81 FR 64182 - Submission for OMB Review; 30-Day Comment Request; National Institute of Neurological Disorders and Stroke Federal Interagency Traumatic Brain Injury Research (FITBIR) Data Access Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 181 (September 19, 2016)

Page Range		64182-64182
FR Document		2016-22561

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. This proposed information collection was previously published in the Federal Register on July 8, 2016, page 44644 (81 FR 44644) 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.

Federal Register, Volume 81 Issue 181 (Monday, September 19, 2016)

[Federal Register Volume 81, Number 181 (Monday, September 19, 2016)]
[Notices]
[Page 64182]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-22561]



[[Page 64182]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request; National 
Institute of Neurological Disorders and Stroke Federal Interagency 
Traumatic Brain Injury Research (FITBIR) Data Access Request

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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. This proposed information 
collection was previously published in the Federal Register on July 8, 
2016, page 44644 (81 FR 44644) 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.

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: 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]

SUPPLEMENTARY INFORMATION: The National Institute of Neurological 
Disorders and Stroke (NINDS), 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 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: National Institute of Neurological Disorders 
and Stroke Federal Interagency Traumatic Brain Injury Research (FITBIR) 
Data Access Request, 0925-0677, Expiration Date 08/31/2016--
REINSTATEMENT with change, 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 ``Recipient'' 
Principal Investigators 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. Type of respondents affected by this 
information collection are researchers, such as Principal Investigators 
(PI), who are interested in obtaining access to study data and images 
from the FITBIR Informatics System for research purposes.
    There are two scenarios for completing the form. The first is where 
the Principal Investigator (PI) completes the entire FITBIR Informatics 
System Data Access Request form, and the second where the PI has the 
Research Assistant begins filling out the form and PI provides the 
final reviews and signs it. Burden for this collection of information 
is estimated to vary from 30-95 minutes per response. The estimated 
annual burden hours to complete the data request form are listed below.
    OMB approval reinstatement is requested for 3 years. The total 
estimated annualized burden hours are 63.

                                                            Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                          Number of      Average burden
                    Form name                             Type of respondent             Number of      responses per     per response     Total annual
                                                                                        respondents       respondent       (in hours)      burden hour
--------------------------------------------------------------------------------------------------------------------------------------------------------
FITBIR Informatics System Data Access Request...  Individuals (Principal                          40                1            95/60               63
                                                   Investigators).
--------------------------------------------------------------------------------------------------------------------------------------------------------


    Dated: September 12, 2016.
Paul Scott,
Project Clearance Liaison Officer, National Institute of Neurological 
Disorders and Stroke, NIH.
[FR Doc. 2016-22561 Filed 9-16-16; 8:45 am]
BILLING CODE 4140-01-P

