[Federal Register: December 1, 2004 (Volume 69, Number 230)]
[Notices]
[Page 69941-69942]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01de04-77]
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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 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) `` 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
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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]
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