[Federal Register Volume 77, Number 36 (Thursday, February 23, 2012)]
[Notices]
[Pages 10750-10751]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-4170]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60 Day-12-0010]


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 for opportunity for public comment on 
proposed data collection projects, the Centers for Disease Control and 
Prevention (CDC) will publish periodic summaries of proposed projects. 
To request more information on the proposed projects or to obtain a 
copy of the data collection plans and instruments, call 404-639-7570 
and send comments to Kimberly Lane, CDC Reports Clearance Officer, 1600 
Clifton Road, MS-D74, Atlanta, GA 30333 or send an email to 
[email protected].
    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 or other 
forms of information technology. Written comments should be received 
within 60 days of this notice.

Proposed Project

    The National Birth Defects Prevention Study (NBDPS), (OMB 0920-
0010)--Reinstatement Without Change--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.
    The National Birth Defects Prevention Study (NBDPS) formerly the 
Birth Defects Risk Factor Surveillance Study (BDRFS) began in 1997. 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. NBDPS 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 to complete. A maximum of four hundred interviews are planned per 
year per center, 300 cases and 100 controls resulting in a maximum 
interview burden of 400 hours for each of the centers each year.

[[Page 10751]]

    Parents are also asked to collect cheek cells from themselves and 
their infant for DNA. The collection of cheek cells by the mother, 
father, and infant takes about 10 minutes per person. Each person rubs 
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 200 
hours per center per year.
    Information gathered from both the interviews and the DNA specimens 
have been and will continue to 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.

                                  Estimated Annualized Burden Hours per Center
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                                                                     Number of
                   Respondents                       Number of     responses per  Average burden   Total burden
                                                    respondents     respondent     per response        hours
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NBDPS case/control interview....................             400               1               1             400
Biologic Specimen Collection....................           1,200               1           10/60             200
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............             600
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Kimberly S. Lane,
Acting Reports Clearance Officer.
[FR Doc. 2012-4170 Filed 2-22-12; 8:45 am]
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