| Page Range | 12618-12621 | |
| FR Document | 2017-04253 |
[Federal Register Volume 82, Number 42 (Monday, March 6, 2017)] [Notices] [Pages 12618-12621] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-04253] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request; CTEP Support Contracts Forms and Surveys, NCI, NIH AGENCY: National Institutes of Health, HHS. ACTION: Notice. ----------------------------------------------------------------------- [[Page 12619]] In compliance with 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 December 13, 2016, page 89955 (81 FR 89955) and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. DATES: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication. ADDRESSES: 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, [email protected] or by fax to 202-395-6974, Attention: Desk Officer for NIH. FOR FURTHER INFORMATION CONTACT: 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., 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: [email protected]. Proposed Collection: CTEP Support Contracts Forms and Surveys, NCI, 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 part 45 and 21 CFR part 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 15,525. CTSU and NCI CIRB Forms and CTSU, CIRB and CTEP Surveys--Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of Average burden Form name Type of Number of responses per per response Total annual respondent respondents respondent (in hours) burden hours ---------------------------------------------------------------------------------------------------------------- CTSU IRB/Regulatory Approval Health Care 2,444 12 2/60 978 Transmittal Form (Attachment Practitioner. A1). CTSU IRB Certification Form Health Care 2,444 12 10/60 4,888 (Attachment A2). Practitioner. Withdrawal from Protocol Health Care 279 1 10/60 47 Participation Form Practitioner. (Attachment A3). Site Addition Form (Attachment Health Care 80 12 10/60 160 A4). Practitioner. CTSU Roster Update Form Health Care 600 1 5/60 50 (Attachment A5). Practitioner. CTSU Request for Clinical Health Care 360 1 10/60 60 Brochure (Attachment A6). Practitioner. CTSU Supply Request Form Health Care 90 12 10/60 180 (Attachment A7). Practitioner. Site Initiated Data Update Health Care 2 12 10/60 4 Form (Attachment A8). Practitioner. Data Clarification Form Health Care 150 24 10/60 600 (Attachment A9). Practitioner. RTOG 0834 CTSU Data Health Care 12 76 10/60 152 Transmittal Form (Attachment Practitioner. A10). MC0845(8233) CTSU Data Health Care 5 12 10/60 10 Transmittal (Attachment A11). Practitioner. CTSU Generic Data Transmittal Health Care 5 12 10/60 10 Form (Attachment A12). Practitioner. TAILORx--PACCT1--Data Health Care 161 96 10/60 2576 Transmittal Form (Attachment Practitioner. A13). Unsolicited Data Modification Health Care 30 12 10/60 60 Form: Protocol: TAILORx/PACCT- Practitioner. 1 (Attachment 14). CTSU Patient Enrollment Health Care 12 12 10/60 24 Transmittal Form (Attachment Practitioner. A15). CTSU Transfer Form (Attachment Health Care 360 2 10/60 120 A16). Practitioner. CTSU System Access Request Health Care 180 1 20/60 60 Form (Attachment A17). Practitioner. [[Page 12620]] NCI CIRB AA & DOR between the Participants.... 50 1 15/60 13 NCI CIRB and Signatory Institution (Attachment B1). NCI CIRB Signatory Enrollment Participants.... 50 1 15/60 13 Form (Attachment B2). CIRB Board Member Biographical Board Member.... 25 1 15/60 6 Sketch Form (Attachment B3). CIRB Board Member Contact Board Member.... 25 1 10/60 4 Information Form (Attachment B4). CIRB Board Member NDA Board Member.... 25 1 10/60 4 (Attachment B6). CIRB Direct Deposit Form Board Member.... 25 1 15/60 6 (Attachment B7). CIRB Member COI Screening Board Members... 12 1 30/60 6 Worksheet (Attachment B8). CIRB COI Screening for CIRB Board Members... 72 1 15/60 18 meetings (Attachment B9). CIRB IR Application Health Care 80 1 1 80 (Attachment B10). Practitioner. CIRB IR Application for Exempt Health Care 4 1 30/60 2 Studies (Attachment B11). Practitioner. CIRB Amendment Review Health Care 400 1 15/60 100 Application (Attachment B12). Practitioner. CIRB Ancillary Studies Health Care 1 1 1 1 Application (Attachment B13). Practitioner. CIRB Continuing Review Health Care 400 1 30/60 200 Application (Attachment B14). Practitioner. Adult IR of Cooperative Group Board Members... 65 1 180/60 195 Protocol (Attachment B15). Pediatric IR of Cooperative Board Members... 15 1 180/60 45 Group Protocol (Attachment B16). Adult Continuing Review of Board Members... 275 1 1 275 Cooperative Group Protocol (Attachment B17) Protocol. Pediatric Continuing Review of Board Members... 