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Submission for OMB Review; 30-Day Comment Request; CTEP Support Contracts Forms and Surveys, NCI, NIH

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National Institutes of Health, HHS.



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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.


Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.


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, or by fax to 202-395-6974, Attention: Desk Officer for NIH.

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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:

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

Form nameType of respondentNumber of respondentsNumber of responses per respondentAverage burden per response (in hours)Total annual burden hours
CTSU IRB/Regulatory Approval Transmittal Form (Attachment A1)Health Care Practitioner2,444122/60978
CTSU IRB Certification Form (Attachment A2)Health Care Practitioner2,4441210/604,888
Withdrawal from Protocol Participation Form (Attachment A3)Health Care Practitioner279110/6047
Site Addition Form (Attachment A4)Health Care Practitioner801210/60160
CTSU Roster Update Form (Attachment A5)Health Care Practitioner60015/6050
CTSU Request for Clinical Brochure (Attachment A6)Health Care Practitioner360110/6060
CTSU Supply Request Form (Attachment A7)Health Care Practitioner901210/60180
Site Initiated Data Update Form (Attachment A8)Health Care Practitioner21210/604
Data Clarification Form (Attachment A9)Health Care Practitioner1502410/60600
RTOG 0834 CTSU Data Transmittal Form (Attachment A10)Health Care Practitioner127610/60152
MC0845(8233) CTSU Data Transmittal (Attachment A11)Health Care Practitioner51210/6010
CTSU Generic Data Transmittal Form (Attachment A12)Health Care Practitioner51210/6010
TAILORx—PACCT1—Data Transmittal Form (Attachment A13)Health Care Practitioner1619610/602576
Unsolicited Data Modification Form: Protocol: TAILORx/PACCT-1 (Attachment 14)Health Care Practitioner301210/6060
CTSU Patient Enrollment Transmittal Form (Attachment A15)Health Care Practitioner121210/6024
CTSU Transfer Form (Attachment A16)Health Care Practitioner360210/60120
CTSU System Access Request Form (Attachment A17)Health Care Practitioner180120/6060
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NCI CIRB AA & DOR between the NCI CIRB and Signatory Institution (Attachment B1)Participants50115/6013
NCI CIRB Signatory Enrollment Form (Attachment B2)Participants50115/6013
CIRB Board Member Biographical Sketch Form (Attachment B3)Board Member25115/606
CIRB Board Member Contact Information Form (Attachment B4)Board Member25110/604
CIRB Board Member NDA (Attachment B6)Board Member25110/604
CIRB Direct Deposit Form (Attachment B7)Board Member25115/606
CIRB Member COI Screening Worksheet (Attachment B8)Board Members12130/606
CIRB COI Screening for CIRB meetings (Attachment B9)Board Members72115/6018
CIRB IR Application (Attachment B10)Health Care Practitioner801180
CIRB IR Application for Exempt Studies (Attachment B11)Health Care Practitioner4130/602
CIRB Amendment Review Application (Attachment B12)Health Care Practitioner400115/60100
CIRB Ancillary Studies Application (Attachment B13)Health Care Practitioner1111
CIRB Continuing Review Application (Attachment B14)Health Care Practitioner400130/60200
Adult IR of Cooperative Group Protocol (Attachment B15)Board Members651180/60195
Pediatric IR of Cooperative Group Protocol (Attachment B16)Board Members151180/6045
Adult Continuing Review of Cooperative Group Protocol (Attachment B17) ProtocolBoard Members27511275
Pediatric Continuing Review of Cooperative Group Protocol (Attachment B18)Board Members13011130
Adult Amendment of Cooperative Group Protocol (Attachment B19)Board Members401120/6080
Pediatric Amendment of Cooperative Group Protocol (Attachment B20)Board Members251120/6050
Pharmacist's Review of a Cooperative Group Study (Attachment B21)Board Members101120/6020
CPC Pharmacist's Review of Cooperative Group Study (Attachment B22)Board Members201120/6040
Adult Expedited Amendment Review (Attachment B23)Board Members348130/60174
Pediatric Expedited Amendment Review (Attachment B24)Board Members140130/6070
Adult Expedited Continuing Review (Attachment B25)Board Members140130/6070
Pediatric Expedited Continuing Review (Attachment B26)Board Members36130/6018
Adult Cooperative Group Response to CIRB Review (Attachment B27)Health Care Practitioner301130
Pediatric Cooperative Group Response to CIRB Review (Attachment B28)Health Care Practitioner5115
Adult Expedited Study Chair Response to Required Mod (Attachment B29)Board Members40115/6010
Pediatric Expedited Study Chair Response to Required Mod (Attachment B30)Board Members40115/6010
Reviewer Worksheet—Determination of UP or SCN (Attachment B31)Board Members360110/6061
Reviewer Worksheet—CIRB Statistical Reviewer Form (Attachment B32)Board Members10011100
CIRB Application for Translated Documents (Attachment B33)Health Care Practitioner100130/6050
Reviewer Worksheet of Translated Documents (Attachment B34)Board Members100115/6025
Reviewer Worksheet of Recruitment Material (Attachment B35)Board Members20115/605
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Reviewer Worksheet Expedited Study Closure Review (Attachment B36)Board Members20115/605
Reviewer Worksheet Expedited Review of Study Chair Response to CIRB-Required Modifications (Attachment B37)Board Members5130/603
Reviewer Worksheet of Expedited IR (Attachment B38)Board Members5130/603
Reviewer Worksheet—CPC—Determination of UP or SCN (Attachment B39)Board Members40115/6010
Annual Signatory Institution Worksheet About Local Context (Attachment B40)Health Care Practitioner400140/60267
Annual Principal Investigator Worksheet About Local Context (Attachment B41)Health Care Practitioner1800120/60600
Study-Specific Worksheet About Local Context (Attachment B42)Health Care Practitioner4800120/601600
Study Closure or Transfer of Study Review Responsibility Form (Attachment B43)Health Care Practitioner1680115/60420
UP or SCN Reporting Form (Attachment B44)Health Care Practitioner360120/60120
Change of SI PI Form (Attachment B45)Health Care Practitioner120115/6030
CTSU Website Customer Satisfaction Survey (Attachment C1)Health Care Practitioner275115/6069
CTSU Help Desk Customer Satisfaction Survey (Attachment C2)Health Care Practitioner325115/6081
CTSU OPEN Survey (Attachment C3)Health Care Practitioner60115/6015
CIRB Customer Satisfaction Survey (Attachment C4) Satisfaction Survey (Attachment C4)Participants600115/60150
Follow-up Survey (Communication Audit) (Attachment C5)Participants/Board Members300115/6075
Website Focus Groups, Communication Project (Attachment C6 A-D)Participants/Board Members181118
CIRB Board Member Annual Assessment Survey (Attachment C7)Board Members60120/6020
PIO Customer Satisfaction Survey (Attachment C8)Health Care Practitioner6015/605
Concept Clinical Trial Survey (Attachment C9)Health Care Practitioner50015/6042
Prospective Clinical Trial Survey (Attachment C10)Health Care Practitioner100011/6017
Low Accrual Clinical Trial Survey (Attachment C11)Health Care Practitioner100011/6017
ETCTN PI Survey (Attachment 12)Physician75115/6019
ETCTN RS Survey (Attachment 13)Health Care Practitioner175115/6044
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Dated: February 15, 2017.

Karla Bailey,

PRA OMB Liaison, Office of Management Policy and Compliance, National Cancer Institute (NCI) National Institutes of Health (NIH).

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[FR Doc. 2017-04253 Filed 3-3-17; 8:45 am]