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 Attachment 3 Registration Data Entry	Form	Modified	Available
Form 1 Reporting Data Entry	Form and Instruction	New	Available
Form 1 Registration Data Entry	Form and Instruction	Modified	Available
Form 1 Registration Data Entry	Form and Instruction	Modified	Available
Form 1 Registration Data Entry	Form and Instruction	Modified	Available
Form 1 Registration Data Entry	Form and Instruction	Modified	Available
Form 2 results	Form and Instruction	Removed	Available
Form 1 registration	Form and Instruction	Removed	Available
Form 2 results	Form and Instruction	Removed	Available
Form 1 registration	Form and Instruction	Removed	Available
Form 1 registration	Form and Instruction	Removed	Available
Form 2 results	Form and Instruction	Removed	Available
Form 2 results	Form and Instruction	Removed	Available
Form 1 registration	Form and Instruction	Removed	Available
Form 1 Registration Data Entry	Form and Instruction	Modified	Available
Form 1 Registration Data Entry	Form and Instruction	Modified	Available
Form 1 Registration Data Entry	Form and Instruction	Modified	Available
Form 1 Registration Data Entry	Form and Instruction	Modified	Available
Form 1 Registration Data Entry	Form and Instruction	Modified	Available
Attachment 2.pdf	Supplementary Document	Uploaded 2012-04-30	Available
Attachment 1.pdf	Supplementary Document	Uploaded 2012-04-30	Available
Privacy Act review by Karen Pla for NLM Clinical Trials gov Extension.doc	Supplementary Document	Uploaded 2012-04-30	Available
ClinicalTrials.gov_Protocol Registry_ Data Element Definitions.pdf	Supplementary Document	Uploaded 2008-12-19	Available
ClinicalTrials.gov _Basic Results_ Data Element Definitions.pdf	Supplementary Document	Uploaded 2008-12-19	Available
ClinicalTrials.gov_Protocol Registry_ Data Element Definitions.pdf	Supplementary Document	Uploaded 2008-12-19	Available
ClinicalTrials.gov _Basic Results_ Data Element Definitions.pdf	Supplementary Document	Uploaded 2008-12-19	Available
NLM Clinical Trials ICR Supporting Statement 04-10-2012_revised 7-13-12.doc	Supporting Statement A	Uploaded 2012-07-13	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
6153	Drug and Biologic - Mandatory Newly registered Trials	Form	Modified	Registration Data Entry
202116	Basic Results Information (All Categories)	Form and Instruction	New	Reporting Data Entry
185105	Device - Voluntary Newly Registered Trials	Form and Instruction	Modified	Registration Data Entry
185104	Device - Mandatory Newly Registered Trials	Form and Instruction	Modified	Registration Data Entry
185103	Drug and Biologic - Voluntary Newly Registered Trials	Form and Instruction	Modified	Registration Data Entry
185102	Drug and Biologic - Mandatory Newly Registered Trials	Form and Instruction	Modified	Registration Data Entry
185101	Devices (Ongoing Trials)	Form and Instruction	Removed	results
185101	Devices (Ongoing Trials)	Form and Instruction	Removed	registration
185100	Devices (Ongoing Trials)	Form and Instruction	Removed	results
185100	Devices (Ongoing Trials)	Form and Instruction	Removed	registration
185099	Drugs and Biologics (Ongoing Trials)	Form and Instruction	Removed	registration
185099	Drugs and Biologics (Ongoing Trials)	Form and Instruction	Removed	results
185098	Drugs and Biologics (Ongoing Trials)	Form and Instruction	Removed	results
185098	Drugs and Biologics (Ongoing Trials)	Form and Instruction	Removed	registration
185097	Other Newly Registered Trials	Form and Instruction	Modified	Registration Data Entry
185096	Other Newly Registered Trials	Form and Instruction	Modified	Registration Data Entry
185095	Device - Voluntary Newly Registered Trials	Form and Instruction	Modified	Registration Data Entry
185094	Device - Mandatory Newly registered Trials	Form and Instruction	Modified	Registration Data Entry
185093	Drug and Biologic - Voluntary Newly Registered Trials	Form and Instruction	Modified	Registration Data Entry

ICR Details

OMB Control No: 0925-0586	ICR Reference No: 201204-0925-002
Status: Historical Active	Previous ICR Reference No: 200901-0925-002
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Information Program on Clinical Trials: Maintaining a Registry and Results Databank (NLM)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 08/20/2012
Retrieve Notice of Action (NOA)	Date Received in OIRA: 04/30/2012
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.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2015	36 Months From Approved	08/31/2012
Responses	168,390	0	175,680
Time Burden (Hours)	474,873	0	435,360
Cost Burden (Dollars)	0	0	0

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Abstract: 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. 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

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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:
	77 FR 6808	02/09/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 22578	04/16/2012
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 11

table that charts list of burden

IC Title	Form No.	Form Name
Basic Results Information (All Categories)	1	Reporting Data Entry
Device - Mandatory Newly Registered Trials	1	Registration Data Entry
Device - Mandatory Newly registered Trials	1	Registration Data Entry
Device - Voluntary Newly Registered Trials	1	Registration Data Entry
Device - Voluntary Newly Registered Trials	1	Registration Data Entry
Devices (Ongoing Trials)	1, 2	registration ,   results
Devices (Ongoing Trials)	2, 1	registration ,   results
Drug and Biologic - Mandatory Newly Registered Trials	1	Registration Data Entry
Drug and Biologic - Mandatory Newly registered Trials	Attachment 3	Registration Data Entry
Drug and Biologic - Voluntary Newly Registered Trials	1	Registration Data Entry
Drug and Biologic - Voluntary Newly Registered Trials	1	Registration Data Entry
Drugs and Biologics (Ongoing Trials)	2, 1	results ,   registration
Drugs and Biologics (Ongoing Trials)	1, 2	registration ,   results
Other Newly Registered Trials	1	Registration Data Entry
Other Newly Registered Trials	1	Registration Data Entry

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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	168,390	175,680	0	8,400	-15,690	0
Annual Time Burden (Hours)	474,873	435,360	0	10,800	28,713	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

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

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Since approval of the previous OMB Paperwork Reduction Act clearance request, the information collection has been modified to make mandatory the submission of adverse event information, consistent with legal requirements of FDAAA (as it modifies section 282(j)(3)(I) of the PHS Act) that took effect on September 27, 2009. Submission of such information was previously voluntary. We have increased the average hourly burden estimates to reflect this change and to reflect user feedback regarding results submission times. We have also increased our estimate of the number of applicable clinical trials that are subject to the registration requirement of the law to more closely track recent trends. The result is an increased annual burden estimated for registration of 39,790 hours above the previous information collection and an increased estimated annual burden of 16,652.5 hours for the submission of basic results information.

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Annual Cost to Federal Government: $4,000,000

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: 04/30/2012

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