Center for Scientific Review; Notice of Closed Meetings, 69280-69281 [2022-25164]
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Federal Register / Vol. 87, No. 222 / Friday, November 18, 2022 / Notices
Dated: November 15, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
for industry for drug products
containing the following active
ingredients:
TABLE 2—REVISED DRAFT PRODUCTSPECIFIC GUIDANCES FOR DRUG
PRODUCTS
Acyclovir.
Baricitinib.
Calcium carbonate; Famotidine; Magnesium
hydroxide.
Daunorubicin citrate.
Deferiprone.
Ethinyl estradiol; Norethindrone acetate.
Ferric oxyhydroxide (multiple reference listed
drugs).
Goserelin acetate (multiple reference listed
drugs).
Icosapent ethyl.
Lapatinib ditosylate.
Lidocaine.
Oxycodone.
Progesterone.
Ranolazine.
Rifaximin.
Sodium phosphate, dibasic, anhydrous; Sodium phosphate, monobasic, monohydrate.
Sumatriptan succinate (multiple product-specific guidances).
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
applicable statutes and regulations.
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.
khammond on DSKJM1Z7X2PROD with NOTICES
V. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
16:46 Nov 17, 2022
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Active ingredient(s)
VerDate Sep<11>2014
[FR Doc. 2022–25210 Filed 11–17–22; 8:45 am]
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National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development; Notice of Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
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 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: National Institute of
Child Health and Human Development
Special Emphasis Panel; Member Conflict.
Date: December 2, 2022.
Time: 11:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Eunice
Kennedy Shriver National Institute of Child
Health and Human Development, 6710B
Rockledge Drive, Room 2131B, Bethesda, MD
20892–7510 (Virtual Meeting).
Contact Person: Jolanta Maria Topczewska,
Ph.D., Scientific Review Branch, Eunice
Kennedy Shriver National Institute of Child
Health and Human Development, National
Institute Health, 6710B Rockledge Drive,
Room 2131B, Bethesda, MD 20892, (301)
451–0000, jolanta.topczewska@nih.gov.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel; Capstone Centers for
Multidisciplinary Research in Child Abuse
and Neglect.
Date: December 8–9, 2022.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Eunice
Kennedy Shriver National Institute of Child
Health and Human Development, 6710B
Rockledge Drive, Room 2137C, Bethesda, MD
20892–7510 (Virtual Meeting).
Contact Person: Kimberly L. Houston, MD,
Scientific Review Officer, Scientific Review
Branch, Eunice Kennedy Shriver National
Institute of Child Health & Human
Development, National Institute Health,
6710B Rockledge Drive, Room 2137C,
PO 00000
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Bethesda, MD 20892, (301) 827–4902,
kimberly.houston@nih.gov.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel; Program Project
Grants for HIV Research.
Date: December 13–14, 2022.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Eunice
Kennedy Shriver National Institute of Child
Health and Human Development, 6710B
Rockledge Drive, Room 2121B, Bethesda, MD
20892–7510 (Virtual Meeting).
Contact Person: Christiane M. Robbins,
Scientific Review Officer, Scientific Review
Branch, Eunice Kennedy Shriver National
Institute of Child Health and Human
Development, National Institute Health,
6710B Rockledge Drive, Room 2121B,
Bethesda, MD 20817, (301) 451–4989,
crobbins@mail.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.865, Research for Mothers
and Children, National Institutes of Health,
HHS)
Dated: November 14, 2022.
David W. Freeman,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–25165 Filed 11–17–22; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
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 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; Member
Conflict: Cardiovascular Sciences.
Date: December 7, 2022.
Time: 8:00 a.m. to 12:00 p.m.
E:\FR\FM\18NON1.SGM
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Federal Register / Vol. 87, No. 222 / Friday, November 18, 2022 / Notices
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Imoh S. Okon, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20817, 301–347–8881, imoh.okon@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Acute
Neural Injury and Epilepsy.
Date: December 7, 2022.
Time: 1:00 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: Paula Elyse Schauwecker,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5201,
Bethesda, MD 20892, 301–760–8207,
schauweckerpe@csr.nih.gov.
(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: November 14, 2022.
