[Federal Register Volume 84, Number 224 (Wednesday, November 20, 2019)]
[Notices]
[Pages 64093-64094]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25114]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; 60-Day Comment Request; National Institute 
of Neurological Disorders and Stroke FITBIR Data Access Request

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 Institute of Neurological Disorders 
and Stroke (NINDS), 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 within 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: Dr. Sophia 
Jeon, Health Science Policy Analyst, Office of Science Policy and 
Planning, OSPP, NINDS, NIH, 31 Center Drive, Building 31, Room 8A03, 
Bethesda, MD 20892, or call non-toll-free number (301) 435-7571, 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: National Institute of Neurological 
Disorders and Stroke FITBIR Data Access Request, 0925-0677, 
REINSTATEMENT with change-, Expiration Date 12/31/2019 National 
Institute of Neurological Disorders and Stroke (NINDS), National 
Institutes of Health (NIH).
    Need and Use of Information Collection: The FITBIR Informatics 
System Data Access Request form is necessary for Principal 
Investigators (PIs) and their organization or corporations with 
approved assurance from the DHHS Office of Human Research Protections 
to access data or images from the FITBIR Informatics System for 
research purposes. The primary use of this information is to document, 
track, monitor, and evaluate the use of the FITBIR datasets, as well as 
to notify interested recipients of updates, corrections or other 
changes to the database. For reinstatement of this collection, the 
agency proposes to add Data Submission Request to allow ``Submitter'' 
Principal Investigators (PIs) to request submission of their data to 
the FITBIR database for broad data sharing and to document, monitor, 
and track the FITBIR data submissions. Types of respondents affected by 
this information collection are researchers, such as ``Recipient'' PIs 
who are interested in obtaining access to study data and images from 
the FITBIR Informatics System for research purposes, or ``Submitter'' 
PIs who are interested in submitting data to contribute to the FITBIR 
database for their data to be shared with the traumatic brain injury 
research community.
    OMB approval reinstatement is requested for 3 years. There are no 
costs to respondents other than their time. The total estimated 
annualized burden hours are 96.

[[Page 64094]]



                                                            Estimated Annualized Burden Hours
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                                                                                                                              Average
                                                                                             Number of       Number of      burden per     Total annual
                   Form name                               Type of respondents              respondents    responses per   response  (in   burden hours
                                                                                                            respondent        hours)
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FITBIR Data Access Request.....................  Individuals (``Recipient'' Principal                 85               1           60/60              85
                                                  Investigators).
FITBIR Data Submission Request.................  Individuals (``Submitter'' Principal                 65               1           10/60              11
                                                  Investigators).
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................  ..............             150  ..............              96
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    Dated: November 14, 2019.
Paul Scott,
Project Clearance Liaison, National Institute of Neurological Disorders 
and Stroke, NIH.
[FR Doc. 2019-25114 Filed 11-19-19; 8:45 am]
 BILLING CODE 4140-01-P