[Federal Register Volume 88, Number 33 (Friday, February 17, 2023)]
[Notices]
[Pages 10356-10358]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-03373]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-2044]


Termination of Authorization of Emergency Use of an In Vitro 
Diagnostic for Detection of Enterovirus D68

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
termination of the May 12, 2015, Emergency Use Authorization (EUA) 
(authorization) issued under the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) for the Centers for Disease Control and Prevention's (CDC) 
Enterovirus D68 (EV-D68) 2014 Real-time RT-PCR Assay (EV-D68 2014 rRT-
PCR) (CDC EV-D68 EUA). Issuance of the CDC EV-D68 EUA

[[Page 10357]]

was supported by former Secretary of Health and Human Services (HHS) 
Sylvia M. Burwell's February 6, 2015, declaration that circumstances 
exist justifying the authorization of emergency use of new in vitro 
diagnostics for detection of EV-D68, pursuant to the FD&C Act. On 
February 6, 2023, the Secretary of HHS terminated the February 6, 2015, 
declaration, effective February 20, 2023, an action that automatically 
terminated any EUAs issued by the FDA pursuant to the declaration, in 
this case, the CDC EV-D68 EUA.

DATES: The CDC EV-D68 EUA is terminated as of February 20, 2023.

ADDRESSES: Submit written requests for single copies of the EUA 
termination 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 EUA termination may be sent. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the EUA termination.

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. EUA Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the 
Project BioShield Act of 2004 (Pub. L. 108-276), the Pandemic and All-
Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5), 21st 
Century Cures Act of 2016 (Pub. L. 114-255), and Public Law 115-92 
(2017), allows FDA to strengthen the public health protections against 
biological, chemical, nuclear, and radiological agents and other agents 
that may cause, or are otherwise associated with, an imminently life-
threatening and specific risk to U.S. military forces. 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.
    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, United States Code, of attack with 
(i) a biological, chemical, radiological, or nuclear agent or agents; 
or (ii) an agent or agents that may cause, or are otherwise associated 
with, an imminently life-threatening and specific risk to U.S. military 
forces; (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 under 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.
    Once the Secretary of HHS has declared that circumstances exist 
justifying an authorization under section 564 of the FD&C Act, 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 CDC (to the extent feasible 
and appropriate given the applicable circumstances), FDA \1\ concludes 
that the statutory criteria for issuance of an EUA are met.
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    \1\ 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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    Under section 564(b)(2) of the FD&C Act, an EUA declaration shall 
be terminated upon the earlier of: (1) a determination by the Secretary 
of HHS that the circumstances described in the EUA declaration have 
ceased to exist or (2) a change in the approval status of the product. 
Under section 564(b)(3)(4) of the FD&C Act, HHS shall provide advance 
notice that an EUA declaration will be terminated and shall publish in 
the Federal Register the advance notice of termination. Termination of 
an EUA declaration will automatically terminate any EUAs that FDA 
issued under the declaration. Under section 564(h)(1) of the FD&C Act, 
FDA is required to publish in the Federal Register a notice of each 
EUA, and each termination or revocation of an EUA, and an explanation 
of the reasons for the action.

II. EUA Declaration and EUA for EV-D68 2014 rRT-PCR

    On February 6, 2015, Sylvia M. Burwell, former Secretary of HHS, 
determined that there is a significant potential for a public health 
emergency that has a significant potential to affect national security 
or the health and security of U.S. citizens living abroad and that 
involves EV-D68. On the basis of such determination, on February 6, 
2015, the former Secretary of HHS also declared that circumstances 
exist justifying the authorization of emergency use of new in vitro 
diagnostics for detection of EV-D68, subject to the terms of any 
authorization issued under 21 U.S.C. 360bbb-3(a) (80 FR 10685). On May 
12, 2015, and on the basis of the February 6, 2015, HHS declaration, 
FDA issued the CDC EV-D68 EUA. Notice of the issuance of the EUA was 
published in the Federal Register on July 1, 2015 (80 FR 37625).
    On September 12, 2022, CDC requested the Secretary of HHS to 
terminate the February 6, 2015, determination, and as a result, FDA to 
revoke the CDC EV-D68 EUA. The EV-D68 2014 rRT-PCR for which an EUA was 
issued is no longer produced and all test kits were destroyed. CDC's 
EV-D68 2014 rRT-PCR was never distributed.
    On February 6, 2023, pursuant to section 564 of the FD&C Act, the 
Secretary of HHS determined that there is no longer a significant 
potential for a public health emergency that has a significant 
potential to affect national security or the health and security of 
United States citizens living abroad and that involves EV-D68. Also on 
February 6, 2023, the Secretary of HHS determined that circumstances 
justifying the authorization of emergency use of new in vitro 
diagnostics for detection of EV-D68 no longer exist. Based on these 
determinations, the Secretary of HHS terminated, effective February 20, 
2023, the February 6, 2015, declaration that circumstances exist 
justifying the authorization of emergency use of new in vitro 
diagnostics for detection of EV-D68. Advance notice of the termination 
of the February 6, 2015, declaration was published in the Federal 
Register on February 10, 2023, as required under

[[Page 10358]]

section 564 of the FD&C Act (88 FR 8874). Termination of the February 
6, 2015, declaration automatically terminated the CDC EV-D68 EUA, which 
was the only EUA issued under the declaration.

III. Electronic Access

    An electronic version of this document is available on the internet 
at https://www.regulations.gov.

IV. Notice of EUA Termination

    Based on the Secretary of HHS's February 6, 2023, termination of 
the February 6, 2015, declaration that circumstances exist justifying 
the authorization of emergency use of new in vitro diagnostics for 
detection of EV-D68, FDA is issuing, under section 564(h)(1) of the 
FD&C Act, this notice of termination of the May 12, 2015, CDC EV-D68 
EUA. Section 564(h)(1) of the FD&C Act requires FDA to provide notice 
of each termination of an authorization under section 564 of the FD&C 
Act, and an explanation of the reasons therefor.

    Dated: February 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-03373 Filed 2-16-23; 8:45 am]
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