[Federal Register Volume 72, Number 184 (Monday, September 24, 2007)]
[Notices]
[Pages 54269-54270]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-18772]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; Comment Request; Quality of Life Outcomes in 
Neurological Disorders

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

[[Page 54270]]

projects to be submitted to the Office of Management and Budget (OMB) 
for review and approval.
    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..........................................            6000               1             0.5           3,000
Children........................................            3000               1             0.5           1,500
                                                 ---------------------------------------------------------------
    Totals......................................            9000  ..............  ..............           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 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.

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. 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: 
[email protected].
    Comments 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.

    Dated: September 6, 2007.
Joellen Harper Austin,
Executive Officer, NINDS, National Institutes of Health.
 [FR Doc. E7-18772 Filed 9-21-07; 8:45 am]
BILLING CODE 4140-01-P