covered countermeasures’’ under the PREP Act and the June 4, 2020 Second Amendment to the Declaration. Nothing in this Declaration shall be construed to affect the National Vaccine Injury Compensation Program, including an injured party’s ability to obtain compensation under that program. Covered countermeasures that are subject to the National Vaccine Injury Compensation Program authorized under 42 U.S.C. 300aa-10 et seq. are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program. All other terms and conditions of the Declaration apply to such covered countermeasures. Section VIII. Category of Disease, Health Condition, or Threat As discussed, the troubling decrease in ACIP-recommended childhood vaccinations and the resulting increased risk of associated diseases, adverse health conditions, and other threats are categories of harms otherwise caused by COVID–19. The Secretary therefore amends section VIII, which describes the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures, to clarify that the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures is not only COVID–19 caused by SARS–CoV– 2 or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID–19, SARS–CoV–2, or a virus mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases. Amendments to Declaration Amended Declaration for Public Readiness and Emergency Preparedness Act Coverage for medical countermeasures against COVID–19. Sections V and VIII of the March 10, 2020 Declaration under the PREP Act for medical countermeasures against COVID–19, as amended April 10, 2020 and June 4, 2020, are further amended pursuant to section 319F–3(b)(4) of the PHS Act as described below. All other sections of the Declaration remain in effect as published at 85 FR 15198 (Mar. 17, 2020) and amended at 85 FR 21012 (Apr. 15, 2020) and 85 FR 35100 (June 8, 2020). 1. Covered Persons, section V, delete in full and replace with: V. Covered Persons 42 U.S.C. 247d–6d(i)(2), (3), (4), (6), (8)(A) and (B) Covered Persons who are afforded liability immunity under this Declaration are ‘‘manufacturers,’’ ‘‘distributors,’’ ‘‘program planners,’’ ‘‘qualified persons,’’ and their officials, agents, and employees, as those terms are defined in the PREP Act, and the United States. In addition, I have determined that the following additional persons are qualified persons: (a) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction, as described in Section VII below, to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a Declaration of an emergency; (b) any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with Section 564 of the FD&C Act; (c) any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the FD&C Act; and (d) a State-licensed pharmacist who orders and administers, and pharmacy interns who administer (if the pharmacy intern acts under the supervision of such pharmacist and the pharmacy intern is licensed or registered by his or her State board of pharmacy), vaccines that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP’s standard immunization schedule. Such State-licensed pharmacists and the State-licensed or registered interns under their supervision are qualified persons only if the following requirements are met: • The vaccine must be FDAauthorized or FDA-approved. • The vaccination must be ordered and administered according to ACIP’s standard immunization schedule. • The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines. • The licensed or registered pharmacy intern must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines. • The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation. • The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period. • The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient’s primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine. • The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregiver accompanying the child of the importance of a well-child visit with a pediatrician or other licensed primarycare provider and refer patients as appropriate. Nothing in this Declaration shall be construed to affect the National Vaccine Injury Compensation Program, including an injured party’s ability to obtain compensation under that program. Covered countermeasures that are subject to the National Vaccine Injury Compensation Program authorized under 42 U.S.C. 300aa–10 et seq. are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program. All other VerDate Sep<11>2014 16:31 Aug 21, 2020 Jkt 250001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\24AUN1.SGM 24AUN1 jbell on DSKJLSW7X2PROD with NOTICES Federal Register / Vol. 85, No. 164 / Monday, August 24, 2020 / Notices 52141 terms and conditions of the Declaration apply to such covered countermeasures. 2. Category of Disease, Health Condition, or Threat, section VIII, delete in full and replace with: VIII. Category of Disease, Health Condition, or Threat 42 U.S.C. 247d–6d(b)(2)(A) The category of disease, health condition, or threat for which I recommend the administration or use of the Covered Countermeasures is not only COVID–19 caused by SARS-CoV– 2 or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID–19, SARS-CoV–2, or a virus mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases. Authority: 42 U.S.C. 247d–6d. Dated: August 19, 2020. Alex M. Azar II, Secretary of Health and Human Services. [FR Doc. 2020–18542 Filed 8–20–20; 4:15 pm] BILLING CODE 4150–03–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Tick-Borne Disease Working Group AGENCY: Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services. ACTION: Notice. SUMMARY: As required by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the Tick-Borne Disease Working Group (TBDWG) will hold a virtual meeting. The meeting will be open to the public. For this meeting, the TBDWG will review the draft 2020 report to the HHS Secretary and Congress and review and approve graphics and images for the report. The 2020 report will address ongoing tickborne disease research, including research related to causes, prevention, treatment, surveillance, diagnosis, diagnostics, and interventions for individuals with tick-borne diseases; advances made pursuant to such research; federal activities related to tick-borne diseases; and gaps in tickborne disease research. DATES: The meeting will be held online via webcast on September 15, 2020 and September 22, 2020 from 9:00 a.m. to 2:30 p.m. ET both days (times are tentative and subject to change). The confirmed times and agenda items for the meeting will be posted on the TBDWG web page at https:// www.hhs.gov/ash/advisory-committees/ tickbornedisease/meetings/2020-9-15/ index.html when this information becomes available. FOR FURTHER INFORMATION CONTACT: James Berger, Designated Federal Officer for the TBDWG; Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, Department of Health and Human Services, Mary E. Switzer Building, 330 C Street SW, Suite L600, Washington, DC, 20024. Email: tickbornedisease@ hhs.gov; Phone: 202–795–7608. SUPPLEMENTARY INFORMATION: The registration link will be posted on the website at https://www.hhs.gov/ash/ advisory-committees/tickbornedisease/ meetings/2020-9-15/index.html when it becomes available. After registering, you will receive an email confirmation with a personalized link to access the webcast on September 15, 2020 and September 22, 2020 The public will have an opportunity to present their views to the TBDWG orally during the meeting’s public comment session or by submitting a written public comment. Comments should be pertinent to the meeting discussion. Persons who wish to provide verbal or written public comment should review instructions at https://www.hhs.gov/ash/advisorycommittees/tickbornedisease/meetings/ 2020-9-15/index.html and respond by midnight September 4, 2020 ET. Verbal comments will be limited to three minutes each to accommodate as many speakers as possible during the 30 minute session. Written public comments will be accessible to the public on the TBDWG web page prior to the meeting. Background and Authority: The TickBorne Disease Working Group was established on August 10, 2017, in accordance with Section 2062 of the 21st Century Cures Act, and the Federal Advisory Committee Act, 5 U.S.C. App., as amended, to provide expertise and review federal efforts related to all tickborne diseases, to help ensure interagency coordination and minimize overlap, and to examine research priorities. The TBDWG is required to submit a report to the HHS Secretary and Congress on their findings and any recommendations for the federal response to tick-borne disease every two years. Dated: August 12, 2020. James J. Berger, Designated Federal Officer, Tick-Borne Disease Working Group, Office of Infectious Disease and HIV/AIDS Policy. [FR Doc. 2020–18519 Filed 8–21–20; 8:45 am] BILLING CODE 4150–28–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel RFA–DK–20–503 Limited Competition: TEDDY Data Coordinating Center. Date: October 7, 2020. Time: 3:00 p.m. to 4:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Dianne Camp, Ph.D., Scientific Review Officer, Review Branch, Division of Extramural Activities, NIDDK, National Institutes of Health, Room 7013, 6707 Democracy Boulevard, Bethesda, MD 20892–2542, (301) 5947682, campd@ extra.niddk.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS) Dated: August 18, 2020. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2020–18438 Filed 8–21–20; 8:45 am]

BILLING CODE 4140–01–P

Tenth Amendment to Declaration Under the PREP Act for Medical Countermeasures Against COVID-19 (January 7, 2022):

35100 Federal Register / Vol. 85, No. 110 / Monday, June 8, 2020 / Notices services is a key component of the HRSA mission. HRSA’s Maternal and Child Health Bureau (MCHB) provides funding to address some of the most urgent issues influencing the high rates of maternal mortality. Recent efforts to address persistent disparities in maternal, infant, and child health have employed a ‘‘life course’’ perspective and health equity lens focused on health promotion and disease prevention. The life course approach can be defined as analyzing people’s lives within structural, social, and cultural contexts through a defined sequence of age categories that people are normally expected to pass through as they progress from birth to death. Health equity is defined as the attainment of the highest level of health for all people. Achieving health equity for pregnant and postpartum women will require attention to barriers in access to quality health services and promotion of equal opportunities to seek the highest possible level of health and well-being. Achieving health equity also requires a focus on social determinants of health. With this emphasis on improving maternal health across the life course and promoting optimal health for all mothers, HRSA is employing a multipronged strategy to address maternal mortality and severe maternal morbidity through the following suite of programs: 1. The State Maternal Health Innovation Program, 2. The Alliance for Innovation on Maternal Health Program, 3. The Alliance for Innovation on Maternal Health—Community Care Initiative, 4. The Rural Maternity and Obstetrics Management Strategies Program, and 5. The Supporting Maternal Health Innovation Program. MCHB is conducting a portfolio-wide evaluation of HRSA-supported Maternal Health Programs with a primary focus on reducing maternal mortality. Through this evaluation, HRSA seeks to identify individual and/or collective strategies, interrelated activities, and common themes within and across the Maternal Health Programs that may be contributing to or driving improvements in key maternal health outcomes. HRSA seeks to ascertain which components should be elevated and replicated to the national level, as well as inform future investments to reduce rates of maternal mortality and severe maternal morbidity. Need and Proposed Use of the Information: HRSA seeks to understand the impact of HRSA’s investments into maternal health programs. These five HRSA maternal health programs represent a total of 12 state-based grantees and three grantees with the potential for national reach. In understanding the strategies that are most effective in reducing maternal morbidity and mortality, HRSA will be able to determine which program elements could be replicated and/or scaled up nationally. Likely Respondents: Likely respondents are recipients of the cooperative agreements mentioned above (State Maternal Health Innovation Program, Alliance for Innovation on Maternal Health Program, Alliance for Innovation on Maternal Health— Community Care Initiative, Rural Maternity and Obstetrics Management Strategies Program, and Supporting Maternal Health Innovation Program) which include 11 state health agencies, 2 national organizations, and 2 academic organizations. Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below. TOTAL ESTIMATED ANNUALIZED BURDEN HOURS Form name Number of respondents Number of responses per respondent Total responses Average burden per response (in hours) Total burden hours Instrument 1: Interview guide for grantee staff ……………….. 75 1 75 1.00 75.0 Instrument 2: Interview guide for HRSA POs …………………. 7 1 7 1.50 10.5 Instrument 3: Partnership Survey …………………………………. 290 1 290 0.25 72.5 Instrument 4: Web-based data collection tool ………………… 15 1 15 0.50 7.5 Total …………………………………………………………………… 387 …………………… 387 …………………… 165.5 HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency’s functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Maria G. Button, Director, Executive Secretariat. [FR Doc. 2020–12308 Filed 6–5–20; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Second Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID–19 ACTION: Notice of amendment. SUMMARY: The Secretary issues this amendment pursuant to section 319F–3 of the Public Health Service Act to clarify that Covered Countermeasures VerDate Sep<11>2014 20:38 Jun 08, 2020 Jkt 250001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\08JNN1.SGM 08JNN1 jbell on DSKJLSW7X2PROD with NOTICES Federal Register / Vol. 85, No. 110 / Monday, June 8, 2020 / Notices 35101 under the Declaration include qualified pandemic and epidemic products that limit the harm COVID–19 might otherwise cause. DATES: This amendment to the Declaration as published on March 17, 2020 (85 FR 15198) was effective as of February 4, 2020. FOR FURTHER INFORMATION CONTACT: Robert P. Kadlec, MD, MTM&H, MS, Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue SW, Washington, DC 20201; Telephone: 202–205–2882. SUPPLEMENTARY INFORMATION: The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to issue a Declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from, the manufacture, distribution, administration, or use of medical countermeasures (Covered Countermeasures), except for claims involving ‘‘willful misconduct’’ as defined in the PREP Act. Under the PREP Act, a Declaration may be amended as circumstances warrant. The PREP Act was enacted on December 30, 2005, as Public Law 109– 148, Division C, § 2. It amended the Public Health Service (PHS) Act, adding section 319F–3, which addresses liability immunity, and section 319F–4, which creates a compensation program. These sections are codified at 42 U.S.C. 247d–6d and 42 U.S.C. 247d–6e, respectively. Section 319F–3 of the PHS Act has been amended by the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113–5, enacted on March 13, 2013, and the Coronavirus Aid, Relief, and Economic Security (CARES) Act, Public Law 116–136, enacted on March 27, 2020, to expand Covered Countermeasures under the PREP Act. On January 31, 2020, the Secretary declared a public health emergency pursuant to section 319 of the PHS Act, 42 U.S.C. 247d, effective January 27, 2020, for the entire United States to aid in the response of the nation’s health care community to the COVID–19 outbreak. Pursuant to section 319 of the PHS Act, the Secretary renewed that Declaration on April 26, 2020. On March 10, 2020, the Secretary issued a Declaration under the PREP Act for medical countermeasures against COVID–19 (85 FR 15198, Mar. 17, 2020). On April 10, the Secretary amended the March 10, 2020 Declaration under the PREP Act to extend liability immunity to covered countermeasures authorized under the CARES Act (85 FR 21012, Apr. 15, 2020). The Secretary now amends the March 10, 2020, Declaration to clarify that covered countermeasures under the Declaration include qualified products that limit the harm COVID–19 might otherwise cause. 42 U.S.C. 247d– 6d(i)(7)(A)(i)(II). This amendment is made in accordance with section 319F– 3(b)(4) of the PHS Act, which authorizes the Secretary to amend a PREP Act Declaration at any time. Description of This Amendment by Section Section VI. Covered Countermeasures Section VI of the Declaration identifies the Covered Countermeasures for which the Secretary has recommended activities under section III of the Declaration. The PREP Act, as amended, states that a ‘‘Covered Countermeasure’’ must be a ‘‘qualified pandemic or epidemic product,’’ a ‘‘security countermeasure,’’ a drug, biological product, or device authorized for emergency use in accordance with sections 564, 564A, or 564B of the Federal Food, Drug, and Cosmetic (FD&C) Act, or a respiratory protective device approved by NIOSH under 42 CFR part 84, or any successor regulations, that the Secretary determines to be a priority for use during a public health emergency declared under section 319 of the PHS Act. As described in section VI of the preamble to the March 10, 2020 Declaration, the PREP Act further defines a ‘‘qualified pandemic or epidemic product’’ to mean a drug or device, as defined in the FD&C Act or a biological product, as defined in the PHS Act that is (i) manufactured, used, designed, developed, modified, licensed or procured to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic or limit the harm such a pandemic or epidemic might otherwise cause; (ii) manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a serious or life-threatening disease or condition caused by such a drug, biological product, or device; or (iii) a product or technology intended to enhance the use or effect of such a drug, biological product, or device. A qualified pandemic or epidemic product must also be approved, cleared, licensed, or authorized for investigational or emergency use under the FD&C Act or PHS Act. The Coronavirus Aid, Relief, and Economic Security (CARES) Act section 3103, Public Law 116–136 (Mar. 27, 2020), amended the PREP Act to add respiratory protective devices to the list of covered countermeasures so long as they are NIOSH approved and determined by the Secretary to be a priority for use during a public health emergency declared by the Secretary under section 319 of the Public Health Service Act. 85 FR 21012 (Apr. 15, 2020) (amending the Declaration effective March 27, 2020 to address this statutory change). The Secretary intended section VI of the March 10, 2020 Declaration to include all qualified pandemic and epidemic products defined under the PREP Act and described in the preamble to the Declaration. But section VI of the March 10, 2020 Declaration identified Covered Countermeasures under the Declaration as ‘‘any antiviral, any other drug, any biologic, any diagnostic, any other device, or any vaccine, used to treat, diagnose, cure, prevent, or mitigate COVID–19, or the transmission of SARS–CoV–2 or a virus mutating therefrom, or any device used in the administration of any such product, and all components and constituent materials of any such product.’’ 85 FR 15202. That description omitted the phrase from the statutory definition that qualified pandemic and epidemic products may also include products that ‘‘limit the harm such a pandemic or epidemic might otherwise cause.’’ The Secretary intended to identify the full range of qualified countermeasures in the March 10, 2020 Declaration. The Secretary accordingly amends section VI of the Declaration to clarify that intent. Qualified pandemic and epidemic products that limit the harm that COVID–19 might otherwise cause are those that would not have been manufactured, administered, used, designed, developed, modified, licensed, or procured but for the COVID–19 pandemic, even when the products are manufactured, administered, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure health threats or conditions other than COVID–19. For example, the COVID–19 pandemic has resulted in shortages of certain drugs and devices that the FDA has authorized. These drugs and devices may be used for COVID–19 and other health conditions. Those shortages are ‘‘harm[s] [COVID–19] might otherwise cause.’’ Filling those shortages caused by COVID–19 reduces the strain on the American healthcare system by mitigating the escalation of adverse VerDate Sep<11>2014 20:38 Jun 08, 2020 Jkt 250001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\08JNN1.SGM 08JNN1 jbell on DSKJLSW7X2PROD with NOTICES 35102 Federal Register / Vol. 85, No. 110 / Monday, June 8, 2020 / Notices health conditions from COVID–19 and non-COVID–19 causes. And mitigating that escalation conserves limited healthcare resources—from personal protective equipment to healthcare providers—which are essential in the whole-of-Nation response to the COVID–19 pandemic. Amendments to Declaration Amended Declaration for Public Readiness and Emergency Preparedness Act Coverage for medical countermeasures against COVID–19. Section VI of the March 10, 2020, Declaration under the PREP Act for medical countermeasures against COVID–19, as amended April 10, 2020, is further amended pursuant to section 319F–3(b)(4) of the PHS Act, as described below. All other sections of the Declaration remain in effect as published at 85 FR 15198 (Mar. 17, 2020) and amended at 85 FR 21012 (Apr. 15, 2020). Covered Countermeasures, section VI, delete in full and replace with: VI. Covered Countermeasures 42 U.S.C. 247d–6b(c)(1)(B), 42 U.S.C. 247d–6d(i)(1) and (7) Covered Countermeasures are (1) any antiviral, any other drug, any biologic, any diagnostic, any other device, any respiratory protective device, or any vaccine, used a. to treat, diagnose, cure, prevent, mitigate or limit the harm from COVID– 19, or the transmission of SARS–CoV– 2 or a virus mutating therefrom, or b. to limit the harm that COVID–19, or the transmission of SARS–CoV–2 or a virus mutating therefrom, might otherwise cause; or (2) any device used in the administration of any such product, and all components and constituent materials of any such product. Covered Countermeasures must be ‘‘qualified pandemic or epidemic products,’’ or ‘‘security countermeasures,’’ or drugs, biological products, or devices authorized for investigational or emergency use, as those terms are defined in the PREP Act, the FD&C Act, and the Public Health Service Act, or a respiratory protective device approved by NIOSH under 42 CFR part 84, or any successor regulations, that the Secretary determines to be a priority for use during a public health emergency declared under section 319 of the PHS Act. Authority: 42 U.S.C. 247d–6d. Dated: June 4, 2020. Alex M. Azar II, Secretary of Health and Human Services. [FR Doc. 2020–12465 Filed 6–4–20; 4:15 pm] BILLING CODE 4150–28–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Minority Health and Health Disparities; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Minority Health and Health Disparities Special Emphasis Panel; Addressing Racial Disparities in Maternal Mortality and Morbidity (R01 Clinical Trial Optional). Date: July 29–30, 2020. Time: 10:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Gateway Plaza, 7201 Wisconsin Avenue, Bethesda, MD 20817 (Virtual Meeting). Contact Person: Deborah Ismond, Ph.D., Scientific Review Officer, Division of Scientific Programs, NIMHD, National Institutes of Health, Gateway Building, 7201 Wisconsin Avenue, Bethesda, MD 20892, (301) 402–1366, ismonddr@mail.nih.gov. Dated: June 2, 2020. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2020–12335 Filed 6–5–20; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel, NIAID Resource Related Research Projects (R24 Clinical Trial Not Allowed). Date: June 30, 2020. Time: 3:00 p.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute of Allergy and Infectious Diseases, National Institutes of Health, 5601 Fishers Lane, Room 3G49, Rockville, MD 20892 (Virtual Meeting). Contact Person: Tara Capece, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, National Institutes of Health, 5601 Fishers Lane, Room 3G49, Rockville, MD 20852, 240–191–4281, capecet2@niaid.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) Dated: June 2, 2020. Tyeshia M. Roberson, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2020–12332 Filed 6–5–20; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of General Medical Sciences; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which

Advisory Opinions of the General Counsel:

First Advisory Opinion on the PREP Act Declaration (May 19, 2020):

DEPARTMENT OF HEALTH & HUMAN SERVICES Office of the Secretary

---

The General Counsel
Washington, D.C. 20201
1
ADVISORY OPINION ON THE PUBLIC READINESS AND EMERGENCY PREPAREDNESS ACT AND
THE MARCH 10, 2020 DECLARATION UNDER THE ACT
APRIL 17, 2020, AS MODIFIED ON MAY 19, 2020
Purpose of this Advisory Opinion
On March 10, 2020, the Secretary of Health and Human Services (Secretary) issued a
Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act), effective
February 4, 2020, for certain medical products to be used against COVID-19. See 85 Fed. Reg. 15,198,
15,202 (March 17, 2020); see also Pub. L. No. 109-148, Public Health Service Act § 319F-3, 42 U.S.C.
§ 247d-6d and 42 U.S.C. § 247d-6e.
We have received requests for advisory opinions, especially from those donating goods and
services, on whether various activities qualify for PREP Act immunity. The Office of the General
Counsel will make every effort to respond to each request. But we have limited resources, especially
in this time of national emergency. To minimize the need to request an advisory opinion, we issue
this omnibus advisory opinion that should address most questions and concerns about the scope of
PREP Act immunity during the Coronavirus disease 2019 (COVID-19) pandemic.
This advisory opinion sets forth the current views of the Office of the General Counsel.1
It
is not a final agency action or a final order. Nor does it bind HHS or the federal courts. It does not
have the force or effect of law.
The PREP Act
PREP Act immunity applies to any “covered person” with respect to all “claims for loss”
caused by, arising out of, relating to, or resulting from the “administration” or the “use” of a “covered
countermeasure” if a declaration has been issued with respect to that countermeasure. 42 U.S.C.
§ 247d-6d(a)(1). We often receive questions about whether a medical product is a covered
countermeasure, whether a person is a covered person, and whether a specific activity qualifies as use
or administration of a covered countermeasure.
Therefore, this advisory opinion
• provides a list of covered countermeasures subject to an Emergency
Use Authorization (EUA);
2
1 See Air Brake Sys., Inc. v. Mineta, 357 F.3d 632, 647-48 (6th Cir. 2004) (holding that the Chief
Counsel of the National Highway Traffic Safety Administration had delegated authority to issue
advisory opinions to regulated entities in fulfillment of a congressional directive to promote regulatory
compliance); 5 U.S.C. § 301 (“The head of an executive department … may prescribe regulations for
the government of his department, the conduct of its employees, [and] the distribution and
performance of its business[.]”).
2 See Appendix A, https://www.fda.gov/media/136702/download Appendix B,
https://www.fda.gov/media/136832/download .
2
• advises that an entity or individual who complies with all other
requirements of the PREP Act and the conditions of the Secretary’s
declaration will not lose PREP Act immunity—even if the medical
product at issue is not a covered countermeasure—if that entity or
individual reasonably could have believed that the product was a
covered countermeasure;
• advises that a person who complies with all other requirements of the
PREP Act and the conditions of the Secretary’s declaration will not
lose PREP Act immunity—even if the person at issue is not a covered
person—if the entity or individual reasonably could have believed that
the person was a covered person; and
• sets forth HHS’s view that covered persons should take, and
document, reasonable precautions under the current emergent
circumstances to facilitate the safe use or administration of covered
countermeasures and to make those documents publicly and easily
available.
If all requirements of the PREP Act and the declaration are met, immunity covers claims for
loss sounding in tort or contract, as well as claims for loss relating to compliance with local,3 state, or
federal laws, regulations, or other legal requirements. Immunity applies when a covered person
engages in activities related to an agreement or arrangement with the federal government, or when a
covered person acts according to an Authority Having Jurisdiction to respond to a declared
emergency. We interpret these two conditions broadly to include (1) any arrangement with the federal
government, or (2) any activity that is part of an authorized emergency response at the federal,
regional, state, or local level. Such activities can be authorized through, among other things, guidance,
requests for assistance, agreements, or other arrangements. Because the Secretary issued a Public
Health Emergency declaration on January 31, 2020, effective as of January 27, 2020, the immunity
granted by the PREP Act under this declaration applies regardless of whether state or local authorities
have declared states of emergencies.
A few caveats about PREP Act immunity: First, PREP Act immunity is not absolute. For
example, the PREP Act does not provide immunity against federal enforcement actions brought by
the federal government—whether civil, criminal, or administrative. Nor does the PREP Act provide
immunity against suit and liability for claims under federal law for equitable relief. PREP Act immunity
(exempting preemption) is also limited to claims for personal injury or damage to property. Second,
the PREP Act replaces certain damages claims that would normally be brought in court with a nofault compensation system outlined at 42 C.F.R. pt. 110. Third, PREP Act immunity must be read in
light of the PREP Act’s broad, express-preemption provision. 4
3 While PREP Act immunity does not expressly extend to local laws, the Act expressly preempts
any State and local law that “is different from, or is in conflict with, any requirement applicable under
[the PREP Act].” 42 U.S.C. § 247d-6d(b)(8).
4 Under § 247d-6d(b)(8)(A), (1) “no State or political subdivision of a State may establish,
enforce, or continue in effect with respect to a covered countermeasure any provision of law or legal
requirement that is different from, or is in conflict with, any requirement applicable under this section”
3
Covered Countermeasures
The PREP Act authorizes the Secretary to issue a declaration to provide liability immunity to
certain individuals and entities (covered persons) against any claim of loss caused by, arising out of,
relating to, or resulting from the manufacture, distribution, administration, or use of medical
countermeasures (covered countermeasures). Under the March 10, 2020 declaration, covered
countermeasures are any
antiviral, any other drug, any biologic, any diagnostic, any other device,
or any vaccine, used to treat, diagnose, cure, prevent, or mitigate
COVID–19, or the transmission of SARS-CoV–2 or a virus mutating
therefrom, or any device used in the administration of any such
product, and all components and constituent materials of any such
product.
85 Fed. Reg. 15,198, 15,202 (March 17, 2020).
Any drug, device, or biological product that is approved, cleared, or licensed by the FDA and
is used to diagnose, mitigate, prevent, treat, cure, or limit the harm of COVID-19 is a covered
countermeasure. The Coronavirus Aid, Relief, and Economic Security (CARES) Act § 3103, Pub. L.
No. 116-136 (March 27, 2020), amended the PREP Act to add respiratory protective devices to the
list of covered countermeasures so long as they are NIOSH approved and determined by the Secretary
to be a priority for use during a public health emergency declared by the Secretary under section 319
of the Public Health Service Act.5
See 42 U.S.C. § § 247d, 247d-6d(i)(1)(D). Any drug, device, or
biological product authorized for emergency use with respect to COVID-19 under an EUA, described
in Emergency Use Instructions (EUI) issued by the CDC, or being researched under certain
investigational provisions (i.e., IND, IDE) to treat COVID-19 is a covered countermeasure. See 21
C.F.R. pts. 312 and 812. In addition, as noted above, the CARES Act amended the PREP Act to
include certain respiratory protective devices. These requirements apply equally to products held in
the public and private sectors.
Covered countermeasures include, among other things, a “qualified pandemic or epidemic
product.” See 42 U.S.C. § 247d-6d(i)(1)(A). The term “qualified pandemic or epidemic product”
means
a drug … biological product … or device [as] defined … [in] the
Federal Food, Drug, and Cosmetic Act … that is
(A) (i) a product manufactured, used, designed, developed, modified,
licensed, or procured— (I) to diagnose, mitigate, prevent, treat, or
cure a pandemic or epidemic; or (II) to limit the harm such
pandemic or epidemic might otherwise cause;

