Good Manufacturing Practices for Cosmetic Products Listening Session; Public Meeting; Request for Comments, 25663-25665 [2023-08942]
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Federal Register / Vol. 88, No. 81 / Thursday, April 27, 2023 / Notices
per response) to yield an approximate
2.3 to one ratio of eligible participants.
We will need to screen approximately
112,000 potential parents and young
adults each month (resulting in
2,688,000 screeners) over the study
period. Since the eligible age for data
collection is 12 to 20 years old, we
intend to screen parents of eligible
youth, as well as young adults. Parents
of the youth participants determined to
be eligible through the screener will
provide parent permission (3 minutes
per response). We estimate that
2,016,000 of the parents who complete
the screener will provide their
permission for their youth to complete
the online survey (approximately 75
percent of the 2,688,000 screened).
Eligible youth (2,016,000) will provide
their assent (3 minutes per response) to
participate in the online survey (25
minutes per response). Participants that
are 18 to 20 (19 to 20 in Alabama and
Nebraska in accordance with state law)
will complete the screener for
themselves and provide their consent (3
minutes per response) to participate in
the online survey. We estimate that
approximately 25 percent of the 48,000
completed surveys will come from
young adults aged 18 to 20 (19 to 20 in
Alabama and Nebraska).
Over the course of the study period,
we intend to survey approximately
2,000 youth and young adults ages 12 to
20 per month for 24 months. From these
completed screeners, we estimate that
we will obtain data from 36,000 youth
and 12,000 young adults. This will give
us a total of 48,000 participants for the
study. The survey will be repeated with
a new cross-sectional sample
approximately every month over a
period of 24 months; however, some
participants will complete more than
one wave. These 48,000 respondents
will receive an invitation email with a
link to take the survey (4 minutes), six
reminder emails (3 minutes each), and
a thank you email (3 minutes) upon
completion of the study for a total of 25
minutes for respondents to read and
respond to the emails.
Dated: April 20, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
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[FR Doc. 2023–08945 Filed 4–26–23; 8:45 am]
BILLING CODE 4164–01–P
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.
Notice of public meeting;
request for comments.
ACTION:
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.
SUMMARY:
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-meetinggood-manufacturing-practices-cosmeticproducts-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.
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
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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-201509-18/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 tollfree number), email:
MoCRAGMPMeeting@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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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
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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-fdaguidance-documents/draft-guidanceindustry-cosmetic-good-manufacturingpractices) 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.
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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-manufacturingpractices-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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Federal Register / Vol. 88, No. 81 / Thursday, April 27, 2023 / Notices
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
MoCRAGMPMeeting@fda.hhs.gov 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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–0390]
Agency Father Generic Information
Collection Request. 30-Day Public
Comment Request
Office of the Secretary, Health
and Human Service, HHS.
ACTION: Notice and request for
comments. Office of the Assistant
Secretary for Public Affairs is requesting
OMB approval for a new father generic
clearance.
lotter on DSK11XQN23PROD with NOTICES1
AGENCY:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
SUMMARY:
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following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before May 29, 2023.
ADDRESSES: Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 264–0041. When requesting
information, please include the
document identifier 0990–0390–30D
and project title for reference.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: Challenge and
Prize Competition Solicitations.
Type of Collection: Extension OMB
No. 0990–0390—Office of the Assistant
Secretary for Health (OASH).
Abstract: The Office of the Secretary
(OS), Department of Health & Human
Services (HHS) requests that the Office
of Management and Budget (OMB)
approve a request for an extension of
generic clearance approval of the
information collected for challenge and
prize competition solicitations. Burden
hours were increased from 333 to 558.3
total burden hours to provide more time
for respondents to complete forms that
may include more questions.
Challenges and prize competitions
enable HHS to tap into the expertise and
creativity of the public in new ways as
well as extend awareness of HHS
programs and priorities. Within HHS,
the Office of the Assistant Secretary for
Health (OASH) has taken lead
responsibility in coordinating
challenges and prize competitions and
implementing policies regarding the use
of these tools. HHS’s goal is to engage
a broader number of stakeholders who
are inspired to work on some of our
most pressing health issues, thus
supporting a new ecosystem of
scientists, developers, and
entrepreneurs who can continue to
innovate for public health.
The generic clearance is necessary for
HHS to launch several challenges or
prize competitions annually in a short
turnaround. The information collected
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for these challenges and prize
competitions will generally include the
submitter’s or other contact person’s
first and last name, organizational
affiliation and role in the organization
(for identification purposes); email
address or other contact information (to
follow up if the submitted solution is
selected as a finalist or winner); street
address (to confirm that the submitter or
affiliated organization is located in the
United States, for eligibility purposes);
information confirming whether the
submitter’s age is 13 years or older (to
ensure compliance with the Children’s
Online Privacy Protection Act of 1998,
15 U.S.C. 6501–6505 (COPPA)) or 18
years or older (to ensure necessary
consents are obtained); and a narrative
description of the solution. HHS may
also request information indicating the
submitter’s technical background,
educational level, ethnicity, age range,
gender, and race (to evaluate entrants’
diversity and backgrounds), how the
submitter learned about the challenge or
prize competition and what the
submitter currently understands about
the HHS agency hosting the challenge or
prize competition (to gauge the effect of
the challenge or prize competition on
increasing public awareness of HHS
programs and priorities, and generally
to enable HHS to improve its outreach
strategies to ensure a diverse and broad
innovator constituency is fostered
through the use of challenges and prize
competitions). Finally, HHS may ask for
additional information tailored to the
challenge or prize competition through
structured questions. This information
will enable HHS to create and
administer challenges and prize
competitions more effectively.
Upon entry or during the judging
process, solvers under the age of 18 will
be asked to confirm parental consent,
which will require them to obtain and
provide a parent or guardian signature
in a format outlined in the specific
criteria of each challenge or prize
competition in order to qualify for the
contest. To protect online privacy of
minors, birthdate may be required by
the website host to ensure the challenge
platform meets the requirements of
COPPA. Eligibility to win a cash prize
will be outlined in the specific criteria
of each contest and will only apply to
U.S. citizens, permanent residents, or
private entities incorporated in and
maintaining a primary place of business
in the U.S. To administer the cash prize,
HHS will need to collect additional
relevant payment information—such as
Social Security Number and/or
Taxpayer ID and information regarding
the winners’ financial institutions—in
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[Page 25664]]
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
