| Page Range | 18576-18579 | |
| FR Document | 2018-08902 |
[Federal Register Volume 83, Number 82 (Friday, April 27, 2018)] [Notices] [Pages 18576-18579] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-08902] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request CTEP Branch and Support Contracts Forms and Surveys (National Cancer Institute) AGENCY: National Institutes of Health, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: 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. 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., Shanda Finnigan, MPH, RN, CCRC or Jacquelyn Goldberg, JD, 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]. SUPPLEMENTARY INFORMATION: This proposed information collection was previously published in the Federal Register on February 21, 2018, page 7483 (83 FR 7483) and allowed 60 days for public comment. No public comments were received. 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. In compliance with 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. Proposed Collection: CTEP Branch and Support Contracts Forms and Surveys, 0925-0753 Expiration Date 06/30/2020, REVISION, 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 implements programs to register clinical site investigators and clinical site staff, and to oversee the conduct of research at the clinical sites. CTEP and DCP also oversee two support programs, the NCI Central Institutional Review Board (CIRB) and the Cancer Trial Support Unit (CTSU). The combined systems and processes for [[Page 18577]] initiating and managing clinical trials is termed the Clinical Oncology Research Enterprise (CORE) and represents an integrated set of information systems and processes which support investigator registration, trial oversight, patient enrollment, and clinical data collection. The information collected is required to ensure compliance with applicable federal regulations governing the conduct of human subjects research (45 CFR 46 and 21 CRF 50), and when CTEP acts as the Investigational New Drug (IND) holder, FDA regulations pertaining to the sponsor of clinical trials and the selection of qualified investigators under 21 CRF 312.53). Information is also collected through surveys to assess satisfaction, provide feedback to guide improvements with processes and technology, and assess health professional's interests in clinical trials. To increase efficiencies, reduce administrative burden and cost, CTEP has requested consolidation of their current OMB submission. Consolidation is justified because although the various branches and contracts are responsible for distinct services, the processes that support the NCI and participating clinical sites efforts are intertwined. This revision of the previous submission includes changes to the NCI CIRB and CTSU form collections and integrates the Clinical Trials Monitoring Branch (CTMB) and Pharmaceutical Management Branch (PMB) form collections related to site audit and clinical investigator and key clinical site staff registration. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 112,798. 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. A01). CTSU IRB Certification Form Health Care 2,444 12 10/60 4,888 (Attachment A02). Practitioner. Withdrawal from Protocol Health Care 279 1 10/60 47 Participation Form Practitioner. (Attachment A03). Site Addition Form (Attachment Health Care 80 12 10/60 160 A04). Practitioner. CTSU Roster Update Form Health Care 600 1 5/60 50 (Attachment A05). Practitioner. CTSU Request for Clinical Health Care 360 1 10/60 60 Brochure (Attachment A06). Practitioner. CTSU Supply Request Form Health Care 90 12 10/60 180 (Attachment A07). Practitioner. Site Initiated Data Update Health Care 2 12 10/60 4 Form (Attachment A08). Practitioner. Data Clarification Form Health Care 150 24 10/60 600 (Attachment A09). Practitioner. RTOG 0834 CTSU Data Health Care 12 76 10/60 152 Transmittal Form (Attachment Practitioner. A10). CTSU Generic Data Transmittal Health Care 5 12 10/60 10 Form (Attachment A12). Practitioner. 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. CTSU OPEN Rave Request Form Health Care 30 21 10/60 105 (Attachment A18). Practitioner. CTSU LPO Form Creation Health Care 5 2 120/60 20 (Attachment A19). Practitioner. CTSU Site Form Creation and Health Care 400 10 30/60 2,000 PDF (Attachment A20). Practitioner. CTSU PDF Signature Form Health Care 400 10 10/60 667 (Attachment A21). Practitioner. NCI CIRB AA & DOR between the Participants.... 50 1 15/60 13 NCI CIRB and Signatory Institution (Attachment B01). NCI CIRB Signatory Enrollment Participants.... 50 1 15/60 13 Form (Attachment B02). CIRB Board Member Application Board Member.... 