Prospective Grant of Exclusive Patent License: Development of a Gene Signature Predictive of Hepatocellular Carcinoma (HCC) Patient Response to Transcatheter Arterial Chemoembolization (TACE), 11362-11363 [2017-03402]
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Federal Register / Vol. 82, No. 34 / Wednesday, February 22, 2017 / Notices
practical utility; (2) Evaluate the
accuracy of the agency’s estimate of the
burden of the proposed collection of
information; (3) Enhance the quality,
utility, and clarity of the information to
be collected; and (4) Minimize the
burden of the collection of information
on those who are to respond; including
through the use of appropriate
automated collection techniques of
other forms of information technology,
e.g., permitting electronic submission of
responses.
Title of Proposal: Mashpee
Wampanoag Indian Health Service Unit
Community Health Assessment.
Type of Information Collection
Request: Three year approval of this
new information collection.
OMB Control Number: To be assigned.
Need and Use of Information
Collection: The Mashpee Wampanoag
Indian Health Service (IHS) Unit seeks
to conduct a health assessment of the
Mashpee Wampanoag Tribe. The
collection of information will be used to
evaluate the health care needs of the
Mashpee Wampanoag Tribal
community. As a healthcare
organization, the Mashpee Wampanoag
Health Service Unit has questions
regarding a respondent’s health status,
behavior and social practices as well as
environmental concerns. These answers
will help the organization assess
healthcare needs of the community and
guide the implementation of programs.
The Mashpee Wampanoag Health
Service Unit will be able to assess the
community’s needs and plan our
Number of
responses
per
respondent
programs accordingly to improve the
health and well-being of the
community.
Status of the Proposed Information
Collection: New request.
Form(s): IHS Mashpee Wampanoag
Community Health Assessment
Questionnaire.
Agency Form Numbers: None.
Members of Affected Public: The
Mashpee Wampanoag Tribal community
members in the Mashpee Wampanoag
Tribal service area.
The table below provides: Type of
data collection instrument, Estimated
number of respondents, Number of
responses per respondent, Annual
number of responses, Average burden
hour per response, and Total annual
burden hour(s).
Total
annual
response
Average
burden
per
response
(hours)
Estimated
burden
hours
Data collection instrument
Type of respondents
Community Health Assessment ........
Individuals ........................................
1
469
25/60
195
Total ...........................................
...........................................................
1
469
25/60
195
received by the National Cancer
Institute’s Technology Transfer Center
on or before March 9, 2017 will be
considered.
There are no direct costs to
respondents to report.
Dated: February 10, 2017.
Chris Buchanan,
Assistant Surgeon General, USPHS, Acting
Director, Indian Health Service.
[FR Doc. 2017–03407 Filed 2–21–17; 8:45 am]
BILLING CODE 4160–16–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent
License: Development of a Gene
Signature Predictive of Hepatocellular
Carcinoma (HCC) Patient Response to
Transcatheter Arterial
Chemoembolization (TACE)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Cancer Institute,
an institute of the National Institutes of
Health, Department of Health and
Human Services, is contemplating the
grant of an Exclusive Patent License to
practice the inventions embodied in the
Patents and Patent Applications listed
in the SUPPLEMENTARY INFORMATION
section of this notice to 3D Medicines
(‘‘3DMed’’) located in Shanghai, China.
DATES: Only written comments and/or
applications for a license which are
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:05 Feb 21, 2017
Jkt 241001
Requests for copies of the
patent application, inquiries, and
comments relating to the contemplated
Exclusive Patent License should be
directed to: Jim Knabb, Ph.D.,
Technology Transfer and Patent
Specialist, NCI Technology Transfer
Center, 9609 Medical Center Drive, RM
1E530 MSC 9702, Bethesda, MD 20892–
9702 (for business mail), Rockville, MD
20850–9702; Telephone: (240) 276–
5530; Facsimile: (240) 276–5504; Email:
jim.knabb@nih.gov.
