National Heart, Lung, and Blood Institute; Notice of Closed Meeting, 66858-66859 [2023-21145]
Download as PDF
<![CDATA[
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
Federal Register / Vol. 88, No. 187 / Thursday, September 28, 2023 / Notices
Institutional Training Mechanism Study
Section.
Date: December 1, 2023.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge I, 6705 Rockledge Drive, Bethesda,
MD 20892 (Virtual Meeting).
Contact Person: Michael P. Reilly, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6705 Rockledge Drive, Room
208–Z, Bethesda, MD 20892, 301–827–7975,
reillymp@nhlbi.nih.gov.
(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: September 22, 2023.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–21145 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
ddrumheller on DSK120RN23PROD with NOTICES1
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; Heart, Lung, and
Blood Program Project Study Section.
Date: December 1, 2023.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: DoubleTree by Hilton McLean
Tysons, 1960 Chain Bridge Rd., McLean, VA
22102.
Contact Person: Melissa H. Nagelin, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, National Institutes of Health,
6705 Rockledge Drive, Room 208–R,
Bethesda, MD 20892, (301) 827–7951,
nagelinmh2@nhlbi.nih.gov.
VerDate Sep<11>2014
18:09 Sep 27, 2023
Jkt 259001
(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: September 22, 2023.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–21146 Filed 9–27–23; 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
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
Dental and Craniofacial Research Special
Emphasis Panel; Review of NIDCR R03 and
DSR Member-Conflict Applications.
Date: November 2, 2023.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Dental and
Craniofacial Research, 6701 Democracy
Boulevard, Bethesda, MD 20892 (Virtual
Meeting).
Contact Person: Yun Mei, MD, Scientific
Review Officer, Scientific Review Branch,
National Institute of Dental and Craniofacial
Research, National Institutes of Health, 6701
Democracy Boulevard, Bethesda, MD 20892,
(301) 827–4639, yun.mei@nih.gov.
Name of Committee: National Institute of
Dental and Craniofacial Research Special
Emphasis Panel; Review of RFA–DE–24–001
and RFA–DE–24–002.
Date: November 15, 2023.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Dental and
Craniofacial Research, 6701 Democracy
Boulevard, Bethesda, MD 20892 (Virtual
Meeting).
Contact Person: Christopher T. Campbell,
Ph.D., MD, Scientific Review Officer,
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
66859
Scientific Review Branch, National Institute
of Dental and Craniofacial Research, National
Institutes of Health, 6701 Democracy
Boulevard, Bethesda, MD 20892, (301) 594–
5593, christopher.campbell@nih.gov.
(Catalogue of Federal Domestic Assistance
Program No. 93.121, Oral Diseases and
Disorders Research, National Institutes of
Health, HHS)
Dated: September 22, 2023.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–21151 Filed 9–27–23; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Establishment of the Applied
Therapeutics for Cancer Integrated
Review Group
Pursuant to the Federal Advisory
Committee Act, as amended (5 U.S.C.
1001–1014), the Director, National
Institutes of Health (NIH) announces the
establishment of the Applied
Therapeutics for Cancer Integrated
Review Group (IRG) as authorized by 42
U.S.C. 282(b)(16), section 402(b)(16) of
the Public Health Service Act, as
amended.
The Director, NIH, has determined
that the Applied Therapeutics for
Cancer IRG is in the public interest in
connection with the performance of
duties imposed on NIH by law, and that
these duties can best be performed
through the advice and counsel of the
committee.
The committee provides advice and
recommendations on funding
applications and proposals, including
but not limited to, the scientific and
technical merit of applications for
grants-in-aid for research, research
training, or research-related grants and
cooperative agreements, or contract
proposals relating to scientific areas
relevant to translational and clinical
investigations that encompass cancer
therapeutic development and cancer
treatment.
Inquiries may be directed to Claire
Harris, Director, Office of Federal
Advisory Committee Policy, Office of
the Director, National Institutes of
Health, 6701 Democracy Boulevard,
Suite 1000, Bethesda, Maryland 20892
(Mail code 4875), Telephone (301) 496–
2123, or Claire.Harris@nih.gov.
E:\FR\FM\28SEN1.SGM
28SEN1
]]>Agencies
[Federal Register Volume 88, Number 187 (Thursday, September 28, 2023)]
[Notices]
[Pages 66858-66859]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-21145]
-----------------------------------------------------------------------
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
[[Page 66859]]
Institutional Training Mechanism Study Section.
Date: December 1, 2023.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge I, 6705
Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Michael P. Reilly, Ph.D., Scientific Review
Officer, Office of Scientific Review/DERA, National Heart, Lung, and
Blood Institute, 6705 Rockledge Drive, Room 208-Z, Bethesda, MD
20892, 301-827-7975, [email protected].
(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: September 22, 2023.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2023-21145 Filed 9-27-23; 8:45 am]
BILLING CODE 4140-01-P
