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.
Start Further Info
FOR FURTHER INFORMATION CONTACT:
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: email@example.com. Formal requests for additional plans and instruments must be requested in writing.
End Further Info
Start Supplemental Information
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 name||Type of respondent||Number of respondents||Number of responses per
respondent||Average burden per
(in hours)||Total annual burden hour|
|CTSU IRB/Regulatory Approval Transmittal Form||Health Care Practitioner||9,000||12||2/60||3,600|
|CTSU IRB Certification Form||Health Care Practitioner||8,500||12||10/60||17,000|
|CTSU Acknowledgement Form||Health Care Practitioner||500||12||5/60||500|
|Withdrawal from Protocol Participation Form||Health Care Practitioner||50||12||5/60||50|
|Start Printed Page 83857|
|Site Addition||Health Care Practitioner||25||12||5/60||25|
|CTSU Roster Update Form||Health Care Practitioner||50||12||4/60||40|
|CTSU Radiation Therapy Facilities Inventory Form||Health Care Practitioner||20||12||30/60||120|
|CTSU IBCSG Drug Accountability Form||Health Care Practitioner||11||12||10/60||22|
|CTSU IBCSG Transfer of Investigational Agent Form||Health Care Practitioner||3||12||20/60||12|
|Site Initiated Data Update Form||Health Care Practitioner||10||12||10/60||20|
|Data Clarification Form||Health Care Practitioner||341||12||20/60||1,364|
|RTOG 0834 CTSU Data Transmittal Form||Health Care Practitioner||60||12||10/60||120|
|MC0845(8233) CTSU Data Transmittal||Health Care Practitioner||50||12||10/60||100|
|CTSU Generic Data Transmittal Form||Health Care Practitioner||500||12||10/60||1,000|
|CTSU Patient Enrollment Transmittal Form||Health Care Practitioner||200||12||10/60||400|
|CTSU P2C Enrollment Transmittal Form||Health Care Practitioner||15||12||10/60||30|
|CTSU Transfer Form||Health Care Practitioner||20||12||10/60||40|
|CTSU System Account Request Form||Health Care Practitioner||20||12||20/60||80|
|CTSU Request for Clinical Brochure||Health Care Practitioner||75||12||10/60||150|
|CTSU Supply Request Form||Health Care Practitioner||75||12||10/60||150|
|CTSU Web Site Customer Satisfaction Survey||Health Care Practitioner||275||1||15/60||69|
|CTSU Helpdesk Customer Satisfaction Survey||Health Care Practitioner||325||1||15/60||81|
|CTSU OPEN Survey||Health Care Practitioner||60||1||15/60||15|
|PIO Customer Satisfaction Survey||Health Care Practitioner||100||1||5/60||8|
|Concept Clinical Trial Survey||Health Care Practitioner||500||1||5/60||42|
|Prospective Clinical Trial Survey||Health Care Practitioner||1,000||1||5/60||83|
|Low Accrual Clinical Trial Survey||Health Care Practitioner||1,000||1||5/60||83|
End Supplemental Information
Dated: November 10, 2016.
Project Clearance Liaison, National Cancer Institute, National Institutes of Health.
[FR Doc. 2016-28004 Filed 11-21-16; 8:45 am]
BILLING CODE 4140-01-P