Center for Scientific Review; Notice of Closed Meetings, 2103-2104 [2023-00439]

Download as PDF 2103 Federal Register / Vol. 88, No. 8 / Thursday, January 12, 2023 / Notices This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘Photobiomodulation (PBM) Devices—Premarket Notification [510(k)] Submissions.’’ 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 Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the internet.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 at https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments. Persons unable to download an electronic copy of ‘‘Photobiomodulation (PBM) Devices— Premarket Notification [510(k)] Submissions’’ may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 16030 and complete title to III. Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501– 3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in the following FDA regulations and guidance have been approved by OMB as listed in the following table: OMB control No. 21 CFR part; guidance Topic 807, subpart E ............................................................................ 812 .............................................................................................. ‘‘Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program’’. 800, 801, and 809 ....................................................................... 50, 56 .......................................................................................... Premarket notification ................................................................ Investigational Device Exemption .............................................. Q-submissions ........................................................................... 0910–0120 0910–0078 0910–0756 Medical Device Labeling Regulations ........................................ Protection of Human Subjects: Informed Consent; Institutional Review Boards. Quality Systems Regulations ..................................................... 0910–0485 0910–0130 820 .............................................................................................. Dated: January 3, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–00422 Filed 1–11–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting khammond on DSKJM1Z7X2PROD with NOTICES identify the guidance you are requesting. Pursuant to section 10(d) 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. Special Emphasis Panel; HiLo Limited Competition (UH3-Clinical Trial Required). Date: March 27, 2023. Time: 1:00 p.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Democracy II, 6707 Democracy Blvd., Bethesda, MD 20892 (Virtual Meeting). Contact Person: Jason D. Hoffert, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 7343, 6707 Democracy Boulevard, Bethesda, MD 20892, 301–496–9010, hoffertj@niddk.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS). Dated: January 9, 2023. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2023–00512 Filed 1–11–23; 8:45 am] BILLING CODE 4140–01–P Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases VerDate Sep<11>2014 17:36 Jan 11, 2023 Jkt 259001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 0910–0073 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) 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: Integrative, Functional and Cognitive Neuroscience Integrated Review Group; Auditory System Study Section. Date: February 7–8, 2023. 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). E:\FR\FM\12JAN1.SGM 12JAN1 khammond on DSKJM1Z7X2PROD with NOTICES 2104 Federal Register / Vol. 88, No. 8 / Thursday, January 12, 2023 / Notices Contact Person: Brian H. Scott, Ph.D., Scientific Review Officer, National Institutes of Health, Center for Scientific Review, 6701 Rockledge Drive, Bethesda, MD 20892, 301– 827–7490, brianscott@mail.nih.gov. Name of Committee: Endocrinology, Metabolism, Nutrition and Reproductive Sciences Integrated Review Group; Cell Signaling and Molecular Endocrinology Study Section. Date: February 7–8, 2023. 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: Latha Malaiyandi, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 812Q, Bethesda, MD 20892, (301) 435–1999, malaiyandilm@csr.nih.gov. Name of Committee: Population Sciences and Epidemiology Integrated Review Group; Population based Research in Infectious Disease Study Section. Date: February 8–9, 2023. Time: 8:00 a.m. to 7:00 p.m. Agenda: To review and evaluate grant applications. Place: Bethesda North Marriott Hotel & Conference Center, 5701 Marinelli Road, Bethesda, MD 20852. Contact Person: Linda MacArthur, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4187, Bethesda, MD 20892, 301–537–9986, macarthurlh@csr.nih.gov. Name of Committee: Infectious Diseases and Immunology A Integrated Review Group; Bacterial Virulence Study Section. Date: February 8–9, 2023. Time: 8:30 a.m. to 7:00 p.m. Agenda: To review and evaluate grant applications. Place: Bethesda North Marriott Hotel & Conference Center, Montgomery County Conference Center Facility, 5701 Marinelli Road, North Bethesda, MD 20852. Contact Person: Susan Daum, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3202, Bethesda, MD 20892, 301–827–7233, susan.boyle-vavra@nih.gov. Name of Committee: Population Sciences and Epidemiology Integrated Review Group; Social and Environmental Determinants of Health Study Section. Date: February 8–9, 2023. Time: 9:00 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: Ananya Paria, DHSC, MPH, MS, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 1007H, Bethesda, MD 20892, (301) 827–6513, pariaa@mail.nih.gov. Name of Committee: Surgical Sciences, Biomedical Imaging and Bioengineering VerDate Sep<11>2014 17:36 Jan 11, 2023 Jkt 259001 Integrated Review Group; Surgery, Anesthesiology and Trauma Study Section. Date: February 8–9, 2023. Time: 9:30 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: Weihua Luo, MD, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5114, MSC 7854, Bethesda, MD 20892, (301) 435– 1170, luow@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; RM–22–016: SCGE Phase II, Platform Clinical Trials of Genome Editors in Multiple Diseases. Date: February 8, 2023. Time: 9:30 a.m. to 2:00 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: Karobi Moitra, Ph.D., Scientific Review Officer, Center for Scientific Review, 6701 Rockledge Drive, Bethesda, MD 20892, (301) 480–6893, karobi.moitra@nih.gov. Name of Committee: Integrative, Functional and Cognitive Neuroscience Integrated Review Group; Neuroscience of Basic Visual Processes Study Section. Date: February 8, 2023. 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: Kirk Thompson, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5184, MSC 7844, Bethesda, MD 20892, 301–435– 1242, kgt@mail.nih.gov. Name of Committee: Brain Disorders and Clinical Neuroscience Integrated Review Group; Developmental Brain Disorders Study Section. Date: February 8–10, 2023. 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: Pat Manos, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5200, MSC 7846, Bethesda, MD 20892, (301) 408– 9866, manospa@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) PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 Dated: January 6, 2023. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2023–00439 Filed 1–11–23; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Dental & Craniofacial Research; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Institute of Dental and Craniofacial Research Special Emphasis Panel, February 2, 2023, 10:00 a.m. to February 2, 2023, 04:00 p.m., National Institute of Dental and Craniofacial Research, 6701 Democracy Boulevard, Bethesda, MD 20892, which was published in the Federal Register on December 19, 2022, 87 FR 77622. This notice is being amended to change the contact SRO from Nisan Bhattacharyya to Yun Mei. Yun Mei’s contact information is as follows: Yun Mei, MD, Scientific Review Officer, Scientific Review Branch, National Institute of Dental and Craniofacial Research, National Institutes of Health, 6701 Democracy Boulevard, Suite #670, Bethesda, MD 20892, (301) 827–4639, yun.mei@ nih.gov. No other details have changed. The meeting is closed to the public. Dated: January 6, 2023. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2023–00431 Filed 1–11–23; 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 10(d) 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, E:\FR\FM\12JAN1.SGM 12JAN1

