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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:
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
Retrieve Notice of Action (NOA)
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
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.
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
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
0925-AA55
Final or interim final rulemaking
81 FR 64981
09/21/2016
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
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 (Reference Document and Screenshorts of Data Entry forms)
Certification to Delay Results
3
Certification Form
Expanded Access Records - Initial
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 (reference document and data entry forms (screenshots))
Extension Requests and Appeals
4
Request for the Extension of the Results Information Submission Deadline (Reference document and Screenshots of Data Entry Forms)
Extension Request
4
Extension Request
Initial Registration
1
ClinicalTrials.gov Registration Data Entry Screen Shots
Initial Registration Data Entry Form
1
Registration Data Entry Forms screenshot
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 Forms screenshot
Initial Results Information Submission
2
Results Information Submission Data Entry Forms (screenshots)
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 Submission
2
ClinicalTrials.gov Results Reporting Data Entry Screen Shots
Registraion Triggered by Voluntary Submission
1
Registration Data Entry Forms screenshot
Registration Updates
1
Registration Data Entry
Result Submission Updates
2
ClinicalTrials.gov Results Reporting Data Entry Screen Shots
Results Triggered by Voluntary Submission
2
Results Information Submission Data Entry Forms (screenshots)
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)
Updated 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
Updates
1
Registration Data Entry Forms screenshot
Updates
2
Results Information Submission Data Entry Forms (screenshots)
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.
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
Agency Contact:
Mikia Currie 3014350941
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:
01/10/2017
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