Termination of Authorization of Emergency Use of an In Vitro Diagnostic for Detection of Enterovirus D68, 10356-10358 [2023-03373]
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Federal Register / Vol. 88, No. 33 / Friday, February 17, 2023 / Notices
TABLE 1—NEW DRAFT PRODUCT-SPECIFIC GUIDANCES FOR DRUG PRODUCTS
Active ingredient(s)
Afamelanotide.
Bismuth subsalicylate; Metronidazole; Tetracycline hydrochloride.
Cabotegravir; Rilpivirine.
Dexmethylphenidate hydrochloride; Serdexmethylphenidate chloride.
Dihydroergotamine mesylate.
Donepezil hydrochloride.
Fexinidazole.
Glucagon.
Golodirsen.
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Infigratinib phosphate.
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Olanzapine; Samidorphan L-malate.
Sirolimus.
Sotorasib.
Testosterone.
Triamcinolone acetonide.
Venlafaxine besylate.
Viltolarsen.
Vosoritide.
III. Drug Products for Which Revised
Draft Product-Specific Guidances Are
Available
for industry for drug products
containing the following active
ingredients:
FDA is announcing the availability of
revised draft product-specific guidances
TABLE 2—REVISED DRAFT PRODUCT-SPECIFIC GUIDANCES FOR DRUG PRODUCTS
Active ingredient(s)
Benzoyl peroxide; Clindamycin phosphate (multiple reference listed drugs).
Hydroxyurea.
Mirabegron.
Naproxen sodium.
Siponimod fumaric acid.
Sucralfate (multiple reference listed drugs).
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For a complete history of previously
published Federal Register notices
related to product-specific guidances, go
to https://www.regulations.gov and
enter Docket No. FDA–2007–D–0369.
These draft guidances are being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). These draft guidances, when
finalized, will represent the current
thinking of FDA on, among other things,
the product-specific design of BE
studies to support ANDAs. They do not
establish any rights for any person and
are not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
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V. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
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guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: February 10, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–03364 Filed 2–16–23; 8:45 am]
BILLING CODE 4164–01–P
IV. Paperwork Reduction Act of 1995
FDA tentatively concludes that these
draft guidances contain no collection of
information. Therefore, clearance by the
Office of Management and Budget under
the Paperwork Reduction Act of 1995 is
not required.
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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.
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
SUMMARY:
E:\FR\FM\17FEN1.SGM
17FEN1
Federal Register / Vol. 88, No. 33 / Friday, February 17, 2023 / Notices
lotter on DSK11XQN23PROD with NOTICES1
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 selfaddressed 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 AllHazards 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
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17:13 Feb 16, 2023
Jkt 259001
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.
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
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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10357
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
E:\FR\FM\17FEN1.SGM
17FEN1
10358
Federal Register / Vol. 88, No. 33 / Friday, February 17, 2023 / Notices
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]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request
Information Collection Request Title:
Healthy Start Evaluation and Quality
Improvement, OMB No. 0915–0338—
Revision.
AGENCY: Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
In compliance with of the
Paperwork Reduction Act of 1995,
HRSA submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period. OMB may act on
HRSA’s ICR only after the 30-day
comment period for this notice has
closed.
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SUMMARY:
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17:13 Feb 16, 2023
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Comments on this ICR should be
received no later than March 20, 2023.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under Review—Open for
Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email
Samantha Miller, the HRSA Information
Collection Clearance Officer, at
paperwork@hrsa.gov or call 301–594–
4394.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the ICR title
for reference.
Information Collection Request Title:
Healthy Start Evaluation and Quality
Improvement OMB No. 0915–0338—
Revision.
Abstract: The National Healthy Start
Program, authorized by 42 U.S.C. 254c–
8 (section 330H of the Public Health
Service Act), and funded through
HRSA, has the goal to improve health
outcomes before, during, and after
pregnancy, and reduce racial/ethnic
differences in rates of infant death and
adverse perinatal outcomes. The
program began as a demonstration
project with 15 grantees in 1991 and has
expanded since then to 101 grantees
across 35 states; Puerto Rico; and
Washington, DC. Healthy Start grantees
operate in communities with rates of
infant mortality at least 1.5 times the
U.S. national average and high rates for
other adverse perinatal outcomes. These
communities are often low-income and
located in geographically, racially,
ethnically, and linguistically diverse
areas. Healthy Start offers services
during the perinatal period (before,
during, after pregnancy) and the
program works with women, men, and
infants/children through the first 18
months after birth. The Healthy Start
program pursues four goals: (1) improve
women’s health, (2) improve family
health and wellness, (3) promote
systems change, and (4) assure impact
and effectiveness. Over the past few
years, HRSA has sought to implement a
uniform set of data elements for
monitoring and conducting an
evaluation to assess grantees’ progress
towards these program goals. Under the
current OMB approval, the data
collection instruments for the program’s
reporting requirements include three
DATES:
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participant-level screening tools: (1)
Background, (2) Prenatal, and (3)
Parenting Information.
In this proposed revision, HRSA plans
to retain the participant-level tools as
approved by OMB in 2020; however,
HRSA did introduce minor changes to
the forms. These changes included only
the following: correction of typos,
addition of response options (e.g.,
‘‘don’t know,’’ ‘‘declined to answer’’),
and clarification of instructions. The
purpose of these minor changes is to
improve the quality of the instruments
and make it easier for the respondents
to complete the forms. The improved
instructions should reduce confusion in
completing the forms. Adding
additional response options will
eliminate forced responses that do not
represent the participant’s intent and
will increase response accuracy.
A 60-day notice published in the
Federal Register, Vol. 87, No. 203, FR
64065–64066 (Friday, October 21, 2022).
There were no public comments.
Need and Proposed Use of the
Information: The purpose of the revised
data collection instruments will be to
assess grantee and participant-level
progress towards meeting Healthy Start
program performance measures. The
data will be used to conduct ongoing
performance monitoring of the program,
thus meeting program needs for
accountability, programmatic decisionmaking, and ongoing quality assurance.
Likely Respondents: For the General
Background, Prenatal, and Parenting
Information participant-level forms,
respondents include pregnant women,
women of reproductive age, and men
who are served by the Healthy Start
program.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose, or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel to be able to respond to a
collection of information; to search data
sources; to complete and review the
collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
Total Estimated Annualized Burden
Hours:
E:\FR\FM\17FEN1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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]
BILLING CODE 4164-01-P
