[Federal Register Volume 78, Number 223 (Tuesday, November 19, 2013)]
[Notices]
[Pages 69428-69429]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-27554]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request: Cancer Trials 
Support Unit (CTSU) (NCI)

SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the National Institutes of Health (NIH), 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 August 30, 2013, Vol. 78, p. 53763 and allowed 60-days for 
public comment. There have been no public comments. The purpose of this 
notice is to allow an additional 30 days for public comment. The 
National Cancer Institute (NCI), National Institutes of Health, 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.

FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data 
collection plans and instruments 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.
    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. 
Additionally, there are three surveys that collect information about 
health professional's interests in clinical trial, potential issues 
with opening and accruing to a clinical trial and reasons for low 
accrual.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 25,205.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                     Type of         Number of       Number of      burden per     Total annual
           Form name               respondent       respondents    responses per   response  (in    burden hour
                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
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.

[[Page 69429]]

 
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.
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.
Concept Clinical Trial Survey.  Health Care                  500               1            5/60              42
                                 Practitioner.
Prospective Clinical Trial      Health Care                1,000               1            5/60              83
 Survey.                         Practitioner.
Low Accrual Clinical Trial      Health Care                1,000               1            5/60              83
 Survey.                         Practitioner.
----------------------------------------------------------------------------------------------------------------


    Dated: November 7, 2013.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2013-27554 Filed 11-18-13; 8:45 am]
BILLING CODE 4140-01-P