[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]
BILLING CODE 4164-01-P


