Center for Scientific Review; Notice of Closed Meetings, 42888-42889 [2024-10716]
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Federal Register / Vol. 89, No. 96 / Thursday, May 16, 2024 / Notices
that it agreed to withdrawal of the
application for this reason only.
For the reasons discussed above, and
in accordance with the applicant’s
request, approval of NDA 214622 for
TRUSELTIQ (infigratinib phosphate)
Capsules, 25 mg and 100 mg, and all
amendments and supplements thereto,
is withdrawn under § 314.150(d).
Distribution of TRUSELTIQ (infigratinib
phosphate) Capsules, 25 mg and 100
mg, into interstate commerce without an
approved application is illegal and
subject to regulatory action (see sections
505(a) and 301(d) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
355(a) and 331(d))).
Dated: May 13, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–10714 Filed 5–15–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
sponsors of approved rare pediatric
disease product applications that meet
certain criteria. FDA has determined
that XOLREMDI (mavorixafor),
manufactured by X4 Pharmaceuticals,
Inc., meets the criteria for a priority
review voucher. XOLREMDI
(mavorixafor) is indicated for the
treatment of WHIM (warts,
hypogammaglobulinemia, infections,
and myelokathexis) syndrome in
patients 12 years of age and older to
increase the number of circulating
mature neutrophils and lymphocytes.
For further information about the Rare
Pediatric Disease Priority Review
Voucher Program and for a link to the
full text of section 529 of the FD&C Act,
go to https://www.fda.gov/ForIndustry/
DevelopingProductsforRareDiseases
Conditions/RarePediatricDiseasePriority
VoucherProgram/default.htm. For
further information about XOLREMDI
(mavorixafor), go to the ‘‘Drugs@FDA’’
website at https://www.accessdata.
fda.gov/scripts/cder/daf/.
Dated: May 13, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
Food and Drug Administration
[Docket No. FDA–2020–N–0026]
[FR Doc. 2024–10715 Filed 5–15–24; 8:45 am]
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product;
XOLREMDI (mavorixafor)
AGENCY:
BILLING CODE 4164–01–P
Food and Drug Administration,
HHS.
ACTION:
Notice.
National Institutes of Health
The Food and Drug
Administration (FDA) is announcing the
issuance of a priority review voucher to
the sponsor of a rare pediatric disease
product application. The Federal Food,
Drug, and Cosmetic Act (FD&C Act)
authorizes FDA to award priority review
vouchers to sponsors of approved rare
pediatric disease product applications
that meet certain criteria. FDA is
required to publish notice of the award
of the priority review voucher. FDA has
determined that XOLREMDI
(mavorixafor), approved on April 26,
2024, manufactured by X4
Pharmaceuticals, Inc., meets the criteria
for a priority review voucher.
FOR FURTHER INFORMATION CONTACT:
Cathryn Lee, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–1394.
SUPPLEMENTARY INFORMATION: FDA is
announcing the issuance of a priority
review voucher to the sponsor of an
approved rare pediatric disease product
application. Under section 529 of the
FD&C Act (21 U.S.C. 360ff), FDA will
award priority review vouchers to
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SUMMARY:
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Jkt 262001
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: Population Sciences
and Epidemiology Integrated Review Group;
Social Sciences and Population Studies A
Study Section.
Date: June 6–7, 2024.
Time: 10:00 a.m. to 6:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892.
PO 00000
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Meeting Format: In Person and Virtual
Meeting.
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: Biobehavioral and
Behavioral Processes Integrated Review
Group; Child Psychopathology and
Developmental Disabilities Study Section.
Date: June 10–11, 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 (Virtual Meeting).
Contact Person: Aruna K Behera, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4211,
MSC 7814, Bethesda, MD 20892, (301) 435–
6809, beheraak@csr.nih.gov.
Name of Committee: Bioengineering
Sciences & Technologies Integrated Review
Group; Instrumentation and Systems
Development Study Section.
Date: June 11–12, 2024.
Time: 8:00 a.m. to 7:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Bethesdan Hotel, 8120
Wisconsin Avenue, Bethesda, MD 20814 (In
Person).
