Center for Scientific Review; Notice of Closed Meetings, 77533-77534 [2024-21617]
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Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Notices
for those products intended to be
licensed under section 351(k) of the
PHS Act and being developed as a
proposed biosimilar to a reference
product.
77533
FDA estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
FDA form; survey
Number of
responses per
respondent
30
6
2
1
Total annual
responses
Average burden per
response
Total hours
60
6
0.5 (30 minutes) .....
1 .............................
30
6
Biosimilar User Fee Cover Sheet (Form FDA 3792) ............
Request for discontinuation from BPD program or to move
products to discontinued section of Biosimilar List.
Biosimilar product & interchangeable product applications
(351(k)); patent infringement notifications (351(l)).
Formal meeting requests as recommended in FDA guidance.
Submission of Pediatric Assessment; iPSP template information, including deferrals of pediatric assessments for
proposed biosimilar products; iPSP amendments as recommended in FDA guidance.
16
∼1.94
31
∼610.90 ..................
18,938
135
2.30
311
21.42 ......................
6,661
11
1
11
∼38.18 ....................
420
Total ................................................................................
....................
........................
419
................................
26,055
Our estimated burden for the
information collection reflects an
overall increase of 13,069 hours and 105
responses annually. Although part of
the increase may be attributed to the
inclusion of burden associated with the
submission of pediatric study plans, we
regard the majority of adjustments as
nominal fluctuations consistent with the
number of applications and submissions
we are receiving.
Dated: September 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–21671 Filed 9–20–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
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.
Name of Committee: Biobehavioral and
Behavioral Processes Integrated Review
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Group; Adult Lifespan Psychopathology
Study Section.
Date: October 17–18, 2024.
Time: 9:00 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.
Meeting Format: Virtual Meeting.
Contact Person: Benjamin G. Shapero,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3182,
MSC 7848, Bethesda, MD 20892, (301) 402–
4786, shaperobg@mail.nih.gov.
Name of Committee: Oncology 1—Basic
Translational Integrated Review Group; Gene
Regulation in Cancer Study Section.
Date: October 21–22, 2024.
Time: 9:30 a.m. to 7:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: Manzoor A. Zarger, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6208,
MSC 7804, Bethesda, MD 20892, (301) 435–
2477, zargerma@csr.nih.gov.
Name of Committee: Biobehavioral and
Behavioral Processes Integrated Review
Group; Biobehavioral Regulation, Learning
and Ethology Study Section.
Date: October 21–22, 2024.
Time: 9:30 a.m. to 7:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: Sara Louise Hargrave,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institute of
Health, 6701 Rockledge Drive, Room 3170,
PO 00000
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Bethesda, MD 20892, (301) 443–7193,
hargravesl@mail.nih.gov.
Name of Committee: Oncology 1—Basic
Translational Integrated Review Group; Basic
Cancer Immunobiology Study Section.
Date: October 22–23, 2024.
Time: 8:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Washington/Rockville, 1750
Rockville Pike, Rockville, MD 20852.
Meeting Format: In Person.
Contact Person: Sarita Kandula Sastry,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20782, 301–402–4788, sarita.sastry@nih.gov.
Name of Committee: Applied Therapeutics
for Cancer Integrated Review Group;
Mechanisms of Cancer Therapeutics C Study
Section.
Date: October 22–23, 2024.
Time: 8:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Darcy Hotel, 1515 Rhode Island
Ave, NW, Washington, DC 20005.
Meeting Format: In Person.
Contact Person: Gloria Huei-Ting Su,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, 301–496–0465, gloria.su@nih.gov.
Name of Committee: Musculoskeletal, Oral
and Skin Sciences Integrated Review Group;
Skeletal Muscle and Exercise Physiology
Study Section.
Date: October 22–23, 2024.
Time: 8:00 a.m. to 10:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road NW,
Washington, DC 20015.
Meeting Format: In Person.
Contact Person: Carmen Bertoni, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 805B,
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77534
Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Notices
Bethesda, MD 20892, (301) 867–5309,
bertonic2@csr.nih.gov.
Name of Committee: Biological Chemistry
and Macromolecular Biophysics Integrated
Review Group; Macromolecular Structure
and Function B Study Section.
