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exclusively in-licensed check point
inhibitor with Ad-Her2 and ME–TARP
vaccine within the Licensed Patent
Rights.
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before April
6, 2016 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, and
comments relating to the contemplated
exclusive license should be directed to:
Sabarni K. Chatterjee, Ph.D., M.B.A.
Senior Licensing and Patenting
Manager, 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)–276–5504E-mail:
[email protected].
SUPPLEMENTARY INFORMATION: This
invention concerns the identification of
immunogenic peptides within TARP,
and their use to create an anti-cancer
immune response in patients. By
introducing these peptides into a
patient, an immune response against
these cancer cells can be initiated by the
peptides, resulting in treatment of the
cancer. A phase I clinical trial in stage
D0 prostate cancer patients is nearing
completion. Initial results indicate a
statistically significant decrease in the
slope of PSA for 48 weeks after
vaccination.
Additionally, a novel vaccine
candidate using recombinant
adenoviruses expressing the
extracellular (EC) and transmembrane
(TM) domains of human HER2
(HER2ECTM) are also being developed
that is within the scope of the field of
use licensed to Midissia. The
recombinant adenovirus expresses a
chimeric fiber protein having the
adenovirus type 35 (Ad5) shaft and
knob domains, which facilitates
transduction of human dendritic cells
by the recombinant HER2ECTM
expressing adenovirus. The vaccine
candidate, namely, AdHer2ECTM) can
potentially to treat patients with Her2
expressing tumors. Clinical studies with
this adenovirus based vaccine is
currently being planned.
Both technologies have the potential
of being developed into a vaccine for
several cancer indications or for the
treatment of any cancer associated with
increased or preferential expression of
TARP and Her 2/neu.
The prospective exclusive license will
be royalty bearing and will comply with
the terms and conditions of 35 U.S.C.
209 and 37 CFR part 404.7. The
prospective exclusive license may be

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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 404.7.
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 exclusive 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: March 16, 2016.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2016–06374 Filed 3–21–16; 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 Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the Board
of Scientific Counselors, NIDDK.
The meeting 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 meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended
for the review, discussion, and
evaluation of individual intramural
programs and projects conducted by the
NATIONAL INSTITUTE OF DIABETES
AND DIGESTIVE AND KIDNEY
DISEASES, including consideration of
personnel qualifications and
performance, and the competence of
individual investigators, the disclosure
of which would constitute a clearly
unwarranted invasion of personal
privacy.
Name of Committee: Board of Scientific
Counselors, NIDDK
Date: April 14–15, 2016.
Open: April 14, 2016, 8:00 a.m. to 8:15 a.m.
Agenda: Introductions and Overview.

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Place: National Institutes of Health, Porter
Neuroscience Research Center, Building 35A
Convent Drive, Rooms 620/630, Bethesda,
MD 20892.
Close: April 14, 2016, 8:15 a.m. to 4:40
p.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Institutes of Health, Porter
Neuroscience Research Center, Building 35A
Convent Drive, Rooms 620/630, Bethesda,
MD 20892.
Close: April 15, 2016, 8:00 a.m. to 4:30
p.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Institutes of Health, Porter
Neuroscience Research Center, Building 35A
Convent Drive, Rooms 620/630, Bethesda,
MD 20892.
Contact Person: Michael W. Krause, Ph.D.,
Scientific Director, National Institute of
Diabetes and Digestive and Kidney Diseases,
National Institute of Health, Building 5,
Room B104, Bethesda, MD 20892–1818, (301)
402–4633, [email protected].
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.
(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: March 15, 2016.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–06336 Filed 3–21–16; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-day
Comment Request: Cancer Genomics
Cloud Pilots Survey (NCI)
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Cancer Institute (NCI), the National
Institutes of Health, has submitted to the
Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on January 13,

SUMMARY:

