78882 Federal Register / Vol. 89, No. 187 / Thursday, September 26, 2024 / Notices 

claim that the date the investigational 

new drug application became effective 

was on January 21, 2009. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 505 

of the FD&C Act: December 27, 2022. 

FDA has verified the applicant’s claim 

that the new drug application (NDA) for 

OGSIVEO (NDA 217677) was initially 

submitted on December 27, 2022. 

3. The date the application was 

approved: November 27, 2023. FDA has 

verified the applicant’s claim that NDA 

217677 was approved on November 27, 

2023. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the USPTO applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its applications for patent extension, 

this applicant seeks 1,826 days of patent 

term extension. 

III. Petitions 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit either electronic or written 

comments and, under 21 CFR 60.24, ask 

for a redetermination (see DATES). 

Furthermore, as specified in § 60.30 (21 

CFR 60.30), any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period. To 

meet its burden, the petition must 

comply with all the requirements of 

§ 60.30, including but not limited to: 

must be timely (see DATES), must be 

filed in accordance with § 10.20, must 

contain sufficient facts to merit an FDA 

investigation, and must certify that a 

true and complete copy of the petition 

has been served upon the patent 

applicant. (See H. Rept. 857, part 1, 98th 

Cong., 2d sess., pp. 41–42, 1984.) 

Petitions should be in the format 

specified in 21 CFR 10.30. 

Submit petitions electronically to 

https://www.regulations.gov at Docket 

No. FDA–2013–S–0610. Submit written 

petitions (two copies are required) to the 

Dockets Management Staff (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852. 

Dated: September 23, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–22105 Filed 9–25–24; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Awards Unsolicited Proposal; Catalog 

of Federal Domestic Assistance 

(CFDA) Number: 93.079 

AGENCY: Office of Population Affairs 

(OPA) and Office of the Assistant 

Secretary for Health, Department of 

Health and Human Services. 

ACTION: Notice of award of an 

unsolicited request for funding to be 

awarded as a single project through a 

grant to Stanford University, Palo Alto, 

CA. 

SUMMARY: OPA announces the award of 

a single-source grant in response to an 

unsolicited proposal from Stanford 

University, Palo Alto, CA. The proposal 

submitted was not solicited either 

formally or informally by any federal 

government official. The grant award is 

administered by OPA in collaboration 

with the Centers for Disease Control and 

Prevention’s Division of Adolescent and 

School Health (CDC DASH). 

DATES: September 13, 2024. 

FOR FURTHER INFORMATION CONTACT: 

Amy Margolis, Deputy Director, Office 

of Population Affairs, Office of the 

Assistant Secretary for Health, 

Department of Health and Human 

Services at amy.margolis@hhs.gov or by 

telephone at 240–453–2820. 

SUPPLEMENTARY INFORMATION: 

Recipient: Stanford University, Palo 

Alto, CA. 

Purpose of the Award: The purpose of 

this award is to conduct and 

disseminate policy research aligned 

with the eight goals of HHS’s Take 

Action for Adolescence: A Call to Action 

for Adolescent Health and Well-being to 

understand the impact of national, state, 

and local policies on meeting 

adolescents’ needs, and to inform efforts 

towards strengthening commitments to 

funding, delivery of services, and 

meaningful youth engagement. 

Amount of Award: $999,855 annually 

for up to five years. 

Project Period: The project period for 

the award will not exceed five years. 

The goals of this project are to 

conduct and disseminate policy 

research aligned with Take Action for 

Adolescents to understand the impact of 

national, state, and local policies on 

access, availability, and quality of 

health care and health education for 

adolescents. Specifically, the project 

will (1) engage key stakeholders 

involved in Take Action for 

Adolescence, (2) conduct policy 

research to identify the impact of 

national, state, and local policies on 

access, availability, and quality of 

health care and health education for 

adolescents, (3) develop a series of 

policy briefs that summarize the 

research and identify strategies to 

improve adolescent health services and 

support Take Action for Adolescents, 

and (4) disseminate the policy briefs 

and effective strategies through 

publications and focused events with 

key stakeholders to support 

sustainability engagements and actions 

plans to improve adolescent health and 

well-being. This project will help 

improve understanding of the impact of 

national, state, and local policy on 

education and services for adolescents, 

and ultimately on their health and wellbeing. 

OPA performed an objective review of 

the unsolicited proposal from Stanford 

University with subject matter 

assistance from within the Department 

of Health and Human Services and 

internal proposal assessments. Based on 

this review, OPA determined that the 

proposal has merit. 

Stanford University, under the 

leadership of Jonathan Klein, has the 

unique breadth of expertise in the field 

of adolescent health and the established 

partnerships with leading adolescent 

health organizations necessary for 

success of this project. Issuing a singlesource award to Stanford University for 

this project will advance our collective 

understanding of the impact of national, 

state, and local policies on meeting 

adolescents’ needs and will identify 

strategies for advancing Take Action for 

Adolescents and improving adolescent 

health and wellbeing. 

This award is being made noncompetitively because there is no 

current, pending, or planned funding 

opportunity announcement under 

which this proposal could compete. 

Legislative Authority: Funding for this 

award is provided by CDC DASH with 

authority under section 301(a) of the 

Public Health Service Act, 42 U.S.C. 

241(a). The grant award will be 

administered by OPA under an 

interagency agreement. 

Dated: September 17, 2024. 

Sarah Rosenthal, 

Deputy Assistant Secretary for Population 

Affairs, Office of Population Affairs, Office 

of the Assistant Secretary for Health. 

[FR Doc. 2024–22029 Filed 9–25–24; 8:45 am] 

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khammond on DSKJM1Z7X2PROD with NOTICES