Information Program on Clinical Trials: Maintaining a Registry and Results Databank (NLM)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 1 Registration Data Entry Forms	Form and Instruction	Modified	Available
Form 1 Registration Data Entry Forms	Form and Instruction	Modified	Repair queued
Form 1 Information Required for Waiver Requests and Appeals	Form and Instruction	New	Available
Form 1 Information Required for Waiver Requests and Appeals	Form and Instruction	New	Repair queued
Form 1 Expanded Access Record Data Element Definitions and Data Entry Forms	Form and Instruction	Modified	Available
Form 1 Expanded Access Record Data Element Definitions and Data Entry Forms	Form and Instruction	Modified	Available
Form 1 Expanded Access Record Data Element Definitions and Data Entry Forms	Form and Instruction	Modified	Available
Form 1 Expanded Access Record Data Element Definitions and Data Entry Forms	Form and Instruction	Modified	Available
Form 1 Request for the Extension of the Results Information Submission Deadline	Form and Instruction	Modified	Available
Form 1 Request for the Extension of the Results Information Submission Deadline	Form and Instruction	Modified	Repair queued
Form 1 Certification to Delay Submission of Results Information	Form and Instruction	Modified	Available
Form 1 Certification to Delay Submission of Results Information	Form and Instruction	Modified	Repair queued
Form 2 Results Information Submission Data Entry Form	Form and Instruction	Modified	Available
Form 2 Results Information Submission Data Entry Form	Form and Instruction	Modified	Available
Form 2 Results Information Submission Data Entry Forms	Form and Instruction	Modified	Available
Form 2 Results Information Submission Data Entry Forms	Form and Instruction	Modified	Available
Form 1 Results Information Submission Data Entry Forms	Form and Instruction	Modified	Available
Form 1 Results Information Submission Data Entry Forms	Form and Instruction	Modified	Available
Form 1 Results Information Submission Data Entry Forms	Form and Instruction	Modified	Available
Form 1 Results Information Submission Data Entry Forms	Form and Instruction	Modified	Repair queued
Form 1 Results Information Submission Data Entry Forms	Form and Instruction	Modified	Available
Form 1 Results Information Submission Data Entry Forms	Form and Instruction	Modified	Repair queued
Form 1 Results Information Submission Data Entry Forms	Form and Instruction	Modified	Available
Form 1 Results Information Submission Data Entry Forms	Form and Instruction	Modified	Available
Form 1 Results Information Submission Data Entry Forms	Form and Instruction	Modified	Available
Form 1 Results Information Submission Data Entry Forms	Form and Instruction	Modified	Repair queued
Form 1 Registration Data Entry Forms	Form and Instruction	Modified	Available
Form 1 Registration Data Entry Forms	Form and Instruction	Modified	Repair queued
Form 1 Registration Data Entry Forms	Form	Modified	Available
Form 1 Registration Data Entry Forms	Form	Modified	Available
Form 1 Registration Data Entry Forms	Form and Instruction	Modified	Available
Form 1 Registration Data Entry Forms	Form and Instruction	Modified	Available
Form 1 Registration Data Entry Forms	Form and Instruction	Modified	Available
Form 1 Registration Data Entry Forms	Form and Instruction	Modified	Repair queued
Form 1 Registration Data Entry Forms	Form and Instruction	Modified	Available
Form 1 Registration Data Entry Forms	Form and Instruction	Modified	Available
Form 1 Registration Data Entry Forms	Form and Instruction	Modified	Available
Form 1 Registration Data Entry Forms	Form and Instruction	Modified	Available
ClinicalTrials.gov Supporting Statement A_Final 2_4_2026.docx	Supporting Statement A	Uploaded 2026-02-19	Available
ClinicalTrials.gov Supporting Statement A_Final 2_4_2026.docx	Supporting Statement A	Uploaded 2026-02-19	Repair queued
Attachment 8 - Privacy Act Memo Signed 2025_8_18.pdf	Supplementary Document	Uploaded 2026-02-19	Available
Attachment 8 - Privacy Act Memo Signed 2025_8_18.pdf	Supplementary Document	Uploaded 2026-02-19	Repair queued
Attachment 9 - Privacy Impact Assessment - 2025Mar11.pdf	Supplementary Document	Uploaded 2026-02-19	Available
Attachment 9 - Privacy Impact Assessment - 2025Mar11.pdf	Supplementary Document	Uploaded 2026-02-19	Missing upstream
30day 0586.pdf	Supplementary Document	Uploaded 2026-02-19	Available
30day 0586.pdf	Supplementary Document	Uploaded 2026-02-19	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
6153	Initial Data Entry Personnel Form	Form and Instruction	Modified	Registration Data Entry Forms
6153	Initial Data Entry Personnel Form	Form and Instruction	Modified	Registration Data Entry Forms
6153	Initial Data Entry Personnel Form	Form and Instruction	Modified
278941	Waiver Requests and Appeals	Form and Instruction	New	Information Required for Waiver Requests and Appeals
278941	Waiver Requests and Appeals	Form and Instruction	New	Information Required for Waiver Requests and Appeals
278941	Waiver Requests and Appeals	Form and Instruction	New
239370	Expanded Access records - Updates	Form and Instruction	Modified	Expanded Access Record Data Element Definitions and Data Entry Forms
239370	Expanded Access records - Updates	Form and Instruction	Modified	Expanded Access Record Data Element Definitions and Data Entry Forms
239370	Expanded Access records - Updates	Form and Instruction	Modified
239368	Expanded Access Records - Initial	Form and Instruction	Modified	Expanded Access Record Data Element Definitions and Data Entry Forms
