Center for Scientific Review; Notice of Closed Meetings, 15227-15228 [2015-06596]
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Federal Register / Vol. 80, No. 55 / Monday, March 23, 2015 / Notices
Requests for copies of the
patent applications, inquiries,
comments, and other materials relating
to the contemplated exclusive
evaluation option license should be
directed to: Jennifer Wong, M.S., Senior
Licensing and Patenting Manager, Office
of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, MD
20852–3804; Telephone: (301) 435–
4633; Facsimile: (301) 402–0220; Email:
wongje@od.nih.gov.
ADDRESSES:
Tyrosine
kinase-like orphan receptor 1 (ROR1) is
a signature cell surface antigen for B-cell
malignancies, most notably, B-cell
chronic lymphocytic leukemia (B–CLL)
and mantle cell lymphoma (MCL) cells,
two incurable diseases. The
investigators have developed a portfolio
of chimeric anti-ROR1 monoclonal
antibodies that selectively target ROR1
malignant B-cells but not normal Bcells. These antibodies may be linked to
chemical drugs or biological toxins thus
providing targeted cytotoxic delivery to
malignant B-cells while sparing normal
cells. Moreover, as these antibodies
selectively target ROR1, they can also be
used to diagnose B-cell malignancies.
The prospective start-up exclusive
evaluation option license is being
considered under the small business
initiative launched on October 1, 2011
and will comply with the terms and
conditions of 35 U.S.C. 209 and 37 CFR
part 404. The prospective start-up
exclusive evaluation option license, and
a subsequent start-up exclusive patent
commercialization license, may be
granted unless within fifteen (15) days
from the date of this published notice,
the NIH 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.
Any additional, properly filed, and
complete applications for a license in
the field of use filed in response to this
notice will be treated as objections to
the grant of the contemplated start-up
exclusive evaluation option 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.
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SUPPLEMENTARY INFORMATION:
Dated: March 16, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology
Transfer, National Institutes of Health.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2); 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 purpose of this
meeting is to evaluate requests for
preclinical development resources for
potential new therapeutics for the
treatment of cancer. The outcome of the
evaluation will provide information to
internal NCI committees that will
decide whether NCI should support
requests and make available contract
resources for development of the
potential therapeutic to improve the
treatment of various forms of cancer.
The research proposals and the
discussions could disclose confidential
trade secrets or commercial property
such as patentable material, and
personal information concerning
individuals associated with the
proposed research projects, the
disclosure of which would constitute a
clearly unwarranted invasion of
personal privacy.
Name of Committee: National Cancer
Institute Special Emphasis Panel; Feb2015
Cycle 19 NExT SEP Committee Meeting.
Date: April 29, 2015.
Time: 8:30 a.m. to 4:30 p.m.
Agenda: To evaluate the NCI Experimental
Therapeutics Program Portfolio.
Place: National Institutes of Health, 9000
Rockville Pike, Campus Building 31,
Conference Room 6C10, Bethesda, MD 20892.
Contact Persons: Barbara Mroczkowski,
Ph.D., Executive Secretary, Discovery
Experimental Therapeutics Program,
National Cancer Institute, NIH, 31 Center
Drive, Room 3A44, Bethesda, MD 20817,
(301) 496–4291, mroczkoskib@mail.nih.gov;
Joseph Tomaszewski, Ph.D., Executive
Secretary, Development Experimental
Therapeutics Program, National Cancer
Institute, NIH, 31 Center Drive, Room 3A44,
Bethesda, MD 20817, (301) 496–6711,
tomaszej@mail.nih.gov.
(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)
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Dated: March 17, 2015.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; 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: Center for Scientific
Review Special Emphasis Panel; Drug
Discovery.
Date: April 2, 2015.
Time: 1:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Peter B. Guthrie, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4142,
MSC 7850, Bethesda, MD 20892, (301) 435–
1239, guthriep@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Exercise in aging, ischemia imaging.
Date: April 2, 2015.