Agencies

[Federal Register Volume 88, Number 8 (Thursday, January 12, 2023)]
[Notices]
[Pages 2103-2104]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-00439]


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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 10(d) 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: Integrative, Functional and Cognitive 
Neuroscience Integrated Review Group; Auditory System Study Section.
    Date: February 7-8, 2023.
    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).

[[Page 2104]]

    Contact Person: Brian H. Scott, Ph.D., Scientific Review 
Officer, National Institutes of Health, Center for Scientific 
Review, 6701 Rockledge Drive, Bethesda, MD 20892, 301-827-7490, 
[email protected].

    Name of Committee: Endocrinology, Metabolism, Nutrition and 
Reproductive Sciences Integrated Review Group; Cell Signaling and 
Molecular Endocrinology Study Section.
    Date: February 7-8, 2023.
    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: Latha Malaiyandi, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 812Q, Bethesda, MD 20892, (301) 
435-1999, [email protected].

    Name of Committee: Population Sciences and Epidemiology 
Integrated Review Group; Population based Research in Infectious 
Disease Study Section.
    Date: February 8-9, 2023.
    Time: 8:00 a.m. to 7:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Bethesda North Marriott Hotel & Conference Center, 5701 
Marinelli Road, Bethesda, MD 20852.
    Contact Person: Linda MacArthur, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 4187, Bethesda, MD 20892, 301-
537-9986, [email protected].

    Name of Committee: Infectious Diseases and Immunology A 
Integrated Review Group; Bacterial Virulence Study Section.
    Date: February 8-9, 2023.
    Time: 8:30 a.m. to 7:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Bethesda North Marriott Hotel & Conference Center, 
Montgomery County Conference Center Facility, 5701 Marinelli Road, 
North Bethesda, MD 20852.
    Contact Person: Susan Daum, Ph.D., Scientific Review Officer, 
Center for Scientific Review, National Institutes of Health, 6701 
Rockledge Drive, Room 3202, Bethesda, MD 20892, 301-827-7233, 
[email protected].

    Name of Committee: Population Sciences and Epidemiology 
Integrated Review Group; Social and Environmental Determinants of 
Health Study Section.
    Date: February 8-9, 2023.
    Time: 9:00 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: Ananya Paria, DHSC, MPH, MS, Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 1007H, Bethesda, MD 20892, (301) 
827-6513, [email protected].

    Name of Committee: Surgical Sciences, Biomedical Imaging and 
Bioengineering Integrated Review Group; Surgery, Anesthesiology and 
Trauma Study Section.
    Date: February 8-9, 2023.
    Time: 9:30 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: Weihua Luo, MD, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 5114, MSC 7854, Bethesda, MD 
20892, (301) 435-1170, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; RM-22-016: SCGE Phase II, Platform Clinical Trials of Genome 
Editors in Multiple Diseases.
    Date: February 8, 2023.
    Time: 9:30 a.m. to 2:00 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: Karobi Moitra, Ph.D., Scientific Review Officer, 
Center for Scientific Review, 6701 Rockledge Drive, Bethesda, MD 
20892, (301) 480-6893, [email protected].

    Name of Committee: Integrative, Functional and Cognitive 
Neuroscience Integrated Review Group; Neuroscience of Basic Visual 
Processes Study Section.
    Date: February 8, 2023.
    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: Kirk Thompson, Ph.D., Scientific Review Officer, 
Center for Scientific Review, National Institutes of Health, 6701 
Rockledge Drive, Room 5184, MSC 7844, Bethesda, MD 20892, 301-435-
1242, [email protected].

    Name of Committee: Brain Disorders and Clinical Neuroscience 
Integrated Review Group; Developmental Brain Disorders Study 
Section.
    Date: February 8-10, 2023.
    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: Pat Manos, Ph.D., Scientific Review Officer, 
Center for Scientific Review, National Institutes of Health, 6701 
Rockledge Drive, Room 5200, MSC 7846, Bethesda, MD 20892, (301) 408-
9866, [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: January 6, 2023.
Miguelina Perez,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2023-00439 Filed 1-11-23; 8:45 am]
BILLING CODE 4140-01-P
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