[Federal Register Volume 66, Number 194 (Friday, October 5, 2001)]
[Notices]
[Page 51049]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-25074]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30DAY-50-01]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) publishes a 
list of information collection requests under review by the Office of 
Management and Budget (OMB) in compliance with the Paperwork Reduction 
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call 
the CDC Reports Clearance Officer at (404) 639-7090. Send written 
comments to CDC, Desk Officer, Human Resources and Housing Branch, New 
Executive Office Building, Room 10235, Washington, DC 20503. Written 
comments should be received within 30 days of this notice.
    Proposed Project: Human Exposure to Cyanobacterial (blue-green 
algal) Toxins in Drinking Water: Risk of Exposure to Microcystins from 
Public Water Systems--New--National Center for Environmental Health 
(NCEH), Centers for Disease Control and Prevention (CDC).
    Cyanobacteria (blue-green algae) can be found in terrestrial, 
fresh, brackish, or marine water environments. Some species of 
cyanobacteria produce toxins that may cause acute or chronic illnesses 
(including neurotoxicity, hepatotoxicity, and skin irritation) in 
humans and animals (including other mammals, fish, and birds). A number 
of human health effects, including gastroenteritis, respiratory 
effects, skin irritations, allergic responses, and liver damage, are 
associated with the ingestion of or contact with water containing 
cyanobacterial blooms. Although the balance of evidence, in conjunction 
with data from laboratory animal research, suggests that cyanobacterial 
toxins are responsible for a range of human health effects, there have 
been few epidemiologic studies of this association. We plan to recruit 
100 people whose tap water comes from a source with a current 
cyanobacteria bloom (i.e., M. aeruginosa) and who report drinking 
unfiltered tap water. We also plan to recruit 100 people who report 
drinking unfiltered tap water but whose tap water source is groundwater 
that has not been contaminated with cyanobacteria. This population will 
serve as our referent population for the analysis of microcystins in 
blood and for the clinical assays. We will administer a questionnaire 
and collect blood samples from all study participants. Blood samples 
will be analyzed using a newly developed molecular assay for levels of 
microcystins--the hepatotoxin produced by Micocystis aeruginosa. We 
also will analyze blood samples for levels of liver enzymes (a 
biological marker of hepatotoxicity) and for a number of clinical 
parameters including hepatitis infection (a potential confounder in our 
study). We will evaluate whether we can (1) detect low levels of 
microcystins (10 ng/ml of blood), in the blood of people who are 
exposed to very low levels of this toxin in their drinking water, (2) 
utilize clinical endpoints such as blood liver enzyme levels as 
biomarkers of exposure and biological effect, and (3) compare the 
analytical results for the exposed population with the results from the 
referent population. The estimated annualized burden is 350 hours.

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                                                                                     Number of    Average burden
                           Respondents                               Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
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Telephone Contact...............................................             300               1           10/60
Survey..........................................................             200               1               1
Tap Water Sample Collection.....................................             200               1           30/60
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    Dated: September 28, 2001.
Nancy E. Cheal,
Acting Associate Director for Policy, Planning and Evaluation, Centers 
for Disease Control and Prevention.
[FR Doc. 01-25074 Filed 10-4-01; 8:45 am]
BILLING CODE 4163-18-P