Document ID: FDA-2022-N-2375-0003
Agency: fda
Document Type: Notice
Title: Authorization of Emergency Use of an In Vitro Diagnostic Device in Response to an Outbreak of Mpox; Availability
Posted Date: 2022-12-30T05:00Z

[Federal Register Volume 87, Number 250 (Friday, December 30, 2022)]
[Notices]
[Pages 80542-80552]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-28460]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-2375]

Authorization of Emergency Use of an In Vitro Diagnostic Device 
in Response to an Outbreak of Mpox; 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 mpox. FDA has issued an Authorization for an in vitro 
diagnostic device as requested by Roche Molecular Systems, Inc. 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 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 U.S. 
citizens living abroad, and that involves monkeypox virus. On the basis 
of such determination, the Secretary of HHS declared, on September 7, 
2022, that circumstances exist justifying the authorization of 
emergency use of in vitro diagnostics for detection and/or diagnosis of 
infection with the monkeypox virus, including in vitro diagnostics that 
detect and/or diagnose infection with non-variola Orthopoxvirus, 
pursuant to the FD&C Act, subject to 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 November 15, 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: Jennifer Ross, Office of 
Counterterrorism and Emerging Threats, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 1, Rm. 4332, 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

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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, or 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) 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 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. Notice of the Secretary's determination was provided 
in the Federal Register on August 15, 2022 (87 FR 50090). On the basis 
of such determination, the Secretary of HHS declared, on September 7, 
2022, that circumstances exist justifying the authorization of 
emergency use of in vitro diagnostics for detection and/or diagnosis of 
infection with the monkeypox virus, including in vitro diagnostics that 
detect and/or diagnose infection with non-variola Orthopoxvirus, 
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 September 13, 2022 
(87 FR 56074). On October 7, 2022, having concluded that the criteria 
for issuance of the Authorization under section 564(c) of the FD&C Act 
are met, FDA issued an EUA to Roche Molecular Systems, Inc. for the 
cobas MPXV for use on the cobas 6800/8800 Systems (cobas MPXV), subject 
to the terms of the Authorization. The 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 revision 
to 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: December 27, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-28460 Filed 12-29-22; 8:45 am]
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