[Federal Register Volume 77, Number 211 (Wednesday, October 31, 2012)]
[Notices]
[Pages 65894-65895]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-26834]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30 Day-13-11EC]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) publishes a 
list of information collection requests under review by the Office of 
Management and Budget (OMB) in compliance with the Paperwork Reduction 
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call 
(404) 639-7570 or send an email to omb@cdc.gov. Send written comments 
to CDC Desk Officer, Office of Management and Budget, Washington, DC 
20503 or by fax to (202) 395-5806. Written comments should be received 
within 30 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 (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 illness (AGI) and acute respiratory illness (ARI).
    Approximately 200 million cases of AGI 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 
AGI or ARI. This study would be, to our knowledge, the first U.S. study 
to systematically examine the association between low pressure events 
and AGI and ARI. 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 systems that use chlorine and 
monochloramine as secondary disinfectants. These water utilities will 
provide information about low pressure events that occur during the 
study period using a standardized form (approximately 12-13 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 a survey consent document and questionnaire. After consenting 
to participate, the selected households will be asked to respond to 
questions about symptoms of AGI and acute respiratory illness (ARI) 
that occurred during the 3-week period following the low pressure 
event. Respondents will also be asked about relevant exposures during 
the 3-week period, such as their household water use, changes noted in 
their water service, international travel, children or adult household 
member employed at daycare, pets in the household and other animal 
contact, and recreational water exposure. Study participants will be 
able to choose among 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. For 
the multi-site study, utility personnel will provide information on 
each of 65 low pressure events, collect and ship water samples to the 
CDC, and provide line listings of affected and unaffected customers to 
CDC. An estimated 6,750 households will be contacted, and we anticipate 
4,050 surveys will be completed and

[[Page 65895]]

returned, providing data on 8,100 utility customers (18 years of age or 
older). We will conduct a pilot study of 6 low pressure events 
(duration approximately 3 months) prior to launching the multi-site 
study. An estimated 630 households will be contacted and we anticipate 
756 adults (18 years of age or older) will consent to participate in 
the pilot study and provide data on individuals. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 588.

                                       Estimate of Annualized Burden Hours
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                                                                                                      Average
                                                                     Number of       Number of      burden per
                      Form name/respondents                         respondents    responses per   response  (in
                                                                                    respondent        hours)
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                                                Multi-Site Study
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Web-based questionnaire--individual customers...................           1,215               1           12/60
Paper-based questionnaire--individual customers.................             810               1           12/60
Low pressure event form & samples--utility employees............               5               7           45/60
Line listings--utility employees................................               5               7               3
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                                                   Pilot Study
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Web-based questionnaire--individual customers...................             114               1           12/60
Paper-based questionnaire--individual customers.................              76               1           12/60
Low pressure event form & samples--utility employees............               1               3           45/60
Line listings--utility employees................................               1               3               3
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    Dated: October 25, 2012.
Ron A. Otten,
Director, Office of Scientific Integrity (OSI), Office of the Associate 
Director for Science (OADS), Office of the Director, Centers for 
Disease Control and Prevention.
[FR Doc. 2012-26834 Filed 10-30-12; 8:45 am]
BILLING CODE 4163-18-P