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###### Department of Health and Human Services

###### Food and Drug Administration

          - [Docket No. FDA-2022-D-0745]

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Notice of availability.

      ( print page 72488)    

# SUMMARY:

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies; Guidance for Industry.” The guidance document describes a standards recognition program for regenerative medicine therapies (SRP-RMT) at FDA's Center for Biologics Evaluation and Research (CBER) designed to identify Voluntary Consensus Standards (VCS) that might be used in the preparation and evaluation of submissions for Regenerative Medicine Therapy (RMT) products regulated by CBER when such standards are appropriate. The use of recognized VCS can assist stakeholders in more efficiently meeting regulatory requirements and increasing regulatory predictability for RMT products. This program is modeled after the formal standards and conformity assessment program (S-CAP) for medical devices where the term “recognize” refers to FDA's formal identification of a standard after the determination that the standard is appropriate to meet relevant requirements as defined by law. CBER encourages the use of appropriate standards in the development of CBER-regulated products. The guidance announced in this notice finalizes the draft guidance of the same title dated June 2022.

# DATES:

                        The announcement of the guidance is published in the                         **Federal Register**                         on October 20, 2023.                    

# 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. [insert docket number FDA-2022-D-0745] for “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” 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 the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist the office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-8010. See the                     **SUPPLEMENTARY INFORMATION**                     section for electronic access to the guidance document.                

# FOR FURTHER INFORMATION CONTACT:

Tami Belouin, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

# SUPPLEMENTARY INFORMATION:

## I. Background

FDA is announcing the availability of a document entitled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies; Guidance for Industry.” The guidance describes a program at FDA's CBER for recognition of VCS relevant to RMT products regulated in CBER. The SRP-RMT is designed to identify and recognize VCS to facilitate the development and assessment of RMT products. The voluntary use of recognized VCS can assist stakeholders in more efficiently meeting regulatory requirements and increasing regulatory predictability for RMT products. The program parallels the S-CAP for medical devices.

                    The guidance describes the purpose of the program, how the SRP-RMT is expected to facilitate RMT development, and describes how the Office of Therapeutic Products in CBER generally intends to evaluate VCS for recognition in the SRP-RMT. This program will not                           ( print page 72489)                        apply to: (1) statutory and regulatory standards that are legally binding, such as certain provisions of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301*et seq.*) and the Public Health Service Act (42 U.S.C. 6A); (2) standards developed by Standards Development Organizations that do not follow consensus mechanisms; or (3) electronic data exchange standards for submissions to CBER.                

                    In the                     **Federal Register**                     of Thursday, June 16, 2022 (87 FR 36327), FDA announced the availability of the draft guidance of the same title dated June 2022. FDA received a few comments on the draft guidance and those comments were considered as the guidance was finalized. A summary of changes includes minor edits to improve clarity and the addition of information regarding information collection provisions under the Paperwork Reduction Act of 1995. The guidance announced in this notice finalizes the draft guidance dated June 2022.                

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” It does not 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.

## II. Paperwork Reduction Act of 1995

This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information have been approved under OMB control number 0910-0338.

## III. Electronic Access

                    Persons with access to the internet may obtain the guidance at                     *https://www.fda.gov/​vaccines-blood-biologics/​guidance-compliance-regulatory-information-biologics/​biologics-guidances, https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents,*                     or                     *https://www.regulations.gov.*

Dated: October 17, 2023.

Lauren K. Roth,

Associate Commissioner for Policy.

[FR Doc. 2023-23156 Filed 10-19-23; 8:45 am]

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