[Federal Register Volume 69, Number 24 (Thursday, February 5, 2004)]
[Notices]
[Pages 5548-5550]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-2395]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Reporting of Pregnancy Success Rates From AssistedReproductive 
Technology Programs

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 each section, the name of each such 
program and each pregnancy success rate which the program failed to 
report.
    CDC first implemented the FCSRCA in 1997, and has obtained and 
published data for ART procedures performed in 1995, 1996, 1997, 1998, 
1999 and 2000. Currently, CDC has a contract with the Society for 
Assisted Reproductive Technology (SART) to annually obtain a copy of 
their clinic-specific database. The existing contract will be used to 
obtain and publish data for ART procedures performed in 2001, 2002 and 
2003. Details on the current process are outlined in the September 1, 
2000 Federal Register notice (Volume 65, No. 171, pages 53310-53316).
    CDC is currently in the process of selecting a contractor for the 
2004, 2005, 2006, 2007, and 2008 data reporting years. We anticipate 
awarding the contract in February, 2004. Based on that timeframe, we 
anticipate that the data collection system for 2004 data reporting will 
be available to clinics in summer, 2004. The new contract to be awarded 
will cover clinic tracking, data collection and quality assurance and 
validation processes for ART procedures performed in 2004, 2005, 2006, 
2007 and 2008. The data collection process is expected to be similar to 
the current data collection process (see September 1, 2000 Federal 
Register notice, Volume 65, No. 171, pages 53310-53316).
    Under the new contract, the contractor shall furnish all personnel, 
facilities, equipment, supplies, and materials necessary to assist CDC 
to produce and publish an annual report of pregnancy success rates and 
embryo laboratory certification status, as

[[Page 5549]]

mandated by the Fertility Clinic Success Rate and Certification Act of 
1992. (FCSRCA), Public Law 102-493. The Contractor shall meet the 
following requirements:

    a. The contractor shall track all clinics performing ART in the 
United States and its territories that are known to be in operation for 
each reporting year and track all clinic reorganizations and closings.
    b. The contractor shall develop a standardized data collection 
system, subject to Office of Management and Budget (OMB) requirements, 
that appropriately collects all specified data from clinics.
    c. The contractor shall implement a quality assurance system each 
year to ensure that the data delivered to CDC are of acceptable quality 
and completeness.
    d. The contractor shall distribute the data collection software, 
along with instructions, to all clinics by preset deadlines.
    e. The contractor shall provide ongoing technical assistance to 
each site as needed by developing, implementing, and maintaining a Web 
site and telephone help line for technical assistance in all data 
collection issues.
    f. The contractor shall deliver to the CDC, preliminary and final 
clinic and cycle specific data for each reporting year. The contractor 
shall deliver all necessary documentation pertaining to the annual data 
sets.
    g. The contractor shall provide: (1) A listing of all assisted 
reproductive technology clinics that are included in the clinic and 
cycle specific datasets each reporting year; and, (2) a listing of all 
assisted reproductive technology clinics that were performing assisted 
reproductive technology cycles and were thus required to report data 
under FCSRCA, but failed to report such data to the contractor. The 
lists of reporting and non-reporting clinics shall include all clinics 
known to be in operation during a given reporting year.
    h. Each year, the contractor shall prepare and describe a data 
validation quality assurance plan in conjunction with the CDC. The 
contractor shall perform data validation site visits, enter the data 
collected during these visits into an electronic data system, and 
provide both the electronic datafile and a hard copy of all abstraction 
forms to the CDC.

    The amount and type of data collected will be similar to the 
current system requirements and will include clinic information, 
patient demographic information, patient history, ART cycle 
information, and ART outcome information. A detailed listing of current 
data elements and definitions for data to be collected are outlined in 
the Federal Register notice (see September 1, 2000 Federal Register 
notice, Volume 65, No. 171, pages 53310-53316).
    The current database system is based on Microsoft Access. In this 
new contract, CDC will require that the contractor develop a new 
database system. The database system developed under this new contract 
must have the capability to record data for every treatment cycle of 
ART initiated, convert collected data to a database such as Microsoft 
Access (and ultimately the database must be converted into SAS System 
Version 8.0 or later). CDC will also require that the database 
developed include all programming necessary to take the data entered 
for each ART cycle initiated and compute all statistics needed for 
presentation in the report. The contractor will submit two datasets to 
CDC--one organized such that each ART cycle initiated is a unique 
observation, and one organized such that summary statistics by each 
clinic is a unique observation.
    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.
    Currently, each ART program must use the required database system 
(developed by SART) to enter and submit data. Under the new contract, 
CDC will continue to require a single data collection system (to be 
developed by the contractor). In addition, each ART program currently 
submits its dataset output from the required software to the contractor 
at a central site. The contractor then compiles all the datasets from 
specific sites into a single dataset. That requirement will continue.
    Currently, all ART programs reporting their data are subject to an 
annual external validation of their data collection and reporting 
activities by appropriately trained professionals from outside the 
clinic staff. This review includes but is not limited to examination of 
medical and laboratory records and comparison of data in the reporting 
database with the data in the medical record. External validation will 
continue with the new contract.
    Every clinic will maintain a copy of all information included in 
the reporting database and must be able to link each patient, cycle and 
oocyte retrieved from the reporting database to the appropriate medical 
and laboratory records for external validation activities. The new 
contractor will provide the necessary personnel to perform the 
validation visits.
    ART success rates will be similar to those currently presented in 
the annual reports and will be defined and characterized as described 
below:
    Success rates for fresh, nondonor cycles will be defined as--
    1. The rate of pregnancy after completion of ART according to the 
number of:
     All ovarian stimulation or monitoring 
procedures.
    2. The rate of live birth after completion of ART according to the 
number of:
    a. All ovarian stimulation or monitoring procedures.
    b. Oocytes retrieval process.
    c. Embryo (or Zygote, or oocyte) transfer procedures.
    3. The rate of singleton live birth after completion of ART 
according to the number of:

    a. All ovarian stimulation or monitoring procedures.
    b. Embryo (or zygote, or oocyte) transfer procedures.

    Success rates for cycles using thawed embryos and cycles using 
donor oocytes or embryos will be defined as--

    4. The rate of live birth after completion of ART according to the 
number of:

     Embryo (or zygote, or oocyte) transfer 
procedures.

    5. The rate of singleton live birth after completion of ART 
according to the number of:

     Embryo (or zygote, or oocyte) transfer 
procedures.

    Reporting requirements, data elements, definitions, and success 
rates will be periodically reviewed and updated as new knowledge 
concerning ART methods and techniques becomes available.
    Until a new contract has been awarded, ART programs are advised to 
refrain from entering 2004 data into the current data collection 
system. CDC will continue to provide information to all

[[Page 5550]]

ART programs regarding the status of the new contract and future years' 
data collection activities as information becomes available.

FOR FURTHER INFORMATION CONTACT: Victoria Wright, Assisted Reproductive 
Technology Epidemiology Unit at (770) 488-6370.

    Dated: January 29, 2004.
Joseph R. Carter,
Deputy Chief Operating Officer, Centers for Disease Control and 
Prevention.
[FR Doc. 04-2395 Filed 2-4-04; 8:45 am]
BILLING CODE 4163-18-P