[Federal Register Volume 73, Number 11 (Wednesday, January 16, 2008)]
[Notices]
[Page 2925]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-606]


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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
                                                 ---------------------------------------------------------------
    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: 
<[email protected]>.
    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