and (2) relates to, among other things, use or administration of the covered countermeasure.
(Emphasis added).
5 The Secretary issued an amendment to the Declaration effective March 27, 2020 to address
this statutory change. 85 Fed. Reg. 21,012 (April 15, 2020).
4
(ii) a product manufactured, used, designed, developed, modified,
licensed, or procured to diagnose, mitigate, prevent, treat, or cure
a serious or life-threatening disease or condition caused by a
product described in clause (i); or
(iii) a product or technology intended to enhance the use or effect
of a drug, biological product, or device described in clause (i) or
(ii); and
(B) (i) approved or cleared under chapter V of the Federal Food, Drug,
and Cosmetic Act [21 U.S.C. § 351 et seq.] or licensed under section
262 of this title;
(ii) the object of research for possible use as described by
subparagraph (A) and is the subject of an exemption under section
505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act [21
U.S.C. §§ 355(i), 360j(g)]; or
(iii) authorized for emergency use in accordance with section 564,
564A, or 564B of the Federal Food, Drug, and Cosmetic Act [21
U.S.C. §§ 360bbb–3, 360bbb–3a, 360bbb–3b].
42 U.S.C. § 247d-6d(i)(7).
Thus, in order to meet the definition of a qualified pandemic or epidemic product, a product
(1) must be used for COVID-19; and
(2) must be
(a) approved, licensed, or cleared by FDA;
(b) authorized under an EUA;
(c) described in an EUI; or
(d) used under either an Investigational New Drug (IND)
application or an Investigational Device Exemption (IDE). 6
The number of products used for COVID-19 that are approved, licensed, or cleared are too
numerous to list. But we have found that industry has often sought clarity regarding whether certain
products, including diagnostic tests and personal protective equipment (PPE), are covered by EUAs.
Footnote 2, above, links to a list those products that are covered by EUAs. We hope that this list
proves helpful. HHS will use its best efforts to regularly update that list, although there may be a lag
between the actual issuance of the EUA by FDA and the product’s appearance on the list.
Given the broad scope of PREP Act immunity, Congress did not intend to impose a strictliability standard on covered persons for determining whether a product is a covered countermeasure.
Instead, we believe that a person or entity that otherwise meets the requirements for PREP Act
immunity will not lose that immunity—even if the product is not a covered countermeasure—if that
person or entity reasonably could have believed that the product was a covered countermeasure. See,
e.g., 42 U.S.C. § 247d-6d(a)(4)(B) (applying the “reasonably-could-have-believed” standard to predicate
6 While certain information about products under an IND or IDE is confidential commercial
information and not subject to disclosure, some information is available to the public on
clinicaltrials.gov.
5
requirements for PREP Act immunity not involving the actual use and administration of covered
countermeasures).
For example, FDA has issued EUAs for certain COVID-19 tests and PPE. A covered person
purchases 500,000 tests or respirators that appear to be authorized under an EUA. The covered
person has taken reasonable steps—under the current, emergent circumstances—to substantiate the
authenticity of the products. But it turns out that some or all of the products are counterfeit. Under
those circumstances, we believe that the person would be immune against a claim arising out of the
use of a counterfeit test or respirator.
Covered Person
The PREP Act provides immunity to a “covered person” for certain activities (e.g.,
manufacturing, distributing, using, or administering) involving a “covered countermeasure,” as
defined in the PREP Act and delineated in a PREP Act declaration issued by the Secretary. The term
“covered person,”
when used with respect to the administration or use of a covered
countermeasure, means—
(A) the United States; or
(B) a person or entity that is—
(i) a manufacturer of such countermeasure;
(ii) a distributor of such countermeasure;
(iii) a program planner of such countermeasure;
(iv) a qualified person who prescribed, administered, or
dispensed such countermeasure; or
(v) an official, agent, or employee of a person or entity
described in clause (i), (ii), (iii), or (iv).
42 U.S.C. § 247d-6d(i)(2). We have received questions about the meaning of “program planner” and
“qualified person.”
The term “program planner” means
a State or local government, including an Indian tribe, a person
employed by the State or local government, or other person who
supervised or administered a program with respect to the
administration, dispensing, distribution, provision, or use of a security
countermeasure or a qualified pandemic or epidemic product,
including a person who has established requirements, provided policy
guidance, or supplied technical or scientific advice or assistance or
provides a facility to administer or use a covered countermeasure in
accordance with [the Secretary’s declaration].
42 U.S.C. § 247d-6d(i)(6).
6
Under the Secretary’s declaration, “[A] private sector employer or community group or other
‘person’ can be a program planner when it carries out the described activities.” 85 Fed. Reg. at 15,202.
The term “qualified person,” when used
with respect to the administration or use of a covered countermeasure,
means— (A) a licensed health professional or other individual who is
authorized to prescribe, administer, or dispense such countermeasures
under the law of the State in which the countermeasure was prescribed,
administered, or dispensed; or (B) a person within a category of
persons so identified in a declaration by the Secretary.
42 U.S.C. § 247d-6d(i)(8).
With respect to that second category, the Secretary, through Section V of his declaration, has
determined that qualified persons also include
[a]ny person authorized in accordance with the public health and
medical emergency response of the Authority Having Jurisdiction, as
described in Section VII below, to prescribe, administer, deliver,
distribute or dispense the Covered Countermeasures, and their
officials, agents, employees, contractors and volunteers, following a
Declaration of an emergency[.]
85 Fed. Reg. at 15,202.
Therefore, an Authority Having Jurisdiction has broad powers to extend PREP Act immunity
to additional individuals as part of a public health and medical emergency response. The Authority
Having Jurisdiction does so by authorizing “any person” to “prescribe, administer, deliver, distribute
or dispense the Covered Countermeasures.” Section VII of the declaration explains that “[t]he
Authority Having Jurisdiction means the public agency or its delegate that has legal responsibility and
authority for responding to an incident, based on political or geographical (e.g., city, county, tribal,
state, or federal boundary lines) or functional (e.g., law enforcement, public health) range or sphere of
authority.” Id. As the lead federal public-health agency that has legal responsibility and authority for
responding to the COVID-19 emergency, HHS is an Authority Having Jurisdiction, but it is not the
only Authority Having Jurisdiction to respond to the COVID-19 emergency.
The following is an example of a qualified person under Sections V and VII of the declaration.
In response to the COVID-19 emergency, the HHS Office of the Assistant Secretary for Health
(OASH) issued guidance for licensed pharmacists to order and administer COVID-19 tests, including
serology tests, that the FDA has authorized. Such tests are covered countermeasures under the
declaration. Thus, under Sections V and VII of the declaration, such pharmacists are covered persons.
Specifically, they are qualified persons, as they are acting in accordance with guidance from HHS—an
Authority Having Jurisdiction to respond—following a declared emergency by the Secretary. The
pharmacists are covered as qualified persons (and hence as covered persons) even if they may not be
7
licensed or authorized by the State to prescribe the tests pursuant to § 247d-6d(i)(8)(A)), because they
fit within the alternative definition of “qualified persons” pursuant to paragraph § 247d-6d(i)(8)(B), as
provided by the Secretary in the declaration.
As with covered countermeasures, an entity or person that otherwise meets the requirements
for PREP Act immunity will not lose that immunity—even if the entity or person is not a covered
person—if that entity or person reasonably could have believed, under the current, emergent
circumstances, that the person was a covered person. See, e.g., 42 U.S.C. § 247d-6d(a)(4)(B).
For example, a pharmacy allows its licensed pharmacists to order FDA-authorized, self-swab
COVID-19 tests pursuant to the OASH guidance. Notwithstanding the pharmacy’s reasonablecompliance measures to ensure current licensure, it turns out that one of the pharmacists had
inadvertently allowed his license to expire. Under those circumstances, the pharmacy would still be
immune against a lawsuit relating to the COVID-19 test prescribed by that pharmacist.
Reasonable Precautions
Under the PREP Act, immunity is broad. As a general matter, a covered person is immune
from liability for all claims for loss except for willful misconduct that proximately caused death or
serious injury. 42 U.S.C. § 247d-6d(c)(3). Suits alleging an exception to immunity for covered persons
can only be brought before a three-judge court in the United States District Court for the District of
Columbia. 42 U.S.C. § 247d-6d(e)(1), (5). And to prevail, a plaintiff must establish, by clear and
convincing evidence, that the willful misconduct proximately caused death or serious injury. 42 U.S.C.
§ 247d-6d(c)(3).
But even then, certain acts or omissions remain immune from suit. For example, under 42
U.S.C. § 247d-6d(c)(4),
Notwithstanding any other provision of law, a program planner or
qualified person shall not have engaged in “willful misconduct” as a
matter of law where such program planner or qualified person acted
consistent with applicable directions, guidelines, or recommendations
by the Secretary regarding the administration or use of a covered
countermeasure that is specified in the declaration under subsection
(b), provided either the Secretary, or a State or local health authority,
was provided with notice of information regarding serious physical
injury or death from the administration or use of a covered
countermeasure that is material to the plaintiff’s alleged loss within 7
days of the actual discovery of such information by such program
planner or qualified person.
And under 42 U.S.C. § 247d-6d(c)(5), certain acts or omissions by a manufacturer or distributor and
“subject to regulation by this chapter or by the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301
et seq.]” will not constitute willful misconduct if (1) “neither the Secretary nor the Attorney General
has initiated an enforcement action with respect to such act or omission” or (2) “such an enforcement
action has been initiated and the action has been terminated or finally resolved without a covered
remedy.”
8
Nevertheless, HHS encourages all covered persons using or administering covered
countermeasures to document the reasonable precautions they have taken to safely use the covered
countermeasures.
For example, consider a distributor of medical products that sources PPE from a new supplier
abroad in a good-faith attempt to quickly deliver PPE to American communities affected by COVID19. Among other things, that distributor assesses the supplier’s facility to confirm that the supplier
actually manufactures the PPE. The distributor also confirms that the supplier has quality-control
processes in place.
Under those circumstances, the distributor may wish to make available to the purchaser
information about the reasonable efforts that the distributor had taken to safely use the covered
countermeasures. Purchasers such as hospitals would then be able to make more informed decisions
about how best to use the PPE. Overall, this would provide greater transparency in implementing the
PREP Act.
Compensation for Injuries
The PREP Act, like workers’ compensation or the National Vaccine Injury Compensation
Program, substitutes a no-fault, speedy compensation system in place of expensive and uncertain
litigation. Those who have been seriously injured or died as the direct result of a covered
countermeasure administered or used under a declaration may seek compensation from the Covered
Countermeasures Process Fund. Requests for benefits must be made to the Health Resources and
Services Administration’s Countermeasures Injury Compensation Program (CICP). Compensation
for serious injuries may be available to eligible requesters under CICP.
A serious injury generally means a physical injury that warranted hospitalization (whether or
not the person was actually hospitalized) or that led to a significant loss of function or disability. 42
C.F.R. § 110.3(z). CICP pays reasonable and necessary medical benefits. CICP also pays lost wages
to eligible recipients. Death benefits may also be available to certain survivors of eligible individuals
who died as a direct result of the administration or use of a covered countermeasure. CICP is payer
of last resort. So benefits are reduced by the amounts payable by other public and private third-party
payers (such as health insurance and workers’ compensation). The regulations implementing the CICP
are at 42 C.F.R. pt. 110.
Compensation for injuries is more limited than the liability immunity afforded under the PREP
Act. As described above, the PREP Act provides immunity for all claims for loss. But CICP will
provide compensation only for eligible claims of serious physical injury or death. CICP will not
compensate claims related to emotional injury, fear of injury, business losses, or other types of claims
for which immunity is provided. Information about this program can be found at
https://www.hrsa.gov/cicp/about/index.html or by calling 855-266-2427.
Limitations
This Advisory Opinion may be supplemented or modified. It is intended to minimize the
need for individual advisory opinions.
9
Persons seeking PREP Act immunity are responsible for determining whether their products
are covered countermeasures, whether a person or entity is a covered person, whether reasonable
precautions have been taken to facilitate the safe use of covered countermeasures, and in general,
whether immunity applies to them and their activities.
Robert P. Charrow
General Counsel
May 19, 2020

Second Advisory Opinion on the PREP Act Declaration (May 19, 2020):

DEPARTMENT OF HEALTH & HUMAN SERVICES Office of the Secretary

---

The General Counsel
Washington, D.C. 20201
1
ADVISORY OPINION 20-02 ON THE PUBLIC READINESS AND EMERGENCY PREPAREDNESS ACT
AND THE SECRETARY’S DECLARATION UNDER THE ACT
MAY 19, 2020
We have received requests from pharmacists, pharmacies, and one trade association asking the
Office of the General Counsel (OGC) whether the Public Readiness and Emergency Preparedness
(PREP) Act preempts state licensing laws that restrict the ability of pharmacists to order and administer COVID-19 diagnostic tests where the Department of Health and Human Services (HHS) has
expressly authorized pharmacists, under the PREP Act, to order and administer those tests. For the
reasons and subject to the limitations set forth below, we conclude that the PREP Act, in conjunction
with the Secretary’s March 10, 2020 declaration, preempts any state or local requirement that prohibits
or effectively prohibits a pharmacist from ordering and administering a COVID-19 diagnostic test
that the Food and Drug Administration (FDA) has authorized.
BACKGROUND
On April 8, 2020, the Office of the Assistant Secretary for Health (OASH) issued guidance
“authorizing licensed pharmacists to order and administer COVID-19 tests, including serology tests,
that the Food and Drug Administration (FDA) has authorized.”1
OASH did so as an Authority Having Jurisdiction pursuant to the Secretary’s March 10, 2020 declaration under the PREP Act. See 85
Fed. Reg. 15,198, 15,202 (March 17, 2020); 85 Fed. Reg. 21,012 (April 15, 2020) (amending the March
10, 2020 declaration); see also Pub. L. No. 109-148, Public Health Service Act §§ 319F-3, 319F-4, 42
U.S.C. §§ 247d-6d, 247d-6e.
Secretary Alex M. Azar II explained the need for the authorization, as follows:
Giving pharmacists the authorization to order and administer
COVID-19 tests to their patients means easier access to testing for
Americans who need it. Pharmacists play a vital role in delivering convenient access to important public health services and information.
The Trump Administration is pleased to give pharmacists the chance
to play a bigger role in the COVID-19 response, alongside all of America’s heroic healthcare workers.2
Assistant Secretary for Health Brett P. Giroir, M.D. further stressed the need for the authorization:
In an effort to expand testing capabilities, we are authorizing licensed
pharmacists to order and administer COVID-19 tests to their patients.
The accessibility and distribution of retail and independent community-based pharmacies make pharmacists the first point of contact with
a healthcare professional for many Americans. This will further expand testing for Americans, particularly our healthcare workers and
1 https://www.hhs.gov/sites/default/files/authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.pdf 2 https://www.hhs.gov/about/news/2020/04/08/hhs-statements-on-authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.html
2
first responders who are working around the clock to provide care,
compassion and safety to others.3
Consistent with that authorization, numerous states have made clear that licensed pharmacists
may order and administer FDA-authorized COVID-19 tests.4
Some of those states—including
Alaska, New Mexico, and Virginia—relied on the HHS guidance when authorizing their licensed pharmacists to order and administer FDA-authorized COVID-19 tests.5
On April 14, 2020, OGC issued an Advisory Opinion on the PREP Act discussing, among
other things, the OASH guidance.
6
The opinion explained (at 6-7) that licensed pharmacists “are
covered as qualified persons (and hence as covered persons) even if they may not be licensed or authorized by the State to prescribe the tests pursuant to § 247d-6d(i)(8)(A), because they fit within the
alternative definition of ‘qualified persons’ pursuant to § 247d-6d(i)(8)(B), as provided by the Secretary
in the declaration.”
Since then, OGC has been asked whether, under the PREP Act, licensed pharmacists may
order and administer COVID-19 tests even in states that prohibit licensed pharmacists from ordering
and administering those tests.
This Advisory Opinion addresses that question and sets forth the current views of OGC.
7
It
is not a final agency action or a final order. Nor does it bind HHS or the federal courts. It does not
have the force or effect of law.
SUMMARY OF CONCLUSIONS
Under the PREP Act, state and local authorities may not prohibit or effectively prohibit “qualified persons” from ordering and administering covered countermeasures for three reasons.
3 Id. 4 See https://naspa.us/resource/covid-19-testing/; see also, e.g., https://www.nacds.org/news/california-urged-to-remove-remaining-covid-19-testing-barriers-on-pharmacists-to-advance-testing-rampup-and-re-opening-of-state/ (noting on April 23, 2020, that “[n]ineteen other states have put into
place policies consistent with the HHS guidance … that authorizes pharmacists to order and conduct
testing for COVID-19 that the [FDA] has authorized”).
5 See, e.g., https://alaskapharmacy.org/wp-content/uploads/2020/03/4-16-20-AK-BOP-COVID-19-
Tests-Ordering-Administering.pdf; https://www.dhp.virginia.gov/Pharmacy/news/COVIDTestingGuidance.pdf; http://www.rld.state.nm.us/uploads/FileLinks/ad6770c244f74bdaaeaa53842023b4c7/Pharmacist_Ordering_and_Administering_COVID_19_Testing.pdf. 6 https://www.hhs.gov/sites/default/files/prep-act-advisory-opinion-april-14-2020.pdf. 7 See Air Brake Sys., Inc. v. Mineta, 357 F.3d 632, 647-48 (6th Cir. 2004) (holding that the Chief Counsel
of the National Highway Traffic Safety Administration had delegated authority to issue advisory opinions to regulated entities in fulfillment of a congressional directive to promote regulatory compliance);
5 U.S.C. § 301 (“The head of an executive department … may prescribe regulations for the government
of his department, the conduct of its employees, [and] the distribution and performance of its business[.]”).
3
First, through his PREP Act declaration, the Secretary can designate a “qualified person” to
use and administer a covered countermeasure even when that person is not authorized to do so under
state law. See § 247d-6d(i)(8)(A)–(B). In his declaration, the Secretary designated licensed pharmacists
as qualified persons for purposes of administering FDA-authorized COVID-19 tests independent of
state licensing laws.
Second, the PREP Act expressly preempts any state or local legal requirement that prohibits or
effectively prohibits a qualified person from ordering and administering a covered countermeasure
pursuant to the Secretary’s declaration.
Third, states and localities cannot challenge in court the Secretary’s designation of persons
authorized to order and administer covered countermeasures. Under the PREP Act, “No court of
the United States, or of any State, shall have subject matter jurisdiction to review, whether by mandamus or otherwise, any action by the Secretary” pursuant to his declaration under § 247d-6d(b).
By including those broad and robust provisions, Congress made clear that states and localities
may not “establish, enforce, or continue in effect” any legal requirement that prohibits or effectively
prohibits licensed pharmacists from ordering and administering FDA-authorized COVID-19 tests.
LEGAL FRAMEWORK
The PREP Act lists five categories of “covered person[s]” who are eligible for PREP Act
immunity when administering or using a “covered countermeasure”—(1) a manufacturer of the countermeasure; (2) a distributor of the countermeasure; (3) a program planner of such countermeasure;
(4) a qualified person who prescribed, administered, or dispensed the countermeasure; and (5) an
official, agent, or employee of a person or entity described in the four categories above. See 42 U.S.C.
§ 247d-6d(i)(2).
There are two categories of “qualified person.” See 42 U.S.C. § 247d-6d(i)(8).8

