[Federal Register Volume 67, Number 200 (Wednesday, October 16, 2002)]
[Notices]
[Page 63934]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-26212]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; Comment Request; Electroencephalogram and 
Event-Related Potential Intermediate Phenotypes for Alcoholism in a Low 
Prevalence American Indian Tribe

SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of 
the Paperwork Reduction Act of 1995, regarding the opportunity for 
public comment on proposed data collection projects, the National 
Institute on Alcohol Abuse and Alcoholism (NIAAA), the National 
Institutes of Health (NIH) will publish periodic summaries of proposed 
projects submitted to the Office of Management and Budget (OMB) for 
review and approval.
    Proposed Collection Title: Electroencephalogram (EEG) and Event-
Related Potential (ERP) intermediate phenotypes for alcoholism in a low 
prevalence American Indian tribe. Type of Information Collection 
Request: New. Need and Use of Information Collection: An extensive data 
set has already been collected by the Laboratory of Neurogenetics, 
NIAAA, on 294 members of a Southeastern American Indian tribe. We 
propose to re-contact these individuals to collect additional 
information. Approximately 100 of the original participants were 
originally selected as a representative sample of the population. The 
remaining 194 individuals are family members of alcoholic probands from 
the population sample. We propose to expand the study to collect (a) 
measures of intermediate phenotypes for alcoholism and (b) survey-based 
selected personality characteristics from the same tribal members. 
Intermediate phenotypes are biological traits that may be influenced by 
variation at fewer genes and may mediate different aspects of the 
disease. The intermediate phenotype measurements that we will collect 
include resting EEG phenotypes (low voltage alpha (LVA) and beta 
spectral power), ERPs and heart rate variability (HRV). LVA has been 
found to be more abundant in alcoholics with co-morbid anxiety 
disorders. Increased beta power has been associated with increased risk 
of relapse. P300 ERP amplitude is reduced in alcoholics and their 
alcohol-na[iuml]ve children. HRV is a potential intermediate phenotype 
for alcoholism and major depression. We also propose to administer the 
Temperament and Character Inventory, a standard, survey-based measure 
of harm avoidance, novelty seeking, reward dependence, and persistence. 
The use of such intermediate phenotypes and personality measures is 
likely to increase our ability to find vulnerability genes for 
alcoholism. We will use these EEG and EKG intermediate phenotypes and 
personality dimensions in (1) candidate gene analyses and (2) linkage 
analyses, utilizing the existing DNA, in order to determine the genes 
that increase an individual's risk for alcoholism and anxiety 
disorders.
    The re-recruitment of the original study participants will start in 
spring 2003. The study is expected to run for 6 months. Frequency of 
response: Once per respondent. Affected Public: Individuals. Type of 
Respondents: Adult members of the Southeastern American Indian tribe 
who were participants in the original study.
    The reporting burden is as follows: Estimated Number of 
Respondents: It is estimated, after a survey by tribal members, that we 
will be able to re-recruit approximately 280 of the 294 original 
participants. Estimated Number of Responses per Respondent'' One 
response per respondent. Average Burden Hours per Response: Three hours 
per individual, for a total respondent burden of 840 hours. Estimated 
Total Annual Burden Hours Requested: 840 hours. There are no Costs to 
Respondents to report. There are no Capital Costs to report. There are 
no Operating or Maintenance costs to report.
    Request for Comments: Written comments and suggestions from the 
public and affected agencies are invited on the following points: (1) 
Whether the data collection 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; (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 contact: To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
instruments, contact Mary-Anne Enoch M.D., NIH/NIAAA/DICBR/LNG, 12420 
Parklawn Drive, Park 5 Building, Room 451, MSC 8110, Bethesda, MD 
20892-8110, or e-mail your request to: [email protected]. Dr. Enoch 
can be contacted by telephone at 301-496-2727.
    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: October 7, 2002.
Stephen Long,
Executive Officer, NIAAA.
[FR Doc. 02-26212 Filed 10-15-02; 8:45 am]
BILLING CODE 4140-01-M