| Page Range | 83856-83857 | |
| FR Document | 2016-28004 |
[Federal Register Volume 81, Number 225 (Tuesday, November 22, 2016)] [Notices] [Pages 83856-83857] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-28004] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; 60-Day Comment Request; Cancer Trials Support Unit (National Cancer Institute) AGENCY: National Institutes of Health. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval. DATES: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. FOR FURTHER INFORMATION CONTACT: 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, Pharm. D., Cancer Therapy Evaluation Program (CTEP), 9609 Medical Center Drive, MSC 9742, Rockville, MD 20850 or call non-toll- free number 240-276-6080 or Email your request, including your address to: [email protected]. Formal requests for additional plans and instruments must be requested in writing. SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires: Written comments and/or suggestions from the public and affected agencies are invited to address 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. Proposed Collection Title: Cancer Trials Support Unit (CTSU) (NCI), 0925-0624, EXTENSION, 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 for an extension to the existing approval is requested for one year. There are no costs to respondents other than their time. The total estimated annualized burden hours are 25,204. Estimated Annualized Burden Hours -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Average burden Form name Type of respondent Number of responses per per response Total annual respondents respondent (in hours) burden hour -------------------------------------------------------------------------------------------------------------------------------------------------------- CTSU IRB/Regulatory Approval Transmittal Health Care Practitioner..................... 9,000 12 2/60 3,600 Form. CTSU IRB Certification Form.............. Health Care Practitioner..................... 8,500 12 10/60 17,000 CTSU Acknowledgement Form................ Health Care Practitioner..................... 500 12 5/60 500 Withdrawal from Protocol Participation Health Care Practitioner..................... 50 12 5/60 50 Form. [[Page 83857]] 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 Health Care Practitioner..................... 20 12 30/60 120 Inventory Form. CTSU IBCSG Drug Accountability Form...... Health Care Practitioner..................... 11 12 10/60 22 CTSU IBCSG Transfer of Investigational Health Care Practitioner..................... 3 12 20/60 12 Agent Form. 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 Health Care Practitioner..................... 275 1 15/60 69 Survey. CTSU Helpdesk Customer Satisfaction Health Care Practitioner..................... 325 1 15/60 81 Survey. 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 --------------------------------------------------------------- Annualized Totals.................... ............................................. 22,785 237,560 .............. 25,204 -------------------------------------------------------------------------------------------------------------------------------------------------------- Dated: November 10, 2016. Karla Bailey, Project Clearance Liaison, National Cancer Institute, National Institutes of Health. [FR Doc. 2016-28004 Filed 11-21-16; 8:45 am] BILLING CODE 4140-01-P
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. | |
| Contact | 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, Pharm. D., Cancer Therapy Evaluation Program (CTEP), 9609 Medical Center Drive, MSC 9742, Rockville, MD 20850 or call non-toll- | |
| FR Citation | 81 FR 83856 |