[Federal Register Volume 88, Number 216 (Thursday, November 9, 2023)]
[Notices]
[Pages 77323-77324]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-24731]


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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.

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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 self-addressed 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: [email protected].

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 
(Sec.  10.115 (21 CFR 10.115)). We are implementing this guidance 
without prior public comment because we have determined that prior 
public

[[Page 77324]]

participation is not feasible or appropriate (Sec.  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 ((Sec.  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/regulatory-information/search-fda-guidance-documents, 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