[Federal Register Volume 88, Number 107 (Monday, June 5, 2023)]
[Notices]
[Pages 36592-36602]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-11852]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-0577]


Authorization of Emergency Use of a Drug 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 an Authorization for the 
drug product GOHIBIC (vilobelimab) as requested by InflaRx GmbH's 
(InflaRx). 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), as amended on March 15, 2023, 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 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 April 4, 2023.

ADDRESSES: Submit written requests for a single copy of the EUA to the 
Office of Executive Programs, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, 6th 
Floor, 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: Johanna McLatchy, Office of Executive 
Programs, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 51, 6th Floor, Silver 
Spring, MD 20993-0002, 301-796-3200 (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 FDA's website. 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

[[Page 36593]]

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) 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, as amended on March 15, 2023, 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 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) and notice of the Secretary's amended 
determination was provided in the Federal Register on March 20, 2023 
(88 FR 16644). 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, on April 4, 2023, FDA issued an EUA to InflaRx for the drug 
product GOHIBIC (vilobelimab), 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/drugs/emergency-preparedness-drugs/emergency-use-authorizations-drugs-and-non-vaccine-biological-products.

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: May 31, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-11852 Filed 6-2-23; 8:45 am]
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