[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
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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
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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]
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