[Federal Register Volume 86, Number 11 (Tuesday, January 19, 2021)]
[Notices]
[Pages 5200-5219]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-01022]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-2358]


Authorizations of Emergency Use of Two Biological Products During 
the COVID-19 Pandemic; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
issuance of two Emergency Use Authorizations (EUAs) (the 
Authorizations) under the Federal Food, Drug, and Cosmetic Act (FD&C 
Act) for biological products for use during the COVID-19 pandemic. FDA 
issued one Authorization for a biological product as requested by 
Pfizer, Inc, and one Authorization for a biological product as 
requested by ModernaTX, Inc. The Authorizations contain, among other 
things, conditions on the emergency use of the authorized products. The 
Authorizations follow the February 4, 2020, determination by the 
Secretary of Health and Human Services (HHS) that there is a public 
health emergency that has a significant potential to affect national 
security or the health and security of U.S. citizens living abroad and 
that involves a novel (new) coronavirus. The virus, now named SARS-CoV-
2, causes the illness COVID-19. On the basis of such determination, the 
Secretary of HHS declared on March 27, 2020, that circumstances exist 
justifying the authorization of emergency use of drugs and biological 
products during the COVID-19 pandemic, pursuant to the FD&C Act, 
subject to the terms of any authorization issued under that section. 
The Authorizations, which include an explanation of the reasons for 
issuance, are reprinted in this document.

DATES: The Authorization for Pfizer, Inc. is effective as of December 
11, 2020; the Authorization for ModernaTX, Inc. is effective as of 
December 18, 2020.

ADDRESSES: Submit written requests for single copies of the EUAs to the 
Office of Counterterrorism and Emerging Threats, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver 
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist 
that office in processing your request or include a Fax number to which 
the Authorizations may be sent. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the Authorizations.

FOR FURTHER INFORMATION CONTACT: Michael Mair, Office of 
Counterterrorism and Emerging Threats, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 1, Rm. 4340, Silver Spring, MD 20993-
0002, 301-796-8510 (this is not a toll-free number).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) allows FDA to 
strengthen the public health protections against biological, chemical, 
nuclear, and radiological agents. Among other things, section 564 of 
the FD&C Act allows FDA to authorize the use of an unapproved medical 
product or an unapproved use of an approved medical product in certain 
situations. With this EUA authority, FDA can help ensure that medical 
countermeasures may be used in emergencies to diagnose, treat, or 
prevent serious or life-threatening diseases or conditions caused by 
biological, chemical, nuclear, or radiological agents when there are no 
adequate, approved, and available alternatives.

II. Criteria for EUA Authorization

    Section 564(b)(1) of the FD&C Act provides that, before an EUA may 
be issued, the Secretary of HHS must declare that circumstances exist 
justifying the authorization based on one of the following grounds: (1) 
A determination by the Secretary of Homeland Security that there is a 
domestic emergency, or a significant potential for a domestic 
emergency, involving a heightened risk of attack

