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 1 survey	Form and Instruction	Modified	Available
Form 2 survey	Form and Instruction	Modified	Available
Form 2 results	Form and Instruction	Modified	Available
Form 1 registration	Form and Instruction	Modified	Available
Form 2 results	Form and Instruction	Modified	Available
Form 1 registration	Form and Instruction	Modified	Available
Form 1 registration	Form and Instruction	Modified	Available
Form 2 results	Form and Instruction	Modified	Available
Form 2 results	Form and Instruction	Modified	Repair queued
Form 1 registration	Form and Instruction	Modified	Available
Form 2 results	Form and Instruction	Modified	Available
Form 1 registration	Form and Instruction	Modified	Available
Form 2 results	Form and Instruction	Modified	Available
Form 1 registration	Form and Instruction	Modified	Available
Form 1 registration	Form and Instruction	Modified	Available
Form 2 results	Form and Instruction	Modified	Available
Form 2 results	Form and Instruction	Modified	Available
Form 1 registration	Form and Instruction	Modified	Available
Form 1 registration	Form and Instruction	Modified	Available
Form 2 results	Form and Instruction	Modified	Available
Form 2 results	Form and Instruction	Modified	Available
Form 1 registration	Form and Instruction	Modified	Available
Form 1 survey	Form and Instruction	Modified	Available
Form 2 survey	Form and Instruction	Modified	Available
Form 2 survey	Form and Instruction	Modified	Available
Form 1 survey	Form and Instruction	Modified	Available
Form 2 survey	Form and Instruction	Modified	Available
Form 1 survey	Form and Instruction	Modified	Available
RESPONSES TO QUESTIONS FROM OMB.doc	Supplementary Document	Uploaded 2009-04-01	Available
NLM Response to OMB for Public Comments - 24Mar09.docx	Supplementary Document	Uploaded 2009-04-01	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 Supporting Statement_CT Registry Results Databank_ PCB revision_12-19-08.docx	Supporting Statement A	Uploaded 2008-12-19	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
6153	Drug and Biologic - Mandatory	Form and Instruction	Modified	survey
6153	Drug and Biologic - Mandatory	Form and Instruction	Modified	survey
185105	Device - Voluntary	Form and Instruction	Modified	results
185105	Device - Voluntary	Form and Instruction	Modified	registration
185104	Device - Mandatory	Form and Instruction	Modified	results
185104	Device - Mandatory	Form and Instruction	Modified	registration
185103	Drug and Biologic - Voluntary	Form and Instruction	Modified	registration
185103	Drug and Biologic - Voluntary	Form and Instruction	Modified	results
185102	Drug and Biologic - Mandatory	Form and Instruction	Modified	results
185102	Drug and Biologic - Mandatory	Form and Instruction	Modified	registration
185101	Devices (Ongoing Trials)	Form and Instruction	Modified	results
185101	Devices (Ongoing Trials)	Form and Instruction	Modified	registration
185100	Devices (Ongoing Trials)	Form and Instruction	Modified	results
185100	Devices (Ongoing Trials)	Form and Instruction	Modified	registration
185099	Drugs and Biologics (Ongoing Trials)	Form and Instruction	Modified	registration
185099	Drugs and Biologics (Ongoing Trials)	Form and Instruction	Modified	results
185098	Drugs and Biologics (Ongoing Trials)	Form and Instruction	Modified	results
185098	Drugs and Biologics (Ongoing Trials)	Form and Instruction	Modified	registration
185097	Other	Form and Instruction	Modified	registration
185097	Other	Form and Instruction	Modified	results
185096	Other	Form and Instruction	Modified	results
185096	Other	Form and Instruction	Modified	registration
185095	Device - Voluntary	Form and Instruction	Modified	survey
185095	Device - Voluntary	Form and Instruction	Modified	survey
185094	Device - Mandatory	Form and Instruction	Modified	survey
185094	Device - Mandatory	Form and Instruction	Modified	survey
185093	Drug and Biologic - Voluntary	Form and Instruction	Modified	survey
185093	Drug and Biologic - Voluntary	Form and Instruction	Modified	survey

ICR Details

OMB Control No: 0925-0586	ICR Reference No: 200901-0925-002
Status: Historical Active	Previous ICR Reference No: 200805-0925-001
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: 04/28/2009
Retrieve Notice of Action (NOA)	Date Received in OIRA: 01/07/2009
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	04/30/2012	36 Months From Approved	04/30/2009
Responses	175,680	0	174,780
Time Burden (Hours)	435,360	0	433,060
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. Members of the public, their physicians and health advisors will use the information to identify locations where the clinical trials are conducted. The registry will provide basic information about the trials, their implementation, and how to enroll. Progress of the trials will be updated so that individuals will have current information on initiatives to intervene to treat, cure, ameliorate or prevent the health conditions with which they are afflicted or at risk. Information will also be collected to distinguish between voluntary and mandatory submissions of information. The Law also requires that the Director of the NIH ensures that the registry data bank is easily used by the public, and that entries are easily compared [PL 110-85, Section 801(a), adding new 42 U.S.C. 282(j)(B)(iv)], making necessary the use of more structured data collection techniques to ensure consistency.

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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: PL: Pub.L. 110 - 85 801 Name of Law: FDA Act of 2007

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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:
	73 FR 58973	10/08/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 448	01/06/2009
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 14

table that charts list of burden

IC Title	Form No.	Form Name
Device - Mandatory	1, 2	survey ,   survey
Device - Mandatory	2, 1	registration ,   results
Device - Voluntary	1, 2	registration ,   results
Device - Voluntary	1, 2	survey ,   survey
Devices (Ongoing Trials)	2, 1	registration ,   results
Devices (Ongoing Trials)	1, 2	registration ,   results
Drug and Biologic - Mandatory	1, 2	registration ,   results
Drug and Biologic - Mandatory	2, 1	survey ,   survey
Drug and Biologic - Voluntary	1, 2	registration ,   results
Drug and Biologic - Voluntary	1, 2	survey ,   survey
Drugs and Biologics (Ongoing Trials)	1, 2	registration ,   results
Drugs and Biologics (Ongoing Trials)	2, 1	results ,   registration
Other	1, 2	registration ,   results
Other	2, 1	results ,   registration

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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	175,680	174,780	900	0	0	0
Annual Time Burden (Hours)	435,360	433,060	2,300	0	0	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: No

Burden Reduction Due to:

Short Statement: The program changes reflected in this request respond to new statutory requirements contained in Section 801 of Public Law 110-85. For registration information, the law expands the types of clinical trials that must be registered in the registration databank and increase the number of data elements that must be submitted. It also requires the submission of basic results information for trials of products that have been approved or cleared by the FDA. The result is an increased annual burden for registration of approximately 152,250 hours above the previous information collection and an additional annual burden of 39,500 hours for the reporting of basic results information.

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Annual Cost to Federal Government: $3,000,000

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

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: 01/07/2009

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