Document ID: FDA-2022-D-0745-0011
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biologics License Applications Procedures and Requirements; Voluntary Consensus Standards
Posted Date: 2023-08-15T04:00Z

[Federal Register Volume 88, Number 156 (Tuesday, August 15, 2023)]
[Notices]
[Pages 55463-55464]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17460]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Biologics License 
Applications Procedures and Requirements; Voluntary Consensus Standards

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing that a proposed collection of information has been submitted 
to the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the 
collection of information by September 14, 2023.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0338. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10 a.m.-12 p.m., 
11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Biologics License Applications (BLAs) Procedures and Requirements

OMB Control Number 0910-0338--Revision

    This information collection helps support FDA implementation of 
statutory and regulatory requirements that govern biologics product 
licensing. We have issued regulations in 21 CFR parts 600-680 setting 
forth applicable standards and procedures that include associated 
reporting, recordkeeping, and disclosure requirements. Respondents to 
the information collection are persons or entities who engage in 
manufacture of biologics products. We provide information on our 
website at https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biologics-license-applications-bla-process-cber 
regarding BLAs, including available Agency resources.
    We are revising the information collection to support 
implementation of a standards recognition program for regenerative 
medicine therapies at FDA's Center for Biologics Evaluation and 
Research (CBER) designed to identify and recognize 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 draft guidance for industry 
entitled ``Voluntary Consensus Standards Recognition Program for 
Regenerative Medicine Therapies'' (June 2022) describes procedures CBER 
will follow when a request for recognition of a VCS is received. The 
draft guidance also explains that any interested party may request 
recognition of a VCS. The draft guidance document is available for 
download at https://www.fda.gov/media/159237/download. We issued the 
guidance document consistent with our Good Guidance Practice 
regulations in 21 CFR 10.115, which provide for public comment at any 
time. We intend on finalizing the guidance document upon OMB approval 
of the attendant information collection.
    The use of recognized VCS can assist stakeholders in more 
efficiently meeting regulatory requirements and increasing regulatory 
predictability for RMT products. We will use requests for recognition 
to help identify appropriate VCS that facilitate the development and 
assessment of RMT products. We encourage sponsors to use FDA-recognized 
VCS in submissions, as conformity to relevant standards helps 
streamline regulatory review, foster quality, and may facilitate a 
manufacturer's preparation of submissions. As explained in Section V of 
the draft guidance document, any stakeholder can request recognition of 
a specific VCS.
    In the Federal Register of June 16, 2022 (87 FR 36327), we 
published a 60-day notice announcing the availability of the draft 
guidance and invited public comment on the proposed collection of 
information. We received comment letters supportive of our use of 
voluntary consensus standards for regenerative medicine therapies. 
Comments encouraged broad application of a voluntary consensus program. 
No comments were received regarding the request for recognition 
information collection provisions and FDA's need for the information; 
the accuracy of our burden estimate; ways to enhance the quality, 
utility, and clarity of the information to be collected in the 
requests; or ways to minimize burden of the requests. Comments are 
being considered as the guidance is finalized.
    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 55464]]

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
 Voluntary consensus standards recognition program for regenerative     Number of      responses per     Total annual    Average burden    Total hours
             medicine therapies; guidance for industry                 respondents       respondent       responses       per response
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Request for recognition of a voluntary consensus standard and                     9                1                9                3               27
 submission of information as specified in Section V...............
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Our estimate is based on our experience with similar information 
collection activities. We note that standards development can be a 
lengthy process and provide an estimate we believe reflects the amount 
of time necessary to prepare and submit the information as discussed in 
Section V of the guidance document.

    Dated: August 9, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-17460 Filed 8-14-23; 8:45 am]
BILLING CODE 4164-01-P