[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]
-----------------------------------------------------------------------
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Products; Draft Guidance for Industry; Availability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.
-----------------------------------------------------------------------
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announcing the availability of a draft guidance for industry entitled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 This draft guidance, when finalized, will assist persons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 This draft guidance is not final nor is it in effect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DATES: Submit either electronic or written comments on the draft
guidance by September 7, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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