[Federal Register Volume 69, Number 230 (Wednesday, December 1, 2004)]
[Notices]
[Pages 69941-69942]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-26486]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-05-0527]


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 404-498-1210 or 
send comments to Seleda Perryman, CDC Assistant Reports Clearance 
Officer, 1600 Clifton Road, MS-E11, 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) `` Revision--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.
    CDC originally planned to conduct a study of human exposure to 
microcystins in drinking water from a source with a cyanobacterial 
bloom. However, regional weather patterns over the last 2 years (since 
the original OMB application was approved) have not supported blooms in 
the lake that is the source of drinking water for our cooperating 
utility. Therefore, we have decided to redirect our activities to 
assess recreational exposures. Anecdotal evidence suggests that 
exposure to cyanobacterial toxins in recreational waters may be an 
important public health issue.
    CDC, National Center for Environmental Health plans to recruit 
2,000 people (2,500 contacts, 80%

[[Page 69942]]

agreeing to participate) as they arrive to participate in recreational 
activities on fresh water bodies with cyanobacteria blooms. 
Questionnaires will be administered to all study participants while 
they are on the beach and again when they leave the beach for the day. 
CDC plans to contact them by phone 7 days after their beach exposure to 
administer a final questionnaire. Water samples for levels of 
cyanobacterial toxins and water quality indicators, including 
microorganisms will also be examined. Blood samples will be collected 
from a subset of study participants who are exposed to recreational 
waters with blooms of Microcystis aeruginosa. Blood samples will be 
analyzed using a newly developed molecular assay for levels of 
microcystin L-R-one of the hepatotoxins produced by this organism. CDC 
will evaluate the probability of detecting (1) increases in symptoms 
after people engage in recreational activities in water bodies during 
cyanobacteria blooms, and (2) low levels of microcystins (<10 ng/ml of 
blood) in the blood of people who are exposed to very low levels of 
this toxin while engaged in recreational activities. There are no costs 
to respondents except their time to participate in the survey.

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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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Recruiting contact..............................            2500               1           10/60             417
Pre-activity survey.............................            2000               1           10/60             334
Post-activity survey............................            2000               1           10/60             334
Telephone follow-up survey......................            2000               1           10/60             334
                                                 -----------------
    Total.......................................  ..............  ..............  ..............           1,419
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    Dated: November 24, 2004.
B. Kathy Skipper,
Acting Director, Management Analysis and Services Office, Centers for 
Disease Control and Prevention.
[FR Doc. 04-26486 Filed 11-30-04; 8:45 am]
BILLING CODE 4163-18-P