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:
201908-0925-008
Status:
Historical Active
Previous ICR Reference No:
201605-0925-006
Agency/Subagency:
HHS/NIH
Agency Tracking No:
19222
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:
10/10/2019
Retrieve Notice of Action (NOA)
Date Received in OIRA:
08/28/2019
Terms of Clearance:
Previous terms continue: The agency is required to display the OMB Control Number and inform respondents of its legal significance in accordance with 5 CFR 1320.5(b).
Inventory as of this Action
Requested
Previously Approved
Expiration Date
10/31/2022
36 Months From Approved
10/31/2019
Responses
27,000
0
27,000
Time Burden (Hours)
18,000
0
18,000
Cost Burden (Dollars)
0
0
0
Abstract:
This is a request for a revision of the “The Clinical Trials Reporting Program (CTRP) Database” for an additional three years. CTRP is an electronic resource that serves as a single, definitive source of information about all NCI-supported clinical research. This resource allows the NCI to consolidate reporting, aggregate information and reduce redundant submissions. Information is submitted by clinical research administrators as designees of clinical investigators who conduct NCI-supported clinical research. The designees can electronically access the CTRP website to complete the initial trial registration for each protocol. Subsequent to registration, up to four amendments and four study subject accrual updates occur per protocol annually. This request is for approval of the aesthetic changes to the website and the technology that currently supports this information collection. There are no changes to the questions asked or the order in which the information is collected.
Authorizing Statute(s):
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
US Code:
42 USC 407 (285a-2(a)(2)(D))
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:
84 FR 25550
06/03/2019
30-day Notice:
Federal Register Citation:
Citation Date:
84 FR 44318
08/23/2019
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
4
IC Title
Form No.
Form Name
Accrual Updates
6, 8, 7
Attach 5c Accural Batch File Tool
,
Attach 3d NCI CTRP Accural Screenshots
,
Attach 3e NCI CTRP Aggregate Screenshot
Amendment
4
Attach 3c NCI CTRP Amendment Screenshots
Initial Registration
1, 2, 3
NCI CTRP Registration Screenshots
,
Attach 5A CTRP Registry Complete Batch Template
,
Attach 5B CTRP Registry Complete Trial Participating Sites Template
Update Screenshots
5
Attach 3b NCI CTRP Update Screenshots
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
27,000
27,000
0
0
0
0
Annual Time Burden (Hours)
18,000
18,000
0
0
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
Annual Cost to Federal Government:
$11,179,021
Does this IC contain surveys, censuses, or employ statistical methods?
No
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
Yes
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
Yes
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Tawanda Abdelmouti 240 276-5530 ta401@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:
08/28/2019
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