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The National Birth Defects Prevention Study (NBDPS)—Revision—National Center on Birth Defects and Developmental Disabilities (NCBDDD), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
Address the following criteria provided in 5 CFR 1320.5(a): CDC 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, which is being requested for OMB clearance for three additional years. Its primary purpose is to describe the spatial and temporal patterns of birth defects occurrence and serves as an early warning system for new Teratogens. In 1997, the Birth Defects Risk Factor Surveillance (BDRFS) study, a case-control study of risk factors for selected birth defects, became the National Birth Defects Prevention Study (NBDPS). The major components of the study did not change.
The NBDPS is a case-control study of major birth defects that includes cases identified from existing birth defect surveillance registries in nine states, Start Printed Page 70355including metropolitan Atlanta. Control infants are randomly selected from birth certificates or birth hospital records. Mothers of case and control infants are interviewed using a computer-assisted telephone interview. The interview is estimated to take one hour. A maximum of thirty-six hundred interviews are planned, 2,700 cases and 900 controls, resulting in a maximum interview burden of 3,600 hours for all Centers.
Parents are also asked to collect cheek cells from themselves and their infants for DNA testing. The collection of cheek cells by the mother, father, and infant is estimated to take about 10 minutes per person. Each person will be asked to rub 1 brush inside the left cheek and 1 brush inside the right cheek for a total of 2 brushes per person. Collection of the cheek cells takes approximately 1-2 minutes, but the estimate of burden is 10 minutes to account for reading and understanding the consent form and specimen collection instructions and mailing back the completed kits. The anticipated maximum burden for collection of the cheek cells is 1,800 hours.
Information gathered from both the interviews and the DNA specimens will be used to study independent genetic and environmental factors as well as gene-environment interactions for a broad range of carefully classified birth defects.
There are no costs to the respondents other than their time. The total estimated annualized burden is 5,400 hours.
|Respondents||Number of respondents||Number of responses per respondent||Avg. burden per response (In hours)|
|NBDPS case/control interview||3,600||1||1|
|Biologic Specimen Collection||10,800||1||10/60|
Dated: November 13, 2008.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. E8-27618 Filed 11-19-08; 8:45 am]
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