The first category includes those who are authorized under state law to take the relevant actions with respect to a covered countermeasure—namely, someone who is “a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed.” 42 U.S.C. § 247d-6d(i)(8)(A).
The second category includes “a person within a category of persons so identified in a declaration by the Secretary under subsection (b).” 42 U.S.C. § 247d-6d(i)(8)(B).
By including that second category, the PREP act makes clear that the Secretary may designate
someone as a “qualified person” even if that person is not authorized to prescribe, administer, or
dispense such countermeasures under state law when that person prescribes, administers, or dispenses the coun-
8 There is only one provision of the PREP Act that discusses those authorized under state law to
prescribe, administer, or dispense a covered countermeasure. And that is the definition of “qualified
person” under § 247d-6d(i)(8).
4
termeasures in that State. Because the definition of “covered person” makes someone’s status as a “qualified person” relevant only to the extent that the person performs one of those three acts, it necessarily
applies to those who act without state authorization.
If the definition of “qualified person” were limited to persons already authorized under state
law to prescribe, administer, or dispense a covered countermeasure, then § 247d-6d(i)(8)(B) would be
superfluous in light of § 247d-6d(i)(8)(A), which automatically includes those who are authorized under state law to do those very things. The Secretary would never have occasion to immunize someone
under § 247d-6d(i)(8)(B) if states and localities could prohibit those persons from prescribing, administering, or dispensing the covered countermeasures in the first place. See TRW Inc. v. Andrews, 534
U.S. 19, 31 (2001) (“It is ‘a cardinal principle of statutory construction’ that ‘a statute ought, upon the
whole, to be so construed that, if it can be prevented, no clause, sentence, or word shall be superfluous,
void, or insignificant.’” (Citations omitted)).
To further effectuate the PREP Act, including § 247d-6d(i)(8)(B), Congress included an express-preemption provision in the PREP Act to preclude state and local governments from establishing or enforcing such prohibitions when they would serve to prohibit “qualified persons” from administering countermeasures recommended by a PREP Act declaration:
During the effective period of [the] declaration …, or at any time with
respect to conduct undertaken in accordance with such declaration, no
State or political subdivision of a State may establish, enforce, or continue in effect with respect to a covered countermeasure any provision
of law or legal requirement that … is different from, or is in conflict
with, any requirement applicable under this section; and relates to the
… prescribing, dispensing, or administration by qualified persons of
the covered countermeasure.
42 U.S.C. § 247d-6d(b)(8).
OGC has not located published federal case law discussing the breadth of the “different from,
or is in conflict with” preemption language. But see, e.g., Casabiana v. Mount Sinai Med. Ctr., 2014 WL
10413521, *2 (N.Y. Sup. Ct. Dec. 2, 2014); Parker v. St. Lawrence Cty. Pub. Health Dep’t, 102 A.D.3d
140, 143-44 (N.Y. Sup. Ct. App. Div. 2012). But courts have broadly interpreted similar preemption
clauses, including those that preempt state or local laws that are “‘different from, or in addition to’”
federal legal requirements. See, e.g., Wolicki-Gables v. Arrow Int’l., Inc., 634 F.3d 1296, 1300 (11th Cir.
2011) (quoting Riegel v. Medtronic, Inc., 552 U.S. 312, 321 (2008)). According to the Supreme Court,
that preemption language “sweeps widely” and preempts any language that “deviates from [requirements] imposed by federal law.” Nat’l Meat Ass’n. v. Harris, 565 U.S. 452, 459, 461 (2012). A state or
local legal requirement is “different from, or in addition to” federal requirements if it is not “genuinely
equivalent” to the federal requirements. Wolicki-Gables, 634 F.3d at 1300 (quoting McMullen v. Medtronic, Inc., 421 F.3d 482, 489 (7th Cir. 2005)).
The PREP Act is distinct from the provision above in that it preempts any state or local legal
requirement that is “different from, or is in conflict with”—instead of “in addition to”—PREP Act
requirements. (Emphasis added). But that difference is immaterial here. The plain meaning of “different” is “not the same” or “having at least one property not possessed by another.” WEBSTER’S
THIRD NEW INTERNATIONAL DICTIONARY 630 (1961). Those definitions of “different” encompass
5
“not genuinely equivalent” and “deviat[ions] from.” So the PREP Act’s preemption clause has a
sufficiently broad sweep to encompass state requirements that would prohibit or effectively prohibit
pharmacists from administering FDA-approved COVID-19 tests.
And at a minimum, that sweep is broad enough to preempt a state or local legal requirement
that prohibits or effectively prohibits activity by qualified persons whom the Secretary has authorized
to perform those activities through his declaration, which is a requirement under the PREP Act. Such
prohibitions are plainly “not genuinely equivalent” to PREP Act requirements. If anything, they are
directly “in conflict with” those requirements.
LICENSED PHARMACISTS AND COVID-19 TESTING
As explained in the April 14, 2020 Advisory Opinion (at 6-7), the Secretary has designated
licensed pharmacists as “qualified persons” under his declaration. And by designating licensed pharmacists as “qualified persons,” the Secretary has also authorized licensed pharmacists to order and
administer FDA-authorized COVID-19 tests in states where the licensed pharmacists are not authorized to do so.
Because of that authorization, “no State or political subdivision of a State may establish, enforce, or continue in effect with respect to [FDA-authorized COVID-19 tests] any provision of law
or legal requirement that is different from, or is in conflict with, any requirement applicable under this
section” and that “relates to … the prescribing, dispensing, or administration by qualified persons of
the covered countermeasure.” 42 U.S.C. § 247d-6d(b)(8)(A).9

As explained above, any state or local law or legal requirement that prohibits or effectively
prohibits licensed pharmacists from ordering and administering FDA-authorized COVID-19 tests are
different from or in conflict with the declaration—and therefore, a legal requirement under the PREP
Act. So during the effective period of the PREP Act declaration, a state or locality cannot establish,
enforce, or continue any such legal requirements under the PREP Act’s preemption provision.
10
It is important to note that the PREP Act does not preempt all state and local legal requirements. Not all legal requirements that regulate the pharmacy profession differ from or conflict with
the PREP Act or any declaration issued under that Act with respect to COVID-19 tests.
9 The Secretary’s declaration under § 247d-6d(b) is a requirement for PREP Act immunity under
§§ 247d-6d(a)(1), (i)(8)(B). The declaration’s designations of covered countermeasures and qualified
persons are also requirements to establish PREP Act immunity under §§ 247d-6d(a)(1), (i)(8)(B).
10 When Congress intends to exempt state-licensing laws from its preemption provisions, Congress
explicitly says so. See, e.g., 42 U.S.C. § 1395w-26(b)(3) (“The standards established under this part shall
supersede any State law or regulation (other than State licensing laws or State laws relating to plan solvency)” (emphasis added)); 8 U.S.C. § 1324a(h)(2) (“The provisions of this section preempt any State
or local law imposing civil or criminal sanctions (other than through licensing and similar laws)” (emphasis
added)). Congress did not do so in the PREP Act. Instead, Congress gave the Secretary virtually
unreviewable authority to immunize and designate a “qualified person” to use a “covered countered
measure.”
6
LIMITATIONS
This Advisory Opinion may be supplemented or changed. It is intended to minimize the need
for individual advisory opinions.
Persons seeking PREP Act immunity are responsible for determining whether their products
are covered countermeasures, whether a person or entity is a covered person, whether reasonable
precautions have been taken to facilitate the safe use of covered countermeasures, and in general,
whether immunity applies to them and their activities.
Robert P. Charrow
General Counsel
May 19, 2020

Third Advisory Opinion on the PREP Act Declaration (October 23, 2020):

DEPARTMENT OF HEALTH & HUMAN SERVICES Office of the Secretary

---

The General Counsel
Washington, D.C. 20201
1
ADVISORY OPINION 20-03 ON THE PUBLIC READINESS AND EMERGENCY PREPAREDNESS ACT
AND THE SECRETARY’S DECLARATION UNDER THE ACT
OCTOBER 22, 2020, AS MODIFIED ON OCTOBER 23, 2020
This Advisory Opinion addresses three vaccination-related issues that have arisen under the
Public Readiness and Emergency Preparedness (PREP) Act, 42 U.S.C. § 247d-6d, as follows:

1. Does the PREP Act preempt state licensing laws that are less stringent than the federal
   standards under the Third Amendment to the Secretary’s March 10, 2020 PREP Act Declaration?1
2. May a state require a pharmacist to enter into a collaborative-practice agreement with a
   licensed physician as a condition of administering ACIP-recommended vaccines to children between ages 3 and 18?
3. Is epinephrine, when used to treat a severe acute vaccine reaction, a “covered countermeasure” within the meaning of the PREP Act?
   States or their sub-units may not impose any requirement that would prohibit or effectively
   prohibit activities authorized by the Secretary in a PREP Act declaration. Accordingly, state-licensing
   laws that are less stringent than those in the Secretary’s Declaration are not preempted, because they
   do not prohibit or effectively prohibit the activity in question—namely, vaccination.
   Conversely, any state or local law requiring a pharmacist to enter into a collaborative-practice
   agreement would be preempted if that requirement prohibits or effectively prohibits a pharmacist
   from ordering and administering vaccines as set forth in the Third Amendment and related issuances.
   Drugs, such as epinephrine, when used to counteract an ACIP-recommended vaccine reaction, are covered countermeasures and subject to PREP Act immunity and preemption.
   I. ANALYSIS
   On June 4, the Secretary amended the Declaration to clarify that “covered countermeasures”
   include products that limit the harm that COVID-19, or the transmission of SARS-CoV-2 or a virus
   mutating therefrom, might otherwise cause.2
   On August 24, the Secretary issued the Third Amendment.3
   It amended the category of disease, health condition, and threat for which the Secretary recommends the administration or use of covered countermeasures to include the decrease in the rate of

1 See Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID–19, 85 Fed. Reg. 15,198 (Mar. 17, 2020) (Declaration); 85 Fed. Reg.
21,012 (Apr. 15, 2020) (First Amendment); 85 Fed. Reg. 35,100 (June 8, 2020) (Second Amendment); 85 Fed. Reg. 52,136 (Aug. 24, 2020) (Third Amendment).
2 See 85 Fed. Reg. at 35,102.
3 See 85 Fed. Reg. 52,136.
2
childhood immunizations during the pandemic.4
To make routine childhood vaccinations more accessible during this pandemic, the Third Amendment also identified state-licensed pharmacists and
pharmacy interns as “qualified persons” when the pharmacist orders and either the pharmacist or the
supervised intern administers Advisory Committee on Immunization Practices (ACIP)-recommended
vaccines to individuals ages three through 18 pursuant to certain requirements.5

A. LESS STRINGENT STATE REQUIREMENTS
The PREP Act specifies two types of “qualified persons” who are eligible for PREP Act immunity. Under § 247d-6d(i)(8)(A), a qualified person may be “a licensed health professional or other
individual who is authorized to prescribe, administer, or dispense [covered] countermeasures under
the law of the State in which the countermeasure was prescribed, administered, or dispensed.” And
under § 247d-6d(i)(8)(B), a qualified person may also be “a person within a category of persons so
identified in a declaration by the Secretary.”6
The Third Amendment identifies, as qualified persons under § 247d-6d(i)(8)(B), certain pharmacists who are not authorized to order and administer, and certain pharmacy interns who are not
authorized to administer, certain childhood vaccines to certain children under state law.7
To become
“qualified persons” under the Declaration, pharmacists and pharmacy interns who are not authorized
to order or administer these childhood vaccines under state law must satisfy the requirements set forth
in the Third Amendment.8
Pharmacists and pharmacy interns who are authorized to order or administer childhood vaccines under state law do not need to satisfy those requirements to be “qualified
persons” under § 247d-6d(i)(8)(A).
The Third Amendment preempts narrower state scope-of-practice laws for pharmacists and
pharmacy interns who meet the requirements set forth in the Third Amendment. But the Third
Amendment does not affect broader state scope-of-practice laws. The preamble to the Third Amendment specifies that “nothing herein shall preempt State laws that permit additional individuals to administer vaccines that ACIP recommends to persons age 18 or younger according to ACIP’s standard
immunization schedule.” 9

For example, the Third Amendment requires the licensed pharmacist seeking PREP Act coverage to “complete a practical training program of at least 20 hours.”10 Some states require less than
20 hours of such training for a licensed pharmacist to order and administer vaccinations to individuals
ages 3 to 18. The Third Amendment does not affect such less-stringent, state-law requirements.
So a pharmacist who seeks PREP Act coverage under § 247d-6d(i)(8)(B) and the Third
Amendment—e.g., because the pharmacist is not authorized to vaccinate under the state scope-ofpractice law—must satisfy the 20-hour requirement. But a pharmacist in a state that requires less than

4 See 85 Fed. Reg. at 52,141.
5 See 85 Fed. Reg. at 52,138.
6
42 U.S.C. 247d-6d(i)(8)(B).
7 See 85 Fed. Reg. at 52,138-39.
8
Id.
9
85 Fed. Reg. at 52,139.
10 85 Fed. Reg. at 52,140.
3
20 hours may still vaccinate under state law even if the pharmacist does not complete 20 hours of
training as required under the Third Amendment. And as explained above, such a pharmacist would
be a “qualified person” under § 247d-6d(i)(8)(A), and therefore eligible for PREP Act coverage if the
pharmacist satisfies those other requirements of the PREP Act and Declaration not associated with
being a “qualified person.”
B. COLLABORATIVE-PRACTICE AGREEMENTS
Certain states require a protocol or a collaborative-practice agreement (CPA) to administer
vaccinations to children of certain ages. Whether the Third Amendment preempts these state requirements depends on whether those requirements prohibit or effectively prohibit qualified pharmacists
from ordering and administering (and qualified interns from administering) ACIP-recommended vaccines to children ages 3-18.
The Third Amendment provides, “Notwithstanding any State or local scope-of-practice legal
requirements, (1) qualified licensed pharmacists are identified as qualified persons to order and administer ACIP-recommended vaccines and (2) qualified State-licensed or registered pharmacy interns
are identified as qualified persons to administer the ACIP-recommended vaccines ordered by their
supervising qualified licensed pharmacist.”11 The Office of the General Counsel’s Advisory Opinion
20-02 explains that under the PREP Act, state and local authorities “may not prohibit or effectively
prohibit ‘qualified persons’ from ordering and administering covered countermeasures.”12

Therefore, during the effective period of the PREP Act declaration, states cannot use any
protocol or CPA to prohibit or effectively prohibit “qualified persons” from ordering and administering ACIP-recommended childhood vaccines in a manner consistent with that specified in the Third
Amendment.13

C. EPINEPHRINE
CDC recommends that immediate intramuscular epinephrine is the treatment of choice for
severe acute vaccine reactions involving respiratory or cardiovascular symptoms, or other signs or
symptoms of anaphylaxis. 14 The preamble to the Second Amendment explained, “The Secretary intended section VI of the March 10, 2020 Declaration to include all qualified pandemic and epidemic
products defined under the PREP Act and described in the preamble to the Declaration.”15 And
under the PREP Act, “covered countermeasures” include qualified products “manufactured, used,

11 Id.
12 Advisory Opinion 20-02 on the Public Readiness and Emergency Preparedness Act and the Secretary’s Declaration under the Act at 2 (May 19, 2020) (PREP Act Advisory Opinion 20-02),
https://www.hhs.gov/sites/default/files/advisory-opinion-20-02-hhs-ogc-prep-act.pdf (last visited
Oct. 23, 2020) (discussing the PREP Act’s preemption provision).
13 See also 42 U.S.C. 247d-6d(b)(8).
14 See, e.g., Preventing and Managing Adverse Reactions, CDC, https://www.cdc.gov/vaccines/hcp/aciprecs/general-recs/adverse-reactions.html (last visited Oct. 23, 2020) (For severe acute vaccine reaction
involving “respiratory or cardiovascular symptoms, or other signs or symptoms of anaphylaxis, immediate intramuscular epinephrine is the treatment of choice.”).
15 85 Fed. Reg. at 35,101.
4
designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a
serious or life-threatening disease or condition caused by such a drug, biological product, or device.”16
Under the Third Amendment, ACIP-recommended vaccines are “covered countermeasures.”
Epinephrine mitigates or treats a serious or life-threating condition that, in some rare instances, may
be a side effect of vaccine administration. Furthermore, the Third Amendment requires qualified
pharmacists and pharmacy interns to, among other things, have sufficient training on “recognition
and treatment of emergency reactions to vaccines.”17 Therefore, epinephrine is a “covered countermeasure” and the PREP Act covers its use as set forth in the Third Amendment to address such
severe acute vaccine reactions. The PREP Act would not cover the administration of epinephrine to
address unrelated respiratory or cardiovascular symptoms.
II. Limitations
This Advisory Opinion may be supplemented or modified. It is intended to minimize the
need for individual advisory opinions. This Advisory Opinion sets forth the current views of the
Office of the General Counsel.18 It is not a final agency action or a final order. Nor does it bind the
Department of Health and Human Services or the federal courts. It does not have the force or effect
of law.
Persons seeking PREP Act immunity are responsible for determining whether their products
are “covered countermeasures,” whether a person or entity is a “covered person,” whether reasonable
precautions have been taken to facilitate the safe use of covered countermeasures, and in general,
whether immunity applies to them and their activities. In order to obtain PREP Act coverage, persons
must meet all requirements set forth in the PREP Act and the Declaration.
Robert P. Charrow
General Counsel
October 23, 2020

16 Id. (emphasis added); see also 42 U.S.C. 247d-6d(i)(7)(A)(ii).
17 85 Fed. Reg. at 52,139.
18 See Air Brake Sys., Inc. v. Mineta, 357 F.3d 632, 647-48 (6th Cir. 2004) (holding that the Chief Counsel of the National Highway Traffic Safety Administration had delegated authority to issue advisory
opinions to regulated entities in fulfillment of a congressional directive to promote regulatory compliance); 5 U.S.C. § 301(“The head of an executive department … may prescribe regulations for the
government of his department, the conduct of its employees, [and] the distribution and performance
of its business[.]”); Statement of Organization, Functions, and Delegations of Authority, 85 Fed.
Reg. 54,581 54,583 (Sept. 2, 2020).

Fourth Advisory Opinion on the PREP Act Declaration (October 23, 2020):

DEPARTMENT OF HEALTH & HUMAN SERVICES Office of the Secretary

---

The General Counsel
Washington, D.C. 20201
1
ADVISORY OPINION 20-04 ON THE PUBLIC READINESS AND EMERGENCY PREPAREDNESS ACT
AND THE SECRETARY’S DECLARATION UNDER THE ACT
OCTOBER 22, 2020, AS MODIFIED ON OCTOBER 23, 2020
The Office of the General Counsel (OGC) has received questions concerning the scope and
meaning of “program planner” and “Authority Having Jurisdiction” under the Public Readiness and
Emergency Preparedness (PREP) Act, 42 U.S.C. § 247d-6d, and its implementing secretarial Declarations. This Advisory Opinion addresses:

1. Who is a program planner under the PREP Act and the Secretary’s March 10, 2020
   Declaration, as amended (Declaration)? 1
2. What is the scope of the proviso in the Declaration limiting PREP Act coverage to,
   inter alia, activities authorized by an “Authority Having Jurisdiction”?
   In this Advisory Opinion, OGC re-emphasizes the breadth of PREP Act immunity. It covers
   a broad range of entities when such entities take reasonable steps to follow public-health guidelines
   and directives in using covered medical products. Such entities are not limited to healthcare professionals and healthcare companies that are part of a government response to the COVID-19 pandemic.
   Such entities may also include businesses, schools, and places of worship.
   I. ANALYSIS
   A. BACKGROUND
   COVID-19 is an unprecedented global challenge. As we learn more about the highly contagious pathogen that causes COVID-19, public-health guidance and directives tend to change to reflect
   the new knowledge. Those changes do not always occur uniformly or simultaneously among scientists
   and across America’s federal, state, territorial, tribal, local, and other public-health authorities—leading
   to uncertainty.
   Those uncertainties present potential legal risk for public and private individuals and organizations as they combat the pandemic, restore and strengthen America’s economy, ensure that transportation remains available, and provide safe environments for education and worship. Unfortunately,
   such perceived risks may hinder those essential efforts.
   They should not. The PREP Act exists, in part, to remove legal uncertainty and risk. When
   an individual or organization satisfies the requirements of the PREP Act and the Declaration, that
   “covered person” “shall be immune from suit and liability under Federal and State law with respect
   to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or
   the use by an individual of a covered countermeasure.” 2

1 See Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID–19, 85 Fed. Reg. 15,198, 15,202 (Mar. 17, 2020) (Declaration); 85 Fed. Reg.
21,012 (Apr. 15, 2020) (First Amendment); 85 Fed. Reg. 35,100 (June 8, 2020) (Second Amendment);
85 Fed. Reg. 52,136 (Aug. 24, 2020) (Third Amendment).
2
42 U.S.C. § 247d-6d(a)(1).
2
Under the PREP Act, the term “covered person” includes a broad range of individuals and
organizations. The term includes, among other things, anyone who supervises or administers a program with respect to the administration, dispensing, distribution, provision, or use of a security countermeasure or a qualified pandemic or epidemic product, including anyone who provides a facility to
administer or use a covered countermeasure in accordance with the Declaration.
The term “covered countermeasure” generally includes products (1) that the Food and Drug
Administration (FDA) has approved, cleared, licensed, or authorized for emergency or investigational
use; and (2) that are used to address COVID-19 or associated health threats, including harms that
COVID-19 might otherwise cause.
The Declaration broadly extends PREP Act immunity to, among other things, a covered person’s conduct relating to the administration or use of covered countermeasures according to applicable public-health guidance and directives during this declared emergency.3

As we have previously explained, when a person complies with all other requirements in the
PREP Act and Declaration, PREP Act immunity applies if
 the person reasonably could have believed that the person was a covered person,
 the person reasonably could have believed that the product was a covered countermeasure, and
 the person did not engage in willful misconduct that proximately caused serious physical injury or death.4
This Advisory Opinion discusses the broad availability of that immunity in more detail. Specifically, we focus on (1) the definition of a “program planner” and (2) the activities authorized by an
“Authority Having Jurisdiction.” This Advisory Opinion also provides examples of PREP Act coverage when a “program planner” follows the public-health guidance or directives of an applicable
“Authority Having Jurisdiction”—even as guidance or directives change or they conflict with other
guidance or directives.
B. PROGRAM PLANNERS
Under the PREP Act, the term “covered person” includes the United States or “manufacturers, distributors, program planners, and qualified persons, and their officials, agents, and employees.”5

3 See 85 Fed. Reg. at 15,200 (affording liability immunity to “covered persons” for “recommended
activities” related to activities authorized in accordance with the public-health and medical response
of the Authority Having Jurisdiction).
4 See Advisory Opinion on the Public Readiness and Emergency Preparedness Act and the March 10,
2020 Declaration under the Act (May 19, 2020), https://www.hhs.gov/sites/default/files/prep-actadvisory-opinion-hhs-ogc.pdf (last visited Oct. 23, 2020) (PREP Act Advisory Opinion); see also 42
U.S.C. § 247d-6d(a)(4)(B).
5
85 Fed. Reg. at 151,199; 42 U.S.C. § 247d-6d(i)(2).
3
The PREP Act broadly defines a “program planner” using three elements: identity, function, and
compliance.
Identity: A program planner is a state or local government, including an Indian tribe, a person
employed by the State or local government, or other “person” who carries out the functions described
immediately below. Under the PREP Act, a “person” includes “an individual, partnership, corporation, association, entity, or public or private corporation, including a Federal, state, or local government agency or department.”6

Function: A program planner performs certain functions, including “supervis[ing] or administer[ing] a program with respect to the administration, dispensing, distribution, provision, or use of a
security countermeasure or a qualified pandemic or epidemic product.”7
The statute explains that
those functions broadly include “establish[ing] requirements, provid[ing] policy guidance, or
suppl[ying] technical or scientific advice or assistance or provid[ing] a facility to administer or use a
covered countermeasure.”8
Compliance: Finally, to qualify as a program planner, the entity must perform those functions
“in accordance with” the Declaration.9
The Declaration incorporates these definitions.10 The Declaration’s preamble further explains
that a program planner can be a “private sector employer or community group” that “carries out the
described activities.”11 Nothing in the preamble or text of the Declaration limits the statutory definitions.
In short, any individual or organization can potentially be a program planner and receive PREP
Act coverage. So for example, private businesses, public and private transportation providers, public
and private schools, and religious organizations are all eligible for PREP Act coverage when they act
in accordance with the PREP Act and the Declaration. It is important to remember, however, that
the PREP Act does not provide immunity against federal enforcement actions.12 And PREP Act
immunity (but not preemption) is limited to claims for death, physical, mental or emotional injury,
illness, disability or condition, fear of such harm or need for medical monitoring, and damage to
property, including business interruption loss.13

6
42 U.S.C. § 247d-6d(i)(5).
7
Id. at § 247d-6d(i)(6).
8
Id.
9 We use the term “entity” to include persons (see 1 U.S.C. § 1) and governmental units, whether state,
tribal, local, or federal.
10 See 85 Fed. Reg. at 15,201.
11 Id. at 15,199.
12 See PREP Act Advisory Opinion at 2.
13 See 42 U.S.C. § 247d-6d; PREP Act Advisory Opinion.
4
C. AUTHORITY HAVING JURISDICTION
In order for there to be PREP Act coverage, there must be a PREP Act declaration.14 Among
other things, such a declaration may specify whether PREP Act immunity “is effective only to a particular means of distribution as provided in subsection (a)(5) for obtaining the countermeasure, and if
so, the particular means to which such subsection is effective.”15
For the COVID-19 public-health emergency, section VII of the Declaration specifies that
“liability immunity is afforded to Covered Persons only for Recommended Activities involving Covered Countermeasures that are related to” (1) federal agreements or (2) “[a]ctivities authorized in accordance with the public health and medical response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures following a Declaration of an emergency.”16 An Authority Having Jurisdiction may authorize such activities through,
among other things, guidance, requests for assistance, agreements, directives, or other arrangements
(collectively guidance).17
Public-health guidance from an applicable Authority Having Jurisdiction that recommends or
requires using covered countermeasures in certain circumstances may qualify as authorizations under
the PREP Act and the Declaration. But to obtain such authorization, a covered person must follow
that public-health guidance. The Declaration explains that the Authority Having Jurisdiction means
the “public agency or its delegate that has legal responsibility and authority for responding to an incident, based on political or geographical (e.g., city, county, tribal, state, or federal boundary lines) or
functional (e.g., law enforcement, public health) range or sphere of authority.”18 Therefore, a covered
person must comply with the public-health guidance issued by an Authority Having Jurisdiction over
the person’s activity or location in order to qualify for PREP Act immunity.
If there are conflicts, PREP Act coverage will apply to a covered person using a covered countermeasure in accordance with any of the guidance. A conflict exists when (1) one guidance includes
a recommendation or mandate that another guidance does not, and (2) there is no order of precedence
under applicable law or in the guidance itself. If the applicable law or the guidance explains which
authority takes precedence, a covered person must follow the guidance of the Authority Having Jurisdiction that takes precedence in order to obtain PREP Act coverage.
To illustrate, if a governor’s order on using face masks preempts or otherwise takes precedence
over a mayor’s order under that state’s law, then the former must be the basis for PREP Act coverage.
If one guidance says that it does not replace another guidance, the latter must be the basis for PREP
Act coverage. For example, the Centers for Disease Control and Prevention’s (CDC) guidance for
“Preparing for a Safe Return to School” specifies that “[t]his guidance is meant to supplement—not
replace—any state, local, territorial, or tribal health and safety laws, rules, and regulations with which

