[Federal Register Volume 67, Number 237 (Tuesday, December 10, 2002)]
[Notices]
[Pages 75860-75861]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-31133]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30DAY-08-03]


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) 498-1210. 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 Microcystin from 
Public Water Systems (OMB. No. 0920-0527)--Revision--National Center 
for Environmental Health (NCEH), Centers for Disease Control and 
Prevention (CDC).

Background

    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, however, 
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 cyanobaterial 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 total annual burden hours is estimated to be 
350.

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                                                                                     Number of     Avg. burden/
                           Respondents                               Number of      responses/     response (in
                                                                    respondents     respondent         hrs.)
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Telephone contact...............................................             300               1           10/60
Survey..........................................................             200               1               1

[[Page 75861]]

 
Tap water sample collection.....................................             200               1           30/60
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    Dated: December 4, 2002.
John Moore,
Acting Deputy Director for Policy, Planning and Evaluation, Centers for 
Disease Control and Prevention.
[FR Doc. 02-31133 Filed 12-9-02; 8:45 am]
BILLING CODE 4163-18-P