E8-2606. National Institutes of Health/National Institute of Environmental Health Sciences; Proposed Collection; Comment Request

The Parkinson's, Genes and Environment (PAGE) Study II

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 Environmental Health Sciences (NIEHS), 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: The Parkinson's, Genes and Environment (PAGE) Study II. Type of Information Collection Request: NEW. Need and Use of Information Collection: We propose a large case-control study to evaluate roles of environmental exposures, genes, and gene-environment interactions in the etiology of late-onset sporadic Parkinson's disease (PD). This project, the Parkinson's, Genes and Environment Study II (PAGE II), will be developed based on the infrastructure that was set up for the ongoing PAGE I project. PAGE I was designed to prospectively evaluate diet and lifestyle exposures in relation to PD risk. In PAGE I, we expect to recruit approximately 1,200 incident PD cases and 2,800 controls from the NIH-AARP Diet and Health (DH) cohort. The dietary and lifestyle data were collected as part of the NIH-AARP DH baseline surveys in the mid-1990s by investigators from the National Institute of Cancer. The cases in PAGE I were PD cases who reported a physician diagnosed PD during the 10 year follow-up of NIH-AARP DH cohort and controls were appropriately selected by frequency matching from participants without PD in the same cohort. As part of PAGE I, we are confirming PD diagnoses for self-identified PD cases by contacting their neurologists and reviewing medical records and are collecting saliva samples for genetic testing from both cases and appropriately selected controls. As the NIH-AARP DH study was designed to examine dietary and lifestyle exposures important in the etiology of cancer, many environmental exposures key to PD research were not collected. Examples include pesticide use, occupational history, history of infections, and use of statins. Therefore the primary aim of the PAGE II project is to retrospectively collect these important environmental exposures from PD cases and appropriately selected controls. Cases and controls identified from PAGE I will be re-contacted and interviewed for data collection in PAGE II. Assuming a 70% response rate from cases and controls, we expect to obtain this information from approximately 850 PD cases and 1960 controls. This data collection, together with the dietary and lifestyle data and genetic samples obtained in PAGE I, will make the PAGE study one of the largest and most comprehensive studies to date to examine environmental and genetic causes of PD. Frequency of Response: One 90 minute long telephone interview. Affected Public: Individuals. Type of Respondents: We will enroll men and women who participated in the PAGE I study. The annual reporting burden is as follows: Estimated Number of Respondents: 2810. Estimated Number of Responses per Respondent: 1 computer assisted telephone interview (CATI). Average Burden Hours per Response: 1.5. Estimated Total Burden Hours Requested: 4215. The annualized cost to respondents is estimated at $30 (assuming $20 hourly wage × 1.50 hours) for the interview. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) 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) 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) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to 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: To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Dr. Honglei Chen, Epidemiology Branch, NIEHS, Building 101, A3-05, P.O. Box 12233, Research Triangle Park, NC 27709 or call non-toll-free number [phone] or E-mail your request, including your address to: chenh2@a_niehs.nih.gov.

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: January 22, 2008.

Marc S. Hollander,

NIEHS, Associate Director for Management.