14 See 42 U.S.C. § 247d-6d(a)(1).
15 42 U.S.C. § 247d-6d(b)(2)(E).
16 See 85 Fed. Reg. at 15,202.
17 PREP Act Advisory Opinion at 2.
18 85 Fed. Reg. at 15,202.
5
schools must comply.”19 So if there were a conflict between that CDC guidance and “any state, local,
territorial, or tribal health and safety laws, rules, and regulations with which schools must comply,” a
covered person must rely on guidance of the latter jurisdiction, and not CDC’s guidance, as the basis
for PREP Act coverage.
If a guidance changes, the guidance in effect during the activity at issue will determine whether
there is PREP Act coverage.
D. EXAMPLES
To illustrate more concretely the discussion above, we provide the following hypothetical examples of program planners using covered countermeasures according to the guidance of an Authority
Having Jurisdiction. We use these examples to help illustrate only the PREP Act doctrines discussed
above.
Testing: Federal, state, and local Authorities Having Jurisdiction issue conflicting guidance on
how frequently to test at universities. Neither the state or federal law, nor the guidance from the state
or federal Authorities Having Jurisdiction, preempts or supersedes the guidance from the local Authority Having Jurisdiction. A private university that has re-opened for in-person learning follows the
guidance of the local Authority Having Jurisdiction in the geographic area where the university is
located. The university uses a COVID-19 test that has received an Emergency Use Authorization
(EUA) by the FDA. The local Authority Having Jurisdiction recommends a lower testing frequency
than the state or federal Authorities Having Jurisdiction. A student who gets COVID-19 sues the
university, claiming that its failure to follow the guidance from the state or federal Authority Having
Jurisdiction caused the student’s injuries.
The university is a program planner because it has, among other things, “supervised or administered a program with respect to the administration … or use of a … qualified pandemic … product.”20 By following the guidance of the local Authority Having Jurisdiction, the university has complied with the Declaration.
The university is immune from suit and liability for loss, assuming that it has satisfied all other
requirements of the PREP Act and Declaration.
Face Masks: FDA has issued an EUA authorizing “the use of face masks, including cloth face
coverings, as source control for use by members of the general public, as well as [health care personnel]
in healthcare settings, to cover their noses and mouths, in accordance with CDC recommendations,
to help prevent the spread of SARS-CoV-2 during the COVID-19 pandemic.”21

19 Preparing K-12 School Administrators for a Safe Return to School in Fall 2020, CDC,
https://www.cdc.gov/coronavirus/2019-ncov/community/schools-childcare/prepare-safe-return.html (last visited Oct. 23, 2020).
20 42 U.S.C. § 247d-6d(i)(6).
21 April 24, 2020 Letter to Manufacturers of Face Masks, FDA, https://www.fda.gov/media/137121/download (last visited Oct. 23, 2020); FAQs on the Emergency Use Authorization for Face
Masks (Non-Surgical), FDA, https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-emergency-use-authorization-face-masks-non-surgical (last visited Oct. 23, 2020).
6
CDC has issued guidance for “Grocery & Food Retail Workers.”22 In that guidance, “CDC
recommends wearing cloth face coverings in public settings where other social distancing measures
are difficult to maintain, especially in areas of significant community-based transmission.” The guidance also directs employers of grocery and food-retail workers to “[f]ollow all applicable local, state,
and federal regulations and public health agency guidelines.”23 A county department of health has
issued a face-mask guidance recommending that those working inside a grocery store should wear
cloth face covering and maintain social distancing.
Following CDC guidance, a grocery store in that county requires its workers to wear cloth face
coverings in the public portions of its stores “where other social distancing measures are difficult to
maintain.” A customer in that store gets COVID-19 and sues the grocery store, claiming that its
failure to follow the county guideline contributed to the customer’s injuries.
Here, the CDC guidance directed the grocery store to follow all local, state, and federal regulations and public-health agency guidelines. The grocery store failed to follow the more stringent
county guideline. Therefore, the grocery store does not have PREP Act immunity against the customer’s claim.
COVID-19 Vaccine Administration. CDC prioritizes certain populations to receive the COVID19 vaccine while there are limited doses. A pharmacy prioritizes the CDC-designated populations for
receiving the COVID-19 vaccine.
Because of that prioritization, someone seeks but does not receive the COVID-19 vaccine
from the pharmacy because of the limited quantity of vaccine doses. That person gets COVID-19
and sues the pharmacy.
The pharmacy is a program planner, as set forth above. Administration of covered countermeasures, as defined in the Declaration, includes both “physical provision of the countermeasures to
recipients” or “activities and decisions directly relating to public and private delivery, distribution and
dispensing of the countermeasures to recipients, management and operation of countermeasure programs, or management and operation of locations for purpose[s] of distributing and dispensing countermeasures.”24 Management and operation of countermeasure programs and decisions directly relating to public and private delivery, distribution, and dispensing of countermeasures involve decisions
regarding prioritization of populations to receive countermeasures while there are limited doses. And
prioritization necessarily entails temporarily withholding limited doses from some recipients, as directed by an Authority Having Jurisdiction.
By administering the COVID-19 vaccine pursuant to CDC prioritization, the pharmacy has
complied with the guidance of an Authority Having Jurisdiction. The pharmacy has PREP Act coverage, assuming that it has also complied with all other requirements of the PREP Act and Declaration.

22 What Grocery and Food Retail Workers Need to Know about COVID-19, CDC,
https://www.cdc.gov/coronavirus/2019-ncov/community/organizations/grocery-food-retail-workers.html (last visited Oct. 23, 2020).
23 Id. (emphasis added).
24 85 Fed. Reg. at 15,202.
7
During the H1N1 pandemic, a New York court addressed a similar situation. In Casabianca v.
Mount Sinai Medical Center, the court concluded that the PREP Act does not cover a provider that
followed guidelines from CDC, the New York State Department of Health, and the New York City
Department of Health. 1014 N.Y. Slip. Op. 33583(U), 2014 WL 10413521 (N.Y. Sup. Dec. 12, 2014).
Under those guidelines, children, pregnant women, and hospital employees received priority for the
H1N1 vaccine while there were shortages. The plaintiff’s husband did not fit into any of those eligibility categories; hence, he did not receive the vaccine. The husband died after a surgical procedure
and exposure to swine flu. His wife sued the provider. The court held that PREP Act immunity did
not apply because it “only applies to the actual use of the vaccine.” Id. at *4.
The court was wrong. As the court acknowledged, “administration” is broader than the “physical provision of a countermeasure to a recipient.” Id. at *3. “Administration” also encompasses
“activities related to management and operation of programs and locations for providing countermeasures to recipients, such as decisions and actions involving security and queuing, but only insofar
as those activities directly relate to the countermeasure activities.” Id.
Activities relating to management and operation of a vaccination program pursuant to an Authority Having Jurisdiction include following CDC directions on who to vaccinate when there are
limited doses. If anything, following CDC directions on vaccination priority has a closer relationship
to the use of the vaccine than decisions about security and queuing recipients of the vaccine, which
may result in “slip and fall injuries and vehicle accidents that are connected to the vaccination process,
be it at a retail store or some other facility.” Id. at 4. The court recognized that PREP Act immunity
can cover such injuries and accidents, but declined to interpret “activities related to management and
operation of programs and locations for providing countermeasures to recipients” consistent with the
plain meaning of that phrase. The plain meaning of “management and operation of programs for
providing countermeasures” includes following CDC vaccine-prioritization guidelines. And if there
were any doubt, the plain meaning of “activities related to” such management and operation is even
broader. And that broader definition would certainly cover running a vaccination program pursuant
to CDC guidelines, even assuming arguendo that “management and operation” does not.
II. Limitations
This Advisory Opinion may be supplemented or modified. It is intended to minimize the
need for individual advisory opinions. This Advisory Opinion sets forth the current views of the
Office of the General Counsel.25 It is not a final agency action or a final order. Nor does it bind the
Department of Health and Human Services or the federal courts. It does not have the force or effect
of law.
Persons seeking PREP Act immunity are responsible for determining whether their products
are “covered countermeasures,” whether a person or entity is a “covered person,” whether reasonable

25 See Air Brake Sys., Inc. v. Mineta, 357 F.3d 632, 647-48 (6th Cir. 2004) (holding that the Chief Counsel
of the National Highway Traffic Safety Administration had delegated authority to issue advisory opinions to regulated entities in fulfillment of a congressional directive to promote regulatory compliance);
5 U.S.C. § 301(“The head of an executive department … may prescribe regulations for the government
of his department, the conduct of its employees, [and] the distribution and performance of its business[.]”); Statement of Organization, Functions, and Delegations of Authority, 85 Fed. Reg. 54,581
54,583 (Sept. 2, 2020).
8
precautions have been taken to facilitate the safe use of covered countermeasures, and in general,
whether immunity applies to them and their activities. In order to obtain PREP Act coverage, persons
must meet all requirements set forth in the PREP Act and the Declaration.
Robert P. Charrow
General Counsel
October 23, 2020

Fifth Advisory Opinion on the PREP Act Declaration (January 8, 2021):

DEPARTMENT OF HEALTH & HUMAN SERVICES Office of the Secretary

---

The General Counsel
Washington, D.C. 20201
ADVISORY OPINION 21-01 ON THE
PUBLIC READINESS AND EMERGENCY PREPAREDNESS ACT
SCOPE OF PREEMPTION PROVISION
JANUARY 8, 2021
Following the issuance by the Secretary on December 3, 2020, of the Fourth Amendment
to his Declaration Under the Public Readiness and Emergency Preparedness Act for Medical
Countermeasures Against COVID-19, we have received questions as to whether the PREP Act
applies where a covered person declined to use a covered countermeasure when it arguably ought
to have been used.
1
See 85 Fed. Reg. 79,190 (Dec. 9, 2020). These inquiries were stimulated, as
we understand, by a spate of recent lawsuits, most involving nursing homes and other healthcare
facilities, where patients or their estates allege that patients contracted COVID-19 because the
facility, among other things, failed to provide its staff with personal protective equipment
(“PPE”), failed to teach the staff how to properly use that equipment, or failed to ensure that its
staff used the PPE that it had been given. This Advisory Opinion addresses these questions in
the context of our administration of the PREP Act and the Secretary’s PREP Act Declaration, as
amended.
I. Analysis
There has been a growing number of suits related to the use or non-use of covered
countermeasures against COVID-19, including PPE. These cases tend to be filed in state courts
alleging a variety of state law-based torts. In this “jurisprudential Kabuki dance” (Maine Public
Utilities Com’n v. F.E.R.C., 625 F.3d 754, 758 (D.C. Cir. 2010)), defendants file removal
petitions and plaintiffs respond with remand motions. To resolve the remand motions, courts
first assess whether the doctrine of complete preemption applies. Ordinary preemption is a
defense and does not support Article III subject matter jurisdiction (usually under 28 U.S.C. §
1331), a prerequisite for removal. See Merrell Dow Pharmaceuticals v. Thompson, 478 U.S. 804
(1986). In contrast, complete preemption is “really a jurisdictional rather than a preemption
doctrine, [as it] confers exclusive federal jurisdiction in certain instances where Congress
intended the scope of a federal law to be so broad as to entirely replace any state-law claim.”
Marin General Hosp. v. Modesto & Empire Traction Co., 581 F.3d 941, 945 (9th Cir. 2009)
(quoting Franciscan Skemp Healthcare, Inc. v. Cent. States Joint Bd. Health & Welfare Trust
Fund, 538 F.3d 594, 596 (7th Cir. 2008) (internal quotations omitted). Relatively few statutes
completely preempt.
1 The PREP Act is the Public Readiness and Emergency Preparedness Act, Pub. L. No.
109-148, div. C, § 2, 119 Stat. 2818 (Dec. 30, 2005), codified at 42 U.S.C. §§ 247d-6d, 247d-6e.
It has been amended through the Pandemic and All-Hazards Preparedness Reauthorization Act of
2013, Pub. L. No. 113–5, title IV, § 402(g)(2), (3), 127 Stat. 196 (Mar. 13, 2013) and further
amended by § 6005 of the Families First Coronavirus Response Act, Pub. L. No. 116-127, 134
Stat. 177 (March 18, 2020) and § 3103 of the Coronavirus Aid Relief, and Economic Security
Act, Pub. L. No. 116-136, 134 Stat. 281 (March 27, 2020).
2
A. The PREP Act is a “Complete Preemption” Statute
The Supreme Court first articulated the doctrine of complete preemption as a basis for
federal question removal jurisdiction under 28 U.S.C. § 1441(a) in Avco Corp. v. Aero Lodge No.
735, Intern. Ass’n of Machinists and Aerospace Workers, 390 U.S. 557, 559 (1968) (holding that
the Labor Management Relations Act, 1947 completely preempted state court jurisdiction).
Thereafter, the doctrine was extended to the Employee Retirement Income Security Act of 1974
in 1987, the National Bank Act in 2003, and the Air Transportation Safety and System Stability
Act in 2005. See Metropolitan Life Insurance Co. v. Taylor, 481 U.S. 58 (1987) (ERISA
completely preempts state law); Aetna Health Inc. v. Davila, 542 U.S. 200 (2004) (the same);
Beneficial Nat’l Bank v. Anderson, 539 U.S. 1, 7–11 (2003) (National Bank Act completely
preeempts); In re WTC Disaster Site, 414 F.3d 352, 375 (2d Cir. 2005) (Air Transportation
Safety and System Stability Act completely preempted state claims and ousted state courts of
jurisdiction by creating an exclusive federal cause of action). The sine qua non of a statute that
completely preempts is that it establishes either a federal cause of action, administrative or
judicial, as the only viable claim or vests exclusive jurisdiction in a federal court. The PREP Act
does both.
Once complete preemption attaches, the district court is usually obligated to dismiss the
case as pleaded, either because no federal cause of action is alleged or the exclusive initial venue
is a federal administrative agency.
All that is well and good, but it does not address the issue that appears to have perplexed
district courts, namely when is the PREP Act triggered. District courts appear to have labored
hard attempting to ordain whether the non-use of a covered countermeasure triggers the PREP
Act and its complete preemption regime. At one extreme, plaintiff may have pleaded that the
facility failed in toto to provide any of its staff or patients with any PPE, a covered
countermeasure if NIOSH approved or FDA cleared or waived. Other plaintiffs allege that the
quantity of PPE was inadequate, that staff were not timely provided PPE or that staff were not
adequately trained to use PPE. The latter three complaints reflect many of the complaints that
we have reviewed.
The PREP Act’s immunity provision, which triggers exclusive federal jurisdiction, states
as follows:
Subject to the other provisions of this section, a covered person shall be immune
from suit and liability under Federal and State law with respect to all claims for
loss caused by, arising out of, relating to, or resulting from the administration to
or the use by an individual of a covered countermeasure if a declaration under
subsection (b) has been issued with respect to such countermeasure.
Public Health Service Act § 319F-3(a)(1), 42 U.S.C. § 247d-6d(a)(1) (emphasis supplied).
The PREP Act goes on to provide that its immunity
applies to any claim for loss that has a causal relationship with the administration
to or use by an individual of a covered countermeasure, including a causal
3
relationship with the design, development, clinical testing or investigation,
manufacture, labeling, distribution, formulation, packaging, marketing,
promotion, sale, purchase, donation, dispensing, prescribing, administration,
licensing, or use of such countermeasure.
Id. at § 319F-3(a)(2)(B), 42 U.S.C. § 247d-6d(a)(2)(B) (emphasis supplied).
Some district courts have interpreted the scope of the immunity in subparagraph (B) as
requiring “use.” Under this view, if a covered countermeasure were not used, then there is no
PREP Act immunity. According to one court, “[t]here is simply no room to read [the PREP Act]
as equally applicable to the non-administration or non-use of a covered countermeasure.” Lutz v.
Big Blue Healthcare, Inc., F. Supp. 3d , 2020 WL 4815100, at *8 (D. Kan. 2020)
(emphasis in original) (granted remand motion).
However, this “black and white” view clashes with the plain language of the PREP Act,
which extends immunity to anything “relating to” the administration of a covered
countermeasure. For example, consider a situation where there is only one dose of a COVID–19
vaccine,2 and a person in a vulnerable population and a person in a less vulnerable population
both request it from a healthcare professional. In that situation, the healthcare professional
administers the one dose to the person who is more vulnerable to COVID–19. In that
circumstance, the failure to administer the COVID–19 vaccine to the person in a less-vulnerable
population “relat[es] to . . . the administration to” the person in a vulnerable population. The
person in the vulnerable population was able to receive the vaccine only because it was not
administered to the person in the less-vulnerable population. Prioritization or purposeful
allocation of a Covered Countermeasure, particularly if done in accordance with a public health
authority’s directive, can fall within the PREP Act and this Declaration’s liability protections.
There can potentially be other situations where a conscious decision not to use a covered
countermeasure could relate to the administration of the countermeasure. In contrast, the failure
to purchase any PPE, if not the outcome of some form of decision-making process may not be
sufficient to trigger the PREP Act.
Where a facility has been allocated a scarce therapeutic purchased by the federal
government and that facility fails to administer that therapeutic to an individual who meets the
requirements of the FDA’s authorization, approval, or license, and whose physician prescribes
that therapeutic, then the facility’s refusal to administer that therapeutic could still trigger the
PREP Act assuming the non-use of the therapeutic was the result of conscious decision-making.
However, the facility may still be liable under the PREP Act, if the plaintiff alleges that the
decision to deny him or her the therapeutic was wanton and willful and resulted in death or
serious injury. See 42 U.S.C. § 247d-6d(d)-(e). Such a case would be transferred to the District
Court for the District of Columbia for resolution by a three-judge panel. The facility may also
be subject to a federal enforcement action.
2 For simplicity, this example assumes a patient only requires one dose of the vaccine.
4
The language of the PREP Act itself supports a distinction between allocation which
results in non-use by some individuals, on the one hand, and nonfeasance, on the other hand, that
also results in non-use.
Included within the set of “covered persons,” i.e., those entitled to immunity, are
“program planners.” 42 U.S.C. § 247d-6d(i)(2)(B)(iii). A “program planner” is
a State or local government, including an Indian tribe, a person employed by the
State or local government, or other person who supervised or administered a
program with respect to the administration, dispensing, distribution, provision, or
use of a security countermeasure or a qualified pandemic or epidemic product,
including a person who has established requirements, provided policy guidance,
or supplied technical or scientific advice or assistance or provides a facility to
administer or use a covered countermeasure in accordance with a declaration
under subsection (b).
Id. at § 247d-6d(i)(6).
A program planner is someone who is involved in providing or allocating covered
countermeasures. Program planning inherently involves the allocation of resources and when
those resources are scarce, some individuals are going to be denied access to them. Therefore,
decision-making that leads to the non-use of covered countermeasures by certain individuals is
the grist of program planning, and is expressly covered by PREP Act
There are going to be circumstances where plaintiff pleads that defendant’s culpability is
the result of its failure to make any decisions whatsoever, thereby abandoning its duty to act as a
program planner or other covered person. Although this is a small hole through which to wiggle
to avoid complete preemption, we are confident, were it not for two legal constraints, that it
would grow as plaintiffs become more adept at fashioning their pleadings. However, “complete
preemption . . . functions as an exception to the well-pleaded complaint rule.” Giles v. NYLCare
Health Plans, Inc., 172 F.3d 332, 336 (5th Cir. 1999). Thus, federal courts are free to entertain
discovery to ascertain, for jurisdictional purposes, the facts underlying the complaint. See United
Surgical Assistants, LLC v. Aetna Life Ins. Co., 2014 WL 4059889, at *1 (M.D. Fla. Aug. 14,
2014) (allowing jurisdictional discovery on whether plaintiff’s claim was completely preempted
by ERISA).
B. Fourth Amendment to the Secretary’s Declaration Supports the Grable Doctrine
In addition to complete preemption as the basis for article III jurisdiction and removal,
the Court recognized a separate doctrine in Grable & Sons Metal Products, Inc. v. Darue
Engineering & Mfg., 545 U.S. 308 (2005). Under Grable, even in the absence of a claim arising
under federal law, “a federal court ought to be able to hear claims recognized under state law that
nonetheless turn on substantial questions of federal law, and thus justify resort to the experience,
solicitude, and hope of uniformity that a federal forum offers on federal issues.” Grable & Sons
Metal Products, Inc. v. Darue Engineering & Mfg., 545 U.S. 308, 312 (2005) (emphasis
supplied). Thus, a substantial federal question is implicated, for example, where “the
5
interpretation of a federal statute [ ] actually is in dispute in the litigation and is so important that
it sensibly belongs in federal court.” 545 U.S. at 315. Here, ordaining the metes and bounds of
PREP Act protection in the context of a national health emergency necessarily means that the
case belongs in federal court. The Secretary, in his Fourth Amendment to his PREP Declaration,
similarly concluded, when he stated that
[t]here are substantial federal legal and policy issues, and substantial federal legal and
policy interests within the meaning of Grable & Sons Metal Products, Inc. v. Darue
Eng’g. & Mf’g., 545 U.S. 308 (2005), in having a unified, whole-of-nation response to
the COVID–19 pandemic among federal, state, local, and private-sector entities.
85 Fed. Reg. at 79,197 (col. c).
See also 42 U.S.C. § 247d-6d(b)(7) (“No court of the United States, or of any State, shall have
subject matter jurisdiction to review, whether by mandamus or otherwise, any action by the
Secretary under this subsection.”). As such, the secretarial determination provides the
underlying basis for invoking the Grable doctrine with respect to all claims for loss caused by,
arising out of, relating to, or resulting from the administration to or the use by an individual of a
covered countermeasure. Once invoked, the court retains the case to decide whether the
immunity and preemption provisions apply; if they do not apply, then the court would try the
case as it would a diversity case. If the court finds, though, that the PREP Act applies, it would
dismiss the case or if death or serious physical injury proximately caused by willful misconduct
is alleged, transfer it to the District Court for the District of Columbia. See 42 U.S.C. § 247d6d(d)-(e).
II. Limitations
This Advisory Opinion may be supplemented or modified. It is intended to minimize the
need for individual advisory opinions. This Advisory Opinion sets forth the current views of the
Office of the General Counsel.3
It is not a final agency action or a final order. It does not have
the force or effect of law.

Robert P. Charrow
General Counsel
January 8, 2021

3
See Air Brake Sys., Inc. v. Mineta, 357 F.3d 632, 647–48 (6th Cir. 2004) (holding that the Chief Counsel of
the National Highway Traffic Safety Administration had delegated authority to issue advisory opinions to regulated
entities in fulfillment of a congressional directive to promote regulatory compliance); 5 U.S.C. § 301 (“The head of
an executive department . . . may prescribe regulations for the government of his department, the conduct of its
employees, [and] the distribution and performance of its business[.]”); Statement of Organization, Functions, and
Delegations of Authority, 85 Fed. Reg. 54,581, 54,583 (Sept. 2, 2020).

