Document ID: FDA-2023-D-1716-0001
Agency: fda
Document Type: Notice
Title: Registration and Listing of Cosmetic Product Facilities and Products; Draft Guidance for Industry; Availability
Posted Date: 2023-08-08T04:00Z

[Federal Register Volume 88, Number 151 (Tuesday, August 8, 2023)]
[Notices]
[Pages 53490-53492]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-16771]

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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Products; Draft Guidance for Industry; Availability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, the Agency, or we) is 
announcing the availability of a draft guidance for industry entitled 
``Registration and Listing of Cosmetic Product Facilities and 
Products.'' This draft guidance, when finalized, will assist persons 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 This draft guidance is not final nor is it in effect 
at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by September 7, 2023 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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.

[[Page 53491]]

     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 draft 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 request. See the SUPPLEMENTARY INFORMATION section 
for electronic access to the draft 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

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Registration and Listing of Cosmetic Product Facilities and 
Products.'' We are issuing the draft guidance consistent with our good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on this topic. It 
does not establish any rights for any person and is not binding on FDA 
or the public. You can use an alternate 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 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 one year after the date of 
enactment. FDA previously had a voluntary cosmetics registration 
program (see 21 CFR parts 710 and 720). Because the information in the 
voluntary cosmetics registration program differs from the information 
required to be submitted under MoCRA, FDA does not consider previous 
submissions to the voluntary cosmetics registration program to satisfy 
the registration and listing mandated by MoCRA. Accordingly, FDA ended 
its voluntary registration program as of March 27, 2023, while we work 
toward establishing a new system, and information in the voluntary 
cosmetics registration program will not be transferred to this new 
system. 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, are exempt from 
the registration and listing requirements.
    While electronic submission of registration and listing information 
is not required, FDA is strongly encouraging electronic submission to 
facilitate efficiency and timeliness of data submission and management 
by FDA. To that end, FDA will make an electronic portal available to 
streamline the data entry process for registration and product listing.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to collections of information subject to 
review and approval by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). As 
required by the PRA, FDA published an analysis of burden associated 
with reporting provisions found in section 607 of the FD&C Act in the 
Federal Register of May 1, 2023 (88 FR 26564) and is currently inviting 
comment on the proposed collection of information. As required by the 
PRA, FDA will publish a subsequent notice announcing that the proposed 
collection of information has been submitted to OMB for review and 
approval, and provide an additional opportunity for public comment.

III. Electronic Access

    Persons with access to the internet may obtain the draft 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

[[Page 53492]]

websites listed in the previous sentence to find the most current 
version of the guidance.

    Dated: August 2, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-16771 Filed 8-7-23; 8:45 am]
BILLING CODE 4164-01-P