[Federal Register Volume 88, Number 81 (Thursday, April 27, 2023)]
[Notices]
[Pages 25663-25665]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-08942]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-1466]
Good Manufacturing Practices for Cosmetic Products Listening
Session; Public Meeting; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing a virtual listening session entitled ``Good Manufacturing
Practices for Cosmetic Products Listening Session.'' The purpose of the
listening session is to consult cosmetics manufacturers, including
smaller businesses, consumer organizations, and other experts, to
inform Agency efforts to develop regulations to establish good
manufacturing practices for facilities that manufacture or process
cosmetic products distributed in the United States.
DATES: The virtual listening session will be held on June 1, 2023, from
10 a.m. to 1 p.m. Eastern Daylight Time (EDT) or until after the last
public commenter has spoken, whichever occurs first. Submit requests to
make oral presentations at the listening session by 6 p.m. EDT, May 18,
2023. Either electronic or written comments on this listening session
must be submitted to the docket by July 3, 2023. See the SUPPLEMENTARY
INFORMATION section for registration date and information.
ADDRESSES: Additional details, such as registration information, are
available at https://www.fda.gov/cosmetics/cosmetics-news-events/public-meeting-good-manufacturing-practices-cosmetic-products-06012023.
FDA is establishing a public docket for this listening session. You
may submit comments as follows. Please note that late, untimely filed
comments will not be considered. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. EDT at
the end of July 3, 2023. Comments received by mail/hand delivery/
courier (for written/paper submissions) will be considered timely if
they are received on or before that date.
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-N-1466 for ``Good Manufacturing Practices for Cosmetic
Products Listening Session.'' Received comments, those filed in a
timely manner (see ADDRESSES), 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
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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.
FOR FURTHER INFORMATION CONTACT: Deborah Smegal, Office of Cosmetics
and Colors, Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 5001 Campus Dr., Rm. 1037 (HFS-125), College Park, MD
20740, 240-402-1130, (this is not a toll-free number), email:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
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 606 to the Federal Food, Drug, and
Cosmetic Act (FD&C Act), requiring FDA to establish by regulation good
manufacturing practices (GMPs) for facilities that manufacture or
process cosmetic products distributed in the United States. MoCRA
specifies that these GMPs are to be consistent, to the extent
practicable, and appropriate, with national and international
standards, in accordance with section 601 of the FD&C Act (21 U.S.C.
361). Any such regulations shall be intended to protect the public
health and ensure that cosmetic products are not adulterated. As
required by MoCRA, before issuing rulemaking, FDA must consult with
cosmetics manufacturers, including smaller businesses, consumer
organizations, and other experts selected by FDA. Further, FDA must
take into account the size and scope of the businesses engaged in the
manufacture of cosmetics, and the risks to public health posed by such
cosmetics and provide sufficient flexibility to be practicable for all
sizes and types of facilities to which such regulations will apply.
Such regulations must include simplified good manufacturing practice
requirements for smaller businesses, as appropriate, to ensure that
such regulations do not impose undue economic hardship for smaller
businesses and may include longer compliance times for smaller
businesses. In addition, MoCRA added section 612 of the FD&C Act, which
exempts certain small businesses from the GMP requirements.
FDA issued a draft guidance, entitled ``Draft Guidance for
Industry: Cosmetic Good Manufacturing Practices,'' (available at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-cosmetic-good-manufacturing-practices) in 2013. We intend to withdraw or revise and reissue this
draft guidance, as appropriate, based on the GMP rulemaking.
II. Topics for Comment
To facilitate input on good manufacturing practices for cosmetic
products, FDA has developed a series of topics covering the types of
information that we are interested in obtaining. In all cases, FDA
encourages stakeholders to provide the specific rationale and basis for
their comments, including any available supporting data and
information.
Respondents need not reply to all topics listed. Please identify
your answers as responses to a specific topic.
Topics Related to Good Manufacturing Practices
1. Identify any national or international standard (e.g.,
International Organization for Standardization (ISO) standard
22716:2007) and the extent to which it would be practicable for good
manufacturing practice regulations for cosmetic products to be
consistent with such standard. Please include whether there are
specific items in the standard which are perceived to be burdensome or
for which a less burdensome alternative exists that would protect the
public health and ensure that cosmetic products are not adulterated.
2. Describe what constitutes sufficient flexibility within good
manufacturing practices for cosmetic products to ensure regulations are
practicable for all sizes and types of facilities to which such
practices may apply. Please take into account the size and scope of the
businesses engaged in the manufacture of cosmetic products and the
risks to public health posed by cosmetic products.
3. Describe what constitutes simplified good manufacturing
practices requirements for cosmetic products for smaller businesses to
ensure regulations do not impose undue economic hardship.
4. Describe appropriate compliance times for good manufacturing
practices regulations.
Topics Related to Economic Impact
5. To what extent are manufacturers of cosmetic products already
following a national or international standard for good manufacturing
practices? For manufacturers of cosmetic products that are not
currently following such a national or international standard, what
would it cost to implement good manufacturing practices consistent with
such a standard?
6. Please provide reports or examples of adverse events or recalls
associated with a cosmetic product that were linked to manufacturing
practices. How would implementing good manufacturing practices impact
the likelihood of recall of cosmetics products? How would implementing
good manufacturing practices impact the likelihood of consumers
experiencing adverse events from the use of cosmetics products? How
would these impacts differ by type of cosmetic product?
III. Participating in the Listening Session
Registration: To register for the free virtual listening session,
please visit the following website: https://www.fda.gov/cosmetics/cosmetics-news-events/public-meeting-good-manufacturing-practices-cosmetic-products-06012023. Registration may be performed at any time
before or during the listening session.
Information on requests for special accommodations due to a
disability will be provided during registration.
Requests to Provide Oral Presentations: During online registration
you may indicate if you wish to present during the listening session.
Requests to provide public comments during the listening session should
be submitted by 6 p.m. EDT, May 18, 2023. We will do our best to
accommodate requests to
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make public comments. Individuals and organizations with common
interests are urged to consolidate or coordinate their presentations,
and request time for a joint presentation, or submit requests for
designated representatives to participate in the focused sessions.
Based on the number of requests we receive, we will determine the
amount of time allotted to each presenter (which we expect to be
approximately 3 minutes) and the approximate time each oral
presentation is to begin. We will select and notify participants at the
time of registration, or by May 19, 2023. If selected for presentation,
participants must email presentation materials to
[email protected] no later than May 22, 2023, 11:59 p.m. EDT.
No commercial or promotional material will be permitted to be presented
or distributed at the public workshop.
Streaming Webcast of the Listening Session: This listening session
will be webcast. Please register online (as described above).
Registrants will receive a hyperlink that provides access to the
webcast.
FDA has verified the website addresses in this document, as of the
date this document publishes in the Federal Register, but websites are
subject to change over time.
Transcripts: Please be advised that as soon as a transcript of the
listening session is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES).
Dated: April 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-08942 Filed 4-26-23; 8:45 am]
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