HHS, Fourth Amendment to the Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID–19, 85 FR 79190 (Dec. 9, 2020)
Summary
This Federal Register notice of December 9, 2020 (85 FR 79190) from the Department of Health and Human Services is a Notice of Amendment and Republished Declaration: the Secretary issues the Fourth Amendment to his March 10, 2020 Declaration under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19. The amendments apply as of February 4, 2020, except as otherwise specified in Section XII. They add healthcare personnel using telehealth to order or administer Covered Countermeasures for patients in another state as Qualified Persons, and modify the training requirements for certain licensed pharmacists and pharmacy interns to administer routine childhood or COVID-19 vaccinations. They also make explicit that Section VI covers all qualified pandemic and epidemic products and add a third method of distribution.
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Full text
79190 Federal Register / Vol. 85, No. 237 / Wednesday, December 9, 2020 / Notices
and/or go to the Dockets Management it received in developing this final previously approved FDA collections of
Staff, 5630 Fishers Lane, Rm. 1061, version of the guidance. information. Therefore, clearance by the
Rockville, MD 20852, 240–402–7500. FDA received several comments on Office of Management and Budget
You may submit comments on any the guidance and revised the guidance (OMB) under the Paperwork Reduction
guidance at any time (see 21 CFR in response to these comments. The Act of 1995 (PRA) (44 U.S.C. 3501–
10.115(g)(5)). revisions include (a) adding a note in 3521) is not required for this guidance.
Submit written requests for single the section discussing the United States The previously approved collections of
copies of this guidance to the Division Adopted Name (USAN) stating that FDA information are subject to review by
of Drug Information, Center for Drug will no longer object to the use of two- OMB under the PRA. The collections of
Evaluation and Research, Food and letter USAN stems in names for information in 21 CFR part 314 have
Drug Administration, 10001 New products that do not share any been approved under OMB control
Hampshire Ave., Hillandale Building, association with the stem in question; number 0910–0001, and the collections
4th Floor, Silver Spring, MD 20993– (b) streamlining the name simulation of information in 21 CFR part 601 have
0002. Send one self-addressed adhesive study section based on the feedback been approved under OMB control
label to assist that office in processing received; (c) providing clarifications to number 0910–0338.
your requests. See the SUPPLEMENTARY the section that discusses medical
abbreviations, modifiers, and III. Electronic Access
INFORMATION section for electronic
access to the guidance document. computational methods; (d) separating Persons with access to the internet
FOR FURTHER INFORMATION CONTACT:
the content pertaining to may obtain the document at https://
Lubna Merchant, Center for Drug nonprescription proprietary names and www.fda.gov/Drugs/
Evaluation and Research, Food and issuing separate guidance to address the GuidanceCompliance
Drug Administration, 10903 New name development process for RegulatoryInformation/Guidances/
Hampshire Ave., Bldg. 22, Rm. 4418, nonprescription drugs; (e) revising the default.htm, https://www.fda.gov/
Silver Spring, MD 20993–0002, 301– misbranding discussion for greater vaccines-blood-biologics/guidance-
clarity and included information on one compliance-regulatory-information-
796–5162, or Stephen Ripley, Center for
possible study methodology that biologics/biologics-guidances, or https://
Biologics Evaluation and Research,
sponsors may consider to test proposed www.regulations.gov.
Food and Drug Administration, 10903
names for misbranding concerns; and (f)
New Hampshire Ave., Bldg. 71, Rm. Dated: December 4, 2020.
adding certain definitions and specific
7301, Silver Spring, MD 20993–0002, Lauren K. Roth,
criteria for prescreening proprietary
240–402–7911. Acting Principal Associate Commissioner for
name candidates and updating
SUPPLEMENTARY INFORMATION: definitions in the glossary and clarified Policy.
I. Background terminology where needed. FDA also [FR Doc. 2020–27058 Filed 12–8–20; 8:45 am]
revised the document throughout to BILLING CODE 4164–01–P
FDA is announcing the availability of ensure consistency in terminology,
a guidance for industry entitled ‘‘Best clarified section headings, and
Practices in Developing Proprietary reordered information for clarity where DEPARTMENT OF HEALTH AND
Names for Human Prescription Drug applicable. HUMAN SERVICES
Products.’’ This guidance describes best Elsewhere in this issue of the Federal
practices to help minimize proprietary Register, FDA is announcing the Office of the Secretary
name-related medication errors and availability of a draft guidance entitled
otherwise avoid adoption of proprietary Fourth Amendment to the Declaration
‘‘Best Practices in Developing
names that contribute to violations of Under the Public Readiness and
Proprietary Names for Human
the FD&C Act and its implementing Emergency Preparedness Act for
Nonprescription Drug Products.’’ That
regulations. This guidance also Medical Countermeasures Against
draft guidance is issued in response to
describes the framework FDA uses in COVID–19 and Republication of the
industry stakeholders’ requests to
evaluating proprietary names that Declaration
specifically address the approaches for
sponsors could use before submitting naming of human nonprescription drug
names for FDA review if they wish. ACTION: Notice of Amendment and
products. The draft guidance is being Republished Declaration.
FDA has long recognized the issued to provide greater clarity on the
importance of proprietary name considerations applicable to SUMMARY: The Secretary issues this
confusion as a potential cause of nonprescription drug products. amendment pursuant to section 319F–3
medication errors and has addressed The guidance announced in this of the Public Health Service Act to
this issue repeatedly in recent decades. notice is being issued consistent with amend his March 10, 2020 Declaration
Our focus has been to develop and FDA’s good guidance practices Under the Public Readiness and
communicate to sponsors a systematic, regulation (21 CFR 10.115). The Emergency Preparedness Act for
standardized, and transparent approach guidance represents the current thinking Medical Countermeasures Against
to proprietary name evaluation within of FDA on ‘‘Best Practices in Developing COVID–19.
the product development, review, and Proprietary Names for Human
approval process. DATES: The amendments to the
Prescription Drug Products.’’ It does not
In the Federal Register of May 29, Declaration are applicable as of
establish any rights for any person and
2014 (79 FR 30852), FDA announced the February 4, 2020, except as otherwise
is not binding on FDA or the public.
availability of a draft guidance entitled specified in Section XII.
You can use an alternative approach if
jbell on DSKJLSW7X2PROD with NOTICES
‘‘Best Practices in Developing it satisfies the requirements of the FOR FURTHER INFORMATION CONTACT:
Proprietary Names for Drugs.’’ The applicable statutes and regulations. Robert P. Kadlec, MD, MTM&H, MS,
guidance announced in this notice Assistant Secretary for Preparedness
finalizes the draft guidance issued in II. Paperwork Reduction Act of 1995 and Response, Office of the Secretary,
May 2014. The Agency has carefully While this guidance contains no Department of Health and Human
reviewed and considered the comments collection of information, it does refer to Services, 200 Independence Avenue
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Federal Register / Vol. 85, No. 237 / Wednesday, December 9, 2020 / Notices 79191
SW, Washington, DC 20201; Telephone: cause.3 On August 19, the Secretary (c) Adds an additional category of
202–205–2882. amended the Declaration to add Qualified Persons under Section V of
SUPPLEMENTARY INFORMATION: The additional categories of Qualified the Declaration and 42 U.S.C. 247d–
Public Readiness and Emergency Persons and to amend the category of 6d(i)(8)(B), i.e., healthcare personnel
Preparedness (PREP) Act, 42 U.S.C. disease, health condition, or threat for using telehealth to order or administer
247d–6d et. seq., authorizes the which he recommends the Covered Countermeasures for patients
Secretary of Health and Human Services administration or use of Covered in a state other than the state where the
(the Secretary) to issue a declaration to Countermeasures.4 healthcare personnel are permitted to
provide liability protections to certain The Secretary now further amends the practice.7
individuals and entities (Covered Declaration pursuant to section 319F–3 (d) Modifies and clarifies the training
Persons) against any claim of loss of the Public Health Service Act. This requirements for certain licensed
caused by, arising out of, relating to, or Fourth Amendment to the Declaration: pharmacists and pharmacy interns to
resulting from, the manufacture, (a) Clarifies that the Declaration must administer certain routine childhood or
distribution, administration, or use of be construed in accordance with the COVID–19 vaccinations.