Date: October 22–23, 2024.
Time: 8:30 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.
Meeting Format: In Person and Virtual
Meeting.
Contact Person: Alexei A. Yeliseev, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 443–0552, yeliseeva@
mail.nih.gov.
Name of Committee: Population Sciences
and Epidemiology Integrated Review Group;
Analytics and Statistics for Population
Research Panel; A Study Section.
Date: October 22–23, 2024.
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.
Meeting Format: Virtual Meeting.
Contact Person: Lisa Steele, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3139,
MSC 7770, Bethesda, MD 20892, (301) 257–
2638, steeleln@csr.nih.gov.
Name of Committee: Social and
Community Influences on Health Integrated
Review Group; Social Sciences and
Population Studies A Study Section.
Date: October 22–23, 2024.
Time: 9:00 a.m. to 7:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: Washington Plaza Hotel, 10 Thomas
Circle NW, Washington, DC 20005.
Meeting Format: In Person.
Contact Person: Suzanne Ryan, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3139,
MSC 7770, Bethesda, MD 20892, (301) 435–
1712, ryansj@csr.nih.gov.
Name of Committee: Molecular, Cellular
and Developmental Neuroscience Integrated
Review Group; Neurodifferentiation,
Plasticity, Regeneration and Rhythmicity
Study Section.
Date: October 22–23, 2024.
Time: 9:00 a.m. to 8:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Washington/Rockville, 1750
Rockville Pike, Rockville, MD 20852.
Meeting Format: In Person.
Contact Person: Jacek Topczewski, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 1002A1,
Bethesda, MD 20892, (301) 594–7574,
topczewskij2@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
VerDate Sep<11>2014
16:57 Sep 20, 2024
Jkt 262001
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: September 17, 2024.
Victoria E. Townsend,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–21617 Filed 9–20–24; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Amended Notice of
Meeting
Notice is hereby given of a change in
the meeting of the Eunice Kennedy
Shriver National Institute of Child
Health and Human Development Initial
Review Group, Population Sciences
Study Section, October 25, 2024, 09:00
a.m. to 05:00 p.m., Hyatt Regency
Bethesda, 7400 Wisconsin Avenue,
Bethesda, MD 20814, which was
published in the Federal Register on
June 17, 2024, FR Doc. No. 2024–13310,
89 FR 51537.
This notice is being amended to
change the start time of the meeting
from 9:00 a.m. to 10:00 a.m. E.T. The
meeting is closed to the public.
Dated: September 18, 2024.
Lauren A. Fleck,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–21662 Filed 9–20–24; 8:45 am]
BILLING CODE 4140–01–P
National Institutes of Health
National Institute of Mental Health;
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
Frm 00064
Fmt 4703
Name of Committee: National Institute of
Mental Health Initial Review Group; Mental
Health Services Study Section.
Date: October 21–22, 2024.
Time: 2:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency, Bethesda, One
Bethesda Metro Center, Bethesda, MD 20814
(Hybrid Meeting).
Contact Person: Aileen Schulte, Ph.D.,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, National Institutes of Health,
Neuroscience Center, 6001 Executive Blvd.,
Bethesda, MD 20852, 301–443–1225, email:
aschulte@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program No. 93.242, Mental Health Research
Grants, National Institutes of Health, HHS)
Dated: September 18, 2024.
Bruce A. George,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–21663 Filed 9–20–24; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request; National Institutes
of Health NeuroBioBank Tissue
Access Request and Progress Report
Forms (National Institute of Mental
Health)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
Paperwork Reduction Act of 1995, the
National Institutes of Health (NIH) has
submitted to the Office of Management
and Budget (OMB) a request for review
and approval of the information
collection listed below.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 30-days of the date of this
publication.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
SUMMARY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
PO 00000
would constitute a clearly unwarranted
invasion of personal privacy.
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]]>Agencies
[Federal Register Volume 89, Number 184 (Monday, September 23, 2024)]
[Notices]
[Pages 77533-77534]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-21617]
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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: Biobehavioral and Behavioral Processes
Integrated Review Group; Adult Lifespan Psychopathology Study
Section.
Date: October 17-18, 2024.
Time: 9:00 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.
Meeting Format: Virtual Meeting.
