View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0925-0600
ICR Reference No:
201001-0925-003
Status:
Historical Active
Previous ICR Reference No:
200906-0925-003
Agency/Subagency:
HHS/NIH
Agency Tracking No:
Title:
The Clinical Trials Reporting Program (CTRP) Database (NCI)
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
03/01/2010
Retrieve Notice of Action (NOA)
Date Received in OIRA:
01/29/2010
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
03/31/2013
36 Months From Approved
02/28/2010
Responses
49,500
0
27,500
Time Burden (Hours)
38,500
0
33,000
Cost Burden (Dollars)
0
0
0
Abstract:
The National Cancer Institute (NCI) is developing an electronic resource, the NCI Clinical Trials Reporting Program (CTRP) Database, which is intended to serve as a single, definitive source of information about all NCI-supported clinical research, thereby enabling the NCI to execute its mission to reduce the burden of cancer and to ensure an optimal return on the nation's investment in cancer clinical research. Deployment and extension of the CTRP Database is an infrastructure development project that will be enabled by public funds expended pursuant to the American Recovery and Reinvestment Act of 2009. In addition, deployment of this resource will allow the NCI to consolidate reporting, aggregate information and reduce redundant submissions. Clinical research administrators, as designees of the clinical investigators, will electronically access the CTRP website to complete the initial trial registration. After the clinical trial has been registered, four amendments and four study subject accrual updates occur per trial annually. The previous submission took into account the initial registration and amendment activities. This current submission will include registration, amendment, as well as data related to study subject accruals.
Authorizing Statute(s):
US Code:
42 USC 407 (285a-2(a)(2)(D))
Name of Law: Public Health Service Act
US Code:
42 USC 410 (285a-2(a)(1))
Name of Law: Public Health Service Act
US Code:
42 USC 410 (285a-4(b))
Name of Law: Public Health Service Act
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
74 FR 57684
11/09/2009
30-day Notice:
Federal Register Citation:
Citation Date:
75 FR 4827
01/29/2010
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
3
IC Title
Form No.
Form Name
Amendment for the Clinical Trials Reporting Program (CTRP) Database (NCI)
2
CTRP Amendment
NCI CTRP Accrual Portal Workflow and Screen Shots
3
CTRP Accural Updates
Registration for the Clinical Trials Reporting Program (CTRP) Database (NCI)
1
CTRP Registration
ICR Summary of Burden
Total Approved
Previously Approved
Change Due to New Statute
Change Due to Agency Discretion
Change Due to Adjustment in Estimate
Change Due to Potential Violation of the PRA
Annual Number of Responses
49,500
27,500
0
22,000
0
0
Annual Time Burden (Hours)
38,500
33,000
0
5,500
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Miscellaneous Actions
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
This program change is being submitted as a revised information collection and includes the study subject accrual aspects of the information collection through the CTRP Database. This revision will result in an increase in burden hours and costs associated with this project. Deployment and extension of the CTRP Database is an infrastructure development project to be conducted pursuant to the American Recovery and Reinvestment Act.
Annual Cost to Federal Government:
$4,200,000
Does this IC contain surveys, censuses, or employ statistical methods?
No
Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002?
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
Uncollected
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
Uncollected
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
Yes
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Marilyn Tuttleman 3015947949 mtuttleman@od.nih.gov
Common Form ICR:
No
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Certification Date:
01/29/2010
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