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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.

	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

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.

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

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:
	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

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute
Annual Number of Responses	175,680	174,780	900
Annual Time Burden (Hours)	435,360	433,060	2,300
Annual Cost Burden (Dollars)	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.

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

Agency Contact: Marilyn Tuttleman 3015947949 mtuttleman@od.nih.gov

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