certain medical countermeasures Department of Health and Human
Services (HHS) Office of the General (e) Makes explicit that Section VI
(Covered Countermeasures), except for covers all qualified pandemic and
claims involving ‘‘willful misconduct,’’ Counsel (OGC) Advisory Opinions on
the Public Readiness and Emergency epidemic products under the PREP Act.
as defined in the PREP Act. Such
declarations are subject to amendment Preparedness Act and the Declaration (f) Adds a third method of
as circumstances warrant. (Advisory Opinions).5 The Declaration distribution under Section VII of the
The PREP Act was enacted on incorporates the Advisory Opinions for Declaration and 42 U.S.C. 247d–6d(a)(5)
December 30, 2005, as Public Law 109– that purpose. that would provide liability protections
148, Division C, Section 2. It amended (b) Incorporates authorizations that for, among other things, additional
the Public Health Service (PHS) Act, the HHS Office of the Assistant private-distribution channels.
adding Section 319F–3, which Secretary for Health (OASH) has issued (g) Makes explicit in Section IX that
addresses liability immunity, and as an Authority Having Jurisdiction.6 there can be situations where not
Section 319F–4, which creates a administering a covered countermeasure
3 85 FR 35100 (June 8, 2020).
compensation program. These sections to a particular individual can fall within
4 85 FR 52136 (Aug. 24, 2020).
are codified at 42 U.S.C. 247d–6d and 5 See, e.g., Advisory Opinion on the Public
the PREP Act and this Declaration’s
42 U.S.C. 247d–6e, respectively. Section Readiness and Emergency Preparedness Act and the
liability protections.
319F–3 of the PHS Act has been March 10, 2020 Declaration under the Act, Apr. 17, (h) Makes explicit in Section XI that
amended by the Pandemic and All- 2020, as Modified on May 19, 2020, available at there are substantial federal legal and
Hazards Preparedness Reauthorization https://www.hhs.gov/guidance/sites/default/files/
hhs-guidance-documents/prep-act-advisory- policy issues, and substantial federal
Act (PAHPRA), Public Law 113–5, opinion-hhs-ogc.pdf (last visited Dec. 1, 2020); legal and policy interests, in having a
enacted on March 13, 2013, and the Advisory Opinion 20–02 on the Public Readiness unified, whole-of-nation response to the
Coronavirus Aid, Relief, and Economic and Emergency Preparedness Act and the COVID–19 pandemic among federal,
Security (CARES) Act, Public Law 116– Secretary’s Declaration under the Act, May 19,
2020, available at https://www.hhs.gov/guidance/ state, local, and private-sector entities.
136, enacted on March 27, 2020, to sites/default/files/hhs-guidance-documents/ The world is facing an unprecedented
expand Covered Countermeasures under advisory-opinion-20-02-hhs-ogc-prep-act.pdf (last pandemic. To effectively respond, there
the PREP Act. visited Dec. 1, 2020); Advisory Opinion 20–03 on must be a more consistent pathway for
On January 31, 2020, the Secretary the Public Readiness and Emergency Preparedness
Act and the Secretary’s Declaration under the Act, Covered Persons to manufacture,
declared a public health emergency Oct. 22, 2020, as Modified on Oct. 23, 2020, distribute, administer or use Covered
pursuant to section 319 of the PHS Act, available at https://www.hhs.gov/guidance/sites/ Countermeasures across the nation and
42 U.S.C. 247d, effective January 27, default/files/hhs-guidance-documents/AO3.1.2_ the world.
2020, for the entire United States to aid Updated_FINAL_SIGNED_10.23.20.pdf (last visited
Dec. 1, 2020); Advisory Opinion 20–04 on the
in the response to the Coronavirus Public Readiness and Emergency Preparedness Act immunity.pdf (last visited Dec. 1, 2020); Guidance
Disease 2019 (COVID–19) outbreak, and the Secretary’s Declaration under the Act, Oct. for PREP Act Coverage for Qualified Pharmacy
which subsequently became a global 22, 2020, as Modified on Oct. 23, 2020, available Technicians and State-Authorized Pharmacy
pandemic. Pursuant to section 319 of at https://www.hhs.gov/guidance/sites/default/files/ Interns for Childhood Vaccines, COVID–19
hhs-guidance-documents/AO%204.2_Updated_ Vaccines, and COVID–19 Testing, OASH, Oct. 20,
the PHS Act, the Secretary renewed that FINAL_SIGNED_10.23.20.pdf (last visited Dec. 1, 2020, available at https://www.hhs.gov/sites/
declaration on April 21, 2020, July 23, 2020). default/files/prep-act-guidance.pdf (last visited
2020, and October 2, 2020. On March 6 See, e.g., Guidance for Licensed Pharmacists, Dec. 1, 2020); PREP Act Authorization for
10, 2020, the Secretary issued a COVID–19 Testing, and Immunity Under the PREP Pharmacies Distributing and Administering Certain
Act, OASH, Apr. 8, 2020, available at https:// Covered Countermeasures, Oct. 29, 2020, available
declaration under the PREP Act for www.hhs.gov/guidance/sites/default/files/hhs- at https://www.hhs.gov/guidance/sites/default/files/
medical countermeasures against guidance-documents//authorizing-licensed- hhs-guidance-documents//prep-act-authorization-
COVID–19.1 On April 10, the Secretary pharmacists-to-order-and-administer-covid-19- pharmacies-administering-covered-
amended the Declaration to extend tests.pdf (last visited Dec. 1, 2020); Guidance for countermeasures.pdf (last visited Dec. 1, 2020)
PREP Act Coverage for COVID–19 Screening Tests (collectively, OASH PREP Act Authorizations).
liability protections to Covered at Nursing Homes, Assisted-Living Facilities, Long- 7 ‘‘Telehealth, telemedicine, and related terms
Countermeasures authorized under the Term-Care Facilities, and other Congregate generally refer to the exchange of medical
CARES Act.2 On June 4, the Secretary Facilities, OASH, Aug. 31, 2020, available at information from one site to another through
amended the Declaration to clarify that https://www.hhs.gov/guidance/sites/default/files/ electronic communication to improve a patient’s
hhs-guidance-documents//prep-act-coverage-for- health.’’ Medicare Telemedicine Health Care
Covered Countermeasures under the
jbell on DSKJLSW7X2PROD with NOTICES
screening-in-congregate-settings.pdf (last visited Provider Fact Sheet, Mar. 17, 2020, available at
Declaration include qualified pandemic Dec. 1, 2020); Guidance for Licensed Pharmacists https://www.cms.gov/newsroom/fact-sheets/
and epidemic products that limit the and Pharmacy Interns Regarding COVID–19 medicare-telemedicine-health-care-provider-fact-
harm that COVID–19 might otherwise Vaccines and Immunity under the PREP Act, sheet (last visited on Dec. 2, 2020). For the
OASH, Sept. 3, 2020, available at https:// Declaration and the Fourth Amendment, the term
www.hhs.gov/guidance/sites/default/files/hhs- ‘‘telehealth’’ includes telehealth, telemedicine, and
1 85 FR 15198 (Mar. 17, 2020).
guidance-documents//licensed-pharmacists-and- related terms as described by the Centers for
2 85 FR 21012 (Apr. 15, 2020). pharmacy-interns-regarding-covid-19-vaccines- Medicare & Medicaid (CMS).
