Notice2023-16772
Pilot Program for Cosmetic Product Facility Registration and Listing Electronic Submissions User Acceptance Testing
Primary source
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
August 8, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 151 (Tuesday, August 8, 2023)</title>
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[Federal Register Volume 88, Number 151 (Tuesday, August 8, 2023)]
[Notices]
[Pages 53499-53500]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-16772]
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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.
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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
<a href="/cdn-cgi/l/email-protection#1174435d523f65746265787f76517775703f7979623f767e67"><span class="__cf_email__" data-cfemail="4f2a1d030c613b2a3c3b2621280f292b2e6127273c61282039">[email protected]</span></a>.
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: <a href="/cdn-cgi/l/email-protection#6702352b2449130214130e090027010306490f0f1449000811"><span class="__cf_email__" data-cfemail="f095a2bcb3de84958384999e97b0969491de989883de979f86">[email protected]</span></a>.
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
<a href="/cdn-cgi/l/email-protection#eb8eb9a7a8c59f8e989f82858cab8d8f8ac5838398c58c849d"><span class="__cf_email__" data-cfemail="bfdaedf3fc91cbdacccbd6d1d8ffd9dbde91d7d7cc91d8d0c9">[email protected]</span></a>. 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
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