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Assisted Reproductive Technology (ART) Program Reporting System—Revision—National Center for Chronic Disease Prevention and Health Promotion (NCDDPHP), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
Section 2(a) of Public Law 102-493 (known as the Fertility Clinic Success Rate and Certification Act of 1992 (FCSRCA), 42 U.S.C. 263a-1(a)) requires that each assisted reproductive technology (ART) program shall annually report to the Secretary through the Centers for Disease Control and Prevention—(1) pregnancy success rates achieved by such ART program, and (2) the identity of each embryo laboratory used by such ART program and whether the laboratory is certified or has applied for such certification under this act.
The Centers for Disease Control and Prevention (CDC) is seeking a 3 year Office of Management and Budget (OMB) approval for a revision of a reporting system for the Assisted Reproductive Technology (ART) Program. This reporting system has been designed by Westat for CDC to comply with the requirements of the FCSRCA. The reporting system includes all ART cycles initiated by any of the approximately 400 ART programs in the United States, and covers the pregnancy outcome of each cycle, as well as a number of data items deemed important to explain variability in success rates across ART programs and across individuals. (An ART cycle is considered to begin when a woman begins taking ovarian stimulatory drugs or starts ovarian monitoring with the intent of having embryos transferred. The data file is organized with one record per cycle.) Data is to be collected through Web-based data collection system developed by Westat in consultation with CDC.
In developing the definition of pregnancy success rates and the list of data items to be reported, CDC has consulted with representatives of the Society for Assisted Reproductive Technology (SART), the American Society for Reproductive Medicine, and RESOLVE, the National Infertility Association (a national, nonprofit consumer organization), as well as a variety of individuals with expertise and interest in this field.
Approximately 400 ART programs reported data in 2002. The average number of ART cycles (responses) per ART program was 288. Using these numbers as a baseline, approximately 10% of the ART programs will be selected for data validation. An average of 50 ART cycles per ART program will be selected for full validation. In addition, an average of 33 ART cycles per selected ART program that resulted in a live birth will be selected for an abbreviated validation.
There are no costs to the respondents other than their time. The total estimated annualized burden hours are 72,313.Start Printed Page 26541
|Respondents||Number of respondents||Number of responses per respondent||Average burden per response (in hours)|
|ART Programs (data entry)||400||288||37/60|
|ART Programs (10% selected for data validation-full validation)||40||50||23/60|
|ART Programs (10% selected for data validation-abbreviated validation on live births)||40||33||23/60|
Dated: April 12, 2006.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. E6-6799 Filed 5-4-06; 8:45 am]
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