National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Meetings, 73601-73602 [2014-29020]
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Federal Register / Vol. 79, No. 238 / Thursday, December 11, 2014 / Notices
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: December 5, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014–29035 Filed 12–10–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of a Start-Up
Exclusive Patent License Agreement:
Use of Compounds Covered by Patent
Rights for Diagnosis of Human Thyroid
Cancer Requiring FDA Premarket
Approval or an Equivalent Authority
Outside of the United States, and
Treatment of Human Thyroid Cancer
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
This is notice, in accordance
with 35 U.S.C. 209 and 37 CFR part 404,
that the National Institutes of Health,
Department of Health and Human
Services, is contemplating the grant of a
Start-Up Exclusive Patent License to
Nova Therapeutics LLC, a company
having a place of business in Delaware,
to practice the inventions embodied in
the following patent applications:
(a) PCT Patent Application No. PCT/
US2008/11958, Filed: October 20,
2008, HHS Ref. No.: E–284–2008/0–
PCT–01
(b) Australian Patent No. 2008–363295,
Filed: October 20, 2008, HHS Ref No.:
E–284–2008/0–AU–02
(c) Canadian Patent Application No.
2,741,030, Filed: October 20, 2008,
HHS Ref. No.: E–284–2008/0–CA–03
(d) European Patent Application No.
08876356.0, Filed: October 20, 2008,
HHS Ref. No.: E–284–2008/0–EP–04
(e) Indian Patent Application No. 3684/
DELNP/2011, Filed: October 20, 2008,
HHS Ref. No.: E–284–2008/0–IN–05
(f) Japanese Patent Application No.
2011–532048, Filed: October 20, 2008,
HHS Ref. No.: E–284–2008/0–JP–06
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SUMMARY:
VerDate Sep<11>2014
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(g) U.S. Patent No. 8,741,259 U.S. Patent
Application No. 13/125,045, Filed:
October 20, 2008, HHS Ref. No.: E–
284–2008/0–US–07
(h) U.S. Patent Application No. 13/
897,330, Filed: October 20, 2008, HHS
Ref. No.: E–284–2008/0–US–08
Current status: pending
(i) U.S. Patent Application No. 14/
243,821, Filed: October 20, 2008, HHS
Ref. No.: E–284–2008/0–US–10
The patent rights in this invention
have been assigned to the Government
of the United States of America. The
territory of the prospective Start-Up
Exclusive Patent License Agreement
may be worldwide and the field of use
may be limited to: Use of compounds
covered by Patent Rights for diagnosis of
human thyroid cancer requiring FDA
premarket approval or an equivalent
authority outside of the United States,
and treatment of human thyroid cancer.
DATES: Only written comments or
applications for a license (or both)
which are received by the NIH Office of
Technology Transfer on or before
December 26, 2014 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated Start-Up Exclusive Patent
License Agreement should be directed
to: Lauren Nguyen-Antczak, Ph.D., J.D.,
Licensing and Patenting Manager, Office
of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, MD
20852–3804; Telephone: (301) 435–
4074; Facsimile: (301) 402–0220; Email:
Lauren.Nguyen-antczak@nih.gov. A
signed confidentiality nondisclosure
agreement will be required to receive
copies of any patent application(s) that
have not been published or issued by
the United States Patent and Trademark
Office of the World Intellectual Property
Organization.
SUPPLEMENTARY INFORMATION: This
invention concerns small molecule
compounds that agonize the activity of
the thyroid stimulating hormone
receptor (‘‘TSHR’’). These TSHR
agonists enhance or activate the thyroid
stimulating hormone (‘‘TSH’’) signaling
pathway by directly binding to the
transmembrane domain of TSHR.
Invention compounds may be
administered alone or in combination
with radioactive iodine to detect thyroid
cancer cells. Additionally, invention
compounds may be administered in
combination with radioactive iodine to
treat thyroid cancer, such as to ablate
thyroid remnants in patients after a
thyroidectomy.
The prospective Start-Up Exclusive
Patent License that is being considered
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73601
can be found at https://www.ott.nih.gov/
forms-model-agreements#SUMLA,
which complies with the terms and
conditions of 35 U.S.C. 209 and 37 CFR
part 404. The prospective Start-Up
Exclusive Patent License is being
provided under the small business
initiative launched on 1 October 2011.
The prospective Start-Up Exclusive
Patent License may be granted unless
the NIH receives written evidence and
argument, within fifteen (15) days from
the date of this published notice, 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 in
the prospective field of use that are filed
in response to this notice will be treated
as objections to the grant of the
contemplated Start-Up Exclusive Patent
License. Comments and objections
submitted to this notice will not be
made available for public inspection
and, to the extent permitted by law, will
not be released under the Freedom of
Information Act, 5 U.S.C. 552.
Dated: December 4, 2014.
Richard U. Rodriguez,
Acting Director, Office of Technology
Transfer, National Institutes of Health.