239368	Expanded Access Records - Initial	Form and Instruction	Modified	Expanded Access Record Data Element Definitions and Data Entry Forms
239368	Expanded Access Records - Initial	Form and Instruction	Modified
239366	Extension Requests and Appeals	Form and Instruction	Modified	Request for the Extension of the Results Information Submission Deadline
239366	Extension Requests and Appeals	Form and Instruction	Modified	Request for the Extension of the Results Information Submission Deadline
239366	Extension Requests and Appeals	Form and Instruction	Modified
239365	Certification to Delay Results	Form and Instruction	Modified	Certification to Delay Submission of Results Information
239365	Certification to Delay Results	Form and Instruction	Modified	Certification to Delay Submission of Results Information
239365	Certification to Delay Results	Form and Instruction	Modified
239364	Update Results Information of Voluntary and Non-regulated Submissions	Form and Instruction	Modified	Results Information Submission Data Entry Form
239364	Update Results Information of Voluntary and Non-regulated Submissions	Form and Instruction	Modified	Results Information Submission Data Entry Form
239364	Update Results Information of Voluntary and Non-regulated Submissions	Form and Instruction	Modified
239363	Initial Results Information of Voluntary and Non-regulated Submissions	Form and Instruction	Modified	Results Information Submission Data Entry Forms
239363	Initial Results Information of Voluntary and Non-regulated Submissions	Form and Instruction	Modified	Results Information Submission Data Entry Forms
239363	Initial Results Information of Voluntary and Non-regulated Submissions	Form and Instruction	Modified
239362	Update Results Information on Non-regulated Submissions related to the NIH Policy	Form and Instruction	Modified	Results Information Submission Data Entry Forms
239362	Update Results Information on Non-regulated Submissions related to the NIH Policy	Form and Instruction	Modified	Results Information Submission Data Entry Forms
239362	Update Results Information on Non-regulated Submissions related to the NIH Policy	Form and Instruction	Modified
239361	Initial Results Information of Non-regulated Submissions related to the NIH policy	Form and Instruction	Modified	Results Information Submission Data Entry Forms
239361	Initial Results Information of Non-regulated Submissions related to the NIH policy	Form and Instruction	Modified	Results Information Submission Data Entry Forms
239361	Initial Results Information of Non-regulated Submissions related to the NIH policy	Form and Instruction	Modified
239360	Results Triggered by Voluntary Submission	Form and Instruction	Modified	Results Information Submission Data Entry Forms
239360	Results Triggered by Voluntary Submission	Form and Instruction	Modified	Results Information Submission Data Entry Forms
239360	Results Triggered by Voluntary Submission	Form and Instruction	Modified
239359	Updates	Form and Instruction	Modified	Results Information Submission Data Entry Forms
239359	Updates	Form and Instruction	Modified	Results Information Submission Data Entry Forms
239359	Updates	Form and Instruction	Modified
239358	Initial Results Information Submission	Form and Instruction	Modified	Results Information Submission Data Entry Forms
239358	Initial Results Information Submission	Form and Instruction	Modified	Results Information Submission Data Entry Forms
239358	Initial Results Information Submission	Form and Instruction	Modified
239357	Updated Registration of Voluntary and Non-regulated Submissions	Form and Instruction	Modified	Registration Data Entry Forms
239357	Updated Registration of Voluntary and Non-regulated Submissions	Form and Instruction	Modified	Registration Data Entry Forms
239357	Updated Registration of Voluntary and Non-regulated Submissions	Form and Instruction	Modified
239356	Initial Registration of Voluntary and Non-regulated Submissions	Form	Modified	Registration Data Entry Forms
239356	Initial Registration of Voluntary and Non-regulated Submissions	Form	Modified	Registration Data Entry Forms
239356	Initial Registration of Voluntary and Non-regulated Submissions	Form	Modified
239355	Updated Registration of Non-regulated Submissions related to the NIH Policy	Form and Instruction	Modified	Registration Data Entry Forms
239355	Updated Registration of Non-regulated Submissions related to the NIH Policy	Form and Instruction	Modified	Registration Data Entry Forms
239355	Updated Registration of Non-regulated Submissions related to the NIH Policy	Form and Instruction	Modified
239347	Initial Registration of Non-regulated Submissions related to NIH Policy	Form and Instruction	Modified	Registration Data Entry Forms
239347	Initial Registration of Non-regulated Submissions related to NIH Policy	Form and Instruction	Modified	Registration Data Entry Forms
239347	Initial Registration of Non-regulated Submissions related to NIH Policy	Form and Instruction	Modified
239344	Registration Triggered by Voluntary Submission	Form and Instruction	Modified	Registration Data Entry Forms
239344	Registration Triggered by Voluntary Submission	Form and Instruction	Modified	Registration Data Entry Forms
239344	Registration Triggered by Voluntary Submission	Form and Instruction	Modified
239338	Updates Data Entry Personnel	Form and Instruction	Modified	Registration Data Entry Forms
239338	Updates Data Entry Personnel	Form and Instruction	Modified	Registration Data Entry Forms
239338	Updates Data Entry Personnel	Form and Instruction	Modified

