Notice2024-31536
Considerations for Including Tissue Biopsies in Clinical Trials; Draft Guidance for Industry, Investigators, Institutions, and Institutional Review Boards; Availability
Primary source
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Published
January 7, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) and the Office for Human Research Protections (OHRP) are announcing the availability of a draft guidance for industry, clinical investigators, institutions, and institutional review boards (IRBs) entitled "Considerations for Including Tissue Biopsies in Clinical Trials." This guidance provides recommendations regarding considerations for tissue biopsies that may be conducted in adults and in children as part of clinical trials evaluating investigational medical products and/or that are conducted or supported by the Department of Health and Human Services (HHS).
Full Text
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<title>Federal Register, Volume 90 Issue 4 (Tuesday, January 7, 2025)</title>
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[Federal Register Volume 90, Number 4 (Tuesday, January 7, 2025)]
[Notices]
[Pages 1173-1175]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-31536]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-D-2402]
Considerations for Including Tissue Biopsies in Clinical Trials;
Draft Guidance for Industry, Investigators, Institutions, and
Institutional Review Boards; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) and the
Office for Human Research Protections (OHRP) are announcing the
availability of a draft guidance for industry, clinical investigators,
institutions, and institutional review boards (IRBs) entitled
``Considerations for Including Tissue Biopsies in Clinical Trials.''
This guidance provides recommendations regarding considerations for
tissue biopsies that may be conducted in adults and in children as part
of clinical trials evaluating investigational medical products and/or
that are conducted or
[[Page 1174]]
supported by the Department of Health and Human Services (HHS).
DATES: Submit either electronic or written comments on the draft
guidance by March 10, 2025. to ensure that the Agency and OHRP consider
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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<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-2024-D-2402 for ``Considerations for Including Tissue Biopsies in
Clinical Trials.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or to the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; or to
the Office of Policy, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431,
Silver Spring, MD 20993-0002; or to the Office for Human Research
Protections, Division of Policy and Assurances, 1101 Wootton Pkwy.,
Suite 200, Rockville, MD 20852. Send one self-addressed adhesive label
to assist that office in processing your requests. See the
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT: Jennifer Gao, Oncology Center of
Excellence/Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2135, Silver
Spring, MD 20993-0002, 301-796-1397; or James Myers, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-
402-7911; or Christina Savisaar, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. G221, Silver Spring, MD 20993-0002, 301-796-6404; or Natalie
Klein, Division of Policy and Assurances, Office for Human Research
Protections, 1101 Wootton Pkwy., Suite 200, Rockville, MD 20852, 240-
453-6900 or 866-447-4777.
SUPPLEMENTARY INFORMATION:
I. Background
FDA and OHRP are announcing the availability of a draft guidance
for industry, clinical investigators, institutions, and IRBs entitled
``Considerations for Including Tissue Biopsies in Clinical Trials.''
This guidance is intended to assist industry, clinical investigators,
institutions, and IRBs in understanding considerations for tissue
biopsies that may be conducted in adults and in children as part of
clinical trials that evaluate investigational medical products and/or
that are conducted or supported by HHS. For the purposes of this
guidance, a biopsy is a procedure that involves acquisition of tissue
from a trial participant as part of a clinical trial protocol.
Although biopsies inherently include varying degrees of risk, in
some circumstances, biopsied tissue(s) may be the only way to obtain
information that is necessary to answer questions of interest in a
clinical trial, such as to determine trial eligibility or to evaluate
treatment effects. In general, when biopsies are to be conducted for
evaluation of non-key secondary endpoint(s) and/or exploratory
endpoints or for unspecified future
[[Page 1175]]
research uses, they should not be required and instead should be
optional.
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 and OHRP on
``Considerations for Including Tissue Biopsies in Clinical Trials.'' It
does not establish any rights for any person and is not binding on FDA,
OHRP, 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
related to the protection of human subjects under 21 CFR part 50 and
the IRB under 21 CFR part 56 have been approved under OMB control
number 0910-0130; the collection of information in 21 CFR part 812 have
been approved under OMB control number 0910-0078; the collections of
information in 21 CFR part 312, including Form FDA 1572, have been
approved under OMB control number 0910-0014 and the collections of
information in the guidance document, ``Requests for Feedback and
Meetings for Medical Device Submissions: The Q-Submission Program''
have been approved under OMB control number 0910-0756. The collections
of information in 21 CFR part 11 have been approved under OMB control
number 0910-0303. The collections of information in 45 CFR part 46 and
the final rule entitled, ``Federal Policy for the Protection of Human
Subjects'' (known as the Common Rule), have been approved under OMB
control number 0990-0260.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: December 27, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-31536 Filed 1-6-25; 8:45 am]
BILLING CODE 4164-01-P
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