[Federal Register: January 16, 2008 (Volume 73, Number 11)]
[Notices]
[Page 2925]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16ja08-64]
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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.
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Number of Frequency of Average time Annual hour
Type of respondents respondents response per response burden
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Adults.......................................... 6,000 1 0.5 3,000
Children........................................ 3,000 1 0.5 1,500
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Totals...................................... 9,000 .............. .............. 4,500
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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