View Information Collection Request (ICR) Package

OMB Control No: 0925-0586	ICR Reference No: 200805-0925-001
Status: Historical Active	Previous ICR Reference No: 200803-0925-002
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: Emergency	Approval Requested By: 06/30/2008
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/03/2008
Retrieve Notice of Action (NOA)	Date Received in OIRA: 05/29/2008
Terms of Clearance: NIH will submit screen shots from each page of the web survey with the main package. In the interim, the supplemental document that contains the element definitions provides the detail regarding the questions that must be completed for each clinical trial. The IC list is confusing: Although there is only one web-based questionnaire, there is a separate IC for each component of the burden (devices vs drugs vs others BY voluntary vs mandatory BY new submissions vs updating old submissions). Thus, there is an IC for mandatory device protocols that are new, and a separate IC for voluntary device protocols that are new, and another one for voluntary device protocols that are simply adding the new data elements to prior submissions, etc etc.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2009	6 Months From Approved	01/31/2011
Responses	174,780	0	43,499
Time Burden (Hours)	433,060	0	200,839
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.

Emergency Justfication: Public Law 110-85 was enacted on September 27, 2007. The statute modified 42 USC 282(j)(1)(A)(ii) to expand the existing data bank of clinical trials registry information that was established under previous law and to make available to the public a searchable data bank of information about certain controlled clinical trials of drugs, biologics and devices, as provided for in the statute. The law mandates the implementation of the revised and expanded clinical trials registry by December 26, 2007. Since the passage of the law, staff at the National Library of Medicine has worked with other NIH officials and representatives of the U.S. Food and Drug Administration to revise the set of data elements needed to register an applicable clinical trial in accordance with the law and to assure smooth transition to the expanded registry. The imminent statutory deadline requires that clearance of the information collection mandated by P.L.110-85 be approved and operational at the earliest possible time. The Director, National Library of Medicine (NLM), has determined, in accordance with 5 CFR 1320.13, that the collection of the information pursuant to 42 USC 282 (j)(1)(A)(ii)is needed: a) prior to the expiration of time periods established under 5 CFR 1320; b) is essential to the mission of the agency; and c) the agency cannot reasonably comply with the normal clearance procedures because the use of the normal clearance procedures is reasonably likely to cause a statutory deadline to be missed.

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
Did the Agency receive public comments on this ICR? No

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion
Annual Number of Responses	174,780	43,499	68,141	63,140
Annual Time Burden (Hours)	433,060	200,839	128,781	103,440
Annual Cost Burden (Dollars)	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: Miscellaneous Actions

Short Statement: The program changes reflected in this request respond to new statutory requirements contained in Section 801 of Public Law 110-85. The law expands the types of clinical trials that must be registered in the registration data bank and increase the number of data elements that must be submitted. The result is an increased annual burden of approximately 152,250 hours above the previous information collection.

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)? Uncollected

Is this ICR related to the Pandemic Response? Uncollected

Agency Contact: Mikia Currie 3014350941

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