Agency Information Collection Activities; Proposals, Submissions, and Approvals
Federal Register: April 11, 2008 (Volume 73, Number 71)
Notices
Page 19853-19854
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DOCID:fr11ap08-61
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
60Day-08-0010
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 Maryam I. Daneshvar, CDC Acting Reports Clearance
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to omb@cdc.gov.
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
The National Birth Defects Prevention Study (NBDPS), (OMB 0920- 0010)--Extension--National Center on Birth Defects and Developmental
Disabilities (NCBDDD), Centers for Disease Control and Prevention
(CDC).
Background and Brief Description
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 serves as an early warning system for new Teratogens. In 1997, the Birth Defects Risk Factor
Surveillance (BDRFS) study, a case-control study of risk factors for selected birth defects, 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 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. The interview is estimated to take one hour. A maximum of four hundred interviews are planned, 300 cases and 100 controls resulting in a maximum interview burden of 400 hours for each of the Centers.
Parents are also asked to collect cheek cells from themselves and their infants for DNA testing. The collection of cheek cells by the mother, father, and infant is estimated to take about 10 minutes per person. Each person will be asked to rub 1 brush inside the left cheek and 1 brush inside the right cheek for a total of 2 brushes per person.
Collection of the cheek cells takes approximately 1-2 minutes, but the estimate of burden is 10 minutes to account for reading and understanding the consent form and specimen collection instructions and mailing back the completed kits. The anticipated maximum burden for
Page 19854
collection of the cheek cells is 200 hours.
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 OMB clearance for three additional years.
There are no costs to the respondents other than their time.
Estimated Annualized Burden Hours
Number of
Avg. burden
Respondents
Number of
responses per per response
Total burden respondents
respondent
(in hours)
hours
NBDPS case/control interview....................
400
1
1
400
Biologic Specimen Collection....................
1,200
1
10/60
200
Total....................................... .............. .............. ..............
600
Dated: April 3, 2008.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
FR Doc. E8-7706 Filed 4-10-08; 8:45 am
BILLING CODE 4163-18-P
