[Federal Register Volume 88, Number 179 (Monday, September 18, 2023)]
[Notices]
[Pages 63960-63963]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.reginfo.gov/public/do/PRAMain. 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, 
[email protected].

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:
     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 
https://www.fda.gov/cosmetics/registration-listing-cosmetic-product-facilities-and-products.
     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 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-registration-and-listing-cosmetic-product-facilities-and-products). 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.
     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.
     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...................................................
                                                         -----------------------------------------------------------------------------------------------
    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).
                               ---------------------------------------------------------------------------------
    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