[Federal Register Volume 77, Number 73 (Monday, April 16, 2012)]
[Notices]
[Pages 22578-22579]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-9083]
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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 February
9, 2012 (Vol. 77, No. 27, p. 6808) and allowed 60-days for public
comment. A single 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 04/30/2012], Form Number: NA; Need and Use
of Information Collection: The National Institutes of Health operates
ClinicalTrials.gov, which was established as a clinical trial registry
under section 113 of the Food and Drug Administration Modernization Act
of 1997 (Pub. L. 105-115) and was expanded to include a results data
bank by Title VIII of the Food and Drug Administration Amendments Act
of 2007 (FDAAA). ClinicalTrials.gov collects registration and results
information for clinical trials and other types of clinical studies
(e.g., observational studies and patient registries) with the
objectives of enhancing patient enrollment and providing a mechanism
for tracking subsequent progress of clinical studies, to the benefit of
public health. It is widely used by patients, physicians, and medical
researchers; in particular those involved in clinical research. While
many clinical studies are registered voluntarily, FDAAA requires the
registration of certain applicable clinical trials of drugs and devices
and the submission of results information for completed applicable
clinical trials of drugs and devices that are approved, licensed, or
cleared by the Food and Drug Administration. Beginning in 2009, results
information was required to include information about serious and
frequent adverse events. As the existing PRA clearance for this
information collection nears expiration, we are making a limited number
of revisions to include additional data elements that may be
voluntarily submitted to describe and aid in the interpretation of any
submitted adverse event information, to facilitate the registration of
patient registries, and to account for the burden of establishing an
account with the ClinicalTrials.gov Protocol Registration System (PRS).
Frequency of Response: For clinical trials that are subject to FDAAA,
responsible parties must register once, not later than 21 days after
enrolling the first subject. Updates to submitted information are
required at least once a year, if there are changes to report, although
changes in recruitment status and completion of a trial must be
reported not later than 30 days after such events. Results information
is to be submitted not later than 12 months after the completion date
(as defined in the law), but can be delayed under certain
circumstances. Other clinical studies also register once, at their
inception, and are requested to update information annually, as
necessary. An organization must establish a PRS account one time in
order to register studies (and submit results) with ClinicalTrials.gov.
Description of Respondents: Respondents include sponsors or
principal investigators of clinical studies. Those subject to FDAAA are
referred to as ``responsible parties,'' which are defined as sponsors
of the clinical trial (as defined in 21 CFR 50.3) or designated
principal investigators who meet requirements specified in the law.
Estimate of Burden: The burden associated with this information
collection is calculated in three parts: the burden associated with the
one-time process of applying for a PRS account at ClinicalTrials.gov;
the burden associated with registration; and the burden associated with
the submission of results information, including adverse events. These
information collections will occur at different times, but the
registration and results information will be integrated into a single
record for each clinical trial, which is entered through the PRS
account. Based on data from 2011, we estimate that 5,500 new PRS
account applications will be submitted annually. The time necessary to
collect the required information and enter it into a new application
form is estimated at 15 minutes. Using these figures, we estimate the
total annual burden of submitting an application for a new PRS account
to be 1,375 hours (5,500 applications per year times 0.25 hours per
application). To estimate the annual reporting burden for registration,
we examined the number of clinical studies registered annually with
ClinicalTrials.gov and found an average of 17,000 registrations per
year since the enactment of FDAAA. From this total, we estimate that
approximately 5,000 studies would be applicable clinical trials of
drugs (including biological products) and 500 would be applicable
trials of devices subject to FDAAA. The remaining 11,500 studies would
be registered voluntarily. We estimate the time to complete an initial
registration
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to be 7 hours (including time to extract, reformat and submit
information which has already been produced for other purposes). This
estimate is consistent with that used on the previous PRA clearance and
incorporates 4 hours for data extraction and 3 hours for reformatting.
Based on previous experience, we estimate that each registration record
will be updated an average of eight times and that each update takes
approximately 2 hours. Applying these figures to the estimated number
of trials to be registered per year produces an annual burden estimate
of 391,000 hours. Of this total, 126,500 hours are associated with the
mandatory registration of trials subject to FDAAA, and 264,500 hours
are associated with voluntary registrations. The burden of results
submission consists of the time and effort needed to summarize
information from a clinical trial, format it, and enter it into the
databank. We estimate that of the 5,500 applicable clinical trials that
are registered each year, approximately 1,845 will be required to
submit results each year (1,500 trials of drugs and biological
products, and 345 trials of devices). We estimate that each results
record will submitted once and updated twice to reflect changes in the
data analysis, additional results of subsequent pre-specified outcome
measures, or additional adverse event information. Based on information
available from various organizations about results submission times,
comments made at a public meeting held in April 2009, responses to
estimates in previous OMB clearance documents (73 FR 58972, Oct. 8,
2008), and feedback from respondents who have submitted results to
ClinicalTrials.gov, we have increased our estimate of the average
response time to 25 hours from the 10 hour estimate included in the
previous OMB clearance request. We estimate that updates take 8 hours,
an increase over the 5 hour estimate included in the previous OMB
clearance request for adverse event information. In addition, we
estimate that 3,655 trials per year will submit certifications to
ClinicalTrials.gov indicating that they qualify for delayed results
submission, and another 200 trials will request extensions to the
submission deadline for good cause, as permitted by FDAAA. We expect
that it would take no more than 30 minutes for a responsible party to
determine that a certification is required and to submit the necessary
information through ClinicalTrials.gov. For extension requests, we
estimate that the time to prepare a request and submit it to
ClinicalTrials.gov would be no more than 2 hours. Using these figures,
we estimate the annualized hourly burden for submitting results
information, certifications, and extension requests to be 77,872.5
hours. 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.
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 email 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: April 10, 2012.
David H. Sharlip,
NLM Project Clearance Liaison, National Library of Medicine, National
Institutes of Health.
[FR Doc. 2012-9083 Filed 4-13-12; 8:45 am]
BILLING CODE 4140-01-P