[Federal Register Volume 73, Number 71 (Friday, April 11, 2008)]
[Notices]
[Pages 19853-19854]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-7706]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-08-0010]


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 404-639-5960 
and send comments to Maryam I. Daneshvar, CDC Acting Reports Clearance 
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail 
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)--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 is estimated to 
take one hour. A maximum of four hundred interviews are planned, 300 
cases and 100 controls resulting in a maximum interview burden of 400 
hours for each of the 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

[[Page 19854]]

collection of the cheek cells is 200 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.
    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
----------------------------------------------------------------------------------------------------------------
                                                                     Number of      Avg. burden
                   Respondents                       Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)         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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    Dated: April 3, 2008.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
 [FR Doc. E8-7706 Filed 4-10-08; 8:45 am]
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