# Registration and Listing of Cosmetic Product Facilities and Products; Draft Guidance for Industry; Availability
**AGENCY:**
Food and Drug Administration, HHS.
**ACTION:**
Notice of availability.
**SUMMARY:**
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled “Registration and Listing of Cosmetic Product Facilities and Products.” This draft guidance, when finalized, will assist persons submitting cosmetic product facility registrations and product listing submissions to FDA under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). This draft guidance is not final nor is it in effect at this time.
**DATES:**
Submit either electronic or written comments on the draft guidance by September 7, 2023 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
**ADDRESSES:**
You may submit comments on any guidance at any time as follows:
**Electronic Submissions**
Submit electronic comments in the following way:
• *Federal eRulemaking Portal: https://www.regulations.gov.* Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to *https://www.regulations.gov* will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on *https://www.regulations.gov.*
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
**Written/Paper Submissions**
Submit written/paper submissions as follows:
• *Mail/Hand Delivery/Courier (for written/paper submissions):* Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
*Instructions:* All submissions received must include the Docket No. FDA-2023-D-1716 for “Registration and Listing of Cosmetic Product Facilities and Products.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at *https://www.regulations.gov* or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on *https://www.regulations.gov.* Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: *https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.*
*Docket:* For access to the docket to read background documents or the electronic and written/paper comments received, go to *https://www.regulations.gov* and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
Submit written requests for single copies of the draft guidance to the Office of Cosmetics and Colors, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the *SUPPLEMENTARY INFORMATION* section for electronic access to the draft guidance.
**FOR FURTHER INFORMATION CONTACT:**
Jennifer Ross, Office of the Chief Scientist, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993-0002, 301-796-4880 (this is not a toll-free number), email: *[email protected].*
**SUPPLEMENTARY INFORMATION:**
**I. Background**
FDA is announcing the availability of a draft guidance for industry entitled “Registration and Listing of Cosmetic Product Facilities and Products.” We are issuing the draft guidance consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternate approach if it satisfies the requirements of the applicable statutes and regulations.
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 one year after the date of enactment. 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. 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.
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.
**II. Paperwork Reduction Act of 1995**
This draft guidance refers to collections of information subject to review and approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). As required by the PRA, FDA published an analysis of burden associated with reporting provisions found in section 607 of the FD&C Act in the *Federal Register* of May 1, 2023 (88 FR 26564) and is currently inviting comment on the proposed collection of information. As required by the PRA, FDA will publish a subsequent notice announcing that the proposed collection of information has been submitted to OMB for review and approval, and provide an additional opportunity for public comment.
**III. Electronic Access**
Persons with access to the internet may obtain the draft guidance at *https://www.fda.gov/CosmeticGuidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents,* or *https://www.regulations.gov.* Use the FDA websites listed in the previous sentence to find the most current version of the guidance.
Dated: August 2, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.