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: montellom@mail.nih.gov. 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 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
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 | Health Care Practitioner | 2,444 | 12 | 2/60 | 978 |
CTSU IRB Certification Form | Health Care Practitioner | 2,444 | 12 | 10/60 | 4,888 |
Withdrawal from Protocol Participation Form | Health Care Practitioner | 279 | 1 | 10/60 | 47 |
Site Addition Form | Health Care Practitioner | 80 | 12 | 10/60 | 160 |
CTSU Roster Update Form | Health Care Practitioner | 600 | 1 | 5/60 | 50 |
CTSU Request for Clinical Brochure | Health Care Practitioner | 360 | 1 | 10/60 | 60 |
CTSU Supply Request Form | Health Care Practitioner | 90 | 12 | 10/60 | 180 |
Site Initiated Data Update Form | Health Care Practitioner | 2 | 12 | 10/60 | 4 |
Data Clarification Form | Health Care Practitioner | 150 | 24 | 10/60 | 600 |
RTOG 0834 CTSU Data Transmittal Form | Health Care Practitioner | 12 | 76 | 10/60 | 152 |
MC0845(8233) CTSU Data Transmittal | Health Care Practitioner | 5 | 12 | 10/60 | 10 |
CTSU Generic Data Transmittal Form | Health Care Practitioner | 5 | 12 | 10/60 | 10 |
TAILORx_PACCT1_Data Transmittal Form | Health Care Practitioner | 161 | 96 | 10/60 | 2,576 |
Unsolicited Data Modification Form: Protocol: TAILORx/PACCT-1 | Health Care Practitioner | 30 | 12 | 10/60 | 60 |
CTSU Patient Enrollment Transmittal Form | Health Care Practitioner | 12 | 12 | 10/60 | 24 |
CTSU Transfer Form | Health Care Practitioner | 360 | 2 | 10/60 | 120 |
CTSU System Access Request Form | Health Care Practitioner | 180 | 1 | 20/60 | 60 |
NCI CIRB AA & DOR between the NCI CIRB and Signatory Institution | Participants | 50 | 1 | 15/60 | 13 |
NCI CIRB Signatory Enrollment Form | Participants | 50 | 1 | 15/60 | 13 |
CIRB Board Member Biographical Sketch Form | Board Member | 25 | 1 | 15/60 | 6 |
CIRB Board Member Contact Information Form | Board Member | 25 | 1 | 10/60 | 4 |
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 Worksheet | Board Members | 12 | 1 | 30/60 | 6 |
CIRB COI Screening for CIRB meetings | Board Members | 72 | 1 | 15/60 | 18 |
CIRB IR Application | Health Care Practitioner | 80 | 1 | 60/60 | 80 |
CIRB IR Application for Exempt Studies | Health Care Practitioner | 4 | 1 | 30/60 | 2 |
CIRB Amendment Review Application | Health Care Practitioner | 400 | 1 | 15/60 | 100 |
CIRB Ancillary Studies Application | Health Care Practitioner | 1 | 1 | 60/60 | 1 |
CIRB Continuing Review Application | Health Care Practitioner | 400 | 1 | 30/60 | 200 |
Adult IR of Cooperative Group Protocol | Board Members | 65 | 1 | 180/60 | 195 |
Pediatric IR of Cooperative Group Protocol | Board Members | 15 | 1 | 180/60 | 45 |
Adult Continuing Review of Cooperative Group Protocol | Board Members | 275 | 1 | 60/60 | 275 |
Pediatric Continuing Review of Cooperative Group Protocol | Board Members | 130 | 1 | 60/60 | 130 |
Adult Amendment of Cooperative Group Protocol | Board Members | 40 | 1 | 120/60 | 80 |
Pediatric Amendment of Cooperative Group Protocol | Board Members | 25 | 1 | 120/60 | 50 |
Pharmacist's Review of a Cooperative Group Study | Board Members | 10 | 1 | 120/60 | 20 |
