Government-Owned Inventions; Availability for Licensing, 12007-12008 [2021-04069]
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12007
Federal Register / Vol. 86, No. 38 / Monday, March 1, 2021 / Notices
RF Program Entrance Survey for
Reentering Fathers.
Æ Exit survey, with five versions: (1)
HM Program Exit Survey for AdultFocused Programs; (2) HM Program Exit
Survey for Youth-Focused Programs; (3)
RF Program Exit Survey for CommunityBased Fathers; (4) RF Program Exit
Survey for Community-Based Mothers;
and (5) RF Program Exit Survey for
Reentering Fathers.
The measures used by the 2015
grantee cohort were developed in 2014
after extensive review of the research
literature and grantees’ past measures.
The performance measures, data
collection instruments, and data
collection system were revised in 2020
based on a targeted analysis of existing
measures, feedback from key
stakeholders, and discussions with ACF
staff and the 2015 cohort of grantees.
ACF required the 2015 cohort of
grantees to submit data on these
standardized measures on a quarterly
basis and proposes the same
requirement for the 2020 cohort. In
addition to the performance measures
mentioned above, ACF proposes to
repeat collection for these data
submissions:
• Semi-annual Performance Progress
Report (PPR), with two versions: (1)
Performance Progress Report for HM
Programs, and (2) Performance Progress
Report for RF Programs; and
• Quarterly Performance Report
(QPR), with two versions: (1) Quarterly
Performance Progress Report for HM
Programs, and (2) Quarterly
Performance Progress Report for RF
Programs.
Grantees in the new cohort will also
be required to engage in continuous
quality improvement (CQI) planning
and implementation using a proposed
CQI plan template developed by ACF.
The estimated burden for completing
and updating this template is included
in the table below.
Respondents: Respondents include
HM and RF grantee staff and program
applicants and participants (participants
are called ‘‘clients’’).
ANNUAL BURDEN ESTIMATES
Number of
responses per
respondent
(total over
request
period)
Number of
respondents
(total over
request
period)
Average
burden per
response
(in hours)
Total
burden
(in hours)
Annual
burden
(in hours)
Instrument
Respondent
1: Applicant Characteristics .................
Program applicants .............................
Program staff ......................................
Program staff ......................................
Program staff ......................................
Program clients (entrance) .................
Program clients (exit) ..........................
Program staff (entrance and exit on
paper).
Program staff ......................................
273,840
408
136
2,040
257,409
169,965
32
1
672
12
126
1
1
3,506
0.25
0.10
0.32
0.50
0.42
0.42
0.10
68,460.0
27,417.6
522.24
128,520.0
108,111.78
71,385.3
11,219.2
22,820.0
9,139.2
174.08
42,840.0
36,037.26
23,795.1
3,739.73
136
6
3
2,448.0
816.0
Program staff ......................................
136
6
1
816.0
272.0
Program staff ......................................
136
3
4
1,632
544.0
2: Program Operations ........................
3: Service Delivery Data ......................
4: Entrance and Exit Surveys ..............
5: Semi-annual Performance Progress
Report (PPR).
6: Quarterly Performance Report
(QPR).
7: CQI Plan ..........................................
patent applications may be obtained by
emailing Brian W. Bailey, Ph.D.,
bbailey@mail.nih.gov, the indicated
licensing contact at the National Heart,
Lung, and Blood, Office of Technology
Transfer and Development Office of
Technology Transfer, 31 Center Drive,
Room 4A29, MSC2479, Bethesda, MD
20892–2479; telephone: 301–402–5579.
A signed Confidential Disclosure
Agreement may be required to receive
any unpublished information.
SUPPLEMENTARY INFORMATION:
Technology description follows.
Estimated Total Annual Burden
Hours: 140,177.37.
Authority: Sec. 403. [42 U.S.C. 603].
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2021–04162 Filed 2–26–21; 8:45 am]
BILLING CODE 4184–73–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
Use of Statins To Treat or Prevent DrugInduced Hearing Loss
National Institutes of Health,
Description of Technology
HHS.
ACTION:
Notice.
The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing to achieve expeditious
commercialization of results of
federally-funded research and
development.
FOR FURTHER INFORMATION CONTACT:
Licensing information and copies of
SUMMARY:
VerDate Sep<11>2014
18:48 Feb 26, 2021
Jkt 253001
Available for licensing and
commercial development are patent
rights covering methods of using
atorvastatin and related statin
compounds and derivatives to reduce or
prevent drug-induced hearing loss that
is caused as a side effect by ototoxic
drugs such as cisplatin, which is
commonly used in cancer therapies. At
present, permanent hearing loss occurs
in approximately half of all patients
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Fmt 4703
Sfmt 4703
treated with cisplatin; consequently,
every year many thousands of
individuals experience partial loss of
hearing and associated quality of life
issues as a result of medically necessary
chemoradiation therapies to treat their
cancers. This technology addresses a
large unmet need to eliminate or reduce
hearing loss in patients that must
undergo therapies involving ototoxic
drugs.
