[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]
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