[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
[email protected].
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