Agency Forms Undergoing Paperwork Reduction Act Review

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.)

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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