100 1 30/60 50 (Attachment B03). CIRB Member COI Screening Board Members... 100 1 15/60 25 Worksheet (Attachment B08). CIRB COI Screening for CIRB Board Members... 72 1 15/60 18 meetings. (Attachment B09).............. CIRB IR Application Health Care 80 1 60/60 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 60/60 1 Application. Practitioner. (Attachment B13).............. CIRB Continuing Review Health Care 400 1 15/60 100 Application. Practitioner. (Attachment B14).............. Adult IR of Cooperative Group Board Members... 65 1 180/60 195 Protocol (Attachment B15). [[Page 18578]] Pediatric IR of Cooperative Board Members... 15 1 180/60 45 Group Protocol (Attachment B16). NCI Adult/Pediatric Continuing Board Members... 275 1 60/60 275 Review of Cooperative Group Protocol. (Attachment B17).............. 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... 50 1 120/60 100 Cooperative Group Study (Attachment B21). 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 60/60 30 Response to CIRB Review Practitioner. (Attachment B27). Pediatric Cooperative Group Health Care 5 1 60/60 5 Response to CIRB Review Practitioner. (Attachment B28). Adult Expedited Study Chair Board Members... 40 1 30/60 20 Response to Required Modifications (Attachment B29). Reviewer Worksheet- Board Members... 400 1 10/60 67 Determination of UP or SCN (Attachment B31). Reviewer Worksheet -CIRB Board Members... 100 1 15/60 25 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). Reviewer Worksheet Expedited Board Members... 20 1 15/60 5 Study Closure Review (Attachment B36). Reviewer Worksheet of Board Members... 5 1 30/60 3 Expedited IR (Attachment B38). Annual Signatory Institution Health Care 400 1 40/60 267 Worksheet About Local Context Practitioner. (Attachment B40). Annual Principal Investigator Health Care 1,800 1 20/60 600 Worksheet About Local Context Practitioner. (Attachment B41). Study-Specific Worksheet About Health Care 4,800 1 20/60 1,600 Local Context (Attachment Practitioner. B42). Study Closure or Transfer of Health Care 1,680 1 20/60 560 Study Review Responsibility Practitioner. (Attachment B43). Unanticipated Problem or Health Care 360 1 20/60 120 Serious or Continuing Practitioner. Noncompliance Reporting Form (Attachment (B44). Change of Signatory Health Care 120 1 20/60 40 Institution PI Form Practitioner. (Attachment B45). Request Waiver of Assent Form ................ 60 1 20/60 20 (Attachment B46). CTSU OPEN Survey (Attachment Health Care 60 1 15/60 15 C03). Practitioner. CIRB Customer Satisfaction Participants.... 600 1 15/60 150 Survey (Attachment C04). Follow-up Survey Participants/ 300 1 15/60 75 (Communication Audit) Board Members. (Attachment C05). CIRB Board Member Annual Board Members... 60 1 15/60 15 Assessment Survey (Attachment C07). PIO Customer Satisfaction Health Care 60 1 5/60 5 Survey (Attachment C08). Practitioner. Concept Clinical Trial Survey Health Care 500 1 5/60 42 (Attachment C09). Practitioner. Prospective Clinical Trial Health Care 1,000 1 1/60 17 Survey (Attachment C10). Practitioner. Low Accrual Clinical Trial Health Care 1,000 1 1/60 17 Survey (Attachment C11). Practitioner. [[Page 18579]] Audit Scheduling Form Group/CTMS Users 152 5 21/60 266 (Attachment D01). Preliminary Audit Findings Auditor......... 152 5 10/60 127 Form (Attachment D02). Audit Maintenance Form Group/CTMS Users 152 5 9/60 114 (Attachment D03). Final Audit Finding Report Group/CTMS Users 75 11 1,098/60 15,098 Form (Attachment D04). Follow-up Form (Attachment Group/CTMS Users 75 7 27/60 236 D05). Roster Maintenance Form CTMS Users...... 5 1 18/60 2 (Attachment D06). Final Report and CAPA Request CTMS Users...... 12 9 1,800/60 3240 Form (Attachment D07). NCI/DCTD/CTEP FDA Form 1572 Physician....... 23,000 1 15/60 5,750 for Annual Submission (Attachment E01). NCI/DCTD/CTE Biosketch Physician; 33,000 1 120/60 66,000 (Attachment E02). Health Care Practitioner. NCI/DCTD/CTEP Financial Physician; 33,000 1 5/60 2,750 Disclosure Form (Attachment Health Care E03). Practitioner. NCI/DCTD/CTEP Agent Shipment Physician....... 23,000 1 10/60 3,833 Form (ASF) (Attachment E04). --------------------------------------------------------------- Totals.................... ................ 136,487 207,989 .............. 112,838 ---------------------------------------------------------------------------------------------------------------- Dated: April 12, 2018. Karla Bailey, Project Clearance Liaison, National Cancer Institute, National Institutes of Health. [FR Doc. 2018-08902 Filed 4-26-18; 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., Shanda Finnigan, MPH, RN, CCRC or Jacquelyn Goldberg, JD, 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 | |
| FR Citation | 83 FR 18576 |