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Federal Register / Vol. 81, No. 55 / Tuesday, March 22, 2016 / Notices
2016, Vol. 81 pp.1633 and allowed 60days for public comment. No public
comments were received. The purpose
of this notice is to allow an additional
30 days for public comment. The
National Cancer Institute (NCI),
National Institutes of Health (NIH), may
not conduct or sponsor, and the
respondent is not required to respond
to, an information collection that has
been extended, revised, or implemented
on or after October 1, 1995, unless it
displays a currently valid OMB control
number.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs,
[email protected] or by
fax to 202–395–6974, Attention: NIH
Desk Officer.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.

scale cancer genomic data and
associated clinical information. The goal
of this effort is to develop an innovative,
cost-effective model for computational
analysis of biological data and provide
broader yet secure access to genomic
data that NCI generates. Cloud
computing will be a valuable tool to
support studies related to the
mechanisms of cancer. This capability
will be equally valuable to other NCI
scientific areas, including clinical trials
and other types of patient-focused
research. In order to understand the
utility and value of the tools being
developed, the NCI has developed a
survey instrument to capture feedback
from the cancer research community.
The information collected as part of this
survey process will be used exclusively
by the NCI to determine future funding
of cloud technology projects.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
375.

To
obtain a copy of the data collection
plans and instruments, or request more
information on the proposed project,
contact: Anthony Kerlavage, NCI CBIIT,
Program Manager, 9609 Medical Center
Drive, Room 1W–436, Rockville, MD
20850 or call non-toll-free number 240–
276–5190 or email your request,
including your address to:
[email protected]. Formal
requests for additional plans and
instruments must be requested in
writing.
Proposed Collection: Cancer
Genomics Cloud Pilots Survey, 0925–
NEW, National Cancer Institute (NCI),
National Institutes of Health (NIH).
Need and Use of Information
Collection Need and Use of Information
Collection: The Center for Biomedical
Informatics and Information Technology
(CBIIT), in collaboration with the Center
for Cancer Genomics at the National
Cancer Instititues (NCI) in the National
Institutes of Health (NIH), is
coordinating a program to develop three
Cancer Genomics Cloud Pilots to help
meet the research community’s needs to
access and analyze high quality, large-

FOR FURTHER INFORMATION CONTACT:

ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)

Number of
responses per
respondent

Total annual
burden hour

Type of respondent

Cloud Pilot Survey ............................

Principal Investigator ........................

1500

1

15/60

375

Totals .........................................

...........................................................

1500

1500

........................

375

Dated: March 14, 2016.
Karla Bailey,
Project Clearance Liaison, National Cancer
Institute, NIH.

notify the Contact Person listed below
in advance of the meeting.

[FR Doc. 2016–06332 Filed 3–21–16; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute, Notice of
Meeting

asabaliauskas on DSK3SPTVN1PROD with NOTICES

Number of
respondents

Form name

Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the meeting of the
President’s Cancer Panel.
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

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Name of Committee: President’s Cancer
Panel.
Date: June 10, 2016.
Time: 9:00 a.m. to 4:00 p.m.
Agenda: Examining the Cancer Drug Cost
and Access Landscape.
Place: New York Hilton Midtown, 1335
Avenue of the Americas, New York, NY
10019.
Contact Person: Abby B. Sandler, Ph.D.,
Executive Secretary, President’s Cancer
Panel, Special Assistant to the Director, NCI
Center for Cancer Research, 9000 Rockville
Pike, Building 31, Room B2B37, MSC 2590,
Bethesda, MD 20892–8349, 301–451–9399,
[email protected].
Information is also available on the
Institute’s/Center’s home page: http://
deainfo.nci.nih.gov/advisory/pcp/index.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

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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: March 16, 2016.
Melanie Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–06335 Filed 3–21–16; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Final Action Under the NIH Guidelines
for Research Involving Recombinant or
Synthetic Nucleic Acid Molecules (NIH
Guidelines)
National Institutes of Health
(NIH), HHS.
ACTION: Notice of changes to the NIH
Guidelines.
AGENCY:

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