63960 Federal Register / Vol. 88, No. 179 / Monday, September 18, 2023 / Notices 

Dated: September 13, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–20141 Filed 9–15–23; 8:45 am] 

BILLING CODE 4164–01–P 

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. 

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, PRAStaff@

fda.hhs.gov. 

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 


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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/registrationlisting-cosmetic-product-facilities-andproducts. 

• 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-fdaguidance-documents/draft-guidanceindustry-registration-and-listingcosmetic-product-facilities-andproducts). 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

Legal authority; information 

collection activity 

Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours Total capital 

costs 2

§ 701.3; ingredients in order of predominance .................................................... 1,518 21 31,878 1 31,878 ........................

§ 701.11; statement of identity ................. 1,518 24 36,432 1 36,432 ........................

§ 701.12; name and place of business .... 1,518 24 36,432 1 36,432 ........................

§ 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 send adverse 

event reports ........................................ 1,518 24 36,432 1 36,432 $91,080,000 

Sec. 609(c) of the FD&C Act (MoCRA); 

professional use only ........................... 100 12 1,200 1 1,200 3,000,000 

Total .................................................. ........................ ........................ ........................ ........................ 178,806 94,080,000 

1There are no operating and maintenance costs associated with this collection of information. 

2One-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 


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63962 Federal Register / Vol. 88, No. 179 / Monday, September 18, 2023 / Notices 

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

Legal authority; information collection 

activity 

No. of 

respondents 

No. of 

responses per 

respondent 

Total annual 

responses Average burden per response Total hours 

Sec. 607(a)(1) of the FD&C Act; initial registrations.3,400 1 3,400 0.5 (30 minutes) ............................... 1,700 

Sec. 607(a)(2) and (5) of the FD&C 

Act; biennial registration renewals.

1,700 1 1,700 0.25 (15 minutes) ............................. 425 

Sec. 607(a)(4) of the FD&C Act; registration updates.100 1 100 0.25 (15 minutes) ............................. 25 

Sec. 607(f) of the FD&C Act; posthearing corrective action plan.5 1 5 10 ..................................................... 50 

Sec. 607(c)(1) and (2) of the FD&C 

Act; cosmetic product listing.

3,400 10 34,000 1 ....................................................... 34,000 

Sec. 607(c)(3) of the FD&C Act; 

product listing abbreviated renewals.

3,400 10 34,000 0.25 (15 minutes) ............................. 8,500 

Sec. 607(c)(5) of the FD&C Act; 

product listing updates.

200 1 200 0.25 (15 minutes) ............................. 50 

Total ........................................... ........................ ........................ ........................ ........................................................... 44,750 

1There 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 paperbased forms. 

TABLE 3—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Legal authority; information 

collection activity 

Number of 

recordkeepers 

Number of records 

per recordkeeper 

Total annual 

records 

Average burden 

per recordkeeping Total hours 

Sec. 605(e) of the FD&C Act; 

adverse events records.

1,000 1 1,000 0.5 (30 minutes) ................... 500 

1There 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 


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Federal Register / Vol. 88, No. 179 / Monday, September 18, 2023 / Notices 63963 

1The following nine jurisdictions receive Title V 

Maternal and Child Health Block Grant Program 

funding: the District of Columbia, the Republic of 

the Marshall Islands, the Federated States of 

Micronesia, the Republic of Palau, the 

Commonwealth of Puerto Rico, the US Virgin 

Islands, Guam, American Samoa, and the 

Commonwealth of the Northern Mariana Islands. 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission to OMB for 

Review and Approval; Public Comment 

Request; Title V Maternal and Child 

Health Services Block Grant to States 

Program: Guidance and Forms for the 

Title V Application/Annual Report, 

OMB No. 0915–0172—Revision 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, 

HRSA submitted an Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and approval. Comments 

submitted during the first public review 

of this ICR will be provided to OMB. 

OMB will accept further comments from 

the public during the review and 

approval period. OMB may act on 

HRSA’s ICR only after the 30-day 

comment period for this notice has 

closed. 

DATES: Comments on this ICR should be 

received no later than October 18, 2023. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to 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. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email 

Joella Roland, the HRSA Information 

Collection Clearance Officer, at 

paperwork@hrsa.gov or call (301) 443– 

3983. 

