Fourth Amendment to the Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 and Republication of the Declaration, 79190-79198 [2020-26977]
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Federal Register / Vol. 85, No. 237 / Wednesday, December 9, 2020 / Notices
and/or go to the Dockets Management
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You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
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INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
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Hampshire Ave., Bldg. 22, Rm. 4418,
Silver Spring, MD 20993–0002, 301–
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SUPPLEMENTARY INFORMATION:
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I. Background
FDA is announcing the availability of
a guidance for industry entitled ‘‘Best
Practices in Developing Proprietary
Names for Human Prescription Drug
Products.’’ This guidance describes best
practices to help minimize proprietary
name-related medication errors and
otherwise avoid adoption of proprietary
names that contribute to violations of
the FD&C Act and its implementing
regulations. This guidance also
describes the framework FDA uses in
evaluating proprietary names that
sponsors could use before submitting
names for FDA review if they wish.
FDA has long recognized the
importance of proprietary name
confusion as a potential cause of
medication errors and has addressed
this issue repeatedly in recent decades.
Our focus has been to develop and
communicate to sponsors a systematic,
standardized, and transparent approach
to proprietary name evaluation within
the product development, review, and
approval process.
In the Federal Register of May 29,
2014 (79 FR 30852), FDA announced the
availability of a draft guidance entitled
‘‘Best Practices in Developing
Proprietary Names for Drugs.’’ The
guidance announced in this notice
finalizes the draft guidance issued in
May 2014. The Agency has carefully
reviewed and considered the comments
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it received in developing this final
version of the guidance.
FDA received several comments on
the guidance and revised the guidance
in response to these comments. The
revisions include (a) adding a note in
the section discussing the United States
Adopted Name (USAN) stating that FDA
will no longer object to the use of twoletter USAN stems in names for
products that do not share any
association with the stem in question;
(b) streamlining the name simulation
study section based on the feedback
received; (c) providing clarifications to
the section that discusses medical
abbreviations, modifiers, and
computational methods; (d) separating
the content pertaining to
nonprescription proprietary names and
issuing separate guidance to address the
name development process for
nonprescription drugs; (e) revising the
misbranding discussion for greater
clarity and included information on one
possible study methodology that
sponsors may consider to test proposed
names for misbranding concerns; and (f)
adding certain definitions and specific
criteria for prescreening proprietary
name candidates and updating
definitions in the glossary and clarified
terminology where needed. FDA also
revised the document throughout to
ensure consistency in terminology,
clarified section headings, and
reordered information for clarity where
applicable.
Elsewhere in this issue of the Federal
Register, FDA is announcing the
availability of a draft guidance entitled
‘‘Best Practices in Developing
Proprietary Names for Human
Nonprescription Drug Products.’’ That
draft guidance is issued in response to
industry stakeholders’ requests to
specifically address the approaches for
naming of human nonprescription drug
products. The draft guidance is being
issued to provide greater clarity on the
considerations applicable to
nonprescription drug products.
The guidance announced in this
notice is being issued consistent with
FDA’s good guidance practices
regulation (21 CFR 10.115). The
guidance represents the current thinking
of FDA on ‘‘Best Practices in Developing
Proprietary Names for Human
Prescription Drug Products.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
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previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in 21 CFR part 314 have
been approved under OMB control
number 0910–0001, and the collections
of information in 21 CFR part 601 have
been approved under OMB control
number 0910–0338.
III. Electronic Access
Persons with access to the internet
may obtain the document at https://
www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, or https://
www.regulations.gov.
Dated: December 4, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–27058 Filed 12–8–20; 8:45 am]
BILLING CODE 4164–01–P
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
Notice of Amendment and
Republished Declaration.
ACTION:
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
SUMMARY:
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Federal Register / Vol. 85, No. 237 / Wednesday, December 9, 2020 / Notices
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 AllHazards 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
1 85
2 85
FR 15198 (Mar. 17, 2020).
FR 21012 (Apr. 15, 2020).
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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
3 85
FR 35100 (June 8, 2020).
FR 52136 (Aug. 24, 2020).
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-advisoryopinion-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).
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/hhsguidance-documents//authorizing-licensedpharmacists-to-order-and-administer-covid-19tests.pdf (last visited Dec. 1, 2020); 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
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/hhsguidance-documents//licensed-pharmacists-andpharmacy-interns-regarding-covid-19-vaccines4 85
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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
(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.
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-authorizationpharmacies-administering-coveredcountermeasures.pdf (last visited Dec. 1, 2020)
(collectively, OASH PREP Act Authorizations).
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-factsheet (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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(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.
