[Federal Register Volume 85, Number 203 (Tuesday, October 20, 2020)]
[Notices]
[Pages 66566-66567]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23188]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket No. CDC-2020-0112]


Assisted Reproductive Technology (ART) Success Rates Reporting 
and Data Validation Procedures

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

ACTION: Request for comment.

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SUMMARY: The Centers for Disease Control and Prevention, within the 
Department of Health and Human Services, announces the opening of a 
public docket to obtain public comment on proposed changes in assisted 
reproductive technology (ART) data validation selection process; data 
validation approach; and data discrepancy reporting.

DATES: Written comments must be received on or before December 21, 
2020.

ADDRESSES: You may submit comments identified by Docket No. CDC-2020-
0112 by any of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: Division of Reproductive Health, National Center for 
Chronic Disease Prevention and Health Promotion, Centers for Disease 
Control and Prevention, 4770 Buford Highway NE, Mailstop S107-2, 
Atlanta, Georgia 30341-3724. Attention: Assisted Reproduction 
Technology Surveillance and Research Team.

FOR FURTHER INFORMATION CONTACT: Jeani Chang, Division of Reproductive 
Health, National Center for Chronic Disease Prevention and Health 
Promotion, Centers for Disease Control and Prevention, 4770 Buford 
Highway NE, Mailstop S107-2, Atlanta, Georgia 30341-3724. Telephone: 
(770) 488-5200. Email: [email protected].

SUPPLEMENTARY INFORMATION:

Public Participation

    Interested persons or organizations are invited to participate by 
submitting written views, recommendations, and data in response to the 
proposed changes described in this notice. CDC invites comments 
specifically on:
     Proposed changes in data validation selection process;
     Data validation approach; and
     Process for identifying discrepancies in reporting of 
pregnancy success rates from ART programs.
    Please note that comments received, including attachments and other 
supporting materials, are part of the public record and are subject to 
public disclosure. Comments will be posted on https://www.regulations.gov. Therefore, do not include any information in your 
comment or supporting materials that you consider confidential or 
inappropriate for public disclosure. If you include your name, contact 
information, or other information that identifies you in the body of 
your comments, that information will be on public display. CDC will 
review all submissions and may choose to redact or withhold submissions 
containing private or proprietary information such as Social Security 
numbers, medical information, inappropriate language, or duplicate/near 
duplicate examples of a mass-mail campaign. CDC will carefully consider 
all comments submitted.

Background

    On May 31, 2018, CDC requested public comment on a plan to (1) 
revise the definition and characterization of Assisted Reproductive 
Technology (ART) success rates and (2) introduce clinic validation 
footnotes for the annual ART Fertility Clinic Success Rates Report (83 
FR 25009). CDC received three public comments, of which one was non-
substantive, one was supportive of CDC's planned approach for revising 
the definition of success rates and introducing clinic validation 
footnotes without further suggestions, and one contained concerns about 
CDC's planned clinic validation footnotes for identified major data 
discrepancies and approach to clinic validation along with recommended 
changes.
    This comment expressed concern that random selection of clinics 
during the current CDC validation system is unable to identify 
systematic reporting errors. It was suggested that targeted selection 
of clinics based on certain reporting characteristics that predict 
erroneously inflated ART success rates is a better approach to identify 
systematic reporting errors. There was also a concern that 
discrepancies identified during on-site data validation are not 
corrected prior to publication of the ART Fertility Clinic Success 
Rates Report. It was suggested that instead of including a footnote, 
identification of erroneous data should result in removing clinic 
success rates from ART Fertility Clinic Success Rates Report, and that 
erroneous data should not be included with data from other clinics. 
Finally, there was a concern that validation footnotes and an appendix 
will not be easily understood by the patients.
    Pursuant to the Fertility Clinic Success Rate and Certification Act 
of 1992, 42 U.S.C. 263a-5, CDC publishes pregnancy success rates 
reported to the agency in accordance with section 263a-1(a)(1). The 
primary goal of public reporting of clinical outcomes of ART is to 
provide accurate data to current or potential ART users. Therefore, 
multiple mechanisms ensuring data accuracy are employed by CDC: 
Conducting data checks for logical errors and inconsistencies during 
data entry stage, verification of data accuracy by clinics' medical 
directors, additional data checks for logical errors and internal 
inconsistencies after submission. If any errors or inconsistencies are 
identified during these stages, clinics are contacted and data are 
immediately corrected. In addition, CDC conducts annual site visits by 
selecting 7-10% of all reporting clinics and about 70-80 cycles per 
clinic for data validation. This data validation process involves 
comparing information of key variables from patient's medical record 
with the data submitted to the National ART Surveillance System (NASS), 
the CDC data reporting system for ART procedures, to calculate 
discrepancy rates for these variables. Data validation is another step 
to ensure that clinics submit accurate data and to identify any 
systematic problems that could cause data collection to be inconsistent 
or incomplete.
    CDC is currently conducting data validation using stratified random 
sampling of reporting clinics to assess discrepancy rates for key 
variables that are generalizable for all reporting clinics as described 
in ``Reporting of Pregnancy Success Rates from Assisted Reproductive 
Technology (ART) Programs'' (80 FR 51811). CDC concurs with comments on 
proposed changes to data validation procedures (83 FR 25009) that 
targeted selection of clinics based on certain reporting 
characteristics is another mechanism to identify systematic reporting 
errors. CDC's current targeted selection practice includes revisiting a 
small number of previously validated clinics to assess whether 
previously identified reporting errors have been corrected. Effective 
for calendar year 2022, CDC proposes to expand targeted selection of 
clinics to better capture systematic reporting errors by assessing 
certain reporting characteristics that may predict erroneously inflated 
ART success rates (e.g. number of cancelled cycles, inability to 
confirm reported live births, etc.). Information gained from targeted 
validation will not be used in

