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Proposed Collection; 60-Day Comment Request; CTEP Support Contracts Forms and Surveys (National Cancer Institute)

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National Institutes of Health, Department of Health and Human Services.




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.


Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication.

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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: Formal requests for additional plans and instruments must be requested in writing.

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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 Start Printed Page 89956information 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 nameType of respondentNumber of respondentsNumber of responses per respondentAverage burden per response (in hours)Total annual burden hours
CTSU IRB/Regulatory Approval Transmittal FormHealth Care Practitioner2,444122/60978
CTSU IRB Certification FormHealth Care Practitioner2,4441210/604,888
Withdrawal from Protocol Participation FormHealth Care Practitioner279110/6047
Site Addition FormHealth Care Practitioner801210/60160
CTSU Roster Update FormHealth Care Practitioner60015/6050
CTSU Request for Clinical BrochureHealth Care Practitioner360110/6060
CTSU Supply Request FormHealth Care Practitioner901210/60180
Site Initiated Data Update FormHealth Care Practitioner21210/604
Data Clarification FormHealth Care Practitioner1502410/60600
RTOG 0834 CTSU Data Transmittal FormHealth Care Practitioner127610/60152
MC0845(8233) CTSU Data TransmittalHealth Care Practitioner51210/6010
CTSU Generic Data Transmittal FormHealth Care Practitioner51210/6010
TAILORx_PACCT1_Data Transmittal FormHealth Care Practitioner1619610/602,576
Unsolicited Data Modification Form: Protocol: TAILORx/PACCT-1Health Care Practitioner301210/6060
CTSU Patient Enrollment Transmittal FormHealth Care Practitioner121210/6024
CTSU Transfer FormHealth Care Practitioner360210/60120
CTSU System Access Request FormHealth Care Practitioner180120/6060
NCI CIRB AA & DOR between the NCI CIRB and Signatory InstitutionParticipants50115/6013
NCI CIRB Signatory Enrollment FormParticipants50115/6013
CIRB Board Member Biographical Sketch FormBoard Member25115/606
CIRB Board Member Contact Information FormBoard Member25110/604
CIRB Board Member W-9Board Member25115/606
CIRB Board Member NDABoard Member25110/604
CIRB Direct Deposit FormBoard Member25115/606
CIRB Member COI Screening WorksheetBoard Members12130/606
CIRB COI Screening for CIRB meetingsBoard Members72115/6018
CIRB IR ApplicationHealth Care Practitioner80160/6080
CIRB IR Application for Exempt StudiesHealth Care Practitioner4130/602
CIRB Amendment Review ApplicationHealth Care Practitioner400115/60100
CIRB Ancillary Studies ApplicationHealth Care Practitioner1160/601
CIRB Continuing Review ApplicationHealth Care Practitioner400130/60200
Adult IR of Cooperative Group ProtocolBoard Members651180/60195
Pediatric IR of Cooperative Group ProtocolBoard Members151180/6045
Adult Continuing Review of Cooperative Group ProtocolBoard Members275160/60275
Pediatric Continuing Review of Cooperative Group ProtocolBoard Members130160/60130
Adult Amendment of Cooperative Group ProtocolBoard Members401120/6080
Pediatric Amendment of Cooperative Group ProtocolBoard Members251120/6050
Pharmacist's Review of a Cooperative Group StudyBoard Members101120/6020
CPC Pharmacist's Review of Cooperative Group StudyBoard Members201120/6040
Adult Expedited Amendment ReviewBoard Members348130/60174
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Pediatric Expedited Amendment ReviewBoard Members140130/6070
Adult Expedited Continuing ReviewBoard Members140130/6070
Pediatric Expedited Continuing ReviewBoard Members36130/6018
Adult Cooperative Group Response to CIRB ReviewHealth Care Practitioner30160/6030
Pediatric Cooperative Group Response to CIRB ReviewHealth Care Practitioner5160/605
Adult Expedited Study Chair Response to Required ModBoard Members40115/6010
Pediatric Expedited Study Chair Response to Required ModBoard Members40115/6010
Reviewer Worksheet—Determination of UP or SCNBoard Members360110/6061
Reviewer Worksheet—CIRB Statistical Reviewer FormBoard Members100160/60100
CIRB Application for Translated DocumentsHealth Care Practitioner100130/6050
Reviewer Worksheet of Translated DocumentsBoard Members100115/6025
Reviewer Worksheet of Recruitment MaterialBoard Members20115/605
Reviewer Worksheet Expedited Study Closure ReviewBoard Members20115/605
Reviewer Worksheet Expedited Review of Study Chair Response to CIRB—Required ModificationsBoard Members5130/603
Reviewer Worksheet of Expedited IRBoard Members5130/603
Reviewer Worksheet—CPC—Determination of UP or SCNBoard Members40115/6010
Annual Signatory Institution Worksheet About Local ContextHealth Care Practitioner400140/60267
Annual Principal Investigator Worksheet About Local ContextHealth Care Practitioner1,800120/60600
Study-Specific Worksheet About Local ContextHealth Care Practitioner4,800120/601,600
Study Closure or Transfer of Study Review Responsibility FormHealth Care Practitioner1,680115/60420
UP or SCN Reporting FormHealth Care Practitioner360120/60120
Change of SI PI FormHealth Care Practitioner120115/6030
CTSU Web site Customer Satisfaction SurveyHealth Care Practitioner275115/6069
CTSU Help Desk Customer Satisfaction SurveyHealth Care Practitioner325115/6081
CTSU OPEN SurveyHealth Care Practitioner60115/6015
CIRB Customer Satisfaction SurveyParticipants600115/60150
Follow-up Survey (Communication Audit)Participants/Board Members300115/6075
Web site Focus Groups, Communication ProjectParticipants/Board Members18160/6018
CIRB Board Member Annual Assessment SurveyBoard Members60120/6020
PIO Customer Satisfaction SurveyHealth Care Practitioner6015/605
Concept Clinical Trial SurveyHealth Care Practitioner50015/6042
Prospective Clinical Trial SurveyHealth Care Practitioner1,00011/6017
Low Accrual Clinical Trial SurveyHealth Care Practitioner1,00011/6017
ETCTN PI SurveyPhysician75115/6019
ETCTN RS SurveyHealth Care Practitioner175115/6044
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Dated: December 1, 2016.

Karla Bailey,

Project Clearance Liaison, National Cancer Institute, National Institutes of Health.

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[FR Doc. 2016-29767 Filed 12-12-16; 8:45 am]