```

[Federal Register Volume 90, Number 4 (Tuesday, January 7, 2025)]
[Notices]
[Pages 1173-1175]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31536]

-----------------------------------------------------------------------

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Draft Guidance for Industry, Investigators, Institutions, and 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.

-----------------------------------------------------------------------

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availability of a draft guidance for industry, clinical investigators, 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DATES: Submit either electronic or written comments on the draft 
guidance by March 10, 2025.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your comment on this draft guidance before it begins work on the final 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:
     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-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 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 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 https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    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
```