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FDA issued a draft guidance entitled 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 

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: http://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, 

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: http://

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. 


ddrumheller on DSK120RN23PROD with NOTICES1