Notice2023-11852
Authorization of Emergency Use of a Drug Product During the COVID-19 Pandemic; Availability
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 5, 2023
Effective
April 4, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 107 (Monday, June 5, 2023)</title>
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[Federal Register Volume 88, Number 107 (Monday, June 5, 2023)]
[Notices]
[Pages 36592-36602]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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: <a href="https://www.fda.gov/drugs/emergency-preparedness-drugs/emergency-use-authorizations-drugs-and-non-vaccine-biological-products">https://www.fda.gov/drugs/emergency-preparedness-drugs/emergency-use-authorizations-drugs-and-non-vaccine-biological-products</a>.
IV. Electronic Access
An electronic version of this document and the full text of the
Authorization is available on the internet at: <a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization">https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization</a>.
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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]
BILLING CODE 4164-01-C
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</html>Indexed from Federal Register on June 5, 2023.
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