[Federal Register Volume 77, Number 81 (Thursday, April 26, 2012)]
[Notices]
[Pages 24960-24961]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-10035]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-12-0010]


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 
(404) 639-7570 or send an email to [email protected]. Send written comments 
to CDC Desk Officer, Office of Management and Budget, Washington, DC or 
by fax to (202) 395-5806. Written comments should be received within 30 
days of this notice.

Proposed Project

    The National Birth Defects Prevention Study (NBDPS)-(0920-0010, 
Expiration 06/30/2012)--Extension--National Center on Birth Defects and 
Developmental Disabilities (NCBDDD), Centers for Disease Control and 
Prevention (CDC).

Background and Brief Description

    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. 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, 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 takes 
approximately one hour. A maximum of thirty-six hundred interviews are 
planned, 2,700 cases and 900 controls, resulting in a maximum interview 
burden of approximately 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 for all Centers.
    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.
    This request is submitted to obtain OMB clearance for three 
additional years.
    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    Average burden
        Type of respondents                   Form name              Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
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Mothers............................  NBDPS mother questionnaire.           3,600               1               1
Mothers, fathers, infants..........  Cheek Cell Specimen                  10,800               1           10/60
                                      Collection.
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[[Page 24961]]

Kimberly S. Lane,
Deputy Director, Office of Science Integrity, Office of the Associate 
Director for Science, Office of the Director, Centers for Disease 
Control and Prevention.
[FR Doc. 2012-10035 Filed 4-25-12; 8:45 am]
BILLING CODE 4163-18-P