Federal Register / Vol. 89, No. 176 / Wednesday, September 11, 2024 / Notices 73663 

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, ZTALMY 

(ganaxolone) indicated for treatment of 

seizures associated with cyclindependent kinase-like 5 deficiency 

disorder in patients 2 years of age and 

older. Subsequent to this approval, the 

USPTO received a patent term 

restoration application for ZTALMY 

(U.S. Patent No. 8,318,714) from 

Marinus Pharmaceuticals, Inc., and the 

USPTO requested FDA’s assistance in 

determining the patent’s eligibility for 

patent term restoration. In a letter dated 

September 28, 2023, FDA advised the 

USPTO that this human drug product 

had undergone a regulatory review 

period and that the approval of 

ZTALMY 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 

ZTALMY is 10,382 days. Of this time, 

10,065 days occurred during the testing 

phase of the regulatory review period, 

while 317 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: December 30, 

1993. FDA has verified the applicant’s 

claim that the date the investigational 

new drug application became effective 

was on December 30, 1993. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 505 

of the FD&C Act: July 20, 2021. FDA has 

verified the applicant’s claim that the 

new drug application (NDA) for 

ZTALMY (NDA 215904) was initially 

submitted on July 20, 2021. 

3. The date the application was 

approved or the effective date of 

approval for a drug product 

recommended for control under the 

Controlled Substances Act (21 U.S.C. 

811): June 1, 2022. FDA has verified the 

applicant’s claim that NDA 215904 was 

approved on March 18, 2022, and that 

the Drug Enforcement Agency issued an 

interim final rule controlling the 

product under section 201(j) of the 

Controlled Substances Act on June 1, 

2022. 

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 application for patent extension, 

this applicant seeks 5 years 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 6, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–20549 Filed 9–10–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Notice of Funding Extension for Rural 

Behavioral Health Workforce Centers— 

Northern Border Region 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice of supplemental funding. 

SUMMARY: HRSA will provide a 

performance period extension with 

supplemental funds to three fiscal year 

(FY) 21 award recipients with a period 

of performance ending on August 31, 

2025. The supplemental funding will 

extend their current period of 

performance by 12 months to align with 

the FY 2022 award to an additional 

recipient, which has a period of 

performance from September 1, 2022, to 

August 31, 2025. 

FOR FURTHER INFORMATION CONTACT: 

Jillian Causey, Division Deputy Director, 

Federal Office of Rural Health Policy, 

Health Resources and Services 

Administration, at jcausey@hrsa.gov 

and 301–443–1493. 

SUPPLEMENTARY INFORMATION: 

Intended Recipient(s) of the Award: 

Three FY 2021 award recipients: Mary 

Hitchcock Memorial Hospital—New 

Hampshire, Medical Care Development, 

Inc.—Maine, Vermont Association For 

Mental Health, Inc.—Vermont. 

Amount of Non-Competitive Award: 

Three awards for $1,000,000 each. 

Period of Performance: September 1, 

2021, to August 31, 2025. 

Assistance Listing (CFDA) Number: 

93.912. 

Award Instrument: Cooperative 

Agreement. 

Authority: Section 711(b)(5) of the 

Social Security Act (42 U.S.C. 

912(b)(5)). 

TABLE 1—RECIPIENTS AND AWARD AMOUNTS

Grant No. Award recipient name State Award amount 

U2SRH43521 ...................................... Mary Hitchcock Memorial Hospital .................................................................. NH $1,000,000 

U2SRH43522 ...................................... Medical Care Development, Inc ...................................................................... ME 1,000,000 

U2SRH43523 ...................................... Vermont Association for Mental Health Inc ..................................................... VT 1,000,000 


lotter on DSK11XQN23PROD with NOTICES1
73664 Federal Register / Vol. 89, No. 176 / Wednesday, September 11, 2024 / Notices 

1https://www.nbrc.gov/content/northern-borderregion. 

Justification: The Northern Border 

Regional Commission (NBRC) is a 

federal/state partnership for economic 

and community development in 

northern Maine, New Hampshire, 

Vermont, and New York. NBRC was 

established by Congress in 2008 to help 

fund promising economic and 

community development projects. The 

states of Maine, New Hampshire, 

Vermont, and New York play a crucial 

role in the NBRC region.1 In FY 2021, 

HRSA competitively funded three 

organizations in the NBRC states of 

Maine, New Hampshire, and Vermont 

for a period of performance of 3 years. 

