[Federal Register Volume 68, Number 70 (Friday, April 11, 2003)]
[Notices]
[Pages 17816-17817]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-8862]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; Comment Request: Electroencephalogram 
(EEG) and Event-Related Potential (ERP) Intermediate Phenotypes for 
Alcoholism in a Low Prevalance American Indian Tribe

    Summary: Under the provisions of section 3507(a)(1)(D) of the 
Paperwork Reduction Act of 1995, the National Institute on Alcohol 
Abuse and Alcoholism (NIAAA), 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 October 16, 2002, page 63934 and allowed 60-days for public 
comment. No public comments were received. 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: Electroencephalogram (EEG) and Event-
Related Potential (ERP) intermediate phenotypes for alcoholism in a low 
prevalance 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 the 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

[[Page 17817]]

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 (log voltae 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 individuals'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: Adults members of the Southeastern American Indian tribe 
who were participants in the original study.
    The annual 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/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.
    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: 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 30-days 
of the date of this publication.

    Dated: February 14, 2003.
Stephen Long,
Executive Officer, NIAAA.
[FR Doc. 03-8862 Filed 4-10-03; 8:45 am]
BILLING CODE 4140-01-M