Proposed Collection; Comment Request: Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics System Data Access Request, 12334-12335 [2013-04130]
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Federal Register / Vol. 78, No. 36 / Friday, February 22, 2013 / Notices
the safety and effectiveness of marketed
and investigational devices.
II. Criteria for Members
Persons nominated for membership as
consumer representatives on the
committees or panels should meet the
following criteria: (1) Demonstrate ties
to consumer and community-based
organizations, (2) be able to analyze
technical data, (3) understand research
design, (4) discuss benefits and risks,
and (5) evaluate the safety and efficacy
of products under review. The
consumer representative should be able
to represent the consumer perspective
on issues and actions before the
advisory committee; serve as a liaison
between the committee and interested
consumers, associations, coalitions, and
consumer organizations; and facilitate
dialogue with the advisory committees
on scientific issues that affect
consumers.
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III. Selection Procedures
Selection of members representing
consumer interests is conducted
through procedures that include the use
of organizations representing the public
interest and public advocacy groups.
These organizations recommend
nominees for the Agency’s selection.
Representatives from the consumer
health branches of Federal, State, and
local governments also may participate
in the selection process. Any consumer
organization interested in participating
in the selection of an appropriate voting
or nonvoting member to represent
consumer interests should send a letter
stating that interest to FDA (see
ADDRESSES) within 30 days of
publication of this document.
Within the subsequent 30 days, FDA
will compile a list of consumer
organizations that will participate in the
selection process and will forward to
each such organization a ballot listing
three to five qualified nominees selected
by the Agency based on the nominations
received, together with each nominee’s
current curriculum vitae or resume.
Ballots are to be filled out and returned
to FDA within 30 days. The nominee
receiving the highest number of votes
ordinarily will be selected to serve as
the member representing consumer
interests for that particular advisory
committee or panel.
IV. Nomination Procedures
Any interested person or organization
may nominate one or more qualified
persons to represent consumer interests
on the Agency’s advisory committees or
panels. Self-nominations are also
accepted. Potential candidates will be
required to provide detailed information
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concerning such matters as financial
holdings, employment, and research
grants and/or contracts to permit
evaluation of possible sources of
conflicts of interest.
All nominations should include: a
cover letter; a curriculum vitae or
resume that includes the nominee’s
office address, telephone number, and
email address; and a list of consumer or
community-based organizations for
which the candidate can demonstrate
active participation.
Nominations also should specify the
advisory committee(s) or panel(s) for
which the nominee is recommended. In
addition, nominations should include
confirmation that the nominee is aware
of the nomination and is willing to serve
as a member of the advisory committee
or panel if selected.
The term of office is up to 4 years.
FDA will review all nominations
received within the specified
timeframes and prepare a ballot
containing the names of qualified
nominees. Names not selected will
remain on a list of eligible nominees
and be reviewed periodically by FDA to
determine continued interest. Upon
selecting qualified nominees for the
ballot, FDA will provide those
consumer organizations that are
participating in the selection process
with the opportunity to vote on the
listed nominees. Only organizations
vote in the selection process. Persons
who nominate themselves to serve as
voting or nonvoting consumer
representatives will not participate in
the selection process.
FDA seeks to include the views of
women and men, members of all racial
and ethnic groups, and individuals with
and without disabilities on its advisory
committees and therefore, encourages
nominations of appropriately qualified
candidates from these groups.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14
relating to advisory committees.
Dated: February 15, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2013–04059 Filed 2–21–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request: Federal Interagency
Traumatic Brain Injury Research
(FITBIR) Informatics System Data
Access Request
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 Institute of Neurological
Disorders and Stroke (NINDS), 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.
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)
The quality, utility, and clarity of the
information to be collected; and (4)
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.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project, obtain a copy of the
data collection plans and instruments,
or to submit written comments, contact
Rebecca L. Frederick, Office of Science
Policy and Planning, OSPP, NINDS,
NIH, 31 Center Drive, Building 31,
Room 8A03, Bethesda, MD 20892; call
301–496–9271; or Email:
rebecca.frederick@nih.gov.
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: Federal
Interagency Traumatic Brain Injury
Research (FITBIR) Informatics System
Data Access Request.
Need and Use of Information
Collection: The FITBIR Informatics
System Data Access Request form is
necessary for ‘‘Recipient’’ Principal
SUMMARY:
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Federal Register / Vol. 78, No. 36 / Friday, February 22, 2013 / Notices
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.
Frequency of Response: Once per
request.
Affected Public: Individuals.
Type of Respondents: Researchers
interested in obtaining access to study
data and images from the FITBIR
Informatics System for research
purposes.
The annual reporting burden is as
follows:
Estimated Number of Respondents:
approximately 40.
Estimated Number of Responses per
Respondent: Once per request.
Average Burden Hours per Response:
95/60.
Estimated Total Annual Burden
Hours Requested: 63.
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. The estimated annual burden hours
to complete the data request form are
listed below.
ESTIMATED ANNUAL BURDEN HOURS
Number of respondents
Form
Frequency of
response
Average time
per response
(in hours)
Annual hour
burden
FITBIR Informatics System Data Access Request ..........................................
