[Federal Register Volume 78, Number 169 (Friday, August 30, 2013)]
[Notices]
[Pages 53763-53764]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-21225]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-day Comment Request Cancer Trials Support
Unit (CTSU) (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 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 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: Michael
Montello, Cancer Therapy Evaluation Program, Division of Cancer
Treatment and Diagnosis, 9609 Medical Center Drive Rockville, MD 20850
or call non-toll-free number 240-276-6080 or Email your request,
including your address to: [email protected]. 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: Cancer Trials Support Unit (CTSU) (NCI), 0925-
0624, Expiration Date 12/31/2013, REVISION, National Cancer Institute
(NCI), National Institutes of Health (NIH).
Need and Use of Information Collection: The Cancer Therapy
Evaluation Program (CTEP) establishes and supports programs to
facilitate the participation of qualified investigators on CTEP-
supported studies, and to institute programs that minimize redundancy
among grant and contract holders, thereby reducing overall cost of
maintaining a robust treatment trials program. Currently guided by the
efforts of the Clinical Trials Working Group (CTWG) and the Institute
of Medicine (IOM) recommendations to revitalize the Cooperative Group
program, CTEP has funded the Cancer Trials Support Unit (CTSU). The
CTSU collects standardized forms to process site regulatory
information, changes to membership, patient enrollment data, and
routing information for case report forms. In addition, CTSU collects
annual surveys of customer satisfaction for clinical site staff using
the CTSU Help Desk, the CTSU Web site, and the Protocol and Information
Office (PIO). An ongoing user satisfaction survey is in place for the
Oncology Patient Enrollment Network (OPEN). User satisfaction surveys
are compiled as part of the project quality assurance activities and
are used to direct improvements to processes and technology.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 24,996.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Type of Number of responses per per response Total annual
respondent respondents respondent (in hours) burden hour
----------------------------------------------------------------------------------------------------------------
CTSU IRB/Regulatory Approval Health Care 9,000 12 2/60 3,600
Transmittal Form. Practitioner.
CTSU IRB Certification Form... Health Care 8,500 12 10/60 17,000
Practitioner.
CTSU Acknowledgement.......... Health Care 500 12 5/60 500
Practitioner.
Withdrawal from Protocol Health Care 50 12 5/60 50
Participation Form. Practitioner.
Site Addition................. Health Care 25 12 5/60 25
Practitioner.
CTSU Roster Update Form....... Health Care 50 12 4/60 40
Practitioner.
CTSU Radiation Therapy Health Care 20 12 30/60 120
Facilities Inventory Form. Practitioner.
CTSU IBCSG Drug Accountability Health Care 11 12 10/60 22
Form. Practitioner.
CTSU IBCSG Transfer of Health Care 3 12 20/60 12
Investigational Agent Form. Practitioner.
Site Initiated Data Update Health Care 10 12 10/60 20
Form. Practitioner.
Data Clarification Form....... Health Care 341 12 20/60 1,364
Practitioner.
RTOG 0834 CTSU Data Health Care 60 12 10/60 120
Transmittal Form. Practitioner.
MC0845(8233) CTSU Data Health Care 50 12 10/60 100
Transmittal. Practitioner.
CTSU Generic Data Transmittal Health Care 500 12 10/60 1,000
Form. Practitioner.
CTSU Patient Enrollment Health Care 200 12 10/60 400
Transmittal Form. Practitioner.
CTSU P2C Enrollment Health Care 15 12 10/60 30
Transmittal Form. Practitioner.
CTSU Transfer Form............ Health Care 20 12 10/60 40
Practitioner.
CTSU System Account Request Health Care 20 12 20/60 80
Form. Practitioner.
CTSU Request for Clinical Health Care 75 12 10/60 150
Brochure. Practitioner.
[[Page 53764]]
CTSU Supply Request Form...... Health Care 75 12 10/60 150
Practitioner.
CTSU Web Site Customer Health Care 275 1 15/60 69
Satisfaction Survey. Practitioner.
CTSU Helpdesk Customer Health Care 325 1 15/60 81
Satisfaction Survey. Practitioner.
CTSU OPEN Survey.............. Health Care 60 1 15/60 15
Practitioner.
PIO Customer Satisfaction Health Care 100 1 5/60 8
Survey. Practitioner.
----------------------------------------------------------------------------------------------------------------
Dated: August 26, 2013.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2013-21225 Filed 8-29-13; 8:45 am]
BILLING CODE 4140-01-P