[Federal Register Volume 89, Number 239 (Thursday, December 12, 2024)]
[Notices]
[Pages 100508-100509]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-29237]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-1716]
Registration and Listing of Cosmetic Product Facilities and
Products; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the availability of a final guidance for industry entitled
``Registration and Listing of Cosmetic Product Facilities and
Products.'' The guidance will assist persons submitting cosmetic
product facility registrations and product listing submissions to FDA
under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
This guidance includes three new draft frequently asked questions and
answers about cosmetic product facility registrations and product
listing submissions, in Appendix B, for comment purposes only. Aside
from the three new draft frequently asked questions and answers, this
guidance finalizes the draft Appendix B published in an otherwise final
guidance on December 19, 2023. This guidance also includes minor
changes to the final guidance for clarity.
DATES: The announcement of the guidance is published in the Federal
Register on December 12, 2024. However, the portion of this guidance in
Appendix B that describes three new frequently asked questions and
answers, is being distributed for comment purposes only. To ensure that
the Agency considers your comment on this draft section before it
begins work on the final version of this section of the guidance,
submit either electronic or written comments on this section by January
13, 2025.
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 ``Registration and Listing of Cosmetic Product
Facilities and Products.'' 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
[[Page 100509]]
``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 Office
of the Chief Scientist, Office of the Commissioner, Food and Drug
Administration, 10903 New Hampshire Ave., WO1, Silver Spring, MD 20993-
0002. Send two self-addressed adhesive labels to assist that office in
processing your request. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.
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).
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Registration and Listing of Cosmetic Product Facilities and
Products.''
On December 29, 2022, the President signed the Consolidated
Appropriations Act, 2023 (Pub. L. 117-328) into law, which included
MoCRA. Among other provisions, MoCRA added section 607 to the Federal
Food, Drug, and Cosmetic Act (FD&C Act), establishing requirements for
cosmetic product facility registration and cosmetic product listing.
Section 607(a) of the FD&C Act (21 U.S.C. 364c(a)) requires every
person that owns or operates a facility that engages in the
manufacturing or processing of a cosmetic product for distribution in
the United States to register each facility. In addition to the
registration requirements, section 607(c) of the FD&C Act requires that
for each cosmetic product, the responsible person submit to FDA ``a
cosmetic product listing.'' Certain small businesses, as defined in
section 612 of the FD&C Act (21 U.S.C. 364h), are exempt from the
registration and listing requirements.
In the Federal Register of December 19, 2023 (88 FR 87780), we made
available a final guidance for industry entitled ``Registration and
Listing of Cosmetic Product Facilities and Products.'' This guidance
also included a new draft section, Appendix B, for comment purposes
only, that describes frequently asked questions and answers about
cosmetic product facility registrations and product listing submissions
and gave interested parties an opportunity to submit comments by
January 18, 2024, for us to consider before beginning work on the final
version of Appendix B. We received a few comments on the draft guidance
Appendix B frequently asked questions and answers and have modified the
final guidance Appendix B in response to these comments and for
clarity, where appropriate. In addition, we made editorial changes to
the final guidance to improve clarity. Finally, three new frequently
asked questions and answers in Appendix B of this guidance are
highlighted in grey and are marked ``for comment purposes only'' to
provide an opportunity for comment before they are finalized. Aside
from the three new frequently asked questions and answers in Appendix
B, this guidance finalizes the draft guidance Appendix B that was
published on December 19, 2023 (88 FR 87780) and reissues the final
guidance with minor changes for clarity. No changes were made to
Appendix A of the final guidance.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Registration and Listing of Cosmetic
Product Facilities and Products.'' 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
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in section 607 of the FD&C Act have been approved under 0910-0599.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
https://www.fda.gov/CosmeticGuidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
Dated: December 5, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-29237 Filed 12-11-24; 8:45 am]
BILLING CODE 4164-01-P