Center for Scientific Review; Notice of Closed Meetings, 37234-37235 [2024-09749]

Download as PDF 37234 Federal Register / Vol. 89, No. 88 / Monday, May 6, 2024 / Notices practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency.’’ 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. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/medical-devices/ device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This guidance document is also available at https://www.regulations.gov and https:// www.fda.gov/regulatory-information/ search-fda-guidance-documents. Persons unable to download an electronic copy of ‘‘Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency’’ may send an email request to CDRH- III. Paperwork Reduction Act of 1995 While this guidance contains no new collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by OMB under the PRA (44 U.S.C. 3501–3521). The collections of information in the following table have been approved by OMB: 21 CFR part or guidance Topic 807, subpart E ......................................................................... 814, subparts A through E ...................................................... 814, subpart H ......................................................................... 812 ........................................................................................... 860, subpart D ......................................................................... 800, 801, 809, and 830 ........................................................... Premarket notification .............................................................. Premarket approval ................................................................. Humanitarian Use Devices; Humanitarian Device Exemption Investigational Device Exemption ........................................... De Novo classification process ............................................... Medical Device Labeling Regulations; Unique Device Identification. Emergency Use Authorization ................................................. 0910–0120 0910–0231 0910–0332 0910–0078 0910–0844 0910–0485 Medical Device Reporting ....................................................... CLIA Administrative Procedures; CLIA Waivers ..................... 0910–0437 0910–0607 ‘‘Emergency Use Authorization of Medical Products and Related Authorities’’. 803 ........................................................................................... ‘‘Administrative Procedures for CLIA Categorization’’ and ‘‘Recommendations: Clinical Laboratory Improvement Amendments of 1988’’ (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices’’. Dated: April 22, 2024. Lauren K. Roth, Associate Commissioner for Policy. Institutes of Health, 6700B Rockledge Drive, Room 2118, Bethesda, MD 20892, (301) 443–2861, marmillotp@ mail.nih.gov. Additionally, the meeting end time on May 8, 2024, has changed from 3:30 p.m. to 3:45 p.m. The meeting on May 7, 2024, is partially closed to the public in accordance with provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended, and the meeting on May 8, 2024, is open to the public. [FR Doc. 2024–08933 Filed 4–29–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Alcohol Abuse and Alcoholism; Amended Notice of Meeting ddrumheller on DSK120RN23PROD with NOTICES1 Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number GUI00007009 and complete title to identify the guidance you are requesting. Notice is hereby given of a change in the meeting of the National Advisory Council on Alcohol Abuse and Alcoholism, May 7, 2024, 10:00 a.m. to May 8, 2024, 3:30 p.m., National Institutes of Health, National Institute on Alcohol Abuse and Alcoholism, 6700B Rockledge Drive, Conference Rooms A, B, & C, Bethesda, MD 20817 which was published in the Federal Register on April 9, 2024, FR Doc. 2024–07500, 89 FR 24846. This notice is being amended to replace the Contact Person from Ranga V. Srinivas, Ph.D. to Philippe Marmillot, Ph.D. Director, Office of Extramural Activities, Office of Extramural Activities, National Institute on Alcohol Abuse and Alcoholism, National VerDate Sep<11>2014 18:02 May 03, 2024 Jkt 262001 Dated: April 30, 2024. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2024–09727 Filed 5–3–24; 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 PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 OMB control No. 0910–0595 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: Center for Scientific Review Special Emphasis Panel; RFA–NS– 24–021: HEAL Initiative: Individual Differences in Human Pain Conditions. Date: June 3–4, 2024. Time: 8:30 a.m. to 8:00 p.m. Agenda: To review and evaluate grant applications. Place: North Bethesda Marriott Hotel & Conference Center, Montgomery County Conference Center Facility, 5701 Marinelli Road, North Bethesda, MD 20852. Contact Person: Mark Allen Vosvick, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3110, Bethesda, MD 20892, 301–402–4128, mark.vosvick@nih.gov. Name of Committee: Biobehavioral and Behavioral Processes Integrated Review Group; Motor Function, Speech and Rehabilitation Study Section. Date: June 3–4, 2024. Time: 9:00 a.m. to 7:00 p.m. E:\FR\FM\06MYN1.SGM 06MYN1 ddrumheller on DSK120RN23PROD with NOTICES1 Federal Register / Vol. 89, No. 88 / Monday, May 6, 2024 / Notices Agenda: To review and evaluate grant applications. Place: Salamander Hotel, Washington, DC, 1330 Maryland Ave. SW, Washington, DC 2024. Contact Person: Stephanie Nagle Emmens, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (301) 594–6604, nagleemmenssc@ csr.nih.gov. Name of Committee: Biological Chemistry and Macromolecular Biophysics Integrated Review Group; Biochemistry and Biophysics of Membranes Study Section. Date: June 4–5, 2024. Time: 8:00 a.m. to 8:00 p.m. Agenda: To review and evaluate grant applications. Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road NW, Washington, DC 20015. Contact Person: Nuria E. Assa-Munt, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4164, MSC 7806, Bethesda, MD 20892, (301) 451– 1323, assamunu@csr.nih.gov. Name of Committee: Integrative, Functional and Cognitive Neuroscience Integrated Review Group; Neurotoxicology and Alcohol Study Section. Date: June 4–5, 2024. Time: 8:00 a.m. to 8:00 p.m. Agenda: To review and evaluate grant applications. Place: Hilton Garden Inn, Bethesda, 7301 Waverly Street, Bethesda, MD 20814. Contact Person: John N. Stabley, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (301) 594–0566, stableyjn@ csr.nih.gov. Name of Committee: Musculoskeletal, Oral and Skin Sciences Integrated Review Group; Skeletal Muscle and Exercise Physiology Study Section. Date: June 4–5, 2024. Time: 9:00 a.m. to 10:00 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: Carmen Bertoni, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 805B, Bethesda, MD 20892, (301) 867–5309, bertonic2@csr.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: April 30, 2024. David W. Freeman, Supervisory Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2024–09749 Filed 5–3–24; 8:45 am] BILLING CODE 4140–01–P VerDate Sep<11>2014 18:02 May 03, 2024 Jkt 262001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute; 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 Heart, Lung, and Blood Advisory Council. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The open session will be videocast and can be access from the NIH Videocasting website https://videocast.nih.gov/or https://www.nhlbi.nih.gov/about/ advisory-and-peer-review-committees/ advisory-council. 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 Heart, Lung, and Blood Advisory Council. Date: June 4, 2024 Closed: 8:00 a.m. to 10:00 a.m. Agenda: To review and evaluate grant applications. Place: Porter Neuroscience Research Center, Building 35A, 35 Convent Drive, Bethesda, MD 20892. Open: 10:00 a.m. to 4:00 p.m. Agenda: To discuss program policies and issues. Place: Porter Neuroscience Research Center, Building 35A, 35 Convent Drive, Bethesda, MD 20892. Meeting Format: In Person. Virtual Access: The meeting will be videocast and can be accessed from the NIH Videocast. https://videocast.nih.gov/ or https://www.nhlbi.nih.gov/about/advisoryand-peer-review-committees/advisorycouncil. Please note, the link to the videocast meeting will be posted within a week of the meeting date. Contact Person: Valerie L. Prenger, Ph.D., Acting Division Director, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive Room 7214, Bethesda, MD 20892–7924, 301–435– 0270, Valerie.Prenger@nih.gov. PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 37235 Any member of the public interested in presenting oral comments to the committee may notify the Contact Person listed on this notice at least 10 days in advance of the meeting. Interested individuals and representatives of organizations may submit a letter of intent, a brief description of the organization represented, and a short description of the oral presentation. Only one representative of an organization may be allowed to present oral comments and if accepted by the committee, presentations may be limited to five minutes. Both printed and electronic copies are requested for the record. In addition, any interested person may file written comments with the committee by forwarding their statement to the Contact Person listed on the notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. 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. Information is also available on the Institute’s/Center’s home page: https:// www.nhlbi.nih.gov/about/advisory-and-peerreview-committees/advisory-council where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS) Dated: April 30, 2024. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2024–09722 Filed 5–3–24; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Dental and Craniofacial Research; 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 E:\FR\FM\06MYN1.SGM 06MYN1