Time: 12:01 p.m. to 1:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Samuel C. Edwards, Ph.D.,
IRG CHIEF, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Room 5210, MSC 7846, Bethesda, MD
20892, (301) 435–1246,
edwardss@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
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Federal Register / Vol. 80, No. 55 / Monday, March 23, 2015 / Notices
(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)
Dated: March 18, 2015.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–06596 Filed 3–20–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; Process and Outcomes
Evaluation of NCI Physical Sciences in
Oncology Centers (PS–OC) Initiative
(NCI)
In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Cancer Institute (NCI),
National Institutes of Health (NIH), will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Written comments and/or suggestions
from the public and affected agencies
are invited on one or more of the
following points: (1) Whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
SUMMARY:
together cancer biologists and
oncologists with scientists from the
fields of physics, mathematics,
chemistry, and engineering to address
some of the major questions and barriers
in cancer research. As part of this
initiative, evaluation plans were
developed and consisted of three
components, dependent on which year
the initiative is in: Prospective for
beginning, structured for mid-point, and
summative/full outcome evaluation for
a decade after the program started. In
2015 the PSO Initiative is transitioning
from the beginning to a mid-point
phase, which represents a critical time
to reflect on the initial outcomes and
restructure the process evaluation to
account for changes mid-way through
the initiative. This proposed request is
to conduct on-line surveys with current
and former trainees and NCI grantees
associated with the program and
comparison groups. Additionally, an
assessment of publications generated
through the PS–OC program will be
conducted via a virtual expert review
panel. The evaluation will address
trainee development and career path
post program involvement as well as the
impact of the program involvement on
program outputs. Results from both the
surveys and the expert peer reviewer
panel will assess research innovation
from the program and inform the future
development of the PSO Initiative. This
request is to gain OMB approval for the
new submission titled, ‘‘Process and
Outcomes Evaluation of NCI Physical
Sciences in Oncology Centers (PS–OC)
Initiative (NCI)’’ for 1 year.
OMB approval is requested for 1 year.
There are no costs to respondents other
than their time. The total estimated
annualized burden hours are 955.
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
Ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) Ways to minimize the
burden of the collection of information
on those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
To Submit Comments And For
Further Information: To obtain a copy of
the data collection plans and
instruments, submit comments in
writing, or request more information on
the proposed project, contact: Nicole
Moore, Division of Cancer Biology, 9609
Medical Center Drive, Room 6W508,
Bethesda, MD 20892–9714 or call nontoll-free number 301–325–7534 or Email
your request, including your address to:
Nicole.Moore@nih.gov. Formal requests
for additional plans and instruments
must be requested in writing.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Proposed Collection: Process and
Outcomes Evaluation of NCI Physical
Sciences in Oncology Centers (PS–OC)
Initiative (NCI), 0925–NEW, National
Cancer Institute (NCI), National
Institutes of Health (NIH)
Need and Use of Information
Collection: The NCI launched the
Physical Sciences—Oncology Center
(PS–OC; https://physics.cancer.gov/)
program in 2009 as Phase I of the
Physical Sciences in Oncology (PSO)
Initiative. The PSO Initiative seeks to
establish research projects that bring
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondent
Survey ...............................................
Survey ...............................................
Survey ...............................................
Scoring Sheet ...................................
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Instrument
Current NCI Trainees .......................
Former NCI Trainees .......................
NCI Grantees ...................................
Expert Reviewers .............................
Number of
responses per
respondent
210
340
300
75
1
1
1
1
Dated: March 16, 2015.
Karla Bailey,
NCI Project Clearance Liaison, National
Institutes of Health.
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Average
burden per
response
(in hours)
25/60
25/60
25/60
8
Total annual
burden hour
88
142
125
600
Agencies
[Federal Register Volume 80, Number 55 (Monday, March 23, 2015)]
[Notices]
[Pages 15227-15228]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-06596]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; 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: Center for Scientific Review Special Emphasis
Panel; Drug Discovery.
Date: April 2, 2015.
Time: 1:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892, (Telephone Conference Call).
Contact Person: Peter B. Guthrie, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4142, MSC 7850, Bethesda, MD
20892, (301) 435-1239, guthriep@csr.nih.gov.
This notice is being published less than 15 days prior to the
meeting due to the timing limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Exercise in aging, ischemia imaging.
Date: April 2, 2015.
Time: 12:01 p.m. to 1:30 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892, (Telephone Conference Call).
Contact Person: Samuel C. Edwards, Ph.D., IRG CHIEF, Center for
Scientific Review, National Institutes of Health, 6701 Rockledge
Drive, Room 5210, MSC 7846, Bethesda, MD 20892, (301) 435-1246,
edwardss@csr.nih.gov.
This notice is being published less than 15 days prior to the
meeting due to the timing limitations imposed by the review and
funding cycle.
[[Page 15228]]
(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)
Dated: March 18, 2015.
Michelle Trout,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2015-06596 Filed 3-20-15; 8:45 am]
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