[Federal Register Volume 88, Number 242 (Tuesday, December 19, 2023)]
[Notices]
[Pages 87780-87781]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27649]
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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.
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SUMMARY: The Food and Drug Administration (FDA 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 also includes 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new draft section, Appendix B, for comment purposes only, that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. Aside from that
section, this guidance finalizes the draft guidance that was published
on August 8, 2023.
DATES: The announcement of the guidance is published in the Federal
Register on December 19, 2023. However, the portion of this guidance
that describes 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distributed for comment purposes only.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 18, 2024.
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
``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 Cosmetics and Colors, Center for Food Safety and Applied Nutrition,
Food and Drug Administration, 5001 5001 Campus Dr., College Park, MD
20740. 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.
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
entitled ``Registration and Listing of Cosmetic Product Facilities and
Products.'' We are issuing this guidance consistent with our good
guidance practices regulation (21 CFR 10.115). The guidance represents
the current thinking of FDA on this topic. It does not
[[Page 87781]]
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.
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 with FDA no later than 1
year after the date of enactment. 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 August 8, 2023 (88 FR 53490), we made
available a draft guidance for industry entitled ``Registration and
Listing of Cosmetic Product Facilities and Products'' and gave
interested parties an opportunity to submit comments by September 7,
2023, for us to consider before beginning work on the final version of
the guidance. We received numerous comments on the draft guidance and
have modified the final guidance where appropriate. Changes to the
guidance include additional information on the facility registration
number, United States agent, electronic and paper submission, as well
as incorporating FDA's compliance policy we made available in a
guidance for industry as described in the Federal Register of November
8, 2023 (88 FR 77323). In addition, we made editorial changes to
improve clarity. New appendix B of this guidance is highlighted in
grey, describes frequently asked questions and answers, and is marked
``for comment purposes only'' to provide an opportunity for comment
before it is finalized. Aside from appendix B, this guidance finalizes
the draft guidance that was published on August 8, 2023.
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. Use the FDA websites listed in the previous
sentence to find the most current version of the guidance.
Dated: December 12, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-27649 Filed 12-18-23; 8:45 am]
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