Contact Person: Zachary Stephen Bailey,
Ph.D., Scientific Review Officer, The Center
for Scientific Review, The National Institutes
of Health, 6701 Rockledge Drive, Bethesda,
MD 20892, (301) 594–4691, zach.bailey@
nih.gov.
Name of Committee: Integrative,
Functional and Cognitive Neuroscience
Integrated Review Group; Neurobiology of
Pain and Itch Study Section.
Date: June 11–12, 2024.
Time: 8:00 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 (In Person and Virtual
Meeting).
Contact Person: Anne-Sophie Marie Lucie
Wattiez, Ph.D., Scientific Review Officer,
Center for Scientific Review, National
Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892, (301) 594–4642, annesophie.wattiez@nih.gov.
Name of Committee: Vascular and
Hematology Integrated Review Group;
Hemostasis, Thrombosis, Blood Cells and
Transfusion Study Section.
Date: June 11–12, 2024.
Time: 8:00 a.m. to 9:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Bethesdan Hotel, 8120
Wisconsin Avenue, Bethesda, MD 20814 (In
Person).
Contact Person: Vivian Tang, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 594–6208, tangvw@csr.nih.gov.
E:\FR\FM\16MYN1.SGM
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ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 96 / Thursday, May 16, 2024 / Notices
Name of Committee: Biological Chemistry
and Macromolecular Biophysics Integrated
Review Group; Macromolecular Structure
and Function B Study Section.
Date: June 11–12, 2024.
Time: 9:30 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).
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: Molecular, Cellular
and Developmental Neuroscience Integrated
Review Group; Neural Oxidative Metabolism
and Death Study Section.
Date: June 11–12, 2024.
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: Christine Jean DiDonato,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 1014J,
Bethesda, MD 20892, (301) 435–1042,
didonatocj@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; AcademicIndustrial Partnerships for Translation of
Technologies.
Date: June 11–12, 2024.
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: Jennifer Ann Sanders,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 496–3553, jennifer.sanders@
nih.gov.
Name of Committee: Endocrinology,
Metabolism, Nutrition and Reproductive
Sciences Integrated Review Group;
Integrative and Clinical Endocrinology and
Reproduction Study Section.
Date: June 11–12, 2024.
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).
Contact Person: Victoria Martinez Virador,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 594–4703, victoria.virador@
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)
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17:50 May 15, 2024
Jkt 262001
Dated: May 10, 2024.
David W. Freeman,
Supervisory Program Analyst, Office of
Federal Advisory Committee Policy.
[FR Doc. 2024–10716 Filed 5–15–24; 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
Special Emphasis Panel, NICHD BioSpecimen Repository, June 18, 2024, 10
a.m. to June 18, 2024, 4 p.m., Eunice
Kennedy Shriver National Institute of
Child, 6710B Rockledge Drive,
Bethesda, MD, 20892, which was
published in the Federal Register on
May 07, 2024, FR Doc. No. 2024–09946,
89 FR 38167.
This notice is being amended to
change the date of the meeting from
June 18, 2024, to June 25, 2024. The
time of the meeting will remain the
same: 10 a.m. to 4 p.m. The meeting is
closed to the public.
Dated: May 10, 2024.
Lauren A. Fleck,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–10712 Filed 5–15–24; 8:45 am]
BILLING CODE 4140–01–P
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; 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 00056
Fmt 4703
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Research Tools for Difficult
to Culture Eukaryotic Pathogens (R61/R33
Clinical Trial Not Allowed).
Date: June 11–12, 2024.
Time: 10:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G22,
Rockville, MD 20852 (Video Assisted
Meeting).
Contact Person: Richard G. Kostriken,
Ph.D., Scientific Review Officer, Scientific
Review Program, Division of Extramural
Activities, National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G22,
Rockville, MD 20852, 240–669–2075,
richard.kostriken@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: May 13, 2024.
Lauren A. Fleck,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–10724 Filed 5–15–24; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Docket ID FEMA–2024–0002]
Changes in Flood Hazard
Determinations
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
PO 00000
42889
Sfmt 4703
Federal Emergency
Management Agency, Department of
Homeland Security.
ACTION: Notice.
