National Institute on Alcohol Abuse and Alcoholism; Notice of Meeting, 77324 [2023-24807]
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77324
Federal Register / Vol. 88, No. 216 / Thursday, November 9, 2023 / Notices
participation is not feasible or
appropriate (§ 10.115(g)(2)) as it
provides time-sensitive information to
industry about our intent to delay
enforcement of the cosmetic product
facility registration and product listing
requirements under section 607 of the
FD&C Act (21 U.S.C. 364c), which
become effective on December 29, 2023,
for 6 months until July 1, 2024.
Although this guidance document is
immediately in effect, it remains subject
to comment in accordance with FDA’s
GGP regulation ((§ 10.115(g)(5)).
On December 29, 2022, the President
signed the Consolidated Appropriations
Act, 2023 (Pub. L. 117–328) into law,
which included the Modernization of
Cosmetics Regulation Act of 2022
(MoCRA). Among other provisions,
MoCRA added section 607 to the FD&C
Act, establishing requirements for
cosmetic product facility registration
and product listing. Section 607 of the
FD&C Act generally imposes an initial
registration and listing deadline of
December 29, 2023, for facilities that
engaged in manufacturing or processing
of a cosmetic product and cosmetic
products that were marketed as of
December 29, 2022, the date MoCRA
was enacted. This guidance announces
FDA’s intent to delay enforcement of the
requirements related to cosmetic
product facility registration and
cosmetic product listing under section
607 of the FD&C Act related to cosmetic
product facility registration and
cosmetic product listing until July 1,
2024, to provide regulated industry
additional time to comply with these
requirements.
FDA issued a draft guidance entitled
‘‘Registration and Listing of Cosmetic
Product Facilities and Products’’ on
August 8, 2023 (88 FR 53490). The draft
guidance, when finalized, will provide
recommendations and instructions to
assist persons submitting cosmetic
product facility registrations and
product listings to FDA. FDA intends to
delay enforcement of the cosmetic
product facility registration and product
listing requirements to help ensure that
owners or operators of cosmetic product
facilities and responsible persons for
cosmetic products have sufficient time
to gather the relevant information
required for facility registration and
product listing, including obtaining
facility registration numbers to associate
with cosmetic product listings,
obtaining access to the electronic
submissions database, and verifying
accurate registration and listing
information for submission.
The guidance represents the current
thinking of FDA on the issues within. It
does not establish any rights for any
VerDate Sep<11>2014
18:22 Nov 08, 2023
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person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations.
II. Paperwork Reduction Act of 1995
This guidance contains no collection
of information. Therefore, clearance by
the Office of Management and Budget
under the Paperwork Reduction Act of
1995 is not required.
III. Electronic Access
Persons with access to the internet
may obtain the document at https://
www.fda.gov/CosmeticGuidances,
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, or https://
www.regulations.gov. Use the FDA
website listed in the previous sentence
to find the most current version of the
guidance.
Dated: November 3, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–24731 Filed 11–8–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Alcohol Abuse
and Alcoholism; Notice of Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Advisory
Council on Alcohol Abuse and
Alcoholism.
The meeting will be held as a virtual
meeting and will be open to the public
as indicated below. Individuals who
plan to view the virtual meeting and
need special assistance or other
reasonable accommodations to view the
meeting, should notify the Contact
Person listed below in advance of the
meeting. The meeting can be accessed
from the NIH VideoCasting at the
following link: https://videocast.nih
.gov/.
A portion of this 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
PO 00000
Frm 00068
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would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Advisory
Council on Alcohol Abuse and Alcoholism.
Date: February 8, 2024.
Closed: 11:00 a.m. to 11:55 a.m.
Agenda: To review and evaluate grant
applications.
Open: 12:00 p.m. to 4:00 p.m.
Agenda: Presentations and other business
of the Council.
Place: National Institutes of Health,
National Institute on Alcohol Abuse and
Alcoholism, 6700B Rockledge Drive
Bethesda, MD 20817 (Virtual Meeting).
Contact Person: Philippe Marmillot, Ph.D.,
Acting Director, Office of Extramural
Activities, National Institute on Alcohol
Abuse and Alcoholism, National Institutes of
Health, 6700B Rockledge Drive, Room 2118
Bethesda, MD 20892, (301) 443–2861,
marmillotp@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.
Information is also available on the
Institute’s/Center’s home page: https://
www.niaaa.nih.gov/AboutNIAAA/
AdvisoryCouncil/Pages/default.aspx, where
an agenda and any additional information for
the meeting will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.273, Alcohol Research
Programs, National Institutes of Health, HHS)
Dated: November 6, 2023.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–24807 Filed 11–8–23; 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 1009 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.
E:\FR\FM\09NON1.SGM
09NON1
]]>Agencies
[Federal Register Volume 88, Number 216 (Thursday, November 9, 2023)]
[Notices]
[Page 77324]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-24807]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of
Meeting
Pursuant to section 1009 of the Federal Advisory Committee Act, as
amended, notice is hereby given of a meeting of the National Advisory
Council on Alcohol Abuse and Alcoholism.
The meeting will be held as a virtual meeting and will be open to
the public as indicated below. Individuals who plan to view the virtual
meeting and need special assistance or other reasonable accommodations
to view the meeting, should notify the Contact Person listed below in
advance of the meeting. The meeting can be accessed from the NIH
VideoCasting at the following link: https://videocast.nih.gov/.
A portion of this 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 Advisory Council on Alcohol Abuse
and Alcoholism.
Date: February 8, 2024.
Closed: 11:00 a.m. to 11:55 a.m.
Agenda: To review and evaluate grant applications.
Open: 12:00 p.m. to 4:00 p.m.
Agenda: Presentations and other business of the Council.
Place: National Institutes of Health, National Institute on
Alcohol Abuse and Alcoholism, 6700B Rockledge Drive Bethesda, MD
20817 (Virtual Meeting).
Contact Person: Philippe Marmillot, Ph.D., Acting Director,
Office of Extramural Activities, National Institute on Alcohol Abuse
and Alcoholism, National Institutes of Health, 6700B Rockledge
Drive, Room 2118 Bethesda, MD 20892, (301) 443-2861,
[email protected].
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.
Information is also available on the Institute's/Center's home
page: https://www.niaaa.nih.gov/AboutNIAAA/AdvisoryCouncil/Pages/default.aspx, where an agenda and any additional information for the
meeting will be posted when available.
(Catalogue of Federal Domestic Assistance Program Nos. 93.273,
Alcohol Research Programs, National Institutes of Health, HHS)
Dated: November 6, 2023.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2023-24807 Filed 11-8-23; 8:45 am]
BILLING CODE 4140-01-P
