National Center for Complementary & Integrative Health; Notice of Meeting, 36566-36567 [2021-14739]
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36566
Federal Register / Vol. 86, No. 130 / Monday, July 12, 2021 / Notices
11, 2015, [HHS Ref. No. E–050–2015–0–
US–01];
II. International Patent Application
No. PCT/US2016/022072 filed Mar. 11,
2015, [HHS Reference No. E–050–2015–
0–PCT–03]; expired
III. Australian National Stage Patent
Application No. 2016228751, filed Mar.
11, 2016, [HHS Ref. No. E–050–2015–0–
AU–04]; pending
IV. Canadian National Stage Patent
Application No. 2979229 filed Mar. 11,
2016, [HHS Ref. No. E–050–2015–0–
CA–05]; pending
V. European national Stage Patent
Application No. 1662623.3 filed Oct. 11,
2016, [HHS Ref. No. E–050–2015–0–EP–
06]; issued (validated in DE, FR and GB)
VI. U.S. national Stage Patent
Application No. 15/556,746 filed Sep. 8,
2017 [HHS Ref. No. E–050–2015–0–US–
08]; issued
VII. Japanese National Stage Patent
Application No. 2017–547425 filed Sep.
8, 2017 [HHS Ref. No. E–050–2015–0–
JP–07]; pending
VIII. Divisional European Patent
Application No. 20176667.2 filed May
26, 2020 [HHS Ref. No. E–050–2015–0–
EP–13]; pending
IX. Divisional Japanese Patent
Application No. 2020–167984 filed Oct.
2, 2020 [HHS Ref. No. E–050–2015–0–
JP–14]; pending
The patent rights in these inventions
have been assigned and/or exclusively
licensed to the government of the
United States of America.
The prospective exclusive license
territory may be worldwide, and the
field of use may be limited to:
‘‘Development and commercialization
of RP2 AAV-based gene human therapy
for any ocular disease, disorder or
condition, including human X-linked
retinitis pigmentosa (XLRP)’’.
This technology discloses AdenoAssociated Viral (AAV) vectors
comprising nucleotide sequences
encoding RP2 or RPGR- ORF 15
transgenes and their use in treating or
preventing X-linked forms of retinitis
pigmentosa (XLRP).
This notice is made in accordance
with 35 U.S.C. 209 and 37 CFR part 404.
The prospective exclusive license will
be royalty bearing, and the prospective
exclusive license may be granted unless
within fifteen (15) days from the date of
this published notice, the National
Cancer Institute 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.
In response to this Notice, the public
may file comments or objections.
Comments and objections, other than
those in the form of a license
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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 in these license
applications will be made only as
required and upon a request under the
Freedom of Information Act, 5 U.S.C.
552.
Dated: July 2, 2021.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2021–14682 Filed 7–9–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting 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
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Motor function in healthy and
clinical populations.
Date: August 3, 2021.
Time: 1:00 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Maribeth Champoux,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3170,
MSC 7848, Bethesda, MD 20892, 301–594–
3163, champoum@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
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Dated: July 6, 2021.
David W. Freeman,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–14697 Filed 7–9–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Complementary &
Integrative Health; Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Advisory
Council for Complementary and
Integrative Health.
The meeting 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
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
The meeting will be held as a virtual
meeting and is open to the public as
indicated below. Individuals who plan
to view the virtual meeting and need
special assistance or other reasonable
accommodations, should notify the
Contact Person listed below in advance
of the meeting. The Open Session will
be open to the public via NIH Videocast.
The URL link to access this meeting is
https://videocast.nih.gov.
Name of Committee: National Advisory
Council for Complementary and Integrative
Health.
Date: September 10, 2021.
Closed: 10:00 a.m. to 11:30 a.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Democracy 2, 6707 Democracy Boulevard,
Bethesda, MD 20817 (Virtual Meeting).
Open: 11:40 a.m. to 5:00 p.m.
Agenda: A report from the Director of the
Center and Other Staff.
Place: National Institutes of Health,
Democracy 2, 6707 Democracy Boulevard,
Bethesda, MD 20817 (Virtual Meeting).
Contact Person: Partap Singh Khalsa,
Ph.D., DC, Director, Division of Extramural
Activities, National Center for
Complementary and Integrative Health,
National Institutes of Health, 6707
Democracy Blvd., Suite 401, Bethesda, MD
20892–5475, 301–594–3462, khalsap@
mail.nih.gov.
Any interested person may file written
comments with the committee by forwarding
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Federal Register / Vol. 86, No. 130 / Monday, July 12, 2021 / Notices
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person. Any
member of the public may submit written
comments no later than 15 days after the
meeting.
Information is also available on the
Institute’s/Center’s home page: https://
www.nccih.nih.gov/news/events/advisorycouncil-78th-meeting, where an agenda and
any additional information for the meeting
will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.213, Research and Training
in Complementary and Alternative Medicine,
National Institutes of Health, HHS)
Dated: July 7, 2021.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–14739 Filed 7–9–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
Patent License: High ASS1 Expressing
Tumors Embody a Purine Rich
Genomic Signature and Sensitivity to
Purine Depletion
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Cancer Institute
(NCI), an institute of the National
Institutes of Health, Department of
Health and Human Services, is
contemplating the grant of an exclusive,
sublicensable patent license to Yeda
Research & Development Co, Ltd
(‘‘YEDA’’), the technology transfer
company of the Weizmann Institute of
Science, a non-profit research
institution located in Rehovot, Israel for
NCI’s rights to the patent applications
listed in the Supplementary Information
section of this notice.
