[Federal Register Volume 85, Number 16 (Friday, January 24, 2020)]
[Notices]
[Pages 4332-4333]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01157]


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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 
(National Library of Medicine)

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: In compliance with 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.

DATES: Comments regarding this information collection are best assured 
of having their full effect if received within 30-days of the date of 
this publication.

ADDRESSES: 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: Desk 
Officer for NIH.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
instruments, 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].

SUPPLEMENTARY INFORMATION: This proposed information collection was 
previously published in the Federal Register on November 19, 2019, 
pages 63884-5 (84 FR 63884) and allowed 60 days for public comment. No 
public comments were 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.
    In compliance with Section 3507(a)(1)(D) of the Paperwork

[[Page 4333]]

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.
    Proposed Collection: 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 results information submitted 
voluntarily, 42 CFR part 11 requires the registration and submission of 
results information for certain 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
    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
                                                 ---------------------------------------------------------------
        Total...................................          64,660         210,037  ..............       1,072,306
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    Dated: January 21, 2020.
David H. Sharlip,
Project Clearance Liaison, National Library of Medicine, National 
Institutes of Health.
[FR Doc. 2020-01157 Filed 1-23-20; 8:45 am]
 BILLING CODE 4140-01-P