This technology is available for
licensing for commercial development
in accordance with 35 U.S.C. 209 and 37
CFR part 404.
Potential Commercial Applications
• Repurposing existing statins,
including atorvastatin, to treat or protect
against permanent hearing loss arising
from chemoradiation therapy involving
ototoxic drugs.
• Development of statin analogues or
derivatives with enhanced abilities to
treat or protect against hearing loss
resulting from therapies involving
cisplatin or other ototoxic drugs.
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01MRN1
12008
Federal Register / Vol. 86, No. 38 / Monday, March 1, 2021 / Notices
Competitive Advantages
• This invention addresses an urgent
need to protect against permanent
hearing loss resulting from therapies
with commonly used but ototoxic drugs,
including cisplatin.
• Statins are already extensively used
therapeutically to lower blood
cholesterol and have well understood
drug profiles, making them ideal
candidates for repurposing.
Development Stage: An observational
clinical trial (NCT03225157) in patients
with head and neck cancers has been
completed.
Inventors: Lisa Lynn Cunningham
(NIDCD), Nicole C. Schmitt (NIDCD),
and Katharine Ann Fernandez (NIDCD).
Publications: J Clin Invest.
2021;131(1):e142616.
Intellectual Property: HHS Reference
No. E–029–2020—PCT/US21/14918
filed January 25, 2021; U.S. Patent
Application No. 62/966,794 filed
January 28, 2020.
Licensing Contact: Brian W. Bailey,
Ph.D.; 301–594–4094; bbailey@
mail.nih.gov.
Bruce D. Goldstein,
Director, National Heart, Lung, and Blood
Institute, Office of Technology Transfer and
Development, National Institutes of Health.
[FR Doc. 2021–04069 Filed 2–26–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Heart, Lung, and
Blood Institute (NHLBI), National
Institutes of Health, Department of
Health and Human Services, is
contemplating the grant of sublicensable
patent licenses to Simon Fraser
University (‘‘Simon Fraser’’), a nonprofit university located in British
Columbia, Canada, and Le Centre
National de la Recherche Scientifique
(‘‘CNRS’’), a public scientific and
technological establishment located in
France, its rights to the inventions and
patents listed in the SUPPLEMENTARY
INFORMATION section of this notice.
DATES: Only written comments and/or
applications for a license which are
received by the NHLBI Office of
Technology Transfer and Development
on or before March 16, 2021 will be
considered.
SUMMARY:
VerDate Sep<11>2014
18:48 Feb 26, 2021
Jkt 253001
Requests for copies of the
patent applications, inquiries, and
comments relating to the contemplated
exclusive patent license should be
directed to: Brian W. Bailey, Ph.D.,
Senior Technology Transfer Manager,
NHLBI Office of Technology Transfer
and Development, 31 Center Drive, Rm.
4A29, MSC 2479, Bethesda, MD 20892–
2479 (for business mail), Telephone
(301) 594–4094; Email: bbailey@
mail.nih.gov.
ADDRESSES:
The
following and all continuing U.S. and
foreign patents/patent applications
thereof are the intellectual properties to
be licensed under the prospective
agreement to Stanford: United States
Provisional Patent Application No. 62/
489,346 filed April 24, 2017 and
entitled ‘‘FLUORIGEN–BINDING RNA
APTAMERS’’ [HHS Reference No. E–
152–2018/0–US–01].
The patent rights in these inventions
have been assigned to the Government
of the United States of America, Simon
Fraser, and CNRS. The prospective
patent license will be for the purpose of
consolidating the patent rights to CNRS,
one of the co-owners of said rights, for
commercial development, and the
purpose of consolidating the patent
rights to CNRS and Simon Fraser for
marketing. Consolidation of these coowned rights is intended to expedite
development of the invention,
consistent with the goals of the BayhDole Act codified as 35 U.S.C. 200–212.
The prospective patent license will be
worldwide, exclusive, and may be
limited to those fields of use
commensurate in scope with the patent
rights. It will be sublicensable, and any
sublicenses granted by CNRS or Simon
Fraser will be subject to the provisions
of 37 CFR part 401 and 404.
This invention pertains to certain
RNA aptamers with optimized
fluorescent properties and fluorophore
binding affinities as well as
corresponding heterocyclic
fluorophores. The technology consists of
a suite of fluorescent RNA-fluorophore
complexes within the ‘‘Mango’’ that
have been optimized for live-cell
imaging of RNA molecules without
altering biological function, in a manner
analogous to the way that fluorescently
labeled proteins are used to study
specific protein functions within cells.