[FR Doc. 2014–29017 Filed 12–10–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of meetings of the National
Diabetes and Digestive and Kidney
Diseases Advisory Council.
The meetings will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
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
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
E:\FR\FM\11DEN1.SGM
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73602
Federal Register / Vol. 79, No. 238 / Thursday, December 11, 2014 / Notices
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individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Diabetes and
Digestive and Kidney Diseases Advisory
Council.
Date: January 28, 2015.
Open: 8:30 a.m. to 12:00 p.m.
Agenda: To present the Director’s Report
and other scientific presentations.
Place: National Institutes of Health,
Building 31, Conference Room 10, 31 Center
Drive, Bethesda, MD 20892.
Closed: 3:45 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Building 31, Conference Room 10, 31 Center
Drive, Bethesda, MD 20892.
Contact Person: Brent B. Stanfield, Ph.D.,
Director, Division of Extramural Activities,
National Institutes of Diabetes and Digestive
and Kidney Diseases, 6707 Democracy Blvd.,
Room 715, MSC 5452, Bethesda, MD 20892,
(301) 594–8843, stanfibr@niddk.nih.gov.
Name of Committee: National Diabetes and
Digestive and Kidney Diseases Advisory
Council; Diabetes, Endocrinology and
Metabolic Diseases Subcommittee.
Date: January 28, 2015.
Open: 1:00 p.m. to 2:30 p.m.
Agenda: To review the Division’s scientific
and planning activities.
Place: National Institutes of Health,
Building 31, Conference Room 10, 31 Center
Drive, Bethesda, MD 20892.
Closed: 2:30 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Building 31, Conference Room 10, 31 Center
Drive, Bethesda, MD 20892.
Contact Person: Brent B. Stanfield, Ph.D.,
Director, Division of Extramural Activities,
National Institutes of Diabetes and Digestive
And Kidney Diseases, 6707 Democracy Blvd.,
Room 715, MSC 5452, Bethesda, MD 20892,
(301) 594–8843, stanfibr@niddk.nih.gov.
Name of Committee: National Diabetes and
Digestive and Kidney Diseases Advisory
Council; Kidney, Urologic and Hematologic
Diseases Subcommittee.
Date: January 28, 2015.
Open: 1:00 p.m. to 3:00 p.m.
Agenda: To review the Division’s scientific
and planning activities.
Place: National Institutes of Health,
Building 31, Conference Room 7, 31 Center
Drive, Bethesda, MD 20892.
Closed: 3:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Building 31, Conference Room 7, 31 Center
Drive, Bethesda, MD 20892.
Contact Person: Brent B. Stanfield, Ph.D.,
Director, Division of Extramural Activities,
National Institutes of Diabetes and Digestive
and Kidney Diseases, 6707 Democracy Blvd.,
Room 715, MSC 5452, Bethesda, MD 20892,
(301) 594–8843, stanfibr@niddk.nih.gov.
Name of Committee: National Diabetes and
Digestive and Kidney Diseases Advisory
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19:07 Dec 10, 2014
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Council; Digestive Diseases and Nutrition
Subcommittee.
Date: January 28, 2015.
Open: 1:00 p.m. to 2:30 p.m.
Agenda: To review the Division’s scientific
and planning activities.
Place: National Institutes of Health,
Building 31, Conference Room 6, 31 Center
Drive, Bethesda, MD 20892.
Closed: 2:30 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Building 31, Conference Room 6, 31 Center
Drive, Bethesda, MD 20892.
Contact Person: Brent B. Stanfield, Ph.D.,
Director, Division of Extramural Activities,
National Institutes of Diabetes and Digestive
and Kidney Diseases, 6707 Democracy Blvd.,
Room 715, MSC 5452, Bethesda, MD 20892,
(301) 594–8843, stanfibr@niddk.nih.gov.
Any interested person may file written
comments with the committee by forwarding
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.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
Information is also available on the
Institute’s/Center’s home page:
www.niddk.nih.gov/fund/divisions/DEA/
Council/coundesc.htm., where an agenda and
any additional information for the meeting
will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: December 5, 2014.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–29020 Filed 12–10–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
PO 00000
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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: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIH Support for
Conferences and Scientific Meetings (R13/
U13).
Date: January 6, 2015.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: 5601 Fishers Lane, Rockville, MD
20852, (Telephone Conference Call).
Contact Person: Vasundhara Varthakavi,
DVM, Ph.D., Scientific Review Officer,
Scientific Review Program, DEA/NIAID/NIH/
DHHS, Room 3E70B, 5601 Fishers Lane,
Rockville, MD 20852, 240–669–5020,
varthakaviv@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: December 5, 2014.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–29019 Filed 12–10–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Neurological
Disorders and Stroke; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), 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
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: Neurological Sciences
Training Initial Review Group; NST–1
Subcommittee.
