[Federal Register Volume 80, Number 111 (Wednesday, June 10, 2015)]
[Notices]
[Pages 32968-32969]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-14169]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed collection; 60-day comment request Information Program
on Clinical Trials: Maintaining a Registry and Results Databank (NLM)
SUMMARY: In compliance with the requirement of section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995, for opportunity for public comment
on proposed data collection projects, the National Library of Medicine
(NLM), 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. This summary
describes the existing information collection at ClinicalTrials.gov,
for which an extension is requested; it does not include any changes to
the information collection that were proposed in the Notice of Proposed
Rulemaking on Clinical Trial Registration and Results Submission that
was issued on November 21, 2014 (79 FR 225, Nov. 21, 2014).
Written comments and/or suggestions from the public and affected
agencies are invited on one or more of the following points: (1)
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) 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) Ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) Ways to 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.
To Submit Comments and For Further Information: To obtain a copy of
the data collection plans and instruments, submit comments in writing,
or request more information on the proposed project, contact: David
Sharlip, Office of Administrative and Management Analysis Services,
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, including your address to: [email protected]
Formal requests for additional plans and instruments must be requested
in writing.
Comment 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.
Proposed Collection: Information Program on Clinical Trials:
Maintaining a Registry and Results Databank (NLM), 0925-0586,
Expiration Date: 08/31/2015, EXTENSION, National Library of Medicine
(NLM), National Institutes of Health (NIH).
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 and submit results information 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.
This extension request does not include any changes to the
information submission requirements for ClinicalTrials.gov that were
proposed in the Notice of Proposed Rulemaking on Clinical Trial
Registration and Results Submission that was issued on November 21,
2014 and for which the public comment period closed on March 23, 2015
(79 FR 225, Nov. 21, 2014). The NIH is continuing to review submitted
public comments as it prepares the final rule. The NIH will make any
corresponding changes to the ClinicalTrials.gov information collection
via separate procedure.
OMB approval is requested for 3 years. The total estimated
annualized cost to respondents is $49,399,851. The total estimated
annualized burden hours are 682,535.
Estimated Annualized Burden Hours
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Number of
Submission type Number of response per Average time Annual hour
respondents respondent per response burden
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PRS Account..................................... 5,700 1 15/60 1,425
Initial Registration............................ 23,000 1 7 161,000
Updates......................................... 23,000 8 2 368,000
Initial Results................................. 3,700 1 25 92,500
Updates......................................... 3,700 2 8 59,200
[[Page 32969]]
Certification to Delay Results.................. 700 1 30/60 350
Extension Request............................... 30 1 2 60
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Total....................................... 33,130 .............. .............. 682,535
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Dated: June 4, 2015.
David Sharlip,
Project Clearance Liaison, NLM, NIH.
[FR Doc. 2015-14169 Filed 6-9-15; 8:45 am]
BILLING CODE 4140-01-P