Agencies

[Federal Register Volume 89, Number 88 (Monday, May 6, 2024)]
[Notices]
[Pages 37234-37235]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09749]


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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: Center for Scientific Review Special Emphasis 
Panel; RFA-NS-24-021: HEAL Initiative: Individual Differences in 
Human Pain Conditions.
    Date: June 3-4, 2024.
    Time: 8:30 a.m. to 8:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: North Bethesda Marriott Hotel & Conference Center, 
Montgomery County Conference Center Facility, 5701 Marinelli Road, 
North Bethesda, MD 20852.
    Contact Person: Mark Allen Vosvick, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 3110, Bethesda, MD 20892, 301-
402-4128, [email protected].

    Name of Committee: Biobehavioral and Behavioral Processes 
Integrated Review Group; Motor Function, Speech and Rehabilitation 
Study Section.
    Date: June 3-4, 2024.
    Time: 9:00 a.m. to 7:00 p.m.

[[Page 37235]]

    Agenda: To review and evaluate grant applications.
    Place: Salamander Hotel, Washington, DC, 1330 Maryland Ave. SW, 
Washington, DC 2024.
    Contact Person: Stephanie Nagle Emmens, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Bethesda, MD 20892, (301) 594-6604, 
[email protected].

    Name of Committee: Biological Chemistry and Macromolecular 
Biophysics Integrated Review Group; Biochemistry and Biophysics of 
Membranes Study Section.
    Date: June 4-5, 2024.
    Time: 8:00 a.m. to 8:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military 
Road NW, Washington, DC 20015.
    Contact Person: Nuria E. Assa-Munt, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 4164, MSC 7806, Bethesda, MD 
20892, (301) 451-1323, [email protected].

    Name of Committee: Integrative, Functional and Cognitive 
Neuroscience Integrated Review Group; Neurotoxicology and Alcohol 
Study Section.
    Date: June 4-5, 2024.
    Time: 8:00 a.m. to 8:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Hilton Garden Inn, Bethesda, 7301 Waverly Street, 
Bethesda, MD 20814.
    Contact Person: John N. Stabley, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Bethesda, MD 20892, (301) 594-0566, 
[email protected].

    Name of Committee: Musculoskeletal, Oral and Skin Sciences 
Integrated Review Group; Skeletal Muscle and Exercise Physiology 
Study Section.
    Date: June 4-5, 2024.
    Time: 9:00 a.m. to 10:00 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: Carmen Bertoni, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 805B, Bethesda, MD 20892, (301) 
867-5309, [email protected].

(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: April 30, 2024.
David W. Freeman,
Supervisory Program Analyst, Office of Federal Advisory Committee 
Policy.
[FR Doc. 2024-09749 Filed 5-3-24; 8:45 am]
BILLING CODE 4140-01-P
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