[Federal Register Volume 67, Number 187 (Thursday, September 26, 2002)]
[Notices]
[Pages 60687-60688]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-24403]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-02-82]


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) 498-1210.
    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 (OMB. No. 0920-0527)--Extension--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. There is no cost to respondents.

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                                                                                          Average
                                                               Number of    Number of     burden/       Total
                         Respondents                          respondents   responses/    response   burden  (in
                                                                            respondent   (in hours)     hours)
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Telephone Contact...........................................          300            1        10/60           50
Survey......................................................          200            1            1          200
Tap water sample collection.................................          200            1        30/60          100
                                                             --------------
    Total...................................................  ...........  ...........  ...........          350
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[[Page 60688]]

    Dated: September 19, 2002.
Nancy E. Cheal,
Acting Associate Director for Policy, Planning and Evaluation, Centers 
for Disease Control and Prevention.
[FR Doc. 02-24403 Filed 9-25-02; 8:45 am]
BILLING CODE 4163-18-P