[Federal Register Volume 84, Number 223 (Tuesday, November 19, 2019)]
[Notices]
[Pages 63884-63885]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24996]


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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 
(National Library of Medicine)

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: In compliance with the requirement of the Paperwork Reduction 
Act of 1995 to provide opportunity for public comment on proposed data 
collection projects, the National Library of Medicine (NLM), the 
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.

DATES: Comments regarding this information collection are best assured 
of having their full effect if received with 60 days of the date of 
this publication.

FOR FURTHER INFORMATION CONTACT: 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) 827-6361, 
or Email your request, including your address to: 
[email protected]. Formal requests for additional plans and 
instruments must be requested in writing.

SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork 
Reduction Act of 1995 requires written comments and/or suggestions from 
the public and affected agencies are invited to address 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.
    Proposed Collection Title: Information Program on Clinical Trials: 
Maintaining a Registry and Results Databank, 0925-0586, Expiration 
Date: 02/29/2020, 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) and by the Clinical Trials Registration 
and Results Information Submission regulations at 42 CFR part 11. 
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, 42 CFR part 11 requires the registration of certain 
applicable clinical trials of drug, biological, and device products and 
the submission of results information for completed applicable clinical 
trials of drug, biological, and device products whether or not they are 
approved, licensed, or cleared by the Food and Drug Administration.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 1,072,306.

                                        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)     burden hours
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Registration--attachment 2:
    Initial.....................................           7,400               1               8          59,200
    Updates.....................................           7,400               8               2         118,400
    Triggered, voluntary........................              88               1               8             704
    Initial, non-regulated, NIH Policy..........             657               1               8           5,256
    Updates, non-regulated, NIH Policy..........             657               8               2          10,512
    Initial, voluntary and non-regulated........          11,244               1               8          89,952
    Updates, voluntary and non-regulated........          11,244               8               2         179,904
Results Information Submission--attachment 5:
    Initial.....................................           7,400               1              40         296,000
    Updates.....................................           7,400               2              10         148,000
    Triggered, voluntary--also attachment 2.....              30               1              45           1,350
    Initial, non-regulated, NIH Policy..........             657               1              40          26,280
    Updates, non-regulated, NIH Policy..........             657               2              10          13,140

[[Page 63885]]

 
    Initial, voluntary and non-regulated........           2,000               1              40          80,000
    Updates, voluntary and non-regulated........           2,000               2              10          40,000
Other:
    Certification to delay results--attachment 6           5,150               1           30/60           2,575
    Extension request--attachment 7.............             250               1               2             500
    Initial, expanded access--attachment 3......             213               1               2             426
    Updates, expanded access--attachment 3......             213               2           15/60             107
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
        Total...................................  ..............         210,037  ..............       1,072,306
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    Dated: November 4, 2019.
David H. Sharlip,
Project Clearance Liaison, National Library of Medicine, National 
Institutes of Health.
[FR Doc. 2019-24996 Filed 11-18-19; 8:45 am]
 BILLING CODE 4140-01-P