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