Notice of Supplemental Funding; National Rural Health Information Clearinghouse Program, 91771 [2024-27099]
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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the listed drug was withdrawn from sale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a listed drug was withdrawn from sale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time after the drug has been withdrawn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gm actuation, was withdrawn from sale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withdrawn for reasons of safety or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withdrawn for reasons of safety or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
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Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
AGENCY:
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[Federal Register Volume 89, Number 224 (Wednesday, November 20, 2024)]
[Notices]
[Page 91771]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-27099]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Notice of Supplemental Funding; National Rural Health Information
Clearinghouse Program
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice of supplemental funding.
-----------------------------------------------------------------------
SUMMARY: 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.
FOR FURTHER INFORMATION CONTACT: Sarah Scott, Federal Office of Rural
Health Policy, HRSA, at [email protected] 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).
Table 1--Recipients and Award Amounts
----------------------------------------------------------------------------------------------------------------
Grant number Award recipient name City, State Award amount
----------------------------------------------------------------------------------------------------------------
U56RH05539.............................. University of North Dakota Grand Forks, ND........... $782,000
----------------------------------------------------------------------------------------------------------------
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 resources on important topics related to rural community
health and health care.
Diana Espinosa,
Principal Deputy Administrator.
[FR Doc. 2024-27099 Filed 11-19-24; 8:45 am]
BILLING CODE 4165-15-P
