Registration and Listing of Cosmetic Product Facilities and Products; Guidance for Industry; Availability, 87780-87781 [2023-27649]

Download as PDF 87780 Federal Register / Vol. 88, No. 242 / Tuesday, December 19, 2023 / Notices as possible to process the request. Closed captioning and live ASL interpreter services will be available. Shenaye´ V. Holmes, Senior Advisor, Federal Privacy Council, Made in America Council, Chief Acquisition Officers Council. [FR Doc. 2023–27781 Filed 12–18–23; 8:45 am] BILLING CODE 6820–69–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2023–D–1716] Registration and Listing of Cosmetic Product Facilities and Products; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled ‘‘Registration and Listing of Cosmetic Product Facilities and Products.’’ The guidance 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 This guidance also includes a new draft section, Appendix B, for comment purposes only, that describes frequently asked questions and answers about cosmetic product facility registrations and product listing submissions. Aside from that section, this guidance finalizes the draft guidance that was published on August 8, 2023. DATES: The announcement of the guidance is published in the Federal Register on December 19, 2023. However, the portion of this guidance that describes frequently asked questions and answers, is being distributed for comment purposes only. To ensure that the Agency considers your comment on this draft section before it begins work on the final version of this section of the guidance, submit either electronic or written comments on this section by January 18, 2024. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: lotter on DSK11XQN23PROD with NOTICES1 SUMMARY: Electronic Submissions Submit electronic comments in the following way: VerDate Sep<11>2014 17:33 Dec 18, 2023 Jkt 262001 • 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 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 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-201509-18/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 guidance to Office of Cosmetics and Colors, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 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 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: QuestionsAboutMoCRA@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background We are announcing the availability of a guidance for industry entitled ‘‘Registration and Listing of Cosmetic Product Facilities and Products.’’ We are issuing this guidance consistent with our good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on this topic. It does not E:\FR\FM\19DEN1.SGM 19DEN1 lotter on DSK11XQN23PROD with NOTICES1 Federal Register / Vol. 88, No. 242 / Tuesday, December 19, 2023 / Notices establish any rights for any person and is not binding on FDA or the public. You can use an alternative 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 (21 U.S.C. 364c(a)) 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 (21 U.S.C. 364h), are exempt from the registration and listing requirements. In the Federal Register of August 8, 2023 (88 FR 53490), we made available a draft guidance for industry entitled ‘‘Registration and Listing of Cosmetic Product Facilities and Products’’ and gave interested parties an opportunity to submit comments by September 7, 2023, for us to consider before beginning work on the final version of the guidance. We received numerous comments on the draft guidance and have modified the final guidance where appropriate. Changes to the guidance include additional information on the facility registration number, United States agent, electronic and paper submission, as well as incorporating FDA’s compliance policy we made available in a guidance for industry as described in the Federal Register of November 8, 2023 (88 FR 77323). In addition, we made editorial changes to improve clarity. New appendix B of this guidance is highlighted in grey, describes frequently asked questions and answers, and is marked ‘‘for comment purposes only’’ to provide an opportunity for comment before it is finalized. Aside from appendix B, this guidance finalizes the draft guidance that was published on August 8, 2023. II. Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. The previously approved VerDate Sep<11>2014 17:33 Dec 18, 2023 Jkt 262001 collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3521). The collections of information in section 607 of the FD&C Act have been approved under 0910– 0599. III. Electronic Access Persons with access to the internet may obtain the guidance at https:// www.fda.gov/CosmeticGuidances, https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, or https:// www.regulations.gov. Use the FDA websites listed in the previous sentence to find the most current version of the guidance. Dated: December 12, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–27649 Filed 12–18–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2023–P–4596] Determination That MEPHYTON (Phytonadione) Tablets, 5 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) has determined that MEPHYTON (phytonadione) tablets, 5 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements. FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5236, Silver Spring, MD 20993–0002, 301–796–8363, Stacy.Kane@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of an ANDA to market a generic version of a SUMMARY: PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 87781 previously approved drug product. To obtain approval, the ANDA applicant must show, among other things, that the generic drug product: (1) has the same active ingredient(s), dosage form, route of administration, strength, conditions of use, and (with certain exceptions) labeling as the listed drug, which is a version of the drug that was previously approved, and (2) is bioequivalent to the listed drug. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). Section 505(j)(7) of the FD&C Act requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the ‘‘Approved Drug Products With Therapeutic Equivalence Evaluations,’’ which is known generally as the ‘‘Orange Book.’’ Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug’s NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug. MEPHYTON (phytonadione) tablets, 5 mg, are the subject of NDA 010104, held by Bausch Health Americas, Inc., and initially approved in 1955. MEPHYTON is a vitamin K replacement indicated for the treatment of adults with the following coagulation disorders, which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity: • Anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives • Hypoprothrombinemia secondary to antibacterial therapy • Hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancreas, and regional enteritis • Other drug-induced hypoprothrombinemia where it is E:\FR\FM\19DEN1.SGM 19DEN1

