[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]


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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