[Federal Register Volume 66, Number 114 (Wednesday, June 13, 2001)]
[Notices]
[Pages 31925-31926]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-14822]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-01-47]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    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 Centers for Disease Control and 
Prevention (CDC) will publish periodic summaries of proposed projects. 
To request more information on the proposed projects or to obtain a 
copy of the data collection plans and instruments, call the CDC Reports 
Clearance Officer on (404) 639-7090.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (d) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology. Send comments to Seleda Perryman, CDC 
Assistant Reports Clearance Officer, 1600 Clifton Road, MS-D24, 
Atlanta, GA 30333. Written comments should be received within 60 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--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. There are no costs to respondents.

 
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                                                                     Number of    Average burden
                   Respondents                       Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
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Telephone Contact...............................             300               1           10/60              50
Interview.......................................             200               1               1             200
Blood Samples Collection........................             200               1           20/60              67
Tap Water Sample Collection.....................             200               1           30/60             100
                                                                                                 ---------------
    Total.......................................  ..............  ..............  ..............             417
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[[Page 31926]]

    Dated: June 4, 2001.
Nancy Cheal,
Acting Associate Director for Policy, Planning and Evaluation Centers 
for Disease Control and Prevention.
[FR Doc. 01-14822 Filed 6-12-01; 8:45 am]
BILLING CODE 4163-18-P