[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]
-----------------------------------------------------------------------
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]]
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
Avg. burden
Respondents Number of Responses/ per respondent
respondents respondents (in hrs.)
----------------------------------------------------------------------------------------------------------------
Recruiting Project Participants................................. 430 1 .26666
Telephone Interview............................................. 400 1 .08333
----------------------------------------------------------------------------------------------------------------
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