E7-18772. 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 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.

Type of respondents	Number of respondents	Frequency of response	Average time per response	Annual hour burden
Adults	6000	1	0.5	3,000
Children	3000	1	0.5	1,500
Totals	9000			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 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: [e-mail].

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.