[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
----------------------------------------------------------------------------------------------------------------
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