National Institute of Neurological Disorders and Stroke; Notice of Meeting, 16004-16005 [2024-04761]

Download as PDF 16004 Federal Register / Vol. 89, No. 45 / Wednesday, March 6, 2024 / Notices ddrumheller on DSK120RN23PROD with NOTICES1 evaluate the safety of a dietary supplement containing an NDI, what to include in an NDIN (including recommendations about identity and safety information), and the procedures for submitting an NDIN. We received significant comments and decided to issue a revised draft guidance. In the Federal Register of August 12, 2016 (81 FR 53486), we announced the availability of a revised draft guidance for industry entitled ‘‘Dietary Supplements: New Dietary Ingredient Notifications and Related Issues; Revised Draft Guidance for Industry’’ to replace the July 2011 draft guidance. In the notice of availability, we gave interested parties an opportunity to submit comments on the 2016 revised draft guidance by October 11, 2016. On October 4, 2016, we extended the comment period for the revised draft guidance to December 12, 2016 (81 FR 68434). We received numerous comments on the 2016 revised draft guidance, including requests for FDA to separate the 2016 revised draft guidance into discrete sections for ease of use. The final guidance whose availability we are announcing through this document reflects that approach. The guidance finalizes Section V of the 2016 revised draft guidance, ‘‘NDI Notification Procedures and Timeframes,’’ as well as several related questions from other sections. Changes since the revised draft guidance include providing the following: additional clarity on the procedures for preparing and submitting an NDIN; technical updates related to recent changes to our online submission portal for NDINs; and more information about communications with FDA during the NDIN review process. In addition, we made editorial changes to improve clarity. We understand the importance of finalizing other parts of the 2016 revised draft guidance, and we plan to finalize other individual sections as we complete our review and analysis of those sections. II. Paperwork Reduction Act of 1995 This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3521). The collections of information in 21 CFR 190.6 and found in the guidance have been approved under OMB control number 0910–0330. III. Electronic Access Persons with access to the internet may obtain the guidance at https:// www.fda.gov/FoodGuidances, https:// www.fda.gov/regulatory-information/ VerDate Sep<11>2014 16:57 Mar 05, 2024 Jkt 262001 search-fda-guidance-documents, or https://www.regulations.gov. Use the FDA website listed in the previous sentence to find the most current version of the guidance. Dated: February 29, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–04718 Filed 3–5–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Vaccine Injury Compensation Program: Revised Amount of the Average Cost of a Health Insurance Policy Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. AGENCY: HRSA is publishing an updated monetary amount of the average cost of a health insurance policy as it relates to the National Vaccine Injury Compensation Program (VICP). FOR FURTHER INFORMATION CONTACT: CDR George Reed Grimes, Director, Division of Injury Compensation Programs, Health Systems Bureau, HRSA, by mail at 5600 Fishers Lane, 8W25A, Rockville, Maryland 20857; or call (301) 443–9350. SUPPLEMENTARY INFORMATION: Section 100.2 of the VICP’s implementing regulation (42 CFR part 100) states that the revised amount of an average cost of a health insurance policy, as determined by the Secretary of Health and Human Services (the Secretary), is effective upon its delivery by the Secretary to the United States Court of Federal Claims (the Court) and will be published periodically in a notice in the Federal Register. This responsibility has been delegated to the Director, Division of Injury Compensation Programs. This figure is calculated using the most recent Medical Expenditure Panel Survey—Insurance Component data available as the baseline for the average monthly cost of a health insurance policy. This baseline is adjusted by the annual percentage increase/decrease obtained from the most recent annual Kaiser Family Foundation Employer Health Benefits Survey. In 2023, the Medical Expenditure Panel Survey—Insurance Component, available at www.meps.ahrq.gov, published the annual 2022 average total single premium per enrolled employee at private-sector establishments that SUMMARY: PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 provide health insurance. The figure published was $7,590. This figure is divided by 12 to determine the cost per month of $632.50. The $632.50 figure is increased or decreased by the percentage change reported by the most recent Kaiser Family Foundation Employer Health Benefits Survey, available at www.kff.org. The increase from 2022 to 2023 was 7 percent. By adding this percentage increase, the calculated average monthly cost of a health insurance policy for a 12-month period is $676.78. Therefore, the Secretary announces that the revised average cost of a health insurance policy under the VICP is $676.78 per month. In accordance with section 100.2, the revised amount was effective upon its delivery by the Secretary to the Court. Such notice was delivered to the Court on February 23, 2024. Suma Nair, Associate Administrator, Health System Bureau. [FR Doc. 2024–04734 Filed 3–5–24; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Neurological Disorders and Stroke; Notice of Meeting Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Advisory Neurological Disorders and Stroke Council. