Skip to main content
An official website of the United States government
The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
Search:
Agenda
Reg Review
ICR
This script is used to control the display of information in this page.
Display additional information by clicking on the following:
All
Brief and OIRA conclusion
Abstract/Justification
Legal Statutes
Rulemaking
FR Notices/Comments
IC List
Burden
Misc.
Common Form Info.
Certification
View Information Collection (IC) List
View Supporting Statement and Other Documents
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:
0925-0586
ICR Reference No:
202001-0925-001
Status:
Historical Active
Previous ICR Reference No:
201701-0925-002
Agency/Subagency:
HHS/NIH
Agency Tracking No:
Title:
Information Program on Clinical Trials: Maintaining a Registry and Results Databank (NLM)
Type of Information Collection:
Extension without change of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
02/28/2020
Retrieve Notice of Action (NOA)
Date Received in OIRA:
01/28/2020
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
02/28/2023
36 Months From Approved
02/29/2020
Responses
210,037
0
210,037
Time Burden (Hours)
1,072,306
0
1,072,306
Cost Burden (Dollars)
0
0
0
Abstract:
This information collection request seeks approval of an extension of the existing Paperwork Reduction Act clearance for the collection of Clinical Trial Registration and Results Information via the ClinicalTrials.gov web site operated by the National Library of Medicine (NLM) under the authority of the Director of the National Institutes of Health (NIH). The purpose of the clinical trials registry data bank is to enhance patient enrollment and provide a mechanism to track the progress of clinical trials. The information is intended to provide current and reliable information on the broadest possible scale to members of the public, including to physicians and researchers, about the existence, nature, enrollment status, location, eligibility criteria, sponsorship and progress of clinical trials.
Authorizing Statute(s):
PL:
Pub.L. 105 - 115 113
Name of Law: FDAMA
US Code:
42 USC 282(j)
Name of Law: Expanded Clinical Trial Registry Databank
US Code:
42 USC 282(i)
Name of Law: None
PL:
Pub.L. 110 - 85 801
Name of Law: FDA Act of 2007
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 63884
11/19/2019
30-day Notice:
Federal Register Citation:
Citation Date:
85 FR 4332
01/24/2020
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
18
IC Title
Form No.
Form Name
Certification to Delay Results
3
Certification to Delay Submission of Results Information
Certification to Delay Results
3
Certification to Delay Submission of Results Information (Reference Document and Screenshorts of Data Entry forms)
Expanded Access Records - Initial
5
Expanded Access Record Data Element Definitions (reference document and data entry forms (screenshots))
Expanded Access Records - Initial
5
Expanded Access Record Data Element Definitions and Data Entry Form
Expanded Access Records - Updates
5
Expanded Access Record Data Element Definitions (reference document and data entry forms (screenshots))
Expanded Access records - Updates
5
Expanded Access Record Data Element Definitions and Data Entry Form
Extension Requests and Appeals
4
Request for the Extension of the Results Information Submission Deadline (Reference document and Screenshots of Data Entry Forms)
Extension Requests and Appeals
4
Request for the Extension of the Results Information Submission Deadline
Initial Data Entry Personnel Form
1
Registration Data Entry Form
Initial Registration of Non-regulated Submissions related to NIH Policy
1
Registration Data Entry Forms
Initial Registration of Non-regulated Submissions related to NIH policy
1
Registration Data Entry Forms screenshot
Initial Registration of Voluntary and Non-regulated Submissions
1
Registration Data Entry Form
Initial Registration of voluntary and Non-regulated Submissions
1
Registration Data Entry Forms screenshot
Initial Results Information Submission
2
Results Information Submission Data Entry Forms (screenshots)
Initial Results Information Submission
2
Results Information Submission Data Entry Form
Initial Results Information of Non-regulated Submissions
2
Results Information Submission Data Entry Forms
Initial Results Information of Non-regulated Submissions
2
Results Information Submission Data Entry Forms (screenshots)
Initial Results Information of Non-regulated Submissions related to NIH policy
2
Results Information Submission Data Entry Forms (screenshots)
Initial Results Information of Non-regulated Submissions related to the NIH policy
2
Results Information Submission Data Entry Form
Registraion Triggered by Voluntary Submission
1
Registration Data Entry Forms screenshot
Registration Triggered by Voluntary Submission
1
Registration Data Entry Form
Results Triggered by Voluntary Submission
2
Results Information Submission Data Entry Forms (screenshots)
Results Triggered by Voluntary Submission
2
Results Information Submission Data Entry Form
Update Results Information of Non-regulated Submissions
2
Results Information Submission Data Entry Form
Update Results Information of Non-regulated Submissions
2
Results Information Submission Data Entry Forms (screenshots)
Update Results Information of Non-regulated Submissions related to NIH policy
2
Results Information Submission Data Entry Forms (screenshots)
Update Results Information on Non-regulated Submissions related to the NIH Policy
2
Results Information Submission Data Entry Form
Updated Registration of Non-regulated Submissions related to NIH policy
1
Registration Data Entry Forms screenshot
Updated Registration of Non-regulated Submissions related to the NIH Policy
1
Registration Data Entry Form
Updated Registration of Voluntary Non-regulated Submissions
1
Registration Data Entry Forms screenshot
Updated Registration of Voluntary and Non-regulated Submissions
1
Registration Data Entry Form
Updates
1
Registration Data Entry Forms screenshot
Updates
2
Results Information Submission Data Entry Forms (screenshots)
Updates
2
Results Information Submission Data Entry Form
Updates Data Entry Personnel
1
Registration Data Entry Form
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
210,037
210,037
0
0
0
0
Annual Time Burden (Hours)
1,072,306
1,072,306
0
0
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:
Yes
Burden Reduction Due to:
Miscellaneous Actions
Short Statement:
This information collection request seeks approval of an extension of the existing Paperwork Reduction Act clearance for the collection of Clinical Trial Registration and Results Information via the ClinicalTrials.gov web site operated by the National Library of Medicine (NLM) under the authority of the Director of the National Institutes of Health (NIH).
Annual Cost to Federal Government:
$10,934,879
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.
No
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:
01/28/2020
An official website of the United States government
The .gov means it's official.
The site is secure.