AGENCY:
New or modified Base (1percent annual chance) Flood
Elevations (BFEs), base flood depths,
Special Flood Hazard Area (SFHA)
boundaries or zone designations, and/or
regulatory floodways (hereinafter
referred to as flood hazard
determinations) as shown on the
indicated Letter of Map Revision
(LOMR) for each of the communities
listed in the table below are finalized.
Each LOMR revises the Flood Insurance
Rate Maps (FIRMs), and in some cases
the Flood Insurance Study (FIS) reports,
currently in effect for the listed
communities.
DATES: Each LOMR was finalized as in
the table below.
SUMMARY:
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]]>Agencies
[Federal Register Volume 89, Number 96 (Thursday, May 16, 2024)]
[Notices]
[Pages 42888-42889]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-10716]
-----------------------------------------------------------------------
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: Population Sciences and Epidemiology
Integrated Review Group; Social Sciences and Population Studies A
Study Section.
Date: June 6-7, 2024.
Time: 10:00 a.m. to 6:30 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701
Rockledge Drive, Bethesda, MD 20892.
Meeting Format: In Person and Virtual Meeting.
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: Biobehavioral and Behavioral Processes
Integrated Review Group; Child Psychopathology and Developmental
Disabilities Study Section.
Date: June 10-11, 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 (Virtual Meeting).
Contact Person: Aruna K Behera, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4211, MSC 7814, Bethesda, MD
20892, (301) 435-6809, [email protected].
Name of Committee: Bioengineering Sciences & Technologies
Integrated Review Group; Instrumentation and Systems Development
Study Section.
Date: June 11-12, 2024.
Time: 8:00 a.m. to 7:30 p.m.
Agenda: To review and evaluate grant applications.
Place: The Bethesdan Hotel, 8120 Wisconsin Avenue, Bethesda, MD
20814 (In Person).
Contact Person: Zachary Stephen Bailey, Ph.D., Scientific Review
Officer, The Center for Scientific Review, The National Institutes
of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (301) 594-4691,
[email protected].
Name of Committee: Integrative, Functional and Cognitive
Neuroscience Integrated Review Group; Neurobiology of Pain and Itch
Study Section.
Date: June 11-12, 2024.
Time: 8:00 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 (In Person and Virtual Meeting).
Contact Person: Anne-Sophie Marie Lucie Wattiez, Ph.D.,
Scientific Review Officer, Center for Scientific Review, National
Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892,
(301) 594-4642, [email protected].
Name of Committee: Vascular and Hematology Integrated Review
Group; Hemostasis, Thrombosis, Blood Cells and Transfusion Study
Section.
Date: June 11-12, 2024.
Time: 8:00 a.m. to 9:00 p.m.
Agenda: To review and evaluate grant applications.
Place: The Bethesdan Hotel, 8120 Wisconsin Avenue, Bethesda, MD
20814 (In Person).
Contact Person: Vivian Tang, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892, (301) 594-6208,
[email protected].
[[Page 42889]]
Name of Committee: Biological Chemistry and Macromolecular
Biophysics Integrated Review Group; Macromolecular Structure and
Function B Study Section.
Date: June 11-12, 2024.
Time: 9:30 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).
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: Molecular, Cellular and Developmental
Neuroscience Integrated Review Group; Neural Oxidative Metabolism
and Death Study Section.
Date: June 11-12, 2024.
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: Christine Jean DiDonato, Ph.D., Scientific
Review Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 1014J, Bethesda, MD 20892, (301)
435-1042, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Academic-Industrial Partnerships for Translation of
Technologies.
Date: June 11-12, 2024.
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: Jennifer Ann Sanders, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD 20892, (301) 496-3553,
[email protected].
Name of Committee: Endocrinology, Metabolism, Nutrition and
Reproductive Sciences Integrated Review Group; Integrative and
Clinical Endocrinology and Reproduction Study Section.
Date: June 11-12, 2024.
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).
Contact Person: Victoria Martinez Virador, Ph.D., Scientific
Review Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD 20892, (301) 594-4703,
[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: May 10, 2024.
David W. Freeman,
Supervisory Program Analyst, Office of Federal Advisory Committee
Policy.
[FR Doc. 2024-10716 Filed 5-15-24; 8:45 am]
BILLING CODE 4140-01-P
