[Federal Register Volume 77, Number 57 (Friday, March 23, 2012)]
[Notices]
[Pages 17066-17068]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-7020]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60-Day-12-11EC]


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 404-639-7570 or 
send comments to Ron Otten, at 1600 Clifton

[[Page 17067]]

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

    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--Centers for Disease Control and Prevention

Background and Brief Description

    In the United States (U.S.), 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 lack 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 using a 
standardized form (approximately 12 events per utility). Utilities will 
provide address listings of households in areas exposed to the low 
pressure event and comparable households in an unexposed area to CDC 
staff, who will randomly select participants and send them an 
introductory letter and questionnaire. Consenting household respondents 
will be asked about symptoms and duration of any recent 
gastrointestinal or respiratory illness, tap water consumption, and 
other exposures including international travel, daycare attendance or 
employment, consumption of under-cooked or unpasteurized food, animal 
contacts, and recreational water exposures. Study participants may 
choose between two methods of survey response: A mail-in paper survey 
and a web-based survey. Participation in this study will be voluntary. 
No financial compensation will be provided to study participants. The 
study duration is anticipated to last 24 months. An estimated 5,200 
individuals will be contacted and we anticipate 2,080 utility customers 
(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 467.
    There are no costs to respondents other than their time.

                                       Estimate of Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondents           Form name       respondents    responses per    respondent      (in hours)
                                                                    respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Full Study:
    Households................  Introductory               2,600               1            1/60              44
                                 letter.
                                Web-based                    624               1           12/60             125
                                 questionnaire.
                                Paper-based                  416               1           12/60              84
                                 questionnaire.
    Utility employees.........  Household                      5               6           15/60               6
                                 Listing.
                                Water sample                   5               6               1              30
                                 collection.
                                Low pressure                   5               6               4             120
                                 event form.
    Pilot Study Households....  Introductory                 500               1            1/60               8
                                 letter.
                                Web-based                    120               1           12/60              24
                                 questionnaire.
                                Paper-based                   80               1           12/60              16
                                 questionnaire.
    Utility employees.........  Household                      1               2           15/60               1
                                 Listing.
                                Water sample                   1               2               1               2
                                 collection.
                                Low pressure                   1               2               4               8
                                 event form.
                               ---------------------------------------------------------------------------------
        Total (Full & Pilot)..  ................  ..............  ..............  ..............             467
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[[Page 17068]]

    Dated: March 19, 2012.
Ron A. Otten,
Director, Office of Scientific Integrity, Office of the Associate 
Director for Science (OADS), Office of the Director, Centers for 
Disease Control and Prevention.
[FR Doc. 2012-7020 Filed 3-22-12; 8:45 am]
BILLING CODE 4163-18-P