ADDRESSES:
SUPPLEMENTARY INFORMATION:
Intellectual Property
United States Provisional Patent
Application No. 62/292,789, filed
February 8, 2016 entitled ‘‘Gene
Signature Predictive of Hepatocellular
Carcinoma Response to Transcatheter
Arterial Chemoembolization’’ [HHS
Reference No. E–101–2016/0–US–01];
PCT Patent Application PCT/US2017/
016851, filed February 7, 2017 and
entitled ‘‘GENE SIGNATURE
PREDICTIVE OF HEPATOCELLULAR
CARCINOMA RESPONSE TO
TRANSCATHETER ARTERIAL
CHEMOEMBOLIZATION (TACE)’’
[HHS Reference No. E–101–2016/0–
PCT–02]; (and U.S. and foreign patent
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
applications claiming priority to the
aforementioned applications).
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 ‘‘the
Development and commercialization of
the transcatheter arterial
chemoembolization (TACE) gene
signature as a diagnostic device
predictive of TACE response in patients
with hepatocellular carcinoma (HCC).
The field of use may be further limited
to companion diagnostic tests that are
sold following Premarket Approval by
the FDA or equivalent regulatory agency
in foreign jurisdictions’’.
This technology discloses a gene
expression signature that is predictive of
HCC patient response to TACE. TACE
therapy is a procedure whereby the
tumor is targeted with both local
chemotherapy and restriction of local
blood supply, and is employed in the
treatment of locally advanced
hepatocellular carcinoma (HCC). Patient
biopsies are analyzed by NextGeneration Sequencing (NGS) and
expression analysis of the gene
signature can be used to stratify patients
for TACE therapy. Through the
commercialization of this gene signature
for TACE efficacy, HCC patients can be
identified as candidates for TACE
E:\FR\FM\22FEN1.SGM
22FEN1
Federal Register / Vol. 82, No. 34 / Wednesday, February 22, 2017 / Notices
therapy, or as needing alternative
treatment strategies.
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.
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 Exclusive Patent License
Agreement. 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: February 15, 2017.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2017–03402 Filed 2–21–17; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Meeting
sradovich on DSK3GMQ082PROD with NOTICES
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Cancer Institute Board of
Scientific Advisors.
The meeting will be open to the
public, 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 meeting
will also be videocast and can be
accessed from the NIH Videocasting and
Podcasting Web site (https://
videocast.nih.gov/).
Name of Committee: National Cancer
Institute Board of Scientific Advisors.
Date: March 21, 2017.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: Acting Director’s Report: Ongoing
and New Business; RFA and RFP Concept
Reviews; and Scientific Presentations.
Place: National Institutes of Health, 31
Center Drive, Building 31, C-Wing, 6th Floor,
Room 10, Bethesda, MD 20892.
VerDate Sep<11>2014
16:05 Feb 21, 2017
Jkt 241001
Contact Person: Paulette S. Gray, Ph.D.,
Director, Division of Extramural Activities,
National Cancer Institute—Shady Grove,
National Institutes of Health, 9609 Medical
Center Drive, 7th Floor, Rm. 7W444,
Bethesda, MD 20892, 240–276–6340, grayp@
mail.nih.gov.
Name of Committee: National Cancer
Institute Board of Scientific Advisors.
Date: March 22, 2017.
Time: 8:30 a.m. to 12:00 p.m.
Agenda: Acting Director’s Report: Ongoing
and New Business; RFA and RFP Concept
Reviews; and Scientific Presentations.
Place: National Institutes of Health, 31
Center Drive, Building 31, C-Wing, 6th Floor,
Room 10, Bethesda, MD 20892.
Contact Person: Paulette S. Gray, Ph.D.,
Director, Division of Extramural Activities,
National Cancer Institute—Shady Grove,
National Institutes of Health, 9609 Medical
Center Drive, 7th Floor, Rm. 7W444,
Bethesda, MD 20892, 240–276–6340, grayp@
mail.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: https://
deainfo.nci.nih.gov/advisory/bsa/bsa.htm,
where an agenda and any additional
information for the meeting will be posted
when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: February 15, 2017.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–03387 Filed 2–21–17; 8:45 am]
BILLING CODE 4140–01–P
PO 00000
11363
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the National Cancer
Institute Clinical Trials and Translation
Research Advisory Committee, March 8,
2017, 8:00 a.m. to March 8, 2017, 3:00
p.m., National Institutes of Health,
Building 31, C-Wing, 6th Floor, Rooms
9 and 10, 31 Center Drive, Bethesda, MD
20892 which was published in the
Federal Register on January 11, 2017, 81
FR 3342.
