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draft guidance of the same title dated June 2022.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