[Federal Register Volume 74, Number 3 (Tuesday, January 6, 2009)]
[Notices]
[Pages 448-449]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-31448]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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

[[Page 449]]

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, [email protected] 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 
[email protected].
    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.
 [FR Doc. E8-31448 Filed 1-5-09; 8:45 am]
BILLING CODE 4140-01-P