CPC Pharmacist's Review of Cooperative Group Study | Board Members | 20 | 1 | 120/60 | 40 |
Adult Expedited Amendment Review | Board Members | 348 | 1 | 30/60 | 174 |
Pediatric Expedited Amendment Review | Board Members | 140 | 1 | 30/60 | 70 |
Adult Expedited Continuing Review | Board Members | 140 | 1 | 30/60 | 70 |
Pediatric Expedited Continuing Review | Board Members | 36 | 1 | 30/60 | 18 |
Adult Cooperative Group Response to CIRB Review | Health Care Practitioner | 30 | 1 | 60/60 | 30 |
Pediatric Cooperative Group Response to CIRB Review | Health Care Practitioner | 5 | 1 | 60/60 | 5 |
Adult Expedited Study Chair Response to Required Mod | Board Members | 40 | 1 | 15/60 | 10 |
Pediatric Expedited Study Chair Response to Required Mod | Board Members | 40 | 1 | 15/60 | 10 |
Reviewer Worksheet—Determination of UP or SCN | Board Members | 360 | 1 | 10/60 | 61 |
Reviewer Worksheet—CIRB Statistical Reviewer Form | Board Members | 100 | 1 | 60/60 | 100 |
CIRB Application for Translated Documents | Health Care Practitioner | 100 | 1 | 30/60 | 50 |
Reviewer Worksheet of Translated Documents | Board Members | 100 | 1 | 15/60 | 25 |
Reviewer Worksheet of Recruitment Material | Board Members | 20 | 1 | 15/60 | 5 |
Reviewer Worksheet Expedited Study Closure Review | Board Members | 20 | 1 | 15/60 | 5 |
Reviewer Worksheet Expedited Review of Study Chair Response to CIRB—Required Modifications | Board Members | 5 | 1 | 30/60 | 3 |
Reviewer Worksheet of Expedited IR | Board Members | 5 | 1 | 30/60 | 3 |
Reviewer Worksheet—CPC—Determination of UP or SCN | Board Members | 40 | 1 | 15/60 | 10 |
Annual Signatory Institution Worksheet About Local Context | Health Care Practitioner | 400 | 1 | 40/60 | 267 |
Annual Principal Investigator Worksheet About Local Context | Health Care Practitioner | 1,800 | 1 | 20/60 | 600 |
Study-Specific Worksheet About Local Context | Health Care Practitioner | 4,800 | 1 | 20/60 | 1,600 |
Study Closure or Transfer of Study Review Responsibility Form | Health Care Practitioner | 1,680 | 1 | 15/60 | 420 |
UP or SCN Reporting Form | Health Care Practitioner | 360 | 1 | 20/60 | 120 |
Change of SI PI Form | Health Care Practitioner | 120 | 1 | 15/60 | 30 |
CTSU Web site Customer Satisfaction Survey | Health Care Practitioner | 275 | 1 | 15/60 | 69 |
CTSU Help Desk Customer Satisfaction Survey | Health Care Practitioner | 325 | 1 | 15/60 | 81 |
CTSU OPEN Survey | Health Care Practitioner | 60 | 1 | 15/60 | 15 |
CIRB Customer Satisfaction Survey | Participants | 600 | 1 | 15/60 | 150 |
Follow-up Survey (Communication Audit) | Participants/Board Members | 300 | 1 | 15/60 | 75 |
Web site Focus Groups, Communication Project | Participants/Board Members | 18 | 1 | 60/60 | 18 |
CIRB Board Member Annual Assessment Survey | Board Members | 60 | 1 | 20/60 | 20 |
PIO Customer Satisfaction Survey | Health Care Practitioner | 60 | 1 | 5/60 | 5 |
Concept Clinical Trial Survey | Health Care Practitioner | 500 | 1 | 5/60 | 42 |
Prospective Clinical Trial Survey | Health Care Practitioner | 1,000 | 1 | 1/60 | 17 |
Low Accrual Clinical Trial Survey | Health Care Practitioner | 1,000 | 1 | 1/60 | 17 |
ETCTN PI Survey | Physician | 75 | 1 | 15/60 | 19 |
ETCTN RS Survey | Health Care Practitioner | 175 | 1 | 15/60 | 44 |
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