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 Form	Form and Instruction	Modified	Available
Form 1 Initial Data Entry Personnel Form	Form and Instruction	Modified	Repair queued
Form 5 Expanded Access DED & PRS Forms	Form and Instruction	Modified	Available
Form 5 Expanded Access records - Updates	Form and Instruction	Modified	Repair queued
Form 5 Expanded Access DED & PRS Forms	Form and Instruction	Modified	Available
Form 5 Expanded Access Records - Initial	Form and Instruction	Modified	Repair queued
Form 4 Extension Request DED & PRS Forms	Form and Instruction	Modified	Available
Form 4 Extension Requests and Appeals	Form and Instruction	Modified	Repair queued
Form 3 Certification DED & PRS Forms	Form and Instruction	Modified	Available
Form 3 Certification to Delay Results	Form and Instruction	Modified	Repair queued
Form 2 Results Information Submission Data Entry Form	Form and Instruction	Modified	Available
Form 2 Update Results Information of Voluntary and Non-regulated Submissions	Form and Instruction	Modified	Repair queued
Form 2 Results Information Submission Data Entry Forms	Form and Instruction	Modified	Available
Form 2 Initial Results Information of Voluntary and Non-regulated Submissions	Form and Instruction	Modified	Repair queued
Form 2 Results Information Submission Data Entry Form	Form and Instruction	Modified	Available
Form 2 Update Results Information on Non-regulated Submissions related to the NIH Policy	Form and Instruction	Modified	Repair queued
Form 2 Results Information Submission Data Entry Form	Form and Instruction	Modified	Available
Form 2 Initial Results Information of Non-regulated Submissions related to the NIH policy	Form and Instruction	Modified	Repair queued
Form 2 Results Information Submission Data Entry Form	Form and Instruction	Modified	Available
Form 2 Results Triggered by Voluntary Submission	Form and Instruction	Modified	Repair queued
Form 2 Results Information Submission Data Entry Form	Form and Instruction	Modified	Available
Form 2 Updates	Form and Instruction	Modified	Repair queued
Form 2 Results Information Submission Data Entry Form	Form and Instruction	Modified	Available
Form 2 Initial Results Information Submission	Form and Instruction	Modified	Repair queued
Form 1 Updated Registration of Voluntary and Non-regulated Submissions	Form and Instruction	Modified	Repair queued
Form 1 Registration Data Entry Form	Form and Instruction	Modified	Available
Form 1 Initial Registration of Voluntary and Non-regulated Submissions	Form and Instruction	Modified	Repair queued
Form 1 Registration Data Entry Form	Form and Instruction	Modified	Available
Form 1 Updated Registration of Non-regulated Submissions related to the NIH Policy	Form and Instruction	Modified	Repair queued
Form 1 Registration Data Entry Forms	Form and Instruction	Modified	Available
Form 1 Initial Registration of Non-regulated Submissions related to NIH Policy	Form and Instruction	Modified	Repair queued
Form 1 Registration Data Entry Form	Form and Instruction	Modified	Available
Form 1 Registration Triggered by Voluntary Submission	Form and Instruction	Modified	Repair queued
Form 1 Registration Data Entry Form	Form and Instruction	Modified	Available
Form 1 Updates Data Entry Personnel	Form and Instruction	Modified	Repair queued
Supporting Statement A - FINAL 01302023 (1).docx	Supporting Statement A	Uploaded 2023-02-08	Repair queued
pub 30-day FRN2023-02381.pdf	Supplementary Document	Uploaded 2023-02-06	Repair queued
Attachment 9 - Privacy Impact Assessment.docx	Supplementary Document	Uploaded 2023-02-06	Repair queued
Attachment 8 - Privacy Act Review (1).pdf	Supplementary Document	Uploaded 2023-02-06	Repair queued
Attachment 4 - Results Information Data Element Definitions (2021).pdf	Supplementary Document	Uploaded 2023-02-06	Repair queued
Attachment 1 - Registration Data Element Definitions (2020).pdf	Supplementary Document	Uploaded 2023-02-06	Repair queued

