Considerations for Including Tissue Biopsies in Clinical Trials; Draft Guidance for Industry, Investigators, Institutions, and Institutional Review Boards; Availability, 1173-1175 [2024-31536]

Download as PDF Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ‘‘Collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway ddrumheller on DSK120RN23PROD with NOTICES1 OMB Control Number 0910–0001— Revision As noted, section 506 of the FD&C Act was modified by section 3210 of the CAA, which granted FDA additional authorities with additional obligations regarding the accelerated approval pathway. Among other revisions, section 3210 of the CAA provides statutory authority to help ensure timely completion of confirmatory trials of accelerated approval products, including that FDA may require as appropriate, a confirmatory study or studies to be underway prior to approval or within a specified time period after the date of approval of the product. The CAA also requires VerDate Sep<11>2014 18:44 Jan 06, 2025 Jkt 265001 sponsors to submit postmarketing reports to FDA on the progress of required confirmatory trials approximately every 180 days. This draft guidance describes FDA’s policies for implementing this statutory authority. FDA will use the reports to monitor the progress of confirmatory trials and take action, if necessary. The information is needed to support FDA’s efforts to protect the health of users of drugs approved under accelerated approval. We are requesting approval to revise the statutory authority reference in approved OMB control numbers 0910–0001 and 0910–0338 to include section 3210 of the CAA. Description of Respondents: Respondents to this information collection are sponsors of human drug and biological products. Burden Estimate: We reviewed the statutory authority granted by section 3210 of the CAA as well as our existing statutory authority and regulations. Section 506B of the FD&C Act (21 U.S.C. 356b), and implementing regulations in §§ 312.20, 314.81 and 601.70 (21 CFR 312.20, 314.81 and 601.70), provide for the submission of postmarket study reports, requiring sponsors of approved drugs and biological products to report to FDA on the progress of their postmarketing study commitments, including reports on required studies, clinical trials, and agreed upon commitments. We tentatively conclude that the change in our statutory authority adds no further information collection requirements and imposes no further burden beyond what is already required in our statutes and regulations and included in the approved ICRs for reporting the status of postmarketing study commitments. This draft guidance also refers to previously approved FDA collections of information. The collections of information in 21 CFR parts 50 and 56 for protection of human subjects and institutional review boards have been approved under OMB control number 0910–0130. The collections of information in 21 CFR part 312 for submission of investigational new drug applications, conduction of clinical trials and good clinical practice, meetings for design and implementation of drug development plans, and reports of data for confirmatory trials have been approved under OMB control number 0910–0014. The collections of information in 21 CFR part 314 for submission of new drug applications and abbreviated new drug applications have been approved under OMB control number 0910–0001. The collections of information in §§ 312.20, 314.81 and PO 00000 Frm 00095 Fmt 4703 Sfmt 4703 1173 601.70 for submission of postmarketing reports including accelerated approval clinical benefit studies have been approved under OMB control numbers 0910–0014, 0910–0001, and 0910–0338. The collections of information in 21 CFR parts 601 and 610 for submission of biologics license applications have been approved under OMB control number 0910–0338. The collections of information for expedited pathways for development programs of drugs and biologics for serious conditions have been approved under OMB control number 0910–0765. III. Electronic Access Persons with access to the internet may obtain the draft guidance at https:// www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/ regulatory-information/search-fdaguidance-documents, https:// www.fda.gov/vaccines-blood-biologics/ guidance-compliance-regulatoryinformation-biologics/biologicsguidances, or https:// www.regulations.gov. Dated: December 27, 2024. Kimberlee Trzeciak, Deputy Commissioner for Policy, Legislation, and International Affairs. [FR Doc. 2024–31527 Filed 1–6–25; 8:45 am] BILLING CODE 4164–01–P 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. 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 SUMMARY: E:\FR\FM\07JAN1.SGM 07JAN1 1174 Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 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’’). ddrumheller on DSK120RN23PROD with NOTICES1 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 VerDate Sep<11>2014 18:44 Jan 06, 2025 Jkt 265001 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-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 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 PO 00000 Frm 00096 Fmt 4703 Sfmt 4703 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 E:\FR\FM\07JAN1.SGM 07JAN1 Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 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. Dated: December 27, 2024. Kimberlee Trzeciak, Deputy Commissioner for Policy, Legislation, and International Affairs. II. Paperwork Reduction Act of 1995 Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. 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 QSubmission 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. ddrumheller on DSK120RN23PROD with NOTICES1 III. Electronic Access Persons with access to the internet may obtain the draft guidance at https:// www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/ regulatory-information/search-fdaguidance-documents, or https:// www.regulations.gov. [FR Doc. 2024–31536 Filed 1–6–25; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; A Solicitation of the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) for Small Business Innovation Research (SBIR) Contract Proposals (PHS 2025–1), NIH/NIAID 142—Adjuvant Development for Vaccines. Date: January 30–31, 2025. Time: 9:00 a.m. to 6:00 p.m. Place: National Institute of Allergy and Infectious Diseases, National Institutes of Health, 5601 Fishers Lane, Room 3G22, Rockville, MD 20892 (Video Assisted Meeting). Agenda: To review and evaluate contract proposals. Contact Person: Michael M. Opata, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 5601 Fishers Lane, Room 3G22, Rockville, MD 20892, 240–627–3319, michael.opata@ nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; HHS–NIH–CDC–SBIR PHS 2025–1 Phase I and Fast Track: Devices and Materials-Based Platforms for the Delivery of Broadly Neutralizing Antibodies (Topic 138). Date: January 24, 2025. Time: 1:00 p.m. to 4:00 p.m. Agenda: To review and evaluate contract proposals. Place: National Institute of Allergy and Infectious Diseases, National Institutes of Health, 5601 Fishers Lane, Room 3E71, Rockville, MD 20892 (Video Assisted Meeting). Contact Person: Samita S. Andreansky, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 5601 Fishers Lane, Room 3E71, Rockville, MD 20892, 240–669–2915, samita.andreansky@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) Dated: January 2, 2025. Victoria E. Townsend, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2025–00101 Filed 1–6–25; 8:45 am] BILLING CODE 4140–01–P Dated: January 2, 2025. Victoria E. Townsend, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2025–00099 Filed 1–6–25; 8:45 am] BILLING CODE 4140–01–P VerDate Sep<11>2014 18:44 Jan 06, 2025 Jkt 265001 PO 00000 Frm 00097 Fmt 4703 Sfmt 9990 1175 E:\FR\FM\07JAN1.SGM 07JAN1

Agencies

[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
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