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with a biological, chemical, radiological, or nuclear agent or agents; 
(2) a determination by the Secretary of Defense that there is a 
military emergency, or a significant potential for a military 
emergency, involving a heightened risk to U.S. military forces, 
including personnel operating under the authority of title 10 or title 
50, United States Code, of attack with (i) a biological, chemical, 
radiological, or nuclear agent or agents; or (ii) an agent or agents 
that may cause, or are otherwise associated with, an imminently life-
threatening and specific risk to U.S. military forces; \1\ (3) a 
determination by the Secretary of HHS that there is a public health 
emergency, or a significant potential for a public health emergency, 
that affects, or has a significant potential to affect, national 
security or the health and security of U.S. citizens living abroad, and 
that involves a biological, chemical, radiological, or nuclear agent or 
agents, or a disease or condition that may be attributable to such 
agent or agents; or (4) the identification of a material threat by the 
Secretary of Homeland Security pursuant to section 319F-2 of the Public 
Health Service (PHS) Act (42 U.S.C. 247d-6b) sufficient to affect 
national security or the health and security of U.S. citizens living 
abroad.
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    \1\ In the case of a determination by the Secretary of Defense, 
the Secretary of HHS shall determine within 45 calendar days of such 
determination, whether to make a declaration under section 564(b)(1) 
of the FD&C Act, and, if appropriate, shall promptly make such a 
declaration.
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    Once the Secretary of HHS has declared that circumstances exist 
justifying an authorization under section 564 of the FD&C Act, FDA may 
authorize the emergency use of a drug, device, or biological product if 
the Agency concludes that the statutory criteria are satisfied. Under 
section 564(h)(1) of the FD&C Act, FDA is required to publish in the 
Federal Register a notice of each authorization, and each termination 
or revocation of an authorization, and an explanation of the reasons 
for the action. Section 564 of the FD&C Act permits FDA to authorize 
the introduction into interstate commerce of a drug, device, or 
biological product intended for use when the Secretary of HHS has 
declared that circumstances exist justifying the authorization of 
emergency use. Products appropriate for emergency use may include 
products and uses that are not approved, cleared, or licensed under 
sections 505, 510(k), 512, or 515 of the FD&C Act (21 U.S.C. 355, 
360(k), 360b, and 360e) or section 351 of the PHS Act (42 U.S.C. 262), 
or conditionally approved under section 571 of the FD&C Act (21 U.S.C. 
360ccc). FDA may issue an EUA only if, after consultation with the HHS 
Assistant Secretary for Preparedness and Response, the Director of the 
National Institutes of Health, and the Director of the Centers for 
Disease Control and Prevention (to the extent feasible and appropriate 
given the applicable circumstances), FDA \2\ concludes: (1) That an 
agent referred to in a declaration of emergency or threat can cause a 
serious or life-threatening disease or condition; (2) that, based on 
the totality of scientific evidence available to FDA, including data 
from adequate and well-controlled clinical trials, if available, it is 
reasonable to believe that: (A) The product may be effective in 
diagnosing, treating, or preventing (i) such disease or condition; or 
(ii) a serious or life-threatening disease or condition caused by a 
product authorized under section 564, approved or cleared under the 
FD&C Act, or licensed under section 351 of the PHS Act, for diagnosing, 
treating, or preventing such a disease or condition caused by such an 
agent; and (B) the known and potential benefits of the product, when 
used to diagnose, prevent, or treat such disease or condition, outweigh 
the known and potential risks of the product, taking into consideration 
the material threat posed by the agent or agents identified in a 
declaration under section 564(b)(1)(D) of the FD&C Act, if applicable; 
(3) that there is no adequate, approved, and available alternative to 
the product for diagnosing, preventing, or treating such disease or 
condition; (4) in the case of a determination described in section 
564(b)(1)(B)(ii), that the request for emergency use is made by the 
Secretary of Defense; and (5) that such other criteria as may be 
prescribed by regulation are satisfied.
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    \2\ The Secretary of HHS has delegated the authority to issue an 
EUA under section 564 of the FD&C Act to the Commissioner of Food 
and Drugs.
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    No other criteria for issuance have been prescribed by regulation 
under section 564(c)(4) of the FD&C Act.

III. The Authorizations

    The Authorizations follow the February 4, 2020, determination by 
the Secretary of HHS that there is a public health emergency that has a 
significant potential to affect national security or the health and 
security of U.S. citizens living abroad and that involves a novel (new) 
coronavirus. The virus, now named SARS-CoV-2, causes the illness COVID-
19. Notice of the Secretary of HHS's determination was provided in the 
Federal Register on February 7, 2020 (85 FR 7316). On the basis of such 
determination, the Secretary of HHS declared on March 27, 2020, that 
circumstances exist justifying the authorization of emergency use of 
drugs and biological products during the COVID-19 pandemic, pursuant to 
section 564 of the FD&C Act, subject to the terms of any authorization 
issued under that section. Notice of the Secretary of HHS's declaration 
was provided in the Federal Register on April 1, 2020 (85 FR 18250). 
Having concluded that the criteria for issuance of the Authorizations 
under section 564(c) of the FD&C Act are met, FDA issued two 
authorizations for the emergency use of biological products during the 
COVID-19 pandemic. On December 11, 2020, FDA issued an EUA to Pfizer, 
Inc. for the Pfizer-BioNTech COVID-19 Vaccine, subject to the terms of 
the Authorization. On December 18, 2020, FDA issued an EUA to 
ModernaTX, Inc. for the Moderna COVID-19 Vaccine, subject to the terms 
of the Authorization. The Authorizations, which are included below 
after section IV. Electronic Access in their entirety (not including 
the authorized versions of the fact sheets and other written 
materials), provide an explanation of the reasons for issuance, as 
required by section 564(h)(1) of the FD&C Act. Any subsequent 
reissuances of these Authorizations can be found on FDA's web page: 
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.

IV. Electronic Access

    An electronic version of this document and the full text of the 
Authorizations are available on the internet at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.
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    Dated: January 12, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-01022 Filed 1-15-21; 8:45 am]
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