76484 Federal Register / Vol. 89, No. 181 / Wednesday, September 18, 2024 / Notices 

regarding the roles and responsibilities 

of sponsors, investigators, healthcare 

institutions, and local healthcare 

providers and addresses using a quality 

by design approach to facilitate the 

conduct of trials in the clinical practice 

setting. 

This draft guidance is being issued 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The draft guidance, when finalized, will 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 

on ‘‘Integrating Randomized Controlled 

Trials for Drug and Biological Products 

Into Routine Clinical Practice.’’ It does 

not establish any rights for any person 

and is not binding on FDA 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 in 21 CFR parts 50 and 56 

have been approved under OMB control 

number 0910–0130; the collections of 

information in 21 CFR part 312 have 

been approved under OMB control 

number 0910–0014; the collections of 

information in 21 CFR part 314 have 

been approved under OMB control 

number 0910–0001; and the collections 

of information in 21 CFR part 601 have 

been approved under OMB control 

number 0910–0338. 

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may obtain the draft guidance at https:// 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/ 

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

https://www.regulations.gov. 

Dated: September 12, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–21077 Filed 9–17–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Drug Abuse; 

Notice of Closed Meetings 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings 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 grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute on 

Drug Abuse Special Emphasis Panel; Cohort 

Studies of HIV/AIDS and Substance Use. 

Date: November 4, 2024. 

Time: 10:00 a.m. to 5:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Health, 

National Institute on Drug Abuse, 301 North 

Stonestreet Avenue, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Soyoun Cho, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, Division of Extramural Research, 

National Institute on Drug Abuse, NIH, 301 

North Stonestreet Avenue, MSC 6021, 

Bethesda, MD 20892, (301) 594–9460, 

Soyoun.cho@nih.gov. 

Name of Committee: National Institute on 

Drug Abuse Special Emphasis Panel; 

Engaging Survivors of Sexual Violence and 

Trafficking in HIV and Substance Use 

Disorder Services. 

Date: November 6, 2024. 

Time: 11:30 a.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Health, 

National Institute on Drug Abuse, 301 North 

Stonestreet Avenue, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Marisa Srivareerat, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, Office of Extramural Policy, National 

Institute on Drug Abuse, NIH, 301 North 

Stonestreet Avenue, MSC 6021, Bethesda, 

MD 20892, (301) 435–1258, 

marisa.srivareerat@nih.gov. 

Name of Committee: National Institute on 

Drug Abuse Special Emphasis Panel; 

Harnessing Artificial Intelligence and 

Polypharmacology to Discover 

Pharmacotherapeutics for Substance Use 

Disorders. 

Date: November 13, 2024. 

Time: 10:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Health, 

National Institute on Drug Abuse, 301 North 

Stonestreet Avenue, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Devon Rene Oskvig, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, Division of Extramural Research, 

National Institute on Drug Abuse, NIH, 301 

North Stonestreet Avenue, MSC 6021, 

Bethesda, MD 20892, (301) 402–6965, 

devon.oskvig@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.277, Drug Abuse Scientist 

Development Award for Clinicians, Scientist 

Development Awards, and Research Scientist 

Awards; 93.278, Drug Abuse National 

Research Service Awards for Research 

Training; 93.279, Drug Abuse and Addiction 

Research Programs, National Institutes of 

Health, HHS) 

Dated: September 12, 2024. 

Lauren A. Fleck, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2024–21152 Filed 9–17–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings 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 grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Oncology 1—Basic 

Translational Integrated Review Group; Basic 

Mechanisms of Cancer Health Disparities 

Study Section. 

Date: October 15–16, 2024. 

Time: 10:00 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Amy L Rubinstein, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5152, 

MSC 7844, Bethesda, MD 20892, 301–408– 

9754, email: rubinsteinal@csr.nih.gov. 

Name of Committee: Oncology 2— 

Translational Clinical Integrated Review 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 89, No. 181 / Wednesday, September 18, 2024 / Notices 76485 

Group; Translational Immuno-oncology 

Study Section. 

Date: October 16–17, 2024. 

Time: 8:00 a.m. to 7:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency, Bethesda, One 

Bethesda Metro Center, Bethesda, MD 20814 

(In Person). 

