National Institute of Dental and Craniofacial Research; Notice of Closed Meeting, 20542 [2023-07217]
Download as PDF
<![CDATA[
ddrumheller on DSK120RN23PROD with NOTICES1
20542
Federal Register / Vol. 88, No. 66 / Thursday, April 6, 2023 / Notices
that the FDA-approved drug product,
when not manufactured in the ready-touse form, is medically unsuitable for
certain patients. Nor do the nominations
and comments establish that drug
products in the relevant concentrations,
including ready-to-use products, cannot
be prepared from the FDA-approved
drug products. Rather, they propose to
compound a ready-to-use product from
bulk drug substances to seek improved
efficiency for prescribers or healthcare
providers, or to address the possibility
that the FDA-approved drug might be
mishandled by a medical professional,
neither of which falls within the
meaning of clinical need to compound
a drug product using a bulk drug
substance.
Two commenters requested changes
to the Interim Policy. These comments
are outside the scope of FDA’s bulk drug
substance evaluations and decisions
that are the subject of this notice. FDA
welcomes public comments on its
guidance documents that address
human drug compounding. Comments
on the Interim Policy may be submitted
to the docket for the guidance, Docket
No. FDA–2015–D–3539, at any time at
https://www.regulations.gov.
Act,’’ January 2017 (available at https://
www.fda.gov/media/94402/download).
2. FDA, Guidance for Industry, ‘‘Evaluation
of Bulk Drug Substances Nominated for
Use in Compounding Under Section
503B of the Federal Food, Drug, and
Cosmetic Act,’’ March 2019 (available at
https://www.fda.gov/media/121315/
download).
3. FDA Memorandum to File, ‘‘Clinical Need
for Quinacrine Hydrochloride in
Compounding Under Section 503B of the
FD&C Act,’’ March 2021.
4. FDA Guidance for Industry, ‘‘Prescription
Requirement Under Section 503A of the
Federal Food, Drug, and Cosmetic Act,’’
December 2016 (available at https://
www.fda.gov/media/97347/download).
V. Conclusion
For the reasons stated above, we find
that there is a clinical need for
outsourcing facilities to compound drug
products using the bulk drug substance
quinacrine HCl for oral use only, and
therefore we are now including it on the
503B Bulks List. In addition, we find
that there is no clinical need for
outsourcing facilities to compound
using the bulk drug substances
hydroxyzine HCl, mannitol,
methacholine chloride, metoclopramide
HCl, nalbuphine HCl, potassium acetate,
procainamide HCl, sodium bicarbonate,
sodium nitroprusside, and verapamil
HCl, and therefore we are not including
these bulk drug substances on the 503B
Bulks List.
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.
VI. References
The following references are on
display at the Dockets Management Staff
(see ADDRESSES) and are available for
viewing by interested persons between
9 a.m. and 4 p.m., Monday through
Friday; they are also available
electronically at https://
www.regulations.gov. FDA has verified
the website addresses, as of the date this
document publishes in the Federal
Register, but websites are subject to
change over time.
1. FDA, Guidance for Industry, ‘‘Interim
Policy on Compounding Using Bulk
Drug Substances Under Section 503B of
the Federal Food, Drug, and Cosmetic
VerDate Sep<11>2014
21:13 Apr 05, 2023
Jkt 259001
Dated: April 3, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–07237 Filed 4–5–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Dental and
Craniofacial Research; Notice of
Closed Meeting
Name of Committee: National Institute of
Dental and Craniofacial Research Special
Emphasis Panel; Practice-Based Research in
Dental Schools.
Date: May 11, 2023.
Time: 9:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Dental and
Craniofacial Research, 6701 Democracy
Boulevard, Bethesda, MD 20892 (Virtual
Meeting).
Contact Person: Yun Mei, MD, Scientific
Review Officer, Scientific Review Branch,
National Institute of Dental and Craniofacial
Research, National Institutes of Health, 6701
Democracy Boulevard, Bethesda, MD 20892,
(301) 827–4639, yun.mei@nih.gov.
(Catalogue of Federal Domestic Assistance
Program No. 93.121, Oral Diseases and
Disorders Research, National Institutes of
Health, HHS)
PO 00000
Frm 00077
Fmt 4703
Sfmt 4703
Dated: April 3, 2023.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–07217 Filed 4–5–23; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed 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
contract proposals 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
and contract proposals, the disclosure of
which would constitute a clearly
unwarranted invasion of personal
privacy.
Name of Committee: National Cancer
Institute Special Emphasis Panel; FFRDC
Review Meeting.
Date: May 4–5, 2023.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Room
7W530, Rockville, Maryland 20850
(Telephone Conference Call).
Contact Person: Shamala K. Srinivas,
Ph.D., Associate Director, Office of Referral,
Review, and Program Coordination, Division
of Extramural Activities, National Cancer
Institute, NIH, 9609 Medical Center Drive,
Room 7W530, Rockville, Maryland 20850,
240–276–6442, ss537t@nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; NCI SPORE
(P50) Review SEP–I.
Date: May 18, 2023.
Time: 9:00 a.m. to 6:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Room
7W244, Rockville, Maryland 20850
(Telephone Conference Call).
Contact Person: John Paul Cairns, Ph.D.,
Scientific Review Officer, Research Programs
Review Branch, Division of Extramural
Activities, National Cancer Institute, NIH,
9609 Medical Center Drive, Room 7W244,
Rockville, Maryland 20850, 240–276–5415,
paul.cairns@nih.gov.
E:\FR\FM\06APN1.SGM
06APN1
]]>Agencies
[Federal Register Volume 88, Number 66 (Thursday, April 6, 2023)]
[Notices]
[Page 20542]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-07217]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Dental and Craniofacial Research; 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 Dental and Craniofacial
Research Special Emphasis Panel; Practice-Based Research in Dental
Schools.
Date: May 11, 2023.
Time: 9:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institute of Dental and Craniofacial Research,
6701 Democracy Boulevard, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Yun Mei, MD, Scientific Review Officer,
Scientific Review Branch, National Institute of Dental and
Craniofacial Research, National Institutes of Health, 6701 Democracy
Boulevard, Bethesda, MD 20892, (301) 827-4639, [email protected].
(Catalogue of Federal Domestic Assistance Program No. 93.121, Oral
Diseases and Disorders Research, National Institutes of Health, HHS)
Dated: April 3, 2023.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2023-07217 Filed 4-5-23; 8:45 am]
BILLING CODE 4140-01-P