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79192 Federal Register / Vol. 85, No. 237 / Wednesday, December 9, 2020 / Notices
(i) Revises the effective time period of during this pandemic. According to the Telehealth, telemedicine, and related terms
the Declaration in light of the Centers for Disease Control and generally refer to the exchange of medical
amendments to the Declaration.8 Prevention (CDC), information from one site to another through
The Secretary republishes the electronic communication to improve a
Telehealth services can facilitate public patient’s health. Innovative uses of this kind
Declaration, as amended, in full. Unless health mitigation strategies during this of technology in the provision of healthcare
otherwise noted, all statutory citations pandemic by increasing social distancing. is increasing. And with the emergence of the
are to the U.S. Code. These services can be a safer option for virus causing the disease COVID–19, there is
[healthcare personnel (HCP)] and patients by an urgency to expand the use of technology
Description of This Amendment
reducing potential infectious exposures. to help people who need routine care, and
Declaration They can reduce the strain on healthcare keep vulnerable beneficiaries and
systems by minimizing the surge of patient beneficiaries with mild symptoms in their
The Declaration has fifteen sections demand on facilities and reduce the use of homes while maintaining access to the care
describing PREP Act coverage for [personal protective equipment (PPE)] by they need. Limiting community spread of the
medical countermeasures against healthcare providers. virus, as well as limiting the exposure to
COVID–19. OGC has issued Advisory Maintaining continuity of care to the extent other patients and staff members will slow
Opinions interpreting the PREP Act and possible can avoid additional negative viral spread.11
reflecting the Secretary’s interpretation consequences from delayed preventive, Accordingly, CMS and other HHS
of the Declaration.9 The Secretary now chronic, or routine care. Remote access to components has substantially expanded
amends the Declaration to clarify that healthcare services may increase
participation for those who are medically or
the scope of services paid under
the Declaration must be construed in Medicare when furnished using
socially vulnerable or who do not have ready
accordance with the Advisory Opinions. access to providers. Remote access can also telehealth technologies during this
The Secretary expressly incorporates the help preserve the patient-provider pandemic.
Advisory Opinions for that purpose. relationship at times when an in-person visit Other HHS components have also
Section V. Covered Persons is not practical or feasible. Telehealth taken steps to expand the use of
services can be used to: telehealth during the pandemic.12
Section V of the Declaration describes • Screen patients who may have symptoms Moreover, to expand the use of
Covered Persons, including additional of COVID–19 and refer as appropriate telehealth during this pandemic, the
qualified persons identified by the • Provide low-risk urgent care for non- Office for Civil Rights (OCR) at HHS is
Secretary, as required under the PREP COVID–19 conditions, identify those persons exercising enforcement discretion and
Act. The Secretary amends Section V to who may need additional medical
consultation or assessment, and refer as
will not impose penalties for
specify an additional category of noncompliance with the regulatory
qualified persons. Specifically, appropriate
• Access primary care providers and requirements under the Health
healthcare personnel who are permitted specialists, including mental and behavioral Insurance Portability and
to order and administer a Covered health, for chronic health conditions and Accountability Act (HIPAA) Rules
Countermeasure through telehealth in a medication management against covered healthcare providers
state may do so for patients in another • Provide coaching and support for that serve patients through everyday
state so long as the healthcare personnel patients managing chronic health conditions, communications technologies during
comply with the legal requirements of including weight management and nutrition the COVID–19 nationwide public health
the state in which the healthcare counseling
• Participate in physical therapy,
emergency.13 This exercise of discretion
personnel are permitted to order and
administer the Covered Countermeasure occupational therapy, and other modalities as
11 Medicare Telemedicine Health Care Provider
by means of telehealth. a hybrid approach to in-person care for
Fact Sheet, Mar. 17, 2020, available at https://
Telehealth is widely recognized as a optimal health www.cms.gov/newsroom/fact-sheets/medicare-
• Monitor clinical signs of certain chronic telemedicine-health-care-provider-fact-sheet (last
valuable tool to promote public health medical conditions (e.g., blood pressure, visited Dec. 1, 2020).
blood glucose, other remote assessments) 12 See, e.g., Trump Administration Drives
• Engage in case management for patients
8 In addition, the Fourth Amendment makes
Telehealth Services in Medicaid and Medicare,
certain non-substantive changes. Those should not
be interpreted to change any substantive provisions.
who have difficulty accessing care (e.g., those CMS, Oct. 14, 2020, available at https://
9 See, e.g., Advisory Opinion on the Public who live in very rural settings, older adults, www.cms.gov/newsroom/press-releases/trump-
those with limited mobility) administration-drives-telehealth-services-medicaid-
Readiness and Emergency Preparedness Act and the and-medicare (last visited Dec. 1, 2020); Secretary
March 10, 2020 Declaration under the Act, Apr. 17, • Follow up with patients after
Azar Announces Historic Expansion of Telehealth
2020, as Modified on May 19, 2020, available at hospitalization Access to Combat COVID–19, Mar. 17, 2020,
https://www.hhs.gov/guidance/sites/default/files/ • Deliver advance care planning and available at https://www.hhs.gov/about/news/2020/
hhs-guidance-documents/prep-act-advisory- counseling to patients and caregivers to 03/17/secretary-azar-announces-historic-
opinion-hhs-ogc.pdf (last visited Dec. 1, 2020);
document preferences if a life-threatening expansion-of-telehealth-access-to-combat-covid-
Advisory Opinion 20–02 on the Public Readiness
and Emergency Preparedness Act and the event or medical crisis occurs 19.html (last visited Nov. 30, 2020); OIG Policy
Secretary’s Declaration under the Act, May 19, • Provide non-emergent care to residents Statement Regarding Physicians and Other
2020, available at https://www.hhs.gov/guidance/ in long-term care facilities Practitioners That Reduce or Waive Amounts Owed
sites/default/files/hhs-guidance-documents/ • Provide education and training for HCP by Federal Health Care Program Beneficiaries for
advisory-opinion-20-02-hhs-ogc-prep-act.pdf (last Telehealth Services During the 2019 Novel
through peer-to-peer professional medical Coronavirus (COVID–19) Outbreak, Mar. 17, 2020,
visited Dec. 1, 2020); Advisory Opinion 20–03 on consultations (inpatient or outpatient) that
the Public Readiness and Emergency Preparedness available at https://oig.hhs.gov/fraud/docs/
are not locally available, particularly in rural alertsandbulletins/2020/policy-telehealth-2020.pdf
Act and the Secretary’s Declaration under the Act,
Oct. 22, 2020, as Modified on Oct. 23, 2020, areas.10 (last visited Nov. 30, 2020).
13 OCR Announces Notification of Enforcement
available at https://www.hhs.gov/guidance/sites/
default/files/hhs-guidance-documents/AO3.1.2_ Similarly, CMS has stressed the Discretion for Telehealth Remote Communications
Updated_FINAL_SIGNED_10.23.20.pdf (last visited importance of telehealth during this During the COVID–19 Nationwide Public Health
jbell on DSKJLSW7X2PROD with NOTICES
Dec. 1, 2020); Advisory Opinion 20–04 on the pandemic: Emergency, Mar. 17, 2020, available at https://
Public Readiness and Emergency Preparedness Act www.hhs.gov/about/news/2020/03/17/ocr-
and the Secretary’s Declaration under the Act, Oct. announces-notification-of-enforcement-discretion-
22, 2020, as Modified on Oct. 23, 2020, available 10 Using Telehealth to Expand Access to Essential for-telehealth-remote-communications-during-the-
at https://www.hhs.gov/guidance/sites/default/files/ Health Services during the COVID–19 Pandemic, covid-19.html (last visited Dec. 1, 2020). The PREP
hhs-guidance-documents/AO%204.2_Updated_ CDC, updated June 10, 2020, available at https:// Act does not provide immunity against federal
FINAL_SIGNED_10.23.20.pdf (last visited Dec. 1, www.cdc.gov/coronavirus/2019-ncov/hcp/ enforcement actions brought by the federal
2020). telehealth.html (last visited Dec. 1, 2020). government. We refer to this exercise of
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Federal Register / Vol. 85, No. 237 / Wednesday, December 9, 2020 / Notices 79193
applies to widely available U.S.C. 247d–6d(i)(8)(B) includes examples are not an exclusive or
communications apps, such as healthcare personnel using telehealth to exhaustive list of persons who are
FaceTime or Skype, when used in good order or administer Covered qualified persons identified by the
faith for any telehealth treatment or Countermeasures for patients in a state Secretary in Section V.
diagnostic purpose, regardless of other than the state where the The Secretary also amends Section V
whether the telehealth service is healthcare personnel are permitted to to make explicit that the requirement in
directly related to COVID–19.14 practice. When ordering and that section for certain qualified persons
Many states have authorized out-of- administering Covered Countermeasures to have a current certificate in basic
state healthcare personnel to deliver through telehealth to patients in a state
cardiopulmonary resuscitation is
telehealth services to in-state patients, where the healthcare personnel are not
either generally or in the context of satisfied by, among other things, a
already permitted to do so, the
COVID–19.15 certification in basic cardiopulmonary
healthcare personnel must comply with
To help maximize the utility of resuscitation by an online program that
all requirements for ordering and
telehealth, the Secretary declares that has received accreditation from the
administering Covered Countermeasures
the term ‘‘qualified person’’ under 42 to patients through telehealth in the American Nurses Credentialing Center,
state where the healthcare personnel are the Accreditation Council for Pharmacy
enforcement discretion as another example of the licensed or otherwise permitted to Education (ACPE), or the Accreditation
Department’s desire to support the expanded use of
practice. Any state law that prohibits or Council for Continuing Medical
telehealth during this pandemic. Education.
