[Federal Register Volume 64, Number 178 (Wednesday, September 15, 1999)]
[Notices]
[Pages 50095-50096]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-24001]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[30 DAY-23-99]


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 
the CDC Reports Clearance Officer at (404) 639-7090. Send written 
comments to CDC, Desk Officer; Human Resources and Housing Branch, New 
Executive Office Building, Room 10235; Washington, DC 20503. Written 
comments should be received within 30 days of this notice.

Proposed Project

    1. National Birth Defects Prevention Study (Formerly called Metro 
Atlanta Birth Defects and Risk Factor Surveillance System)--(0920-
0010)--Revision--National Center for Environmental Health (NCEH). The 
Division of Birth Defects and Pediatric Genetics (DBDPG), NCEH has been 
monitoring the occurrence of serious birth defects and genetic diseases 
in Atlanta since 1967 through the Metropolitan Atlanta Congenital 
Defects Program (MACDP). The MACDP is a population-based surveillance 
system for birth defects in the 5 counties of Metropolitan Atlanta. Its 
primary purpose is to describe the spatial and temporal patterns of 
birth defects occurrence and serve as an early warning system for new 
teratogens. Since 1993, the DBDPG has also been conducting the Birth 
Defects Risk Factor Surveillance (BDRFS) now called the National Birth 
Defects Prevention Study (and formerly called the Metro Atlanta Birth 
Defect and Risk Factor Surveillance System), a case-control study of 
risk factors for selected birth defects. Infants with birth defects are 
identified through the MACDP and maternal interviews. Clinical/
laboratory tests are conducted on approximately 300 cases and 100 
controls per year. Controls are selected from among normal births in 
the same population. OMB approval (OMB 0920-0010) for MACDP and BDRFS 
which is now called the National Birth Defects Prevention Study (and 
formerly called the Metro Atlanta Birth Defects and Risk Factor 
Surveillance System) was renewed in 1996 and will expire 30 September 
1999.
    This request is for a 3-year renewal with two changes listed below 
including a change in the study name:
    A. In 1996, MACDP was still obtaining assistance from more than 10 
Atlanta hospitals to conduct birth defects surveillance. Therefore, 
MACDP renewed its OMB approval at that time. In 1997, however, the 
State of Georgia exercised its option to require the reporting of birth 
defects under the state's disease reporting regulations, which list 
birth defects as a condition whose reporting is required by law. The 
Georgia Division of Health authorized the CDC to serve as its agent in 
the collection of these case reports. MACDP findings are shared with 
the state. Since birth defects surveillance in Atlanta is now a state 
requirement, the CDC is no longer requesting OMB clearance for this 
activity. Therefore, the Division of Birth Defects and Pediatric 
Genetics is not seeking renewal of its OMB clearance for the 
surveillance activities involved in MACDP.
    B. The BDRFS is now called the National Birth Defects Prevention 
Study (and formerly called the Metro Atlanta Birth Defects and Risk 
Factor Surveillance Program). The major components of this study have 
not changed. Infants with birth defects are identified through MACDP. 
Control infants are selected from birth hospitals in the same 
population. Mothers of case and control infants are interviewed by 
phone about their medical history, pregnancies, environmental exposures 
and lifestyle. The interview still takes about 1 hour, but it is now a 
computer-based interview and answers are entered directly into the 
database instead of recorded on paper. Another change from the BDRFS is 
that we are no longer asking participants to come to a clinic for blood 
drawing. Instead of using blood to study genetic risk factors for birth 
defects, we will be studying DNA from cheek cells. After completing the 
interview, participants are sent a packet in the mail and are asked to 
collect cheek cells using small brushes from the mother, father, and 
infant. The brushes containing cheek cells are then sent back to the 
lab by mail. The cheek cell kits will include $20.00 as an incentive to 
complete them and send them back. The total annual burden hours are 
600.

[[Page 50096]]



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                                                                                      No. of       Avg. burden/
                              Forms                                  Number of      responses/     response  (in
                                                                    respondents     respondents        hrs.)
----------------------------------------------------------------------------------------------------------------
NBDPS case/control interview....................................             400               1          1
Biologic specimen collection....................................           1,200               2           .1666
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    2. Case-Control Study of Lifetime Exposure to Drinking Water 
Disinfection By-products (DBPs) and Bladder Cancer in Pet Dogs--New--
National Center for Environmental Health (NCEH). Current drinking water 
treatment practices in the U.S. typically include disinfection to 
control the pathogenic organisms responsible for waterborne diseases. 
Chlorine is the most commonly used chemical for drinking water 
disinfection; however, chlorine reacts with other drinking water 
contaminants to generate compounds that may cause cancer (e.g., bladder 
cancer) in people. The long latency period for the development of 
bladder cancer and the difficulty in reconstructing water consumption 
and exposure history make it difficult to verify the association 
between DBPs exposure and bladder cancer occurrence that has been 
reported in human epidemiologic studies. It would be useful to have an 
alternative method to examine this association. We propose to conduct a 
case-control study of pet dogs to test the hypothesis that consumption 
of water containing chlorination DBPs increases the dogs' risk for 
canine bladder cancer in a dose-dependent manner. Specifically, we are 
interested in examining the type of water disinfection treatment 
(chlorination, chloramination, or no disinfection) of the tap water 
consumed by dogs with and without bladder cancer. The total annual 
burden hours are 309.

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                                                                                                    Avg. burden
                           Respondents                               Number of      Responses/    per respondent
                                                                    respondents     respondents      (in hrs.)
----------------------------------------------------------------------------------------------------------------
Recruiting Project Participants.................................             430               1          .26666
Telephone Interview.............................................             400               1          .08333
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    Dated: September 9, 1999.
Nancy Cheal,
Acting Associate Director for Policy, Planning, and Evaluation, Centers 
for Disease Control and Prevention (CDC).
[FR Doc. 99-24001 Filed 9-14-99; 8:45 am]
BILLING CODE 4163-18-P