Contact Person: Benjamin G. Shapero, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3182, MSC 7848, Bethesda, MD
20892, (301) 402-4786, [email protected].
Name of Committee: Oncology 1--Basic Translational Integrated
Review Group; Gene Regulation in Cancer Study Section.
Date: October 21-22, 2024.
Time: 9:30 a.m. to 7:30 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701
Rockledge Drive, Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: Manzoor A. Zarger, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6208, MSC 7804, Bethesda, MD
20892, (301) 435-2477, [email protected].
Name of Committee: Biobehavioral and Behavioral Processes
Integrated Review Group; Biobehavioral Regulation, Learning and
Ethology Study Section.
Date: October 21-22, 2024.
Time: 9:30 a.m. to 7:30 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701
Rockledge Drive, Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: Sara Louise Hargrave, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institute of Health,
6701 Rockledge Drive, Room 3170, Bethesda, MD 20892, (301) 443-7193,
[email protected].
Name of Committee: Oncology 1--Basic Translational Integrated
Review Group; Basic Cancer Immunobiology Study Section.
Date: October 22-23, 2024.
Time: 8:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Hilton Washington/Rockville, 1750 Rockville Pike,
Rockville, MD 20852.
Meeting Format: In Person.
Contact Person: Sarita Kandula Sastry, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD 20782, 301-402-4788,
[email protected].
Name of Committee: Applied Therapeutics for Cancer Integrated
Review Group; Mechanisms of Cancer Therapeutics C Study Section.
Date: October 22-23, 2024.
Time: 8:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant applications.
Place: The Darcy Hotel, 1515 Rhode Island Ave, NW, Washington,
DC 20005.
Meeting Format: In Person.
Contact Person: Gloria Huei-Ting Su, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD 20892, 301-496-0465,
[email protected].
Name of Committee: Musculoskeletal, Oral and Skin Sciences
Integrated Review Group; Skeletal Muscle and Exercise Physiology
Study Section.
Date: October 22-23, 2024.
Time: 8:00 a.m. to 10:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military
Road NW, Washington, DC 20015.
Meeting Format: In Person.
Contact Person: Carmen Bertoni, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 805B,
[[Page 77534]]
Bethesda, MD 20892, (301) 867-5309, [email protected].
Name of Committee: Biological Chemistry and Macromolecular
Biophysics Integrated Review Group; Macromolecular Structure and
Function B Study Section.
Date: October 22-23, 2024.
Time: 8:30 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.
Meeting Format: In Person and Virtual Meeting.
Contact Person: Alexei A. Yeliseev, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD 20892, (301) 443-0552,
[email protected].
Name of Committee: Population Sciences and Epidemiology
Integrated Review Group; Analytics and Statistics for Population
Research Panel; A Study Section.
Date: October 22-23, 2024.
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.
Meeting Format: Virtual Meeting.
Contact Person: Lisa Steele, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 3139, MSC 7770, Bethesda, MD 20892, (301) 257-
2638, [email protected].
Name of Committee: Social and Community Influences on Health
Integrated Review Group; Social Sciences and Population Studies A
Study Section.
Date: October 22-23, 2024.
Time: 9:00 a.m. to 7:30 p.m.
Agenda: To review and evaluate grant applications.
Place: Washington Plaza Hotel, 10 Thomas Circle NW, Washington,
DC 20005.
Meeting Format: In Person.
Contact Person: Suzanne Ryan, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 3139, MSC 7770, Bethesda, MD 20892, (301) 435-
1712, [email protected].
Name of Committee: Molecular, Cellular and Developmental
Neuroscience Integrated Review Group; Neurodifferentiation,
Plasticity, Regeneration and Rhythmicity Study Section.
Date: October 22-23, 2024.
Time: 9:00 a.m. to 8:30 p.m.
Agenda: To review and evaluate grant applications.
Place: Hilton Washington/Rockville, 1750 Rockville Pike,
Rockville, MD 20852.
Meeting Format: In Person.
Contact Person: Jacek Topczewski, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 1002A1, Bethesda, MD 20892, (301)
594-7574, [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: September 17, 2024.
Victoria E. Townsend,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2024-21617 Filed 9-20-24; 8:45 am]
BILLING CODE 4140-01-P