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend as well as those who need special assistance, such as sign language interpretation or other reasonable accommodations, must notify the Contact Person listed below in advance of the meeting. The open session will be videocast and can be accessed from the NIH Videocasting and Podcasting website (https:// videocast.nih.gov/). 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 E:\FR\FM\06MRN1.SGM 06MRN1 Federal Register / Vol. 89, No. 45 / Wednesday, March 6, 2024 / Notices which would constitute a clearly unwarranted invasion of personal privacy. DEPARTMENT OF HEALTH AND HUMAN SERVICES ddrumheller on DSK120RN23PROD with NOTICES1 Name of Committee: National Advisory Neurological Disorders and Stroke Council. Date: May 15–16, 2024. Open: May 15, 2024, 10:00 a.m. to 5:30 p.m. Agenda: Report by the Director, NINDS; Report by the Acting Director, Division of Extramural Activities; and Administrative and Program Developments. Open session will be videocast from this link: https://videocast.nih.gov/. Closed: May 16, 2024, 10:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6001 Executive Boulevard, Room 1131, Rockville, Maryland 20852 (Hybrid). Contact Person: David Owens, Ph.D., Director of Extramural Activities (Acting), National Institute of Neurological Disorders and Stroke, NIH, 6001 Executive Blvd., 5th Floor, MSC 9531, Bethesda, MD 20892, (301) 496–9248, owensd@ninds.nih.gov. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice at least 10 days in advance of the meeting. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. Information is also available on the Institute’s/Center’s home page: www.ninds.nih.gov, where an agenda and any additional information for the meeting will be posted when available. In the interest of security, NIH has procedures at https://www.nih.gov/aboutnih/visitor-information/campus-accesssecurity for entrance into on-campus and offcampus facilities. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors attending a meeting on campus or at an off-campus federal facility will be asked to show one form of identification (for example, a governmentissued photo ID, driver’s license, or passport) and to state the purpose of their visit. (Catalogue of Federal Domestic Assistance Program Nos. 93.853, Clinical Research Related to Neurological Disorders; 93.854, Biological Basis Research in the Neurosciences, National Institutes of Health, HHS.) Dated: March 1, 2024. Lauren A. Fleck, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2024–04761 Filed 3–5–24; 8:45 am] BILLING CODE 4140–01–P VerDate Sep<11>2014 16:57 Mar 05, 2024 Jkt 262001 National Institutes of Health National Eye Institute; 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 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; Mentored Clinical Scientist Research Career Development Award (K08/K23). Date: April 4, 2024. Time: 10:00 a.m. to 1:30 p.m. Agenda: To review and evaluate grant applications. Place: National Eye Institute, 6700 Rockledge Drive, Bethesda, MD 20817. Contact Person: Jennifer C. Schiltz, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Activities, National Eye Institute, 6700 Rockledge Drive, Bethesda, MD 20817, 240–276–5864, jennifer.schiltz@nih.gov. (Catalogue of Federal Domestic Assistance Program No. 93.867, Vision Research, National Institutes of Health, HHS) Dated: March 1, 2024. Victoria E. Townsend, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2024–04762 Filed 3–5–24; 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 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 16005 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: Center for Scientific Review Special Emphasis Panel; Biomaterials, Tissue Engineering, and Drug Delivery. Date: March 27, 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: Jingwu Xie, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (301) 594–8625, jingwu.xie@nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Fellowships: Chemistry, Biochemistry and Biophysics A. Date: March 27–28, 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: Shan Wang, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (301) 496–4390, shan.wang@nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Fellowships: Cancer Biology. Date: March 27, 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: Charles Morrow, Ph.D., MD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6202, MSC 7804, Bethesda, MD 20892, 301–408– 9850, morrowcs@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business: Applied Immunology and Vaccine Development. Date: March 27–28, 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: Dayadevi Jirage, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4422, Bethesda, MD 20892, (301) 867–5309, jiragedb@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Auditory, Visual and Cognitive Neuroscience. E:\FR\FM\06MRN1.SGM 06MRN1

