Proposed Data Collections Submitted for Public Comment and Recommendations

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.

----------------------------------------------------------------------------------------------------------------

No. of Avg. burden/

Forms No. of responses/ response (in Total Burden

respondents respondents hrs.) (in hrs.)

----------------------------------------------------------------------------------------------------------------

NBDPS case/control interview.................... 400 1 1 400

Biologic specimen collection.................... 1,200 2 .1666 400

---------------------------------------------------------------

Total....................................... .............. .............. .............. 800

----------------------------------------------------------------------------------------------------------------

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.

----------------------------------------------------------------------------------------------------------------

Avg. burden

Respondents No. of Responses/ per respondent Total burden

respondents respondents (in hrs.) (in hrs.)

----------------------------------------------------------------------------------------------------------------

Recruiting Project Participants................. 430 1 .26666 115

Telephone Interview............................. 400 1 .08333 33

---------------------------------------------------------------

Total....................................... .............. .............. .............. 148

----------------------------------------------------------------------------------------------------------------

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