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 Form
6153	Initial Data Entry Personnel Form	Form and Instruction	Modified
239370	Expanded Access records - Updates	Form and Instruction	Modified	Expanded Access DED & PRS Forms
239370	Expanded Access records - Updates	Form and Instruction	Modified
239368	Expanded Access Records - Initial	Form and Instruction	Modified	Expanded Access DED & PRS Forms
239368	Expanded Access Records - Initial	Form and Instruction	Modified
239366	Extension Requests and Appeals	Form and Instruction	Modified	Extension Request DED & PRS Forms
239366	Extension Requests and Appeals	Form and Instruction	Modified
239365	Certification to Delay Results	Form and Instruction	Modified	Certification DED & PRS Forms
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
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 Form
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 Form
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 Form
239360	Results Triggered by Voluntary Submission	Form and Instruction	Modified
239359	Updates	Form and Instruction	Modified	Results Information Submission Data Entry Form
239359	Updates	Form and Instruction	Modified
239358	Initial Results Information Submission	Form and Instruction	Modified	Results Information Submission Data Entry Form
239358	Initial Results Information Submission	Form and Instruction	Modified
239357	Updated Registration of Voluntary and Non-regulated Submissions	Form and Instruction	Modified
239357	Updated Registration of Voluntary and Non-regulated Submissions		Modified
239356	Initial Registration of Voluntary and Non-regulated Submissions	Form and Instruction	Modified	Registration Data Entry Form
239356	Initial Registration of Voluntary and Non-regulated Submissions	Form and Instruction	Modified
239355	Updated Registration of Non-regulated Submissions related to the NIH Policy	Form and Instruction	Modified	Registration Data Entry Form
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
239344	Registration Triggered by Voluntary Submission	Form and Instruction	Modified	Registration Data Entry Form
239344	Registration Triggered by Voluntary Submission	Form and Instruction	Modified
239338	Updates Data Entry Personnel	Form and Instruction	Modified	Registration Data Entry Form
239338	Updates Data Entry Personnel	Form and Instruction	Modified

ICR Details

OMB Control No: 0925-0586	ICR Reference No: 202302-0925-001
Status: Historical Active	Previous ICR Reference No: 202001-0925-001
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Information Program on Clinical Trials: Maintaining a Registry and Results Databank (NLM)
Type of Information Collection: 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: 03/15/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 02/08/2023
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2026	36 Months From Approved	03/31/2023
Responses	271,122	0	210,037
Time Burden (Hours)	1,219,801	0	1,072,306
Cost Burden (Dollars)	0	0	0

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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.

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Authorizing Statute(s): 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
   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:
	87 FR 68508	11/15/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 7743	02/06/2023
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 18

table that charts list of burden

IC Title	Form No.	Form Name
Certification to Delay Results	3	Certification DED & PRS Forms
Expanded Access Records - Initial	5	Expanded Access DED & PRS Forms
Expanded Access records - Updates	5	Expanded Access DED & PRS Forms
Extension Requests and Appeals	4	Extension Request DED & PRS Forms
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 Voluntary and Non-regulated Submissions	1	Registration Data Entry Form
Initial Results Information Submission	2	Results Information Submission Data Entry Form
Initial Results Information of Non-regulated Submissions related to the NIH policy	2	Results Information Submission Data Entry Form
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 Form
Results Triggered by Voluntary Submission	2	Results Information Submission Data Entry Form
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	2	Results Information Submission Data Entry Form
Updated Registration of Non-regulated Submissions related to the NIH Policy	1	Registration Data Entry Form
Updated Registration of Voluntary and Non-regulated Submissions	1
Updates	2	Results Information Submission Data Entry Form
Updates Data Entry Personnel	1	Registration Data Entry Form

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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	271,122	210,037	0	61,085	0	0
Annual Time Burden (Hours)	1,219,801	1,072,306	0	147,495	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: The program changes reported in this supporting statement reflect adjustments to the burden hours, which increased from 1,072,306 to 1, 219,801 hours per year. This change corresponds to an increase in the total number of respondents from 64,660 to 77,769.

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Annual Cost to Federal Government: $14,491,060

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: 02/08/2023

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