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This draft guidance is being issued 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The draft guidance, when finalized, will 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may obtain the draft guidance at https:// 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] 

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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 


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