[Federal Register Volume 73, Number 30 (Wednesday, February 13, 2008)]
[Notices]
[Pages 8326-8327]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-2606]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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

[[Page 8327]]

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 x 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 (919) 541-3782 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.
[FR Doc. E8-2606 Filed 2-12-08; 8:45 am]
BILLING CODE 4140-01-P