This meeting notice is amended to
change the meeting format and start and
end times. The meeting will now be
held virtually from 11:00 a.m. to 1:30
p.m. due to a change in the agenda
which reduced the time required for
deliberation and discussion. The
meeting will still be held at the National
Institutes of Health, Building 31, CWing, 6th Floor, Rooms 9 and 10, 31
Center Drive, Bethesda, MD 20892 and
can also be accessed via NIH Videocast
at https://videocast.nih.gov. This
meeting is open to the public.
Dated: February 16, 2017.
Melanie J. Gray-Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–03448 Filed 2–21–17; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; 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
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 on
Aging Special Emphasis Panel; Second Stage
P01 Review.
Date: March 15, 2017.
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Agencies
[Federal Register Volume 82, Number 34 (Wednesday, February 22, 2017)]
[Notices]
[Pages 11362-11363]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03402]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent License: Development of a
Gene Signature Predictive of Hepatocellular Carcinoma (HCC) Patient
Response to Transcatheter Arterial Chemoembolization (TACE)
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Cancer Institute, an institute of the National
Institutes of Health, Department of Health and Human Services, is
contemplating the grant of an Exclusive Patent License to practice the
inventions embodied in the Patents and Patent Applications listed in
the Supplementary Information section of this notice to 3D Medicines
(``3DMed'') located in Shanghai, China.
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 March 9, 2017 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: Jim Knabb, Ph.D., Technology Transfer and Patent
Specialist, NCI Technology Transfer Center, 9609 Medical Center Drive,
RM 1E530 MSC 9702, Bethesda, MD 20892-9702 (for business mail),
Rockville, MD 20850-9702; Telephone: (240) 276-5530; Facsimile: (240)
276-5504; Email: jim.knabb@nih.gov.
SUPPLEMENTARY INFORMATION:
Intellectual Property
United States Provisional Patent Application No. 62/292,789, filed
February 8, 2016 entitled ``Gene Signature Predictive of Hepatocellular
Carcinoma Response to Transcatheter Arterial Chemoembolization'' [HHS
Reference No. E-101-2016/0-US-01]; PCT Patent Application PCT/US2017/
016851, filed February 7, 2017 and entitled ``GENE SIGNATURE PREDICTIVE
OF HEPATOCELLULAR CARCINOMA RESPONSE TO TRANSCATHETER ARTERIAL
CHEMOEMBOLIZATION (TACE)'' [HHS Reference No. E-101-2016/0-PCT-02];
(and U.S. and foreign patent applications claiming priority to the
aforementioned applications).
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 ``the Development and
commercialization of the transcatheter arterial chemoembolization
(TACE) gene signature as a diagnostic device predictive of TACE
response in patients with hepatocellular carcinoma (HCC). The field of
use may be further limited to companion diagnostic tests that are sold
following Premarket Approval by the FDA or equivalent regulatory agency
in foreign jurisdictions''.
This technology discloses a gene expression signature that is
predictive of HCC patient response to TACE. TACE therapy is a procedure
whereby the tumor is targeted with both local chemotherapy and
restriction of local blood supply, and is employed in the treatment of
locally advanced hepatocellular carcinoma (HCC). Patient biopsies are
analyzed by Next-Generation Sequencing (NGS) and expression analysis of
the gene signature can be used to stratify patients for TACE therapy.
Through the commercialization of this gene signature for TACE efficacy,
HCC patients can be identified as candidates for TACE
[[Page 11363]]
therapy, or as needing alternative treatment strategies.
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.
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 Exclusive Patent License Agreement.
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: February 15, 2017.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2017-03402 Filed 2-21-17; 8:45 am]
BILLING CODE 4140-01-P