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Food and Drug Administration, HHS.
Notice of availability.
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(FDA or Agency) and the Office for Human Research Protections (OHRP) are announcing the availability of a draft guidance for industry, clinical investigators, institutions, and institutional review boards (IRBs) entitled “Considerations for Including Tissue Biopsies in Clinical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 ( printed page 1174) supported by the Department of Health and Human Services (HHS).
Submit either electronic or written comments on the draft guidance by March 10, 2025. to ensure that the Agency and OHRP consider your comment on this draft guidance before it begins work on the final version of the guidance.
You may submit comments on any guidance at any time as follows:
Submit electronic comments in the following way:
Submit written/paper submissions as follows:
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.
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Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th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.
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.
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 ( printed 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.
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.
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]
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