[Federal Register: February 1, 2005 (Volume 70, Number 20)]
[Notices]
[Page 5187-5188]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01fe05-65]
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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
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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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