National Institute of General Medical Sciences; Notice of Closed Meetings, 36822-36823 [2024-09671]

Download as PDF 36822 Federal Register / Vol. 89, No. 87 / Friday, May 3, 2024 / Notices ‘‘Reference Drug’’) on the selected drug list for a given initial price applicability year (the ‘‘Biosimilar Delay’’). This information is required in order for CMS to accurately determine if a drug meets the criteria for the Biosimilar Delay for initial price applicability year 2027 in accordance with section 1192(f) of the Act. To ensure that the delay of selection and negotiation of biologics is only applied if there is a high likelihood of biosimilar market entry that meets the requirements for the Biosimilar Delay, a Biosimilar Manufacturer that seeks the Biosimilar Delay must submit information to CMS related to the Biosimilar. This information includes identifying information for the Biosimilar and the Reference Drug; the licensure status of the Biosimilar; attestations that the Biosimilar Manufacturer is not the same or treated as the same entity as the Reference Manufacturer, that the Biosimilar Manufacturer and the Reference Manufacturer (who is the manufacturer of the Reference Drug) have not entered into an agreement that requires or incentivizes the Biosimilar Manufacturer to submit the Biosimilar Delay, or directly or indirectly restricts the quantity of the Biosimilar that may be sold in the United States over a specified period of time; and documentation specified under section 1192(f)(3) of the Act to demonstrate there is a high likelihood of Biosimilar market entry within two years of the statutorily-defined selected drug publication date for initial price applicability year 2027. Form Number: CMS–10844 (OMB control number: 0938–1443); Frequency: Once; Affected Public: Private sector, Business or other for-profit; Number of Respondents: 25; Number of Responses: 25; Total Annual Hours: 415. (For policy questions regarding this collection contact Elisabeth Daniel at 667–290–8793.) William N. Parham, III Director, Division of Information Collections and Regulatory Impacts, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2024–09699 Filed 5–2–24; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES lotter on DSK11XQN23PROD with NOTICES1 National Institutes of Health National Institute on Aging; Notice of Closed Meeting Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. VerDate Sep<11>2014 18:11 May 02, 2024 Jkt 262001 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 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 Aging Special Emphasis Panel; Lifestyle Intervention for Late-midlife Adults. Date: May 29, 2024. Time: 2:00 p.m. to 4:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Janetta Lun, Ph.D., Scientific Review Officer, National Institute on Aging, National Institutes of Health, 7201 Wisconsin Avenue (#213), Bethesda, MD 20814, (301) 827–4588, janetta.lun@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS) Dated: April 29, 2024. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2024–09629 Filed 5–2–24; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Eye Institute; 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 Eye Institute Special Emphasis Panel; Stimulating Access to Research in Residency (StARR) Applications. Date: June 5, 2024. Time: 10:00 a.m. to 1:00 p.m. PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 Agenda: To review and evaluate grant applications. Place: National Eye Institute, 6700 Rockledge Dr., Bethesda, MD 20817 (Virtual Meeting). Contact Person: Brian Hoshaw, Ph.D., Designated Federal Official, Division of Extramural Research, National Eye Institute, National Institutes of Health, 6700 B Rockledge Dr., Rockville, MD 20892, 301– 451–2020, hoshawb@mail.nih.gov. Name of Committee: National Eye Institute Special Emphasis Panel; BRAIN InitiativeRelated Research Education: Short Courses (R25). Date: June 14, 2024. Time: 11:00 a.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: National Eye Institute, 6700 Rockledge Dr., Bethesda, MD 20817 (Virtual Meeting). Contact Person: Brian Hoshaw, Ph.D., Designated Federal Official, Division of Extramural Research, National Eye Institute, National Institutes of Health, 6700 B Rockledge Dr., Rockville, MD 20892, 301– 451–2020, hoshawb@mail.nih.gov. Name of Committee: National Eye Institute Special Emphasis Panel; Secondary Data Analysis (R21) Applications. Date: June 25, 2024. Time: 12:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Eye Institute, 6700 Rockledge Dr., Bethesda, MD 20817 (Virtual Meeting). Contact Person: Brian Hoshaw, Ph.D., Designated Federal Official, Division of Extramural Research, National Eye Institute, National Institutes of Health, 6700 B Rockledge Dr., Rockville, MD 20892, 301– 451–2020, hoshawb@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program No. 93.867, Vision Research, National Institutes of Health, HHS) Dated: April 29, 2024. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2024–09627 Filed 5–2–24; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of General Medical 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 E:\FR\FM\03MYN1.SGM 03MYN1 Federal Register / Vol. 89, No. 87 / Friday, May 3, 2024 / Notices 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 of General Medical Sciences Initial Review Group; Training and Workforce Development Study Section—D Review of IMSD, G–RISE and PREP Applications. Date: June 13–14, 2024. Time: 9:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: The Bethesdan Hotel, Tapestry Collection by Hilton, 8120 Wisconsin Avenue, Bethesda, Maryland 20892 (InPerson and Virtual). Contact Person: Sonia Ivette OrtizMiranda, Ph.D., Scientific Review Officer, Scientific Review Branch, National Institute of General Medical Sciences, National Institutes of Health, 45 Center Drive, MSC 6200, Bethesda, Maryland 20892, 301–402– 9448, sonia.ortiz-miranda@nih.gov. Name of Committee: National Institute of General Medical Sciences Initial Review Group; Training and Workforce Development Study Section—C Review of IMSD, G–RISE and PREP Applications. Date: June 20–21, 2024. Time: 9:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: The Bethesdan Hotel, Tapestry Collection by Hilton, 8120 Wisconsin Avenue, Bethesda, Maryland 20892 (InPerson and Virtual). Contact Person: Sonia Ivette OrtizMiranda, Ph.D., Scientific Review Officer, Scientific Review Branch, National Institute of General Medical Sciences, National Institutes of Health, 45 Center Drive, MSC 6200, Bethesda, Maryland 20892, 301–402– 9448, sonia.ortiz-miranda@nih.gov. (Catalogue of Federal Domestic Assistance Program No. 93.859, Biomedical Research and Research Training, National Institutes of Health, HHS) Dated: April 30, 2024. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2024–09671 Filed 5–2–24; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES lotter on DSK11XQN23PROD with NOTICES1 National Institutes of Health 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 contract proposals/ 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 of Dental and Craniofacial Research Special Emphasis Panel; CROMS Contract Review. Date: May 30, 2024. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate contract proposals. Place: National Institute of Dental & Craniofacial Research, 6701 Democracy Boulevard, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Christopher Campbell, Ph.D., M.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Activities, National Institute of Dental & Craniofacial Research, 6701 Democracy Boulevard, Bethesda, MD 20892, 301–827–4603, christopher.campbell@ nih.gov. Name of Committee: National Institute of Dental and Craniofacial Research Special Emphasis Panel; Award for Sustaining Outstanding Achievement in Research (SOAR). Date: June 13, 2024. Time: 10:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute of Dental & Craniofacial Research, 6701 Democracy Boulevard, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Christopher Campbell, Ph.D., M.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Activities, National Institute of Dental & Craniofacial Research, 6701 Democracy Boulevard, Bethesda, MD 20892, 301–827–4603, christopher.campbell@ nih.gov. (Catalogue of Federal Domestic Assistance Program No. 93.121, Oral Diseases and Disorders Research, National Institutes of Health, HHS) Dated: April 29, 2024. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. National Institute of Dental and Craniofacial Research; Notice of Closed Meetings [FR Doc. 2024–09638 Filed 5–2–24; 8:45 am] Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. VerDate Sep<11>2014 18:11 May 02, 2024 Jkt 262001 BILLING CODE 4140–01–P PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 36823 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: Brain Disorders and Clinical Neuroscience Integrated Review Group; Pathophysiological Basis of Mental Disorders and Addictions Study Section. Date: May 29–30, 2024. Time: 10:00 a.m. to 7:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Boris P. Sokolov, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5217A, MSC 7846, Bethesda, MD 20892, 301–408– 9115, bsokolov@csr.nih.gov. Name of Committee: Biological Chemistry and Macromolecular Biophysics Integrated Review Group; Macromolecular Structure and Function A Study Section. Date: May 29–30, 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: Ian Frederick Thorpe, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 903K, Bethesda, MD 20892, (301) 480–8662, ian.thorpe@nih.gov. Name of Committee: Integrative, Functional and Cognitive Neuroscience Integrated Review Group; Behavioral Neuroendocrinology, Neuroimmunology, Rhythms, and Sleep Study Section. Date: May 30–31, 2024. Time: 8:00 a.m. to 8:00 p.m. Agenda: To review and evaluate grant applications. Place: The Watergate, 2650 Virginia Avenue NW, Washington, DC 20037. Contact Person: Michael Selmanoff, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of E:\FR\FM\03MYN1.SGM 03MYN1

