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

Forms and Documents

Document Name	Status
Form 1 Initial Data Entry Personnel Form Form and Instruction	Modified
Form 5 Expanded Access records - Updates Form and Instruction	New
Form 5 Expanded Access Records - Initial Form and Instruction	New
Form 4 Extension Requests and Appeals Form and Instruction	New
Form 3 Certification to Delay Results Form and Instruction	New
Form 2 Update Results Information of Non-regulated Submissions Form and Instruction	New
Form 2 Initial Results Information of Non-regulated Submissions Form and Instruction	New
Form 2 Update Results Information on Non-regulated Submissions related to the NIH Policy Form and Instruction	New
Form 2 Initial Results Information of Non-regulated Submissions related to the NIH policy Form and Instruction	New
Form 2 Results Triggered by Voluntary Submission Form and Instruction	New
Form 2 Updates Form and Instruction	New
Form 2 Initial Results Information Submission Form and Instruction	New
Form 1 Updated Registration of Voluntary and Non-regulated Submissions Form and Instruction	New
Form 1 Initial Registration of Voluntary and Non-regulated Submissions Form and Instruction	New
Form 1 Updated Registration of Non-regulated Submissions related to the NIH Policy Form and Instruction	New
Form 1 Initial Registration of Non-regulated Submissions related to NIH Policy Form and Instruction	New
Form 1 Registration Triggered by Voluntary Submission Form and Instruction	New
Form 1 Updates Data Entry Personnel Form and Instruction	New
Form 5 Expanded Access Records - Updates Form and Instruction	Removed
Form 5 Expanded Access Records - Initial Form and Instruction	Removed
Form 4 Extension Requests and Appeals Form and Instruction	Removed
Form 3 Certification to Delay Results Form and Instruction	Removed
Form 2 Update Results Information of Non-regulated Submissions Form and Instruction	Removed
Form 2 Initial Results Information of Non-regulated Submissions Form and Instruction	Removed
Form 2 Update Results Information of Non-regulated Submissions related to NIH policy Form and Instruction	Removed
Form 2 Initial Results Information of Non-regulated Submissions related to NIH policy Form and Instruction	Removed
Form 2 Results Triggered by Voluntary Submission Form and Instruction	Removed
Form 2 Updates Form and Instruction	Removed
Form 2 Initial Results Information Submission Form and Instruction	Removed
Form 1 Updated Registration of Voluntary Non-regulated Submissions Form and Instruction	Removed
Form 1 Initial Registration of voluntary and Non-regulated Submissions Form and Instruction	Removed
Form 1 Updated Registration of Non-regulated Submissions related to NIH policy Form and Instruction	Removed
Form 1 Initial Registration of Non-regulated Submissions related to NIH policy Form and Instruction	Removed
Form 1 Registraion Triggered by Voluntary Submission Form and Instruction	Removed
Form 1 Updates Form and Instruction	Removed
30-day FRN 2020-01157.pdf Supplementary Document	2020-01-27
Attachment 9 - Privacy Impact Assessment.docx Supplementary Document	2020-01-21
Attachment 8 - Privacy Act Review (1).pdf Supplementary Document	2020-01-21
Attachment 4 - Results Information Data Element Definitions.pdf Supplementary Document	2020-01-21
Attachment 1 - Registration Data Element Definitions.pdf Supplementary Document	2020-01-21
NLM CT.gov Supporting Statement A (Jan 2020) (1).docx Supporting Statement A	2020-01-21

