78880 Federal Register / Vol. 89, No. 187 / Thursday, September 26, 2024 / Notices 

purpose of this project is to improve the 

quality of life for people with 

intellectual and/or developmental 

disabilities (I/DD), brain injuries, and 

co-occurring mental health conditions 

by supporting state agencies with policy 

development, service design, and 

service coordination resources, and 

sharing resources to individuals, 

families, direct support professionals, 

clinicians, and other policymakers. The 

administrative supplement for FY 2024 

will amount to $410,318 bringing the 

total award for FY 2024 to $1,060,000. 

FOR FURTHER INFORMATION CONTACT: For 

further information or comments 

regarding this program supplement, 

contact Dana Fink, U.S. Department of 

Health and Human Services, 

Administration for Community Living, 

Administration on Disabilities, (202) 

795–7604 or via email dana.fink@

acl.hhs.gov. 

SUPPLEMENTARY INFORMATION: This 

supplementary funding will expand the 

Co-Occurring Resource Center for 

Individuals with ID/DD (The Link 

Center)’s engagement and technical 

assistance efforts around supporting 

people with co-occurring I/DD, brain 

injuries, and co-occurring mental health 

conditions to live well in the 

community. Additionally, this 

supplement includes funding from 

SAMHSA through an interagency 

agreement to perform an environmental 

assessment of cross-system strategies to 

support children with I/DD, brain 

injuries, and other neurodevelopmental 

disabilities who also have complex 

behavioral health conditions. As a result 

of funding this center and the 

environmental assessment, ACL 

expects: 

• Improved coordination between 

mental health, DD, Medicaid, and child 

welfare service systems to develop and/ 

or amend policies and practices that fill 

service gaps, recruit and train 

competent staff, and assure equitable 

access to quality services. 

• Increased number of mental health 

professionals and paraprofessionals, 

including community-based mobile 

crisis intervention service personnel, 

peer support workers, and service 

providers for the 988 Dialing Code for 

the National Suicide Prevention 

Lifeline, with the competencies needed 

to provide effective and culturally 

competent supports to individuals with 

co-occurring I/DD and mental health 

disabilities. 

• Increased number of community 

service providers, who have the 

capacity to support children and adults 

with I/DD and co-occurring mental 

health disabilities. 

• Improved awareness and 

knowledge of the strengths, needs, 

challenges, and systemic barriers 

experienced by children and adults with 

co-occurring I/DD and mental health 

disabilities. 

• Improved ability to deliver 

responsive and equitable programming, 

training, and technical assistance. 

• Increased self-determination, 

empowerment, and quality of life for 

people with co-occurring I/DD and 

mental health disabilities. 

• Enhanced service delivery 

infrastructure, including mechanisms 

for ongoing and sustained engagement 

of individuals with lived experience. 

This supplement will fund: 

• Enhanced efforts related to children 

and families, including development of 

relationships with key national child 

welfare organizations. 

• 10 focus groups of cross-system 

leaders in 10 states on system gaps 

resulting in adverse impacts on children 

with complex behavioral health needs. 

• An in-person summit with federal 

and state officials and subject matter 

experts to discuss findings from the 

environmental assessment of promising 

practices and gaps related to children 

with complex behavioral health needs. 

• Increased staff time for 

coordination, resource development, 

and accessibility efforts. 

• Increased contributions from brain 

injury partners to align with that of 

other key partners more closely and 

better reflect the need to serve people 

with brain injury as well as I/DD. 

• Resource development including 

paid participation of experts with lived 

experience to assist in development. 

• Additional accessibility and 

language translation services. 

Program Name: Co-Occurring 

Resource Center for Individuals with I/ 

DD (The Link Center). 

Recipient: The National Association 

of State Directors of Developmental 

Disabilities Services. 

Period of Performance: The 

supplement award will be issued for the 

third year of the five-year project period 

of September 1, 2024, through August 

31, 2025. 

Total Supplement Award Amount: 

$410,318. 

Award Type: Cooperative Agreement. 

Statutory Authority: This program is 

authorized under the Developmental 

Disabilities Assistance and Bill of Rights 

Act of 2000 Public Law 106–402, 

Section 161(2) (B), (C) and (D) (42 U.S.C. 

15081(2)). 

Basis for Award: The National 

Association of State Directors of 

Developmental Disabilities Services is 

currently funded to carry out this 

cooperative agreement for the period of 

September 1, 2022, through August 31, 

2027. Much work has already been 

completed and further tasks are 

currently being accomplished. It would 

be unnecessarily time consuming and 

disruptive to the Link Center project 

and the beneficiaries being served for 

ACL to establish a new grantee at this 

time when critical services are presently 

being provided in an efficient manner. 