Sixth Advisory Opinion on the PREP Act Declaration (January 12, 2021):

DEPARTMENT OF HEALTH & HUMAN SERVICES Office of the Secretary

---

The General Counsel
Washington, D.C. 20201
1
ADVISORY OPINION 21-02 ON THE PUBLIC READINESS AND EMERGENCY PREPAREDNESS ACT
AND THE SECRETARY’S DECLARATION UNDER THE ACT
JANUARY 12, 2021
This Advisory Opinion responds to requests received by the Office of the General Counsel
to clarify the meaning of the requirement, in certain PREP Act issuances (also known as “PREP Act
Authorizations,” as referenced in n. 1, infra) , that a COVID-19 vaccination “must be ordered and
administered according to ACIP’s COVID-19 vaccine recommendation(s).”1
Some have raised concerns that satisfying the Advisory Committee on Immunization Practices’ (ACIP) allocation recommendations is a precondition to PREP Act coverage. It is not.
I. ANALYSIS
As used in the PREP Act Authorizations, the phrase, “must be ordered and administered
according to ACIP’s COVID-19 vaccine recommendation(s),” means that the vaccine must be one
that ACIP recommends for the prevention of COVID-19; it does not mean that the vaccine be administered pursuant to any particular allocation guidance or recommendation.2
This is clear when one
reads these authorizations in context. The Secretary’s Third Amendment to his PREP Act Declaration
(“Third Amendment”) authorized certain pharmacists and pharmacy interns to administer childhood
vaccines. A requirement to do so, however, was that the vaccination “must be ordered and administered according to ACIP’s standard immunization schedule.”3
ACIP develops recommendations for
which age groups should receive particular vaccines.4
Thus, when the Third Amendment provided
that a childhood vaccination “must be ordered and administered according to ACIP’s standard immunization schedule,” it meant that, to be a “qualified person” under 42 U.S.C. § 247d-6d(i)(8)(B),

1 See Fourth Amendment to the Secretary’s PREP Act Declaration, 85 Fed. Reg.79,190, 79,195 (Dec.
9, 2020); Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID–19 Vaccines
and Immunity under the PREP Act, OASH, Sept. 3, 2020, available at https://www.hhs.gov/sites/default/files/licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf; Guidance for
PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns
for Childhood Vaccines, COVID–19 Vaccines, and COVID–19 Testing, OASH, Oct. 20, 2020,
available at https://www.hhs.gov/sites/default/files/prep-act-guidance.pdf ; Guidance for National Guard
Personnel Regarding COVID-19 Vaccines and Immunity under the PREP Act, Dec. 18, 2020, available at https://www.hhs.gov/about/news/2020/12/18/guidance-for-national-guard-personnel-regarding-covid-19-
vaccines-immunity-under-prep-act.html (collectively, “PREP Act Authorizations”).
2
The analysis herein is specifically limited to the phrase “must be ordered and administered according to ACIP’s COVID-19 vaccine recommendation(s),” as used in the PREP Act Authorizations. It
does not bear on the interpretation of the phrase “Authority Having Jurisdiction.”
3
85 Fed. Reg. 52,136, 52,140 (Aug. 24, 2020).
4 See https://www.cdc.gov/vaccines/schedules/hcp/index.html.
2
pharmacists and pharmacy interns could only order or administer a vaccine that ACIP had recommended, and only to individuals in the age groups that ACIP recommended receive the vaccine.
Subsequent PREP Act Authorizations simply adopted this requirement for the COVID-19
vaccine. When these authorizations (some of which were issued well before ACIP opined on how to
allocate a COVID-19 vaccine) provided that “the vaccination must be ordered and administered according to ACIP’s COVID-19 vaccine recommendation(s),” the authorizations meant that only
COVID-19 vaccines that ACIP had recommended for use should be administered.5

In its longstanding routine general vaccination recommendation role, ACIP on December 12,
2020 voted in favor of recommending amendment of the Recommended Child and Adolescent Immunization
Schedule, United States, 2021 and Recommended Adult Immunization Schedule, United States, 2021 to include
COVID-19 vaccines. In addition, on December 12, 2020 and December 19, 2020 ACIP voted to
specifically recommend administration in the United States of Pfizer-BioNTech’s COVID-19 vaccine
(for persons age 16 years and older) and Moderna’s COVID-19 vaccine (for persons aged 18 years
and older), respectively.6
The PREP Act Authorizations’ reference to ACIP’s recommendations is to
those recommendations.
Given the anticipated limited availability of COVID-19 vaccine doses at the beginning of the
vaccination program, CDC also sought ACIP’s insights on allocation for administering those limited
doses. Those ACIP allocation recommendations are not relevant to the determination of whether,
under the PREP Act Authorizations, a vaccination was “ordered and administered according to
ACIP’s COVID-19 vaccine recommendation(s).”
Therefore, any person who orders or administers the Pfizer-BioNTech COVID-19 vaccine to
individuals age 16 or older or the Moderna COVID-19 vaccine to individuals age 18 or older7
satisfies
the PREP Act Authorizations’ requirement that the vaccination be “ordered and administered according to ACIP’s COVID-19 vaccine recommendation(s).”8
This is true regardless of whether the vaccine
was ordered or administered to a person in a prioritized group.

5
The PREP Act Authorizations use the phrase “vaccine recommendation,” not “standard immunization schedule” as used in the Third Amendment, but that is only because no standard immunization schedule existed for a COVID-19 vaccine at the time of most of the authorizations.
6 See https://www.cdc.gov/mmwr/volumes/69/wr/mm6950e2.htm?s_cid=mm6950e2_w;
https://www.cdc.gov/mmwr/volumes/69/wr/mm695152e1.htm?s_cid=mm695152e1_w.
7
If ACIP subsequently recommends one or both of these vaccines for use in individuals in a different age group, the PREP Act Authorization requirement would be satisfied by ordering or administering such vaccine to individuals in that different age group.
8
This does not bear on whether the person satisfies the other requirements for PREP Act coverage.
3
II. Limitations
This Advisory Opinion may be supplemented or modified. It is intended to minimize the
need for individual advisory opinions. This Advisory Opinion sets forth the current views of the
Office of the General Counsel.9
It is not a final agency action or a final order.
Persons seeking PREP Act immunity are responsible for determining whether their products
are covered countermeasures, whether a person or entity is a covered person, whether reasonable
precautions have been taken to facilitate the safe use of covered countermeasures, and in general,
whether immunity applies to them and their activities. In order to obtain PREP Act coverage, persons
must meet all requirements set forth in the PREP Act and the Declaration.
Robert P. Charrow
General Counsel
January 12, 2021

9 See Air Brake Sys., Inc. v. Mineta, 357 F.3d 632, 647-48 (6th Cir. 2004) (holding that the Chief Counsel
of the National Highway Traffic Safety Administration had delegated authority to issue advisory opinions to regulated entities in fulfillment of a congressional directive to promote regulatory compliance);
5 U.S.C. § 301(“The head of an executive department … may prescribe regulations for the government
of his department, the conduct of its employees, [and] the distribution and performance of its business[.]”); Statement of Organization, Functions, and Delegations of Authority, 85 Fed. Reg. 54,581, 54,583
(Sept. 2, 2020).

HHS Guidance:

Guidance for National Guard Personnel Regarding COVID-19 Vaccines and Immunity under the PREP Act (December 18, 2020):

PAGE NOT FOUND.

Guidance for Department of Defense Personnel, Contractors, and Volunteers Regarding COVID-19 Vaccines and Immunity under the PREP Act (February 2, 2021):

PAGE NOT FOUND.

PREP Act Authorization for Pharmacies Distributing and Administering Certain Covered Countermeasures (October 29, 2020):

DEPARTMENT OF HEALTH AND HUMAN SERVICES Guidance
Office of the Secretary
Office of the Assistant Secretary for Health
Washington, D.C. 20201
U.S. Department of Health & Human Services
Office of the Assistant Secretary for Health
October 29, 2020
PREP Act Authorization for Pharmacies Distributing and Administering Certain Covered
Countermeasures
On January 31, 2020, the Secretary of Health and Human Services (Secretary) declared that the 2019 novel
coronavirus disease (COVID-19) is a public health emergency for the United States.1
The United States
Department of Health and Human Services (HHS) is the lead agency for the federal government’s response
to the COVID-19 pandemic.
Key components of that response are rapidly expanding COVID-19 testing across America, expanding
access to childhood vaccinations to help address a decrease in childhood vaccination rates due to the
COVID-19 pandemic, and expanding access to COVID-19 vaccines when they become available. Within
HHS, the Office of the Assistant Secretary for Health (OASH) serves a leading role for such expansions.
Pharmacies and pharmacists, in partnership with other healthcare providers, are well positioned to aid with
efforts to expand access to testing for COVID-19 and to expand access both to routine childhood vaccines
for individuals age 3–18 years and to COVID-19 vaccines. Pharmacists are trusted healthcare providers
with established relationships with patients in their communities. The vast majority of Americans live close
to a retail or independent community-based pharmacy. That proximity reduces travel to COVID-19 testing
or vaccination locations. Pharmacists also have strong relationships with medical providers and hospitals to
appropriately refer patients when necessary.
On March 10, 2020, the Secretary issued a Declaration under the Public Readiness and Emergency
Preparedness (PREP) Act.2
With promulgation of the third amendment to the Declaration on August 24,
2020,3
and guidances for pharmacists, pharmacy interns, and pharmacy technicians, certain pharmacists
(and pharmacy interns and technicians) are covered persons under the PREP Act when they administer
certain covered countermeasures, including certain COVID-19 tests, routine childhood vaccinations, and
COVID-19 vaccinations, provided that the conditions described in the Secretary’s Declaration have been
satisfied.4

1
The Secretary’s declaration of a public health emergency was retroactively effective on January 27, 2020.
2 See Declaration Under the Public Readiness and Emergency Preparedness Act for Medical
Countermeasures Against COVID-19, 85 Fed. Reg. 15,198 (Mar. 17, 2020); 85 Fed. Reg. 21,012 (Apr. 15,
2020); 85 Fed. Reg. 35,100 (June 8, 2020); 85 Fed. Reg. 52,136 (Aug. 24, 2020); see also Pub. L. No. 109-
148, Public Health Service Act § 319F-3, 42 U.S.C. § 247d-6d and 42 U.S.C. § 247d-6e.
3
85 Fed. Reg. 52,136 (Aug. 24, 2020).
4
Guidance for Licensed Pharmacists, COVID-19 Testing, and Immunity Under the PREP Act, OASH, (Apr.
8, 2020), https://www.hhs.gov/sites/default/files/authorizing-licensed-pharmacists-to-order-and-administercovid-19-tests.pdf; Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID-19
Vaccines and Immunity under the PREP Act, OASH, (Sept. 3, 2020),
https://www.hhs.gov/sites/default/files/licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-
vaccines-immunity.pdf; Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-

---

U.S. Public Health Service

Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing (October 20, 2020):

DEPARTMENT OF HEALTH AND HUMAN SERVICES Guidance
Office of the Secretary
Office of the Assistant Secretary forHealth
Washington, D.C. 20201
U.S. Department of Health & Human Services
Office of the Assistant Secretary for Health
October 20, 2020
Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized
Pharmacy Interns for Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing
On January 31, 2020, the Secretary of Health and Human Services declared that the 2019 novel
coronavirus disease (COVID-19) is a public health emergency for the United States.1 The United
States Department of Health and Human Services (HHS) is the lead agency for the federal
government’s response to the COVID-19 pandemic.
Key components of that response are rapidly expanding COVID-19 testing across America,
expanding access to childhood vaccinations to help address a decrease in childhood vaccination
rates due to the COVID-19 pandemic, and expanding access to COVID-19 vaccines when they
become available. Within HHS, the Office of the Assistant Secretary for Health (OASH) leads
federal efforts to support such expansions.
Childhood and COVID-19 Vaccine Guidance for Qualified Pharmacy Technicians
And State-Authorized Pharmacy Interns
Pharmacies, in partnership with other healthcare providers, are well positioned to increase access
to vaccinations—particularly in certain areas that have too few pediatricians and other primary care
providers, or that are otherwise medically underserved.2 For example, pharmacists already play a
significant role in annual influenza vaccination. In the early 2018-19 season, pharmacists
administered the influenza vaccine to nearly a third of all adults who received the vaccine.3 Some
states permit pharmacy technicians to administer vaccines to both adults and children under certain
circumstances.4
1 The Secretary’s declaration of a public health emergency was retroactively effective on January 27, 2020.
2 See, e.g., Guidance for Pharmacists and Pharmacy Technicians in Community Pharmacies during the
COVID-19 Response, CDC, https://www.cdc.gov/coronavirus/2019-ncov/hcp/pharmacies.html (last updated
June 28, 2020) (“As a vital part of the healthcare system, pharmacies play an important role in providing
medicines, therapeutics, vaccines, and critical health services to the public.”); Kimberly McKeirnan &
Gregory Sarchet, Implementing Immunizing Pharmacy Technicians in a Federal Healthcare Facility, 7
PHARMACY 1, 7 (2019), https://www.mdpi.com/2226-4787/7/4/152/htm (last visited Aug. 5, 2020)
(Indian Health Service study demonstrating “the effective implementation of immunization-trained
pharmacy technicians and the positive impact utilization of pharmacy support personnel can create” on
childhood vaccination rates in medically underserved populations).
3
Early-Season Flu Vaccination Coverage — United States, November 2018, CDC,
https://www.cdc.gov/flu/fluvaxview/nifs-estimates-nov2018.htm (last visited July 14, 2020).
4 Deeb Eid, et al., Moving the Needle: A 50-State and District of Columbia Landscape Review of Laws
Regarding Pharmacy Technician Vaccine Administration, Pharmacy 7, 168 (2019) available at
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6958442/.
On March 10, 2020, the Secretary of Health and Human Services (Secretary) issued a Declaration
under the Public Readiness and Emergency Preparedness (PREP) Act.5 On August 19, 2020, the
Secretary amended the March 10, 2020 declaration to identify an additional category of persons
who are qualified persons for liability protection under 42 U.S.C. § 247d-6d(i)(8)(B) of the PREP
Act.6
The definition of qualified persons in this Third Amendment included pharmacy interns
authorized to administer to persons ages three through 18 childhood vaccines that the Advisory
Committee on Immunization Practices (ACIP) recommends according to ACIP’s standard
immunization schedule, provided that certain conditions are met.7 For PREP Act liability
protection to attach, the Third Amendment also required the pharmacy intern to act under the
supervision of a pharmacist and to be licensed or registered by his or her State board of pharmacy.8
On September 3, 2020, OASH issued guidance authorizing State-licensed pharmacists to order and
administer, and State-licensed or registered pharmacy interns acting under the supervision of the
qualified pharmacist to administer, to persons ages three or older, COVID-19 vaccinations that
have been authorized or licensed by the Food and Drug Administration (FDA), provided that
certain conditions are met—thereby making them “covered persons” under the PREP Act with
respect to this activity.9
Some states do not require pharmacy interns to be licensed or registered by the State board of
pharmacy.10 This guidance clarifies that the pharmacy intern must be authorized by the state or
board of pharmacy in the state in which the practical pharmacy internship occurs, but this
authorization need not take the form of a license from, or registration with, the State board of
pharmacy.
Similarly, states vary on licensure and registration requirements for pharmacy technicians. Some
states require certain education, training, and/or certification for licensure or registration; others
either have no prerequisites for licensure or registration or do not require licensure or registration
at all. For purposes of this guidance, to be a “qualified pharmacy technician,” pharmacy
technicians working in states with licensure and/or registration requirements must be licensed
and/or registered in accordance with state requirements; pharmacy technicians working in states
without licensure and/or registration requirements must have a Certified Pharmacy Technician
(CPhT) certification from either the Pharmacy Technician Certification Board or National
Healthcareer Association.
Therefore, as an Authority Having Jurisdiction under the Secretary’s March 10, 2020 declaration
under the PREP Act, OASH issues this guidance. Subject to satisfaction of the requirements listed
below, this guidance authorizes both qualified pharmacy technicians and State-authorized
5 See Declaration Under the Public Readiness and Emergency Preparedness Act for Medical
Countermeasures Against COVID-19, 85 Fed. Reg. 15,198 (Mar. 17, 2020); 85 Fed. Reg. 21,012 (Apr. 15,
2020); 85 Fed. Reg. 35,100 (June 8, 2020); 85 Fed. Reg. 52,136 (Aug. 24, 2020); see also Pub. L. No. 109-
148, Public Health Service Act § 319F-3, 42 U.S.C. § 247d-6d and 42 U.S.C. § 247d-6e.
6 See Third Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for
Medical Countermeasures Against COVID-19, 85 Fed. Reg. 52,136, 52,140 (Aug. 24, 2020) (Third
Amendment).
7 Id. 8 Id. Pharmacists, pharmacy interns, and pharmacy technicians might have already been subject to PREP
Act immunity for certain activities prior to this amendment.
9 See https://www.hhs.gov/sites/default/files/licensed-pharmacists-and-pharmacy-interns-regarding-covid19-vaccines-immunity.pdf (last visited Sept. 28, 2020).
10 See e.g., 21 N.C.A.C. 46.1317 (West 2020) (requiring an intern to be registered with the State board of
pharmacy or be enrolled in approved academic internship program); Tenn. Code Ann. § 63-10-204 (West
2020) (requiring enrollment in or graduation from recognized school or college of pharmacy under rules
established by board); Wis. Stat. § 450.03 (West 2020) (requiring completion of second year of and current
enrollment at accredited school of pharmacy).
pharmacy interns acting under the supervision of a qualified pharmacist11 to administer FDAauthorized or FDA-licensed COVID-19 vaccines to persons ages three or older and to administer
FDA-authorized or FDA-licensed ACIP-recommended vaccines to persons ages three through 18
according to ACIP’s standard immunization schedule.
Such qualified pharmacy technicians and State-authorized pharmacy interns will qualify as
“covered persons” under the PREP Act, subject to other applicable requirements of the Act and the
requirements discussed below. They may also receive immunity under the PREP Act with respect
to all claims for loss caused by, arising out of, relating to, or resulting from, the administration or
use of such vaccines. 42 U.S.C. § 247d-6d(a)(1).12
To qualify as “qualified persons” under 42 U.S.C. § 247d-6d(i)(8)(B) when administering FDAauthorized or FDA-licensed COVID-19 vaccines to persons ages three or older or ACIPrecommended childhood vaccinations to persons ages three through 18, qualified pharmacy
technicians and State-authorized pharmacy interns must satisfy the following requirements:
• The vaccination must be ordered by the supervising qualified pharmacist.
• The supervising qualified pharmacist must be readily and immediately available to the
immunizing qualified pharmacy technicians.
• The vaccine must be FDA-authorized or FDA-licensed.
• In the case of a COVID-19 vaccine, the vaccination must be ordered and administered
according to ACIP’s COVID-19 vaccine recommendation(s).
• In the case of a childhood vaccine, the vaccination must be ordered and administered according
to ACIP’s standard immunization schedule.
• The qualified pharmacy technician or State-authorized pharmacy intern must complete a
practical training program that is approved by the Accreditation Council for Pharmacy
Education (ACPE). This training program must include hands-on injection technique and
the recognition and treatment of emergency reactions to vaccines.
• The qualified pharmacy technician or State-authorized pharmacy intern must have a current
certificate in basic cardiopulmonary resuscitation.
• The qualified pharmacy technician must complete a minimum of two hours of ACPEapproved, immunization-related continuing pharmacy education during the relevant State
licensing period(s).
• The supervising qualified pharmacist must comply with recordkeeping and reporting
requirements of the jurisdiction in which he or she administers vaccines, including informing
the patient’s primary care provider when available and submitting the required immunization
information to the state or local immunization information system (vaccine registry).
11 For purposes of this guidance, “qualified pharmacist” means those pharmacists who satisfy the
requirements listed in Section V(d) of the Third Amendment. See 85 Fed. Reg. at 52140 (Aug. 24, 2020).
12 Regarding vaccines subject to the National Vaccine Injury Compensation Program, the Third Amendment
to the COVID-19 PREP Act Declaration states: “Nothing in this Declaration shall be construed to affect the
National Vaccine Injury Compensation Program, including an injured party’s ability to obtain compensation
under that program. Covered countermeasures that are subject to the National Vaccine Injury
Compensation Program authorized under 42 U.S.C. 300aa-10 et seq. are covered under this Declaration for
the purposes of liability immunity and injury compensation only to the extent that injury compensation is
not provided under that Program.” 85 Fed. Reg. at 52140 (Aug. 24, 2020).
• The supervising qualified pharmacist is responsible for complying with requirements related to
reporting adverse events.
• The supervising qualified pharmacist must review the vaccine registry or other vaccination
records prior to ordering the vaccination to be administered by the qualified pharmacy
technician or State-authorized pharmacy intern.
• The qualified pharmacy technician and State-authorized pharmacy intern must, if the patient is
18 years of age or younger, inform the patient and the adult caregiver accompanying the patient
of the importance of a well-child visit with a pediatrician or other licensed primary-care
provider and refer patients as appropriate.
• The supervising qualified pharmacist must comply with any applicable requirements (or
conditions of use) as set forth in the CDC’s COVID-19 vaccination provider agreement and
any other federal requirements that apply to the administration of COVID-19 vaccine(s).
This authorization preempts any state and local law that prohibits or effectively prohibits those
who satisfy these requirements from administering COVID-19 or routine childhood vaccines as set
forth above. It does not preempt state and local laws that permit additional individuals to
administer COVID-19 or routine childhood vaccines to additional persons.13
COVID-19 Testing Guidance for Qualified Pharmacy Technicians and State-Authorized
Pharmacy Interns
For the reasons stated herein, pharmacies, in partnership with other healthcare providers, are also
well positioned to aid COVID-19 testing expansion. Pharmacists are trusted healthcare providers
with established relationships with their patients. As of 2018, nearly 90 percent of Americans
lived within five miles of a community pharmacy.14 That proximity reduces travel to testing
locations, which is an important mitigation measure. Pharmacies often offer extended hours and
added convenience. Pharmacists supervising qualified pharmacy technicians and State-authorized
pharmacy interns also have strong relationships with medical providers and hospitals to
appropriately refer patients when necessary.
Therefore, as an Authority Having Jurisdiction under the Secretary’s PREP Act Declaration,
OASH issues this guidance authorizing qualified pharmacy technicians and State-authorized
pharmacy interns to administer COVID-19 tests, including serology tests, that the FDA has
approved, cleared, or authorized.15 By doing so, such qualified pharmacy technicians and Stateauthorized pharmacy interns will qualify as “covered persons” under the PREP Act. And they
may receive immunity under the PREP Act with respect to all claims for loss caused by, arising
out of, relating to, or resulting from, the administration or use of FDA-authorized COVID-19 tests.
42 U.S.C. § 247d-6d(a)(1).
13 Nothing herein shall affect federal-law requirements in 42 C.F.R. Part 455, subpart E regarding screening
and enrollment of Medicaid and Children’s Health Insurance Program (CHIP) providers. This guidance
does not speak to or change reimbursement policy with respect to whether a qualified pharmacy technician
or State-authorized pharmacy intern may obtain reimbursement from a government or private payer for
ordering or administering an FDA-authorized test, administering a COVID-19 vaccine, or administering
routine childhood immunizations.
14 Get to Know Your Pharmacist, CDC, https://www.cdc.gov/features/pharmacist-month/index.html (last
visited July 14, 2020).
15 FDA’s Emergency Use Authorizations for diagnostic and therapeutic medical devices to diagnose and
respond to particular public health emergencies are available at https://www.fda.gov/emergencypreparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.
This authorization preempts any state and local law that prohibits or effectively prohibits those
who satisfy these requirements from administering COVID-19 tests as set forth above. It does not
preempt state and local laws that permit additional individuals to administer COVID-19 tests to
additional persons.16
16 Nothing herein shall affect federal-law requirements in 42 C.F.R. Part 455, subpart E regarding screening and
enrollment of Medicaid and CHIP providers. This guidance does not speak to or change reimbursement policy with
respect to whether a qualified pharmacy technician or State-authorized pharmacy intern may obtain reimbursement
from a government or private payer for ordering or administering an FDA-authorized test, administering a COVID19 vaccine, or administering routine childhood immunizations.

Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act (September 3, 2020):

PAGE NOT FOUND.

Guidance for Licensed Pharmacists, COVID-19 Testing, and Immunity under the PREP Act (April 8. 2020):

PAGE NOT FOUND.

Guidance for PREP Act Coverage for COVID-19 Screening Tests at Nursing Homes, Assisted-Living Facilities, Long-Term-Care Facilities, and other Congregate Facilities (August 31, 2020):

PAGE NOT FOUND.

PREP Act Glossary of Terms

A biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic or analogous product, arsphenamine or its derivative (or any other trivalent organic arsenic compound) applicable to the prevention, treatment, or cure of a disease or condition of human beings.

A device includes an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals or intended to affect the structure or function of the body of man or other animals which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

A distributor means a person or entity engaged in the distribution of drugs, biologics, or devices, including but not limited to: manufacturers; repackagers; common carriers; contract carriers; air carriers; own-label distributors; private-label distributors; jobbers; brokers; warehouses and wholesale drug warehouses; independent wholesale drug traders; and retail pharmacies.

A drug includes articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals, and articles (other than food) intended to affect the structure or function of the body of man or other animals.

A manufacturer includes a contractor or subcontractor of a manufacturer; a supplier or licenser of any product, intellectual property, service, research tool or component or other article used in the design, development, clinical testing, investigation or manufacturing of a covered countermeasure; and any or all of the parent companies, subsidiaries, affiliates, successors, and assigns of a manufacturer.

A program planner means a State or local government, including an Indian Tribe; a person employed by the State or local government; or other person (such as a private sector employer or community group) who supervises or administers a program with respect to the administration, dispensing, distribution, provision, or use of a countermeasure. This includes persons who establish requirements or provide policy guidance ,or who supply technical or scientific advice or assistance or who provide a facility to administer or use a “covered countermeasure” in accordance with a Declaration.

