E6-3916. 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 404-639-5960 and send comments to Seleda Perryman, CDC Assistant Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to [e-mail].

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

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

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 (NBDPS) (OMB# 0920-0010) 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 professional's 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 in NCBDDD, the Pregnancy Risk Assessment Monitoring System (PRAMS) in National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), and 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 NBDPS. There are no costs to the respondents other than their time to participate in the survey.

Estimated Annualized Burden

Instrument	Number of respondents	Frequency of response	Average burden/response (in hours)	Annual burden hours
Telephone Contact	90	1	5/60	7.5
Focus Group Discussion	45	1	2	90

Dated: March 12, 2006.

Joan F. Karr,

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