130 1 1 130 Cooperative Group Protocol (Attachment B18). Adult Amendment of Cooperative Board Members... 40 1 120/60 80 Group Protocol (Attachment B19). Pediatric Amendment of Board Members... 25 1 120/60 50 Cooperative Group Protocol (Attachment B20). Pharmacist's Review of a Board Members... 10 1 120/60 20 Cooperative Group Study (Attachment B21). CPC Pharmacist's Review of Board Members... 20 1 120/60 40 Cooperative Group Study (Attachment B22). Adult Expedited Amendment Board Members... 348 1 30/60 174 Review (Attachment B23). Pediatric Expedited Amendment Board Members... 140 1 30/60 70 Review (Attachment B24). Adult Expedited Continuing Board Members... 140 1 30/60 70 Review (Attachment B25). Pediatric Expedited Continuing Board Members... 36 1 30/60 18 Review (Attachment B26). Adult Cooperative Group Health Care 30 1 1 30 Response to CIRB Review Practitioner. (Attachment B27). Pediatric Cooperative Group Health Care 5 1 1 5 Response to CIRB Review Practitioner. (Attachment B28). Adult Expedited Study Chair Board Members... 40 1 15/60 10 Response to Required Mod (Attachment B29). Pediatric Expedited Study Board Members... 40 1 15/60 10 Chair Response to Required Mod (Attachment B30). Reviewer Worksheet-- Board Members... 360 1 10/60 61 Determination of UP or SCN (Attachment B31). Reviewer Worksheet--CIRB Board Members... 100 1 1 100 Statistical Reviewer Form (Attachment B32). CIRB Application for Health Care 100 1 30/60 50 Translated Documents Practitioner. (Attachment B33). Reviewer Worksheet of Board Members... 100 1 15/60 25 Translated Documents (Attachment B34). Reviewer Worksheet of Board Members... 20 1 15/60 5 Recruitment Material (Attachment B35). [[Page 12621]] Reviewer Worksheet Expedited Board Members... 20 1 15/60 5 Study Closure Review (Attachment B36). Reviewer Worksheet Expedited Board Members... 5 1 30/60 3 Review of Study Chair Response to CIRB-Required Modifications (Attachment B37). Reviewer Worksheet of Board Members... 5 1 30/60 3 Expedited IR (Attachment B38). Reviewer Worksheet--CPC-- Board Members... 40 1 15/60 10 Determination of UP or SCN (Attachment B39). Annual Signatory Institution Health Care 400 1 40/60 267 Worksheet About Local Context Practitioner. (Attachment B40). Annual Principal Investigator Health Care 1800 1 20/60 600 Worksheet About Local Context Practitioner. (Attachment B41). Study-Specific Worksheet About Health Care 4800 1 20/60 1600 Local Context (Attachment Practitioner. B42). Study Closure or Transfer of Health Care 1680 1 15/60 420 Study Review Responsibility Practitioner. Form (Attachment B43). UP or SCN Reporting Form Health Care 360 1 20/60 120 (Attachment B44). Practitioner. Change of SI PI Form Health Care 120 1 15/60 30 (Attachment B45). Practitioner. CTSU Website Customer Health Care 275 1 15/60 69 Satisfaction Survey Practitioner. (Attachment C1). CTSU Help Desk Customer Health Care 325 1 15/60 81 Satisfaction Survey Practitioner. (Attachment C2). CTSU OPEN Survey (Attachment Health Care 60 1 15/60 15 C3). Practitioner. CIRB Customer Satisfaction Participants.... 600 1 15/60 150 Survey (Attachment C4) Satisfaction Survey (Attachment C4). Follow-up Survey Participants/ 300 1 15/60 75 (Communication Audit) Board Members. (Attachment C5). Website Focus Groups, Participants/ 18 1 1 18 Communication Project Board Members. (Attachment C6 A-D). CIRB Board Member Annual Board Members... 60 1 20/60 20 Assessment Survey (Attachment C7). PIO Customer Satisfaction Health Care 60 1 5/60 5 Survey (Attachment C8). Practitioner. Concept Clinical Trial Survey Health Care 500 1 5/60 42 (Attachment C9). Practitioner. Prospective Clinical Trial Health Care 1000 1 1/60 17 Survey (Attachment C10). Practitioner. Low Accrual Clinical Trial Health Care 1000 1 1/60 17 Survey (Attachment C11). Practitioner. ETCTN PI Survey (Attachment Physician....... 75 1 15/60 19 12). ETCTN RS Survey (Attachment Health Care 175 1 15/60 44 13). Practitioner. --------------------------------------------------------------- Totals.................... ................ 24,100 100,337 .............. 15,525 ---------------------------------------------------------------------------------------------------------------- Dated: February 15, 2017. Karla Bailey, PRA OMB Liaison, Office of Management Policy and Compliance, National Cancer Institute (NCI) National Institutes of Health (NIH). [FR Doc. 2017-04253 Filed 3-3-17; 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 30-days of the date of this publication. | |
| Contact | 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., Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, 9609 Medical Center Drive, Rockville, MD 20850 or call non-toll-free number | |
| FR Citation | 82 FR 12618 |