Notice of Funding Extension for Rural Behavioral Health Workforce Centers-Northern Border Region, 73663-73664 [2024-20584]
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73663
Federal Register / Vol. 89, No. 176 / Wednesday, September 11, 2024 / Notices
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.
lotter on DSK11XQN23PROD with NOTICES1
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
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
AGENCY:
ACTION:
Notice of supplemental funding.
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.
SUMMARY:
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
U2SRH43521 ......................................
U2SRH43522 ......................................
U2SRH43523 ......................................
Mary Hitchcock Memorial Hospital ..................................................................
Medical Care Development, Inc ......................................................................
Vermont Association for Mental Health Inc .....................................................
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State
11SEN1
NH
ME
VT
Award amount
$1,000,000
1,000,000
1,000,000
73664
Federal Register / Vol. 89, No. 176 / Wednesday, September 11, 2024 / Notices
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 1year 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
ACTION:
Notice of supplemental award.
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.
SUMMARY:
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 5year 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).
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
AGENCY:
lotter on DSK11XQN23PROD with NOTICES1
TABLE 1—AWARD RECIPIENT AND AWARD AMOUNT
Grant No.
Award recipient name
UT7MC45949 .......................
Johns Hopkins University ...............................................................................................
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
State
17:42 Sep 10, 2024
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$457,833
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.
1 https://www.nbrc.gov/content/northern-borderregion.
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Award amount
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[Federal Register Volume 89, Number 176 (Wednesday, September 11, 2024)]
[Notices]
[Pages 73663-73664]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-20584]
-----------------------------------------------------------------------
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 [email protected] 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 NH $1,000,000
Hospital.
U2SRH43522.............................. Medical Care Development, Inc.. ME 1,000,000
U2SRH43523.............................. Vermont Association for Mental VT 1,000,000
Health Inc.
----------------------------------------------------------------------------------------------------------------
[[Page 73664]]
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.
---------------------------------------------------------------------------
\1\ https://www.nbrc.gov/content/northern-border-region.
---------------------------------------------------------------------------
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
