03-227. 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 [phone]. Send written comments to CDC, Desk Officer, Human Resources and Housing Branch, New Executive Office Building, Room 10235, Washington, DC 20503. Written comments should be received within 30 days of this notice.

Proposed Project: The National Birth Defects Prevention Study (OMB 0920-0010)—Extension—National Center on Birth Defects and Developmental Disabilities (NCBDDD), Centers for Disease Control and Prevention (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 in the five counties of Metropolitan Atlanta. Its primary purpose is to describe the spatial and temporal patterns of birth defects occurrence and serve as an early warning system for new teratogens. From 1993 to 1996, NCBDDD conducted the Birth Defects Risk Factor Surveillance (BDRFS) study, a case-control study of risk factors for selected birth defects. Infants with birth defects were identified through MACDP and maternal interviews, and clinical/laboratory tests were conducted on approximately 300 cases and 100 controls per year. Controls were selected from among normal births in the same population. In 1997 the BDRFS became the National Birth Defects Prevention Study (NBDPS). The major components of the study did not change.

The NBDPS is a case-control study of major birth defects that includes cases identified from existing birth defect surveillance registries in ten 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 request is submitted to obtain approval for current NBDPS activities for three more years with one change indicated below:

The CDC NBDPS currently remunerates participants for the biologic sample collection portion of the study. The cheek cell kits include $20.00 as an incentive to complete them and send them back. Overall, only 50% of participants completing the interview send in a completed cheek cell kit. While some subjects have stated that they do not wish to provide buccal samples due to their concerns about genetic testing, many subjects state that it is time consuming and difficult to remember to complete the kit and mail it back. An additional $20.00 incentive will be added that is linked to the return of the cheek cell kits. It is appropriate to have a higher level of compensation for those who spend the additional time to complete the cheek cell collection and return the kit than for those who only receive the kit and invest no time in further participation. This would make a total of $60.00 compensation ($20.00 for the completing of the interview, $20.00 for receiving the cheek cell kit and $20.00 for returning the kit) for subjects who choose to complete the entire study including the return of the cheek cell samples for herself and the baby or for just herself if the baby is deceased. While samples are requested from the father, the third incentive would not be dependent on the cooperation of the father since this may pose a hardship to those mothers who are not in regular contact with the father. Given the time and inconvenience required for the entire study (interview and cheek cell), a total of $60.00 is an appropriate level of compensation. The additional $20.00 money order is expected to increase the number of kits that are completed and returned and will be included in the thank you letter that each participant receives upon completion of the study. The estimated annualized burden is 1600 hours.

Survey	No. of respondents	No. of responses/respondent	Avg. burden/response (in hrs.)
NBDPS Case/Control Interview	400	1	1
Cheek Cell Collection (mother/father/infant)	1,200	2	20/60
Completion of Entire Study	400	1	1

Dated: December 31, 2002.

Nancy E. Cheal,

Acting Associate Director for Policy, Planning and Evaluation, Centers for Disease Control and Prevention.