E8-31448. Submission for OMB Review; Comment Request Information Program on Clinical Trials: Maintaining a Registry and Results Databank

SUMMARY:

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Library of Medicine (NLM), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on October 8, 2008 (Vol. 73, No. 196, p. 58973) and allowed 60 days for public comment. One public comment was received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

Proposed Collection: Title: Information Program on Clinical Trials: Maintaining a Registry and Results Databank; Type of Information Collection Request: Revision of currently approved collection [OMB No. 0925-0586, expiration date 01/31/2009], Form Number: N/A; Need and Use of Information Collection: The National Institutes of Health is modifying the clinical trial registry databank established under previous law [FDAMA, Section 113] to comply with provisions of Title VIII of Public Law 110-85 (Food and Drug Administration Amendments Act of 2007). The databank collects specified registration and results information on certain clinical trials identified in the law, with the objective of enhancing patient enrollment and providing a mechanism for tracking subsequent progress of clinical trials, to the benefit of public health. The databank is widely used by patients, physicians, and medical researchers; in particular, those involved in clinical research studies. Public Law 110-85 expands the scope of clinical trials that must be registered in ClinicalTrials.gov, increases the clinical trial information that must be submitted as part of each registration, and requires the submission of basic results information for registered trials of approved drugs, biologics and devices. Frequency of Response: Responsible parties must submit the required registration information not later than 21 days after enrolling the first subject. Results information is to be reported not later than 12 months after the completion date (as defined in the law), but the responsible party may request an extension of the deadline or delay submission by certifying that the drug or device under study has not yet been approved. Updates to submitted information are required at least once a year, unless there are no changes to report. Changes in recruitment status and completion of a trial must be reported not later than 30 days after such events. Description of Respondents: Respondents are referred to in the law as “responsible parties,” and are defined as: (1) The sponsor of the clinical trial (as defined in 21 CFR 50.3) or (2) the principal investigator of such clinical trial if so designated by a sponsor, grantee, contractor, or awardee, provided that “the principal investigator is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements” for submitting information under the law. Estimate of Burden: The burden associated with this information collection consists of two parts: the burden associated with registration of clinical trials; and the burden associated with the reporting of results information. In both cases, the burden includes the time necessary to extract information from the study protocol or results record, reformat and review it, enter it into the databank, and provide necessary updating over the course of the study. It is estimated that registration information will be required for 3,000 trials of drugs and biologics and 445 trials of medical devices each year.

Each initial registration is estimated to take 7 hours and each of the subsequent 8 updates to the record are estimated to take 2 hours, resulting in an annual burden of 79,235 hours. It is estimated that there will be voluntary submissions of registration information for 6,000 trials of drugs and biologics, 545 trials of devices, and 5,280 trials of other types of medical interventions. Using the same hour estimates as for mandatory registration, the burden associated with voluntary registrations is estimated at 271,975 hours, bringing the total registration burden to 351,210 hours. In the first year of operation, it is estimated that there will be an additional burden of 84,150 hours associated with the updating of information for 7,000 trials of drugs and biologics and 650 trials of medical devices that were previously registered in the databank and ongoing as of December 26, 2007 (90 days after enactment). It is estimated that such trials will require one update of 3 hours to bring them into compliance with the new law (FDAAA) and 4 subsequent updates of 2 hours each. Submisson of results information is required only for those applicable clinical trials of drugs, biologics, and devices that are subject to the mandatory registration requirements of FDAAA and for which the product(s) under study have been approved or cleared by the FDA. It is estimated that results reporting will be required for 1,645 trials of drugs and biologics and 375 trials of medical devices each year. Initial submission of results information is estimated to require 10 hours, and each result submission is expected to require two updates that take 5 hours each. It is estimated that 2,345 trials per year will submit certifications for delayed reporting of results information or a request for an extension of the reporting deadline. Preparation and submission of such information is estimated to take 1 hour. The total burden for results reporting is therefore estimated at 42,745 hours per year. There are no capital costs to report. The operating and maintenance budget for the Clinical Trials Registry Databank in FY2009 is projected to be approximately $3 million.

Request For Comments: Written comments and/or suggestions from the public and affected agencies should address one or more of the following points: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, [e-mail] or by fax to 202-395-6974, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: David Sharlip, National Library of Medicine, Building 38A, Room B2N12, 8600 Rockville Pike, Bethesda, MD 20894, or call non-toll free number 301-402-9680 or e-mail your request to [e-mail].

Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.

Dated: December 17, 2008.

Betsy L. Humphreys,

Deputy Director, National Library of Medicine, National Institutes of Health.