40
1
95/60
63
Total ..........................................................................................................
........................
........................
........................
63
Dated: February 13, 2013.
Caroline Lewis,
Executive Officer, National Institute of
Neurological Disorders and Stroke, National
Institutes of Health.
[FR Doc. 2013–04130 Filed 2–21–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB review; Comment
Request: Methodological Studies for
the Population Assessment of
Tobacco and Health (PATH) Study
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institute on Drug Abuse (NIDA), the
National Institutes of Health (NIH) has
submitted to the Office of Management
and Budget (OMB) a request to review
and approve the information collection
listed below. This proposed information
collection was previously published in
SUMMARY:
the Federal Register on November 26,
2012, Vol. 77, No. 227, p. 70451 and
allowed 60-days for public comment.
Two comments were received in
support of this request. The purpose of
this notice is to allow an additional 30
days for public comment. The 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.
Proposed Collection: Title: Cognitive
Testing of Instrumentation and
Materials for Population Assessment of
Tobacco and Health (PATH) Study.
Type of Information Collection Request:
New. Need and Use of Information
Collection: The PATH study will
establish a population-based framework
for monitoring and assessing the
behavioral and health impacts of
regulatory provisions implemented as
part of the Family Smoking Prevention
and Tobacco Control Act (FSPTCA) by
the Food and Drug Administration
(FDA). NIDA is requesting generic
approval from OMB for methodological
studies to improve the PATH study
instrumentation and data collection
procedures. These methodological
studies will support ongoing assessment
and refinement of the PATH study’s
design, and highlight ways to improve
study implementation, data collection
procedures, and techniques for retention
and followup. Data collection methods
to be used in these methodological
studies include: in-person and
telephone surveys; web and
smartphone/mobile phone surveys; and
focus group and individual in-depth
qualitative interviews. Biospecimens
may also be collected from adults.
Frequency of Response: Annual [As
needed on an on-going and concurrent
basis]. Affected Public: Individuals.
Type of Respondents: Youth (ages 12–
17) and Adults (ages 18+). Annual
Reporting Burden: See Table 1. The
annualized cost to respondents is
estimated at: $371,284. There are no
capital, operating or maintenance costs.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN SUMMARY—METHODOLOGICAL STUDIES FOR THE PATH STUDY
Number of
respondents
Responses
per
respondent
Hours per
response
Annual hour
burden
Type of respondent
In-person and telephone surveys .....
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Data collection activity
Adults ...............................................
Youth ................................................
Adults ...............................................
5,000
3,500
5,000
1
1
1
90 60
Youth ................................................
Adults ...............................................
3,500
1,000
1
1
90 60
Youth ................................................
Adults ...............................................
1,000
1,000
1
1
Web and smartphone/mobile phone
surveys.
Focus groups and individual in-depth
qualitative interviews.
Biospecimen collection .....................
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⁄
⁄
90⁄60
7,500
5,250
7,500
⁄
2
5,250
2,000
2
2,000
250
90 60
⁄
15 60
]]>Agencies
[Federal Register Volume 78, Number 36 (Friday, February 22, 2013)]
[Notices]
[Pages 12334-12335]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04130]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment Request: Federal Interagency
Traumatic Brain Injury Research (FITBIR) Informatics System Data Access
Request
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 Institute of
Neurological Disorders and Stroke (NINDS), 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.
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) The quality, utility, and clarity of the information to be
collected; and (4) 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.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project, obtain a copy of the data collection plans and
instruments, or to submit written comments, contact Rebecca L.
Frederick, Office of Science Policy and Planning, OSPP, NINDS, NIH, 31
Center Drive, Building 31, Room 8A03, Bethesda, MD 20892; call 301-496-
9271; or Email: rebecca.frederick@nih.gov.
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: Federal Interagency Traumatic Brain Injury
Research (FITBIR) Informatics System Data Access Request.
Need and Use of Information Collection: The FITBIR Informatics
System Data Access Request form is necessary for ``Recipient''
Principal
[[Page 12335]]
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.
Frequency of Response: Once per request.
Affected Public: Individuals.
Type of Respondents: Researchers interested in obtaining access to
study data and images from the FITBIR Informatics System for research
purposes.
The annual reporting burden is as follows:
Estimated Number of Respondents: approximately 40.
Estimated Number of Responses per Respondent: Once per request.
Average Burden Hours per Response: 95/60.
Estimated Total Annual Burden Hours Requested: 63.
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. The estimated annual burden hours to
complete the data request form are listed below.
Estimated Annual Burden Hours
----------------------------------------------------------------------------------------------------------------
Average time
Form Number of Frequency of per response Annual hour
respondents response (in hours) burden
----------------------------------------------------------------------------------------------------------------
FITBIR Informatics System Data Access Request... 40 1 95/60 63
---------------------------------------------------------------
Total....................................... .............. .............. .............. 63
----------------------------------------------------------------------------------------------------------------
Dated: February 13, 2013.
Caroline Lewis,
Executive Officer, National Institute of Neurological Disorders and
Stroke, National Institutes of Health.
[FR Doc. 2013-04130 Filed 2-21-13; 8:45 am]
BILLING CODE 4140-01-P