64182 Federal Register / Vol. 81, No. 181 / Monday, September 19, 2016 / Notices

DEPARTMENT OF HEALTH AND OIRA_submission@omb.eop.gov or by (NINDS), National Institutes of Health
HUMAN SERVICES fax to 202–395–6974, Attention: Desk (NIH).
Officer for NIH. Need and Use of Information
National Institutes of Health Collection: The FITBIR Informatics
FOR FURTHER INFORMATION CONTACT: To
request more information on the System Data Access Request form is
Submission for OMB Review; 30-Day necessary for ‘‘Recipient’’ Principal
Comment Request; National Institute proposed project or to obtain a copy of
the data collection plans and Investigators and their organization or
of Neurological Disorders and Stroke corporations with approved assurance
Federal Interagency Traumatic Brain instruments, contact: Dr. Sophia Jeon,
Health Science Policy Analyst, Office of from the DHHS Office of Human
Injury Research (FITBIR) Data Access Research Protections to access data or
Request Science Policy and Planning (OSPP),
NINDS, NIH, 31 Center Drive, Building images from the FITBIR Informatics
AGENCY: National Institutes of Health, 31, Room 8A03, Bethesda, MD 20892, or System for research purposes. The
HHS. call non-toll-free number (301) 435– primary use of this information is to
ACTION: Notice. 7571, or Email your request, including document, track, monitor, and evaluate
your address to: sophia.jeon@nih.gov the use of the FITBIR datasets, as well
SUMMARY: In compliance with the as to notify interested recipients of
Paperwork Reduction Act of 1995, the SUPPLEMENTARY INFORMATION: The updates, corrections or other changes to
National Institutes of Health (NIH) has National Institute of Neurological the database. Type of respondents
submitted to the Office of Management Disorders and Stroke (NINDS), National affected by this information collection
and Budget (OMB) a request for review Institutes of Health, may not conduct or are researchers, such as Principal
and approval of the information sponsor, and the respondent is not Investigators (PI), who are interested in
collection listed below. This proposed required to respond to, an information obtaining access to study data and
information collection was previously collection that has been extended, images from the FITBIR Informatics
published in the Federal Register on revised, or implemented on or after System for research purposes.
July 8, 2016, page 44644 (81 FR 44644) October 1, 1995, unless it displays a There are two scenarios for
and allowed 60 days for public currently valid OMB control number. completing the form. The first is where
comment. No public comments were In compliance with Section the Principal Investigator (PI) completes
received. The purpose of this notice is 3507(a)(1)(D) of the Paperwork the entire FITBIR Informatics System
to allow an additional 30 days for public Reduction Act of 1995, the National Data Access Request form, and the
comment. Institutes of Health (NIH) has submitted second where the PI has the Research
DATES: Comments regarding this to the Office of Management and Budget Assistant begins filling out the form and
information collection are best assured (OMB) a request for review and PI provides the final reviews and signs
of having their full effect if received approval of the information collection it. Burden for this collection of
within 30-days of the date of this listed below. information is estimated to vary from
publication. Proposed Collection: National 30–95 minutes per response. The
ADDRESSES: Written comments and/or Institute of Neurological Disorders and estimated annual burden hours to
suggestions regarding the item(s) Stroke Federal Interagency Traumatic complete the data request form are
contained in this notice, especially Brain Injury Research (FITBIR) Data listed below.
regarding the estimated public burden Access Request, 0925–0677, Expiration OMB approval reinstatement is
and associated response time, should be Date 08/31/2016—REINSTATEMENT requested for 3 years. The total
directed to the: Office of Management with change, National Institute of estimated annualized burden hours are
and Budget, Office of Regulatory Affairs, Neurological Disorders and Stroke 63.

ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total annual
Form name Type of respondent responses per
respondents response burden hour
respondent (in hours)

FITBIR Informatics System Data Ac- Individuals (Principal Investigators) 40 1 95/60 63
cess Request.

Dated: September 12, 2016. DEPARTMENT OF HEALTH AND 04:00 p.m., National Institutes of Health,
Paul Scott, HUMAN SERVICES 6710B Rockledge Drive, Bethesda, MD
Project Clearance Liaison Officer, National 20892 which was published in the
Institute of Neurological Disorders and National Institutes of Health Federal Register on September 08, 2016,
Stroke, NIH. 18 FR 62158.
[FR Doc. 2016–22561 Filed 9–16–16; 8:45 am] Eunice Kennedy Shriver National
The meeting date has changed from
Institute of Child Health & Human
BILLING CODE 4140–01–P October 18, 2016, 2:00 p.m. to 4:00 p.m.
Development; Amended Notice of
mstockstill on DSK3G9T082PROD with NOTICES

to October 26, 2016, 2:00 p.m. to 4:00
Meeting
p.m. The meeting is closed to the
Notice is hereby given of a change in public.
the meeting of the National Institute of
Child Health and Human Development
Special Emphasis Panel, October 18,
2016, 02:00 p.m. to October 18, 2016,

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Document Created: 2016-09-17 02:29:44
Document Modified: 2016-09-17 02:29:44

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
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.
Contact		To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, 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
FR Citation		81 FR 64182

81 FR 64182 - Submission for OMB Review; 30-Day Comment Request; National Institute of Neurological Disorders and Stroke Federal Interagency Traumatic Brain Injury Research (FITBIR) Data Access Request

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 81, Issue 181 (September 19, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health