[Federal Register Volume 73, Number 225 (Thursday, November 20, 2008)]
[Notices]
[Pages 70354-70355]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-27618]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-08-0010]


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) 639-5960 or send an e-mail 
to [email protected]. Send written comments to CDC Desk Officer, Office of 
Management and Budget, Washington, DC or by fax to (202) 395-6974. 
Written comments should be received within 30 days of this notice.

Proposed Project

    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,

[[Page 70355]]

including 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.

                                        Estimated Annualized Burden Table
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                                                                                     Number of      Avg. burden
                           Respondents                               Number of     responses per   per response
                                                                    respondents     respondent      (In hours)
----------------------------------------------------------------------------------------------------------------
NBDPS case/control interview....................................           3,600               1               1
Biologic Specimen Collection....................................          10,800               1           10/60
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    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]
BILLING CODE 4163-18-P