Notice2023-17460
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biologics License Applications Procedures and Requirements; Voluntary Consensus Standards
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 15, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 156 (Tuesday, August 15, 2023)</title>
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[Federal Register Volume 88, Number 156 (Tuesday, August 15, 2023)]
[Notices]
[Pages 55463-55464]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#510103100225303737113735307f3939227f363e27"><span class="__cf_email__" data-cfemail="4a1a180b193e2b2c2c0a2c2e2b64222239642d253c">[email protected]</span></a>.
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 <a href="https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biologics-license-applications-bla-process-cber">https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biologics-license-applications-bla-process-cber</a>
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 <a href="https://www.fda.gov/media/159237/download">https://www.fda.gov/media/159237/download</a>. 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
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