Awards Unsolicited Proposal; Catalog of Federal Domestic Assistance (CFDA) Number: 93.079, 78882 [2024-22029]
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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.
khammond on DSKJM1Z7X2PROD with NOTICES
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comments and, under 21 CFR 60.24, ask
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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
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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
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.
AGENCY:
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
SUMMARY:
PO 00000
Frm 00042
Fmt 4703
Sfmt 9990
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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]]>Agencies
[Federal Register Volume 89, Number 187 (Thursday, September 26, 2024)]
[Notices]
[Page 78882]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-22029]
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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 [email protected] 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 well-being.
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 single-
source 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 non-competitively 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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