14 Id. effectively prohibits such a qualified
15 See, e.g., 2020 Alaska Laws Ch. 10 (S.B. 241) person from ordering and administering The Secretary also amends Section
Sec. 7 (healthcare provider can perform telehealth Covered Countermeasures through V’s training requirements for licensed
if, among other things, ‘‘the health care provider is telehealth is preempted.16 Nothing in pharmacists to order and administer
licensed, permitted, or certified to provide
healthcare services in another jurisdiction and is in
this Declaration shall preempt state laws certain childhood or COVID–19
good standing in the jurisdiction that issued the that permit additional persons to deliver vaccines. To order and administer
license, permit, or certification’’); CT Exec. Order telehealth services. vaccines, the licensed pharmacist must
No. 7G, Sec. 5(b), Mar. 19, 2020, available at https:// The Secretary also amends Section V have completed the immunization
portal.ct.gov/-/media/Office-of-the-Governor/
Executive-Orders/Lamont-Executive-Orders/
to include several examples of Covered training that the licensing State requires
Executive-Order-No-7G.pdf (last visited Dec. 1, Persons who are Qualified Persons, in order for pharmacists to administer
2020) (‘‘Subsection (a)(12)’s requirements for the because they are authorized in vaccines. If the State does not specify
licensure, certification or registration of telehealth accordance with the public health and
providers shall be suspended for such telehealth
training requirements for the licensed
providers that are Medicaid enrolled providers or
medical emergency response of the pharmacist to order and administer
in-network providers for commercial fully insured Authority Having Jurisdiction to vaccines, the licensed pharmacist must
health insurance providing telehealth services to prescribe, administer, deliver, distribute complete a vaccination training program
patients’’); Fl. Emerg. Order, DOH No. 20–002, In or dispense the Covered
Re: Suspension of Statutes, Rules, and Orders,
of at least 20 hours that is approved by
Made Necessary by COVID–19, Mar. 16, 2020,
Countermeasures. Those examples the Accreditation Council for Pharmacy
available at http://www.flhealthsource.gov/pdf/ include certain pharmacists, pharmacy Education (ACPE) to order and
emergencyorder-20-002.pdf?inf_contact_ interns, and pharmacy technicians who administer vaccines. This training
key=c1be7c474d297aa416752a23d269 order or administer certain COVID–19
4901680f8914173f9191b1c0223e68310bb1 (last program must include hands-on
visited Dec. 1, 2020) (‘‘For purposes of preparing
tests and certain vaccines.17 These injection technique, clinical evaluation
for, responding to, and mitigating any effect of of indications and contraindications of
16 Advisory Opinion 20–02 on the Public
COVID–19, health care professionals not licensed in
this state may provide health care services to a Readiness and Emergency Preparedness Act and the vaccines, and the recognition and
patient licensed in this state using telehealth, Secretary’s Declaration under the Act, May 19, treatment of emergency reactions to
notwithstanding the requirements of section 2020, available at https://www.hhs.gov/guidance/ vaccines.
456.47(4)(a) through (c), (h), and (i), Florida Statutes sites/default/files/hhs-guidance-documents/
. . . . This exemption shall apply only to the advisory-opinion-20-02-hhs-ogc-prep-act.pdf (last Other than the basic cardiopulmonary
following out of state health care professionals visited Dec. 1, 2020). resuscitation requirement and the
holding a valid, clear, and unrestricted license in 17 See, e.g., Guidance for Licensed Pharmacists,
practical training program requirement,
another state or territory in the United States who COVID–19 Testing, and Immunity Under the PREP
are not currently under investigation or prosecution Act, OASH, Apr. 8, 2020, available at https://
this Amendment does not change the
in any disciplinary proceeding in any of the states www.hhs.gov/guidance/sites/default/files/hhs- requirements for a pharmacist,
in which they hold a license: physicians, guidance-documents//authorizing-licensed- pharmacy intern, or pharmacy
osteopathic physicians, physician assistants, and pharmacists-to-order-and-administer-covid-19- technician to be a ‘‘qualified person’’
advanced practice registered nurses.’’); IA Emer. tests.pdf (last visited Dec. 1, 2020); Guidance for
Dec., Sec. 39 (Nov. 10, 2020), available at https:// PREP Act Coverage for COVID–19 Screening Tests under 42 U.S.C. 247d–6d(i)(8)(B) who
governor.iowa.gov/sites/default/files/documents/ at Nursing Homes, Assisted-Living Facilities, Long- can order or administer childhood or
Public%20Health%20Proclamation%20- Term-Care Facilities, and other Congregate COVID–19 vaccines pursuant to the
%202020.11.10.pdf (last visited Dec. 1, 2020) Facilities, OASH, Aug. 31, 2020, available at Declaration.
(temporarily suspending any statute or rule defining https://www.hhs.gov/guidance/sites/default/files/
a doctor or medical staff as ‘‘requiring all doctors hhs-guidance-documents//prep-act-coverage-for- Section VI. Covered Countermeasures
and medical staff be licensed to practice in this screening-in-congregate-settings.pdf (last visited
state, to the extent that individual is licensed to Dec. 1, 2020); Guidance for Licensed Pharmacists
practice in another state’’); NH Emer. Order # 15 and Pharmacy Interns Regarding COVID–19
The Secretary amends Section VI to
Pursuant to Exec. Order 2020–4, Sec. 1, Mar. 23, Vaccines and Immunity under the PREP Act, make explicit that Section VI covers all
2020, available at https://www.governor.nh.gov/ OASH, Sept. 3, 2020, available at https:// qualified pandemic and epidemic
sites/g/files/ehbemt336/files/documents/ www.hhs.gov/guidance/sites/default/files/hhs- products under the PREP Act.
emergency-order-15.pdf (last visited Dec. 1, 2020) guidance-documents//licensed-pharmacists-and-
jbell on DSKJLSW7X2PROD with NOTICES
(‘‘any out-of-state medical provider whose pharmacy-interns-regarding-covid-19-vaccines-
profession is licensed within this State shall be immunity.pdf (last visited Dec. 1, 2020); Guidance Dec. 1, 2020); PREP Act Authorization for
allowed to perform any medically necessary service for PREP Act Coverage for Qualified Pharmacy Pharmacies Distributing and Administering Certain
as if the medical provider were licensed to perform Technicians and State-Authorized Pharmacy Covered Countermeasures, Oct. 29, 2020, available
such service within the state of New Hampshire Interns for Childhood Vaccines, COVID–19 at https://www.hhs.gov/guidance/sites/default/files/
subject to,’’ among other things, the medical Vaccines, and COVID–19 Testing, OASH, Oct. 20, hhs-guidance-documents//prep-act-authorization-
provider being ‘‘licensed and in good standing in 2020, available at https://www.hhs.gov/sites/ pharmacies-administering-covered-
another United States jurisdiction’’). default/files/prep-act-guidance.pdf (last visited countermeasures.pdf (last visited Dec. 1, 2020).
