National Institute on Drug Abuse; Notice of Closed Meetings, 76484 [2024-21152]

Download as PDF 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 This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine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 Electronic Access khammond on DSKJM1Z7X2PROD with NOTICES Persons with access to the internet may obtain the draft guidance at https:// www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/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 VerDate Sep<11>2014 17:11 Sep 17, 2024 Jkt 262001 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. PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 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 E:\FR\FM\18SEN1.SGM 18SEN1

Agencies

[Federal Register Volume 89, Number 181 (Wednesday, September 18, 2024)]
[Notices]
[Page 76484]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-21152]


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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, [email protected].

    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, 
[email protected].

    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, [email protected].

(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


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