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

Forms and Documents

Document Name	Status
Form 1 Initial Registration Data Entry 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 of Non-regulated Submissions related to NIH policy Form and Instruction	New
Form 2 Initial Results Information of Non-regulated Submissions related to 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 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 NIH policy Form and Instruction	New
Form 1 Initial Registration of Non-regulated Submissions related to NIH policy Form and Instruction	New
Form 1 Registraion Triggered by Voluntary Submission Form and Instruction	New
Form 1 Updates Form and Instruction	New
Form 4 Extension Request Form and Instruction	Removed
Form 3 Certification to Delay Results Form and Instruction	Removed
Form 2 Result Submission Updates Form and Instruction	Removed
Form 2 Initial Results Submission Form and Instruction	Removed
Form 1 Registration Updates Form and Instruction	Removed
Form 1 Initial Registration Form and Instruction	Removed
Attachment 8 - Privacy Act Review.pdf Supplementary Document	2017-01-09
Attachment 4 – Results Information Data Element Definitions (Reference Document).pdf Supplementary Document	2017-01-09
Attachment 1 - Registration Data Element Definitions (Reference Document).pdf Supplementary Document	2017-01-09
ClinicalTrials gov Supporting Statement Final.docx Supporting Statement A	2017-01-06

IC Document Collections

IC ID	Document Title	Status
6153	Initial Registration Data Entry Form Form and Instruction	Modified
225089	Expanded Access Records - Updates Form and Instruction	New
225088	Expanded Access Records - Initial Form and Instruction	New
225087	Extension Requests and Appeals Form and Instruction	New
225086	Certification to Delay Results Form and Instruction	New
225085	Update Results Information of Non-regulated Submissions Form and Instruction	New
225084	Initial Results Information of Non-regulated Submissions Form and Instruction	New
225083	Update Results Information of Non-regulated Submissions related to NIH policy Form and Instruction	New
225082	Initial Results Information of Non-regulated Submissions related to NIH policy Form and Instruction	New
225081	Results Triggered by Voluntary Submission Form and Instruction	New
225080	Updates Form and Instruction	New
225079	Initial Results Information Submission Form and Instruction	New
225077	Updated Registration of Voluntary Non-regulated Submissions Form and Instruction	New
225076	Initial Registration of voluntary and Non-regulated Submissions Form and Instruction	New
225075	Updated Registration of Non-regulated Submissions related to NIH policy Form and Instruction	New
225074	Initial Registration of Non-regulated Submissions related to NIH policy Form and Instruction	New
225073	Registraion Triggered by Voluntary Submission Form and Instruction	New
225072	Updates Form and Instruction	New
185102	Extension Request Form and Instruction	Removed
185097	Certification to Delay Results Form and Instruction	Removed
185096	Result Submission Updates Form and Instruction	Removed
185095	Initial Results Submission Form and Instruction	Removed
185094	Registration Updates Form and Instruction	Removed
185093	Initial Registration Form and Instruction	Removed

ICR Details

OMB Control No: 0925-0586	ICR Reference No: 201701-0925-002
Status: Historical Active	Previous ICR Reference No: 201508-0925-001
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: 02/28/2017
	Date Received in OIRA: 01/10/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/29/2020	36 Months From Approved	11/30/2018
Responses	210,037	0	224,530
Time Burden (Hours)	1,072,306	0	682,535
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection request seeks a revision 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, National Institutes of Health (NIH). The NPRM on Clinical Trials Registration and Results Submission was issued on November 21, 2014 (79 FR 69566, Nov. 21, 2014) for public comment. The NPRM proposed several modifications to the information collection, including the scope of trials for which results reporting is required and the types of information to be provided. 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): PL: Pub.L. 110 - 85 801 Name of Law: FDA Act of 2007
   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
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0925-AA55	Final or interim final rulemaking	81 FR 64981	09/21/2016

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 64981	09/21/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 64981	09/21/2016
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Initial Registration Data Entry Form	1	Registration Data Entry Forms screenshot
Initial Registration	1	ClinicalTrials.gov Registration Data Entry Screen Shots
Registration Updates	1	Registration Data Entry
Extension Requests and Appeals	4	Request for the Extension of the Results Information Submission Deadline (Reference document and Screenshots of Data Entry Forms)
Result Submission Updates	2	ClinicalTrials.gov Results Reporting Data Entry Screen Shots
Certification to Delay Results	3	Certification Form
Registraion Triggered by Voluntary Submission	1	Registration Data Entry Forms screenshot
Initial Registration of Non-regulated Submissions related to NIH policy	1	Registration Data Entry Forms screenshot
Updated Registration of Voluntary Non-regulated Submissions	1	Registration Data Entry Forms screenshot
Certification to Delay Results	3	Certification to Delay Submission of Results Information (Reference Document and Screenshorts of Data Entry forms)
Updated Registration of Non-regulated Submissions related to NIH policy	1	Registration Data Entry Forms screenshot
Updates	2	Results Information Submission Data Entry Forms (screenshots)
Results Triggered by Voluntary Submission	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)
Updates	1	Registration Data Entry Forms screenshot
Initial Results Submission	2	ClinicalTrials.gov Results Reporting Data Entry Screen Shots
Extension Request	4	Extension Request
Expanded Access Records - Initial	5	Expanded Access Record Data Element Definitions (reference document and data entry forms (screenshots))
Initial Registration of voluntary and Non-regulated Submissions	1	Registration Data Entry Forms screenshot
Update 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	2	Results Information Submission Data Entry Forms (screenshots)
Update Results Information of Non-regulated Submissions	2	Results Information Submission Data Entry Forms (screenshots)
Expanded Access Records - Updates	5	Expanded Access Record Data Element Definitions (reference document and data entry forms (screenshots))
Initial Results Information Submission	2	Results Information Submission Data Entry Forms (screenshots)

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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	224,530	0	-14,493	0	0
Annual Time Burden (Hours)	1,072,306	682,535	0	389,771	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: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Changing Forms

Short Statement: The program changes reported in this supporting statement reflect the requirements under the final rule (42 CFR part 11), promulgated to further the implementation of FDAAA. The final rule clarifies, modifies, and expands the information collection requirements that were previously cleared by OMB. Additionally, this supporting statement includes adjustments to the burden estimates to reflect increases in average burden per response due to the new regulatory requirements in section A12-1 (i.e., initial registration increased by 1 hour, from 7 hours to 8 hours; initial results submission increased by 15 hours, from 25 hours to 40 hours) and hourly wage increases in section A12-2, reflecting updated, 2015 data from the BLS (from $64.88 per hour to $72.04 per hour for Data Entry Personnel and from $98.52 per hour to $110.04 per hour for Medical Scientists). It also includes increases in registration and results information from voluntary and non-regulated submissions following the NIH Policy on Dissemination of NIH-Funded Clinical Trial Information.

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Annual Cost to Federal Government: $6,190,784

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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

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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: 01/10/2017

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