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Notice

Reporting of Pregnancy Success Rates From Assisted Reproductive Technology Programs

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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AGENCY:

Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (DHHS).

ACTION:

Notice.

SUMMARY:

The CDC is tasked with implementing the Fertility Clinic Success Rate and Certification Act of 1992 (FCSRCA), Public Law 102-493. As mandated by this law CDC publishes annual reports of pregnancy success rates from ART clinics and embryo laboratory certification status of these clinics. Section 2(a) of Public Law 102-493 (42 U.S.C. 263a-1) requires that each assisted reproductive technology (ART) program shall annually report to the Secretary, through the Centers for Disease Control and Prevention, (a) pregnancy success rates achieved by such ART programs, and (b) the identity of each embryo laboratory used by such ART programs, and whether the laboratory is certified or has applied for such certification under this act. Section (6) states that the Secretary, through the CDC, shall annually publish and distribute to the States and the public, pregnancy success rates reported to the Secretary under section 2(a)(1) and, in the case of an assisted reproductive technology program which failed to report one or more success rates as required under such section, the name Start Printed Page 5188of each such program and each pregnancy success rate which the program failed to report.

This Announcement includes information on the change in the data collection contractor and the change in the approved data reporting system for the 2004, 2005, 2006, 2007, and 2008 ART data reporting years in accordance with the FCSRCA. This Announcement supplements the September 1, 2000 and the February 5, 2004, notices.

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SUPPLEMENTARY INFORMATION:

CDC has contracted with Westat to develop a data reporting system and to collect annual clinic-specific and cycle-specific data from all practicing assisted reproductive technology clinics in the U.S. and its territories for the 2004, 2005, 2006, 2007, and 2008 ART data reporting years. The contract covers clinic tracking, data collection and quality assurance, and validation activities. As such, Westat is the new contractor for ART data collection for the 2004 through 2008 ART data reporting years.

The new Web-based data reporting system (developed by Westat) for the 2004, 2005, 2006, 2007, and 2008 ART data reporting years will be called the National ART Surveillance System (NASS). As such, NASS will be the only approved data reporting system for 2004 through 2008 ART data submissions. ART programs should be aware that Westat will develop and provide all necessary instruction materials for extracting and importing data from other electronic medical record systems into NASS and for checking imported data to ensure that it retains the accuracy and compatibility of the data entry system from which it was extracted.

The anticipated deadline for reporting is December 15 of the year 1 year subsequent to the reporting year in question. (For example, the anticipated deadline to report data on cycles initiated in 2004 is December 15, 2005.) An ART program will not be considered to be in compliance with the federal reporting requirements of FCSRCA if the ART program was in operation in the full year that is being reported, i.e., the clinic was in operation after January 1 of the reporting year, and fails to submit a dataset to Westat in the required data reporting system (NASS) by the reporting deadline. ART programs considered to not be compliant with the federal reporting requirements of FCSRCA will be listed as non-reporters in the published report.

The data reporting activities and the amount and type of data collected will be similar to the current system requirements outlined in the September 1, 2000 Federal Register notice (Volume 65, No. 171, pages 53310-53316). CDC has completely funded the data reporting activities for the 2004 through 2008 reporting years. Thus, ART programs will not be charged fees to obtain the new reporting system or to submit data using the new reporting system.

Validation activities for the 2004 through 2008 data reporting years will be similar to those described in the September 1, 2000 Federal Register notice (Volume 65, No. 171, pages 53310-53316). Westat will provide the necessary personnel to perform the validation site visits.

Each ART program should be aware that the Paperwork Reduction Act is applicable to this data collection. Under the Paperwork Reduction Act of 1995, a Federal agency shall not conduct or sponsor a collection of information from ten or more persons other than Federal employees, unless the agency has submitted a Standard Form 83, Clearance Request, to the Director of the Office of Management and Budget (OMB), and OMB has approved the collection of information. A person is not required to respond to a collection of information unless it displays a currently valid OMB control number. CDC has obtained OMB approval to collect this data under OMB control No. 0920-0556.

CDC will continue to provide information to all ART programs regarding data collection activities as information becomes available.

FOR FURTHER INFORMATION CONTACT:

Victoria Wright, Assisted Reproductive Technology Epidemiology Unit at (770) 488-6384.

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Dated: January 25, 2005.

James D. Seligman,

Associate Director for Program Services, Centers for Disease Control and Prevention.

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[FR Doc. 05-1787 Filed 1-31-05; 8:45 am]

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