[Federal Register Volume 88, Number 248 (Thursday, December 28, 2023)]
[Notices]
[Pages 89707-89709]
[FR Doc No: 2023-28596]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-4299]

Potency Assurance for Cellular and Gene Therapy Products; Draft
Guidance for Industry; Availability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, Agency, or we) is
announcing the availability of a draft guidance entitled ``Potency
Assurance for Cellular and Gene Therapy Products.'' FDA is issuing this
draft guidance to provide recommendations to help assure the potency of
human cellular therapy or gene therapy (CGT) products at all stages of
the product lifecycle. FDA is recommending a comprehensive approach to
potency assurance of CGT products that is grounded in quality risk
management. For investigational products, we describe how to
progressively implement a strategy for potency assurance during product
development and provide additional considerations to help assure the
potency of products that are undergoing rapid clinical development. For
licensed products, we describe requirements for potency assurance,
including testing required for lot release.

DATES: Submit either electronic or written comments on the draft
guidance by March 27, 2024 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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.
FDA-2023-D-4299 for ``Potency Assurance for Cellular and Gene Therapy
Products.'' 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,<PHONE_NUMBER>.
     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,<PHONE_NUMBER>.
    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<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Myrna Hanna, 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 draft document entitled
``Potency Assurance for Cellular and Gene Therapy Products.'' FDA is
issuing this draft guidance to provide recommendations to help assure
the potency of human CGT products that are regulated as biological
products under section 351 of the Public Health Service Act (42 U.S.C.
262).
    In this draft guidance, we provide recommendations for developing a
science- and risk-based strategy to help assure the potency of human
CGT products. A potency assurance strategy is a multifaceted approach
that reduces risks to the potency of a product through: (1)
manufacturing process design, (2) manufacturing process control, (3)
material control, (4) in-process testing, and (5) potency lot release
assays. The goal of a potency assurance strategy is to ensure that
every lot of a product released will have the specific ability or
capacity to achieve the intended therapeutic effect.
    In this draft guidance, we emphasize that potency assays and their
corresponding acceptance criteria should be designed to make meaningful
contributions to potency assurance by reducing risks to product
potency. We provide illustrative examples of approaches to potency
assay development that are grounded in quality risk management. Due to
the diversity of CGT products and the product-specific nature of
potency assays, the recommendations in this draft guidance regarding
the selection and design of potency assays are necessarily general.
    This draft guidance, when finalized, is intended to supersede the
document entitled ``Guidance for Industry: Potency Tests for Cellular
and Gene Therapy Products,'' dated January 2011.
    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 potency
assurance for cellular and gene therapy products. 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

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in 21 CFR part 211 have been approved under OMB control number 0910-
0139; the collections of information in 21 CFR 312.23 have been

approved under OMB control number 0910-0014; the collections of
information in 21 CFR 600.14 have been approved under OMB control
number 0910-0458; and the collections of information in 21 CFR part 601
have been approved under OMB control number 0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, http://www.fda.gov/regulatory-information/search-fda-guidance-documents, or
https://www.regulations.gov.

    Dated: December 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-28596 Filed 12-27-23; 8:45 am]
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[Federal Register Volume 78, Number 163 (Thursday, August 22, 2013)]
[Notices]
[Page 52190]
[FR Doc No: 2013-20459]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. EF13-7-000, EF13-8-000, EF13-9-000, EF13-10-000, EF13-11-
000, EF13-12-000, EF13-13-000, EF13-14-000]

United States Department of Energy, Bonneville Power
Administration: Notice of Filing

    Take notice that on July 29, 2013, as supplemented on August 1,
2013, and August 14, 2013, the Bonneville Power Administration
submitted its Proposed 2014 Wholesale Power and Transmission Rates Rate
Adjustment, for confirmation and approval, to be effective October 1,
2013, through September 30, 2015.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on August 28, 2013.

    Dated: August 15, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-20459 Filed 8-21-13; 8:45 am]
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[Federal Register Volume 77, Number 25 (Tuesday, February 7, 2012)]
[Notices]
[Page 6112]
[FR Doc No: 2012-2705]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Commissioner and Staff Attendance at North American
Electric Reliability Corporation Meetings

    The Federal Energy Regulatory Commission hereby gives notice that
members of the Commission and/or Commission staff may attend the
following meetings:

North American Electric Reliability Corporation, Member Representatives
Committee and Board of Trustees Meetings.
Arizona Grand Resort, 8000 S. Arizona Grand Parkway, Phoenix, AZ 85044.

February 8, 2012 (1 p.m.-5 p.m.) and 9 (8 a.m.-1 p.m.)

    Further information regarding these meetings may be found at:
http://www.nerc.com/calendar.php.
    The discussions at the meetings, which are open to the public, may
address matters at issue in the following Commission proceedings:

Docket No. RC08-5, North American Electric Reliability Corporation
Docket No. RC11-1, North American Electric Reliability Corporation
Docket No. RC11-2, North American Electric Reliability Corporation
Docket No. RC11-5, North American Electric Reliability Corporation
Docket No. RC11-6, North American Electric Reliability Corporation
Docket No. RR08-4, North American Electric Reliability Corporation
Docket No. RR10-11, North American Electric Reliability Corporation
Docket No. RR12-3, North American Electric Reliability Corporation
Docket No. RD09-11, North American Electric Reliability Corporation
Docket No. RD10-2, North American Electric Reliability Corporation
Docket No. RD11-5, North American Electric Reliability Corporation
Docket No. R11-13, North American Electric Reliability Corporation
Docket No. RD12-3, North American Electric Reliability Corporation
Docket No. RD12-10, North American Electric Reliability Corporation
Docket No. NP11-238, North American Electric Reliability Corporation

    For further information, please contact Jonathan First, (202) 502-
8529, or<EMAIL_ADDRESS>
    Dated: February 1, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-2705 Filed 2-6-12; 8:45 am]
BILLING CODE 6717-01-P