ICR Details

OMB Control No: 0925-0586	ICR Reference No: 202512-0925-004
Status: Active	Previous ICR Reference No: 202302-0925-001
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Information Program on Clinical Trials: Maintaining a Registry and Results Databank (NLM)
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: 05/01/2026
Retrieve Notice of Action (NOA)	Date Received in OIRA: 02/20/2026
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2029	36 Months From Approved	04/30/2026
Responses	323,878	0	271,122
Time Burden (Hours)	1,411,181	0	1,219,801
Cost Burden (Dollars)	0	0	0

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Abstract: This is a revision of a previously approved submission. The National Library of Medicine (NLM) operates the ClinicalTrials.gov website under the authority of the Director of the National Institutes of Health (NIH). ClinicalTrials.gov supports the collection of Clinical Trial Registration and Results Information necessary to implement statutory requirements of Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA 801) and regulatory requirements at 42 Code of Federal Regulations (CFR) Part 11. Information collection at ClinicalTrials.gov also serves as a means of enhancing enrollment or complying with policies of federal agencies and other organizations. Information is collected via electronic submission to the ClinicalTrials.gov Protocol Registration and Results System (PRS). The information in the databank is publicly available. It is intended to provide current and reliable information on the broadest possible scale to members of the public, including patients, physicians, and researchers, about the existence, nature, enrollment status, location, eligibility criteria, sponsorship, progress, and outcomes of clinical trials.

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Authorizing Statute(s): US Code: 42 USC 282(i) Name of Law: None
   US Code: 42 USC 282(j) Name of Law: Expanded Clinical Trial Registry Databank
   PL: Pub.L. 110 - 85 801 Name of Law: FDA Act of 2007
   PL: Pub.L. 105 - 115 113 Name of Law: FDAMA
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 54340	11/26/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 8012	02/19/2026
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 19

table that charts list of burden

IC Title	Form No.	Form Name
Certification to Delay Results	1	Certification to Delay Submission of Results Information
Expanded Access Records - Initial	1	Expanded Access Record Data Element Definitions and Data Entry Forms
Expanded Access records - Updates	1	Expanded Access Record Data Element Definitions and Data Entry Forms
Extension Requests and Appeals	1	Request for the Extension of the Results Information Submission Deadline
Initial Data Entry Personnel Form	1	Registration Data Entry Forms
Initial Registration of Non-regulated Submissions related to NIH Policy	1	Registration Data Entry Forms
Initial Registration of Voluntary and Non-regulated Submissions	1	Registration Data Entry Forms
Initial Results Information Submission	1	Results Information Submission Data Entry Forms
Initial Results Information of Non-regulated Submissions related to the NIH policy	1	Results Information Submission Data Entry Forms
Initial Results Information of Voluntary and Non-regulated Submissions	2	Results Information Submission Data Entry Forms
Registration Triggered by Voluntary Submission	1	Registration Data Entry Forms
Results Triggered by Voluntary Submission	1	Results Information Submission Data Entry Forms
Update Results Information of Voluntary and Non-regulated Submissions	2	Results Information Submission Data Entry Form
Update Results Information on Non-regulated Submissions related to the NIH Policy	1	Results Information Submission Data Entry Forms
Updated Registration of Non-regulated Submissions related to the NIH Policy	1	Registration Data Entry Forms
Updated Registration of Voluntary and Non-regulated Submissions	1	Registration Data Entry Forms
Updates	1	Results Information Submission Data Entry Forms
Updates Data Entry Personnel	1	Registration Data Entry Forms
Waiver Requests and Appeals	1	Information Required for Waiver Requests and Appeals

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ICR Summary of Burden

table that charts list 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	323,878	271,122	0	52,756	0	0
Annual Time Burden (Hours)	1,411,181	1,219,801	0	191,380	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 submission accounts for the information collection burden associated with the waiver request and appeal process under 42 CFR 11.54. This information is currently collected via e-mail and is anticipated to be implemented within the PRS in the future. During the past three years, no changes were made to information collection in the clinical trials registry under 42 CFR 11.28(a)(2), (b)(2), and (c); the PRS Account Application Form; and clinical trials results database under 42 CFR 11.48(a). Since information collection was determined to be consistent with Executive Order 14168 and 42 CFR Part 11, changes were not considered necessary.

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Annual Cost to Federal Government: $17,090,270

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? No

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Common Form ICR:  No

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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: 02/20/2026

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