Center for Scientific Review; Notice of Closed Meeting, 16645 [2023-05631]
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lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 88, No. 53 / Monday, March 20, 2023 / Notices
receptor binding domain. Evolution of
the virus also raises similar concerns
about the continued efficacy of certain
categories of therapeutics, such as
monoclonal antibodies. The distribution
of Omicron sublineages varies at
different points in time in different
regions of the world. The large number
of mutations in the Omicron variant
sublineages and the ongoing evolution
of the virus remain a concern for
potential evasion of vaccine immunity.
In light of this, I have now amended
the February 4, 2020 determination to
recognize the fact 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
biological agent, namely the novel (new)
coronavirus (nCoV) first detected in
Wuhan City, Hubei Province, China in
2019 (2019–nCoV, or SARS–CoV–2).
(Emphasis added). If the current
conditions change such that there is no
longer a ‘‘public health emergency’’
within the meaning of section 564, the
section 564(b)(1)(C) determination
would remain in place because I have
determined that there is also a
‘‘significant potential for a public health
emergency’’ under that section. This
avoids the need to issue a new
determination under section 564 when
there is no longer a ‘‘public health
emergency,’’ but there is still a
‘‘significant potential for a public health
emergency’’ involving SARS–CoV–2.
The four previously-issued section
564 declarations that refer to the
February 4, 2020 determination have
not been terminated by the Secretary
because, among other things, the
circumstances described in section
564(b)(1) continue to exist—i.e.,
COVID–19, a disease attributable to
SARS–CoV–2, continues to present 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.
Consistent with section 564(f), the
currently-in-effect Emergency Use
Authorizations (EUAs) issued under
those section 564 declarations remain in
effect until the earlier of the termination
of relevant section 564 declarations
under section 564(b), or revocation of
the EUAs. Therefore, these EUAs
continue in effect.
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III. Declarations of the Secretary of
Health and Human Services; EUAs
Issued Under the Declarations
Based on the February 4, 2020
determination, in February and March
2020, the Secretary of HHS, pursuant to
section 564 of the FD&C Act and subject
to the terms of any authorization issued
under that section, declared that
circumstances exist justifying the
authorization of emergency use of: (1) in
vitro diagnostics for detection and/or
diagnosis of this novel coronavirus, 85
FR 7316; (2) personal respiratory
protective devices, 85 FR 13907; (3)
other medical devices including
alternative products used as medical
devices, 85 FR 17335; and (4) drugs and
biological products, 85 FR 18250.
These section 564 declarations
continue in effect. Specifically, under
section 564(b)(2)(A), a declaration made
under section 564 will not terminate
unless the Secretary determines that
‘‘the circumstances described in [section
564(b)(1)] have ceased to exist,’’ or there
is ‘‘a change in the approval status of
the [authorized] product such that the
circumstances described in subsection
(a)(2) have ceased to exist.’’ Section
564(b)(2)(A) of the FD&C Act. The first
basis for termination is not met because
the circumstances described in section
564(b)(1) have not ceased to exist; to the
contrary, as described above, I have
determined that the circumstances
described in section 564(b)(1)(C)
continue to exist. The second basis for
termination is not met because each
declaration covers many products, or
emergency uses of products, at least
some of which remain ‘‘unapproved’’
within the meaning of section 564(a)(2).
Consistent with section 564(f), the
EUAs issued under these declarations
remain in effect until the earlier of the
termination of relevant section 564
declarations or revocation of the EUAs.
Accordingly, the currently-in-effect
EUAs issued under the section 564
determination/declarations for COVID–
19 also continue in effect.
Xavier Becerra,
Secretary, Department of Health and Human
Services.
[FR Doc. 2023–05609 Filed 3–17–23; 8:45 am]
BILLING CODE 4150–37–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
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16645
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Care Quality
Across the Lifespan.
Date: March 28, 2023.
Time: 12:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Mary Kate Baker, DRPH,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 594–5117, katie.baker2@
nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: March 15, 2023.
David W. Freeman,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–05631 Filed 3–17–23; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The purpose of this
meeting is to evaluate requests for
preclinical development resources for
potential new therapeutics for the
treatment of cancer. The outcome of the
evaluation will provide information to
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[Federal Register Volume 88, Number 53 (Monday, March 20, 2023)]
[Notices]
[Page 16645]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-05631]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5
U.S.C., as amended. The grant applications and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the grant applications, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Care Quality Across the Lifespan.
Date: March 28, 2023.
Time: 12:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701
Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Mary Kate Baker, DRPH, Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD 20892, (301) 594-5117,
[email protected].
This notice is being published less than 15 days prior to the
meeting due to the timing limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance Program Nos. 93.306,
Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893,
National Institutes of Health, HHS)
Dated: March 15, 2023.
David W. Freeman,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2023-05631 Filed 3-17-23; 8:45 am]
BILLING CODE 4140-01-P
