85 FR 196 pgs. 63561-63564 - Proposed Collection; 60-Day Comment Request; Cancer Therapy Evaluation Program (CTEP) Branch and Support Contracts Forms and Surveys (National Cancer Institute)
Type: NOTICEVolume: 85Number: 196Pages: 63561 - 63564
Pages: 63561, 63562, 63563FR document: [FR Doc. 2020-22265 Filed 10-7-20; 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
Proposed Collection; 60-Day Comment Request; Cancer Therapy Evaluation Program (CTEP) Branch and Support Contracts Forms and Surveys (National Cancer Institute)
AGENCY:
National Institutes of Health, HHS.
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: montellom@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing.
SUPPLEMENTARY INFORMATION:
[top] Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires: Written
Proposed Collection Title: CTEP Support Contract Forms and Surveys (NCI), 0925-0753 Expiration Date 07/31/2021, 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 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). Survey collections assess satisfaction and provide feedback to guide improvements with processes and technology.
OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 151,716.
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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 hours |
|---|---|---|---|---|---|
| CTSU IRB/Regulatory Approval Transmittal Form (Attach. A01) | Health Care Practitioner | 2,444 | 12 | 2/60 | 978 |
| CTSU IRB Certification Form (Attach. A02) | Health Care Practitioner | 2,444 | 12 | 10/60 | 4,888 |
| Withdrawal from Protocol Participation Form (Attach. A03) | Health Care Practitioner | 279 | 1 | 10/60 | 47 |
| Site Addition Form (Attach. A04) | Health Care Practitioner | 80 | 12 | 10/60 | 160 |
| CTSU Request for Clinical Brochure (Attach. A06) | Health Care Practitioner | 360 | 1 | 10/60 | 60 |
| CTSU Supply Request Form (Attach. A07) | Health Care Practitioner | 90 | 12 | 10/60 | 180 |
| RTOG 0834 CTSU Data Transmittal Form (Attach. A10) | Health Care Practitioner | 12 | 76 | 10/60 | 152 |
| CTSU Patient Enrollment Transmittal Form (Attach. A15) | Health Care Practitioner | 12 | 12 | 10/60 | 24 |
| CTSU Transfer Form (Attach. A16) | Health Care Practitioner | 360 | 2 | 10/60 | 120 |
| CTSU System Access Request Form (Attach. A17) | Health Care Practitioner | 180 | 1 | 10/60 | 30 |
| CTSU OPEN Rave Request Form (Attach. A18) | Health Care Practitioner | 30 | 21 | 10/60 | 105 |
| CTSU LPO Form Creation (Attach. A19) | Health Care Practitioner | 5 | 2 | 120/60 | 20 |
| CTSU Site Form Creation and PDF (Attach. A20) | Health Care Practitioner | 400 | 10 | 30/60 | 2,000 |
| CTSU PDF Signature Form (Attach. A21) | Health Care Practitioner | 400 | 10 | 10/60 | 667 |
| NCI CIRB AA & DOR between the NCI CIRB and Signatory Institution (Attach. B01) | Participants | 50 | 1 | 15/60 | 13 |
| NCI CIRB Signatory Enrollment Form (Attach. B02) | Participants | 50 | 1 | 15/60 | 13 |
| CIRB Board Member Application (Attach. B03) | Board Member | 100 | 1 | 30/60 | 50 |
| CIRB Member COI Screening Worksheet (Attach. B08) | Board Members | 100 | 1 | 15/60 | 25 |
| CIRB COI Screening for CIRB meetings (Attach. B09) | Board Members | 72 | 1 | 15/60 | 18 |
| CIRB IR Application (Attach. B10) | Health Care Practitioner | 80 | 1 | 1 | 80 |
| CIRB IR Application for Exempt Studies (Attach. B11) | Health Care Practitioner | 4 | 1 | 30/60 | 2 |
| CIRB Amendment Review Application (Attach. B12) | Health Care Practitioner | 400 | 1 | 15/60 | 100 |
| CIRB Ancillary Studies Application (Attach. B13) | Health Care Practitioner | 1 | 1 | 1 | 1 |
| CIRB Continuing Review Application (Attach. B14) | Health Care Practitioner | 400 | 1 | 15/60 | 100 |
| Adult IR of Cooperative Group Protocol (Attach. B15) | Board Members | 65 | 1 | 180/60 | 195 |
| Pediatric IR of Cooperative Group Protocol (Attach. B16) | Board Members | 15 | 1 | 180/60 | 45 |
| NCI Adult/Pediatric Continuing Review of Cooperative Group Protocol (Attach. B17) | Board Members | 275 | 1 | 1 | 275 |
| Adult Amendment of Cooperative Group Protocol (Attach. B19) | Board Members | 40 | 1 | 120/60 | 80 |
| Pediatric Amendment of Cooperative Group Protocol (Attach. B20) | Board Members | 25 | 1 | 120/60 | 50 |
| Pharmacist's Review of a Cooperative Group Study (Attach. B21) | Board Members | 50 | 1 | 120/60 | 100 |
