Notice of Supplemental Funding; Rural Health and Economic Development Analysis Program, 91771-91772 [2024-27109]
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91771
Federal Register / Vol. 89, No. 224 / Wednesday, November 20, 2024 / Notices
ANDA for reasons of safety or
effectiveness or if FDA determines that
the listed drug was withdrawn from sale
for reasons of safety or effectiveness (21
CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
FORTESTA (testosterone) Gel, 10 mg/
0.5 gm actuation, is the subject of NDA
021463, held by Endo Operations Ltd.,
and initially approved on December 29,
2020. FORTESTA is indicated for
replacement therapy in males for
conditions associated with a deficiency
or absence of endogenous testosterone:
primary hypogonadism (congenital or
acquired), hypogonadotropic
hypogonadism (congenital or acquired).
In a letter dated December 1, 2023,
Endo Operations Ltd., notified FDA that
FORTESTA (testosterone) gel, 10 mg/0.5
gm actuation, was being discontinued,
and FDA moved the drug product to the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
Encube Ethicals Private Limited
submitted a citizen petition dated May
22, 2024 (Docket No. FDA–2024–P–
2515), under 21 CFR 10.30, requesting
that the Agency determine whether
FORTESTA (testosterone) gel, 10 mg/0.5
gm actuation, was withdrawn from sale
for reasons of safety or effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that FORTESTA (testosterone)
gel, 10 mg/0.5 gm actuation, was not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that this drug product was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
FORTESTA (testosterone) gel, 10 mg/0.5
gm actuation, from sale. We have also
independently evaluated relevant
literature and data for possible postmarketing adverse events. We have
found no information that would
indicate that this drug product was
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list FORTESTA
(testosterone) gel, 10 mg/0.5 gm
actuation, in the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ delineates, among other items,
drug products that have been
discontinued from marketing for reasons
other than safety or effectiveness. FDA
will not begin procedures to withdraw
approval of approved ANDAs that refer
to this drug product. Additional ANDAs
for this drug product may also be
approved by the Agency as long as they
meet all other legal and regulatory
requirements for the approval of
ANDAs. If FDA determines that labeling
for this drug product should be revised
to meet current standards, the Agency
will advise ANDA applicants to submit
such labeling.
Dated: November 7, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation,
and International Affairs.
[FR Doc. 2024–27103 Filed 11–19–24; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Notice of Supplemental Funding;
National Rural Health Information
Clearinghouse Program
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
AGENCY:
ACTION:
Notice of supplemental funding.
HRSA provided supplemental
funds to the National Rural Health
Information Clearinghouse Program
recipient, University of North Dakota, to
develop toolkits and other resources
that address strategies to promote rural
community health and support the
improvement of health care in rural
areas.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Sarah Scott, Federal Office of Rural
Health Policy, HRSA, at sscott2@
hrsa.gov and 301–287–2619.
SUPPLEMENTARY INFORMATION:
Intended Recipient of the Award:
University of North Dakota.
Amount of Non-Competitive Award:
One award for $782,000.
Project Period: June 1, 2020, through
May 31, 2025.
Assistance Listing (CFDA) Number:
93.223.
Award Instrument: Cooperative
Agreement Supplement for Services.
Authority: Section 711 of the Social
Security Act (42 U.S.C. 912).
BILLING CODE 4164–01–P
khammond on DSK9W7S144PROD with NOTICES
TABLE 1—RECIPIENTS AND AWARD AMOUNTS
Grant number
Award recipient name
City, State
U56RH05539 ..................................
University of North Dakota .........................................
Grand Forks, ND ............................
Justification: This supplement allows
the University of North Dakota to build
on past and ongoing projects to improve
health care in rural areas by advancing
the knowledge base regarding strategies
to support and enhance rural
community health. The University of
North Dakota has longstanding
experience developing resources like
toolkits and webinars to support a broad
range of rural health topics. The
supplement will allow the University of
North Dakota to create new toolkits and
VerDate Sep<11>2014
18:39 Nov 19, 2024
Jkt 265001
Award amount
$782,000
resources on important topics related to
rural community health and health care.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Diana Espinosa,
Principal Deputy Administrator.
Health Resources and Services
Administration
[FR Doc. 2024–27099 Filed 11–19–24; 8:45 am]
Notice of Supplemental Funding; Rural
Health and Economic Development
Analysis Program
BILLING CODE 4165–15–P
PO 00000
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
AGENCY:
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91772
ACTION:
Federal Register / Vol. 89, No. 224 / Wednesday, November 20, 2024 / Notices
Notice of supplemental funding.
HRSA provided supplemental
funds to the sole award recipient of the
Rural Health and Economic
Development Analysis Program to
support a research project that
quantifies the relationships between
health care and economic factors in
rural communities.
SUMMARY:
Project Period: September 1, 2022,
through August 31, 2025.
Assistance Listing (CFDA) Number:
93.155.
Award Instrument: Cooperative
Agreement Supplement for Research.
Authority: Section 711 of the Social
Security Act (42 U.S.C. 912).
FOR FURTHER INFORMATION CONTACT:
Karis Tyner, Federal Office of Rural
Health Policy, HRSA, at ktyner@
hrsa.gov and 240–645–5756.
SUPPLEMENTARY INFORMATION:
Intended Recipient of the Award:
University of Kentucky.
Amount of Non-Competitive Award:
One award for $175,000.
TABLE 1—RECIPIENTS AND AWARD AMOUNTS
Grant No.
Award recipient name
City, state
U1ZRH33331 .................................
University of Kentucky ................................................
Lexington, KY .................................
