[Federal Register Volume 88, Number 83 (Monday, May 1, 2023)]
[Notices]
[Pages 26564-26566]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-09178]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-1029]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Cosmetic Labeling Requirements and Facility
Registration and Cosmetic Product Listing Program
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection
provisions in FDA's cosmetic labeling regulations and new statutory
provisions for cosmetic labeling, facility registration, and products
listing.
DATES: Either electronic or written comments on the collection of
information must be submitted by June 30, 2023.
ADDRESSES: 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. Eastern Time at the end of June 30, 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-1029 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Cosmetic Labeling Requirements
and Facility Registration and Cosmetic Product Listing Program.''
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 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: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA`s
functions, including whether the information will have practical
utility; (2) the accuracy of FDA`s estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the
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information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
Cosmetic Labeling Requirements and Facility Registration and Cosmetic
Product Listing Program
OMB Control Number 0910-0599--Revision
This information collection supports FDA's cosmetic labeling
regulations and new statutory provisions for cosmetic labeling,
facility registration, and products listing. On December 29, 2022, the
President signed into law the Consolidated Appropriations Act, 2023
(Pub. L. 117-328), which included the Modernization of Cosmetics
Registration Act of 2022 (MoCRA). MoCRA amended the Federal Food, Drug,
and Cosmetic Act (FD&C Act) by requiring, among other requirements,
manufacturers of cosmetic products to label products intended for use
only by licensed professionals to bear a label that the product must be
administered or used only by licensed professionals, in addition to
providing the same information on the label that is required of
cosmetic products intended for consumers. MoCRA also added the
requirement for cosmetic product labels to include contact information
through which the responsible person can receive adverse event reports.
Other requirements introduced by MoCRA include facility registration
and cosmetic product listing.
Cosmetic Labeling Requirements
The FD&C Act and the Fair Packaging and Labeling Act (the FPLA)
require that cosmetic manufacturers, packers, and distributors disclose
information about themselves or their products on the labels or
labeling of their products. Sections 201, 301, 502, 601, 602, 603, 701,
and 704 of the FD&C Act (21 U.S.C. 321, 331, 352, 361, 362, 363, 371,
and 374) and sections 4 and 5 of the FPLA (15 U.S.C. 1453 and 1454)
provide authority to FDA to regulate the labeling of cosmetic products.
Failure to comply with the requirements for cosmetic labeling may
render a cosmetic adulterated under section 601 of the FD&C Act or
misbranded under section 602 of the FD&C Act.
FDA's cosmetic labeling regulations are codified in part 701 (21
CFR part 701). Section 701.3 (21 CFR 701.3) requires the label of a
cosmetic product to bear a declaration of the ingredients in descending
order of predominance. Section 701.11 (21 CFR 701.11) requires the
principal display panel of a cosmetic product to bear a statement of
the identity of the product. Section 701.12 (21 CFR 701.12) requires
the label of a cosmetic product to specify the name and place of
business of the manufacturer, packer, or distributor. Section 701.13
(21 CFR 701.13) requires the label of a cosmetic product to declare the
net quantity of contents of the product.
MoCRA amended the FD&C Act by requiring, among other requirements,
manufacturers of cosmetic products to label products intended for use
only by licensed professionals to bear a label that the product must be
administered or used only by licensed professionals, in addition to
providing the same information on the label that is required of
cosmetic products intended for consumers. MoCRA also added the
requirement for cosmetic product labels to include contact information
(domestic address, phone number, or electronic contact information that
may include a website) through which the responsible person can receive
adverse event reports.
Facility Registration and Cosmetic Product Listing Program
MoCRA amended the FD&C Act by requiring, among other requirements,
operators and owners of facilities manufacturing or processing cosmetic
products to register with FDA and renew such registrations biennially.
Facilities will also need to notify FDA of any changes to information
that was required as part of registration. FDA may suspend registration
if we determine that a cosmetic product manufactured or processed by a
registered facility has a reasonable probability of causing serious
adverse health consequences or death. Upon notice that FDA intends to
suspend registration, the responsible person for the facility may
submit a corrective action plan for addressing the reasons for possible
suspension of the facility registration. MoCRA also added the
requirement for responsible persons to submit a product listing for
each of their cosmetic products to FDA.