A qualified pandemic or epidemic product means a drug, biological product, or device that is:

Manufactured, used, designed, developed, modified, licensed or procured to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic, or limit the harm such a pandemic or epidemic might otherwise cause; manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a serious or life-threatening disease or condition caused by such a drug, biological product or device; or

intended to enhance the use or effect of these drugs, biological products or devices and

• Approved, licensed or cleared FDA;
• Authorized for emergency use by FDA;
• Permitted to be used pursuant to Federal law in conditions inconsistent with its approval, clearance, or licensing;
• Shipped and held by a government agency or someone working on that agency’s behalf for emergency use only when authorized, or
• Exempted by FDA for use as an investigational drug or device under research for possible use to diagnose, mitigate, prevent, treat, cure or limit harm of a pandemic or epidemic or life-threatening condition caused by such a drug or device.

A qualified person means:

• a licensed health professional or other individual who is authorized to prescribe, administer, or dispense covered countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed; or
• a person within a category identified as “qualified” in a Declaration, such as volunteers.

A security countermeasure is a drug, biological product, or device that the Health and Human Services Secretary determines to be a priority:

To treat, identify, or prevent harm from any biological, chemical, radiological, or nuclear agent identified as a material threat by the Secretary of Homeland Security, or to treat, identify, or prevent harm from a condition that may result in adverse health consequences or death and may be caused by administering a drug, biological product, or device against such an agent;

Is determined by the HHS to be a necessary countermeasure to protect public health; and is

• Approved or cleared by FDA;
• Licensed by FDA;
• May reasonably be determined to qualify for approval or licensing within eight years after HHS decides to purchase the countermeasure; or
• Authorized for emergency use by FDA.

Notice of Amendment to the January 1, 2016 Republished Declaration Under the Public Readiness and Emergency Preparedness Act:

ACTION:

Notice of amendment.

SUMMARY:

The Secretary is amending the declaration first issued on October 10, 2008, and amended and republished effective January 1, 2016 for Smallpox countermeasures and countermeasures against other orthopoxviruses pursuant to section 319F-3 of the Public Health Service Act to emphasize that the declaration applies to monkeypox virus, to expand the categories of providers authorized to administer vaccines and therapeutics against smallpox (variola virus), monkeypox virus, and other orthopoxviruses in a declared emergency, and to extend the duration of the declaration.

DATES:

This amendment of the January 1, 2016 republished declaration is effective September 28, 2022.

FOR FURTHER INFORMATION CONTACT:

L. Paige Ezernack, Administration for Strategic Preparedness and Response, Department of Health and Human Services, 200 Independence Avenue SW, Washington, DC 20201;

202-260-0365, paige.ezernack@hhs.gov.

SUPPLEMENTARY INFORMATION:

The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to issue a declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the administration or use of medical countermeasures (Covered Countermeasures), except for claims that meet the PREP Act’s definition of willful misconduct. The Secretary may, though publication in the Federal Register , amend any portion of a declaration. Using this authority, the Secretary issued a declaration for smallpox countermeasures against variola virus or other orthopoxviruses on October 10, 2008, amended the declaration effective January 1, 2016, and is further amending this declaration.

The PREP Act was enacted on December 30, 2005, as Public Law 109-148, Division C, Section 2. It amended the Public Health Service (PHS) Act, adding section 319F-3, which addresses liability immunity, and section 319F-4, which creates a compensation program. These sections are codified in the U.S. Code as 42 U.S.C. 247d-6d and 42 U.S.C. 247d-6e, respectively. Section 319F-3 of the PHS Act has been amended by the Pandemic and All-Hazards Preparedness Reauthorization Act, Public Law 113-5, enacted on March 13, 2013, and the Coronavirus Aid, Relief, and Economic Security (CARES) Act, Public Law 116-136, enacted on March 27, 2020, to expand Covered Countermeasures under the PREP Act.

On August 4, 2022, the Secretary determined pursuant to section 319 of the PHS Act, 42 U.S.C. 247d, that a public health emergency exists nationwide as a result of the consequences of an outbreak of monkeypox cases across multiple states. Monkeypox is a rare disease caused by infection with the monkeypox virus. Monkeypox virus is an orthopoxvirus, part of the same family of viruses as variola virus, the virus that causes smallpox.

The Secretary is now amending this PREP Act declaration to: amend the title of the declaration to emphasize that it covers monkeypox virus; add to Section I his determination that the 2022 outbreak of monkeypox cases in the United States caused by the monkeypox virus presents a public health emergency for the purposes of the PREP Act; make more explicit in Section I that the declaration applies to public health threats arising from smallpox (variola virus), monkeypox virus, and other orthopoxviruses; authorize in section V additional qualified persons to administer vaccines and therapeutics to address the current public health emergency caused by the 2022 outbreak of monkeypox cases and the risk of future public health threats arising from smallpox (variola virus), monkeypox virus, or other orthopoxviruses; update in Section VI the definition of Covered Countermeasures to reflect amendments to the PREP Act and to refer explicitly to monkeypox; update section VIII to refer explicitly to monkeypox; extend in Section XII the effective time period of the declaration; and republish the declaration in its entirety, as amended.

Unless otherwise noted, all statutory citations below are to the U.S. Code.

Description of Amendments by Section

The Secretary is amending the title of the declaration to “Declaration, as Amended, for Public Readiness and Emergency Preparedness Act Coverage for Countermeasures against Smallpox, Monkeypox, and other Orthopoxviruses.”

Section I, Determination of Public Health Emergency or Credible Risk of Future Public Health Emergency

Before issuing a declaration under the PREP Act, the Secretary is required to determine that a disease or other health condition or threat to health constitutes a public health emergency or that there is a credible risk that the disease, condition, or threat may in the future constitute such an emergency. This determination is separate and apart from a declaration issued by the Secretary under section 319 of the PHS Act that a disease or disorder presents a public health emergency or that a public health emergency, including significant outbreaks of infectious diseases or bioterrorist attacks, otherwise exists, or other declarations or determinations made under other authorities of the Secretary.

The Secretary is amending this determination to clarify that a risk of future public health threats is posed by smallpox (variola virus), monkeypox virus, or other orthopoxviruses, and to state that the 2022 outbreak of monkeypox cases in the United States presents a public health emergency for purposes of the PREP Act.

Section V, Covered Persons

The PREP Act’s liability immunity applies to “Covered Persons” with respect to administration or use of a Covered Countermeasure. The term “Covered Persons” has a specific meaning and is defined in the PREP Act to include manufacturers, distributors, program planners, and qualified persons, and their officials, agents, and employees, and the United States.

A “qualified person” is one category of “covered person.” A qualified person means a licensed health professional or other individual who is authorized to prescribe, administer, or dispense Covered Countermeasures under the law of the state in which the countermeasure was prescribed, administered, or dispensed; or a person within a category of persons identified as qualified in the Secretary’s declaration. Under this definition, the Secretary can describe in the declaration other qualified persons, who are Covered Persons.

Subject to certain limitations, a covered person is immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration or use of a Covered Countermeasure if a declaration under the PREP Act has been issued with respect to such countermeasure. To the extent that any State law that would otherwise prohibit a “qualified person” from prescribing, dispensing, or administering Covered Countermeasures, such law is preempted.^[1] A State remains free to expand the universe of individuals authorized to administer Covered Countermeasures within its jurisdiction under State law.

The Secretary anticipates that there will be a need to increase the available pool of providers should a large-scale vaccination or therapeutic administration effort be required for the current monkeypox outbreak or future public health threats arising from smallpox (variola virus), monkeypox virus, or other orthopoxviruses. Variola virus, monkeypox virus, and other orthopoxviruses have the potential to inflict significant burden and strain on the U.S. healthcare system in their own right; and in conjunction with the ongoing COVID-19 pandemic, a spike in current monkeypox cases could overwhelm healthcare providers. The health care system capacity and the healthcare workforce are likely to become increasingly strained throughout the nation. Allowing additional healthcare providers to administer smallpox (variola virus), monkeypox virus, or other orthopoxvirus vaccines or therapeutics in accordance with applicable Federal Food and Drug Administration (FDA) licenses, approvals, or authorizations during a declared emergency allows states maximum flexibility in limiting potential impacts of illness.

By this amendment to the declaration, the Secretary identifies additional categories of persons who are qualified persons covered by the PREP Act.

Section VI, Covered Countermeasures

The Secretary is amending Section VI to update the definition as amended by the CARES Act.

Section VIII, Category of Disease, Health Condition, or Threat

The Secretary is amending the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures to include explicitly disease and disease threat resulting from exposure to monkeypox virus.

Section XII, Effective Time Period

The Secretary must identify, for each Covered Countermeasure, the period or periods during which liability immunity is in effect, designated by dates, milestones, or other description of events, including factors specified in the PREP Act.

The Secretary is amending the declaration to extend the period for which liability immunity is in effect. The previous amended declaration was in effect through December 31, 2022. We have extended the effective time period to December 31, 2032.

Declaration, as Amended, for Public Readiness and Emergency Preparedness Act Coverage for Countermeasures Against Smallpox, Monkeypox, and Other Orthopoxviruses

This declaration amends and republishes the January 1, 2016 Amended Declaration Under the Public Readiness and Emergency Preparedness Act (“PREP Act”) for smallpox and other orthopoxvirus countermeasures. To the extent any term of the January 1, 2016 declaration is inconsistent with any provision of this republished declaration, the terms of this republished declaration are controlling.

I. Determination of Public Health Emergency or Credible Risk of Future Public Health Emergency

42 U.S.C. 247d-6d(b)(1)

I have determined that there is a credible risk that smallpox (variola virus), monkeypox virus, or other orthopoxviruses and the resulting disease or conditions may in the future constitute a public health emergency and that the 2022 outbreak of monkeypox cases in the United States presents a public health emergency.

II. Factors Considered

42 U.S.C. 247d-6d(b)(6)

I have considered the desirability of encouraging the design, development, clinical testing or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, and use of the Covered Countermeasures.

III. Recommended Activities

42 U.S.C. 247d-6d(b)(1)

I recommend, under the conditions stated in this declaration, the manufacture, testing, development, distribution, administration, or use of the Covered Countermeasures.

IV. Liability Immunity

42 U.S.C. 247d-6d(a), 247d-6d(b)(1)

Liability immunity as prescribed in the PREP Act and conditions stated in this declaration is in effect for the Recommended Activities described in section III.

V. Covered Persons

42 U.S.C. 247d-6d(i)(2),(3),(4),(6),(8)(A) and (B)

Covered Persons who are afforded liability immunity under this declaration are “manufacturers,” distributors, program planners, qualified persons, and their officials, agents, and employees, as those terms are defined in the PREP Act, and the United States. In addition, I have determined that the following additional persons are qualified persons:

(a) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction, as described in section VII below, to prescribe, administer, deliver, distribute, or dispense the Covered Countermeasures, and their officials, agents, employees, contractors, and volunteers, following a declaration of an emergency, subject to the requirements of this paragraph:

The person so authorized must have documentation of completion of the Centers for Disease Control and Prevention (CDC)-provided or -recommended training for the countermeasure and any additional training required in the FDA license, approval, or authorization. In the absence of training requirements or recommendations from the CDC, other training(s) may be substituted if:

(i) it is approved or accredited training from a national or state recognized accrediting body or association, the FDA, or equivalent organization for the administration route of the medical countermeasure,

(ii) it includes hands-on instruction for the administration route as appropriate for the countermeasure, supervised by someone that administers within their normal scope of practice,

(iii) it includes clinical evaluations of indications or contraindications of smallpox (variola virus), monkeypox virus, or other orthopoxvirus countermeasures, and

(iv) it includes the recognition and treatment of emergency reactions to smallpox (variola virus), monkeypox virus, or other orthopoxvirus countermeasures;

If applicable, such additional training as may be required by the State, territory, locality, or Tribal area in which they are prescribing, dispensing, or administering smallpox (variola virus), monkeypox virus, or other orthopoxvirus vaccines or therapeutics.

(b) Any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with section 564 of the Food, Drug, and Cosmetic (FD&C) Act.

(c) any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the FD&C Act.

(d) The following healthcare professionals and students in a healthcare profession training program following a declaration of an emergency as defined in section VII of this declaration, subject to the requirements of this paragraph:

1. To the extent not already licensed or authorized under state law, any dentist, advanced or intermediate emergency medical technician, licensed or certified professional midwife, nurse, advanced practice registered nurse, registered nurse, licensed practical nurse, optometrist, paramedic, pharmacist, pharmacy intern, pharmacy technician, physician, physician assistant, podiatrist, respiratory therapist, or veterinarian who is licensed or certified to practice under the law of any state who prescribes, dispenses, or administers smallpox (variola virus), monkeypox virus, or other orthopoxvirus vaccines or therapeutics by the route of administration and to the population specified in the relevant FDA license, approval, or authorization, including intramuscular, intradermal, or subcutaneous injection, dermal/percutaneous scarification, intranasal or oral administration, that are Covered Countermeasures under section VI of this declaration in any jurisdiction where the PREP Act applies in association with a smallpox (variola virus), monkeypox virus, or other orthopoxvirus vaccination or therapeutics effort by a State, local, Tribal or territorial authority or by an institution in which the smallpox (variola virus), monkeypox virus, or other orthopoxvirus vaccine or therapeutic is administered;

2. Any dentist, advanced or intermediate emergency medical technician, licensed or certified professional midwife, nurse, advanced practice registered nurse, registered nurse, licensed practical nurse, optometrist, paramedic, pharmacist, pharmacy intern, physician, physician assistant, podiatrist, respiratory therapist, or veterinarian who has held an active license or certification under the law of any State within the last five years, which is inactive, expired or lapsed, who prescribes, dispenses, or administers smallpox (variola virus), monkeypox virus, or other orthopoxvirus vaccines or therapeutics by the route of administration and to the population specified in the relevant FDA license, approval or authorization, including intramuscular, intradermal, or subcutaneous injection, dermal/percutaneous scarification, intranasal or oral administration, that are Covered Countermeasures under section VI of this declaration in any jurisdiction where the PREP Act applies in association with a smallpox (variola virus), monkeypox virus, or other orthopoxvirus vaccination or therapeutics effort by a State, local, Tribal or territorial authority or by an institution in which the smallpox (variola virus), monkeypox virus, or other orthopoxvirus vaccine or therapeutic is administered, so long as the license or certification was active and in good standing prior to the date it went inactive, expired or lapsed and was not revoked by the licensing authority, surrendered while under suspension, discipline or investigation by a licensing authority or surrendered following an arrest, and the individual is not on the List of Excluded Individuals/Entities maintained by the Office of Inspector General;

3. Any dental, advanced or intermediate emergency medical technician, medical, licensed or certified professional midwife, nursing, optometry, paramedic, pharmacy, pharmacy intern, physician assistant, podiatry, respiratory therapist, or veterinary student with appropriate training in administering vaccines or therapeutics as determined by their school or training program and supervision by a currently practicing healthcare professional, experienced in the route of administration and to the population specified in the relevant FDA license, approval, or authorization, who administers smallpox (variola virus), monkeypox virus, or other orthopoxvirus vaccines or therapeutics by the route of administration and to the population specified in the relevant FDA license, approval, or authorization, including intramuscular, intradermal, or subcutaneous injection, dermal/percutaneous scarification, intranasal or oral administration that are Covered Countermeasures under section VI of this declaration in any jurisdiction where the PREP Act applies in association with a smallpox (variola virus), monkeypox virus, or other orthopoxvirus vaccination or therapeutics effort by a State, local, Tribal or territorial authority or by an institution in which the smallpox (variola virus), monkeypox virus, or other orthopoxvirus vaccine or therapeutic is administered;

Subject to the following requirements:

(i) The vaccine or therapeutic must be authorized, approved, or licensed by the FDA;

(ii) Vaccination must be ordered and administered according to CDC’s/ACIP’s smallpox (variola virus), monkeypox virus, or other orthopoxvirus vaccine recommendation(s);

(iii) The healthcare professionals and students must have documentation of completion of the CDC-provided or -recommended training for the countermeasure and any additional training required in the FDA licensing, approval, authorization. In the absence of training requirements or recommendations from the CDC, other training(s) may be substituted if:

(1) it is approved or accredited training from a national or state recognized accrediting body or association, the FDA, or equivalent organization for the administration route of the medical countermeasure,

(2) it includes hands-on instruction for the administration route as appropriate for the countermeasure, supervised by someone that administers within their normal scope of practice,

(3) it includes clinical evaluations of indications or contraindications of smallpox (variola virus), monkeypox virus, or other orthopoxvirus countermeasures, and

(4) it includes the recognition and treatment of emergency reactions to smallpox (variola virus), monkeypox virus, or other orthopoxvirus countermeasures;

If applicable, such additional training as may be required by the State, territory, locality, or Tribal area in which they are prescribing, dispensing, or administering smallpox (variola virus), monkeypox virus, or other orthopoxvirus vaccines or therapeutics;

(iv) The healthcare professionals and students must have documentation of an observation period by a currently practicing healthcare professional experienced in the appropriate route of intradermal, subcutaneous, or intramuscular injections, dermal/percutaneous scarification, intranasal or oral administration and for whom the appropriate route of intradermal, subcutaneous, or intramuscular injections, dermal/percutaneous scarification, intranasal or oral administration is in their ordinary scope of practice, who confirms competency of the healthcare provider or student in preparation and administration of the smallpox (variola virus), monkeypox virus, or other orthopoxvirus vaccines or therapeutics to be administered and, if applicable, such additional training as may be required by the State, territory, locality, or Tribal area in which they are prescribing, dispensing, or administering smallpox (variola virus), monkeypox virus, or other orthopoxvirus vaccines or therapeutics;

(v) The healthcare professionals and students must have a current certificate in basic cardiopulmonary resuscitation;

(vi) The healthcare professionals and students must comply with recordkeeping and reporting

requirements of the jurisdiction in which they administer vaccines or therapeutics, including informing the patient’s primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine; and

(viii) The healthcare professionals and students comply with any applicable requirements (or conditions of use) as set forth in the CDC provider agreement and any other federal requirements that apply to the administration of smallpox (variola virus), monkeypox virus, or other orthopoxvirus vaccines or therapeutics.

(e) Any healthcare professional or other individual who holds an active license or certification permitting the person to prescribe, dispense, or administer vaccines or therapeutics under the law of any State as of the effective date of this amendment, or healthcare professional as authorized under the sections V(d)(1) and (2) of this declaration, who, following a declared emergency as defined in section VII of this declaration, prescribes, dispenses, or administers smallpox (variola virus), monkeypox virus, or other orthopoxvirus vaccines or therapeutics by the route of administration and to the population specified in the relevant FDA license, approval, or authorization, including intramuscular, intradermal, or subcutaneous injection, dermal/percutaneous scarification, intranasal or oral administration that are Covered Countermeasures under section VI of this declaration in any jurisdiction where the PREP Act applies, other than the State in which the license or certification is held, in association with a smallpox (variola virus), monkeypox virus, or other orthopoxvirus vaccination or therapeutics effort by a federal, State, local Tribal or territorial authority or by an institution in the State in which the smallpox (variola virus), monkeypox virus, or other orthopoxvirus vaccine or therapeutic is administered, so long as the license or certification of the healthcare professional has not been suspended or restricted by any licensing authority, surrendered while under suspension, discipline or investigation by a licensing authority or surrendered following an arrest, and the individual is not on the List of Excluded Individuals/Entities maintained by the Office of Inspector General, subject to:

(i) documentation of completion of the appropriate training; CDC provided or recommended training for the countermeasure and any additional training required in the FDA license, approval, or authorization. In the absence of training requirements or recommendations from the CDC, other training(s) may be substituted if:

(1) it is approved or accredited training from a national or state recognized accrediting body or association, the FDA, or equivalent organization for the administration route of the medical countermeasure,

(2) it includes hands-on instruction for the administration route as appropriate for the countermeasure, supervised by someone that administers within their normal scope of practice,

(3) it includes clinical evaluations of indications or contraindications of smallpox (variola virus), monkeypox virus, or other orthopoxvirus countermeasures, and

(4) it includes the recognition and treatment of emergency reactions to smallpox (variola virus), monkeypox virus, or other orthopoxvirus countermeasures;

If applicable, such additional training as may be required by the State, territory, locality, or Tribal area in which they are prescribing, dispensing, or administering smallpox (variola virus), monkeypox virus, or other orthopoxvirus vaccines or therapeutics;

and

(ii) for healthcare providers who are not currently practicing, documentation of an observation period by a currently practicing healthcare in experienced in the appropriate route of intradermal, subcutaneous, or intramuscular injections, dermal/percutaneous scarification, intranasal or oral administration, and for whom the appropriate route of intradermal, subcutaneous, or intramuscular injections, dermal/percutaneous scarification, intranasal or oral administration is in their ordinary scope of practice, who confirms competency of the healthcare provider in preparation and administration of the smallpox (variola virus), monkeypox virus, or other orthopoxvirus vaccines or therapeutics to be administered.

(f) Any member of a uniformed service (including members of the National Guard in a Title 32 duty status) (hereafter in this paragraph “service member”) or Federal government employee, contractor, or volunteer who prescribes, administers, delivers, distributes, or dispenses smallpox (variola virus), monkeypox virus, or other orthopoxvirus Covered Countermeasures. Such Federal government service members, employees, contractors, or volunteers are qualified persons if the following requirements are met:

(i) The executive department or agency by or for which the Federal service member, employee, contractor, or volunteer is employed, contracts, or volunteers has authorized or could authorize that service member, employee, contractor, or volunteer to prescribe, administer, deliver, distribute, or dispense the Covered Countermeasure as any part of the duties or responsibilities of that service member, employee, contractor, or volunteer, even if those authorized duties or responsibilities ordinarily would not extend to members of the public or otherwise would be more limited in scope than the activities such service member, employees, contractors, or volunteers are authorized to carry out under this declaration;

(ii) The Federal service member or Federal government, employee, contractor, or volunteer must have documentation of completion of the CDC provided or recommended training for the countermeasure and any additional training required in the FDA license, approval, or authorization. In the absence of training requirements or recommendations from the CDC, other training(s) may be substituted if:

(1) it is approved or accredited training from a national or state recognized accrediting body or association, the FDA, or equivalent organization for the administration route of the medical countermeasure,

(2) it includes hands-on instruction for the administration route as appropriate for the countermeasure, supervised by someone that administers within their normal scope of practice,

(3) it includes clinical evaluations of indications or contraindications of smallpox (variola virus), monkeypox virus, or other orthopoxvirus countermeasures, and

(4) it includes the recognition and treatment of emergency reactions to smallpox (variola virus), monkeypox virus, or other orthopoxvirus countermeasures;

If applicable, such additional training as may be required by the State, territory, locality, or Tribal area in which they are prescribing, dispensing, or administering smallpox (variola virus), monkeypox virus, or other orthopoxvirus vaccines or therapeutics.

VI. Covered Countermeasures

42 U.S.C. 247d-6b(c)(1)(B), 42 U.S.C. 247d-6d(i)(1) and (7)

Covered Countermeasures are any vaccine, including all components and constituent materials of these vaccines, and all devices and their constituent components used in the administration of these vaccines; any antiviral; any other drug; any biologic; or any diagnostic or other device to identify, or any respiratory protective device to prevent or treat smallpox (variola virus), monkeypox virus, or other orthopoxvirus or adverse events from such countermeasures. Covered Countermeasures must be “qualified pandemic or epidemic products,” or “security countermeasures,” or drugs, biological products, or devices authorized for investigational or emergency use, or a respiratory protective device as those terms are defined in the PREP Act, the FD&C Act, and the Public Health Service Act.

VII. Limitations on Distribution

42 U.S.C. 247d-6d(a)(5) and (b)(2)(E)

I have determined that liability immunity is afforded to Covered Persons only for Recommended Activities involving Covered Countermeasures that are related to:

(a) Present or future federal contracts, cooperative agreements, grants, other transactions, interagency agreements, memoranda of understanding, or other federal agreements, or activities directly conducted by the federal government; or

(b) Activities authorized in accordance with the public health and medical response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute, or dispense the Covered Countermeasures following a declaration of an emergency.

i. The Authority Having Jurisdiction means the public agency or its delegate that has legal responsibility and authority for responding to an incident, based on political or geographical ( e.g., city, county, tribal, state, or federal boundary lines) or functional ( e.g., law enforcement, public health) range or sphere of authority.

ii. A declaration of emergency means any declaration by any authorized local, regional, state, or federal official of an emergency specific to events that indicate an immediate need to administer and use the Covered Countermeasures, with the exception of a federal declaration in support of an Emergency Use Authorization under section 564 of the FD&C Act unless such declaration specifies otherwise.

I have also determined that for governmental program planners only, liability immunity is afforded only to the extent such program planners obtain Covered Countermeasures through voluntary means, such as (1) donation; (2) commercial sale; (3) deployment of Covered Countermeasures from federal stockpiles; or (4) deployment of donated, purchased, or otherwise voluntarily obtained Covered Countermeasures from State, local, or private stockpiles.

