Notice2023-03373
Termination of Authorization of Emergency Use of an In Vitro Diagnostic for Detection of Enterovirus D68
Primary source
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Published
February 17, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 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.
Full Text
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<title>Federal Register, Volume 88 Issue 33 (Friday, February 17, 2023)</title>
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[Federal Register Volume 88, Number 33 (Friday, February 17, 2023)]
[Notices]
[Pages 10356-10358]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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]
BILLING CODE 4164-01-P
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