Notice2022-12928
Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
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Published
June 16, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled "Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies; Draft Guidance for Industry." The draft guidance describes a standards recognition program for regenerative medicine therapies (SRP-RMT) at FDA's Center for Biologics Evaluation and Research (CBER) designed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) to facilitate the development and assessment of regenerative medicine therapy (RMT) products regulated by CBER when such standards are appropriate. The voluntary use of recognized VCS can assist stakeholders in more efficiently meeting regulatory requirements and increasing regulatory predictability for RMT products. The program is modeled after the formal standards and conformity assessment program (S-CAP) for medical devices.
Full Text
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<title>Federal Register, Volume 87 Issue 116 (Thursday, June 16, 2022)</title>
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[Federal Register Volume 87, Number 116 (Thursday, June 16, 2022)]
[Notices]
[Pages 36327-36329]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-12928]
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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Regenerative Medicine Therapies; Draft Guidance for Industry;
Availability; Agency Information Collection Activities; Proposed
Collection; Comment Request
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 draft document entitled ``Voluntary Consensus
Standards Recognition Program for Regenerative Medicine Therapies;
Draft Guidance for Industry.'' The draft guidance describes a standards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) to facilitate the
development and assessment of regenerative medicine therapy (RMT)
products regulated by CBER when such standards are appropriate. The
voluntary use of recognized VCS can assist stakeholders in more
efficiently meeting regulatory requirements and increasing regulatory
predictability for RMT products. The program is modeled after the
formal standards and conformity assessment program (S-CAP) for medical
devices.
DATES: Submit either electronic or written comments on the draft
guidance by September 14, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance. Submit either electronic or written comments
on the collection of information by August 15, 2022.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2022-D-0745 for ``Voluntary Consensus Standards Recognition Program
for Regenerative Medicine Therapies; Draft Guidance for Industry.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the
[[Page 36328]]
electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 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 draft 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 draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Regarding the draft guidance: 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.
Regarding the proposed collection of information: JonnaLynn
Capezzuto, Office of Operations, Food and Drug Administration, Three
White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD
20852, 301-796-3794, <a href="/cdn-cgi/l/email-protection#603032213314010606200604014e0808134e070f16"><span class="__cf_email__" data-cfemail="e8b8baa9bb9c898e8ea88e8c89c680809bc68f879e">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft document entitled
``Voluntary Consensus Standards Recognition Program for Regenerative
Medicine Therapies; Draft Guidance for Industry.'' The draft 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. CBER is issuing this draft guidance to
obtain public comments on the program.
The draft guidance describes the purpose of the program, how the
SRP-RMT is expected to facilitate RMT development, and describes how
the Office of Tissues and Advanced Therapies in CBER generally intends
to evaluate VCS for recognition in the SRP-RMT. This program will not
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.); (2) standards developed by
Standards Development Organizations (SDOs) that do not follow consensus
mechanisms; or (3) electronic data exchange standards for submissions
to CBER.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent 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
Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3521), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a
60-day notice in the Federal Register concerning each proposed
collection of information before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Request for Recognition of a Voluntary Consensus Standard
OMB Control Number 0910-0338--Revision
Description: The draft guidance for industry entitled ``Voluntary
Consensus Standards Recognition Program for Regenerative Medicine
Therapies'' provides guidance to industry about a program at CBER for
recognition of VCS relevant to RMT products regulated in CBER. The
voluntary use of recognized standards can assist stakeholders in more
efficiently meeting regulatory requirements and increasing regulatory
predictability for RMT products.
The draft guidance describes the procedures CBER follows when a
request for recognition of a VCS is received. The draft guidance also
provides that any interested party may request recognition of a VCS.
Section V of the draft guidance provides that a stakeholder can request
recognition of a specific VCS by submitting an email request to SRP-
RMT, and recommends that the request should, at a minimum, contain the
following information:
<bullet> Name and electronic or mailing address of the requester;
<bullet> Name of the SDO;
<bullet> Title of the VCS;
<bullet> The VCS reference or SDO designation number and
publication date (e.g., Q1234-2019);
<bullet> Proposed list of products for which a standard could apply
routinely;
<bullet> Rationale for request; and
<bullet> A brief description of the testing, performance, or other
characteristics of the RMT products(s) or process(es) that would be
addressed by the proposed standard.
We will use the requests to help identify for recognition
appropriate VCS to facilitate the development and assessment of RMT
products. The information is needed to support FDA's efforts to protect
the public health and increase regulatory predictability for RMT
products. We are requesting approval to revise the information
collections included in OMB control number 0910-0338 to include the
information collection associated with the draft guidance.
Description of Respondents: Respondents to this collection of
information are product sponsors, applicants and other stakeholders
interested in the development of RMT products regulated in CBER.
We estimate the burden of this collection of information as
follows:
[[Page 36329]]
Table 1--Estimated Annual Reporting Burden 1
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Number of
Activity/draft guidance section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Request for recognition of a voluntary consensus standard/Section V 9 1 9 3 27
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
In preparing our estimates of the annual number of respondents and
the average burden per response, we reviewed estimates made by other
FDA Centers regarding similar requests for recognition of standards,
specifically the Center for Devices and Radiological Health (83 FR
46740 at 46742; September 14, 2018) and the Center for Drug Evaluation
and Research (84 FR 4076 at 4078; February 14, 2019). We note that
standards development is a lengthy process and the list of VCS that are
potentially suitable for recognition by CBER is growing but not
extensive. We determined that it would be reasonable to use an estimate
of nine respondents, consistent with the estimates made by the other
Centers. However, we increased our estimate of the amount of time it
would take to prepare a request from 1 hour to 3 hours, given the
amount of information that needs to be included in each VCS request.
Still, because this is a new program, FDA is uncertain of the burden
and seeks input on this estimate.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at either <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</a>,
<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: June 9, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-12928 Filed 6-15-22; 8:45 am]
BILLING CODE 4164-01-P
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