| Page Range | 89955-89957 | |
| FR Document | 2016-29767 |
[Federal Register Volume 81, Number 239 (Tuesday, December 13, 2016)] [Notices] [Pages 89955-89957] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-29767] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; 60-Day Comment Request; CTEP Support Contracts Forms and Surveys (National Cancer Institute) AGENCY: National Institutes of Health, Department of Health and Human Services. 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 minimizes the burden of the collection of [[Page 89956]] 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: CTEP Support Contracts Forms and Surveys, 0925--NEW National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP) and the Division of Cancer Prevention (DCP) fund an extensive national program of cancer research, sponsoring clinical trials in cancer prevention, symptom management and treatment for qualified clinical investigators. As part of this effort, CTEP and DCP oversee two support programs, the NCI Central Institutional Review Board (CIRB) and the Cancer Trial Support Unit (CTSU). The purpose of the support programs is to increase efficiency and minimizing burden. The NCI CIRB provides trial oversight satisfying the requirements of 45 CFR 45 and 21 CFR 56 for review of NCI supported studies. The CTSU provides program and systems support for regulatory document collection, membership, data management and patient enrollment. The two programs use integrated systems and processes for managing participant information and documentation of regulatory review. To meet the responsibilities of each program, information is collected from the sites for purposes of membership, enrollment, opening of IRB approved studies, documenting IRB review, regulatory approval (for sites not using the CIRB), patient enrollment, and routing of case report forms. Several surveys are collected to assess satisfaction and provide feedback to guide improvements with processes and technology. Other Surveys have been developed to assess health professional's interests in clinical trials. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 15,531. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Average Type of Number of Number of burden per Total annual Form name respondent respondents responses per response (in burden hours respondent hours) ---------------------------------------------------------------------------------------------------------------- CTSU IRB/Regulatory Approval Health Care 2,444 12 2/60 978 Transmittal Form. Practitioner. CTSU IRB Certification Form... Health Care 2,444 12 10/60 4,888 Practitioner. Withdrawal from Protocol Health Care 279 1 10/60 47 Participation Form. Practitioner. Site Addition Form............ Health Care 80 12 10/60 160 Practitioner. CTSU Roster Update Form....... Health Care 600 1 5/60 50 Practitioner. CTSU Request for Clinical Health Care 360 1 10/60 60 Brochure. Practitioner. CTSU Supply Request Form...... Health Care 90 12 10/60 180 Practitioner. Site Initiated Data Update Health Care 2 12 10/60 4 Form. Practitioner. Data Clarification Form....... Health Care 150 24 10/60 600 Practitioner. RTOG 0834 CTSU Data Health Care 12 76 10/60 152 Transmittal Form. Practitioner. MC0845(8233) CTSU Data Health Care 5 12 10/60 10 Transmittal. Practitioner. CTSU Generic Data Transmittal Health Care 5 12 10/60 10 Form. Practitioner. TAILORx_PACCT1_Data Health Care 161 96 10/60 2,576 Transmittal Form. Practitioner. Unsolicited Data Modification Health Care 30 12 10/60 60 Form: Protocol: TAILORx/PACCT- Practitioner. 1. CTSU Patient Enrollment Health Care 12 12 10/60 24 Transmittal Form. Practitioner. CTSU Transfer Form............ Health Care 360 2 10/60 120 Practitioner. CTSU System Access Request Health Care 180 1 20/60 60 Form. Practitioner. NCI CIRB AA & DOR between the Participants.... 50 1 15/60 13 NCI CIRB and Signatory Institution. NCI CIRB Signatory Enrollment Participants.... 50 1 15/60 13 Form. CIRB Board Member Biographical Board Member.... 25 1 15/60 6 Sketch Form. CIRB Board Member Contact Board Member.... 25 1 10/60 4 Information Form. CIRB Board Member W-9......... Board Member.... 25 1 15/60 6 CIRB Board Member NDA......... Board Member.... 25 1 10/60 4 CIRB Direct Deposit Form...... Board Member.... 25 1 15/60 6 CIRB Member COI Screening Board Members... 12 1 30/60 6 Worksheet. CIRB COI Screening for CIRB Board Members... 