Notice2023-02872
Termination of Declaration Authorizing Emergency Use of New In Vitro Diagnostics for Detection of Enterovirus D68
Primary source
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Published
February 10, 2023
Effective
February 20, 2023
Issuing agencies
Health and Human Services Department
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 28 (Friday, February 10, 2023)</title>
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[Federal Register Volume 88, Number 28 (Friday, February 10, 2023)]
[Notices]
[Pages 8874-8875]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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]
BILLING CODE 4150-37-P
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</html>Indexed from Federal Register on February 10, 2023.
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