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Proposed Collection; 60-Day Comment Request; Cancer Trials Support Unit (National Cancer Institute)

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National Institutes of Health.




In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.


Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication.

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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, Pharm. D., Cancer Therapy Evaluation Program (CTEP), 9609 Medical Center Drive, MSC 9742, 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.

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Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires: 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) 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.

Proposed Collection Title: Cancer Trials Support Unit (CTSU) (NCI), 0925-0624, EXTENSION, 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 for an extension to the existing approval is requested for one year. There are no costs to respondents other than their time. The total estimated annualized burden hours are 25,204.

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 Acknowledgement FormHealth Care Practitioner500125/60500
Withdrawal from Protocol Participation FormHealth Care Practitioner50125/6050
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Site AdditionHealth Care Practitioner25125/6025
CTSU Roster Update FormHealth Care Practitioner50124/6040
CTSU Radiation Therapy Facilities Inventory FormHealth Care Practitioner201230/60120
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
Annualized Totals22,785237,56025,204
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Dated: November 10, 2016.

Karla Bailey,

Project Clearance Liaison, National Cancer Institute, National Institutes of Health.

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[FR Doc. 2016-28004 Filed 11-21-16; 8:45 am]