[Federal Register Volume 77, Number 27 (Thursday, February 9, 2012)]
[Pages 6808-6809]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-3048]



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 (PRA) 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 

Proposed Collection

    Title: Information Program on Clinical Trials: Maintaining a 
Registry and Results Databank.
    Type of Information Collection Request: Revision of OMB No. 0925-
0586, expiration date April 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 and to facilitate the registration of patient registries.
    Frequency of Response: For clinical trials that are subject to 
FDAAA, responsible parties must submit the required registration 
information not later than 21 days after enrolling the first subject. 
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. Updates to most submitted information are 
required at least once a year, if there are changes to report, but 
changes in recruitment status and completion of a trial must be 
reported not later than 30 days after such events. Other clinical 
studies register once, at their inception, and are requested to update 
information annually, as necessary.
    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 consists of the burden associated with registration of 
clinical studies and the burden associated with the submission of 
results information (including adverse events). These information 
collections will occur at different times, but submitted information is 
integrated into a single record for each clinical trial. 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 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,

[[Page 6809]]

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.

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 Email your request to 
[email protected].

DATES: 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: February 2, 2012.
David H. Sharlip,
OMB Project Clearance Liaison, National Library of Medicine, National 
Institutes of Health.
[FR Doc. 2012-3048 Filed 2-8-12; 8:45 am]