Submission for OMB Review; Comment Request; Quality of Life Outcomes in Neurological Disorders, 2925 [E8-606]
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Federal Register / Vol. 73, No. 11 / Wednesday, January 16, 2008 / Notices
regarding their request to speak by
January 11, 2008.
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: January 10, 2008.
Randall W. Lutter,
Assistant Commissioner for Policy.
[FR Doc. E8–726 Filed 1–15–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request; Quality of Life
Outcomes in Neurological Disorders
SUMMARY: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institute of Neurological Disorders and
Stroke (NINDS), 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 the Federal
Register on September 24, 2007, page
number 54269 and allowed 60 days for
public comment. One public comment
was received; also received were one
request for the data collection plans and
proposed instruments and a request for
information on a related Web site. 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: Quality of
Life Outcomes in Neurological
Disorders; Type of Information
Collection Request: New; Form Number:
NA; Need and Use of Information
Collection: In order to improve outcome
Number of
respondents
Type of respondents
measurement in clinical trials of
neurological conditions, NINDS is
developing a health-related quality of
life (HRQL) measurement system for
major neurological diseases that affect
the United States population. This
measurement system must be consistent
enough across the selected conditions to
allow for cross-disease comparison, and
yet flexible enough to capture
condition-specific HRQL issues. The
primary end users of this measurement
system will be clinical trialists and
other clinical neurology researchers;
however the measurement system will
also be appropriate for clinical practice.
The proposed information collection
will support psychometric testing of
HRQL item banks and testing of Spanish
translation of the final questionnaires.
Frequency of Response: Once; Affected
Public: Individuals; Type of
Respondent: Adults and children. The
annual reporting burden is shown in the
following table. There are no Capital
Costs, Operating Costs or Maintenance
Costs to report.
Frequency of
response
Average time
per response
Annual hour
burden
6,000
3,000
1
1
0.5
0.5
3,000
1,500
Totals ........................................................................................................
jlentini on PROD1PC65 with NOTICES
Adults ...............................................................................................................
Children ............................................................................................................
9,000
........................
........................
4,500
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies should
address one or more of the following
points: (1) Evaluate 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) Evaluate 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) Enhance 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.
Direct Comments to OMB: 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, New Executive
VerDate Aug<31>2005
17:55 Jan 15, 2008
Jkt 214001
Office Building, Room 10235,
Washington, DC 20503, Attention: Desk
Officer for NIH. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact: Dr.
Claudia Moy, Program Director, Clinical
Trials Group, NINDS, NIH,
Neuroscience Center, 6001 Executive
Boulevard, Room 2214, Bethesda, MD
20892, or call non-toll-free number 301–
496–2789 or e-mail your request,
including your address to:
<moyc@ninds.nih.gov>.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30-days of the date of
this publication.
Dated: December 20, 2007.
Joellen Austin Harper,
Executive Officer, NINDS, National Institutes
of Health.
[FR Doc. E8–606 Filed 1–15–08; 8:45 am]
BILLING CODE 4140–01–P
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Child Health and
Human Development; Longitudinal
Investigation of Fertility and the
Environment Study
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 Child Health and
Human Development (NICHD), 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. This is a request
for renewal of an information collection
request that was approved (OMB
Clearance 0925–0543) following
publication in the Federal Register on
January 9, 2004, page 1589 and
December 2, 2004, page 70153.
Proposed Collection: Title:
Longitudinal Investigation of Fertility
and the Environment Study. Type of
E:\FR\FM\16JAN1.SGM
16JAN1
]]>Agencies
[Federal Register Volume 73, Number 11 (Wednesday, January 16, 2008)]
[Notices]
[Page 2925]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-606]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request; Quality of Life
Outcomes in Neurological Disorders
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Institute of Neurological Disorders
and Stroke (NINDS), 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 the Federal
Register on September 24, 2007, page number 54269 and allowed 60 days
for public comment. One public comment was received; also received were
one request for the data collection plans and proposed instruments and
a request for information on a related Web site. 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: Quality of Life Outcomes in
Neurological Disorders; Type of Information Collection Request: New;
Form Number: NA; Need and Use of Information Collection: In order to
improve outcome measurement in clinical trials of neurological
conditions, NINDS is developing a health-related quality of life (HRQL)
measurement system for major neurological diseases that affect the
United States population. This measurement system must be consistent
enough across the selected conditions to allow for cross-disease
comparison, and yet flexible enough to capture condition-specific HRQL
issues. The primary end users of this measurement system will be
clinical trialists and other clinical neurology researchers; however
the measurement system will also be appropriate for clinical practice.
The proposed information collection will support psychometric testing
of HRQL item banks and testing of Spanish translation of the final
questionnaires. Frequency of Response: Once; Affected Public:
Individuals; Type of Respondent: Adults and children. The annual
reporting burden is shown in the following table. There are no Capital
Costs, Operating Costs or Maintenance Costs to report.
----------------------------------------------------------------------------------------------------------------
Number of Frequency of Average time Annual hour
Type of respondents respondents response per response burden
----------------------------------------------------------------------------------------------------------------
Adults.......................................... 6,000 1 0.5 3,000
Children........................................ 3,000 1 0.5 1,500
---------------------------------------------------------------
Totals...................................... 9,000 .............. .............. 4,500
----------------------------------------------------------------------------------------------------------------
Request for Comments: Written comments and/or suggestions from the
public and affected agencies should address one or more of the
following points: (1) Evaluate 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) Evaluate 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) Enhance 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.
Direct Comments to OMB: 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, New Executive Office Building, Room 10235, Washington, DC
20503, Attention: Desk Officer for NIH. To request more information on
the proposed project or to obtain a copy of the data collection plans
and instruments, contact: Dr. Claudia Moy, Program Director, Clinical
Trials Group, NINDS, NIH, Neuroscience Center, 6001 Executive
Boulevard, Room 2214, Bethesda, MD 20892, or call non-toll-free number
301-496-2789 or e-mail your request, including your address to:
<moyc@ninds.nih.gov>.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30-days
of the date of this publication.
Dated: December 20, 2007.
Joellen Austin Harper,
Executive Officer, NINDS, National Institutes of Health.
[FR Doc. E8-606 Filed 1-15-08; 8:45 am]
BILLING CODE 4140-01-P
