[Federal Register Volume 87, Number 55 (Tuesday, March 22, 2022)]
[Notices]
[Pages 16201-16212]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-06009]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0335]


Authorization of Emergency Use of a Biological Product 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 an Emergency Use Authorization (EUA) (the Authorization) 
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for use 
during the COVID-19 pandemic. FDA has issued one Authorization for a 
biological product as requested by Eli Lilly and Company (Lilly). The 
Authorization contains, among other things, conditions on the emergency 
use of the authorized product. The Authorization follows 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 Authorization, 
which includes an explanation of the reasons for issuance, is reprinted 
in this document.

DATES: The Authorization is effective as of February 11, 2022.

ADDRESSES: Submit written requests for a single copy of the EUA 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 Authorization may be sent. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the Authorization.

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 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 (among other criteria).

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 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, U.S. Code, of attack with (A) a 
biological, chemical, radiological, or nuclear agent or agents; or (B) 
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. Under section 564(h)(1) of the FD&C Act, revisions to 
an authorization shall be made available on the internet website of 
FDA. 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 in an actual or potential emergency 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),

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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) of the FD&C Act, 
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 Authorization

    The Authorization follows 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'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's declaration was 
provided in the Federal Register on April 1, 2020 (85 FR 18250). Having 
concluded that the criteria for issuance of the Authorization under 
section 564(c) of the FD&C Act are met, FDA has issued the 
authorization for the emergency use of a biological product during the 
COVID-19 pandemic. On February 11, 2022, FDA issued an EUA to Lilly for 
the biological product bebtelovimab, subject to the terms of the 
Authorization. The initial Authorization, which is included below in 
its entirety after section IV of this document (not including the 
authorized versions of the fact sheets and other written materials), 
provides an explanation of the reasons for issuance, as required by 
section 564(h)(1) of the FD&C Act. Any subsequent reissuance of the 
Authorization can be found on FDA's web page at: 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 
Authorization is 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: March 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-06009 Filed 3-21-22; 8:45 am]
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