[Federal Register Volume 73, Number 196 (Wednesday, October 8, 2008)]
[Notices]
[Pages 58972-58973]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-23790]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; Comment Request; Information Program on 
Clinical Trials: Maintaining a Registry and Results Databank

SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of 
the Paperwork Reduction Act of 1995 to provide opportunity for public 
comment on proposed data collection projects, the National Library of 
Medicine (NLM), the National Institutes of Health (NIH) will publish 
periodic summaries of proposed projects to be submitted to the Office 
of Management and Budget (OMB) for review and approval.
    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: NA; 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 can be delayed under 
certain circumstances. 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 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

[[Page 58973]]

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 hrs each. 
Results reporting 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. The total burden for results reporting is therefore 
estimated at 40,400 hours per year. There are no capital costs to 
report.
    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.

FOR FURTHER INFORMATION CONTACT: 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 
<a href="/cdn-cgi/l/email-protection#37445f56455b5e4753775a565e5b19595e5f19505841"><span class="__cf_email__" data-cfemail="2f5c474e5d43465f4b6f424e46430141464701484059">[email protected]</span></a>.
    Comments Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 60 days 
of the date of this publication.

    Dated: September 30, 2008.
Betsy L. Humphreys,
Deputy Director, National Library of Medicine, National Institutes of 
Health.
 [FR Doc. E8-23790 Filed 10-7-08; 8:45 am]
BILLING CODE 4140-01-P


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