
[Federal Register Volume 88, Number 151 (Tuesday, August 8, 2023)]
[Notices]
[Pages 53499-53500]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-16772]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-3107]


Pilot Program for Cosmetic Product Facility Registration and 
Listing Electronic Submissions User Acceptance Testing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Office of Cosmetics and Colors (OCAC) and the Office of 
the Chief Scientist (OCS) in the Food and Drug Administration (FDA, 
Agency, or we) are soliciting applications from members of the cosmetic 
product industry interested in participating in a voluntary pilot 
program to conduct user acceptance testing to help OCAC and OCS 
evaluate a potential new electronic submissions portal for cosmetic 
product facility registration and listing. This electronic submission 
portal is being implemented pursuant to the Modernization of Cosmetics 
Regulation Act of 2022 (MoCRA). OCAC and OCS plan to accept up to nine 
participants for the pilot program. The pilot program is intended to 
provide OCAC and OCS input to inform evaluation of this new electronic 
submission portal.

DATES: Interested parties should submit an electronic application to 
participate in this pilot program by August 22, 2023. We plan to 
conduct pilot testing beginning on or about September 15, 2023. See 
section III of this document for information on applying for 
participation.

ADDRESSES: If you are interested in participating in this pilot 
program, please submit an electronic application to 
[email protected].

FOR FURTHER INFORMATION CONTACT: Jennifer Ross, Office of the Chief 
Scientist, Food and Drug Administration, 301-796-4880 (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 
MoCRA. Among other provisions, MoCRA added section 607 to the Federal 
Food, Drug, and Cosmetic Act (FD&C Act), establishing requirements for 
cosmetic product facility registration and cosmetic product listing.
    Section 607(a) of the FD&C Act requires every person that owns or 
operates a facility that engages in the manufacturing or processing of 
a cosmetic product for distribution in the United States to register 
each facility with FDA no later than 1 year after the date of 
enactment. In addition to the registration requirements, section 607(c) 
of the FD&C Act requires that for each cosmetic product, the 
responsible person submit to FDA ``a cosmetic product listing.'' 
Certain small businesses, as defined in section 612 of the FD&C Act, 
are exempt from the registration and listing requirements.
    FDA previously had a voluntary cosmetics registration program (see 
21 CFR parts 710 and 720). Because the information in the voluntary 
cosmetics registration program differs from the information required to 
be submitted under MoCRA, FDA does not consider previous submissions to 
the voluntary cosmetics registration program to satisfy the 
registration and listing mandated by MoCRA. Accordingly, FDA ended its 
voluntary registration program as of March 27, 2023, while we work 
toward establishing a new system, and information in the voluntary 
cosmetics registration program will not be transferred to this new 
system.
    While electronic submission of registration and listing information 
is not required, FDA is strongly encouraging electronic submission to 
facilitate efficiency and timeliness of data submission and management 
by FDA. To that end, FDA will make an electronic portal available to 
streamline the data entry process for registration and product listing. 
Consequently, OCAC and OCS are announcing a pilot program to test the 
functionality and usability of the new electronic submission process.

II. Pilot Program Participation

    The pilot program to evaluate the cosmetic product facility 
registration and listing electronic submission processes is to begin on 
or about September 15, 2023, and last approximately 2 weeks. FDA plans 
to select up to nine participants who represent a broad spectrum 
representation of the cosmetic product industry. Pilot program 
participants will receive training and may be asked to submit simulated 
regulatory submissions and/or information for their cosmetic products. 
During the pilot program, staff will be available to

[[Page 53500]]

address questions or concerns that may arise. Pilot program 
participants will also be asked to provide written and verbal feedback 
during their training and after they submit the simulated registration 
and listing information. This feedback will assist OCAC and OCS in 
ensuring the electronic submission portal is usable and functional to 
ensure industry will be able to meet its statutory obligations. OCAC 
and OCS estimate that each individual participant's involvement may 
require about 8 hours over the 2-week period. OCAC and OCS are 
soliciting applications from members of the cosmetic product industry 
who will be required to register their facilities and list their 
products, such as cosmetic product manufacturers, as well as entities 
that may act as authorized agents for manufacturers. At its discretion, 
OCAC and OCS may withdraw a participant from the pilot program for not 
completing the requested activities within requested timeframes.
    None of the information submitted during the pilot will fulfill a 
participant's registration and listing responsibilities pursuant to 
MoCRA. Participants will need to submit their information in the 
electronic registration and listing system once it is available for 
submissions or through a paper form to fulfill their registration and 
listing responsibilities pursuant to MoCRA.
    Entities that may be eligible to participate in this voluntary 
pilot program for cosmetic product facility registration and listing 
are limited to those firms following the procedures set out in section 
III. and that also meet the two selection criteria that follow:
    1. required to submit cosmetic product facility registration and 
listing information to FDA pursuant to MoCRA by December 29, 2023; and,
    2. willing to provide feedback on the cosmetic product facility 
registration and listing electronic submission process.

III. Applications for Participation

    To be considered to participate in the pilot program, entities 
should submit a statement of interest for participation to 
[email protected]. The statement of interest should include the 
following information: company and contact name, contact phone number, 
and contact email address, size of the company (i.e., number of 
personnel and the approximate amount of revenue per year), agreement to 
the selection criteria in section II of this document, as well as the 
number of cosmetic product(s) and a description of the cosmetic 
product(s) intended to be submitted in the pilot program in enough 
detail to verify that the cosmetic product(s) are not drug product(s). 
A firm can choose to submit information for a subset of their products 
rather than all their products in the pilot program.
    Additionally, although not required for consideration, FDA is 
interested in whether you are a manufacturer or may act as an 
authorized agent, and whether you have previously submitted 
registration and listing information to the Agency for any regulated 
product. Once statements of interest for participation in the pilot are 
received, FDA will contact interested applicants to confirm selection 
for the pilot program. FDA will not notify interested applicants who 
are not selected for the pilot program. FDA will select no more than 
nine participants, who best meet the selection criteria and who reflect 
a broad spectrum of cosmetic product manufacturers and processors, 
including companies that range in size and develop a range of products, 
or are an authorized agent. In the event a large number of submissions 
are received, FDA may only review a small number of submissions in 
order to identify nine (or fewer) for the pilot program.

    Dated: August 2, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-16772 Filed 8-7-23; 8:45 am]
BILLING CODE 4164-01-P


