[Federal Register: April 11, 2008 (Volume 73, Number 71)]
[Notices]
[Page 19853-19854]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11ap08-61]
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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 omb@cdc.gov.
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
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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
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Biologic Specimen Collection.................... 1,200 1 10/60 200
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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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