[Federal Register Volume 88, Number 28 (Friday, February 10, 2023)]
[Notices]
[Pages 8874-8875]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-02872]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Termination of Declaration Authorizing Emergency Use of New In 
Vitro Diagnostics for Detection of Enterovirus D68

AGENCY: Office of the Secretary, Department of Health and Human 
Services.

ACTION: Notice.

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SUMMARY: The Secretary of Health and Human Services (HHS) is issuing 
this notice pursuant to section 564 of the Federal Food, Drug, and 
Cosmetic (FD&C) Act. On February 6, 2015, pursuant to section 564 of 
the FD&C Act, Sylvia M. Burwell, former Secretary of HHS, determined 
that there was a significant potential for a public health emergency 
that had a significant potential to affect national security or the 
health and security of United States citizens living abroad and that 
involved enterovirus D68 (EV-D68). Also on February 6, 2015, based on 
that determination, former Secretary Burwell declared that 
circumstances existed justifying the authorization of emergency use of 
new in vitro diagnostics for detection of EV-D68 pursuant to section 
564 of the FD&C Act, subject to the terms of any authorization issued 
under that section. As of September 2022, the Centers for Disease 
Control and Prevention's (CDC's) 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. The Secretary of HHS also 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 the declaration, 
effective February 20, 2023, that circumstances justifying the 
authorization of emergency use of new in vitro diagnostics for 
detection of EV-D68 exist.

DATES: Termination of the declaration is effective February 20, 2023.

FOR FURTHER INFORMATION CONTACT: Dawn O'Connell, Assistant Secretary 
for Preparedness and Response,

[[Page 8875]]

Administration for Strategic Preparedness and Response, Department of 
Health and Human Services, 200 Independence Avenue SW, Washington, DC 
20201, telephone (202) 205-2882 (this is not a toll-free number).

SUPPLEMENTARY INFORMATION: 

I. Background

    Under section 564 of the FD&C Act, the Commissioner of the Food and 
Drug Administration (FDA), acting under delegated authority from the 
Secretary of HHS, may issue an EUA authorizing (1) the emergency use of 
an unapproved drug, an unapproved or uncleared device, or an unlicensed 
biological product; or (2) an unapproved use of an approved drug, 
approved or cleared device, or licensed biological product. Before an 
EUA may be issued, the Secretary of HHS must declare that circumstances 
exist justifying the authorization based on one of four determinations: 
(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 (``CBRN'') agent or agents; (2) the 
identification of a material threat by the Secretary of Homeland 
Security pursuant to section 319F-2 of the Public Health Service (PHS) 
Act \1\ sufficient to affect national security or the health and 
security of United States citizens living abroad; (3) 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 United States military forces, including personnel operating 
under the authority of title 10 or title 50, 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 United States military 
forces; or (4) a determination by the Secretary 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 citizens 
living abroad, and that involves a CBRN agent or agents, or a disease 
or condition that may be attributable to such agent or agents.
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    \1\ 42 U.S.C. 247d-6b, which states: ``[t]he Homeland Security 
Secretary, in consultation with the Secretary and the heads of other 
agencies as appropriate, shall on an ongoing basis--(i) assess 
current and emerging threats of chemical, biological, radiological, 
and nuclear agents; and (ii) determine which of such agents present 
a material threat against the United States population sufficient to 
affect national security.''
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    Based on any of these four determinations, the Secretary of HHS may 
then declare that circumstances exist that justify the EUA, at which 
point FDA may issue an EUA if the criteria for issuance of an 
authorization under section 564 of the FD&C Act are met.
    A declaration justifying an authorization under section 564 of the 
FD&C Act terminates upon the earlier of: a determination by the 
Secretary of HHS, in consultation as appropriate with the Secretary of 
Homeland Security or the Secretary of Defense, that the circumstances 
justifying emergency authorization have ceased to exist; or a change in 
the approval status of the product under emergency authorization such 
that the product is no longer unapproved, unlicensed, or uncleared, or 
is no longer intended for an unapproved use.
    The Secretary must provide advance notice of any termination of a 
declaration under section 564 of the FD&C Act. The period of advance 
notice must be a period reasonably determined to provide: in the case 
of an unapproved product, a sufficient period for disposition of the 
product, including the return of such product (except such quantities 
of product as are necessary to provide for continued use consistent 
with section 564(f)(2) of the FD&C Act) to the manufacturer (in the 
case of a manufacturer that chooses to have such product returned); 
and, in the case of an unapproved use of an approved product, a 
sufficient period for the disposition of any labeling, or any 
information under section 564(e)(2)(B)(ii) of the FD&C Act, as the case 
may be, that was provided with respect to the emergency use involved. 
If an EUA for an unapproved product issued by FDA ceases to be 
effective due to the termination of the Secretary of HHS's declaration 
justifying emergency use, the Secretary of HHS shall consult with the 
manufacturer of such product with respect to the appropriate 
disposition of the product. As of September 2022, the CDC's EV-D68 2014 
rRT-PCR, which is the only EUA issued under the Secretary's 
declaration, is no longer produced and all test kits were destroyed. 
CDC's EV-D68 2014 rRT-PCR was never distributed. Therefore, a 14-day 
period of advance notice has been determined to be sufficient, as 
disposition of the only associated product is already complete.

II. Determination of a Significant Potential for a Public Health 
Emergency and Declaration That Emergency Use Is Justified by the 
Secretary of Health and Human Services

    On February 6, 2015, pursuant to section 564 of the FD&C Act, 
Sylvia M. Burwell, former Secretary of HHS, determined that there was a 
significant potential for a public health emergency that had a 
significant potential to affect national security or the health and 
security of United States citizens living abroad and that involved EV-
D68. Also on February 6, 2015, based on that determination, former 
Secretary Burwell declared that circumstances existed justifying the 
authorization of emergency use of new in vitro diagnostics for 
detection of EV-D68 pursuant to section 564 of the FD&C Act, subject to 
the terms of any authorization issued under that section.

III. Determination of the Secretary of Health and Human Services 
Terminating Declaration That Emergency Use Is Justified

    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 declaration that circumstances justifying the authorization 
of emergency use of new in vitro diagnostics for detection of EV-D68 
exist.
    This Federal Register notice serves as advance notice that this 
declaration will be terminated, effective February 20, 2023, as 
required under section 564 of the FD&C Act. Notice of termination of an 
EUA issued by FDA pursuant to this declaration will be provided by FDA 
in the Federal Register, as required under section 564 of the FD&C Act.

    Dated: February 7, 2023.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2023-02872 Filed 2-9-23; 8:45 am]
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