[Federal Register Volume 71, Number 219 (Tuesday, November 14, 2006)]
[Notices]
[Pages 66331-66332]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-19144]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-07-06AW]


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 
the CDC Reports Clearance Officer at (404) 639-5960 or send an e-mail 
to [email protected]. Send written comments to CDC Desk Officer, Office of 
Management and Budget, Washington, DC or by fax to (202) 395-6974. 
Written comments should be received within 30 days of this notice.

Proposed Project

    Supplement to the National Birth Defects Prevention Study: 
Qualitative Assessment of the Attitudes Mothers Have Toward Collecting 
Biological Specimens on their Infants and Young Children to Study Risk 
Factors for Birth Defects and Preterm Delivery--New--National Center on 
Birth Defects and Developmental Disabilities (NCBDDD), Centers for 
Disease Control and Prevention (CDC).

Background and Brief Description

    The National Center on Birth Defects and Developmental Disabilities 
(NCBDDD), Centers for Disease Control and Prevention (CDC), has been 
conducting the National Birth Defects Prevention Study (OMB number 
0920-0010, Exp. 5/31/2009) since 1997. 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. 
Parents are asked to collect cheek cells from themselves and their 
infants for DNA testing. 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 proposed supplement to the National Birth Defects Prevention 
Study will use qualitative research to provide data on the barriers to 
participation in the collection of biological specimens by mothers on 
themselves, their infants, and young children. It is costly to 
implement the collection of biological specimens into an interview/
questionnaire-based study. However, an ever-increasing number of 
studies include the examination of environmental and genetic 
interactions to help medical and public health professionals' better 
target appropriate interventions. A critical component for studies of 
gene variants is the collection of biological specimens. Participation 
and non-participation in the collection of biological specimens is not 
fully understood. We will conduct multiple well-designed focus groups 
to assess the attitudes of both mothers who participated and mothers 
who did not participate in the collection of biological specimens to 
increase the effectiveness of these studies. This information will be 
useful to many groups at the CDC who are currently collecting 
biological specimens from infants and their families but with less than 
optimal response rates and those who are working to implement studies 
that include the use of biological specimens.
    Scientists from the National Birth Defects Prevention Study (NBDPS) 
in NCBDDD, the Pregnancy Risk Assessment Monitoring System (PRAMS) in 
NCCDPHP, and the Office of Genomics and Disease Prevention (OGDP) have 
received Collaborative Initiative intramural funding to conduct focus 
groups aimed at gaining insight into the barriers and motivations women 
have for participating in the collection of biological specimens. Among 
the three collaborating Centers within the Coordinating Center for 
Health Promotion, NCBDDD's National Birth Defects Prevention Study 
provides a unique opportunity for exploring the barriers and 
motivations toward collection of genetic material. This focus group 
project will recruit mothers who participated in the maternal interview 
for the National Birth Defects Prevention Study (NBDPS). There are no 
costs to the respondents other than their time. The total estimated 
annualized burden hours are 214.

[[Page 66332]]



                                        Estimated Annualized Burden Hours
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                                                                                   Avg. burden/
               Type of respondent                    Number of     Frequency of    response  (in   Annual burden
                                                    respondents      response         hours)        (in hours)
----------------------------------------------------------------------------------------------------------------
Focus group Participants........................              72               1             2.5             180
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    Dated: November 6, 2006.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
 [FR Doc. E6-19144 Filed 11-13-06; 8:45 am]
BILLING CODE 4163-18-P