[Federal Register Volume 78, Number 158 (Thursday, August 15, 2013)]
[Notices]
[Pages 49758-49759]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-19839]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60-Day-13-0010]
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 or
send comments to Leroy Richardson, at 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
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
[[Page 49759]]
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, 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 5 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.
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
Type of respondents Form name Number of responses per per response Total burden
respondents respondent (in hours) hours
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Mothers (interview)........... Telephone 1,925 1 45/60 1,444
consent and BD-
STEPS
questionnaire.
Mothers, fathers, infants Written consent 5,775 1 15/60 1,444
(saliva samples). for saliva
collection and
collection of
saliva samples.
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TOTAL..................... ................ .............. .............. .............. 2,888
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Leroy A. 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. 2013-19839 Filed 8-14-13; 8:45 am]
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