[Federal Register Volume 70, Number 20 (Tuesday, February 1, 2005)]
[Notices]
[Pages 5187-5188]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-1787]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Reporting of Pregnancy Success Rates From Assisted Reproductive 
Technology Programs

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

ACTION: Notice.

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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

[[Page 5188]]

of 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.

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.

    Dated: January 25, 2005.
James D. Seligman,
Associate Director for Program Services, Centers for Disease Control 
and Prevention.
[FR Doc. 05-1787 Filed 1-31-05; 8:45 am]
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