Notice2022-21834
Authorization of Emergency Use of a Biological Product in Response to an Outbreak of Monkeypox; 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
October 7, 2022
Effective
August 9, 2022
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) in response to an outbreak of monkeypox. FDA has issued one Authorization for a biological product as requested by the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health. The Authorization contains, among other things, conditions on the emergency use of the authorized product. The Authorization follows the August 9, 2022, determination by the Secretary of the Department of Health and Human Services (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 United States (U.S.) citizens living abroad, and that involves monkeypox virus. On the basis of such determination, the Secretary of HHS declared, on August 9, 2022, that circumstances exist justifying the authorization of emergency use of vaccines 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 87 Issue 194 (Friday, October 7, 2022)</title>
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[Federal Register Volume 87, Number 194 (Friday, October 7, 2022)]
[Notices]
[Pages 61054-61063]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-21834]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-2389]
Authorization of Emergency Use of a Biological Product in
Response to an Outbreak of Monkeypox; 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) in response
to an outbreak of monkeypox. FDA has issued one Authorization for a
biological product as requested by the National Institute of Allergy
and Infectious Diseases (NIAID), a part of the National Institutes of
Health. The Authorization contains, among other things, conditions on
the emergency use of the authorized product. The Authorization follows
the August 9, 2022, determination by the Secretary of the Department of
Health and Human Services (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 United States (U.S.) citizens
living abroad, and that involves monkeypox virus. On the basis of such
determination, the Secretary of HHS declared, on August 9, 2022, that
circumstances exist justifying the authorization of emergency use of
vaccines 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 August 9, 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 Public Health
Service Act (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
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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
of the FD&C Act, 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)(5) of the FD&C Act.
III. The Authorization
The Authorization follows the August 9, 2022, 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
monkeypox virus. On the basis of such determination, the Secretary of
HHS declared, on August 9, 2022, that circumstances exist justifying
the authorization of emergency use of vaccines 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 determination and declaration
was provided in the Federal Register on August 15, 2022 (87 FR 50090).
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
monkeypox outbreak. On August 9, 2022, FDA issued an EUA to NIAID for
the biological product JYNNEOS, 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/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>.
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: September 30, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-21834 Filed 10-6-22; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on October 7, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.