Contact Person: Maria Elena CardenasCorona, Ph.D., Scientific Review Officer, 

Center for Scientific Review, National 

Institutes of Health, 6701 Rockledge Drive, 

Bethesda, MD 20817, 301–867–5309, email: 

maria.cardenas-corona@nih.gov. 

Name of Committee: Bioengineering 

Sciences & Technologies Integrated Review 

Group; Drug and Biologic Therapeutic 

Delivery Study Section. 

Date: October 16–17, 2024. 

Time: 8:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: St. Gregory Hotel, 2033 M Street 

NW, Washington, DC 20036 (In Person). 

Contact Person: Janice Duy, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, 6701 Rockledge Drive, 

Bethesda, MD 20892, 301–594–3139, email: 

janice.duy@nih.gov. 

Name of Committee: Musculoskeletal, Oral 

and Skin Sciences Integrated Review Group; 

Musculoskeletal Rehabilitation Sciences 

Study Section. 

Date: October 16–17, 2024. 

Time: 9:00 a.m. to 9:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Richard Michael Lovering, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 1000J, 

Bethesda, MD 20892, (301) 867–5309, email: 

loveringrm@mail.nih.gov. 

Name of Committee: Population Sciences 

and Epidemiology Integrated Review Group; 

Social and Environmental Determinants of 

Health Study Section. 

Date: October 16–17, 2024. 

Time: 9:00 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda Marriott, 5151 Pooks Hill 

Road, Bethesda, MD 20814 (In Person). 

Contact Person: Ananya Paria, MPH, MS, 

DHSC, Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 1007H, 

Bethesda, MD 20892, (301) 827–6513, email: 

pariaa@mail.nih.gov. 

Name of Committee: Social and 

Community Influences on Health Integrated 

Review Group; Health Promotion in 

Communities Study Section. 

Date: October 16–17, 2024. 

Time: 9:00 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Helena Eryam Dagadu, 

MPH, Ph.D., Scientific Review Officer, Center 

for Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3137, 

Bethesda, MD 20892, (301) 435–1266, email: 

dagaduhe@csr.nih.gov. 

Name of Committee: Interdisciplinary 

Molecular Sciences and Training Integrated 

Review Group; Cellular and Molecular 

Technologies Study Section. 

Date: October 16–17, 2024. 

Time: 9:00 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Tatiana V Cohen, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5213, 

Bethesda, MD 20892, 301–455–2364, email: 

tatiana.cohen@nih.gov. 

Name of Committee: Biological Chemistry 

and Macromolecular Biophysics Integrated 

Review Group; Biochemistry and Biophysics 

of Membranes Study Section. 

Date: October 16–17, 2024. 

Time: 9:30 a.m. to 8:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: James W Mack, Ph.D., 

Scientific Review Administrator, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4154, 

MSC 7806, Bethesda, MD 20892, (301) 435– 

2037, email: mackj2@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; PAR Panel: 

Academic-Industrial Partnerships for 

Translation of Technologies. 

Date: October 16, 2024. 

Time: 10:00 a.m. to 7:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Jennifer Ann Sanders, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Bethesda, MD 

20892, (301) 496–3553, email: 

jennifer.sanders@nih.gov. 

Name of Committee: Cell Biology 

Integrated Review Group; Biology and 

Development of the Eye Study Section. 

Date: October 16–17, 2024. 

Time: 10:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Robert O’Hagan, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Bethesda, MD 

20892, (240) 909–6378, email: ohaganr2@

csr.nih.gov. 

Name of Committee: Infectious Diseases 

and Immunology A Integrated Review Group; 

Bacterial Virulence Study Section. 

Date: October 16–17, 2024. 

Time: 10:00 a.m. to 9:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Susan Daum, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3202, 

Bethesda, MD 20892, 301–827–7233, email: 

susan.boyle-vavra@nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; BRAIN 

Initiative: Preclinical Proof of Concept for 

Novel Recording and Modulation 

Technologies in the Human CNS. 

Date: October 16, 2024. 

Time: 1:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Aurea D De Sousa, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5186, 

Bethesda, MD 20892, (301) 827–6829, email: 

aurea.desousa@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: September 12, 2024. 

Bruce A. George, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2024–21150 Filed 9–17–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Environmental 

Health Sciences; Notice of Closed 

Meetings 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings 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 grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Environmental Health 

Sciences Review Committee. 


khammond on DSKJM1Z7X2PROD with NOTICES