Considerations for the Development of Chimeric Antigen Receptor T Cell Products; Guidance for Industry; Availability, 5910-5911 [2024-01789]
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5910
Federal Register / Vol. 89, No. 20 / Tuesday, January 30, 2024 / Notices
Emergency Preparedness and Response,
which is the lead in HHS for human
service preparation for, response to, and
recovery from, natural disasters.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2024–01728 Filed 1–29–24; 8:45 am]
BILLING CODE 4184–PC–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–D–0404]
Considerations for the Development of
Chimeric Antigen Receptor T Cell
Products; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance entitled ‘‘Considerations for
the Development of Chimeric Antigen
Receptor (CAR) T Cell Products;
Guidance for Industry.’’ The guidance is
intended to assist sponsors, including
industry and academic sponsors,
developing ex vivo-manufactured CAR
T cell products. The guidance provides
CAR T cell specific recommendations
regarding chemistry, manufacturing,
and control (CMC), pharmacology and
toxicology, and design of clinical
studies for oncology indications
(including hematologic malignancies
and solid tumors). The guidance
announced in this notice finalizes the
draft guidance of the same title dated
March 2022.
DATES: The announcement of the
guidance is published in the Federal
Register on January 30, 2024.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
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
VerDate Sep<11>2014
17:23 Jan 29, 2024
Jkt 262001
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–
2021–D–0404 for ‘‘Considerations for
the Development of Chimeric Antigen
Receptor (CAR) T Cell Products;
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.
• 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
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
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-201509-18/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, 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 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 240–402–8010. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
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.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a document entitled ‘‘Considerations for
the Development of Chimeric Antigen
Receptor (CAR) T Cell Products;
Guidance for Industry.’’ The guidance is
intended to assist sponsors, including
industry and academic sponsors,
developing ex vivo-manufactured CAR
T cell products. The guidance provides
CAR T cell specific recommendations
regarding CMC, pharmacology and
toxicology, and design of clinical
studies for oncology indications
(including hematologic malignancies
and solid tumors). Recommendations
E:\FR\FM\30JAN1.SGM
30JAN1
Federal Register / Vol. 89, No. 20 / Tuesday, January 30, 2024 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
specific to autologous or allogeneic CAR
T cell products are noted in the
guidance. The guidance also provides
recommendations for analytical
comparability studies for CAR T cell
products. While the guidance
specifically focuses on CAR T cell
products, some of the information and
recommendations provided may also be
applicable to other genetically modified
lymphocyte products, such as CAR
Natural Killer cells or T cell receptor
modified T cells.
In the Federal Register of March 16,
2022 (87 FR 14893), FDA announced the
availability of the draft guidance of the
same title dated March 2022. FDA
received numerous comments on the
draft guidance and those comments
were considered as the guidance was
finalized. Changes to the guidance
include clarifying the scope, focusing on
treatment for oncology indications, and
the recommendations for CAR T cells
manufactured using cellular starting
material from patients who have
received CAR T cells previously,
potency for CAR T cells that express
multiple transgene elements, stability
studies, and clinical monitoring. In
addition, editorial changes were made
to improve clarity. The guidance
announced in this notice finalizes the
draft guidance dated March 2022.
Elsewhere in this issue of the Federal
Register, FDA is announcing the
availability of another human gene
therapy final guidance entitled ‘‘Human
Gene Therapy Products Incorporating
Human Genome Editing; Guidance for
Industry.’’
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Considerations for
the Development of Chimeric Antigen
Receptor (CAR) T Cell 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 (44 U.S.C. 3501–
3521). The collections of information in
21 CFR part 50 have been approved
under OMB control number 0910–0130;
the collections of information in 21 CFR
part 211 have been approved under
OMB control number 0910–0139; the
VerDate Sep<11>2014
17:23 Jan 29, 2024
Jkt 262001
collections of information in 21 CFR
part 312 have been approved under
OMB control number 0910–0014; the
collections of information in 21 CFR
part 601 have been approved under
OMB control number 0910–0338; and
the collections of information in 21 CFR
part 1271 have been approved under
OMB control number 0910–0543.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/vaccines-blood-biologics/
guidance-compliance-regulatoryinformation-biologics/biologicsguidances, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Date: January 24, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–01789 Filed 1–29–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–3561]
Collection of Race and Ethnicity Data
in Clinical Trials and Clinical Studies
for Food and Drug AdministrationRegulated Medical Products; Draft
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Collection of Race and Ethnicity Data
in Clinical Trials and Clinical Studies
for FDA-Regulated Medical Products.’’
