Rules and Regulations. DEPARTMENT OF HEALTH AND HUMAN SERVICES
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/register/2013/08/30/2013-21225·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 6820-EP-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; 60-day Comment Request Cancer Trials Support Unit
(NCI)SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget
(OMB)for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on 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. *To Submit Comments and For Further Information:* 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, Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, 9609 Medical Center Drive Rockville, MD 20850 or call non-toll-free number 240-276-6080 or Email your request, including your address to: *montellom@mail.nih.gov.* Formal requests for additional plans and instruments must be requested in writing. *Comment Due Date:* Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. *Proposed Collection:* Cancer Trials Support Unit
(CTSU)(NCI), 0925-0624, Expiration Date 12/31/2013, REVISION, 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 is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 24,996. Estimated Annualized Burden Hours Form name Type of respondent Number of respondents Number of responses per respondent Average burden per response (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 Health Care Practitioner 500 12 5/60 500 Withdrawal from Protocol Participation Form Health Care Practitioner 50 12 5/60 50 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 Dated: August 26, 2013. Vivian Horovitch-Kelley, NCI Project Clearance Liaison, National Institutes of Health. [FR Doc. 2013-21225 Filed 8-29-13; 8:45 am]