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

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Information about this document as published in the Federal Register.

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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, 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.

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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: 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

Form nameType of respondentNumber of respondentsNumber of responses per respondentAverage burden per response (in hours)Total annual burden hour
CTSU IRB/Regulatory Approval Transmittal FormHealth Care Practitioner9,000122/603,600
CTSU IRB Certification FormHealth Care Practitioner8,5001210/6017,000
CTSU AcknowledgementHealth Care Practitioner500125/60500
Withdrawal from Protocol Participation FormHealth Care Practitioner50125/6050
Site AdditionHealth Care Practitioner25125/6025
CTSU Roster Update FormHealth Care Practitioner50124/6040
CTSU Radiation Therapy Facilities Inventory FormHealth Care Practitioner201230/60120
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CTSU IBCSG Drug Accountability FormHealth Care Practitioner111210/6022
CTSU IBCSG Transfer of Investigational Agent FormHealth Care Practitioner31220/6012
Site Initiated Data Update FormHealth Care Practitioner101210/6020
Data Clarification FormHealth Care Practitioner3411220/601,364
RTOG 0834 CTSU Data Transmittal FormHealth Care Practitioner601210/60120
MC0845(8233) CTSU Data TransmittalHealth Care Practitioner501210/60100
CTSU Generic Data Transmittal FormHealth Care Practitioner5001210/601,000
CTSU Patient Enrollment Transmittal FormHealth Care Practitioner2001210/60400
CTSU P2C Enrollment Transmittal FormHealth Care Practitioner151210/6030
CTSU Transfer FormHealth Care Practitioner201210/6040
CTSU System Account Request FormHealth Care Practitioner201220/6080
CTSU Request for Clinical BrochureHealth Care Practitioner751210/60150
CTSU Supply Request FormHealth Care Practitioner751210/60150
CTSU Web Site Customer Satisfaction SurveyHealth Care Practitioner275115/6069
CTSU Helpdesk Customer Satisfaction SurveyHealth Care Practitioner325115/6081
CTSU OPEN SurveyHealth Care Practitioner60115/6015
PIO Customer Satisfaction SurveyHealth Care Practitioner10015/608
Concept Clinical Trial SurveyHealth Care Practitioner50015/6042
Prospective Clinical Trial SurveyHealth Care Practitioner1,00015/6083
Low Accrual Clinical Trial SurveyHealth Care Practitioner1,00015/6083
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Dated: November 7, 2013.

Vivian Horovitch-Kelley,

NCI Project Clearance Liaison, National Institutes of Health.

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[FR Doc. 2013-27554 Filed 11-18-13; 8:45 am]