[Federal Register Volume 85, Number 237 (Wednesday, December 9, 2020)]
[Notices]
[Pages 79190-79198]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26977]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Fourth Amendment to the Declaration Under the Public Readiness 
and Emergency Preparedness Act for Medical Countermeasures Against 
COVID-19 and Republication of the Declaration

ACTION: Notice of Amendment and Republished Declaration.

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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

[[Page 79191]]

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\
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    \1\ 85 FR 15198 (Mar. 17, 2020).
    \2\ 85 FR 21012 (Apr. 15, 2020).
    \3\ 85 FR 35100 (June 8, 2020).
    \4\ 85 FR 52136 (Aug. 24, 2020).
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    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.
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    \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).
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    (b) Incorporates authorizations that the HHS Office of the 
Assistant Secretary for Health (OASH) has issued as an Authority Having 
Jurisdiction.\6\
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    \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).
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    (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\
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    \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).
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    (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.

[[Page 79192]]

    (i) Revises the effective time period of the Declaration in light 
of the amendments to the Declaration.\8\
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    \8\ In addition, the Fourth Amendment makes certain non-
substantive changes. Those should not be interpreted to change any 
substantive provisions.
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    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.
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    \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).
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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:
    <bullet> Screen patients who may have symptoms of COVID-19 and 
refer as appropriate
    <bullet> 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
    <bullet> Access primary care providers and specialists, 
including mental and behavioral health, for chronic health 
conditions and medication management
    <bullet> Provide coaching and support for patients managing 
chronic health conditions, including weight management and nutrition 
counseling
    <bullet> Participate in physical therapy, occupational therapy, 
and other modalities as a hybrid approach to in-person care for 
optimal health
    <bullet> Monitor clinical signs of certain chronic medical 
conditions (e.g., blood pressure, blood glucose, other remote 
assessments)
    <bullet> 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)
    <bullet> Follow up with patients after hospitalization
    <bullet> Deliver advance care planning and counseling to 
patients and caregivers to document preferences if a life-
threatening event or medical crisis occurs
    <bullet> Provide non-emergent care to residents in long-term 
care facilities
    <bullet> 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\
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    \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).

    Similarly, CMS has stressed the importance of telehealth during 
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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\
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    \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).

    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\
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    \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).
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    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

[[Page 79193]]

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\
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    \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.
    \14\ Id.
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    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\
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    \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'').
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    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.
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    \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).
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    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.
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    \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).
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    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.

[[Page 79194]]

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\
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    \18\ See 85 FR 52136 (Aug. 24, 2020).
---------------------------------------------------------------------------

    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

[[Page 79195]]

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.
---------------------------------------------------------------------------

    \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.
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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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    (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:
---------------------------------------------------------------------------

    \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).
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    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

[[Page 79196]]

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\
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    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

[[Page 79197]]

    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.
---------------------------------------------------------------------------

    \24\ For simplicity, this example assumes a patient only 
requires one dose of the vaccine.
---------------------------------------------------------------------------

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

[[Page 79198]]

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\
---------------------------------------------------------------------------

    \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.''
---------------------------------------------------------------------------

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.
[FR Doc. 2020-26977 Filed 12-8-20; 8:45 am]
BILLING CODE 4150-37-P