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79194 Federal Register / Vol. 85, No. 237 / Wednesday, December 9, 2020 / Notices
Section VII. Limitations on Distribution to the FDA licensure, approval, a Covered Person for death or serious
The Secretary may specify that clearance, or authorization (or pursuant physical injury proximately caused by
liability protections are in effect only for to an Investigational New Drug willful misconduct by such Covered
Covered Countermeasures obtained Application or Investigational Device Person. In all other cases, an injured
through a particular means of Exemption), or the NIOSH approval. party’s exclusive remedy is an
This third distribution channel may administrative remedy under section
distribution. The Declaration previously
extend PREP Act coverage when there is 319F–4 of the PHS Act. Through the
stated that liability immunity is afforded
no federal agreement or authorization in PREP Act, Congress delegated to me the
to Covered Persons only for
accordance with the public health and authority to strike the appropriate
Recommended Activities related to (a)
medical response of the Authority Federal-state balance with respect to
present or future federal contracts,
Having Jurisdiction to prescribe, particular Covered Countermeasures
cooperative agreements, grants, other
administer, deliver, distribute or through PREP Act declarations.
transactions, interagency agreements, or dispense the Covered Countermeasures
memoranda of understanding or other following a declaration of an emergency. Section XII. Effective Time Period
federal agreements; or (b) activities For example, a manufacturer, The Secretary amends Section XII to
authorized in accordance with the distributor, program planner, or provide that liability protections for all
public health and medical response of qualified person engages in Covered Countermeasures administered
the Authority Having Jurisdiction to manufacturing, testing, development, and used in accordance with the public
prescribe, administer, deliver, distribution, administration, or use of a health and medical response of the
distribute, or dispense the Covered COVID–19 test pursuant to an FDA Authority Having Jurisdiction, as
Countermeasures following a Emergency Use Authorization for that identified in Section VII(b) of this
declaration of an emergency. COVID–19 test. If the Covered Person Declaration, begins with a ‘‘Declaration
COVID–19 is an unprecedented global satisfies all other requirements of the of Emergency,’’ as defined in Section VII
challenge that requires a whole-of- PREP Act and Declaration, there will be (except that, with respect to qualified
nation response that utilizes federal-, PREP Act coverage even if there is no persons who order or administer a
state-, and local- distribution channels federal agreement to cover those routine childhood vaccination that ACIP
as well as private-distribution channels. activities and those activities are not recommends to persons ages three
Given the broad scale of this pandemic, part of the authorized activity of an through 18 according to ACIP’s standard
the Secretary amends the Declaration to Authority Having Jurisdiction. immunization schedule, PREP Act
extend PREP Act coverage to additional coverage began on August 24, 2020),
private-distribution channels, as set Section IX. Administration of Covered
Countermeasures and lasts through (a) the final day the
forth below. Declaration of Emergency is in effect, or
The amended Section VII adds that The Secretary amends Section IX to (b) October 1, 2024, whichever occurs
PREP Act liability protections also make explicit that there can be first. This change is to conform the text
extend to Covered Persons for situations where not administering a of the Declaration to the Third
Recommended Activities that are covered countermeasure to a particular Amendment.18
related to any Covered Countermeasure individual can fall within the PREP Act The Secretary also amends Section XII
that is: and this Declaration’s liability to provide that liability protections for
(a) Licensed, approved, cleared, or protections. all Covered Countermeasures identified
authorized by the Food and Drug in Section VII(c) of this Declaration
Administration (FDA) (or that is Section XI. Geographic Area
begins on the date of this amended
permitted to be used under an The Secretary makes explicit in
Declaration and lasts through (a) the
Investigational New Drug Application or Section XI that there are substantial
final day the Declaration of Emergency
an Investigational Device Exemption) federal legal and policy issues, and
is in effect, or (b) October 1, 2024,
under the Federal Food, Drug, and substantial federal legal and policy
whichever occurs first. Because the
Cosmetic (FD&C) Act or Public Health interests within the meaning of Grable
Secretary is adding Section VII(c) to the
Service (PHS) Act to treat, diagnose, & Sons Metal Products, Inc. v. Darue
Declaration in this Amendment, Section
cure, prevent, mitigate or limit the harm Eng’g. & Mf’g., 545 U.S. 308 (2005), in
XII provides that Section VII(c) is
from COVID–19, or the transmission of having a unified, whole-of-nation
effective as of the date this amended
SARS–CoV–2 or a virus mutating response to the COVID–19 pandemic
Declaration is published.
therefrom; or among federal, state, local, and private-
(b) a respiratory protective device sector entities. The world is facing an Additional Amendments
approved by the National Institute for unprecedented global pandemic. To The Secretary also makes other, non-
Occupational Safety and Health effectively respond, there must be a substantive amendments.
(NIOSH) under 42 CFR part 84, or any more consistent pathway for Covered
successor regulations, that the Secretary Persons to manufacture, distribute, Declaration, as Amended, for Public
determines to be a priority for use administer or use Covered Readiness and Emergency
during a public health emergency Countermeasures across the nation and Preparedness Act Coverage for Medical
declared under section 319 of the PHS the world. Thus, there are substantial Countermeasures Against COVID–19
Act to prevent, mitigate, or limit the federal legal and policy issues, and To the extent any term previously in
harm from, COVID–19, or the substantial federal legal and policy the Declaration, including its
transmission of SARS–CoV–2 or a virus interests within the meaning of Grable amendments, is inconsistent with any
mutating therefrom. & Sons Metal Products, Inc. v. Darue provision of this Republished
jbell on DSKJLSW7X2PROD with NOTICES
To qualify for this third distribution Eng’g. & Mf’g., 545 U.S. 308 (2005), in Declaration, the terms of this
channel (but not necessarily to qualify having a uniform interpretation of the Republished Declaration are controlling.
for the other distribution channels), a PREP Act. Under the PREP Act, the sole This Declaration must be construed in
Covered Person must manufacture, test, exception to the immunity from suit and accordance with the Advisory Opinions
develop, distribute, administer, or use liability of covered persons is an
the Covered Countermeasure pursuant exclusive Federal cause of action against 18 See 85 FR 52136 (Aug. 24, 2020).
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Federal Register / Vol. 85, No. 237 / Wednesday, December 9, 2020 / Notices 79195
of the Office of the General Counsel distribution, administration, and use of (b) any person authorized to
(Advisory Opinions). I incorporate those the Covered Countermeasures. prescribe, administer, or dispense the
Advisory Opinions as part of this Covered Countermeasures or who is
IV. Liability Protections
Declaration.19 This Declaration is a otherwise authorized to perform an
‘‘requirement’’ under the PREP Act. 42 U.S.C. 247d–6d(a), 247d–6d(b)(1) activity under an Emergency Use
Liability protections as prescribed in Authorization in accordance with
I. Determination of Public Health Section 564 of the FD&C Act;
Emergency the PREP Act and conditions stated in
(c) any person authorized to prescribe,
this Declaration are in effect for the
42 U.S.C. 247d–6d(b)(1) administer, or dispense Covered
Recommended Activities described in
Countermeasures in accordance with
I have determined that the spread of Section III.
Section 564A of the FD&C Act;
SARS–CoV–2 or a virus mutating V. Covered Persons (d) a State-licensed pharmacist who
therefrom and the resulting disease orders and administers, and pharmacy
COVID–19 constitutes a public health 42 U.S.C. 247d–6d(i)(2), (3), (4), (6), interns who administer (if the pharmacy
emergency. I further determine that use (8)(A) and (B) intern acts under the supervision of
of any respiratory protective device Covered Persons who are afforded such pharmacist and the pharmacy
approved by NIOSH under 42 CFR part liability protections under this intern is licensed or registered by his or
84, or any successor regulations, is a Declaration are ‘‘manufacturers,’’ her State board of pharmacy), 21 (1)
priority for use during the public health ‘‘distributors,’’ ‘‘program planners,’’ and vaccines that the Advisory Committee
emergency that I declared on January ‘‘qualified persons,’’ as those terms are on Immunization Practices (ACIP)
31, 2020 under section 319 of the PHS defined in the PREP Act; their officials, recommends to persons ages three
Act for the entire United States to aid in agents, and employees; and the United through 18 according to ACIP’s standard
the response of the nation’s healthcare States. immunization schedule or (2) FDA-
community to the COVID–19 outbreak. In addition, I have determined that authorized or FDA-licensed COVID–19
II. Factors Considered the following additional persons are vaccines to persons ages three or older.
qualified persons: Such State-licensed pharmacists and the
42 U.S.C. 247d–6d(b)(6) (a) Any person authorized in State-licensed or registered interns
I have considered the desirability of accordance with the public health and under their supervision are qualified
encouraging the design, development, medical emergency response of the persons only if the following
clinical testing, or investigation, Authority Having Jurisdiction, as requirements are met:
manufacture, labeling, distribution, described in Section VII below, to i. The vaccine must be authorized,
formulation, packaging, marketing, prescribe, administer, deliver, distribute approved, or licensed by the FDA;
promotion, sale, purchase, donation, or dispense the Covered ii. In the case of a COVID–19 vaccine,
dispensing, prescribing, administration, Countermeasures, and their officials, the vaccination must be ordered and
licensing, and use of the Covered agents, employees, contractors and administered according to ACIP’s
Countermeasures. volunteers, following a Declaration of COVID–19 vaccine recommendation(s).