David W. Freeman,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–25164 Filed 11–17–22; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
khammond on DSKJM1Z7X2PROD with NOTICES
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
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 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; RFA–RM–
22–017 Somatic Cell Genome Editing
Program Translational Coordination and
Dissemination Center.
Date: December 14, 2022.
Time: 11:00 a.m. to 3:00 p.m.
VerDate Sep<11>2014
16:46 Nov 17, 2022
Jkt 259001
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Rebecca Catherine
Burgess, Ph.D., Scientific Review Officer,
Center for Scientific Review, National
Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892, (301) 480–8034,
rebecca.burgess@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Topics on Tumor Biology.
Date: December 14, 2022.
Time: 12:00 p.m. to 6:00 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: Jingwu Xie, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 594–8625, jingwu.xie@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Respiratory Sciences.
Date: December 15–16, 2022.
Time: 9:00 a.m. to 6:00 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: Ghenima Dirami, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4122,
MSC 7814, Bethesda, MD 20892, (240) 498–
7546, diramig@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Topics in
Autoimmunity.
Date: December 15, 2022.
Time: 1:00 p.m. to 6:00 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: Xinrui Li, Ph.D., Scientific
Review Officer, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Bethesda, MD 20892, (301) 594–2084,
xinrui.li@nih.gov.
(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: November 14, 2022.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–25167 Filed 11–17–22; 8:45 am]
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69281
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2021–0830]
National Boating Safety Advisory
Committee; Vacancies
Coast Guard, Department of
Homeland Security.
ACTION: Request for applications.
AGENCY:
SUMMARY: The U.S. Coast Guard is
accepting applications to fill two
vacancies on the National Boating
Safety Advisory Committee
(Committee). This Committee advises
the Secretary of Homeland Security, via
the Commandant of the U.S. Coast
Guard, on matters relating to national
recreational boating safety.
DATES: Completed applications must
reach the U.S. Coast Guard on or before
December 19, 2022.
ADDRESSES: Applications must be
emailed to Mr. Jeff Decker at NBSAC@
uscg.mil with subject line ‘‘Application
for NBSAC’’.
FOR FURTHER INFORMATION CONTACT: Mr.
Jeff Decker, Alternate Designated
Federal Officer of the National Boating
Safety Advisory Committee; telephone
202–372–1507 or email at NBSAC@
uscg.mil.
The
National Boating Safety Advisory
Committee is a Federal advisory
committee. The Committee was
established on December 4, 2018, by
section 601 of the Frank LoBiondo Coast
Guard Authorization Act of 2018, Public
Law No 115–282, 132 Stat. 4192
(codified, at 46 U.S.C. 15105). The
Committee operates under the
provisions of the Federal Advisory
Committee Act, (5 U.S.C. appendix), and
46 U.S.C. 15109. The National Boating
Safety Advisory Committee provides
advice, consults with, and make
recommendations to the Secretary of
Homeland Security, via the
Commandant of the U.S. Coast Guard,
on matters relating to national
recreational boating safety.
The Committee is required to meet at
least once a year in accordance with 46
U.S.C. 15109(a). We expect the
Committee will hold meetings at least
twice a year, but it may meet more
frequently.
All members serve at their own
expense and receive no salary or other
compensation from the Federal
Government. Members may be
reimbursed for travel and per diem in
accordance with Federal Travel
Regulations.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\18NON1.SGM
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]]>Agencies
[Federal Register Volume 87, Number 222 (Friday, November 18, 2022)]
[Notices]
[Pages 69280-69281]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-25164]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended, notice is hereby given of the following meetings.
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 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; Member Conflict: Cardiovascular Sciences.
Date: December 7, 2022.
Time: 8:00 a.m. to 12:00 p.m.
[[Page 69281]]
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701
Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Imoh S. Okon, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20817, 301-347-8881,
[email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Acute Neural Injury and Epilepsy.
Date: December 7, 2022.
Time: 1:00 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: Paula Elyse Schauwecker, Ph.D., Scientific
Review Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5201, Bethesda, MD 20892, 301-
760-8207, [email protected].
(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: November 14, 2022.
David W. Freeman,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2022-25164 Filed 11-17-22; 8:45 am]
BILLING CODE 4140-01-P
