[Federal Register Volume 87, Number 116 (Thursday, June 16, 2022)]
[Notices]
[Pages 36327-36329]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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Regenerative Medicine Therapies; Draft Guidance for Industry; 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Draft Guidance for Industry.'' The draft guidance describes a standards 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DATES: Submit either electronic or written comments on the draft 
guidance by September 14, 2022 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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: 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.
    <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 https://www.regulations.gov 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 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

[[Page 36328]]

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 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Request for recognition of a voluntary consensus standard/Section V               9                1                9                3               27
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 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: 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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