Agencies

[Federal Register Volume 89, Number 87 (Friday, May 3, 2024)]
[Notices]
[Pages 36822-36823]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09671]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of General Medical 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

[[Page 36823]]

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 of General Medical 
Sciences Initial Review Group; Training and Workforce Development 
Study Section--D Review of IMSD, G-RISE and PREP Applications.
    Date: June 13-14, 2024.
    Time: 9:00 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: The Bethesdan Hotel, Tapestry Collection by Hilton, 8120 
Wisconsin Avenue, Bethesda, Maryland 20892 (In-Person and Virtual).
    Contact Person: Sonia Ivette Ortiz-Miranda, Ph.D., Scientific 
Review Officer, Scientific Review Branch, National Institute of 
General Medical Sciences, National Institutes of Health, 45 Center 
Drive, MSC 6200, Bethesda, Maryland 20892, 301-402-9448, 
[email protected].

    Name of Committee: National Institute of General Medical 
Sciences Initial Review Group; Training and Workforce Development 
Study Section--C Review of IMSD, G-RISE and PREP Applications.
    Date: June 20-21, 2024.
    Time: 9:00 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: The Bethesdan Hotel, Tapestry Collection by Hilton, 8120 
Wisconsin Avenue, Bethesda, Maryland 20892 (In-Person and Virtual).
    Contact Person: Sonia Ivette Ortiz-Miranda, Ph.D., Scientific 
Review Officer, Scientific Review Branch, National Institute of 
General Medical Sciences, National Institutes of Health, 45 Center 
Drive, MSC 6200, Bethesda, Maryland 20892, 301-402-9448, 
[email protected].

(Catalogue of Federal Domestic Assistance Program No. 93.859, 
Biomedical Research and Research Training, National Institutes of 
Health, HHS)

    Dated: April 30, 2024.
Miguelina Perez,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2024-09671 Filed 5-2-24; 8:45 am]
BILLING CODE 4140-01-P

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