Authorization of Emergency Use of an In Vitro Diagnostic Device in Response to an Outbreak of Mpox; Availability, 23433-23444 [2023-08023]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 88, Number 73 (Monday, April 17, 2023)]
[Notices]
[Pages 23433-23444]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-08023]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-0249]


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 Cue Health, 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 March 17, 2023.

ADDRESSES: Submit written requests for single copies of an EUA to the 
Office of Policy, Center for Devices and Radiological Health, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, 
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: Kim Sapsford-Medintz, Office of 
Product Evaluation and Quality, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Rm. 3216, Silver Spring, MD 20993-0002, 301-796-0311 (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, 
radiological, or nuclear agent or 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, radiological, or nuclear agent or 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, 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).

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    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 March 17, 2023, 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 Cue Health, Inc., for the Cue Mpox 
(Monkeypox) Molecular Test, 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 
from 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: April 12, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-08023 Filed 4-14-23; 8:45 am]
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