[Federal Register Volume 68, Number 13 (Tuesday, January 21, 2003)]
[Notices]
[Pages 2777-2778]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-1180]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-03-36]


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 the CDC Reports 
Clearance Officer on (404) 498-1210.
    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. Send comments to Seleda Perryman , CDC 
Assistant Reports Clearance Officer, 1600 Clifton Road, MS-D24, 
Atlanta, GA 30333. Written comments should be received within 60 days 
of this notice.
    Proposed Project: Epidemiologic Study Of Gastrointestinal Health 
Effects And Exposure To Disinfection By-products Associated With 
Consumption Of Conventionally Treated Groundwater--New--National Center 
for Environmental Health (NCEH), Centers for Disease Control and 
Prevention (CDC).

Background

    The primary goal of drinking water treatment is the removal of 
microorganisms responsible for waterborne disease. The addition of 
disinfectants such as chlorine is one of the most important steps in 
pathogen inactivation and may in some cases (such as in many 
groundwater systems) be the only treatment employed. However, chlorine 
also reacts with organic compounds in the water to produce halogenated 
organic by-products (disinfection by-products [DBPs]). One of the most 
commonly measured groups of DBPs is the trihalomethanes (THMs). Human 
exposure to THMs has been associated with bladder and colorectal 
cancer. Public water providers must constantly balance the acute risks 
of gastrointestinal (GI) illness associated with exposure to microbial 
pathogens against the long-term risks associated with exposure to DBPs.
    This study will estimate the risks for endemic GI illness 
associated with

[[Page 2778]]

drinking conventionally treated groundwater and evaluate exposure to 
THMs in the same people. We plan to recruit 900 households who report 
that they drink unfiltered tap water from a specific public water 
system that treats and distributes water from a groundwater source. 
This utility has agreed to collaborate on the study. The study 
households will be randomized into one of three groups: (1) Households 
drinking highly treated bottled water purchased from a bottled water 
company, (2) households drinking groundwater that has been 
conventionally treated by the collaborating utility and collected and 
bottled at the water treatment plant (bottled plant water), or (3) 
households drinking municipal tap water from the distribution system of 
the collaborating utility (tap water). We will administer a 
questionnaire at the beginning of the study to collect data about water 
use habits and possible exposures to microbial pathogens and THMs. Each 
study household also will be called weekly for 52 weeks for a short 
telephone interview to document whether anyone in the household had any 
gastrointestinal symptoms during the past week. Blood and serum samples 
will be collected from a subset (50%) of adult household members at the 
beginning and end of the study. All household members will be asked to 
provide a saliva specimen each month for the duration of the one-year 
study. Stool specimens will be collected during episodes of GI 
symptoms. Blood samples will be analyzed for THMs, and serum, saliva, 
and stool samples will be stored for later analysis for enteric 
pathogens. Water samples will be collected from each participating 
household at the beginning and a subset (50%) of the households at the 
end of the study and analyzed for THMs. Water samples for microbial 
analysis will be taken routinely from the source, the finished water, 
and designated locations in the distribution system.
    The specific aims of the study are to (1) determine the risk for GI 
illness associated with source water quality and treatment efficacy by 
comparing GI illness rates in people drinking highly treated bottled 
water with GI illness rates in people drinking bottled plant water; (2) 
determine the risk for GI illness associated with the distribution 
system by comparing GI illness rates in people drinking bottled plant 
water with GI illness rates in people drinking tap water; (3) determine 
water concentrations and associated blood concentrations of THMs in the 
study population; and (4) validate and refine existing models of THM 
exposure using the THM data collected at the participating households 
and hydraulic and water quality data collected in the distribution 
system at the time of household recruitment. There is no cost to 
respondents.

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                                                                     Number of    Average burden/
                   Respondents                       Number of      responses/     response  (in   Total burden
                                                    respondents     respondent        hours)        (in hours)
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Telephone contact...............................           2,500               1           10/60             417
Household survey................................             900               1           30/60             450
Blood and serum sample collection...............             900               2           15/60             450
Initial tap water sample collection.............             900               1           10/60             150
Final tap water sample collection...............             450               1           10/60              75
Weekly telephone interview......................             900              52           15/60             780
Saliva specimen collection......................             900              12            5/60             900
Stool specimen collection.......................             900               2            5/60             150
                                                 -----------------
    Total.......................................  ..............  ..............  ..............           3,372
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    Dated: January 10, 2003.
Thomas Bartenfeld,
Acting Associate Director for Policy, Planning and Evaluation, Centers 
for Disease Control and Prevention.
[FR Doc. 03-1180 Filed 1-17-03; 8:45 am]
BILLING CODE 4163-18-P