72 1 15/60 18 meetings. CIRB IR Application........... Health Care 80 1 60/60 80 Practitioner. CIRB IR Application for Exempt Health Care 4 1 30/60 2 Studies. Practitioner. CIRB Amendment Review Health Care 400 1 15/60 100 Application. Practitioner. CIRB Ancillary Studies Health Care 1 1 60/60 1 Application. Practitioner. CIRB Continuing Review Health Care 400 1 30/60 200 Application. Practitioner. Adult IR of Cooperative Group Board Members... 65 1 180/60 195 Protocol. Pediatric IR of Cooperative Board Members... 15 1 180/60 45 Group Protocol. Adult Continuing Review of Board Members... 275 1 60/60 275 Cooperative Group Protocol. Pediatric Continuing Review of Board Members... 130 1 60/60 130 Cooperative Group Protocol. Adult Amendment of Cooperative Board Members... 40 1 120/60 80 Group Protocol. Pediatric Amendment of Board Members... 25 1 120/60 50 Cooperative Group Protocol. Pharmacist's Review of a Board Members... 10 1 120/60 20 Cooperative Group Study. CPC Pharmacist's Review of Board Members... 20 1 120/60 40 Cooperative Group Study. Adult Expedited Amendment Board Members... 348 1 30/60 174 Review. [[Page 89957]] Pediatric Expedited Amendment Board Members... 140 1 30/60 70 Review. Adult Expedited Continuing Board Members... 140 1 30/60 70 Review. Pediatric Expedited Continuing Board Members... 36 1 30/60 18 Review. Adult Cooperative Group Health Care 30 1 60/60 30 Response to CIRB Review. Practitioner. Pediatric Cooperative Group Health Care 5 1 60/60 5 Response to CIRB Review. Practitioner. Adult Expedited Study Chair Board Members... 40 1 15/60 10 Response to Required Mod. Pediatric Expedited Study Board Members... 40 1 15/60 10 Chair Response to Required Mod. Reviewer Worksheet-- Board Members... 360 1 10/60 61 Determination of UP or SCN. Reviewer Worksheet--CIRB Board Members... 100 1 60/60 100 Statistical Reviewer Form. CIRB Application for Health Care 100 1 30/60 50 Translated Documents. Practitioner. Reviewer Worksheet of Board Members... 100 1 15/60 25 Translated Documents. Reviewer Worksheet of Board Members... 20 1 15/60 5 Recruitment Material. Reviewer Worksheet Expedited Board Members... 20 1 15/60 5 Study Closure Review. Reviewer Worksheet Expedited Board Members... 5 1 30/60 3 Review of Study Chair Response to CIRB--Required Modifications. Reviewer Worksheet of Board Members... 5 1 30/60 3 Expedited IR. Reviewer Worksheet--CPC-- Board Members... 40 1 15/60 10 Determination of UP or SCN. Annual Signatory Institution Health Care 400 1 40/60 267 Worksheet About Local Context. Practitioner. Annual Principal Investigator Health Care 1,800 1 20/60 600 Worksheet About Local Context. Practitioner. Study-Specific Worksheet About Health Care 4,800 1 20/60 1,600 Local Context. Practitioner. Study Closure or Transfer of Health Care 1,680 1 15/60 420 Study Review Responsibility Practitioner. Form. UP or SCN Reporting Form...... Health Care 360 1 20/60 120 Practitioner. Change of SI PI Form.......... Health Care 120 1 15/60 30 Practitioner. CTSU Web site Customer Health Care 275 1 15/60 69 Satisfaction Survey. Practitioner. CTSU Help Desk Customer Health Care 325 1 15/60 81 Satisfaction Survey. Practitioner. CTSU OPEN Survey.............. Health Care 60 1 15/60 15 Practitioner. CIRB Customer Satisfaction Participants.... 600 1 15/60 150 Survey. Follow-up Survey Participants/ 300 1 15/60 75 (Communication Audit). Board Members. Web site Focus Groups, Participants/ 18 1 60/60 18 Communication Project. Board Members. CIRB Board Member Annual Board Members... 60 1 20/60 20 Assessment Survey. PIO Customer Satisfaction Health Care 60 1 5/60 5 Survey. Practitioner. Concept Clinical Trial Survey. Health Care 500 1 5/60 42 Practitioner. Prospective Clinical Trial Health Care 1,000 1 1/60 17 Survey. Practitioner. Low Accrual Clinical Trial Health Care 1,000 1 1/60 17 Survey. Practitioner. ETCTN PI Survey............... Physician....... 75 1 15/60 19 ETCTN RS Survey............... Health Care 175 1 15/60 44 Practitioner. rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr Totals.................... ................ 24,125 100,362 .............. 15,531 ---------------------------------------------------------------------------------------------------------------- Dated: December 1, 2016. Karla Bailey, Project Clearance Liaison, National Cancer Institute, National Institutes of Health. [FR Doc. 2016-29767 Filed 12-12-16; 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 89955 |