[Federal Register Volume 68, Number 4 (Tuesday, January 7, 2003)]
[Notices]
[Pages 785-786]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-227]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30DAY-17-03]


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) 498-1210. 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

[[Page 786]]

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.

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                                                                                     No. of        Avg. burden/
                            Survey                                  No. of         responses/      response (in
                                                                 respondents       respondent         hrs.)
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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
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    Dated: December 31, 2002.
Nancy E. Cheal,
Acting Associate Director for Policy, Planning and Evaluation, Centers 
for Disease Control and Prevention.
[FR Doc. 03-227 Filed 1-6-03; 8:45 am]
BILLING CODE 4163-18-P