Date: February 9–10, 2015.
E:\FR\FM\11DEN1.SGM
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[Federal Register Volume 79, Number 238 (Thursday, December 11, 2014)]
[Notices]
[Pages 73601-73602]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-29020]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases;
Notice of Meetings
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is hereby given of meetings of the
National Diabetes and Digestive and Kidney Diseases Advisory Council.
The meetings will be open to the public as indicated below, with
attendance limited to space available. Individuals who plan to attend
and need special assistance, such as sign language interpretation or
other reasonable accommodations, should notify the Contact Person
listed below in advance of the meeting.
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 the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning
[[Page 73602]]
individuals associated with the grant applications, the disclosure of
which would constitute a clearly unwarranted invasion of personal
privacy.
Name of Committee: National Diabetes and Digestive and Kidney
Diseases Advisory Council.
Date: January 28, 2015.
Open: 8:30 a.m. to 12:00 p.m.
Agenda: To present the Director's Report and other scientific
presentations.
Place: National Institutes of Health, Building 31, Conference
Room 10, 31 Center Drive, Bethesda, MD 20892.
Closed: 3:45 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Building 31, Conference
Room 10, 31 Center Drive, Bethesda, MD 20892.
Contact Person: Brent B. Stanfield, Ph.D., Director, Division of
Extramural Activities, National Institutes of Diabetes and Digestive
and Kidney Diseases, 6707 Democracy Blvd., Room 715, MSC 5452,
Bethesda, MD 20892, (301) 594-8843, stanfibr@niddk.nih.gov.
Name of Committee: National Diabetes and Digestive and Kidney
Diseases Advisory Council; Diabetes, Endocrinology and Metabolic
Diseases Subcommittee.
Date: January 28, 2015.
Open: 1:00 p.m. to 2:30 p.m.
Agenda: To review the Division's scientific and planning
activities.
Place: National Institutes of Health, Building 31, Conference
Room 10, 31 Center Drive, Bethesda, MD 20892.
Closed: 2:30 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Building 31, Conference
Room 10, 31 Center Drive, Bethesda, MD 20892.
Contact Person: Brent B. Stanfield, Ph.D., Director, Division of
Extramural Activities, National Institutes of Diabetes and Digestive
And Kidney Diseases, 6707 Democracy Blvd., Room 715, MSC 5452,
Bethesda, MD 20892, (301) 594-8843, stanfibr@niddk.nih.gov.
Name of Committee: National Diabetes and Digestive and Kidney
Diseases Advisory Council; Kidney, Urologic and Hematologic Diseases
Subcommittee.
Date: January 28, 2015.
Open: 1:00 p.m. to 3:00 p.m.
Agenda: To review the Division's scientific and planning
activities.
Place: National Institutes of Health, Building 31, Conference
Room 7, 31 Center Drive, Bethesda, MD 20892.
Closed: 3:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Building 31, Conference
Room 7, 31 Center Drive, Bethesda, MD 20892.
Contact Person: Brent B. Stanfield, Ph.D., Director, Division of
Extramural Activities, National Institutes of Diabetes and Digestive
and Kidney Diseases, 6707 Democracy Blvd., Room 715, MSC 5452,
Bethesda, MD 20892, (301) 594-8843, stanfibr@niddk.nih.gov.
Name of Committee: National Diabetes and Digestive and Kidney
Diseases Advisory Council; Digestive Diseases and Nutrition
Subcommittee.
Date: January 28, 2015.
Open: 1:00 p.m. to 2:30 p.m.
Agenda: To review the Division's scientific and planning
activities.
Place: National Institutes of Health, Building 31, Conference
Room 6, 31 Center Drive, Bethesda, MD 20892.
Closed: 2:30 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Building 31, Conference
Room 6, 31 Center Drive, Bethesda, MD 20892.
Contact Person: Brent B. Stanfield, Ph.D., Director, Division of
Extramural Activities, National Institutes of Diabetes and Digestive
and Kidney Diseases, 6707 Democracy Blvd., Room 715, MSC 5452,
Bethesda, MD 20892, (301) 594-8843, stanfibr@niddk.nih.gov.
Any interested person may file written comments with the
committee by forwarding 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.
In the interest of security, NIH has instituted stringent
procedures for entrance onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles will be inspected
before being allowed on campus. Visitors will be asked to show one
form of identification (for example, a government-issued photo ID,
driver's license, or passport) and to state the purpose of their
visit.
Information is also available on the Institute's/Center's home
page: www.niddk.nih.gov/fund/divisions/DEA/Council/coundesc.htm.,
where an agenda and any additional information for the meeting will
be posted when available.
(Catalogue of Federal Domestic Assistance Program Nos. 93.847,
Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive
Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes of Health, HHS)
Dated: December 5, 2014.
David Clary,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2014-29020 Filed 12-10-14; 8:45 am]
BILLING CODE 4140-01-P