Emergency, as that term is defined in iii. In the case of a childhood vaccine,
III. Recommended Activities Section VII of this Declaration; 20 the vaccination must be ordered and
administered according to ACIP’s
42 U.S.C. 247d–6d(b)(1) 20 See, e.g., Guidance for Licensed Pharmacists, standard immunization schedule;
I recommend, under the conditions COVID–19 Testing, and Immunity Under the PREP iv. The licensed pharmacist must
stated in this Declaration, the Act, OASH, Apr. 8, 2020, available at https:// have completed the immunization
www.hhs.gov/guidance/sites/default/files/hhs-
manufacture, testing, development, guidance-documents//authorizing-licensed-
training that the licensing State requires
pharmacists-to-order-and-administer-covid-19- in order for pharmacists to order and
19 See, e.g., Advisory Opinion on the Public tests.pdf (last visited Dec. 1, 2020); Guidance for administer vaccines. If the State does
Readiness and Emergency Preparedness Act and the PREP Act Coverage for COVID–19 Screening Tests not specify training requirements for the
March 10, 2020 Declaration under the Act, Apr. 17, at Nursing Homes, Assisted-Living Facilities, Long-
2020, as Modified on May 19, 2020, available at Term-Care Facilities, and other Congregate
licensed pharmacist to order and
https://www.hhs.gov/guidance/sites/default/files/ Facilities, OASH, Aug. 31, 2020, available at administer vaccines, the licensed
hhs-guidance-documents/prep-act-advisory- https://www.hhs.gov/guidance/sites/default/files/ pharmacist must complete a vaccination
opinion-hhs-ogc.pdf (last visited Dec. 1, 2020); hhs-guidance-documents//prep-act-coverage-for- training program of at least 20 hours
Advisory Opinion 20–02 on the Public Readiness screening-in-congregate-settings.pdf (last visited
and Emergency Preparedness Act and the Dec. 1, 2020); Guidance for Licensed Pharmacists
that is approved by the Accreditation
Secretary’s Declaration under the Act, May 19, and Pharmacy Interns Regarding COVID–19
2020, available at https://www.hhs.gov/guidance/ Vaccines and Immunity under the PREP Act, the Declaration, the foregoing are the only persons
sites/default/files/hhs-guidance-documents/ OASH, Sept. 3, 2020, available at https:// authorized in accordance with the public health
advisory-opinion-20-02-hhs-ogc-prep-act.pdf (last www.hhs.gov/guidance/sites/default/files/hhs- and medical emergency response of the Authority
visited Dec. 1, 2020); Advisory Opinion 20–03 on guidance-documents//licensed-pharmacists-and- Having Jurisdiction.
the Public Readiness and Emergency Preparedness pharmacy-interns-regarding-covid-19-vaccines- 21 Some states do not require pharmacy interns to
Act and the Secretary’s Declaration under the Act, immunity.pdf (last visited Dec. 1, 2020); Guidance be licensed or registered by the state board of
Oct. 22, 2020, as Modified on Oct. 23, 2020, for PREP Act Coverage for Qualified Pharmacy pharmacy. As used herein, ‘‘State-licensed or
available at https://www.hhs.gov/guidance/sites/ Technicians and State-Authorized Pharmacy registered intern’’ (or equivalent phrases) refers to
default/files/hhs-guidance-documents/AO3.1.2_ Interns for Childhood Vaccines, COVID–19 pharmacy interns authorized by the state or board
Updated_FINAL_SIGNED_10.23.20.pdf (last visited Vaccines, and COVID–19 Testing, OASH, Oct. 20, of pharmacy in the state in which the practical
Dec. 1, 2020); Advisory Opinion 20–04 on the 2020, available at https://www.hhs.gov/sites/ pharmacy internship occurs. The authorization can,
Public Readiness and Emergency Preparedness Act default/files/prep-act-guidance.pdf (last visited but need not, take the form of a license from, or
and the Secretary’s Declaration under the Act, Oct. Dec. 1, 2020); PREP Act Authorization for registration with, the State board of pharmacy. See
jbell on DSKJLSW7X2PROD with NOTICES
22, 2020, as Modified on Oct. 23, 2020, available Pharmacies Distributing and Administering Certain Guidance for PREP Act Coverage for Qualified
at https://www.hhs.gov/guidance/sites/default/files/ Covered Countermeasures, Oct. 29, 2020, available Pharmacy Technicians and State-Authorized
hhs-guidance-documents/AO%204.2_Updated_ at https://www.hhs.gov/guidance/sites/default/files/ Pharmacy Interns for Childhood Vaccines, COVID–
FINAL_SIGNED_10.23.20.pdf (last visited Dec. 1, hhs-guidance-documents//prep-act-authorization- 19 Vaccines, and COVID–19 Testing, OASH, Oct.
2020). This is not to suggest that other PREP Act pharmacies-administering-covered- 20, 2020 at 2, available at https://www.hhs.gov/
declarations should be construed in a manner countermeasures.pdf (last visited Dec. 1, 2020) guidance/sites/default/files/hhs-guidance-
contrary to the interpretation provided in the (collectively, OASH PREP Act Authorizations). documents//prep-act-guidance.pdf (last visited Dec.
Advisory Opinions. Nothing herein shall suggest that, for purposes of 1, 2020).
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79196 Federal Register / Vol. 85, No. 237 / Wednesday, December 9, 2020 / Notices
Council for Pharmacy Education (ACPE) importance of a well-child visit with a (a) Any antiviral, any drug, any
to order and administer vaccines. Such pediatrician or other licensed primary biologic, any diagnostic, any other
a training program must include hands- care provider and refer patients as device, any respiratory protective
on injection technique, clinical appropriate. device, or any vaccine manufactured,
evaluation of indications and x. The licensed pharmacist and the used, designed, developed, modified,
contraindications of vaccines, and the licensed or registered pharmacy intern licensed, or procured:
recognition and treatment of emergency must comply with any applicable i. To diagnose, mitigate, prevent, treat,
reactions to vaccines; requirements (or conditions of use) as or cure COVID–19, or the transmission
v. The licensed or registered set forth in the Centers for Disease of SARS–CoV–2 or a virus mutating
pharmacy intern must complete a Control and Prevention (CDC) COVID– therefrom; or
practical training program that is 19 vaccination provider agreement and ii. to limit the harm that COVID–19,
approved by the ACPE. This training any other federal requirements that or the transmission of SARS–CoV–2 or
program must include hands-on apply to the administration of COVID– a virus mutating therefrom, might
injection technique, clinical evaluation 19 vaccine(s). otherwise cause;
of indications and contraindications of (e) Healthcare personnel using (b) a product manufactured, used,
vaccines, and the recognition and telehealth to order or administer designed, developed, modified,
treatment of emergency reactions to Covered Countermeasures for patients licensed, or procured to diagnose,
vaccines; in a state other than the state where the mitigate, prevent, treat, or cure a serious
vi. The licensed pharmacist and healthcare personnel are licensed or or life-threatening disease or condition
licensed or registered pharmacy intern otherwise permitted to practice. When caused by a product described in
must have a current certificate in basic ordering and administering Covered paragraph (a) above;
cardiopulmonary resuscitation; 22 Countermeasures by means of telehealth (c) a product or technology intended
vii. The licensed pharmacist must to patients in a state where the to enhance the use or effect of a product
complete a minimum of two hours of healthcare personnel are not already described in paragraph (a) or (b) above;
ACPE-approved, immunization-related permitted to practice, the healthcare or
continuing pharmacy education during personnel must comply with all (d) any device used in the
each State licensing period; requirements for ordering and administration of any such product, and
viii. The licensed pharmacist must administering Covered Countermeasures all components and constituent
comply with recordkeeping and to patients by means of telehealth in the materials of any such product.
