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. The purpose of this notice is to allow an additional 30 days for public comment. 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. Frequency of Response: The help desk and Web site survey are collected annually. The OPEN survey is ongoing. Submission of forms varies 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 27,861 hours and the annualized cost to respondents is estimated to be $757,828. 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 |
|---|---|---|---|---|---|---|
| 1a | CTSU IRB/Regulatory Approval Transmittal Form | 9,000 | 2 | 0.03 | 12.00 | 3,240 |
| 1b | CTSU IRB Certification Form | 8,500 | 10 | 0.17 | 12.00 | 17,340 |
| 1c | CTSU Acknowledgement Form | 500 | 5 | 0.08 | 12.00 | 480 |
| 1d | Optional Form 1—Withdrawal from Protocol Participation Form | 10 | 5 | 0.08 | 12.00 | 10 |
| Roster Forms | ||||||
| 1e | CTSU Roster Update Form | 50 | 2-4 | 0.07 | 12.00 | 42 |
| 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) | 10 | 5-10 | 0.17 | 12.00 | 20 |
| 1j | N0147 CTSU Data Transmittal Form | 330 | 5-10 | 0.17 | 12.00 | 673 |
| 1k | Site Intimated Data Update Form (DUF), Protocol: NCCTG N0147* | 30 | 5-10 | 0.17 | 12.00 | 61 |
| 1l | TAILORX/PACCT 1 CTSU Data Transmittal Form | 1200 | 5-10 | 0.17 | 12.00 | 2,448 |
| 1m | Data Clarification Form | 144 | 15-20 | 0.33 | 12.00 | 570 |
| 1n | Unsolicited Data Modification Form (UDM), Protocol:TAILORx/PACCT1 | 30 | 5-10 | 0.17 | 12.00 | 61 |
| 1o | Z4032 CTSU Data Transmittal Form | 58 | 5-10 | 0.17 | 12.00 | 118 |
| 1p | Z1031 CTSU Data Transmittal Form | 54 | 5-10 | 0.17 | 12.00 | 110 |
| 1q | Z1041 CTSU Data Transmittal Form | 48 | 5-10 | 0.17 | 12.00 | 98 |
| 1r | Z6051 CTSU Data Transmittal Form | 12 | 5-10 | 0.17 | 12.00 | 24 |
| 1s | RTOG 0834 CTSU Data Transmittal Form* | 60 | 5-10 | 0.17 | 12.00 | 122 |
| 1t | CTSU 7868 Data Transmittal Form | 30 | 5-10 | 0.17 | 12.00 | 61 |
| 1u | Site Initiated Data Update Form, Protocol 7868 | 10 | 5-10 | 0.17 | 12.00 | 20 |
| 1v | MC0845(8233) CTSU Data Transmittal* | 40 | 5-10 | 0.17 | 12.00 | 82 |
| 1w | 8121 CTSU Data Transmittal Form* | 40 | 5-10 | 0.17 | 12.00 | 82 |
| 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 | 102 |
| 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 | 1,224 |
| 1bb | CTSU P2C Enrollment Transmittal Form | 30 | 5-10 | 0.17 | 12.00 | 61 |
| 1cc | CTSU Transfer Form | 40 | 5-10 | 0.17 | 12.00 | 82 |
| Administrative | ||||||
| 1dd | CTSU System Account Request Form | 10 | 15-20 | 0.33 | 12.00 | 40 |
| 1ee | CTSU Request for Clinical Brochure | 35 | 10 | 0.17 | 12.00 | 71 |
| 1ff | CTSU Supply Request Form | 130 | 5-10 | 0.17 | 12.00 | 265 |
| 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 | 27,861 |
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 oira_submission@omb.eop.gov 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. all non-toll-free number 301-435-9206 or e-mail your request, including your address to: montellom@mail.nih.gov.
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: September 7, 2010.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2010-22710 Filed 9-10-10; 8:45 am]
BILLING CODE 4140-01-P