[Federal Register Volume 78, Number 231 (Monday, December 2, 2013)]
[Notices]
[Pages 72087-72088]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-28756]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30 Day-14-0010]
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
20503 or by fax to (202) 395-5806. Written comments should be received
within 30 days of this notice.
Proposed Project
Birth Defects Study To Evaluate Pregnancy exposureS (BD-STEPS)
(formerly titled The National Birth Defects Prevention Study (NBDPS)),
(OMB 0920-0010, Expiration 04/30/2015)--Revision--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 currently covering three counties
in Metropolitan Atlanta.
Since 1997, CDC has funded case-control studies of major birth
defects that utilize existing birth defect surveillance registries
(including MACDP) to identify cases and study birth defects causes in
participating states/municipalities across the United States.
BD-STEPS is a case-control study that is similar to the previous
CDC-funded birth defects case-control study, NBDPS, which stopped
interviewing participants in 2013. As with NBDPS,
[[Page 72088]]
control infants will be randomly selected from birth certificates or
birth hospital records; mothers of case and control infants will be
interviewed using a computer-assisted telephone interview.
The BD-STEPS interview takes approximately forty-five minutes to
complete. A maximum of 275 interviews are planned per year per center,
200 cases and 75 controls. With seven centers planned, the maximum
interview burden for all centers combined would be approximately 1,444
hours. As with NBDPS, parents in BD-STEPS will be asked to collect
deoxyribonucleic acid (DNA) samples from themselves and their infants.
The collection of saliva cells by the mother, father and infant takes
about 15 minutes per person. For the infant sample, the parent will rub
long-handled sponges between the infant's cheek and gum; parents will
be asked to swab a total of five sponges per infant. The infant's
mother and father will be asked to provide their own saliva samples by
spitting into a funnel connected to small collection tubes. Collection
of the saliva samples takes approximately 2-5 minutes per person, but
the estimate of burden is 15 minutes per person 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 saliva samples for all centers combined would be
approximately 1,444 hours.
Information gathered from both the interviews and the DNA specimens
has 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. The total estimated
annualized burden is 2,888 hours.
This request is submitted to obtain Office of Management and Budget
(OMB) clearance for three additional years.
There are no costs to the respondents other than their time.
Estimates of Annualized Burden Hours
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Number of Avg. burden
Respondents Activity Number of responses per per response
respondents respondent (In hours)
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Mothers (interview)................... Telephone consent and BD- 1,925 1 45/60
STEPS questionnaire.
Mothers, fathers, infants (saliva Written consent for 5,775 1 15/60
samples). saliva collection and
collection of saliva
samples.
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LeRoy Richardson,
Chief, Information Collection Review Office, Office of Scientific
Integrity, Office of the Associate Director for Science, Office of the
Director, Centers for Disease Control and Prevention.
[FR Doc. 2013-28756 Filed 11-29-13; 8:45 am]
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