DATES: Only written comments and/or
applications for a license which are
received by the National Cancer
Institute’s Technology Transfer Center
on or before July 27, 2021 will be
considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, and
comments relating to the contemplated
exclusive patent license should be
directed to: Kevin W. Chang, Ph.D.,
Senior Licensing and Patenting Manager
at Telephone: (240)–276–6910 or at
Email: changke@mail.nih.gov.
SUPPLEMENTARY INFORMATION:
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SUMMARY:
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Intellectual Property
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 YEDA: PCT Patent
Application PCT/IL2020/050708, filed
June 24, 2020 and entitled ‘‘High ASS1
Expressing Tumors Embody A Purine
Rich Genomic Signature And Sensitivity
To Purine Depletion’’ [HHS Reference
No. E–210–2020–0–PCT–01].
The patent rights in these inventions
have been assigned to the Government
of the United States of America and
YEDA. The prospective license will be
for the purpose of consolidating the
patent rights to YEDA, one of the coowners of said rights, for commercial
development and marketing.
Consolidation of these co-owned rights
is intended to expedite development of
the invention, consistent with the goals
of the Bayh-Dole 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 YEDA will be
subject to the provisions of 37 CFR parts
401 and 404.
This technology discloses methods of
treating a high argininosuccinate
synthase (ASS1) expressing solid tumor
with a combination of a purine synthase
inhibitor or an agent that increases the
pyrimidine to purine ratio in a cell, and
an immune-modulating drug, such as a
checkpoint inhibitor.
This notice is made in accordance
with 35 U.S.C. 209 and 37 CFR part 404.
The prospective exclusive license will
include terms for the sharing of royalty
income with NCI from commercial
sublicenses of the patent rights. The
prospective exclusive license may be
granted unless within fifteen (15) days
from the date of this published notice,
the National Cancer Institute 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.
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36567
License applications submitted in
response to this Notice will be
presumed to contain business
confidential information and any release
of information in these license
applications will be made only as
required and upon a request under the
Freedom of Information Act, 5 U.S.C.
552.
Dated: July 6, 2021.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2021–14681 Filed 7–9–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Notice To Announce Request for
Information (RFI) Inviting Input on the
ICCFASD 2022–2026 Strategic Plan
Outline
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The Interagency Coordinating
Committee on Fetal Alcohol Spectrum
Disorders (ICCFASD) is developing an
updated strategic plan to guide its
efforts over the next five years. As
sponsor and chair of the ICCFASD, the
National Institute on Alcohol Abuse and
Alcoholism (NIAAA) will be issuing a
Request for Information to seek
comments on the draft outline of the
ICCFASD’s 2022–2026 Strategic Plan
from diverse stakeholders, including
scientific experts, health care providers,
patients and family members, advocacy
groups, other federal agencies, and nongovernmental scientific, professional,
and healthcare organizations.
DATES: Comments must be received by
August 31, 2021, to ensure
consideration. Responses will be
reviewed by ICCFASD members and
considered during the development of
the 2022–2026 Strategic Plan.
ADDRESSES: To view and comment on
the strategic plan outline, please visit
our online response form: RFI online
response form.
FOR FURTHER INFORMATION CONTACT:
Tatiana Balachova, ICCFASD Executive
Secretary, National Institute on Alcohol
Abuse and Alcoholism, NIH, 6700B
Rockledge Drive, Bethesda, MD 20817.
Phone: 301–443–5726, Email: NIAAAICCFASD@mail.nih.gov.
SUPPLEMENTARY INFORMATION: In
accordance with the 21st Century Cures
Act, NIH institutes are required to
SUMMARY:
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Agencies
[Federal Register Volume 86, Number 130 (Monday, July 12, 2021)]
[Notices]
[Pages 36566-36567]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14739]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Center for Complementary & Integrative Health; Notice of
Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended, notice is hereby given of a meeting of the National Advisory
Council for Complementary and Integrative Health.
The meeting 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 the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the grant applications, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
The meeting will be held as a virtual meeting and is open to the
public as indicated below. Individuals who plan to view the virtual
meeting and need special assistance or other reasonable accommodations,
should notify the Contact Person listed below in advance of the
meeting. The Open Session will be open to the public via NIH Videocast.
The URL link to access this meeting is https://videocast.nih.gov.
Name of Committee: National Advisory Council for Complementary
and Integrative Health.
Date: September 10, 2021.
Closed: 10:00 a.m. to 11:30 a.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Democracy 2, 6707
Democracy Boulevard, Bethesda, MD 20817 (Virtual Meeting).
Open: 11:40 a.m. to 5:00 p.m.
Agenda: A report from the Director of the Center and Other
Staff.
Place: National Institutes of Health, Democracy 2, 6707
Democracy Boulevard, Bethesda, MD 20817 (Virtual Meeting).
Contact Person: Partap Singh Khalsa, Ph.D., DC, Director,
Division of Extramural Activities, National Center for Complementary
and Integrative Health, National Institutes of Health, 6707
Democracy Blvd., Suite 401, Bethesda, MD 20892-5475, 301-594-3462,
[email protected].
Any interested person may file written comments with the
committee by forwarding
[[Page 36567]]
the statement to the Contact Person listed on this notice. The
statement should include the name, address, telephone number and
when applicable, the business or professional affiliation of the
interested person. Any member of the public may submit written
comments no later than 15 days after the meeting.
Information is also available on the Institute's/Center's home
page: https://www.nccih.nih.gov/news/events/advisory-council-78th-meeting, where an agenda and any additional information for the
meeting will be posted when available.
(Catalogue of Federal Domestic Assistance Program Nos. 93.213,
Research and Training in Complementary and Alternative Medicine,
National Institutes of Health, HHS)
Dated: July 7, 2021.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2021-14739 Filed 7-9-21; 8:45 am]
BILLING CODE 4140-01-P