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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:
201508-0925-001
Status:
Historical Active
Previous ICR Reference No:
201204-0925-002
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:
11/25/2015
Retrieve Notice of Action (NOA)
Date Received in OIRA:
08/28/2015
Terms of Clearance:
Approved consistent with previous terms of clearance: This collection is approved consistent with the agreement that NIH will continue to work with OMB and other interested agencies as they move forward with the rule making process that will eventually define the adverse event reporting framework in response to U.S. Public Law 110-85 (i.e., determining the best method for including in the registry and results databank appropriate results information on serious adverse and frequent adverse events.) These terms of clearance do not preclude the option of NIH using the FDAAA default as a starting point for adverse event reporting. OMB understands that NIH will seek public comments through rulemaking and incorporate prior experience with the optional reporting system to ensure that the default elements are incorporated and displayed in an appropriate and meaningful way
Inventory as of this Action
Requested
Previously Approved
Expiration Date
11/30/2018
36 Months From Approved
11/30/2015
Responses
224,530
0
168,390
Time Burden (Hours)
682,535
0
474,873
Cost Burden (Dollars)
0
0
0
Abstract:
This information collection request seeks 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, National Institutes of Health (NIH). The Office of Management and Budget (OMB) Notice-of-Action authorizing the current 3-year approval of the information collection (OMB No. 0925-0586) was issued August 20, 2012 and is due to expire on August 31, 2015. 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
PL:
Pub.L. 110 - 85 801
Name of Law: FDA Act of 2007
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:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
80 FR 32968
06/10/2015
30-day Notice:
Federal Register Citation:
Citation Date:
80 FR 50297
08/19/2015
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
7
IC Title
Form No.
Form Name
Basic Results Information (All Categories)
1
Reporting Data Entry
Certification to Delay Results
3
Certification Form
Device - Mandatory Newly Registered Trials
1
Registration Data Entry
Device - Voluntary Newly Registered Trials
1
Registration Data Entry
Drug and Biologic - Voluntary Newly Registered Trials
1
Registration Data Entry
Extension Request
4
Extension Request
Initial Registration
1
ClinicalTrials.gov Registration Data Entry Screen Shots
Initial Results Submission
2
ClinicalTrials.gov Results Reporting Data Entry Screen Shots
PRS Account
1
ClinicalTrials.gov Registration Data Entry Screen Shots
Registration Updates
1
Registration Data Entry
Result Submission Updates
2
ClinicalTrials.gov Results Reporting Data Entry Screen Shots
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
224,530
168,390
0
111,130
-54,990
0
Annual Time Burden (Hours)
682,535
474,873
0
376,735
-169,073
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:
Changing Forms
Short Statement:
This supporting statement includes an adjustment to the burden estimates to reflect recent growth in the number of studies for which registration and results information are submitted on an annual basis to ClinicalTrials.gov. The result is an increased annual burden estimated for registration of 138,000 hours above the previous information collection and an increased estimated annual burden of 74,000 hours for the submission of results information. Much of this increase results from the voluntary use of ClinicalTrials.gov for registration and results submission by those who conduct clinical studies.
Annual Cost to Federal Government:
$4,826,307
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:
08/28/2015
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