Proposed Collection; Comment Request (60-Day FRN); The Clinical Trials Reporting Program (CTRP) Database (NCI), 7437-7438 [2013-02123]
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Federal Register / Vol. 78, No. 22 / Friday, February 1, 2013 / Notices
for health care services performed by
such providers; and to serve as a legal
document for health and medical care
authorized by IHS and rendered by
health care providers under contract
with the IHS. Affected Public: Patients,
instruments, Estimated number of
respondents, Number of responses per
respondent, Average burden hour per
response, and Total annual burden
hours.
health and medical care providers or
Tribal Governments. Type of
Respondents: Health and medical care
providers.
Burden Hours: The table below
provides: Types of data collection
Estimated
number of
respondents
Data collection instrument(s)
Responses
per
respondent
Average
burden hour
per response*
Total annual
burden hours
IHS 843–1A .....................................................................................................
7,977
52
3/60
20,740
Total ..........................................................................................................
........................
........................
........................
20,740
srobinson on DSK4SPTVN1PROD with NOTICES
* For ease of understanding, burden hours are also provided in actual minutes.
The total estimated burden for this
collection is 20,740 hours.
There are no Capital Costs, Operating
Costs, and/or Maintenance Costs to
report.
Request for Comments: Your written
comments and/or suggestions are
invited on one or more of the following
points: (a) Whether the information
collection activity is necessary to carry
out an agency function; (b) whether the
IHS processes the information collected
in a useful and timely fashion; (c) the
accuracy of the public burden estimate
(this is the amount of time needed for
individual respondents to provide the
requested information); (d) whether the
methodology and assumptions used to
determine the estimate are logical; (e)
ways to enhance the quality, utility, and
clarity of the information being
collected; and (f) ways to minimize the
public burden through the use of
automated, electronic, mechanical, or
other technological collection
techniques or other forms of information
technology.
Direct your comments to OMB: Send
your comments and suggestions
regarding the proposed information
collection contained in this notice,
especially regarding the estimated
public burden and associated response
time to: Office of Management and
Budget, Office of Regulatory Affairs,
New Executive Office Building, Room
10235, Washington, DC 20503,
Attention: Desk Officer for IHS.
To request more information on the
proposed collection, or to obtain a copy
of the data collection instruments and/
or instruction(s) contact: Tamara Clay,
Reports Clearance Officer, 801
Thompson Avenue, TMP, Suite 450,
Rockville, MD 20852, call non-toll free
(301) 443–4750, send via facsimile to
(301) 443–2316, or send your email
requests, comments, and return address
to: Tamara.Clay@ihs.gov.
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Comment Due Date: March 4,
2013. Your comments regarding this
information collection are best assured
of having full effect if received within
30 days of the date of this publication.
DATES:
Dated: January 23, 2013.
Yvette Roubideaux,
Director, Indian Health Service.
[FR Doc. 2013–02140 Filed 1–31–13; 8:45 am]
BILLING CODE 4165–16–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request (60-Day FRN); The Clinical
Trials Reporting Program (CTRP)
Database (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 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 to address 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
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
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
SUMMARY:
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respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology. To submit
comments in writing, request more
information on the proposed project, or
to obtain a copy of the data collection
plans and instruments, contact: Jose
Galvez, Office of the Director, National
Cancer Institute, 2115 East Jefferson
Street, Rockville, MD 20852 or call nontoll-free number 301–443–6141 or Email
your request, including your address to:
jose.galvez@nih.gov.
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: The Clinical
Trials Reporting Program (CTRP)
Database, 0925–0600, Expiration Date 3/
31/2013—EXTENSION, National Cancer
Institute (NCI), National Institutes of
Health (NIH).
Need and Use of Information
Collection: The Clinical Trials Reporting
Program (CTRP) is an electronic
resource that serves as a single,
definitive source of information about
all NCI-supported clinical research. This
resource allows the NCI to consolidate
reporting, aggregate information and
reduce redundant submissions.
Information is submitted by clinical
research administrators as designees of
clinical investigators who conduct NCIsupported clinical research. The
designees can electronically access the
CTRP Web site to complete the initial
trial registration. Subsequent to
registration, four amendments and four
study subject accrual updates occur per
trial annually.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The estimated
annualized burden hours are 38,500.
E:\FR\FM\01FEN1.SGM
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7438
Federal Register / Vol. 78, No. 22 / Friday, February 1, 2013 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Number of
respondents
Average time
per response
(in hours)
Annual burden
hours
Type of respondents
Instrument
Clinical Trials .....................................
Initial Registration .............................
Amendment ......................................
Accrual Updates ...............................
5,500
5,500
5,500
1
4
4
2
1
15/60
11,000
22,000
5,500
Total ...........................................
...........................................................
16,500
........................
........................
38,500
Dated: January 25, 2013.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National
Cancer Institute (NCI), National Institutes of
Health (NIH).
[FR Doc. 2013–02123 Filed 1–31–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Development of Human
Monoclonal Antibodies Against DR4
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
This is notice, in accordance
with 35 U.S.C. 209(c)(1) and 37 CFR
404.7(a)(1)(i), that the National
Institutes of Health, Department of
Health and Human Services, is
contemplating the grant of an exclusive
evaluation option license to practice the
inventions embodied in PCT Patent
Application No. PCT/US2011/040750
and foreign equivalents thereof entitled
‘‘Agonistic Human Monoclonal
Antibodies Against DR4’’ (HHS Ref. No.