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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
8 In addition, the Fourth Amendment makes
certain non-substantive changes. Those should not
be interpreted to change any substantive provisions.
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-advisoryopinion-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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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 nonCOVID–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:
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).
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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
11 Medicare Telemedicine Health Care Provider
Fact Sheet, Mar. 17, 2020, available at https://
www.cms.gov/newsroom/fact-sheets/medicaretelemedicine-health-care-provider-fact-sheet (last
visited Dec. 1, 2020).
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/trumpadministration-drives-telehealth-services-medicaidand-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-historicexpansion-of-telehealth-access-to-combat-covid19.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).
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/ocrannounces-notification-of-enforcement-discretionfor-telehealth-remote-communications-during-thecovid-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
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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-ofstate 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
enforcement discretion as another example of the
Department’s desire to support the expanded use of
telehealth during this pandemic.
14 Id.
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 https://www.flhealthsource.gov/pdf/
emergencyorder-20-002.pdf?inf_contact_
key=c1be7c474d297aa416752a23d269
4901680f8914173f9191b1c0223e68310bb1 (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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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
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).
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/hhsguidance-documents//authorizing-licensedpharmacists-to-order-and-administer-covid-19tests.pdf (last visited Dec. 1, 2020); 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
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/hhsguidance-documents//licensed-pharmacists-andpharmacy-interns-regarding-covid-19-vaccinesimmunity.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
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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.
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-authorizationpharmacies-administering-coveredcountermeasures.pdf (last visited Dec. 1, 2020).
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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-ofnation 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
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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 privatesector 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
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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, nonsubstantive 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
18 See
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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)
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I recommend, under the conditions
stated in this Declaration, the
manufacture, testing, development,
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-advisoryopinion-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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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/hhsguidance-documents//authorizing-licensedpharmacists-to-order-and-administer-covid-19tests.pdf (last visited Dec. 1, 2020); 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
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/hhsguidance-documents//licensed-pharmacists-andpharmacy-interns-regarding-covid-19-vaccinesimmunity.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-authorizationpharmacies-administering-coveredcountermeasures.pdf (last visited Dec. 1, 2020)
(collectively, OASH PREP Act Authorizations).
Nothing herein shall suggest that, for purposes of
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79195
(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) FDAauthorized 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
the Declaration, the foregoing are the only persons
authorized in accordance with the public health
and medical emergency response of the Authority
Having Jurisdiction.
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-guidancedocuments//prep-act-guidance.pdf (last visited Dec.
1, 2020).
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Council for Pharmacy Education (ACPE)
to order and administer vaccines. Such
a training program must include handson 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
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-internsregarding-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-actguidance.pdf (last visited Dec. 1, 2020).
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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:
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-guidancedocuments/advisory-opinion-20-02-hhs-ogc-prepact.pdf (last visited Dec. 1, 2020).
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(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
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Federal Register / Vol. 85, No. 237 / Wednesday, December 9, 2020 / Notices
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
jbell on DSKJLSW7X2PROD with NOTICES
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
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16:16 Dec 08, 2020
Jkt 253001
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.
24 For simplicity, this example assumes a patient
only requires one dose of the vaccine.
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79197
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
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Federal Register / Vol. 85, No. 237 / Wednesday, December 9, 2020 / Notices
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.
jbell on DSKJLSW7X2PROD with NOTICES
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
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.’’
VerDate Sep<11>2014
16:16 Dec 08, 2020
Jkt 253001
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 https://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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Notice of Declaration Under the Public
Readiness and Emergency
Preparedness Act for
Countermeasures Against
Marburgvirus and/or Marburg Disease
The Secretary is issuing this
Declaration pursuant to section 319F–3
of the Public Health Service Act to
provide limited immunity for activities
SUMMARY:
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
related to countermeasures against
marburgvirus and/or Marburg disease.
DATES: The Declaration is effective as of
November 25, 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. This
Declaration is 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.
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 Federal Food,
Drug, and Cosmetic (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 (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 that may be covered
under a PREP Act Declaration 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
E:\FR\FM\09DEN1.SGM
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]]>Agencies
[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.
-----------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
(b) Incorporates authorizations that the HHS Office of the
Assistant Secretary for Health (OASH) has issued as an Authority Having
Jurisdiction.\6\
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
(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\
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
(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\
---------------------------------------------------------------------------
\8\ In addition, the Fourth Amendment makes certain non-
substantive changes. Those should not be interpreted to change any
substantive provisions.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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\
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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 https://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).
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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.
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\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\
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\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.
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(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:
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\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\
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\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).
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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.
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\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).
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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.
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\24\ For simplicity, this example assumes a patient only
requires one dose of the vaccine.
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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\
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\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.''
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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 https://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
