Skip to Content


Submission for OMB Review; Comment Request; Cancer Trials Support Unit (CTSU) Public Use Forms and Customer Satisfaction Surveys (NCI)

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble


Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on July 13, 2010 (75 FR 39950) and allowed 60-days for public comment. There have been no public comments. Additionally, the 30-day Federal Register was published on September 13, 2010. The purpose of this notice is to allow an additional 30 days for public comment to the revisions. The 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.

Proposed Collection: Title: Cancer Trial Support Unit (CTSU). Type of Information Collection Request: Existing Collection in Use Without an OMB Number. Need and Use of Information Collection: CTSU collects annual surveys of customer satisfaction for clinical site staff using the CTSU Help Desk and the CTSU Web site. 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 used to direct improvements to processes and technology. In addition, the CTSU collects standardized forms to process site regulatory information, changes to membership, patient enrollment data, and routing information for case report forms. This questionnaire adheres to The Public Health Service Act, Section 413 (42 U.S.C. 285a-2) authorizes CTEP to establish and support 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. Based on a conversation with the Office of Management and Budget on October 17, 2010, the burden table has been revised to take into account future submissions of a generic data transmittal forms (see Attachment 1gg in the Table below). It was agreed that the generic forms will be finalized and submitted in the future as non-substantive change requests for OMB clearance as needed. Frequency of Response: The help desk and Web site survey are collected annually. The OPEN survey is ongoing. The form submissions vary depending on the purpose of the form and the activity of the local site. Affected Public: CTSU's target audience is staff members at clinical sites and CTEP-supported programs. Respondent and burden estimates are listed in the Table below. The annualized burden is estimated to be 34,802 hours and the annualized cost to respondents is estimated to be $946, 601. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.

Attach No.Section/form or survey titleUse metrics/ month— # respondEstimated time for site to complete (minutes)Estimated burden (minutes/ hours)Frequency of responseTotal annual usage/annual burden hours
1aCTSU IRB/Regulatory Approval Transmittal Form9,00020.0312.003,600
1bCTSU IRB Certification Form8,500100.1712.0017,000
1cCTSU Acknowledgement Form50050.0812.00500
1dOptional Form 1—Withdrawal from Protocol Participation Form5050.0812.0050
Roster Forms
1eCTSU Roster Update Form502-40.0712.0040
1fCTSU Radiation Therapy Facilities Inventory Form20300.5012.00120
Drug shipment
Start Printed Page 66768
1gCTSU IBCSG Drug Accountability Form115-100.1712.0022
1hCTSU IBCSG Transfer of Investigational Agent Form3200.3312.0012
Data Management
1iSite Initiated Data Update Form (generic)1005-100.1712.00200
1jN0147 CTSU Data Transmittal Form10005-100.1712.002,000
1kSite Intimated Data Update Form (DUF), Protocol: NCCTG N0147*755-100.1712.00150
1lTAILORX/PACCT 1 CTSU Data Transmittal Form21005-100.1712.004,200
1mData Clarification Form65015-200.3312.002,600
1nUnsolicited Data Modification Form (UDM), Protocol: TAILORx/PACCT1755-100.1712.00150
1oZ4032 CTSU Data Transmittal Form505-100.1712.00100
1pZ1031 CTSU Data Transmittal Form505-100.1712.00100
1qZ1041 CTSU Data Transmittal Form505-100.1712.00100
1rZ6051 CTSU Data Transmittal Form755-100.1712.00150
1sRTOG 0834 CTSU Data Transmittal Form*605-100.1712.00120
1tCTSU 7868 Data Transmittal Form505-100.1712.00100
1uSite Initiated Data Update Form, protocol 7868105-100.1712.0020
1vMC0845(8233) CTSU Data Transmittal*505-100.1712.00100
1w8121 CTSU Data Transmittal Form*1005-100.1712.00200
1xSite Initiated Data Update Form, Protocol 8121105-100.1712.0020
1yUSMCI 8214/Z6091: CTSU Data Transmittal *In Development505-100.1712.00100
1zUSMCI 8214/Z6091 Crossover Request/Checklist Transmittal Form55-100.1712.0010
Patient Enrollment
1aaCTSU Patient Enrollment Transmittal Form6005-100.1712.001,200
1bbCTSU P2C Enrollment Transmittal Form305-100.1712.0060
1ccCTSU Transfer Form405-100.1712.0080
1ddCTSU System Account Request Form5015-200.3312.00200
1eeCTSU Request for Clinical Brochure35100.1712.0070
1ffCTSU Supply Request Form1305-100.1712.00260
1ggCTSU Generic Data Transmittal Form5005-100.1712.001000.00
Surveys/Web Forms
2CTSU Web Site Customer Satisfaction Survey25010-150.25001.0063
3CTSU Helpdesk Customer Satisfaction Survey30010-150.25001.0075
4CTSU OPEN Survey12010-150.25001.0030
Annual Totals

Request for Comments: Written comments and/or suggestions from the public and affected agencies should address one or more of the following points: (1) Evaluate 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) Evaluate 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) Enhance the quality, utility, and clarity of the information to be collected; and (4) 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.

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 Attention: NIH Desk Officer, Office of Management and Budget, at or by fax to 202-395-6974. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Michael Montello, Pharm. D., CTEP, 6130 Executive Blvd., Rockville, MD 20852, call non-toll-free number 301-435-9206 or e-mail your request, including your address to: Start Printed Page 66769

Comments 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.

Start Signature

Dated: October 21, 2010.

Vivian Horovitch-Kelley,

NCI Project Clearance Liaison, National Institutes of Health.

End Signature End Preamble

[FR Doc. 2010-27330 Filed 10-28-10; 8:45 am]