[Federal Register Volume 80, Number 160 (Wednesday, August 19, 2015)]
[Notices]
[Pages 50297-50298]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20473]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request; Information
Program on Clinical Trials: Maintaining a Registry and Results Databank
(NLM)
Summary: Under the provisions of Section 3507(a)(1)(D) of the
Paperwork Reduction Act of 1995, the National Institutes of Health
(NIH) has submitted to the Office of Management and Budget (OMB) a
request for review and approval of the information collection listed
below. This proposed information collection was previously published in
the Federal Register on June 10, 2015, page 32968 and allowed 60-days
for public comment. One public comment was received. The purpose of
this notice is to allow an additional 30 days for public comment. The
National Library of Medicine (NLM), 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.
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: NIH Desk Officer.
Comment 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.
For Further Information Contact: To obtain a copy of the data
collection plans and instruments 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.
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.
[[Page 50298]]
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. There are no costs to
respondents other than there their time. The total estimated annualized
burden hours are 682,535.
Estimated Annualized Burden Hours
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Number of Average time
Submission type Number of responses per per response Total annual
respondents respondent (in hours) hour 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
Certification to Delay Results.................. 700 1 30/60 350
Extension Request............................... 30 1 2 60
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Dated: August 13, 2015.
David Sharlip,
Project Clearance Liaison, NLM, NIH.
[FR Doc. 2015-20473 Filed 8-18-15; 8:45 am]
BILLING CODE 4140-01-P