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Notice

Submission for OMB Review; Comment Request; Quality of Life Outcomes in Neurological Disorders

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Information about this document as published in the Federal Register.

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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.

Type of respondentsNumber of respondentsFrequency of responseAverage time per responseAnnual hour burden
Adults6,00010.53,000
Children3,00010.51,500
Totals9,0004,500

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.

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Dated: December 20, 2007.

Joellen Austin Harper,

Executive Officer, NINDS, National Institutes of Health.

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[FR Doc. E8-606 Filed 1-15-08; 8:45 am]

BILLING CODE 4140-01-P