Notice2023-20139
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Cosmetic Facility Registration, Product Listing, and Labeling Requirements
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Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 18, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Full Text
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<title>Federal Register, Volume 88 Issue 179 (Monday, September 18, 2023)</title>
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[Federal Register Volume 88, Number 179 (Monday, September 18, 2023)]
[Notices]
[Pages 63960-63963]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-20139]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-1029]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Cosmetic Facility
Registration, Product Listing, and Labeling Requirements
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing that a proposed collection of information has been submitted
to the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by October 18, 2023.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0599. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#2d7d7f6c7e594c4b4b6d4b494c0345455e034a425b"><span class="__cf_email__" data-cfemail="08585a495b7c696e6e486e6c692660607b266f677e">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Cosmetic Facility Registration, Product Listing, and Labeling
Requirements
OMB Control Number 0910-0599--Revision
This information collection supports implementation of statutory
and regulatory provisions that govern cosmetics. 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,
cosmetic product listing, and associated recordkeeping.
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 update our infrastructure to include a mechanism 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).
In the Federal Register of May 1, 2023 (88 FR 26564), we published
a 60-day notice requesting public comment on the proposed collection of
information. Several comments were received, however those not
pertaining to the PRA topics solicited in the notice are not addressed.
Comments pertaining to the necessity and practical utility of the
information being collected included concerns with protecting privacy
and
[[Page 63961]]
confidential commercial information. One comment expressed concern for
the disclosure of a person's residential address while another
suggested that a contract manufacturer would not be able to comply with
the facility registration provisions without disclosing the brands it
is manufacturing.
Comments pertaining to the accuracy of our burden estimates
questioned whether FDA assumes manufactures will need to change their
label due to new labeling requirements, whether our listing figures
reflect only products in the U.S. market or the number of products each
manufacturer makes, and another comment suggested that submissions for
registration and product listing will take more time than FDA estimated
based on its experience with VCRP.
Comments regarding ways to enhance the quality, utility, and
clarity of the information to be collected suggested that registration
under MoCRA should mirror FDA's Food Facility Registration program,
including aligning the biennial registration schedule between the
programs. Finally, comments regarding ways to minimize the burden of
the collection of information on respondents requested that FDA extend
the deadline for manufacturers to comply with the newly mandated
labeling, registration, and product listing requirements. Other
comments sought more information about the electronic system and forms
for registration and product listing including whether there is a fee.
While we have increased burden estimates we attribute to product
listing reporting activities in response to these public comments, we
intend to refrain from making further modifications to our burden
estimates until we have more experience with implementation of the new
mandatory requirements. Privacy and trade-secret, commercial
confidential information is governed by the Privacy Act of 1974 and
part 20 of our regulations (21 CFR part 20). The registration and
listing requirements set forth in section 605 of the FD&C Act (21
U.S.C. 364(c)) require that FDA begin receiving registration and
listing information no later than December 29, 2023. We have therefore
made no other modifications to the proposed collections of information.
At the same time, on our own initiative we have taken the following
actions:
<bullet> We have developed Form FDA 5066 entitled ``Registration of
Cosmetic Product Facility,'' and Form FDA 5067 entitled ``Cosmetic
Product Listing,'' to be used for registrations and product listings,
respectively. These forms will be available in paper format or via an
electronic system for submission. Draft screenshots of the paper forms
and electronic system for submission are available for viewing at
<a href="https://www.fda.gov/cosmetics/registration-listing-cosmetic-product-facilities-and-products">https://www.fda.gov/cosmetics/registration-listing-cosmetic-product-facilities-and-products</a>.
<bullet> We developed Agency guidance to further assist industry
with cosmetic registration and product listing requirements. In the
Federal Register of August 8, 2023 (88 FR 53490), we announced the
availability of a draft guidance for industry entitled ``Registration
and Listing of Cosmetic Product Facilities and Products'' (available at
<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-registration-and-listing-cosmetic-product-facilities-and-products">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-registration-and-listing-cosmetic-product-facilities-and-products</a>). The draft guidance, when finalized,
is intended to provide instruction and further assist industry in
preparing and submitting registrations and product listings required by
MoCRA. The draft guidance discusses, among other things, who must
register and list, when, and what must be submitted.
<bullet> Also in the Federal Register of August 8, 2023 (88 FR
53499), we announced a pilot, including instruction on participation,
intended to gather input to inform evaluation of the new electronic
cosmetic registration and listing submission portal.
