[Federal Register Volume 71, Number 243 (Tuesday, December 19, 2006)]
[Notices]
[Pages 75966-75967]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-21584]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-07-0527]


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 404-639-4766 or 
send comments to Seleda Perryman, CDC Assistant Reports Clearance 
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail 
to [email protected].
    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. 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 and Brief Description

    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

[[Page 75967]]

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.
    CDC plans 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 is not 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 and (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.
    CDC is working with a group of utility companies that are 
interested in the project and plan to discuss implementation logistics 
early in 2007. There are no costs to respondents except their time to 
participate in the survey.

                                        Estimated Annualized Burden Hours
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                                                                      No. of      Average burden
                   Respondents                        No. 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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    Dated: December 13, 2006.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
[FR Doc. E6-21584 Filed 12-18-06; 8:45 am]
BILLING CODE 4163-18-P