E–158–2010/0) to Customized
Biosciences, Inc., which is located in
Pasadena, CA. The patent rights in these
inventions have been assigned to the
United States of America.
The prospective start-up exclusive
commercial license territory may be
worldwide and the field of use may be
limited to ‘‘use of the Licensed Patent
Rights to develop therapeutic agents for
the treatment of lymphomas, leukemias,
hepatocellular cancer, colorectal cancer,
ovarian cancer, lung cancer, rheumatoid
arthritis, systemic lupus erythematosus,
multiple sclerosis, amyotrophic lateral
sclerosis, and Alzheimer’s disease’’.
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before
February 19, 2013 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, comments,
srobinson on DSK4SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:26 Jan 31, 2013
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and other materials relating to the
contemplated exclusive evaluation
option license should be directed to:
Whitney A. Hastings, Ph.D., Licensing
and Patenting Manager, Office of
Technology Transfer, National Institutes
of Health, 6011 Executive Boulevard,
Suite 325, Rockville, MD 20852–3804;
Telephone: (301) 451–7337; Facsimile:
(301) 402–0220; Email:
hastingw@mail.nih.gov.
SUPPLEMENTARY INFORMATION: The tumor
necrosis factor (TNF)-related apoptosisinducing ligand (TRAIL) and its
functional receptors, DR4 and DR5, have
been recognized as promising targets for
cancer treatment. Therapeutics targeting
TRAIL and its receptors are not only
effective in killing many types of tumors
but they also synergize with traditional
therapies, and show efficacy against
tumors that are otherwise resistant to
conventional treatments.
The above identified patent
application relates to the development
of two human monoclonal antibodies
(mAbs) that bind to death receptor 4
(‘‘DR4’’). The two mAbs were selected
from a human phage displayed Fab
library by panning against a
recombinant DR4 extracellular domain.
Therefore the two mAbs are fully
human. These antibodies could have
considerable potential as cancer
therapeutics alone or in combination
with other drugs. Further, these
antibodies could be used as a research
tool for the study of DR4.
The prospective start-up exclusive
commercial license is being considered
under the small business initiative
launched on 1 October 2011, and will
comply with the terms and conditions
of 35 U.S.C. 209 and 37 CFR 404.7. The
prospective start-up exclusive
commercial license, may be granted
unless 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 404.7 within
fifteen (15) days from the date of this
published notice.
Complete applications for a license in
the field of use filed in response to this
notice will be treated as objections to
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the grant of the contemplated start-up
exclusive commercial 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: January 24, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2013–02152 Filed 1–31–13; 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 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, RFA Panel:
Studies in Neonatal Resuscitation.
Date: February 27–28, 2013.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Gary Hunnicutt, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6164,
MSC 7892, Bethesda, MD 20892, 301–435–
0229, gary.hunnicutt@nih.gov.
E:\FR\FM\01FEN1.SGM
01FEN1
]]>Agencies
[Federal Register Volume 78, Number 22 (Friday, February 1, 2013)]
[Notices]
[Pages 7437-7438]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-02123]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment Request (60-Day FRN); The Clinical
Trials Reporting Program (CTRP) Database (NCI)
SUMMARY: 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 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 to address 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 proposed collection of
information, including the validity of the methodology and assumptions
used; (3) 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 the use of appropriate
automated, electronic, mechanical, or other technological collection
techniques or other forms of information technology. To submit comments
in writing, request more information on the proposed project, or to
obtain a copy of the data collection plans and instruments, contact:
Jose Galvez, Office of the Director, National Cancer Institute, 2115
East Jefferson Street, Rockville, MD 20852 or call non-toll-free number
301-443-6141 or Email your request, including your address to:
jose.galvez@nih.gov.
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: The Clinical Trials Reporting Program (CTRP)
Database, 0925-0600, Expiration Date 3/31/2013--EXTENSION, National
Cancer Institute (NCI), National Institutes of Health (NIH).
Need and Use of Information Collection: The Clinical Trials
Reporting Program (CTRP) is an electronic resource that serves as a
single, definitive source of information about all NCI-supported
clinical research. This resource allows the NCI to consolidate
reporting, aggregate information and reduce redundant submissions.
Information is submitted by clinical research administrators as
designees of clinical investigators who conduct NCI-supported clinical
research. The designees can electronically access the CTRP Web site to
complete the initial trial registration. Subsequent to registration,
four amendments and four study subject accrual updates occur per trial
annually.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The estimated annualized burden
hours are 38,500.
[[Page 7438]]
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average time
Type of respondents Instrument Number of responses per per response Annual burden
respondents respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
Clinical Trials............... Initial 5,500 1 2 11,000
Registration.
Amendment....... 5,500 4 1 22,000
Accrual Updates. 5,500 4 15/60 5,500
---------------------------------------------------------------
Total..................... ................ 16,500 .............. .............. 38,500
----------------------------------------------------------------------------------------------------------------
Dated: January 25, 2013.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Cancer Institute (NCI),
National Institutes of Health (NIH).
[FR Doc. 2013-02123 Filed 1-31-13; 8:45 am]
BILLING CODE 4140-01-P