Agencies

[Federal Register Volume 88, Number 242 (Tuesday, December 19, 2023)]
[Notices]
[Pages 87780-87781]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27649]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-1716]


Registration and Listing of Cosmetic Product Facilities and 
Products; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a final guidance for industry entitled ``Registration 
and Listing of Cosmetic Product Facilities and Products.'' The guidance 
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 guidance also includes a 
new draft section, Appendix B, for comment purposes only, that 
describes frequently asked questions and answers about cosmetic product 
facility registrations and product listing submissions. Aside from that 
section, this guidance finalizes the draft guidance that was published 
on August 8, 2023.

DATES: The announcement of the guidance is published in the Federal 
Register on December 19, 2023. However, the portion of this guidance 
that describes frequently asked questions and answers, is being 
distributed for comment purposes only. To ensure that the Agency 
considers your comment on this draft section before it begins work on 
the final version of this section of the guidance, submit either 
electronic or written comments on this section by January 18, 2024.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances 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 guidance to Office 
of Cosmetics and Colors, Center for Food Safety and Applied Nutrition, 
Food and Drug Administration, 5001 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 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

    We are announcing the availability of a guidance for industry 
entitled ``Registration and Listing of Cosmetic Product Facilities and 
Products.'' We are issuing this guidance consistent with our good 
guidance practices regulation (21 CFR 10.115). The guidance represents 
the current thinking of FDA on this topic. It does not

[[Page 87781]]

establish any rights for any person and is not binding on FDA or the 
public. You can use an alternative 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 (21 U.S.C. 364c(a)) 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 (21 U.S.C. 364h), are exempt from the registration and 
listing requirements.
    In the Federal Register of August 8, 2023 (88 FR 53490), we made 
available a draft guidance for industry entitled ``Registration and 
Listing of Cosmetic Product Facilities and Products'' and gave 
interested parties an opportunity to submit comments by September 7, 
2023, for us to consider before beginning work on the final version of 
the guidance. We received numerous comments on the draft guidance and 
have modified the final guidance where appropriate. Changes to the 
guidance include additional information on the facility registration 
number, United States agent, electronic and paper submission, as well 
as incorporating FDA's compliance policy we made available in a 
guidance for industry as described in the Federal Register of November 
8, 2023 (88 FR 77323). In addition, we made editorial changes to 
improve clarity. New appendix B of this guidance is highlighted in 
grey, describes frequently asked questions and answers, and is marked 
``for comment purposes only'' to provide an opportunity for comment 
before it is finalized. Aside from appendix B, this guidance finalizes 
the draft guidance that was published on August 8, 2023.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. The 
previously approved collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information 
in section 607 of the FD&C Act have been approved under 0910-0599.

III. Electronic Access

    Persons with access to the internet may obtain the 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: December 12, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-27649 Filed 12-18-23; 8:45 am]
BILLING CODE 4164-01-P

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