[Federal Register Volume 76, Number 67 (Thursday, April 7, 2011)]
[Notices]
[Pages 19362-19363]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-8271]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-11-11EC]


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 
and send comments to Daniel Holcomb, CDC Acting Reports Clearance 
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail 
to <a href="/cdn-cgi/l/email-protection#fc93919ebc9f989fd29b938a"><span class="__cf_email__" data-cfemail="d6b9bbb496b5b2b5f8b1b9a0">[email protected]</span></a>.
    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

    Epidemiologic Study of Health Effects Associated With Low Pressure 
Events in Drinking Water Distribution Systems --New--National Center 
for Emerging and Zoonotic Infectious Diseases--Office of Infectious 
Diseases--CDC.

Background and Brief Description

    In the United States, drinking water distribution systems are 
designed to deliver safe, pressurized drinking water to our homes, 
hospitals, schools and businesses. However, the water distribution 
infrastructure is 50-100 years old in much of the U.S. and an estimated 
240,000 water main breaks occur each year. Failures in the distribution 
system such as water main breaks, cross-connections, back-flow, and 
pressure fluctuations can result in potential intrusion of microbes and 
other contaminants that can cause health effects, including acute 
gastrointestinal and respiratory illness.
    Approximately 200 million cases of acute gastrointestinal illness 
occur in the U.S. each year, but we don't have reliable data to assess 
how many of these cases are associated with drinking water. Further, 
data are even more limited on the human health risks associated with 
exposure to drinking water during and after the occurrence of low 
pressure events (such as water main breaks) in drinking water 
distribution systems. A study conducted in Norway from 2003-2004 found 
that people exposed to low pressure events in the water distribution 
system had a higher risk for gastrointestinal illness. A similar study 
is needed in the United States.
    The purpose of this data collection is to conduct an epidemiologic 
study in the U.S. to assess whether individuals exposed to low pressure 
events in the water distribution system are at an increased risk for 
acute gastrointestinal or respiratory illness. This study would be, to 
our knowledge, the first U.S. study to systematically examine the 
association between low pressure events and acute gastrointestinal and 
respiratory illnesses. Study findings will inform the Environmental 
Protection Agency (EPA), CDC, and other drinking water stakeholders of 
the potential health risks associated with low pressure events in 
drinking water distribution systems and whether additional measures 
(e.g., new standards, additional research, or policy development) are 
needed to reduce the risk for health effects associated with low 
pressure events in the drinking water distribution system.
    We will conduct a cohort study among households that receive water 
from five water utilities across the U.S. The water systems will be 
geographically diverse and will include both chlorinated and 
chloraminated systems. These water utilities will provide information 
about low pressure events that occur during the study period. 
Households in areas exposed to the low pressure event and an equal 
number of households in an unexposed area will be randomly selected and 
sent a survey questionnaire. After consenting to participate, 
households will be asked about symptoms and duration of any recent 
gastrointestinal or respiratory illness, tap water consumption, and 
other factors including international travel, daycare attendance or 
employment, and exposure to under-cooked or unpasteurized food, pets 
and other animal contact, and recreational water. Study participants 
will be able to choose their method of survey response from a variety 
of options including a paper survey, telephone-administered survey, or 
Web-based survey. A Spanish language version of the survey for all 
response options will also be available. Participation in this study 
will be voluntary. No financial compensation will be provided to study 
participants. The study duration is anticipated to last 12 months. An 
estimated 5,200 individuals will be contacted and we anticipate 2,080 
adults (18 years of age or older) will consent to participate in this 
study. We will conduct a pilot study (duration 3 months) prior to 
launching the full epidemiologic study. An estimated 1,000 individuals 
will be contacted and we anticipate 400 adults (18 years of age or 
older) will consent to participate in the pilot study. The total 
estimated annualized hours associated with this study, including the 
pilot, is expected to be 601.

[[Page 19363]]



                                       Estimate of Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondents           Form name       respondents    responses per     response         (hours)
                                                                    respondent        (hours)
----------------------------------------------------------------------------------------------------------------
Full Study:
    Households................  Introductory               5,200               1            1/60              87
                                 letter and
                                 consent form.
    Households................  Web-based                  1,248               1           12/60             250
                                 questionnaire.
    Households................  Paper-based                  624               1           12/60             125
                                 questionnaire.
    Households................  Telephone-based              208               1           12/60              42
                                 questionnaire.
                                                 ---------------------------------------------------------------
        Total (full study):...  ................  ..............  ..............  ..............             504
----------------------------------------------------------------------------------------------------------------
Pilot Study:
    Households................  Introductory                1000               1            1/60              17
                                 letter and
                                 consent form.
    Households................  Web-based                    240               1           12/60              48
                                 questionnaire.
    Households................  Paper-based                  120               1           12/60              24
                                 questionnaire.
    Households................  Telephone-based               40               1           12/60               8
                                 questionnaire.
                                                 ---------------------------------------------------------------
        Total (pilot study)...  ................  ..............  ..............  ..............              97
                                                 ---------------------------------------------------------------
        Total (Full & Pilot)..  ................  ..............  ..............  ..............             601
----------------------------------------------------------------------------------------------------------------


Daniel Holcomb,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. 2011-8271 Filed 4-6-11; 8:45 am]
BILLING CODE 4163-18-P


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