Center for Scientific Review; Notice of Closed Meetings, 72771 [2023-23325]
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Federal Register / Vol. 88, No. 203 / Monday, October 23, 2023 / Notices
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abbreviated application arrives at FDA’s
CVM. FDA records the official
abbreviated application receipt date as
the later of the following: the date the
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The tax identification number of FDA
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lotter on DSK11XQN23PROD with NOTICES1
B. Application and JINAD File
Submission Cover Sheet Procedures
Step One: Create a user account and
password. Log onto the AGDUFA
website at https://www.fda.gov/
ForIndustry/UserFees/AnimalGeneric
DrugUserFeeActAGDUFA/ucm137049.
htm and, under Application Submission
Information, click on ‘‘Create AGDUFA
User Fee Cover Sheet’’ and follow the
directions. For security reasons, each
firm submitting an application and/or a
JINAD file submission will be assigned
an organization identification number,
and each user will also be required to
set up a user account and password the
first time you use this site. Online
instructions will walk you through this
process.
Step Two: Create an Animal Generic
Drug User Fee Cover Sheet, transmit it
to FDA, and print a copy. After logging
into your account with your username
and password, complete the steps
required to create an Animal Generic
Drug User Fee Cover Sheet. One cover
sheet is needed for each abbreviated
application for a generic new animal
drug or JINAD file submission. Once
you are satisfied that the data on the
cover sheet is accurate and you have
finalized the cover sheet, you will be
able to transmit it electronically to FDA
and you will be able to print a copy of
your cover sheet showing your unique
PIN.
Step Three: Send the payment for
your application or JINAD file
submission as described in section
VIII.A.
Step Four: Submit your application or
JINAD file submission.
VerDate Sep<11>2014
17:24 Oct 20, 2023
Jkt 262001
C. Product and Sponsor Fees
By December 31, 2023, FDA will issue
invoices and payment instructions for
product and sponsor fees for FY 2024
using this fee schedule. Payment will be
due by January 31, 2024. FDA will issue
invoices in November 2024 for any
products and sponsors subject to fees for
FY 2024 that qualify for fees after the
December 2023 billing.
Dated: October 18, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–23374 Filed 10–20–23; 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
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; Member
Conflict: Cardiovascular Sciences.
Date: November 16, 2023.
Time: 10:00 a.m. to 4:00 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: Margaret Chandler, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4126,
MSC 7814, Bethesda, MD 20892, (301) 435–
1743, margaret.chandler@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Topics in Infection Immunology,
Immune Tolerance, and Transplantation.
Date: November 20, 2023.
Time: 12:00 p.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: Xinrui Li, Ph.D., Scientific
Review Officer, Center for Scientific Review,
PO 00000
Frm 00043
Fmt 4703
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72771
National Institutes of Health, 6701 Rockledge
Drive, Bethesda, MD 20892, (301) 594–2084,
xinrui.li@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Topics in Nephrology and Urology.
Date: December 7, 2023.
Time: 9:00 a.m. to 8:30 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: Stacey Nicole Williams,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 867–5309, stacey.williams@
nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR:
Countermeasures Against Chemical Threats
Exploratory/Developmental and Full
Projects.
Date: December 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: Jodie Michelle Fleming,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 812R,
Bethesda, MD 20892, (301) 867–5309,
flemingjm@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: October 17, 2023.
David W. Freeman,
Supervisory Program Analyst, Office of
Federal Advisory Committee Policy.
[FR Doc. 2023–23325 Filed 10–20–23; 8:45 am]
BILLING CODE 4140–01–P
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HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
In compliance with section
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opportunity for public comment on
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will publish periodic summaries of
proposed projects. To request more
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to obtain a copy of the information
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E:\FR\FM\23OCN1.SGM
23OCN1
]]>Agencies
[Federal Register Volume 88, Number 203 (Monday, October 23, 2023)]
[Notices]
[Page 72771]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-23325]
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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; Member Conflict: Cardiovascular Sciences.
Date: November 16, 2023.
Time: 10:00 a.m. to 4:00 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: Margaret Chandler, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4126, MSC 7814, Bethesda, MD
20892, (301) 435-1743, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Topics in Infection Immunology, Immune
Tolerance, and Transplantation.
Date: November 20, 2023.
Time: 12:00 p.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: Xinrui Li, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892, (301) 594-2084,
[email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Topics in Nephrology and Urology.
Date: December 7, 2023.
Time: 9:00 a.m. to 8:30 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: Stacey Nicole Williams, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD 20892, (301) 867-5309,
[email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; PAR: Countermeasures Against Chemical Threats Exploratory/
Developmental and Full Projects.
Date: December 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: Jodie Michelle Fleming, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 812R, 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: October 17, 2023.
David W. Freeman,
Supervisory Program Analyst, Office of Federal Advisory Committee
Policy.
[FR Doc. 2023-23325 Filed 10-20-23; 8:45 am]
BILLING CODE 4140-01-P