| Adult Expedited Amendment Review (Attach. B23) | Board Members | 348 | 1 | 30/60 | 174 |
| Pediatric Expedited Amendment Review (Attach. B24) | Board Members | 140 | 1 | 30/60 | 70 |
| Adult Expedited Continuing Review (Attach. B25) | Board Members | 140 | 1 | 30/60 | 70 |
| Pediatric Expedited Continuing Review (Attach. B26) | Board Members | 36 | 1 | 30/60 | 18 |
| Adult Cooperative Group Response to CIRB Review (Attach. B27) | Health Care Practitioner | 30 | 1 | 1 | 30 |
| Pediatric Cooperative Group Response to CIRB Review (Attach. B28) | Health Care Practitioner | 5 | 1 | 1 | 5 |
| Adult Expedited Study Chair Response to Required Modifications (Attach. B29) | Board Members | 40 | 1 | 30/60 | 20 |
| Reviewer Worksheet- Determination of UP or SCN (Attach. B31) | Board Members | 400 | 1 | 10/60 | 67 |
| Reviewer Worksheet -CIRB Statistical Reviewer Form (Attach. B32) | Board Members | 100 | 1 | 15/60 | 25 |
| CIRB Application for Translated Documents (Attach. B33) | Health Care Practitioner | 100 | 1 | 30/60 | 50 |
| Reviewer Worksheet of Translated Documents (Attach. B34) | Board Members | 100 | 1 | 15/60 | 25 |
| Reviewer Worksheet of Recruitment Material (Attach. B35) | Board Members | 20 | 1 | 15/60 | 5 |
| Reviewer Worksheet Expedited Study Closure Review (Attach. B36) | Board Members | 20 | 1 | 15/60 | 5 |
| Reviewer Worksheet of Expedited IR (Attach. B38) | Board Members | 5 | 1 | 30/60 | 3 |
| Annual Signatory Institution Worksheet About Local Context (Attach. B40) | Health Care Practitioner | 400 | 1 | 40/60 | 267 |
| Annual Principal Investigator Worksheet About Local Context (Attach. B41) | Health Care Practitioner | 1,800 | 1 | 20/60 | 600 |
| Study-Specific Worksheet About Local Context (Attach. B42) | Health Care Practitioner | 4,800 | 1 | 15/60 | 1,200 |
| Study Closure or Transfer of Study Review Resp. (Attach. B43) | Health Care Practitioner | 1,680 | 1 | 15/60 | 344 |
| Unanticipated Problem or Serious or Continuing Noncompliance Reporting Form (Attach. (B44) | Health Care Practitioner | 360 | 1 | 20/60 | 120 |
| Change of Signatory Institution PI Form (Attach. B45) | Health Care Practitioner | 120 | 1 | 20/60 | 40 |
| Request Waiver of Assent Form (Attach. B46) | Health Care Practitioner | 35 | 1 | 20/60 | 12 |
| CIRB Waiver of Consent Request Supplemental Form (Attachment B47) | Health Care Practitioner | 20 | 1 | 15/60 | 5 |
| Review Worksheet CIRB Review for Inclusion of Incarcerated Participants (Attachment B48) | Board Members | 20 | 1 | 1 | 20 |
| Notification of Incarcerated Participant Form (B49) | Health Care Practitioner | 20 | 1 | 20/60 | 7 |
| CTSU OPEN Survey (Attach. C03) | Health Care Practitioner | 10 | 1 | 15/60 | 3 |
| CIRB Customer Satisfaction Survey (Attach. C04) | Participants | 600 | 1 | 15/60 | 150 |
| Follow-up Survey (Communication Audit) (Attach. C05) | Participants/Board Members | 300 | 1 | 15/60 | 75 |
| CIRB Board Member Annual Assessment Survey (Attach. C07) | Board Members | 60 | 1 | 15/60 | 15 |
| PIO Customer Satisfaction Survey (Attach. C08) | Health Care Practitioner | 60 | 1 | 5/60 | 5 |
| Audit Scheduling Form (Attach. D01) | Group/CTMS Users | 152 | 5 | 21/60 | 266 |
| Preliminary Audit Findings Form (Attach. D02) | Auditor | 152 | 5 | 10/60 | 127 |
| Audit Maintenance Form (Attach. D03) | Group/CTMS Users | 152 | 5 | 9/60 | 114 |
| Final Audit Finding Report Form (Attach. D04) | Group/CTMS Users | 75 | 11 | 1,098/60 | 15,098 |
| Follow-up Form (Attach. D05) | Group/CTMS Users | 75 | 7 | 27/60 | 236 |
| Roster Maintenance Form (Attach. D06) | CTMS Users | 5 | 1 | 18/60 | 2 |
| Final Report and CAPA Request Form (Attach. D07) | CTMS Users | 12 | 9 | 1,800/60 | 3,240 |
| NCI/DCTD/CTEP FDA Form 1572 for Annual Submission (Attach. E01) | Physician | 26,500 | 1 | 15/60 | 6,625 |
| NCI/DCTD/CTE Biosketch (Attach. E02) | Physician; Health Care Practitioner | 48,000 | 1 | 120/60 | 96,000 |
| NCI/DCTD/CTEP Financial Disclosure Form (Attach. E03) | Physician; Health Care Practitioner | 48,000 | 1 | 15/60 | 12,000 |
| NCI/DCTD/CTEP Agent Shipment Form (ASF) (Attach. E04) | Physician | 24,000 | 1 | 10/60 | 4,000 |
| Totals | 167,715 | 276 | 151,716 |
Dated: October 1, 2020.
Diane Kreinbrink,
Project Clearance Liaison, National Cancer Institute, National Institutes of Health.
[FR Doc. 2020-22265 Filed 10-7-20; 8:45 am]
BILLING CODE 4140-01-P