80 FR 32968 - Proposed collection; 60-day comment request Information Program on Clinical Trials: Maintaining a Registry and Results Databank (NLM)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 111 (June 10, 2015)

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.

[Federal Register Volume 80, Number 111 (Wednesday, June 10, 2015)]
[Notices]
[Pages 32968-32969]
From the Federal Register Online  [www.thefederalregister.org]
[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
----------------------------------------------------------------------------------------------------------------
                                                                     Number of
                 Submission type                     Number of     response per    Average time     Annual hour
                                                    respondents     respondent     per response       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

[[Page 32969]]

 
Certification to Delay Results..................             700               1           30/60             350
Extension Request...............................              30               1               2              60
                                                 ---------------------------------------------------------------
    Total.......................................          33,130  ..............  ..............         682,535
----------------------------------------------------------------------------------------------------------------


    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