Dated: September 21, 2024. 

Alison Barkoff, 

Principal Deputy Administrator for the 

Administration for Community Living, 

performing the delegable duties of the 

Administrator and the Assistant Secretary for 

Aging. 

[FR Doc. 2024–22037 Filed 9–25–24; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2024–E–0434, FDA– 

2024–E–0436, and FDA–2024–E–0437] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; OGSIVEO 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) has 

determined the regulatory review period 

for OGSIVEO and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission applications to the Director 

of the U.S. Patent and Trademark Office 

(USPTO), Department of Commerce, for 

the extension of a patent which claims 

that human drug product. 

DATES: Anyone with knowledge that any 

of the dates as published (see 

SUPPLEMENTARY INFORMATION) are 

incorrect must submit either electronic 

or written comments and ask for a 

redetermination by November 25, 2024. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

March 25, 2025. See ‘‘Petitions’’ in the 

SUPPLEMENTARY INFORMATION section for 

more information. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 


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Federal Register / Vol. 89, No. 187 / Thursday, September 26, 2024 / Notices 78881 

11:59 p.m. Eastern Time at the end of 

November 25, 2024. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are received 

on or before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket Nos. FDA– 

2024–E–0434, FDA–2024–E–0436, and 

FDA–2024–E–0437 for ‘‘Determination 

of Regulatory Review Period for 

Purposes of Patent Extension; 

OGSIVEO.’’ Received comments, those 

filed in a timely manner (see 

ADDRESSES), will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with § 10.20 (21 

CFR 10.20) and other applicable 

disclosure law. For more information 

about FDA’s posting of comments to 

public dockets, see 80 FR 56469, 

September 18, 2015, or access the 

information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 

Rm. 6200, Silver Spring, MD 20993, 

301–796–3600. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Drug Price Competition and 

Patent Term Restoration Act of 1984 

(Pub. L. 98–417) and the Generic 

Animal Drug and Patent Term 

Restoration Act (Pub. L. 100–670) 

generally provide that a patent may be 

extended for a period of up to 5 years 

so long as the patented item (human 

drug or biological product, animal drug 

product, medical device, food additive, 

or color additive) was subject to 

regulatory review by FDA before the 

item was marketed. Under these acts, a 

product’s regulatory review period 

forms the basis for determining the 

amount of extension an applicant may 

receive. 

A regulatory review period consists of 

two periods of time: a testing phase and 

an approval phase. For human drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the drug becomes 

effective and runs until the approval 

phase begins. The approval phase starts 

with the initial submission of an 

application to market the human drug 

product and continues until FDA grants 

permission to market the drug product. 

Although only a portion of a regulatory 

review period may count toward the 

actual amount of extension that the 

Director of USPTO may award (for 

example, half the testing phase must be 

subtracted as well as any time that may 

have occurred before the patent was 

issued), FDA’s determination of the 

length of a regulatory review period for 

a human drug product will include all 

of the testing phase and approval phase 

as specified in 35 U.S.C. 156(g)(1)(B). 

FDA has approved for marketing the 

human drug product, OGSIVEO 

(nirogacestat hydrobromide) indicated 

for adult patients with progressing 

desmoid tumors who require systemic 

treatment. Subsequent to this approval, 

the USPTO received patent term 

restoration applications for OGSIVEO 

(U.S. Patent Nos. 7,342,118; 7,795,447; 

and 7,951,958) from SpringWorks 

Therapeutics Inc., and the USPTO 

requested FDA’s assistance in 

determining the patents’ eligibility for 

patent term restoration. In a letter dated 

April 17, 2024, FDA advised the USPTO 

that this human drug product had 

undergone a regulatory review period 

and that the approval of OGSIVEO 

represented the first permitted 

commercial marketing or use of the 

product. Thereafter, the USPTO 

requested that FDA determine the 

product’s regulatory review period. 

II. Determination of Regulatory Review 

Period 

FDA has determined that the 

applicable regulatory review period for 

OGSIVEO is 5,425 days. Of this time, 

5,089 days occurred during the testing 

phase of the regulatory review period, 

while 336 days occurred during the 

approval phase. These periods of time 

were derived from the following dates: 

1. The date an exemption under 

section 505(i) of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) (21 U.S.C. 

355(i)) became effective: January 21, 

2009. FDA has verified the applicant’s 


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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] 

BILLING CODE 4164–01–P 

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] 

BILLING CODE 4150–28–P 


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