E6-19144. Agency Forms Undergoing Paperwork Reduction Act Review

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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.

Estimated Annualized Burden Hours

Type of respondent	Number of respondents	Frequency of response	Avg. burden/response (in hours)	Annual burden (in hours)
Focus group Participants	72	1	2.5	180

Dated: November 6, 2006.

Joan F. Karr,

Acting Reports Clearance Officer, Centers for Disease Control and Prevention.