As we develop a process to accept submissions for registrations and
product listings consistent with the provisions in MoCRA, we have
discontinued use of Forms FDA 2511, 2512, and 2512a, previously used
for voluntary registration activities and have stopped accepting new
submissions to the Voluntary Cosmetic Registration Program (VCRP).
Description of Respondents: Respondents to this collection of
information include cosmetic manufacturers and processors. Respondents
are from the private sector (for-profit businesses).
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Third-Party Disclosure Burden \1\
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Number of Average
21 CFR or FD&C Act section; activity Number of disclosures per Total annual burden per Total hours Total capital
respondents respondent disclosures disclosure costs \2\
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Sec. 701.3; ingredients in order of predominance........... 1,518 21 31,878 1 31,878 ..............
Sec. 701.11; statement of identity......................... 1,518 24 36,432 1 36,432 ..............
Sec. 701.12; name and place of business.................... 1,518 24 36,432 1 36,432 ..............
Sec. 701.13; net quantity of contents...................... 1,518 24 36,432 1 36,432 ..............
Sec. 609(a) of the FD&C Act (MoCRA); contact information to 1,518 24 36,432 1 36,432 $91,080,000
send adverse event reports..................................
Sec. 609(c) of the FD&C Act (MoCRA); professional use only... 100 12 1,200 1 1,200 3,000,000
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Total.................................................... .............. ............... .............. ........... 178,806 $94,080,000
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\1\ There are no operating and maintenance costs associated with this collection of information.
\2\ One-time burden for capital costs.
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The estimated annual third-party disclosure burden for labeling is
based on data available to the Agency, our knowledge of and experience
with cosmetics, and informal communications with industry. The hour
burden is the additional or incremental time that establishments need
to design and print labeling that includes the following required
elements: a declaration of ingredients in decreasing order of
predominance, a statement of the identity of the product, a
specification of the name and place of business of the establishment,
and a declaration of the net quantity of contents. These requirements
increase the time establishments needed to design labels because they
increase the number of label elements that establishments must consider
when designing labels. These requirements do not generate any recurring
burden per label because establishments must already print and affix
labels to cosmetic products as part of normal business practices.
Regarding the new statutory labeling requirements for products intended
for professional use only and contact information for manufacturers to
receive reports of adverse events, we estimate that there will be a
capital cost of $94,080,000 associated with relabeling. This is the
cost of designing a revised label and incorporating it into the
manufacturing process. We believe that this will be a one-time cost. We
estimate that the total third-party disclosure burden is 178,806 hours.
Table 2--Estimated Annual Reporting Burden \1\
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Number of
MoCRA citation; activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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Sec. 607(a)(1) of the FD&C Act; initial 3,400 1 3,400 1....................................... 3,400
registrations.
Sec. 607(a)(2) and (5) of the FD&C Act; 1,700 1 1,700 0.25 (15 minutes)....................... 425
biennial registration renewals.
Sec. 607(a)(4) of the FD&C Act; registration 100 1 100 0.25 (15 minutes)....................... 25
updates.
Sec. 607(f) of the FD&C Act; post-hearing 5 1 5 10...................................... 50
corrective action plan.
Sec. 607(c)(1) and (2) of the FD&C Act; 3,400 5 17,000 0.50 (30 minutes)....................... 8,500
cosmetic product listing.
Sec. 607(c)(3) of the FD&C Act; product 3,400 5 17,000 0.25 (15 minutes)....................... 4,250
listing renewals.
Sec. 607(c)(5) of the FD&C Act; product 200 1 200 0.25 (15 minutes)....................... 50
listing updates.
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Total..................................... .............. .............. .............. ........................................ 16,700
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
We base our estimate of reporting burden hours on information from
the VCRP, because it provided the best available data to FDA in terms
of the number of respondents and responses. We believe that the VCRP
reflected less than half of cosmetic manufacturers and processors
because it was a voluntary system. Accordingly, we doubled our estimate
for the number of respondents registering and used this number to
estimate other activities related to facility registration and cosmetic
product listing. Based on a review of the information collection since
our last request for OMB approval, we have increased our estimate to
account for an anticipated increase in respondents resulting from new
statutory requirements.
Dated: April 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-09178 Filed 4-28-23; 8:45 am]
BILLING CODE 4164-01-P