IC Document Collections

IC ID	Document Title	Status
6153	Initial Data Entry Personnel Form Form and Instruction	Modified
239370	Expanded Access records - Updates Form and Instruction	New
239368	Expanded Access Records - Initial Form and Instruction	New
239366	Extension Requests and Appeals Form and Instruction	New
239365	Certification to Delay Results Form and Instruction	New
239364	Update Results Information of Non-regulated Submissions Form and Instruction	New
239363	Initial Results Information of Non-regulated Submissions Form and Instruction	New
239362	Update Results Information on Non-regulated Submissions related to the NIH Policy Form and Instruction	New
239361	Initial Results Information of Non-regulated Submissions related to the NIH policy Form and Instruction	New
239360	Results Triggered by Voluntary Submission Form and Instruction	New
239359	Updates Form and Instruction	New
239358	Initial Results Information Submission Form and Instruction	New
239357	Updated Registration of Voluntary and Non-regulated Submissions Form and Instruction	New
239356	Initial Registration of Voluntary and Non-regulated Submissions Form and Instruction	New
239355	Updated Registration of Non-regulated Submissions related to the NIH Policy Form and Instruction	New
239347	Initial Registration of Non-regulated Submissions related to NIH Policy Form and Instruction	New
239344	Registration Triggered by Voluntary Submission Form and Instruction	New
239338	Updates Data Entry Personnel Form and Instruction	New
225089	Expanded Access Records - Updates Form and Instruction	Removed
225088	Expanded Access Records - Initial Form and Instruction	Removed
225087	Extension Requests and Appeals Form and Instruction	Removed
225086	Certification to Delay Results Form and Instruction	Removed
225085	Update Results Information of Non-regulated Submissions Form and Instruction	Removed
225084	Initial Results Information of Non-regulated Submissions Form and Instruction	Removed
225083	Update Results Information of Non-regulated Submissions related to NIH policy Form and Instruction	Removed
225082	Initial Results Information of Non-regulated Submissions related to NIH policy Form and Instruction	Removed
225081	Results Triggered by Voluntary Submission Form and Instruction	Removed
225080	Updates Form and Instruction	Removed
225079	Initial Results Information Submission Form and Instruction	Removed
225077	Updated Registration of Voluntary Non-regulated Submissions Form and Instruction	Removed
225076	Initial Registration of voluntary and Non-regulated Submissions Form and Instruction	Removed
225075	Updated Registration of Non-regulated Submissions related to NIH policy Form and Instruction	Removed
225074	Initial Registration of Non-regulated Submissions related to NIH policy Form and Instruction	Removed
225073	Registraion Triggered by Voluntary Submission Form and Instruction	Removed
225072	Updates Form and Instruction	Removed

ICR Details

OMB Control No: 0925-0586	ICR Reference No: 202001-0925-001
Status: 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
	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
Expanded Access Records - Initial	5	Expanded Access Record Data Element Definitions (reference document and data entry forms (screenshots))
Initial Data Entry Personnel Form	1	Registration Data Entry Form
Updates	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)
Update Results Information of Non-regulated Submissions related to NIH policy	2	Results Information Submission Data Entry Forms (screenshots)
Update Results Information of Non-regulated Submissions	2	Results Information Submission Data Entry Forms (screenshots)
Certification to Delay Results	3	Certification to Delay Submission of Results Information (Reference Document and Screenshorts of Data Entry forms)
Results Triggered by Voluntary Submission	2	Results Information Submission Data Entry Forms (screenshots)
Updates	1	Registration Data Entry Forms screenshot
Initial Registration of Non-regulated Submissions related to NIH policy	1	Registration Data Entry Forms screenshot
Updates Data Entry Personnel	1	Registration Data Entry Form
Registraion Triggered by Voluntary Submission	1	Registration Data Entry Forms screenshot
Expanded Access Records - Updates	5	Expanded Access Record Data Element Definitions (reference document and data entry forms (screenshots))
Updated Registration of Voluntary Non-regulated Submissions	1	Registration Data Entry Forms screenshot
Initial Results Information of Non-regulated Submissions	2	Results Information Submission Data Entry Forms (screenshots)
Updated 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 Forms screenshot
Initial Results Information Submission	2	Results Information Submission Data Entry Forms (screenshots)
Registration Triggered by Voluntary Submission	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
Updated Registration of Voluntary and Non-regulated Submissions	1	Registration Data Entry Form
Initial Results Information Submission	2	Results Information Submission Data Entry Form
Results Triggered by Voluntary Submission	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
Initial Results Information of Non-regulated Submissions	2	Results Information Submission Data Entry Forms
Update Results Information of Non-regulated Submissions	2	Results Information Submission Data Entry Form
Certification to Delay Results	3	Certification to Delay Submission of Results Information
Extension Requests and Appeals	4	Request for the Extension of the Results Information Submission Deadline
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 and Data Entry Form
Updated Registration of Non-regulated Submissions related to the NIH Policy	1	Registration 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)
Updates	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

---

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

---

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

---