Justification: The University of
Kentucky, the sole recipient of the Rural
Health and Economic Development
Analysis Program funding, possesses
specialized experience in rural health
care research and economic analysis
that positions it to be the most qualified
entity to perform this work. The funding
allows the University of Kentucky to
collect and analyze additional data on
health care and economic impacts,
building on the planned research project
and providing more information to
inform policy makers and other rural
stakeholders. Its research may focus on
emerging issues at the intersection of
rural health care improvement and rural
economic analysis.
Diana Espinosa,
Principal Deputy Administrator.
[FR Doc. 2024–27109 Filed 11–19–24; 8:45 am]
BILLING CODE 4165–15–P
Award amount
$175,000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
work to support a toolkit designed to
assist rural health networks.
Health Resources and Services
Administration
FOR FURTHER INFORMATION CONTACT:
Alexa Ofori, Senior Advisor, Federal
Office of Rural Health Policy, HRSA, at
aofori@hrsa.gov and 301–945–3986.
Notice of Supplemental Funding;
National Rural Health Policy,
Community, and Collaboration
Program
SUPPLEMENTARY INFORMATION:
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice of supplemental funding.
AGENCY:
HRSA provided supplemental
funds to the sole award recipient of the
National Rural Health Policy,
Community, and Collaboration Program
to enhance rural health state
partnerships, support ongoing work
with technical assistance recipients, and
SUMMARY:
Intended Recipient of the Award:
National Rural Health Association.
Amount of Non-Competitive Award:
One award for $710,000.
Project Period: August 1, 2024,
through July 31, 2029.
Assistance Listing (CFDA) Number:
93.155.
Authority: Section 711 of the Social
Security Act (42 U.S.C. 912).
khammond on DSK9W7S144PROD with NOTICES
TABLE 1—RECIPIENTS AND AWARD AMOUNTS
Grant No.
Award recipient name
City, State
U16RH03702 .........................
National Rural Health Association .........................................
Leawood, KS .........................
Justification: The purpose of the
National Rural Health Policy,
Community, and Collaboration Program
is to identify, engage, educate, and
collaborate with rural stakeholders on
national rural health policy issues and
promising practices to improve health
care in rural areas nationwide. These
activities build on past and ongoing
National Rural Health Association
projects supported by HRSA and align
with the goals of the program to educate
rural stakeholders about national policy
issues and promising practices for rural
health and to facilitate collaboration
with key stakeholders to improve the
exchange of information and promising
practices that support rural health.
Diana Espinosa,
Principal Deputy Administrator.
[FR Doc. 2024–27088 Filed 11–19–24; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Committee on Vital and Health
Statistics
Centers for Disease Control and
Prevention, Department of Health and
Human Services.
AGENCY:
ACTION:
VerDate Sep<11>2014
18:39 Nov 19, 2024
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PO 00000
Notice of meeting.
Frm 00101
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Award amount
$710,000
Pursuant to the Federal
Advisory Committee Act, the
Department of Health and Human
Services (HHS) announces the following
advisory committee meeting. This
meeting is open to the public.
Name: National Committee on Vital
and Health Statistics (NCVHS) Meeting.
DATES: Tuesday, December 3, 2024: 10
a.m.–5 p.m. EST, and Wednesday,
December 4, 2024: 10 a.m.–3 p.m. EST.
ADDRESSES: Virtual open meeting. The
public is welcome to obtain a link to
attend this meeting by following the
instructions posted on the Committee
website: https://ncvhs.hhs.gov/
meetings/full-committee-meeting-22/.
FOR FURTHER INFORMATION CONTACT:
Substantive program information may
be obtained from Naomi Michaelis,
SUMMARY:
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]]>Agencies
[Federal Register Volume 89, Number 224 (Wednesday, November 20, 2024)]
[Notices]
[Pages 91771-91772]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-27109]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Notice of Supplemental Funding; Rural Health and Economic
Development Analysis Program
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
[[Page 91772]]
ACTION: Notice of supplemental funding.
-----------------------------------------------------------------------
SUMMARY: HRSA provided supplemental funds to the sole award recipient
of the Rural Health and Economic Development Analysis Program to
support a research project that quantifies the relationships between
health care and economic factors in rural communities.
FOR FURTHER INFORMATION CONTACT: Karis Tyner, Federal Office of Rural
Health Policy, HRSA, at [email protected] and 240-645-5756.
SUPPLEMENTARY INFORMATION:
Intended Recipient of the Award: University of Kentucky.
Amount of Non-Competitive Award: One award for $175,000.
Project Period: September 1, 2022, through August 31, 2025.
Assistance Listing (CFDA) Number: 93.155.
Award Instrument: Cooperative Agreement Supplement for Research.
Authority: Section 711 of the Social Security Act (42 U.S.C. 912).
Table 1--Recipients and Award Amounts
----------------------------------------------------------------------------------------------------------------
Grant No. Award recipient name City, state Award amount
----------------------------------------------------------------------------------------------------------------
U1ZRH33331.............................. University of Kentucky.... Lexington, KY............. $175,000
----------------------------------------------------------------------------------------------------------------
Justification: The University of Kentucky, the sole recipient of
the Rural Health and Economic Development Analysis Program funding,
possesses specialized experience in rural health care research and
economic analysis that positions it to be the most qualified entity to
perform this work. The funding allows the University of Kentucky to
collect and analyze additional data on health care and economic
impacts, building on the planned research project and providing more
information to inform policy makers and other rural stakeholders. Its
research may focus on emerging issues at the intersection of rural
health care improvement and rural economic analysis.
Diana Espinosa,
Principal Deputy Administrator.
[FR Doc. 2024-27109 Filed 11-19-24; 8:45 am]
BILLING CODE 4165-15-P
