[Federal Register: January 7, 2003 (Volume 68, Number 4)]
[Notices]
[Page 785-786]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07ja03-62]
-----------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
No. of Avg. burden/
Survey No. of responses/ response (in
respondents respondent 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.
[FR Doc. 03-227 Filed 1-6-03; 8:45 am]
BILLING CODE 4163-18-P