# 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 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.