The purpose of this guidance is to
provide FDA’s expectations for, and
recommendations on, use of a
standardized approach for collecting
and reporting race and ethnicity data in
submissions including information
collected and reported from clinical
studies and clinical trials for FDAregulated medical products. Using
standard terminology for race and
ethnicity helps ensure that data are
collected and reported consistently in
submissions to FDA. This draft
guidance revises the final guidance for
industry and FDA staff entitled
‘‘Collection of Race and Ethnicity Data
in Clinical Trials’’ issued on October 26,
2016.
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
5911
Submit either electronic or
written comments on the draft guidance
by April 29, 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:
DATES:
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–
2016–D–3561 for ‘‘Collection of Race
and Ethnicity Data in Clinical Trials and
Clinical Studies for FDA-Regulated
Medical 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, 240–402–7500.
E:\FR\FM\30JAN1.SGM
30JAN1
]]>Agencies
[Federal Register Volume 89, Number 20 (Tuesday, January 30, 2024)]
[Notices]
[Pages 5910-5911]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-01789]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-D-0404]
Considerations for the Development of Chimeric Antigen Receptor T
Cell Products; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Considerations for the
Development of Chimeric Antigen Receptor (CAR) T Cell Products;
Guidance for Industry.'' The guidance is intended to assist sponsors,
including industry and academic sponsors, developing ex vivo-
manufactured CAR T cell products. The guidance provides CAR T cell
specific recommendations regarding chemistry, manufacturing, and
control (CMC), pharmacology and toxicology, and design of clinical
studies for oncology indications (including hematologic malignancies
and solid tumors). The guidance announced in this notice finalizes the
draft guidance of the same title dated March 2022.
DATES: The announcement of the guidance is published in the Federal
Register on January 30, 2024.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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-2021-D-0404 for ``Considerations for the Development of Chimeric
Antigen Receptor (CAR) T Cell Products; 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.
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, 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 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 240-402-8010. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT: 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.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a document entitled
``Considerations for the Development of Chimeric Antigen Receptor (CAR)
T Cell Products; Guidance for Industry.'' The guidance is intended to
assist sponsors, including industry and academic sponsors, developing
ex vivo-manufactured CAR T cell products. The guidance provides CAR T
cell specific recommendations regarding CMC, pharmacology and
toxicology, and design of clinical studies for oncology indications
(including hematologic malignancies and solid tumors). Recommendations
[[Page 5911]]
specific to autologous or allogeneic CAR T cell products are noted in
the guidance. The guidance also provides recommendations for analytical
comparability studies for CAR T cell products. While the guidance
specifically focuses on CAR T cell products, some of the information
and recommendations provided may also be applicable to other
genetically modified lymphocyte products, such as CAR Natural Killer
cells or T cell receptor modified T cells.
In the Federal Register of March 16, 2022 (87 FR 14893), FDA
announced the availability of the draft guidance of the same title
dated March 2022. FDA received numerous comments on the draft guidance
and those comments were considered as the guidance was finalized.
Changes to the guidance include clarifying the scope, focusing on
treatment for oncology indications, and the recommendations for CAR T
cells manufactured using cellular starting material from patients who
have received CAR T cells previously, potency for CAR T cells that
express multiple transgene elements, stability studies, and clinical
monitoring. In addition, editorial changes were made to improve
clarity. The guidance announced in this notice finalizes the draft
guidance dated March 2022.
Elsewhere in this issue of the Federal Register, FDA is announcing
the availability of another human gene therapy final guidance entitled
``Human Gene Therapy Products Incorporating Human Genome Editing;
Guidance for Industry.''
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Considerations for the Development of
Chimeric Antigen Receptor (CAR) T Cell 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 (44 U.S.C. 3501-3521). The collections of information in 21
CFR part 50 have been approved under OMB control number 0910-0130; 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
part 312 have been approved under OMB control number 0910-0014; the
collections of information in 21 CFR part 601 have been approved under
OMB control number 0910-0338; and the collections of information in 21
CFR part 1271 have been approved under OMB control number 0910-0543.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
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.
Date: January 24, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-01789 Filed 1-29-24; 8:45 am]
BILLING CODE 4164-01-P
