National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting, 71655 [2022-25521]
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Federal Register / Vol. 87, No. 225 / Wednesday, November 23, 2022 / Notices
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lotter on DSK11XQN23PROD with NOTICES1
I. Background
We are announcing the availability of
a guidance for industry entitled
‘‘Compounding Certain Beta-Lactam
Products in Shortage Under Section
503A of the Federal Food, Drug, and
Cosmetic Act.’’ This guidance is being
implemented without prior public
comment because FDA has determined
that prior public participation for this
guidance is not feasible or appropriate
(see section 701(h)(1)(C) of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 371(h)(1)(C)) and 21 CFR
VerDate Sep<11>2014
16:45 Nov 22, 2022
Jkt 259001
10.115(g)(2)). This guidance document
is being implemented immediately
because of the public health need for
amoxicillin oral antibiotic suspension
products, but it remains subject to
comment in accordance with the
Agency’s good guidance practices.
This guidance describes the Agency’s
regulatory and enforcement priorities
regarding preparation of beta-lactam
oral antibiotic suspension products that
appear on FDA’s drug shortage list by a
licensed pharmacist in a State-licensed
pharmacy or Federal facility. FDA has
received a number of reports related to
increased demand for amoxicillin oral
antibiotic suspension products in
particular. Amoxicillin oral antibiotic
powder for suspension products
currently appear on FDA’s drug shortage
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clarification about preparation of
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This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Compounding
Certain Beta-Lactam Products in
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71655
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; 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: National Institute of
Diabetes and Digestive and Kidney Diseases
Initial Review Group Kidney, Urologic and
Hematologic Diseases D Study Section.
Date: February 28–March 2, 2023.
Time: 5:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute of Diabetes and Digestive
and Kidney Diseases, 2 Democracy, 6707
Democracy Blvd., Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Jason D. Hoffert, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 7343, 6707 Democracy Boulevard,
Bethesda, MD 20817, 301–496–9010,
hoffertj@niddk.nih.gov.
Information is also available on the
Institute’s/Center’s home page:
www.niddk.nih.gov/, where an agenda and
any additional information for the meeting
will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: November 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
Dated: November 17, 2022.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–25622 Filed 11–22–22; 8:45 am]
[FR Doc. 2022–25521 Filed 11–22–22; 8:45 am]
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[Federal Register Volume 87, Number 225 (Wednesday, November 23, 2022)]
[Notices]
[Page 71655]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-25521]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases;
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: National Institute of Diabetes and Digestive
and Kidney Diseases Initial Review Group Kidney, Urologic and
Hematologic Diseases D Study Section.
Date: February 28-March 2, 2023.
Time: 5:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, National Institute of
Diabetes and Digestive and Kidney Diseases, 2 Democracy, 6707
Democracy Blvd., Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Jason D. Hoffert, Ph.D., Scientific Review
Officer, Review Branch, DEA, NIDDK, National Institutes of Health,
Room 7343, 6707 Democracy Boulevard, Bethesda, MD 20817, 301-496-
9010, [email protected].
Information is also available on the Institute's/Center's home
page: www.niddk.nih.gov/, where an agenda and any additional
information for the meeting will be posted when available.
(Catalogue of Federal Domestic Assistance Program Nos. 93.847,
Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive
Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes of Health, HHS)
Dated: November 17, 2022.
Miguelina Perez,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2022-25521 Filed 11-22-22; 8:45 am]
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