reporting requirements of the state where the healthcare personnel are To be a Covered Countermeasure
jurisdiction in which he or she permitted to practice. Any state law that under the Declaration, a product must
administers vaccines, including prohibits or effectively prohibits such a also meet 42 U.S.C. 247d–6d(i)(1)’s
informing the patient’s primary-care qualified person from ordering and definition of ‘‘Covered
provider when available, submitting the administering Covered Countermeasures Countermeasure.’’
required immunization information to by means of telehealth is preempted.23 VII. Limitations on Distribution
the State or local immunization Nothing in this Declaration shall
information system (vaccine registry), preempt state laws that permit 42 U.S.C. 247d–6d(a)(5) and (b)(2)(E)
complying with requirements with additional persons to deliver telehealth I have determined that liability
respect to reporting adverse events, and services. protections are afforded to Covered
complying with requirements whereby Nothing in this Declaration shall be Persons only for Recommended
the person administering a vaccine must construed to affect the National Vaccine Activities involving:
review the vaccine registry or other Injury Compensation Program, (a) Covered Countermeasures that are
vaccination records prior to including an injured party’s ability to related to present or future federal
administering a vaccine; and obtain compensation under that contracts, cooperative agreements,
ix. The licensed pharmacist must program. Covered Countermeasures that grants, other transactions, interagency
inform his or her childhood-vaccination are subject to the National Vaccine agreements, memoranda of
patients and the adult caregiver Injury Compensation Program understanding, or other federal
accompanying the child of the authorized under 42 U.S.C. 300aa–10 et agreements;
seq. are covered under this Declaration (b) Covered Countermeasures that are
22 This requirement is satisfied by, among other
for the purposes of liability immunity related to activities authorized in
things, a certification in basic cardiopulmonary
resuscitation by an online program that has
and injury compensation only to the accordance with the public health and
received accreditation from the American Nurses extent that injury compensation is not medical response of the Authority
Credentialing Center, the ACPE, or the provided under that Program. All other Having Jurisdiction to prescribe,
Accreditation Council for Continuing Medical terms and conditions of the Declaration
Education. The phrase ‘‘current certificate in basic
administer, deliver, distribute or
cardiopulmonary resuscitation,’’ when used in the
apply to such Covered dispense the Covered Countermeasures
September 3, 2020 or October 20, 2020 OASH Countermeasures. following a Declaration of Emergency;
authorizations, shall be interpreted the same way. or
See Guidance for Licensed Pharmacists and VI. Covered Countermeasures
Pharmacy Interns Regarding COVID–19 Vaccines
(c) Covered Countermeasures that are:
and Immunity under the PREP Act, OASH, Sept. 3,
42 U.S.C. 247d–6b(c)(1)(B), 42 U.S.C. i. Licensed, approved, cleared, or
2020, available at https://www.hhs.gov/guidance/ 247d–6d(i)(1) and (7) authorized by the FDA (or that are
sites/default/files/hhs-guidance-documents// permitted to be used under an
licensed-pharmacists-and-pharmacy-interns-
Covered Countermeasures are:
Investigational New Drug Application or
jbell on DSKJLSW7X2PROD with NOTICES
regarding-covid-19-vaccines-immunity.pdf (last
visited Dec. 1, 2020); Guidance for PREP Act 23 See, e.g., Advisory Opinion 20–02 on the an Investigational Device Exemption)
Coverage for Qualified Pharmacy Technicians and Public Readiness and Emergency Preparedness Act under the FD&C Act or PHS Act to treat,
State-Authorized Pharmacy Interns for Childhood and the Secretary’s Declaration under the Act, May diagnose, cure, prevent, mitigate, or
Vaccines, COVID–19 Vaccines, and COVID–19 19, 2020, available at https://www.hhs.gov/
Testing, OASH, Oct. 20, 2020, available at https:// guidance/sites/default/files/hhs-guidance-
limit the harm from COVID–19, or the
www.hhs.gov/sites/default/files/prep-act- documents/advisory-opinion-20-02-hhs-ogc-prep- transmission of SARS–CoV–2 or a virus
guidance.pdf (last visited Dec. 1, 2020). act.pdf (last visited Dec. 1, 2020). mutating therefrom; or
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Federal Register / Vol. 85, No. 237 / Wednesday, December 9, 2020 / Notices 79197
ii. a respiratory protective device threats that may have been caused by Liability protections are afforded to
approved by NIOSH under 42 CFR part COVID–19, SARS–CoV–2, or a virus manufacturers and distributors without
84, or any successor regulations, that the mutating therefrom, including the regard to whether the countermeasure is
Secretary determines to be a priority for decrease in the rate of childhood used by or administered to this
use during a public health emergency immunizations, which will lead to an population; liability protections are
declared under section 319 of the PHS increase in the rate of infectious afforded to program planners and
Act to prevent, mitigate, or limit the diseases. qualified persons when the
harm from COVID–19, or the IX. Administration of Covered countermeasure is used by or
transmission of SARS–CoV–2 or a virus Countermeasures administered to this population, or the
mutating therefrom. program planner or qualified person
To qualify for this third distribution 42 U.S.C. 247d–6d(a)(2)(B) reasonably could have believed the
channel, a Covered Person must Administration of the Covered recipient was in this population.
manufacture, test, develop, distribute, Countermeasure means physical XI. Geographic Area
administer, or use the Covered provision of the countermeasures to
Countermeasure pursuant to the FDA recipients, or activities and decisions 42 U.S.C. 247d–6d(a)(4), 247d–
licensure, approval, clearance, or directly relating to public and private 6d(b)(2)(D)
authorization (or pursuant to an delivery, distribution and dispensing of Liability protections are afforded for
Investigational New Drug Application or the countermeasures to recipients, the administration or use of a Covered
Investigational Device Exemption), or management and operation of Countermeasure without geographic
the NIOSH approval. countermeasure programs, or limitation.
As used in this Declaration, the terms management and operation of locations Liability protections are afforded to
‘‘Authority Having Jurisdiction’’ and for the purpose of distributing and manufacturers and distributors without
‘‘Declaration of Emergency’’ have the dispensing countermeasures. regard to whether the Covered
following meanings: Where there are limited Covered Countermeasure is used by or
(a) The Authority Having Jurisdiction Countermeasures, not administering a administered in any designated
means the public agency or its delegate Covered Countermeasure to one geographic area; liability protections are
that has legal responsibility and individual in order to administer it to afforded to program planners and
authority for responding to an incident, another individual can constitute qualified persons when the
based on political or geographical (e.g., ‘‘relating to . . . the administration to countermeasure is used by or
city, county, tribal, state, or federal . . . an individual’’ under 42 U.S.C. administered in any designated
boundary lines) or functional (e.g., law 247d–6d. For example, consider a geographic area, or the program planner
enforcement, public health) range or situation where there is only one dose 24 or qualified person reasonably could
sphere of authority. of a COVID–19 vaccine, and a person in have believed the recipient was in that
(b) A Declaration of Emergency means a vulnerable population and a person in geographic area.
any declaration by any authorized local, a less vulnerable population both COVID–19 is a global challenge that
regional, state, or federal official of an request it from a healthcare requires a whole-of-nation response.