Agencies

[Federal Register Volume 89, Number 45 (Wednesday, March 6, 2024)]
[Notices]
[Pages 16004-16005]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-04761]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Neurological Disorders and Stroke; Notice 
of Meeting

    Pursuant to section 1009 of the Federal Advisory Committee Act, as 
amended, notice is hereby given of a meeting of the National Advisory 
Neurological Disorders and Stroke Council.
    The meeting will be open to the public as indicated below, with 
attendance limited to space available. Individuals who plan to attend 
as well as those who need special assistance, such as sign language 
interpretation or other reasonable accommodations, must notify the 
Contact Person listed below in advance of the meeting. The open session 
will be videocast and can be accessed from the NIH Videocasting and 
Podcasting website (https://videocast.nih.gov/).
    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

[[Page 16005]]

which would constitute a clearly unwarranted invasion of personal 
privacy.

    Name of Committee: National Advisory Neurological Disorders and 
Stroke Council.
    Date: May 15-16, 2024.
    Open: May 15, 2024, 10:00 a.m. to 5:30 p.m.
    Agenda: Report by the Director, NINDS; Report by the Acting 
Director, Division of Extramural Activities; and Administrative and 
Program Developments.
    Open session will be videocast from this link: https://videocast.nih.gov/.
    Closed: May 16, 2024, 10:00 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6001 Executive Boulevard, 
Room 1131, Rockville, Maryland 20852 (Hybrid).
    Contact Person: David Owens, Ph.D., Director of Extramural 
Activities (Acting), National Institute of Neurological Disorders 
and Stroke, NIH, 6001 Executive Blvd., 5th Floor, MSC 9531, 
Bethesda, MD 20892, (301) 496-9248, [email protected].

    Any interested person may file written comments with the 
committee by forwarding the statement to the Contact Person listed 
on this notice at least 10 days in advance of the meeting. The 
statement should include the name, address, telephone number and 
when applicable, the business or professional affiliation of the 
interested person.
    Information is also available on the Institute's/Center's home 
page: www.ninds.nih.gov, where an agenda and any additional 
information for the meeting will be posted when available.
    In the interest of security, NIH has procedures at https://www.nih.gov/about-nih/visitor-information/campus-access-security for 
entrance into on-campus and off-campus facilities. All visitor 
vehicles, including taxicabs, hotel, and airport shuttles will be 
inspected before being allowed on campus. Visitors attending a 
meeting on campus or at an off-campus federal facility will be asked 
to show one form of identification (for example, a government-issued 
photo ID, driver's license, or passport) and to state the purpose of 
their visit.

(Catalogue of Federal Domestic Assistance Program Nos. 93.853, 
Clinical Research Related to Neurological Disorders; 93.854, 
Biological Basis Research in the Neurosciences, National Institutes 
of Health, HHS.)

    Dated: March 1, 2024.
Lauren A. Fleck,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2024-04761 Filed 3-5-24; 8:45 am]
BILLING CODE 4140-01-P

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