<bullet> We have added information collection elements to account
for mandatory adverse event recordkeeping requirements under new
section 605 of the FD&C Act added by MoCRA, and we are revising OMB
control number 0910-0291 to include corresponding adverse event
reporting. We are currently modifying our MedWatch forms, approved in
0910-0291, to receive mandated adverse event reporting elements
associated with cosmetic products as introduced by MoCRA.
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
Legal authority; information collection activity Number of disclosures Total annual burden per Total hours Total capital
respondents per 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 1,518 24 36,432 1 36,432 $91,080,000
to send adverse event reports..........................
Sec. 609(c) of the FD&C Act (MoCRA); professional use 100 12 1,200 1 1,200 3,000,000
only...................................................
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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.
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
[[Page 63962]]
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.
Table 2--Estimated Annual Reporting Burden \1\
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No. of
Legal authority; information No. of responses per Total annual Average burden Total hours
collection activity respondents respondent responses per response
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Sec. 607(a)(1) of the FD&C 3,400 1 3,400 0.5 (30 minutes) 1,700
Act; initial registrations.
Sec. 607(a)(2) and (5) of the 1,700 1 1,700 0.25 (15 425
FD&C Act; biennial minutes).
registration renewals.
Sec. 607(a)(4) of the FD&C 100 1 100 0.25 (15 25
Act; registration updates. minutes).
Sec. 607(f) of the FD&C Act; 5 1 5 10.............. 50
post-hearing corrective
action plan.
Sec. 607(c)(1) and (2) of the 3,400 10 34,000 1............... 34,000
FD&C Act; cosmetic product
listing.
Sec. 607(c)(3) of the FD&C 3,400 10 34,000 0.25 (15 8,500
Act; product listing minutes).
abbreviated renewals.
Sec. 607(c)(5) of the FD&C 200 1 200 0.25 (15 50
Act; product listing updates. minutes).
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Total..................... .............. .............. .............. ................ 44,750
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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. We initially 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. We have since further increased the number of product
listings per respondent, which also increases the number of responses
(products). 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 and responses
resulting from new statutory requirements.
MoCRA amended the FD&C Act by adding section 605 to require, among
other requirements, responsible persons to submit reports of serious
adverse events to FDA no later than 15 business days after receiving
the report, including any new medical information received within 1
year of the initial report. The responsible person shall receive
adverse event reports through the domestic address, domestic telephone
number, or electronic contact information included on the label.
Further, FDA may request a complete list of ingredients in specific
fragrances or flavors in a cosmetic product if FDA has reasonable
grounds to believe that an ingredient or combination of ingredients has
caused a serious adverse event. We are revising the scope of OMB
control number 0910-0291 to include this reporting activity as we
modify corresponding electronic and paper-based forms.
Table 3--Estimated Annual Recordkeeping Burden \1\
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Legal authority; information collection Number of Number of records Total annual Average burden per
activity recordkeepers per recordkeeper records recordkeeping Total hours
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Sec. 605(e) of the FD&C Act; adverse 1,000 1 1,000 0.5 (30 minutes)............ 500
events records.
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\1\ There are no capital costs or operating costs associated with the collection of information.
MoCRA also amended the FD&C Act by adding recordkeeping
requirements. Responsible persons are required to maintain records
related to each report of an adverse event for a period of 6 years (or
3 years for a small business that does not manufacture or process
certain cosmetic products) and authorizes FDA to have access to such
records during an inspection. We base our estimate of recordkeeping
burden hours on estimates found in the information collection approved
under OMB control number 0910-0291 (FDA's Adverse Event and Product
Experience Reporting Program). The collection currently estimates 1,793
paper reports and 1,398 Safety Reporting Portal submissions, for CFSAN
which includes food, infant formula, and cosmetic products, equaling
3,191. We estimate that cosmetic products account for around a third of
the reports (estimating 1,000) with each report corresponding to a
separate recordkeeping. We estimate that maintaining the record will
take 30 minutes. However, once the
[[Page 63963]]
documents pertaining to an adverse event report have been assembled and
filed in accordance with MoCRA, we expect the records retention burden
to be minimal, as we believe most responsible persons would normally
keep this kind of record for at least several years after creating the
document, as a matter of usual and customary business practice.
Dated: September 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-20139 Filed 9-15-23; 8:45 am]
BILLING CODE 4164-01-P
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