[Federal Register: December 19, 2006 (Volume 71, Number 243)]
[Notices]
[Page 75966-75967]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19de06-66]
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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 omb@cdc.gov.
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]
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