Federal Register / Vol. 88, No. 216 / Thursday, November 9, 2023 / Notices 77323 

Chiquita Brooks-LaSure, having 

reviewed and approved this document, 

authorizes Chyana Woodyard, who is 

the Federal Register Liaison, to 

electronically sign this document for 

purposes of publication in the Federal 

Register. 

Chyana Woodyard, 

Federal Register Liaison, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2023–24850 Filed 11–8–23; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–D–1716] 

Compliance Policy for Cosmetic 

Product Facility Registration and 

Cosmetic Product Listing; Guidance 

for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing the availability of a final 

guidance for industry and the public on 

the requirements related to cosmetic 

product facility registration and 

cosmetic product listing under the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) entitled ‘‘Compliance Policy 

for Cosmetic Product Facility 

Registration and Cosmetic Product 

Listing.’’ This guidance announces 

FDA’s intention to delay enforcement of 

the requirements related to cosmetic 

product facility registration and 

cosmetic product listing for an 

additional 6 months after the initial 

December 29, 2023, deadline. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on November 9, 2023. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2023–D–1716 for ‘‘Compliance Policy 

for Cosmetic Product Facility 

Registration and Cosmetic Product 

Listing; Guidance for Industry; 

Availability.’’ Received comments will 

be placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the guidance to the Office of 

Cosmetics and Colors, Center for Food 

Safety and Applied Nutrition, Food and 

Drug Administration, 5001 Campus Dr., 

College Park, MD 20740. Send two selfaddressed adhesive labels to assist that 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer Ross, Office of the Chief 

Scientist, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 1, Rm. 4332, Silver Spring, 

MD 20993–0002, 301–796–4880 (this is 

not a toll-free number), email: 

QuestionsAboutMoCRA@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

We are announcing the availability of 

a guidance for industry and the public 

entitled ‘‘Compliance Policy for 

Cosmetic Product Facility Registration 

and Cosmetic Product Listing.’’ This 

guidance is intended to assist owners or 

operators of cosmetic product facilities 

that are subject to the requirements 

related to facility registration and 

responsible persons that are subject to 

the requirements related to cosmetic 

product listing under the FD&C Act. We 

are issuing this guidance consistent 

with our good guidance practices (GGP) 

regulation (§ 10.115 (21 CFR 10.115)). 

We are implementing this guidance 

without prior public comment because 

we have determined that prior public 


ddrumheller on DSK120RN23PROD with NOTICES1
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