The Clinical Trials Reporting Program (CTRP) Database (NCI)

ICR 201908-0925-008

OMB: 0925-0600

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Supporting Statement A
2019-08-28
Supplementary Document
2019-08-28
Supplementary Document
2019-08-28
Supplementary Document
2019-08-28
Supplementary Document
2019-08-28
Supplementary Document
2019-08-28
Supplementary Document
2019-08-28
Supplementary Document
2019-08-28
Supplementary Document
2019-08-28
Supplementary Document
2019-08-28
Supplementary Document
2019-08-28
IC Document Collections
ICR Details
0925-0600 201908-0925-008
Active 201605-0925-006
HHS/NIH 19222
The Clinical Trials Reporting Program (CTRP) Database (NCI)
Revision of a currently approved collection   No
Regular
Approved without change 10/10/2019
Retrieve Notice of Action (NOA) 08/28/2019
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
10/31/2022 36 Months From Approved 10/31/2019
27,000 0 27,000
18,000 0 18,000
0 0 0

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.

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
  
None

Not associated with rulemaking

  84 FR 25550 06/03/2019
84 FR 44318 08/23/2019
No

  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
No
No

$11,179,021
No
    Yes
    Yes
No
No
No
Uncollected
Tawanda Abdelmouti 240 276-5530 [email protected]

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
08/28/2019


© 2024 OMB.report | Privacy Policy