Proposed Collection; 60-Day Comment Request; CTEP Support Contracts Forms and Surveys (National Cancer Institute)
Federal RegisterDec 13, 2016
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; CTEP Support Contracts Forms and Surveys (National Cancer Institute)
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
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