[Federal Register Volume 77, Number 211 (Wednesday, October 31, 2012)]
[Notices]
[Pages 65894-65895]
From the Federal Register Online via the Government Publishing 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 [email protected]. 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