Federal Register / Vol. 89, No. 224 / Wednesday, November 20, 2024 / Notices 91771 

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the listed drug was withdrawn from sale 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a listed drug was withdrawn from sale 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time after the drug has been withdrawn 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gm actuation, was withdrawn from sale 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withdrawn for reasons of safety or 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withdrawn for reasons of safety or 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] 

BILLING CODE 4164–01–P 

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 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). 

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 

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. 


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