[Federal Register Volume 64, Number 84 (Monday, May 3, 1999)]
[Notices]
[Pages 23650-23651]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-10971]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[INFO-99-15]


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, the Centers for Disease Control and 
Prevention is providing opportunity for public comment on proposed data 
collection 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) 639-7090.
    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 for 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

    1. National Birth Defects Prevention Study--(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) study, a case-control study of risk factors 
for selected birth defects.
    Infants with birth defects are identified through 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 was renewed in 1996 and will expire 
30 September 1999.
    This request is for a 3-year renewal with several changes listed 
below including a change in the study name:

[[Page 23651]]

    1. 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.
    2. The BDRFS is now called the National Birth Defects Prevention 
Study. 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 cost to the respondents is $0.00.

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                                                                      No. of       Avg. burden/
                      Forms                           No. of        responses/     response  (in   Total  Burden
                                                    respondents     respondents        hrs.)         (in hrs.)
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NBDPS case/control interview....................             400               1          1                  400
Biologic specimen collection....................           1,200               2           .1666             400
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............             800
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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 cost to 
respondents is $0.00.

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                                                                                    Avg. burden
                   Respondents                        No. of        Responses/    per respondent   Total burden
                                                    respondents     respondents      (in hrs.)       (in hrs.)
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Recruiting Project Participants.................             430               1          .26666             115
Telephone Interview.............................             400               1          .08333              33
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............             148
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Nancy Cheal,
Acting Associate Director for Policy, Planning, and Evaluation, Centers 
for Disease Control and Prevention (CDC).
[FR Doc. 99-10971 Filed 4-30-99; 8:45 am]
BILLING CODE 4163-18-P