VIII. Category of Disease, Health Condition, or Threat

42 U.S.C. 247d-6d(b)(2)(A)

The category of disease, health condition, or threat for which I recommend the administration or use of the Covered Countermeasures is smallpox resulting from exposure to variola virus, monkeypox resulting from exposure to monkeypox virus, or other infectious disease resulting from exposure to other orthopoxviruses, and the threat of disease resulting from exposure to any of these viruses.

IX. Administration of Covered Countermeasures

42 U.S.C. 247d-6d(a)(2)(B)

Administration of the Covered Countermeasure means physical provision of the countermeasures to recipients, or activities and decisions directly relating to public and private delivery, distribution and dispensing of the countermeasures to recipients, management and operation of countermeasure programs, or management and operation of locations for purpose of distributing and dispensing countermeasures.

X. Population

42 U.S.C. 247d-6d(a)(4), 247d-6d(b)(2)(C)

The populations of individuals include any individual who uses or is administered the Covered Countermeasures in accordance with this declaration.

Liability immunity is afforded to manufacturers and distributors without regard to whether the countermeasure is used by or administered to this population; liability immunity is afforded to program planners and qualified persons when the countermeasure is used by or administered to this population or the program planner or qualified person reasonably could have believed the recipient was in this population.

XI. Geographic Area

42 U.S.C. 247d-6d(a)(4), 247d-6d(b)(2)(D)

Liability immunity is afforded for the administration or use of a Covered Countermeasure without geographic limitation.

Liability immunity is afforded to manufacturers and distributors without regard to whether the countermeasure is used by or administered in these geographic areas; liability immunity is afforded to program planners and qualified persons when the countermeasure is used by or administered in these geographic areas, or the program planner or qualified person reasonably could have believed the recipient was in these geographic areas.

XII. Effective Time Period

42 U.S.C. 247d-6d(b)(2)(B)

Liability immunity for Covered Countermeasures obtained through means of distribution other than in accordance with the public health and medical response of the Authority Having Jurisdiction extends through December 31, 2032.

Liability immunity for Covered Countermeasures administered and used in accordance with the public health and medical response of the Authority Having Jurisdiction begins with a declaration and lasts through (1) the final day the emergency declaration is in effect or (2) December 31, 2032, whichever occurs first.

Liability immunity for Covered Countermeasures administered and used by additional qualified persons in sections V(d) and V(e) begins with a declaration and lasts through (1) the final day the emergency declaration is in effect or (2) December 31, 2032, whichever occurs first.

Covered Countermeasures obtained for the Strategic National Stockpile (SNS) during the effective period of this declaration for Covered Countermeasures are covered through the date of administration or use pursuant to a distribution or release from the SNS.

XIII. Additional Time Period of Coverage

42 U.S.C. 247d-6d(b)(3)(A), (B) and (C)

I have determined that an additional twelve (12) months of liability protection is reasonable to allow for the manufacturer(s) to arrange for disposition of the Covered Countermeasure, including return of the Covered Countermeasures to the manufacturer, and for Covered Persons to take such other actions as are appropriate to limit the administration or use of the Covered Countermeasures.

XIV. Countermeasures Injury Compensation Program

42 U.S.C. 247d-6e

The PREP Act authorizes the Countermeasures Injury Compensation Program (CICP) to provide benefits to certain individuals or estates of individuals who sustain a serious physical covered injury as the direct result of the administration or use of the Covered Countermeasures and/or benefits to certain survivors of individuals who die as a direct result of the administration or use of the Covered Countermeasures. The causal connection between the countermeasure and the serious physical injury must be supported by compelling, reliable, valid, medical and scientific evidence in order for the individual to be considered for compensation. The CICP is administered by the Health Resources and Services Administration, within the Department of Health and Human Services. Information about the CICP is available at 855-266-2427 (toll-free) or http://www.hrsa.gov/​cicp/​.

XV. Amendments

42 U.S.C. 247d-6d(b)(4)

The October 10, 2008 declaration under the PREP Act for smallpox countermeasures was first published on October 17, 2008 and amended and republished on January 1, 2016. This is the second amendment to and republication of the declaration.

Any further amendments to this declaration will be published in the Federal Register .

(Authority: 42 U.S.C. 247d-6d)

Xavier Becerra,

Secretary.

Footnotes

1.  See, “Preemption of State and Local Requirements Under a PREP Act Declaration,” Memorandum Opinion for the General Counsel Department of Health and Human Services, January 19, 2021, available at: https://www.justice.gov/​sites/​default/​files/​opinions/​attachments/​2021/​01/​19/​2021-01-19-prep-act-preemption.pdf. Back to Citation

[FR Doc. 2022-21412 Filed 9-30-22; 8:45 am]

BILLING CODE 4150-28-P

Smallpox Medical Countermeasures (amended effective January 1, 2016):

ACTION:

Notice of Amendment to the October 10, 2008 Declaration under the Public Readiness and Emergency Preparedness Act.

SUMMARY:

The Secretary is amending the declaration issued on October 10, 2008, (73 FR 61869) pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d) to: Include countermeasures authorized for use under sections 564A and 564B of the Federal Food, Drug, and Cosmetic (FD&C) Act (21 U.S.C. 360bbb-3a and 360bbb-3b); clarify the description of covered countermeasures; extend the effective time period of the declaration; reformat the declaration; modify or clarify terms of the declaration; and republish the declaration in its entirety, as amended.

DATES:

The amendment of the October 10, 2008, declaration is effective as of January 1, 2016.

FOR FURTHER INFORMATION CONTACT:

Nicole Lurie, MD, MSPH, Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue SW., Washington, DC 20201, Telephone 202-205-2882.

SUPPLEMENTARY INFORMATION:

Background

The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to issue a declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the administration or use of medical countermeasures (Covered Countermeasures), except for claims that meet the PREP Act’s definition of willful misconduct. The Secretary may, though publication in the Federal Register, amend any portion of a declaration. Using this authority, the Secretary issued a declaration for smallpox countermeasures against variola virus or other orthopoxviruses on October 10, 2008, and is amending this declaration.^[1]

The major actions taken by this amendment to the smallpox countermeasures declaration include are the following: (1) Updating the description of covered countermeasures to include countermeasures authorized for use under sections 564A and 564B of the FD&C Act; ^[2] (2) revising the description of covered countermeasures to clarify that coverage for vaccines includes all components and constituent materials of the vaccines and all devices and their constituent components used in the administration of the vaccines, and to add biologics; (3) changing the description of qualified persons to include persons authorized to prescribe, administer, or dispense covered countermeasures in accordance with Section 564A of the FD&C Act; (4) clarifying that liability immunity extends to other transactions and to activities related to any federal agreements including clinical trials agreements by adding the terms “other transactions” and “other Federal agreements” to the clause describing the types of federal agreements for which immunity is in effect; (5) deleting references to specific federal contracts to clarify that immunity is not limited to activities conducted under listed contracts; (6) clarifying that liability immunity extends to activities directly conducted by the federal government by adding the phrase “or directly conducted by the Federal Government” to the section describing methods of distribution for which liability immunity is in effect; (7) narrowing the definition of “administration” to cover “slip-and-fall” claims only to the extent they are directly tied to the operation of a countermeasure program; (8) extending the time period for which liability immunity is in effect for the Covered Countermeasures to December 31, 2022, and (9) changing the entire declaration to the new format that was first used with the February 29, 2012, amendment to the declaration for pandemic influenza to make the declaration easier for readers to follow. Other minor modifications and clarifications are also made, as fully explained below.

The declaration is republished in full. We explain both the substantive and format changes in this supplementary section.

The PREP Act was enacted on December 30, 2005, as Public Law 109-148, Division C, Section 2. It amended the Public Health Service (PHS) Act, adding section 319F-3, which addresses liability immunity, and section 319F-4, which creates a compensation program. These sections are codified in the U.S. Code as 42 U.S.C. 247d-6d and 42 U.S.C. 247d-6e, respectively.

The Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, was enacted on March 13, 2013. Among other things, PAHPRA added sections 564A and 564B to the FD&C Act to provide new authorities for the emergency use of approved products in emergencies and products held for emergency use. PAHPRA accordingly amended the definitions of “Covered Countermeasures” and “qualified pandemic and epidemic products” in section 319F-3 of the Public Health Service Act (the PREP Act provisions), so that products made available under these new FD&C Act authorities could be covered under PREP Act declarations. PAHPRA also extended the definition of qualified pandemic and epidemic products to include products or technologies intended to enhance the use or effect of a drug, biological product, or device used against the pandemic or epidemic or against adverse events from these products.

Unless otherwise noted, all statutory citations below are to the U.S. Code.

Section I, Determination of Public Health Emergency or Credible Risk of Future Public Health Emergency

Before issuing a declaration under the PREP Act, the Secretary is required to determine that a disease or other health condition or threat to health constitutes a public health emergency or that there is a credible risk that the disease, condition, or threat may in the future constitute such an emergency.^[3] This determination is separate and apart from a declaration issued by the Secretary under section 319 of the PHS Act ^[4] that a disease or disorder presents a public health emergency or that a public health emergency, including significant outbreaks of infectious diseases or bioterrorist attacks, otherwise exists, or other declarations or determinations made under other authorities of the Secretary. In the previous PREP Act declaration for smallpox countermeasures (“declaration”), this determination appeared in the declaration’s introduction as the conclusion to the “whereas” clauses. The determination is stated in the first section of the declaration. This change was made to improve readability and is not intended to have any substantive legal effect.

In addition, we made a substantive change to the determination. The determination made in the “whereas” clauses in the October 10, 2008, declaration stated that the Secretary “determined there is a credible risk that the exposure to variola virus or other orthopoxvirus disease and the resulting disease constitutes a public health emergency.” The Secretary is amending this determination to state that the threat may be “in the future,” to refer to release of variola virus or orthopox virus rather than exposure, and to refer to both diseases and conditions, to more accurately describe the risk and to be consistent with the language used in the PREP Act.^[5] Thus, in this amended declaration, the Secretary determines “that there is a credible risk that the release of variola virus or other orthopoxvirus and the resulting disease or conditions may in the future constitute a public health emergency.” This change is provided for clarification.

Section II, Factors Considered

In deciding whether and under what circumstances to issue a declaration with respect to a Covered Countermeasure, the Secretary must consider the desirability of encouraging the design, development, clinical testing or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, and use of the countermeasure.^[6] We previously stated these considerations in the introductory “whereas” clauses to the declaration. The declaration now states these considerations in section II. We made this change to improve readability and do not intend that it have any substantive legal effect.

Section III, Recommended Activities

The Secretary must recommend the activities for which the PREP Act’s liability immunity is in effect. These activities may include, under conditions as the Secretary may specify, the manufacture, testing, development, distribution, administration, or use of one or more Covered Countermeasures (“Recommended Activities”).^[7] In the previous declaration, we included the Recommended Activities in section I of the declaration, “Covered Countermeasures.” The declaration now states them in section III. We made this change to improve readability and do not intend that it have any substantive legal effect. In addition, we deleted the phrases “as defined in section IX below” and “with respect to the category of disease and population described in sections II and IV below” for consistency with formatting changes, and changed “and usage” to “or use” for consistency with the statute. These changes are not intended to have any substantive legal effect.

Section IV, Liability Immunity

The Secretary must also state that liability protections available under the PREP Act are in effect with respect to the Recommended Activities.^[8] These liability protections provide that, “[s]ubject to other provisions of [the PREP Act], a covered person shall be immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or use by an individual of a covered countermeasure if a declaration . . . has been issued with respect to such countermeasure.” ^[9] In the previous declaration, we included a statement referring to liability immunity specified under the PREP Act in section I of the declaration, “Covered Countermeasures.” The declaration now includes the statement that liability immunity is in effect for Recommended Activities in a separate section IV. We made this change to improve readability and do not intend that it have any substantive legal effect.

Section V, Covered Persons

The PREP Act’s liability immunity applies to “Covered Persons” with respect to administration or use of a Covered Countermeasure. The term “Covered Persons” has a specific meaning, and is defined in the PREP Act to include manufacturers, distributors, program planners, and qualified persons, and their officials, agents, and employees, and the United States.^[10] The PREP Act further defines the terms “manufacturer,” “distributor,” “program planner,” and “qualified person” as described below.^[11]

A manufacturer includes a contractor or subcontractor of a manufacturer; a supplier or licenser of any product, intellectual property, service, research tool or component or other article used in the design, development, clinical testing, investigation or manufacturing of a Covered Countermeasure; and any or all of the parents, subsidiaries, affiliates, successors, and assigns of a manufacturer; ^[12]

A distributor means a person or entity engaged in the distribution of drug, biologics, or devices, including but not limited to: manufacturers; repackers; common carriers; contract carriers; air carriers; own-label distributors; private-label distributors; jobbers; brokers; warehouses and wholesale drug warehouses; independent wholesale drug traders; and retail pharmacies; ^[13]

A program planner means a state or local government, including an Indian tribe; a person employed by the state or local government; or other person who supervises or administers a program with respect to the administration, dispensing, distribution, provision, or use of a Covered Countermeasure, including a person who establishes requirements, provides policy guidance, or supplies technical or scientific advice or assistance or provides a facility to administer or use a Covered Countermeasure in accordance with the Secretary’s declaration; ^[14] Under this definition, a private sector employer or community group or other person can be a program planner when it carries out the described activities.

A qualified person means a licensed health professional or other individual who is authorized to prescribe, administer, or dispense Covered Countermeasures under the law of the state in which the countermeasure was prescribed, administered, or dispensed; or a person within a category of persons identified as qualified in the Secretary’s declaration.^[15] Under this definition, the Secretary can describe in the declaration other qualified persons, such as volunteers, who are Covered Persons. Section V describes other qualified persons covered by this declaration. The PREP Act also defines “person” as used in the Act: A person includes an individual, partnership, corporation, association, entity, or public or private corporation, including a federal, state, or local government agency or department.^[16]

The provisions regarding Covered Persons previously appeared in the declaration as a definition in section IX, “Definitions” and in section VI, “Qualified Persons.” We combined these two provisions into a new section V, “Covered Persons” and added “to perform an activity” to the description of “Other Qualified Persons” authorized under an Emergency Use Authorization (EUA) for clarity. We made these changes to improve readability and clarity and do not intend them to have any substantive legal effect.

We also modified the description of Covered Persons to include a new category of qualified persons: “Any person authorized to prescribe, administer, or dispense covered countermeasures in accordance with Section 564A of the FD&C Act.” This change ensures that persons who prescribe, administer, or dispense covered countermeasures in accordance with section 564A of the FD&C Act are Covered Persons under the declaration.

Section VI, Covered Countermeasures

As noted above, section III describes the Secretary’s Recommended Activities for which liability immunity is in effect. This section identifies the countermeasures for which the Secretary has recommended such activities. The PREP Act states that a “Covered Countermeasure” must be: A “qualified pandemic or epidemic product,” or a “security countermeasure,” as described immediately below; or a drug, biological product or device authorized for emergency use in accordance with section 564, 564A, or 564B of the FD&C Act.^[17]

A qualified pandemic or epidemic product means a drug or device, as defined in the FD&C Act or a biological product, as defined in the PHS Act ^[18] that is: (i) Manufactured, used, designed, developed, modified, licensed or procured to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic or limit the harm such a pandemic or epidemic might otherwise cause; (ii) manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a serious or life-threatening disease or condition caused by such a drug, biological product or device; (iii) or a product or technology intended to enhance the use or effect of such a drug, biological product, or device.^[19]

A security countermeasure is a drug or device, as defined in the FD&C Act or a biological product, as defined in the PHS Act ^[20] that: (i) (a) the Secretary determines to be a priority to diagnose, mitigate, prevent or treat harm from any biological, chemical, radiological, or nuclear agent identified as a material threat by the Secretary of Homeland Security, or (b) to diagnose, mitigate, prevent, or treat harm from a condition that may result in adverse health consequences or death and may be caused by administering a drug, biological product, or device against such an agent; and (ii) is determined by the Secretary of Health and Human Services to be a necessary countermeasure to protect public health.^[21]

To be a Covered Countermeasure, qualified pandemic or epidemic products and security countermeasures also must be approved or cleared under the FD&C Act; ^[22] licensed under the PHS Act; ^[23] authorized for emergency use under sections 564, 564A, or 564B of the FD&C Act.^[24]

A qualified pandemic or epidemic product also may be a Covered Countermeasure when it is subject to an exemption (that is, it is permitted to be used under an Investigational Drug Application or an Investigational Device Exemption) under the FD&C Act ^[25] and is the object of research for possible use for diagnosis, mitigation, prevention, treatment, cure or limit harm of a pandemic or epidemic or serious or life-threatening condition caused by such a drug or device. A security countermeasure also may be a Covered Countermeasure if it may reasonably be determined to qualify for approval or licensing within 10 years after the Department’s determination that procurement of the countermeasure is appropriate.

Provisions regarding Covered Countermeasures appeared in section I of the declaration, “Covered Countermeasures” and section IX of the declaration, “Definitions.” Section I included not only a description of the Covered Countermeasure but also the Secretary’s recommendation, statement regarding liability immunity, and additional conditions characterizing countermeasures. We have combined sections I and IX and simplified the language so that it now only identifies the Covered Countermeasures. We have relocated the other conditions included in the “Covered Countermeasure” section to new sections, “Recommended Activities,” “Liability Immunity,” and “Limitations on Distribution,” to improve readability. We do not intend for this change to have any substantive legal effect.

Section I of the declaration also stated that the declaration applied to Covered Countermeasures administered or used during the effective time period of the declaration. We have deleted this language as it is redundant of the provisions stated in sections XII, “Effective Time Period,” and XIII, “Additional Time Period of Coverage.”

We also revised the description and definition of the Covered Countermeasure that previously appeared in sections I, “Covered Countermeasures” and IX, “Definitions.” Section I referred to the Act for the definition of “Covered Countermeasures,” and section IX defined the term “Smallpox Countermeasure” as “Any vaccine; antiviral, other drug; or diagnostic or device to identify, prevent or treat smallpox or orthopoxvirus or adverse events from such countermeasures (1) Licensed under section 351 of the Public Health Service Act; (2) approved under section 505 or section 515 of the Federal Food, Drug, and Cosmetic Act (FDCA); (3) cleared under section 510(k) of the FDCA; (4) authorized for emergency use under section 564 of the FDCA ; (5) used under section 505(i) of the FDCA or section 351(a)(3) of the PHS Act, and 21 CFR part 312; or (6) used under section 520(g) of the FDCA and 21 CFR part 812.”

We revised the description of smallpox countermeasures to clarify that coverage for vaccines includes components and constituent materials of the vaccines and device and constituent components used in administration of the vaccines. We also added the term “biologic” to more accurately describe the types of countermeasures used against smallpox and added “other” before “drug” and “device” for accuracy. The definition now reads: “any vaccine, including all components and constituent materials of these vaccines, and all devices and their constituent components used in the administration of these vaccines; any antiviral; any other drug; any biologic; or any diagnostic or other device to identify, prevent or treat smallpox or orthopoxvirus or adverse events from such countermeasures.” These changes are intended as clarification.

We also added a statement referencing the statutory definitions of Covered Countermeasures to make clear that these statutory definitions limit the scope of Covered Countermeasures. Specifically, we noted that they must be “qualified pandemic or epidemic products,” or “security countermeasures,” or drugs, biological products, or devices authorized for investigational or emergency use, as those terms are defined in the PREP Act, the FD&C Act, and the Public Health Service Act.” By referencing the statutory provisions, the revised definition also incorporates changes to the PREP Act definitions of covered countermeasure and qualified pandemic or epidemic product made by PAHPRA.

Section VII, Limitations on Distribution

The Secretary may specify that liability immunity is in effect only to Covered Countermeasures obtained through a particular means of distribution.^[26] These limitations on distribution previously appeared in section I, “Covered Countermeasures,” and section IX, “Definitions.” We now state the limitations in a separate section and combine them with relevant definitions for improved readability.

The declaration now states that liability immunity is afforded to Covered Persons for Recommended Activities related to:

(a) Present or future federal contracts, cooperative agreements, grants, other transactions, interagency agreements, or memoranda of understanding or other federal agreements or activities directly conducted by the federal government; or

(b) Activities authorized in accordance with the public health and medical response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures following a declaration of an emergency.

For governmental program planners only, liability immunity is afforded only to the extent they obtain Covered Countermeasures through voluntary means, such as (1) donation; (2) commercial sale; (3) deployment of Covered Countermeasures from Federal stockpiles; or (4) deployment of donated, purchased, or otherwise voluntarily obtained Covered Countermeasures from State, local, or private stockpiles.

In regard to (a), we, added the phrase “other transactions,” which may be used for some Covered Countermeasure activities,^[27] added the phrase “or other Federal agreements” to clarify that the provision is intended to cover all types of Federal agreements, and added the phrase “or activities directly conducted by the Federal Government” to clarify that activities such as manufacture of vaccines for clinical trials by the HHS National Institutes of Health Vaccine Research Center or distribution of countermeasures by federal employees are covered. We changed the conjunction “and” to “or” between (a) and (b) to clarify that immunity is available under either of these circumstances; the activities do not have to both relate to a Federal award or agreement and be used in a public health and medical response in order for immunity to apply. The conjunction “and” used in the previous declaration was a drafting error; the Secretary’s intent in that previous declarations has been the meaning conferred by the term “or.” Provisions (a) and (b) are intended to afford immunity to Federal government conducted and supported activities that precede a public health emergency and to activities in accordance with all Authorities Having Jurisdiction during a declared public health emergency. These changes are intended as clarifications and to improve readability, and are not intended as substantive changes.

In regard to (b), the meaning of the terms “Authority Having Jurisdiction” and “Declaration of an Emergency” are unchanged.

Finally, we slightly modified the last limitation by deleting extraneous statutory references and other language and by replacing the final sentence with the word “only” after “planners” to improve readability. We do not intend for the changes to this provision to alter its substantive legal effect. As stated in the “whereas” clauses of the prior declaration, this limitation on distribution is intended to deter program planners that are government entities from seizing privately held stockpiles of Covered Countermeasures. It does not apply to any other Covered Persons, including other program planners who are not government entities.

Section VIII, Category of Disease, Health Condition, or Threat

The Secretary must identify, for each Covered Countermeasure, the categories of diseases, health conditions, or threats to health for which the Secretary recommends the administration or use of the countermeasure.^[28] This information previously appeared in section II, “Category of Disease.”

Section IX, Administration of Covered Countermeasures

The PREP Act does not explicitly define the term “administration” but does assign the Secretary the responsibility to provide relevant conditions in the declaration. This definition previously appeared in section IX, “Definitions.” We have moved it to a separate section to improve readability. The Secretary has also narrowed the definition of “administration” that was previously provided in the declaration. The declaration previously defined the term “administration” to include physical provision of a Covered Countermeasure, as well as management and operation of systems and locations at which Covered Countermeasures may be provided to recipients:

Administration of a Covered Countermeasure: As used in section 319F-3(a)(2)(B) of the Act includes, but is not limited to, public and private delivery, distribution, and dispensing activities relating to physical administration of the countermeasures to patients/recipients, management and operation of delivery systems, and management and operation of distribution and dispensing locations.

The definition has been revised as follows:

Administration of a Covered Countermeasure means physical provision of the countermeasures to recipients, or activities and decisions directly relating to public and private delivery, distribution and dispensing of the countermeasures to recipients; management and operation of countermeasure programs; or management and operation of locations for purpose of distributing and dispensing countermeasures.

As clarified, administration extends only to physical provision of a countermeasure to a recipient, such as vaccination or handing drugs to patients, and to activities related to management and operation of programs and locations for providing countermeasures to recipients, such as decisions and actions involving security and queuing, but only insofar as those activities directly relate to the countermeasure activities. Claims for which Covered Persons are provided immunity under the Act are losses caused by, arising out of, relating to, or resulting from the administration to or use by an individual of a Covered Countermeasure consistent with the terms of a declaration issued under the Act.^[29] Under the Secretary’s definition, these liability claims are precluded if the claims allege an injury caused by physical provision of a countermeasure to a recipient, or if the claims are directly due to conditions of delivery, distribution, dispensing, or management and operation of countermeasure programs at distribution and dispensing sites.

Thus, it is the Secretary’s interpretation that, when a declaration is in effect, the Act precludes, for example, liability claims alleging negligence by a manufacturer in creating a vaccine, or negligence by a health care provider in prescribing the wrong dose, absent willful misconduct. Likewise, the Act precludes a liability claim relating to the management and operation of a countermeasure distribution program or site, such as a “slip-and-fall” injury or vehicle collision by a recipient receiving a countermeasure at a retail store serving as an administration or dispensing location that alleges, for example, lax security or chaotic crowd control. However, a liability claim alleging an injury occurring at the site that was not directly related to the countermeasure activities is not covered, such as a slip and fall with no direct connection to the countermeasure’s administration or use. In each case, whether immunity is applicable will depend on the particular facts and circumstances.