As such, this technology can be used as
a powerful tool for live-cell study of
RNA function and activity for research
and diagnostic purposes. The
prospective exclusive patent license
will include terms for the sharing of
royalty income with NHLBI from
commercial sublicenses of the patent
SUPPLEMENTARY INFORMATION:
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rights and may be granted unless within
fifteen (15) days from the date of this
published notice the NHLBI receives
written evidence and argument that
establishes that the grant of the license
would not be consistent with the
requirements of 35 U.S.C. 209 and 37
CFR part 404.
Complete applications for a license
that are timely filed in response to this
notice will be treated as objections to
the grant of the contemplated exclusive
patent license. In response to this
Notice, the public may file comments or
objections. Comments and objections,
other than those in the form of a license
application, will not be treated
confidentially, and may be made
publicly available.
License applications submitted in
response to this Notice will be
presumed to contain business
confidential information and any release
of information from these license
applications will be made only as
required and upon a request under the
Freedom of Information Act, 5
U.S.C. 552.
Licensing information and copies of
patent applications may be obtained by
emailing Brian W. Bailey, Ph.D.,
bbailey@mail.nih.gov, the indicated
licensing contact at the National Heart,
Lung, and Blood, Office of Technology
Transfer and Development Office of
Technology Transfer, 31 Center Drive,
Room 4A29, MSC2479, Bethesda, MD
20892–2479; telephone: 301–402–5579.
A signed Confidential Disclosure
Agreement may be required to receive
any unpublished information.
Licensing Contact: Brian W. Bailey,
Ph.D.; 301–594–4094; bbailey@
mail.nih.gov.
Bruce D. Goldstein,
Director, Office of Technology Transfer and
Development, National Heart, Lung, and
Blood Institute, National Institutes of Health.
[FR Doc. 2021–04070 Filed 2–26–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
E:\FR\FM\01MRN1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 38 (Monday, March 1, 2021)]
[Notices]
[Pages 12007-12008]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04069]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The inventions listed below are owned by an agency of the U.S.
Government and are available for licensing to achieve expeditious
commercialization of results of federally-funded research and
development.
FOR FURTHER INFORMATION CONTACT: Licensing information and copies of
patent applications may be obtained by emailing Brian W. Bailey, Ph.D.,
[email protected], the indicated licensing contact at the National
Heart, Lung, and Blood, Office of Technology Transfer and Development
Office of Technology Transfer, 31 Center Drive, Room 4A29, MSC2479,
Bethesda, MD 20892-2479; telephone: 301-402-5579. A signed Confidential
Disclosure Agreement may be required to receive any unpublished
information.
SUPPLEMENTARY INFORMATION:
Technology description follows.
Use of Statins To Treat or Prevent Drug-Induced Hearing Loss
Description of Technology
Available for licensing and commercial development are patent
rights covering methods of using atorvastatin and related statin
compounds and derivatives to reduce or prevent drug-induced hearing
loss that is caused as a side effect by ototoxic drugs such as
cisplatin, which is commonly used in cancer therapies. At present,
permanent hearing loss occurs in approximately half of all patients
treated with cisplatin; consequently, every year many thousands of
individuals experience partial loss of hearing and associated quality
of life issues as a result of medically necessary chemoradiation
therapies to treat their cancers. This technology addresses a large
unmet need to eliminate or reduce hearing loss in patients that must
undergo therapies involving ototoxic drugs.
This technology is available for licensing for commercial
development in accordance with 35 U.S.C. 209 and 37 CFR part 404.
Potential Commercial Applications
Repurposing existing statins, including atorvastatin, to
treat or protect against permanent hearing loss arising from
chemoradiation therapy involving ototoxic drugs.
Development of statin analogues or derivatives with
enhanced abilities to treat or protect against hearing loss resulting
from therapies involving cisplatin or other ototoxic drugs.
[[Page 12008]]
Competitive Advantages
This invention addresses an urgent need to protect against
permanent hearing loss resulting from therapies with commonly used but
ototoxic drugs, including cisplatin.
Statins are already extensively used therapeutically to
lower blood cholesterol and have well understood drug profiles, making
them ideal candidates for repurposing.
Development Stage: An observational clinical trial (NCT03225157) in
patients with head and neck cancers has been completed.
Inventors: Lisa Lynn Cunningham (NIDCD), Nicole C. Schmitt (NIDCD),
and Katharine Ann Fernandez (NIDCD).
Publications: J Clin Invest. 2021;131(1):e142616.
Intellectual Property: HHS Reference No. E-029-2020--PCT/US21/14918
filed January 25, 2021; U.S. Patent Application No. 62/966,794 filed
January 28, 2020.
Licensing Contact: Brian W. Bailey, Ph.D.; 301-594-4094;
[email protected].
Bruce D. Goldstein,
Director, National Heart, Lung, and Blood Institute, Office of
Technology Transfer and Development, National Institutes of Health.
[FR Doc. 2021-04069 Filed 2-26-21; 8:45 am]
BILLING CODE 4140-01-P
