[Federal Register Volume 67, Number 199 (Tuesday, October 15, 2002)]
[Notices]
[Pages 63663-63664]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-26049]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-03-01]


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 the CDC Reports 
Clearance Officer on (404) 498-1210.
    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. Send comments to Seleda Perryman, CDC 
Assistant Reports Clearance Officer, 1600 Clifton Road, MS-D24, 
Atlanta, GA 30333. Written comments should be received within 60 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 5 
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.
    OMB approval for NBDPS was obtained in September 1999 and will 
expire 30 November 2002. 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. This is no 
cost to respondents.

----------------------------------------------------------------------------------------------------------------
                                                                        No. of        Avg. burden/      Total
                      Survey                           No. of         responses/      response (in    burden in
                                                     respondents      respondent         hrs.)          hours
----------------------------------------------------------------------------------------------------------------
NBDPS Case/Control Interview.....................             400               1                1           400
Cheek Cell Collection (mother/father/infant).....           1,200               2            20/60           800
Completion of Entire Study.......................             400               1                1           400
                                                  -----------------
Total............................................  ..............  ...............  ...............         1600
----------------------------------------------------------------------------------------------------------------



[[Page 63664]]

    Dated: October 7, 2002.
Nancy E. Cheal,
Acting Associate Director for Policy, Planning and Evaluation, Centers 
for Disease Control and Prevention.
[FR Doc. 02-26049 Filed 10-11-02; 8:45 am]
BILLING CODE 4163-18-P