[Federal Register Volume 81, Number 225 (Tuesday, November 22, 2016)]
[Notices]
[Pages 83856-83857]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-28004]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; 60-Day Comment Request; Cancer Trials 
Support Unit (National Cancer Institute)

AGENCY: National Institutes of Health.

ACTION: Notice.

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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: [email protected]. 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 minimize 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: Cancer Trials Support Unit (CTSU) (NCI), 
0925-0624, EXTENSION, National Cancer Institute (NCI), National 
Institutes of Health (NIH).
    Need and Use of Information Collection: The Cancer Therapy 
Evaluation Program (CTEP) establishes and supports programs to 
facilitate the participation of qualified investigators on CTEP-
supported studies, and to institute programs that minimize redundancy 
among grant and contract holders, thereby reducing overall cost of 
maintaining a robust treatment trials program. Currently guided by the 
efforts of the Clinical Trials Working Group (CTWG) and the Institute 
of Medicine (IOM) recommendations to revitalize the Cooperative Group 
program, CTEP has funded the Cancer Trials Support Unit (CTSU). The 
CTSU collects standardized forms to process site regulatory 
information, changes to membership, patient enrollment data, and 
routing information for case report forms. In addition, CTSU collects 
annual surveys of customer satisfaction for clinical site staff using 
the CTSU Help Desk, the CTSU Web site, and the Protocol and Information 
Office (PIO). An ongoing user satisfaction survey is in place for the 
Oncology Patient Enrollment Network (OPEN). User satisfaction surveys 
are compiled as part of the project quality assurance activities and 
are used to direct improvements to processes and technology.
    OMB approval for an extension to the existing approval is requested 
for one year. There are no costs to respondents other than their time. 
The total estimated annualized burden hours are 25,204.

                                                            Estimated Annualized Burden Hours
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                                                                                                             Number of    Average burden
                Form name                                Type of respondent                  Number of     responses per   per response    Total annual
                                                                                            respondents     respondent      (in hours)      burden hour
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CTSU IRB/Regulatory Approval Transmittal   Health Care Practitioner.....................           9,000              12            2/60           3,600
 Form.
CTSU IRB Certification Form..............  Health Care Practitioner.....................           8,500              12           10/60          17,000
CTSU Acknowledgement Form................  Health Care Practitioner.....................             500              12            5/60             500
Withdrawal from Protocol Participation     Health Care Practitioner.....................              50              12            5/60              50
 Form.

[[Page 83857]]

 
Site Addition............................  Health Care Practitioner.....................              25              12            5/60              25
CTSU Roster Update Form..................  Health Care Practitioner.....................              50              12            4/60              40
CTSU Radiation Therapy Facilities          Health Care Practitioner.....................              20              12           30/60             120
 Inventory Form.
CTSU IBCSG Drug Accountability Form......  Health Care Practitioner.....................              11              12           10/60              22
CTSU IBCSG Transfer of Investigational     Health Care Practitioner.....................               3              12           20/60              12
 Agent Form.
Site Initiated Data Update Form..........  Health Care Practitioner.....................              10              12           10/60              20
Data Clarification Form..................  Health Care Practitioner.....................             341              12           20/60           1,364
RTOG 0834 CTSU Data Transmittal Form.....  Health Care Practitioner.....................              60              12           10/60             120
MC0845(8233) CTSU Data Transmittal.......  Health Care Practitioner.....................              50              12           10/60             100
CTSU Generic Data Transmittal Form.......  Health Care Practitioner.....................             500              12           10/60           1,000
CTSU Patient Enrollment Transmittal Form.  Health Care Practitioner.....................             200              12           10/60             400
CTSU P2C Enrollment Transmittal Form.....  Health Care Practitioner.....................              15              12           10/60              30
CTSU Transfer Form.......................  Health Care Practitioner.....................              20              12           10/60              40
CTSU System Account Request Form.........  Health Care Practitioner.....................              20              12           20/60              80
CTSU Request for Clinical Brochure.......  Health Care Practitioner.....................              75              12           10/60             150
CTSU Supply Request Form.................  Health Care Practitioner.....................              75              12           10/60             150
CTSU Web Site Customer Satisfaction        Health Care Practitioner.....................             275               1           15/60              69
 Survey.
CTSU Helpdesk Customer Satisfaction        Health Care Practitioner.....................             325               1           15/60              81
 Survey.
CTSU OPEN Survey.........................  Health Care Practitioner.....................              60               1           15/60              15
PIO Customer Satisfaction Survey.........  Health Care Practitioner.....................             100               1            5/60               8
Concept Clinical Trial Survey............  Health Care Practitioner.....................             500               1            5/60              42
Prospective Clinical Trial Survey........  Health Care Practitioner.....................           1,000               1            5/60              83
Low Accrual Clinical Trial Survey........  Health Care Practitioner.....................           1,000               1            5/60              83
                                                                                         ---------------------------------------------------------------
    Annualized Totals....................  .............................................          22,785         237,560  ..............          25,204
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    Dated: November 10, 2016.
Karla Bailey,
Project Clearance Liaison, National Cancer Institute, National 
Institutes of Health.
[FR Doc. 2016-28004 Filed 11-21-16; 8:45 am]
 BILLING CODE 4140-01-P