Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 1173 

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 

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 

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 

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. 

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 


ddrumheller on DSK120RN23PROD with NOTICES1
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’’). 

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 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 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 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. 

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. 

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 

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; 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) 

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 

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 


ddrumheller on DSK120RN23PROD with NOTICES1