SUPPLEMENTARY INFORMATION: 

Information Collection Request Title: 

Title V Maternal and Child Health 

(MCH) Services Block Grant to States 

Program: Guidance and Forms for the 

Title V Application/Annual Report 

OMB No. 0915–0172—Revision 

Abstract: The Title V MCH Services 

Block Grant to States Program is 

authorized by Sections 501–509 of Title 

V of the Social Security Act (42 U.S.C. 

701–709). HRSA is updating the Title V 

MCH Services Block Grant to States 

Program: Guidance and Forms for the 

Title V Application/Annual Report 

(‘‘Guidance’’). The updated edition will 

be the tenth edition of the Guidance. 

This Guidance is used annually by the 

50 states and nine jurisdictions 1

(hereafter referred to as ‘‘state’’) in 

applying for Block Grants under Title V 

of the Social Security Act and in 

preparing the required Annual Report. 

The updates being proposed by HRSA’s 

Maternal and Child Health Bureau for 

the tenth edition of the Guidance 

continue to support the federal-state 

partnership that is supported by the 

Title V MCH Services Block Grant and 

the state’s role in developing a 5-Year 

Action Plan that addresses its 

individual priority needs. These 

proposed updates build on and further 

refine the reporting structure and vision 

that was outlined in the previous ninth 

edition. As such, they are intended to 

enable a state to articulate a 

comprehensive description of its Title V 

program activities and its leadership 

efforts in advancing and assuring a 

public health system that serves the 

MCH population. HRSA’s proposed 

updates to the tenth edition of the 

Guidance were informed by 

consultation with State Title V MCH 

agencies, and by comments received 

from State Title V program leadership, 

national MCH leaders, other MCH 

stakeholders, and the public. A 60-day 

notice was published in the Federal 

Register on May 5, 2023, vol. 88, No. 87; 

pp. 29135–37 FR 29135–37. HRSA 

received 170 comments on the proposed 

updates to the tenth edition of the 

Guidance, from a variety of responders, 

including state Title V Programs, other 

state agencies, public health 

organizations, universities, members of 

the community, and other stakeholders. 

Of the 170 comments, 80 requested that 

stillbirth be addressed in the Guidance, 

and 71 requested that the oral health 

performance measures be retained as a 

national performance measure. The 

remainder of 19 comments included 

suggestions for clarifying instructions in 

certain sections of the Guidance, 

including examples of partnership with 

non-governmental organizations and 

family organizations, or responding to 

reporting burden on the universal 

performance measures. HRSA 

considered all public comments as part 

of its deliberative process in finalizing 

updates to the tenth edition of the Title 

V MCH Services Block Grant to States 

Program: Guidance and Forms for the 

Title V Application/Annual Report. 

A discussion of the public comments 

received during the 60-day comment 

period and HRSA’s response to the 

comments is set below: 

(1) Revised Approach for Interim-Year 

Reporting: States and diverse 

stakeholders expressed strong support 

for the proposed approach that would 

allow states to decide whether updates 

are needed to numerous sections of the 

guidance during interim years 2 through 

5, following submission of the 5-year 

Needs Assessment in year 1. In response 

to these comments, HRSA will maintain 

this approach in the tenth edition of the 

Guidance. 

(2) Streamlining and Reorganizing of 

the Guidance: States and diverse 

stakeholders expressed strong support 

for the proposed approach of 

streamlining and reorganizing the 

requirements for state narrative 

reporting, in order to eliminate 

duplication. In response to these 

comments, HRSA will maintain this 

approach in the tenth edition of the 

Guidance. 

(3) Family and Community 

Partnership: HRSA received comments 

related to clarifying expectations on 

reporting about family and community 

partnerships. In response to these 

comments, expectations around state 

Title V reporting on family and 

community partnerships will be 

clarified, such as reporting on 

partnership with HRSA’s Family-toFamily Health Information Centers, 

discussion on the impact these 

partnerships have on the MCH 

population, and their value in 

improving outcomes. 

(4) Health Equity: Comments received 

from states and stakeholders support the 

stronger emphasis on health equity, 

including it being a guiding principle of 

the Title V Program. In response to these 

comments, HRSA will maintain this 

approach in the tenth edition of the 

Guidance. 


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