2010-27330. Submission for OMB Review; Comment Request; Cancer Trials Support Unit (CTSU) Public Use Forms and Customer Satisfaction Surveys (NCI)

SUMMARY:

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 title	Use metrics/ month— # respond	Estimated time for site to complete (minutes)	Estimated burden (minutes/ hours)	Frequency of response	Total annual usage/annual burden hours
Regulatory/Roster
1a	CTSU IRB/Regulatory Approval Transmittal Form	9,000	2	0.03	12.00	3,600
1b	CTSU IRB Certification Form	8,500	10	0.17	12.00	17,000
1c	CTSU Acknowledgement Form	500	5	0.08	12.00	500
1d	Optional Form 1—Withdrawal from Protocol Participation Form	50	5	0.08	12.00	50
Roster Forms
1e	CTSU Roster Update Form	50	2-4	0.07	12.00	40
1f	CTSU Radiation Therapy Facilities Inventory Form	20	30	0.50	12.00	120
Drug shipment
1g	CTSU IBCSG Drug Accountability Form	11	5-10	0.17	12.00	22
1h	CTSU IBCSG Transfer of Investigational Agent Form	3	20	0.33	12.00	12
Data Management
1i	Site Initiated Data Update Form (generic)	100	5-10	0.17	12.00	200
1j	N0147 CTSU Data Transmittal Form	1000	5-10	0.17	12.00	2,000
1k	Site Intimated Data Update Form (DUF), Protocol: NCCTG N0147*	75	5-10	0.17	12.00	150
1l	TAILORX/PACCT 1 CTSU Data Transmittal Form	2100	5-10	0.17	12.00	4,200
1m	Data Clarification Form	650	15-20	0.33	12.00	2,600
1n	Unsolicited Data Modification Form (UDM), Protocol: TAILORx/PACCT1	75	5-10	0.17	12.00	150
1o	Z4032 CTSU Data Transmittal Form	50	5-10	0.17	12.00	100
1p	Z1031 CTSU Data Transmittal Form	50	5-10	0.17	12.00	100
1q	Z1041 CTSU Data Transmittal Form	50	5-10	0.17	12.00	100
1r	Z6051 CTSU Data Transmittal Form	75	5-10	0.17	12.00	150
1s	RTOG 0834 CTSU Data Transmittal Form*	60	5-10	0.17	12.00	120
1t	CTSU 7868 Data Transmittal Form	50	5-10	0.17	12.00	100
1u	Site Initiated Data Update Form, protocol 7868	10	5-10	0.17	12.00	20
1v	MC0845(8233) CTSU Data Transmittal*	50	5-10	0.17	12.00	100
1w	8121 CTSU Data Transmittal Form*	100	5-10	0.17	12.00	200
1x	Site Initiated Data Update Form, Protocol 8121	10	5-10	0.17	12.00	20
1y	USMCI 8214/Z6091: CTSU Data Transmittal *In Development	50	5-10	0.17	12.00	100
1z	USMCI 8214/Z6091 Crossover Request/Checklist Transmittal Form	5	5-10	0.17	12.00	10
Patient Enrollment
1aa	CTSU Patient Enrollment Transmittal Form	600	5-10	0.17	12.00	1,200
1bb	CTSU P2C Enrollment Transmittal Form	30	5-10	0.17	12.00	60
1cc	CTSU Transfer Form	40	5-10	0.17	12.00	80
Administrative
1dd	CTSU System Account Request Form	50	15-20	0.33	12.00	200
1ee	CTSU Request for Clinical Brochure	35	10	0.17	12.00	70
1ff	CTSU Supply Request Form	130	5-10	0.17	12.00	260
1gg	CTSU Generic Data Transmittal Form	500	5-10	0.17	12.00	1000.00
Surveys/Web Forms
2	CTSU Web Site Customer Satisfaction Survey	250	10-15	0.2500	1.00	63
3	CTSU Helpdesk Customer Satisfaction Survey	300	10-15	0.2500	1.00	75
4	CTSU OPEN Survey	120	10-15	0.2500	1.00	30
Annual Totals
	21,770					34,802

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 [e-mail] 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: [e-mail].

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.

Dated: October 21, 2010.

Vivian Horovitch-Kelley,

NCI Project Clearance Liaison, National Institutes of Health.