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calculating discrepancy rates since it cannot be generalizable for all 
reporting clinics.
    Since information on potential data errors is not available from 
non-validated clinics and CDC's annual data validation only represents 
a very small proportion of clinics (7-10%) and cycles (1% of total 
reported cycles), correcting identified discrepancies in the final 
dataset for a small subset of cycles will not have any significant 
effect on data quality or published success rates. However, CDC took 
into account comments that publishing inaccurate data with known major 
discrepancies can be misleading, even in the presence of a footnote 
describing data quality concerns. Therefore, if a clinic is selected to 
participate in the NASS data validation process (either through 
stratified random sampling or through targeted selection), does 
participate, and major data discrepancies are identified (e.g., lack of 
supporting information for a significant proportion of reported 
pregnancy outcomes, inability to confirm a significant proportion of 
reported live births, underreporting a significant proportion of 
cycles, etc.), a message will be displayed in the ART Fertility Clinic 
Success Rates Report for the clinic as:

    CDC conducts data validation of a sample of reporting clinics to 
assess discrepancy rates for key variables helping, in part, to 
ensure clinics submit accurate data and to identify any systematic 
problems. This clinic was visited for validation of (insert: 
reporting year) data and major data discrepancies were identified. 
This clinic's reported success rates data are therefore not 
published in this report and not included in aggregate national data 
reports.

    CDC may re-select this ART program for data validation during the 
following reporting year(s) to assess corrections of identified data 
errors.
    In addition, CDC will publish information in the annual ART 
Fertility Clinic Success Rates Report to identify clinics that are 
selected by CDC to participate in the NASS data validation but decline 
to participate. (See 80 FR 51811 for further information concerning 
external validation of clinic data). If a clinic is selected to 
participate in the NASS data validation process and declines to 
participate, the following message will be displayed in the ART 
Fertility Clinic Success Rates Report for the clinic as:

    CDC conducts data validation of a sample of reporting clinics to 
assess discrepancy rates for key variables helping, in part, to 
ensure clinics submit accurate data and to identify any systematic 
problems. This clinic was selected for validation of (insert: 
reporting year) data, but declined to participate. This clinic's 
reported data are therefore not published in this report and not 
included in aggregate national data reports.

    CDC may re-select this ART program for data validation during the 
following reporting year(s). Participation in data validation is 
integral to helping ensure the accuracy of the required pregnancy 
success rates reported to have been achieved by clinics. Therefore, 
displaying this message, as well as the other messages outlined herein, 
is important in providing the public with the most accurate 
information.
    For consistency, for all other clinics that are selected to 
participate in the NASS data validation and do participate, the 
following footnote will be added:

    CDC conducts data validation of a sample of reporting clinics to 
assess discrepancy rates for key variables helping, in part, to 
ensure clinics submit accurate data and to identify any systematic 
problems. This clinic was visited for validation of (insert: 
reporting year) data and no systematic problems were identified.

    Any messages added to a clinic's success rates page in the ART 
Fertility Clinic Success Rates Report will appear only for the 
reporting year that the clinic was selected for validation. These 
enhanced processes and messages in the annual ART Fertility Clinic 
Success Rates Report will help to inform the public if there are issues 
with data quality, thereby increasing the transparency and help ensure 
the accuracy of the NASS data reporting.
    For 2017 reporting year, CDC started reporting cumulative success 
rates which take into account successes over all embryo transfers 
within 12-month period from a single oocyte retrieval and, therefore, 
span two reporting years (83 FR 53253). Effective for data validation 
conducted in calendar year 2021, data validation approach will be 
aligned with ART reporting approach and will also span two reporting 
years. Data validation conducted in 2021 will cover oocyte retrievals 
conducted in reporting year 2018 and associated embryo transfers that 
took place within 12-month period from oocyte retrievals (reporting 
years 2018 and 2019). As a result of this transition to a cumulative 
approach in data validation and due to impacts of the COVID-19 pandemic 
(i.e., travel restrictions), no data validations will be conducted in 
calendar year 2020.

    Dated: October 15, 2020.
Sandra Cashman,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2020-23188 Filed 10-19-20; 8:45 am]
BILLING CODE 4163-18-P