Document ID: FDA-2022-D-0745-0012
Agency: fda
Document Type: Notice
Title: Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies; Guidance for
Industry; Availability
Posted Date: 2023-10-20T04:00Z

[Federal Register Volume 88, Number 202 (Friday, October 20, 2023)]
[Notices]
[Pages 72487-72489]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-23156]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Voluntary Consensus Standards Recognition Program for 
Regenerative Medicine Therapies; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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[[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draft guidance of the same title dated June 2022.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

[[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]
BILLING CODE 4164-01-P