[Federal Register Volume 72, Number 28 (Monday, February 12, 2007)]
[Notices]
[Pages 6570-6571]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-2309]


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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 404-639-5960 or 
send comments to Joan F. Karr, CDC Reports Clearance Officer, 1600 
Clifton Road, MS-D74, Atlanta, GA 30333 or send an email 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 Toxins in Water (OMB No. 0920-
0527)--Reinstatement--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 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.
    During August 2006, we conducted our first study to assess exposure 
to microcystins in recreational waters with a bloom of Microcystis 
aeruginosa. We recruited 104 people who gave informed consent to 
participate. Ninety seven people did their recreational activities on 
Lake 1, which had a confirmed M. aeruginosa bloom, and 7 others did 
their activities on Lake 2, which had no bloom. Study participants 
completed a pre-activity questionnaire, a post-activity questionnaire, 
provided a 10-ml blood sample, and completed a telephone symptom survey 
7-10 days after exposure. The concentrations of microcystins in Lake 1 
ranged from 2 to 5 ug/L and in Lake 2 were all below the limit of 
detection (LOD). When we designed the study, we calculated that a 
person exposed to recreationally-generated aerosols from water 
containing 10 ug/L of microcystins should have levels of microcystins 
in

[[Page 6571]]

their blood. However, the microcystin concentrations in Lake 2 were 
below the LOD and in Lake 1 were actually 2ug/L to 5ug/L, much lower 
than we anticipated based on data from the previous week. Thus, the 
recreational exposures were not likely high enough for us to quantify 
microcystins in blood and the serum samples were all below the LOD for 
microcystins.
    For the new data collection, we will recruit 100 study participants 
who are at risk for swallowing water or inhaling spray (i.e., water 
skiers, jet skiers, people sailing small boats) and who would normally 
be doing these activities, even in the presence of a bloom. We may 
recruit people who train for organized swimming events (e.g., 
triathlons) in lakes. In addition, we will recruit 50 study 
participants from lakes with no blooms as a comparison group to assess 
the health effects associated with recreational activities on ``clean'' 
lakes. Study participants will be asked to sign a consent form, 
complete a symptom survey before and after doing their recreational 
water activities, provide one 10-ml whole blood sample after their 
recreational activities, and complete a telephone symptom survey 8-10 
days after doing study activities.
    The purpose of the new data collection is to continue assessing the 
public health impact of exposure to the cyanobacterial toxins, 
microcystins, during recreational activities. We will examine the 
extent of human exposure to microcystins present in recreational waters 
and associated aerosols and whether serum levels of microcystins can be 
used as a biomarker of exposure.
    There is no cost to the respondents other than their time.

                                       Estimate of Annualized Burden Hours
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                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
                      Forms                         respondents   responses  per   response (in        hours
                                                                    respondent        hours)
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Screening Questionnaire.........................             188               1           10/60              31
Pre-exposure Questionnaire......................             150               1           10/60              25
Post-exposure Questionnaire.....................             150               1           10/60              25
10-day post exposure Questionnaire..............             150               1           10/60              25
    Total.......................................  ..............  ..............  ..............             106
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    Dated: February 6, 2007.
Joan F. Karr,
Acting Reports Clearance Officer. Centers for Disease Control and 
Prevention.
 [FR Doc. E7-2309 Filed 2-9-07; 8:45 am]
BILLING CODE 4163-18-P