[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

[[Page 22579]]

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