Section X, Population

The Secretary must identify, for each Covered Countermeasure specified in a declaration, the population or populations of individuals for which liability immunity is in effect with respect to administration or use of the countermeasure.^[30] This section explains which individuals should use the countermeasure or to whom the countermeasure should be administered—in short, those who should be vaccinated or take a drug or other countermeasure. These provisions previously appeared in section IV, “Population.” The previous declaration stated that the population specified in the declaration included:

The populations specified in this declaration are all persons who use a Covered Countermeasure or to whom a Covered Countermeasure is administered in accordance with this declaration, including, but not limited to: (1) Any person conducting research and development of Covered Countermeasures directly for the federal government or pursuant to a contract, grant, or cooperative agreement with the federal government; (2) any person who receives a Covered Countermeasure from persons authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute, or dispense the Covered Countermeasure, and their officials, agents, employees, contractors, and volunteers following a declaration of an emergency; (3) any person who receives a Covered Countermeasure from a person authorized to prescribe, administer or dispense the countermeasure or who is otherwise authorized to prescribe, administer or dispense the countermeasure under an Emergency Use Authorization; (4) any person who receives a Covered Countermeasure as an investigational new drug in human clinical trials being conducted directly by the federal government or pursuant to a contract, grant, or cooperative agreement with the federal government.

We have amended the declaration to provide that the population includes “any individual who uses or who is administered a Covered Countermeasure in accordance with the declaration.” We believe this broad statement accurately encompasses all of the previously listed populations given as examples of that phrase and ensures that no populations that use or are administered the Covered Countermeasures in accordance with the terms of the declaration are omitted.

In addition, the PREP Act specifies that liability immunity is afforded: (1) To manufacturers and distributors without regard to whether the countermeasure is used by or administered to this population; and (2) to program planners and qualified persons when the countermeasure is either used by or administered to this population or the program planner or qualified person reasonably could have believed the recipient was in this population.^[31] We included these statutory conditions in the declaration for clarity.

Section XI, Geographic Area

The Secretary must identify, for each Covered Countermeasure specified in the declaration, the geographic area or areas for which liability immunity is in effect with respect to administration or use of the countermeasure, including, as appropriate, whether the declaration applies only to individuals physically present in the area or, in addition, applies to individuals who have a described connection to the area.^[32] This section appeared in section V, “Geographic Area.”

In addition, the PREP Act specifies that liability immunity is afforded: (1) To manufacturers and distributors without regard to whether the countermeasure is used by or administered to individuals in the geographic areas; and (2) to program planners and qualified persons when the countermeasure is either used or administered in the geographic areas or the program planner or qualified person reasonably could have believed the countermeasure was used or administered in the areas.^[33] We included these statutory conditions in the declaration for clarity.

Section XII, Effective Time Period

The Secretary must identify, for each Covered Countermeasure, the period or periods during which liability immunity is in effect, designated by dates, milestones, or other description of events, including factors specified in the PREP Act.^[34] This section appeared as section III, “Effective Time Period.”

The declaration is amended to clarify when liability takes effect for different means of distribution and to delete language referring to the Smallpox Emergency Personnel Protection Act (SEPPA) of 2003. These changes are intended to have no legal effect. The time frame for filing claims under the Secretary’s SEPPA declaration expired in January 2010. The declaration is also amended to extend the period for which liability immunity is in effect. The previous declaration was in effect through December 31, 2015. We have extended the effective time period to December 31, 2022.

Section XIII, Additional Time Period of Coverage

The Secretary must specify a date after the ending date of the effective period of the declaration that is reasonable for manufacturers to arrange for disposition of the Covered Countermeasure, including return of the product to the manufacturer, and for other Covered Persons to take appropriate actions to limit administration or use of the Covered Countermeasure.^[35] In addition, the PREP Act specifies that for Covered Countermeasures that are subject to a declaration at the time they are obtained for the Strategic National Stockpile (SNS) under 42 U.S.C. 247d-6b(a), the effective period of the declaration extends through the time the countermeasure is used or administered pursuant to a distribution or release from the SNS. Liability immunity under the provisions of the PREP Act and the conditions of the declaration continues during these additional time periods. Thus, liability immunity is afforded during the “Effective Time Period,” described under XII of the declaration, plus the “Additional Time Period” described under section XIII of the declaration.

The provision for additional time periods previously appeared as section VII, “Additional Time Periods of Coverage After Expiration of the Declaration.” The provision is amended to clarify the statutory provisions as they apply to manufacturers and to other covered persons, and to clarify that extended coverage applies to any products obtained for the Strategic National Stockpile during the effective period of the declaration. We included the statutory provision for clarity.

Section XIV, Countermeasures Injury Compensation Program

Section 319F-4 of the PREP Act authorizes the Countermeasures Injury Compensation Program (CICP) to provide benefits to eligible individuals who sustain a serious physical injury or die as a direct result of the administration or use of a Covered Countermeasure.^[36] Compensation under the CICP for an injury directly caused by a Covered Countermeasure is based on the requirements set forth in this declaration, the administrative rules for the Program,^[37] and the statute.^[38] To show direct causation between a Covered Countermeasure and a serious physical injury, the statute requires “compelling, reliable, valid, medical and scientific evidence.” ^[39] The administrative rules for the Program further explain the necessary requirements for eligibility under the CICP. Please note that, by statute, requirements for compensation under the CICP may not always align with the requirements for liability immunity provided under the PREP Act. We have added section XIV, “Countermeasures Injury Compensation Program” to explain the types of injury and standard of evidence needed to be considered for compensation under the CICP. We included this information to inform readers of this Program.

Section XV, Amendments

The Secretary may amend any portion of a declaration through publication in the Federal Register.^[40] This section appeared in section VIII, “Amendments.” It has been updated to reflect that the Republished Declaration amends the prior October 10, 2008, declaration.

Deleted Sections

The prior declaration included a number of “whereas” clauses as introductory to the declaration. As described above, we have incorporated “whereas” clauses that made necessary findings under the PREP Act into the text of the declaration itself. We have deleted the remaining “whereas” clauses. We do not intend this change to have legal effect.

The prior declaration contained a definitions section. These definitions have been incorporated into the relevant sections of the declaration as noted above, and modified or deleted where indicated above.

An appendix previously appeared in the declaration that listed federal government contracts for research, development, and procurement of Covered Countermeasures. We deleted this appendix to clarify that liability immunity under the provisions of the PREP Act and terms of the declaration is not limited to the contracts listed in the appendix. Coverage is available for any award or agreement that meets the description provided in section VII of the declaration. In addition, deleting the appendix relieves the Department of the need to periodically update the appendix.

We made these deletions for clarity and do not intend them to have legal effect.

Republished Declaration

Declaration, as Amended, for Public Readiness and Emergency Preparedness Act Coverage for Smallpox Countermeasures

This declaration amends and republishes the October 10, 2008, Declaration Under the Public Readiness and Emergency Preparedness Act (“PREP Act”) for smallpox countermeasures. To the extent any term of the October 10, 2008, Declaration is inconsistent with any provision of this Republished Declaration, the terms of this Republished Declaration are controlling.

I. Determination of Public Health Emergency or Credible Risk of Future Public Health Emergency

42 U.S.C. 247d-6d(b)(1)

I have determined that there is a credible risk the release of variola virus or other orthopoxvirus and the resulting disease or conditions may in the future constitute a public health emergency.

II. Factors Considered

42 U.S.C. 247d-6d(b)(6)

I have considered the desirability of encouraging the design, development, clinical testing or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, and use of the Covered Countermeasures.

III. Recommended Activities

42 U.S.C. 247d-6d(b)(1)

I recommend, under the conditions stated in this declaration, the manufacture, testing, development, distribution, administration, or use of the Covered Countermeasures.

IV. Liability Immunity

42 U.S.C. 247d-6d(a), 247d-6d(b)(1)

Liability immunity as prescribed in the PREP Act and conditions stated in this declaration is in effect for the Recommended Activities described in section III.

V. Covered Persons

42 U.S.C. 247d-6d(i)(2),(3),(4),(6),(8)(A) and (B)

Covered Persons who are afforded liability immunity under this declaration are “manufacturers,” distributors, program planners, qualified persons, and their officials, agents, and employees, as those terms are defined in the PREP Act, and the United States.

In addition, I have determined that the following additional persons are qualified persons: (a) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction, as described in section VII below, to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a declaration of an emergency; (b) Any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with section 564 of the FD&C Act; (c) any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the FD&C Act.

VI. Covered Countermeasures

42 U.S.C. 247d-6b(c)(1)(B), 42 U.S.C. 247d-6d(i)(1) and (7)

Covered Countermeasures are any vaccine, including all components and constituent materials of these vaccines, and all devices and their constituent components used in the administration of these vaccines; any antiviral; any other drug; any biologic; or any diagnostic or other device to identify, prevent or treat smallpox or orthopoxvirus or adverse events from such countermeasures.

Covered Countermeasures must be “qualified pandemic or epidemic products,” or “security countermeasures,” or drugs, biological products, or devices authorized for investigational or emergency use, as those terms are defined in the PREP Act, the FD&C Act, and the Public Health Service Act.

VII. Limitations on Distribution

42 U.S.C. 247d-6d(a)(5) and (b)(2)(E)

I have determined that liability immunity is afforded to Covered Persons only for Recommended Activities involving Covered Countermeasures that are related to:

(a) Present or future federal contracts, cooperative agreements, grants, other transactions, interagency agreements, memoranda of understanding, or other federal agreements, or activities directly conducted by the federal government;

or

(b) Activities authorized in accordance with the public health and medical response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures following a declaration of an emergency.

i. The Authority Having Jurisdiction means the public agency or its delegate that has legal responsibility and authority for responding to an incident, based on political or geographical (e.g., city, county, tribal, state, or federal boundary lines) or functional (e.g., law enforcement, public health) range or sphere of authority.

ii. A declaration of emergency means any declaration by any authorized local, regional, state, or federal official of an emergency specific to events that indicate an immediate need to administer and use the Covered Countermeasures, with the exception of a federal declaration in support of an Emergency Use Authorization under section 564 of the FD&C Act unless such declaration specifies otherwise;

I have also determined that for governmental program planners only, liability immunity is afforded only to the extent such program planners obtain Covered Countermeasures through voluntary means, such as (1) donation; (2) commercial sale; (3) deployment of Covered Countermeasures from federal stockpiles; or (4) deployment of donated, purchased, or otherwise voluntarily obtained Covered Countermeasures from State, local, or private stockpiles.

VIII. Category of Disease, Health Condition, or Threat

42 U.S.C. 247d-6d(b)(2)(A)

The category of disease, health condition, or threat for which I recommend the administration or use of the Covered Countermeasures is smallpox resulting from exposure to variola virus and the threat of disease resulting from exposure to other orthodox viruses.

IX. Administration of Covered Countermeasures

42 U.S.C. 247d-6d(a)(2)(B)

Administration of the Covered Countermeasure means physical provision of the countermeasures to recipients, or activities and decisions directly relating to public and private delivery, distribution and dispensing of the countermeasures to recipients, management and operation of countermeasure programs, or management and operation of locations for purpose of distributing and dispensing countermeasures.

X. Population

42 U.S.C. 247d-6d(a)(4), 247d-6d(b)(2)(C)

The populations of individuals include any individual who uses or is administered the Covered Countermeasures in accordance with this declaration.

Liability immunity is afforded to manufacturers and distributors without regard to whether the countermeasure is used by or administered to this population; liability immunity is afforded to program planners and qualified persons when the countermeasure is used by or administered to this population or the program planner or qualified person reasonably could have believed the recipient was in this population.

XI. Geographic Area

42 U.S.C. 247d-6d(a)(4), 247d-6d(b)(2)(D)

Liability immunity is afforded for the administration or use of a Covered Countermeasure without geographic limitation.

Liability immunity is afforded to manufacturers and distributors without regard to whether the countermeasure is used by or administered in these geographic areas; liability immunity is afforded to program planners and qualified persons when the countermeasure is used by or administered in these geographic areas, or the program planner or qualified person reasonably could have believed the recipient was in these geographic areas.

XII. Effective Time Period

42 U.S.C. 247d-6d(b)(2)(B)

Liability immunity for Covered Countermeasures obtained through means of distribution other than in accordance with the public health and medical response of the Authority Having Jurisdiction extends through December 31, 2022.

Liability immunity for Covered Countermeasures administered and used in accordance with the public health and medical response of the Authority Having Jurisdiction begins with a declaration and lasts through (1) the final day the emergency declaration is in effect or (2) December 31, 2022, whichever occurs first.

XIII. Additional Time Period of Coverage

42 U.S.C. 247d-6d(b)(3)(A), (B) and (C)

I have determined that an additional twelve (12) months of liability protection is reasonable to allow for the manufacturer(s) to arrange for disposition of the Covered Countermeasure, including return of the Covered Countermeasures to the manufacturer, and for Covered Persons to take such other actions as are appropriate to limit the administration or use of the Covered Countermeasures.

Covered Countermeasures obtained for the SNS during the effective period of this declaration for Covered Countermeasures obtained through means of distribution other than in accordance with the public health and medical response of the Authority Having Jurisdiction are covered through the date of administration or use pursuant to a distribution or release from the SNS.

XIV. Countermeasures Injury Compensation Program

42 U.S.C. 247d-6e

The PREP Act authorizes the Countermeasures Injury Compensation Program (CICP) to provide benefits to certain individuals or estates of individuals who sustain a serious physical covered injury as the direct result of the administration or use of the Covered Countermeasures and/or benefits to certain survivors of individuals who die as a direct result of the administration or use of the Covered Countermeasures. The causal connection between the countermeasure and the serious physical injury must be supported by compelling, reliable, valid, medical and scientific evidence in order for the individual to be considered for compensation. The CICP is administered by the Health Resources and Services Administration, within the Department of Health and Human Services. Information about the CICP is available at 855-266-2427 (toll-free) or http://www.hrsa.gov/​cicp/​.

XV. Amendments

42 U.S.C. 247d-6d(b)(4)

The October 10, 2008 Declaration Under the Public Readiness and Emergency Preparedness Act for smallpox countermeasures was first published on October 17, 2008. This is the first amendment to that declaration.

Any further amendments to this declaration will be published in the Federal Register.

Authority: 42 U.S.C. 247d-6d.

Dated: December 1, 2015.

Sylvia M. Burwell,

Secretary.

Footnotes

1.  73 FR 61869. Back to Citation

2.  21 U.S.C. 360bbb-3a and 360bbb-3b. Back to Citation

3.  42 U.S.C. 247d-6d(b)(1). Back to Citation

4.  42 U.S.C. 247d. Back to Citation

5.  See 42 U.S.C. 247d-6d(b)(1). Back to Citation

6.  42 U.S.C. 247d-6d(b)(6). Back to Citation

7.  42 U.S.C. 247d-6d(b)(1). Back to Citation

8.  42 U.S.C. 247d-6d(b)(1). Back to Citation

9.  42 U.S.C. 247d-6d(a)(1). Back to Citation

10.  42 U.S.C. 247d-6d (i)(2). Back to Citation

11.  42 U.S.C. 247d-6d(i). Back to Citation

12.  42 U.S.C. 247d-6d(i)(4). Back to Citation

13.  42 U.S.C. 247d-6d(i)(3). Back to Citation

14.  42 U.S.C. 247d-6d(i)(6). Back to Citation

15.  42 U.S.C. 247d-6d(i)(8). Back to Citation

16.  42 U.S.C. 247d-6d(i)(5). Back to Citation

17.  42 U.S.C. 247d-6d(i)(1). Sections 564, 564A, and 564B of the FD&C Act may be found at 21 U.S.C. 360bbb-3, 360bbb-3a, and 360bbb-3b. Back to Citation

18.  21 U.S.C. 321(g)(1), (h); 42 U.S.C. 262(i). Back to Citation

19.  42 U.S.C. 247d-6d(i)(1)(A), (i)(7). Back to Citation

20.  21 U.S.C. 321(g)(1), (h);42 U.S.C. 262(i). Back to Citation

21.  42 U.S.C. 247d-6d(i)(1)(B),(c)(1)(B). Back to Citation

22.  21 U.S.C. 301 et seq. Back to Citation

23.  42 U.S.C. 262. Back to Citation

24.  21 U.S.C. 360bbb-3, 360bbb-3a, 360bbb-3b. Back to Citation

25.  21 U.S.C. 355(i), 360j(g). Back to Citation

26.  42 U.S.C. 247d-6d(a)(5), (b)(2)(E). Back to Citation

27.  See, e.g., 42 U.S.C. 247d-7d(c)(5). Back to Citation

28.  42 U.S.C. 247d-6d(b)(2)(A). Back to Citation

29.  42 U.S.C. 247d-6d(a). Back to Citation

30.  42 U.S.C. 247d-6d(b)(2)(C). Back to Citation

31.  42 U.S.C. 247d-6d(a)(4). Back to Citation

32.  42 U.S.C. 247d-6d(b)(2)(D). Back to Citation

33.  42 U.S.C. 247d-6d(a)(4). Back to Citation

34.  42 U.S.C. 246d-6d(b)(2)(B), (b)(6). Back to Citation

35.  42 U.S.C. 247d-6d(b)(3). Back to Citation

36.  42 U.S.C. 247d-6e. Back to Citation

37.  42 CFR part 110. Back to Citation

38.  42 U.S.C. 247d-6e. Back to Citation

39.  42 U.S.C. 247d-6e(b)(4). Back to Citation

40.  42 U.S.C. 247d-6d(b)(4). Back to Citation

[FR Doc. 2015-31092 Filed 12-8-15; 8:45 am]

BILLING CODE P

PREP Act Coverage: Frequently Asked Questions for Moneybox :

1. What is the PREP Act?

The Public Readiness and Emergency Preparedness (PREP) Act authorizes the Secretary of the Department of Health and Human Services (Secretary) to issue a PREP Act declaration. The PREP Act Declaration for Smallpox, Monkeypox, and Other Orthopoxvirus Countermeasures, as amended:

• Reflects a determination by the Secretary that there is a credible risk that smallpox (variola virus), monkeypox virus, or other orthopoxviruses and the resulting disease or conditions in the future may constitute a public health emergency and that the 2022 outbreak of monkeypox cases in the United States presents a public health emergency;
• Provides liability immunity (except for willful misconduct) to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of such countermeasures;
• Authorizes additional providers to administer vaccines and therapeutics for the identified diseases, threats, and conditions during a declared emergency; and
• Provides liability immunity for claims of loss caused, arising out of, relating to, or resulting from administration or use of countermeasures to the identified diseases, threats and conditions.

A PREP Act declaration is specifically for the purpose of providing immunity from liability, and is different from, and not dependent on, other emergency declarations.

2. Does the current declaration, as amended, for PREP Act Coverage for Countermeasures against Smallpox, Monkeypox, and other Orthopoxviruses cover monkeypox countermeasures?

Yes, the 2022 declaration, as amended, for PREP Act Coverage for Countermeasures against Smallpox, Monkeypox, and other Orthopoxviruses includes liability coverage for countermeasures against smallpox (variola virus), monkeypox virus, and other orthopoxviruses.  Prior to the 2022 amendment, the January 2016 amendment to the PREP Act Declaration for Smallpox Countermeasures included liability coverage for “smallpox countermeasures against variola virus or other orthopoxviruses”.  The virus causing monkeypox is an orthopoxvirus, and therefore monkeypox countermeasures were covered under the January 16 amendment, even though the amendment did not explicitly refer to monkeypox.   

3. What providers are covered by the declaration, as amended, for PREP Act Coverage for Countermeasures against Smallpox, Monkeypox, and other Orthopoxviruses when they administer monkeypox countermeasures?

The PREP Act’s liability immunity applies to “covered persons” with respect to administration or use of a “covered countermeasure.” Qualified persons are one category of covered person. “Qualified person” is defined in the PREP Act as:

• A licensed health professional or other individual who is authorized to prescribe, administer, or dispense covered countermeasures under the law of the state in which the countermeasure was prescribed, administered, or dispensed; or 

A person within a category of persons identified as qualified in the Secretary’s declaration.  

Thus, the current PREP Act Declaration covers any provider authorized under state law, as well as additional categories of persons identified in the declaration. 

Additional qualified persons identified in the declaration include any individual acting in accordance with the authority having jurisdiction to respond to a declared emergency, such as those authorized under state emergency authorities responding to a state emergency, individuals identified under certain authorities under the Federal Food, Drug & Cosmetic (FD&C) Act, and persons.

Qualified persons include specified active and recently retired healthcare professionals and students of healthcare professions, with specified training and/or supervision specified in the declaration who administer vaccines and therapeutics against smallpox (variola virus), monkeypox virus, and other orthopoxviruses via subcutaneous, intradermal, or intramuscular injections, via dermal/percutaneous scarification, or administered orally or intranasally during a federal, state, regional, or local declared emergency.

These specified professionals and students include any dentist, advanced or intermediate emergency medical technician, licensed or certified professional midwife, nurse, advanced practice registered nurse, registered nurse, licensed practical nurse, optometrist, paramedic, pharmacist, pharmacy intern, pharmacy technician, physician, physician assistant, podiatrist, respiratory therapist, or veterinarian

Covered countermeasures may include vaccines, therapeutics, drugs or diagnostics that are used in accordance with certain authorizations provided by the Food and Drug Administration (FDA) (i.e., license, clearance, approval, emergency use authorization (EUA), or authorization for investigational use) or emergency use instructions provided by the CDC and respiratory protection devices regulated by the National Institute of Occupational Safety and Health. Active and recently retired healthcare professionals and students of healthcare professions are authorized to administer vaccines and therapeutics during a declared emergency under the conditions stated in the declaration. Other qualified persons, such as providers authorized under state law, may administer any countermeasure covered by the declaration.

For full list of covered and qualified persons please see section V of the declaration, as amended, for PREP Act Coverage for Countermeasures against Smallpox, Monkeypox, and other Orthopoxviruses.

4. What is an EUA under section 564 of the FD&C Act and what EUAs are currently in place for the monkeypox public health emergency?

Under section 564 of the FD&C Act, when the Secretary declares that an EUA is appropriate, FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by chemical, biological, radiological, and nuclear (CBRN) threat agents when certain criteria are met, including when the known and potential benefits of the authorized use outweigh the known and potential risks.

The EUA authority allows FDA to help strengthen the nation’s public health protections against CBRN threats including infectious diseases, by facilitating the availability and use of medical countermeasures needed during public health emergencies. 

On August 9th, 2022, an EUA was issued for the JYNNEOS vaccine, an FDA-licensed vaccine approved for the prevention of smallpox and monkeypox, to provide for an unapproved use of the product. Specifically, the EUA allows: (i) two doses (0.1 mL each) of JYNNEOS 4 weeks apart via the intradermal route of administration to individuals 18 years and older determined to be at high risk for monkeypox infection; and (ii) two doses (0.5 mL) of JYNNEOS 4 weeks apart via a subcutaneous route of administration to individuals younger than 18 years of age determined to be at high risk for monkeypox infection.

5. What is section 564A of the FD&C Act?

Section 564A of the FD&C Act authorizes HHS to take other emergency actions to facilitate availability and use of medical countermeasures during public health emergencies, such as issuing emergency dispensing orders, or issuing emergency use instructions.

6. What types of claims are subject to liability immunity?

The PREP Act provides liability immunity against all claims for loss caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure for which a PREP Act declaration has been issued by the Secretary. Under the PREP Act, “loss” means any type loss, including (i) death; (ii) physical, mental, or emotional injury, illness, disability, or condition; (iii) fear of physical, mental, or emotional injury, illness, disability, or condition, including any need for medical monitoring; and (iv) loss of or damage to property, including business interruption loss.

The only exception to liability immunity under the PREP Act is a claim for willful misconduct, which is defined in the PREP Act as an act or omission that is taken (i) intentionally to achieve a wrongful purpose; (ii) knowingly without legal or factual justification; and (iii) in disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit. The PREP Act specifies that criteria for willful misconduct must be construed to establish a standard for liability that is more stringent than a standard of negligence in any form or recklessness.

7. Where can countermeasure recipients file claims if they are injured?

The PREP Act authorizes the Countermeasures Injury Compensation Program (CICP) to provide benefits to certain individuals or estates of individuals who sustain a serious physical covered injury as the direct result of the administration or use of the Covered Countermeasures and/or benefits to certain survivors of individuals who die as a direct result of the administration or use of the Covered Countermeasures. The causal connection between the countermeasure and the serious physical injury must be supported by compelling, reliable, valid, medical and scientific evidence in order for the individual to be considered for compensation. The CICP is administered by the Health Resources and Services Administration, within the Department of Health and Human Services. Information about the CICP is available at 855-266-2427 (toll-free) or http://www.hrsa.gov/cicp/.