78 FR 223 pgs. 69428-69429 - Submission for OMB Review; 30-Day Comment Request: Cancer Trials Support Unit (CTSU) (NCI)
Type: NOTICEVolume: 78Number: 223Pages: 69428 - 69429
Pages: 69428, 69429FR document: [FR Doc. 2013-27554 Filed 11-18-13; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: National Institutes of Health
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request: Cancer Trials Support Unit (CTSU) (NCI)
SUMMARY:
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on August 30, 2013, Vol. 78, p. 53763 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 Cancer Institute (NCI), 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.
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: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer.
Comment 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.
FOR FURTHER INFORMATION CONTACT:
To obtain a copy of the data collection plans and instruments 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.
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. Additionally, there are three surveys that collect information about health professional's interests in clinical trial, potential issues with opening and accruing to a clinical trial and reasons for low accrual.
OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 25,205.
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| 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 |
| 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 |
Dated: November 7, 2013.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2013-27554 Filed 11-18-13; 8:45 am]
BILLING CODE 4140-01-P