emergency specific to events that professional. In that situation, the There are substantial federal legal and
indicate an immediate need to healthcare professional administers the policy issues, and substantial federal
administer and use the Covered one dose to the person who is more legal and policy interests within the
Countermeasures, with the exception of vulnerable to COVID–19. In that meaning of Grable & Sons Metal
a federal declaration in support of an circumstance, the failure to administer Products, Inc. v. Darue Eng’g. & Mf’g.,
Emergency Use Authorization under the COVID–19 vaccine to the person in 545 U.S. 308 (2005), in having a unified,
Section 564 of the FD&C Act unless a less-vulnerable population ‘‘relat[es] whole-of-nation response to the COVID–
such declaration specifies otherwise. to . . . the administration to’’ the 19 pandemic among federal, state, local,
I have also determined that, for person in a vulnerable population. The and private-sector entities. The world is
governmental program planners only, person in the vulnerable population was facing an unprecedented pandemic. To
liability protections are afforded only to able to receive the vaccine only because effectively respond, there must be a
the extent such program planners obtain it was not administered to the person in more consistent pathway for Covered
Covered Countermeasures through the less-vulnerable population. Persons to manufacture, distribute,
voluntary means, such as (a) donation; Prioritization or purposeful allocation of administer or use Covered
(b) commercial sale; (c) deployment of a Covered Countermeasure, particularly Countermeasures across the nation and
Covered Countermeasures from federal if done in accordance with a public the world. Thus, there are substantial
stockpiles; or (d) deployment of health authority’s directive, can fall federal legal and policy issues, and
donated, purchased, or otherwise within the PREP Act and this substantial federal legal and policy
voluntarily obtained Covered Declaration’s liability protections. interests within the meaning of Grable
Countermeasures from state, local, or & Sons Metal Products, Inc. v. Darue
private stockpiles. X. Population
Eng’g. & Mf’g., 545 U.S. 308 (2005), in
VIII. Category of Disease, Health 42 U.S.C. 247d–6d(a)(4), 247d– having a uniform interpretation of the
Condition, or Threat 6d(b)(2)(C) PREP Act. Under the PREP Act, the sole
The populations of individuals to exception to the immunity from suit and
42 U.S.C. 247d–6d(b)(2)(A) liability of covered persons under the
whom the liability protections of this
The category of disease, health Declaration extend include any PREP Act is an exclusive Federal cause
jbell on DSKJLSW7X2PROD with NOTICES
condition, or threat for which I individual who uses or is administered of action against a covered person for
recommend the administration or use of the Covered Countermeasures in death or serious physical injury
the Covered Countermeasures is not accordance with this Declaration. proximately caused by willful
only COVID–19 caused by SARS–CoV– misconduct by such covered person. In
2, or a virus mutating therefrom, but 24 For simplicity, this example assumes a patient all other cases, an injured party’s
also other diseases, health conditions, or only requires one dose of the vaccine. exclusive remedy is an administrative
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79198 Federal Register / Vol. 85, No. 237 / Wednesday, December 9, 2020 / Notices
remedy under section 319F–4 of the manufacturer, and for Covered Persons related to countermeasures against
PHS Act. Through the PREP Act, to take such other actions as are marburgvirus and/or Marburg disease.
Congress delegated to me the authority appropriate to limit the administration DATES: The Declaration is effective as of
to strike the appropriate Federal-state or use of the Covered Countermeasures. November 25, 2020.
balance with respect to particular Covered Countermeasures obtained FOR FURTHER INFORMATION CONTACT:
Covered Countermeasures through PREP for the SNS during the effective period Robert P. Kadlec, MD, MTM&H, MS,
Act declarations.25 of this Declaration are covered through Assistant Secretary for Preparedness
XII. Effective Time Period the date of administration or use and Response, Office of the Secretary,
pursuant to a distribution or release Department of Health and Human
42 U.S.C. 247d–6d(b)(2)(B) from the SNS. Services, 200 Independence Avenue
Liability protections for any XIV. Countermeasures Injury SW, Washington, DC 20201; Telephone:
respiratory protective device approved Compensation Program 202–205–2882.
by NIOSH under 42 CFR part 84, or any SUPPLEMENTARY INFORMATION: The
successor regulations, through the 42 U.S.C 247d–6e Public Readiness and Emergency
means of distribution identified in The PREP Act authorizes the Preparedness Act (PREP Act) authorizes
Section VII(a) of this Declaration, begin Countermeasures Injury Compensation the Secretary of Health and Human
on March 27, 2020 and extend through Program (CICP) to provide benefits to Services (the Secretary) to issue a
October 1, 2024. certain individuals or estates of Declaration to provide liability
Liability protections for all other immunity to certain individuals and
individuals who sustain a covered
Covered Countermeasures identified in entities (Covered Persons) against any
serious physical injury as the direct
Section VI of this Declaration, through claim of loss caused by, arising out of,
result of the administration or use of the
means of distribution identified in relating to, or resulting from the
Section VII(a) of this Declaration, begin Covered Countermeasures, and benefits
to certain survivors of individuals who manufacture, distribution,
on February 4, 2020 and extend through administration, or use of medical
October 1, 2024. die as a direct result of the
administration or use of the Covered countermeasures (Covered
Liability protections for all Covered Countermeasures), except for claims
Countermeasures administered and Countermeasures. The causal
connection between the countermeasure involving ‘‘willful misconduct’’ as
used in accordance with the public defined in the PREP Act. This
health and medical response of the and the serious physical injury must be
supported by compelling, reliable, valid, Declaration is subject to amendment as
Authority Having Jurisdiction, as
medical and scientific evidence in order circumstances warrant.
identified in Section VII(b) of this The PREP Act was enacted on
Declaration, begin with a Declaration of for the individual to be considered for
compensation. The CICP is December 30, 2005, as Public Law 109–
Emergency as that term is defined in 148, Division C, Section 2. It amended
Section VII (except that, with respect to administered by the Health Resources
and Services Administration, within the the Public Health Service (PHS) Act,
qualified persons who order or adding Section 319F–3, which
administer a routine childhood Department of Health and Human
Services. Information about the CICP is addresses liability immunity, and
vaccination that ACIP recommends to Section 319F–4, which creates a
persons ages three through 18 according available at the toll-free number 1–855–
266–2427 or http://www.hrsa.gov/cicp/. compensation program. These sections
to ACIP’s standard immunization are codified at 42 U.S.C. 247d–6d and
schedule, liability protections began on XV. Amendments 42 U.S.C. 247d–6e, respectively.
August 24, 2020), and last through (a) The Pandemic and All-Hazards
the final day the Declaration of 42 U.S.C. 247d–6d(b)(4)
Preparedness Reauthorization Act
Emergency is in effect, or (b) October 1, Amendments to this Declaration will (PAHPRA), Public Law 113–5, was
2024, whichever occurs first. be published in the Federal Register, as enacted on March 13, 2013. Among
Liability protections for all Covered warranted. other things, PAHPRA added sections
Countermeasures identified in Section 564A and 564B to the Federal Food,
VII(c) of this Declaration begin on the Authority: 42 U.S.C. 247d–6d.
Drug, and Cosmetic (FD&C) Act to
date of this amended Declaration and Dated: December 3, 2020.
provide new authorities for the
last through (a) the final day the Alex M. Azar II,
emergency use of approved products in
Declaration of Emergency is in effect, or Secretary of Health and Human Services. emergencies and products held for
(b) October 1, 2024, whichever occurs [FR Doc. 2020–26977 Filed 12–8–20; 8:45 am] emergency use. PAHPRA accordingly
first. BILLING CODE 4150–37–P amended the definitions of ‘‘Covered
XIII. Additional Time Period of Countermeasures’’ and ‘‘qualified
Coverage pandemic and epidemic products’’ in
DEPARTMENT OF HEALTH AND Section 319F–3 of the Public Health
42 U.S.C. 247d–6d(b)(3)(B) and (C) HUMAN SERVICES Service Act (PREP Act provisions), so
I have determined that an additional that products made available under
12 months of liability protection is Office of the Secretary
these new FD&C Act authorities could
reasonable to allow for the be covered under PREP Act
Notice of Declaration Under the Public
manufacturer(s) to arrange for Declarations. PAHPRA also extended
Readiness and Emergency
disposition of the Covered the definition of qualified pandemic and
Preparedness Act for
Countermeasure, including return of the epidemic products that may be covered
Countermeasures Against
jbell on DSKJLSW7X2PROD with NOTICES
Covered Countermeasures to the under a PREP Act Declaration to include
Marburgvirus and/or Marburg Disease
products or technologies intended to
25 42 U.S.C. 247d–6d(b)(7) provides that ‘‘[n]o
SUMMARY: The Secretary is issuing this enhance the use or effect of a drug,
court of the United States, or of any State, shall
have subject matter jurisdiction to review, whether
Declaration pursuant to section 319F–3 biological product, or device used
by mandamus or otherwise, any action by the of the Public Health Service Act to against the pandemic or epidemic or
Secretary under this subsection.’’ provide limited immunity for activities against adverse events from these
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