In FY 2022, HRSA competitively funded 

another organization in the NBRC state 

of New York for a 3-year period of 

performance. HRSA is providing a 1- 

year extension of funding for the FY 

2021 awards to align with the FY 2022 

award. This would align all awards with 

a period of performance end date of 

August 31, 2025. 

HRSA is implementing this extension 

to continue the work of the three 

recipients because of their benefit to the 

NBRC region. During their project 

period, they have increased access to 

behavioral health and substance use 

disorder services and strengthened the 

behavioral health workforce in the 

NBRC region to improve the health 

outcomes of NBRC residents. 

With program funding, recipients 

have provided scholarships to mental 

health rehabilitation technicians to 

work in rural communities and 

supported intern work, providing 

critically needed direct services to the 

region’s neediest, rural residents. 

Recipients have also funded supervision 

for several behavioral health clinician 

positions that serve rural counties, 

bringing in social workers and 

postdoctoral psychologist fellows who 

were able to provide care where there 

previously had been none. Recipients 

also have increased access by 

connecting community members to 

important resources in their states, 

including how to find or become a peer 

recovery coach. 

Recipients have also worked to 

strengthen the behavioral health 

workforce through training programs 

such as Project Extension for 

Community Healthcare Outcomes 

(Project ECHO, including Medications 

for Opioid Use Disorder Project ECHO 

and created the ‘‘Recovery Jobs for 

Beginners’’ program for individuals 

seeking to work as Peer Recovery 

Specialists. This program has provided 

rural communities in the NBRC region 

with peer recovery specialists where 

there often are few or none and 

increased provider skillsets and 

knowledge. In addition, recipients 

launched the Mental Health Peer 

Specialist Certification program within 

local community colleges in January 

2024. 

HRSA is implementing project period 

alignment of the three FY 2021 awards 

with the FY 2022 award recipient to 

allow for a seamless continuation of 

activities and trainings in the region to 

continue while also allowing all four 

organizations to identify sustainability 

strategies over the next fiscal year. 

Carole Johnson, 

Administrator. 

[FR Doc. 2024–20584 Filed 9–10–24; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Notice of Supplemental Award; Autism 

Longitudinal Data Project 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice of supplemental award. 

SUMMARY: HRSA is announcing 

supplemental award funds through the 

Patient-Centered Outcomes Research 

Trust Fund to the current HRSA award 

recipient to expand activities under the 

Autism Longitudinal Data Project 

(ALDP). The funding will be used to 

create and share a combined deidentified dataset from the Boston Birth 

Cohort (BBC), Massachusetts Pregnancy 

to Early Life Longitudinal Data System, 

and Agency for Healthcare Research and 

Quality Social Determinants of Health 

database. 

FOR FURTHER INFORMATION CONTACT: 

Jessica DiBari, Senior Health Scientist, 

Division of Research, Office of 

Epidemiology and Research, Maternal 

and Child Health Bureau, HRSA, at 

JDiBari@hrsa.gov or 301–443–2170. 

SUPPLEMENTARY INFORMATION: 

(Intended Recipient) of the Award: 

Johns Hopkins University. 

Project Period: The cooperative 

agreement is currently in year 2 of a 5- 

year grant cycle. Johns Hopkins 

University will track the supplemental 

award from the Patient-Centered 

Outcomes Research Trust Fund 

separately from the UT7MC45949 

award. 

Amount of Award: One award for 

$457,833. 

Assistance Listing (CFDA) Number: 

93.877. 

Award Instrument: Non-competitive 

single-source supplement. 

Authority: 26 U.S.C. 9511(d)(2)(C). 

TABLE 1—AWARD RECIPIENT AND AWARD AMOUNT

Grant No. Award recipient name State Award amount 

UT7MC45949 ....................... Johns Hopkins University ............................................................................................... MD $457,833 

Justification: In fiscal year 2024, the 

Office of the Secretary’s PatientCentered Outcomes Research Trust 

Fund, administered by the Office of the 

Assistant Secretary for Planning and 

Evaluation, will support a supplement 

to the HRSA-funded ALDP to create a 

longitudinal dataset for conducting 

patient-centered maternal and infant 

health research by linking multiple 

databases. Through this supplement, 

ALDP will develop a dataset on 

maternal and infant biological, socioeconomic, behavioral risk and 

protective factors, and health services 

indicators. The ALDP current recipient 

is uniquely qualified to conduct this 

work because it has: 

• A long-standing record of 

successfully completing governmentfunded projects. 

• Led and managed the BBC since its 

inception in 1998. 


lotter on DSK11XQN23PROD with NOTICES1