National Institute of General Medical Sciences; Notice of Closed Meetings, 66858 [2023-21154]
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66858
Federal Register / Vol. 88, No. 187 / Thursday, September 28, 2023 / Notices
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN—BIOLOGICAL PRODUCTS 1
Number of
recordkeepers
21 CFR section; activity
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeper
(in hours)
Total hours
600.12; 2 Maintenance of Records ....................................................................
600.12(b)(2); Recall Records ............................................................................
600.80(c)(1) and 600.80(k); AER Records .......................................................
131
216
109
40.145
3.4028
7,503.95
5,259
735
817,931
32
24
1
168,288
17,640
817,931
Total ...........................................................................................................
..........................
..........................
........................
........................
1,003,859
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 The recordkeeping requirements in § 610.18(b) are included in the estimate for § 600.12.
TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN—COMBINATION PRODUCTS 1
Number of
respondents
21 CFR section; activity
4.102, 4.103, 4.104, 4.105; Postmarketing Safety Reporting for Combination
Products, including associated reports and sharing information with other
constituent part applicants.
1 There
11
Average
burden per
disclosure
(in hours)
Total annual
disclosures
18
198
Total
hours
0.35 (21 minutes) ...
69
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden for this information
collection has changed since the last
OMB approval. The reporting and
recordkeeping burden has increased
mostly due to an increase in the number
of AER reports submitted to FDA and
the associated recordkeeping with these
reports. We have also added burden we
believe attributable to post marketing
safety reporting and attendant
recordkeeping and disclosures, as
required under part 4, subpart B.
Dated: September 23, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–21252 Filed 9–27–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of General Medical
Sciences; Notice of Closed Meetings
ddrumheller on DSK120RN23PROD with NOTICES1
Number of
disclosures
per respondents
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.
VerDate Sep<11>2014
18:09 Sep 27, 2023
Jkt 259001
Name of Committee: National Institute of
General Medical Sciences Special Emphasis
Panel; Renewal of Centers of Biomedical
Research Excellence (COBRE) (Phase 2).
Date: November 7–8, 2023.
Time: 9:30 a.m. to 1:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute of General Medical
Sciences, Natcher Building, 45 Center Drive,
Bethesda, Maryland 20892 (Virtual Meeting).
Contact Person: Nina Sidorova, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, National Institute of General Medical
Sciences, National Institutes of Health, 45
Center Drive, MSC 6200, Room 3AN18–01,
Bethesda, Maryland 20892, 301–594–3663,
sidorova@nigms.nih.gov.
Name of Committee: National Institute of
General Medical Sciences Special Emphasis
Panel; Review of MOSAIC K99/R00
applications.
Date: November 9, 2023.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute of General Medical
Sciences, Natcher Building, 45 Center Drive,
Bethesda, Maryland 20892 (Virtual Meeting).
Contact Person: Rebecca H. Johnson, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, National Institute of General Medical
Sciences, National Institutes of Health, 45
Center Drive, MSC 6200, Room 3AN12B,
Bethesda, Maryland 20892, 301–594–2771,
johnsonrh@nigms.nih.gov.
Name of Committee: National Institute of
General Medical Sciences Special Emphasis
Panel; Review of Support for Research
Excellence (SuRE) Program (R16).
Date: November 17, 2023.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute of General Medical
Sciences, Natcher Building, 45 Center Drive,
Bethesda, Maryland 20892 (Virtual Meeting).
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
Contact Person: Rebecca H. Johnson, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, National Institute of General Medical
Sciences, National Institutes of Health, 45
Center Drive, MSC 6200, Room 3AN12B,
Bethesda, Maryland 20892, 301–594–2771,
johnsonrh@nigms.nih.gov.
(Catalogue of Federal Domestic Assistance
Program No. 93.859, Biomedical Research
and Research Training, National Institutes of
Health, HHS)
Dated: September 22, 2023.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–21154 Filed 9–27–23; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
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: Heart, Lung, and
Blood Initial Review Group; NHLBI
E:\FR\FM\28SEN1.SGM
28SEN1
Agencies
[Federal Register Volume 88, Number 187 (Thursday, September 28, 2023)]
[Notices]
[Page 66858]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-21154]
-----------------------------------------------------------------------
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 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 Special Emphasis Panel; Renewal of Centers of Biomedical
Research Excellence (COBRE) (Phase 2).
Date: November 7-8, 2023.
Time: 9:30 a.m. to 1:30 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, National Institute of
General Medical Sciences, Natcher Building, 45 Center Drive,
Bethesda, Maryland 20892 (Virtual Meeting).
Contact Person: Nina Sidorova, Ph.D., Scientific Review Officer,
Scientific Review Branch, National Institute of General Medical
Sciences, National Institutes of Health, 45 Center Drive, MSC 6200,
Room 3AN18-01, Bethesda, Maryland 20892, 301-594-3663,
[email protected].
Name of Committee: National Institute of General Medical
Sciences Special Emphasis Panel; Review of MOSAIC K99/R00
applications.
Date: November 9, 2023.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, National Institute of
General Medical Sciences, Natcher Building, 45 Center Drive,
Bethesda, Maryland 20892 (Virtual Meeting).
Contact Person: Rebecca H. Johnson, Ph.D., Scientific Review
Officer, Office of Scientific Review, National Institute of General
Medical Sciences, National Institutes of Health, 45 Center Drive,
MSC 6200, Room 3AN12B, Bethesda, Maryland 20892, 301-594-2771,
[email protected].
Name of Committee: National Institute of General Medical
Sciences Special Emphasis Panel; Review of Support for Research
Excellence (SuRE) Program (R16).
Date: November 17, 2023.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, National Institute of
General Medical Sciences, Natcher Building, 45 Center Drive,
Bethesda, Maryland 20892 (Virtual Meeting).
Contact Person: Rebecca H. Johnson, Ph.D., Scientific Review
Officer, Office of Scientific Review, National Institute of General
Medical Sciences, National Institutes of Health, 45 Center Drive,
MSC 6200, Room 3AN12B, Bethesda, Maryland 20892, 301-594-2771,
[email protected].
(Catalogue of Federal Domestic Assistance Program No. 93.859,
Biomedical Research and Research Training, National Institutes of
Health, HHS)
Dated: September 22, 2023.
Miguelina Perez,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2023-21154 Filed 9-27-23; 8:45 am]
BILLING CODE 4140-01-P