National Eye Institute; Notice of Closed Meetings, 36822 [2024-09627]

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

Agencies

[Federal Register Volume 89, Number 87 (Friday, May 3, 2024)]
[Notices]
[Page 36822]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09627]


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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.
    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, [email protected].

    Name of Committee: National Eye Institute Special Emphasis 
Panel; BRAIN Initiative-Related 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, [email protected].

    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, [email protected].

(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
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