[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)
----------------------------------------------------------------------------------------------------------------
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]
BILLING CODE 4163-18-P