Notice2024-19392
Reporting of Pregnancy Success Rates From Assisted Reproductive Technology (ART) Programs; Proposed Modifications to Data Collection Fields and Data Validation Procedures; Final Notice
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 29, 2024
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) announces revised plans for data collection fields for reporting of pregnancy success rates from assisted reproductive technology (ART) programs and for data validation procedures. This reporting is required by the Fertility Clinic Success Rate and Certification Act of 1992 (FCSRCA). This notice also responds to public comments received in response to CDC's 2023 request for comment in a Federal Register notice.
Full Text
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<title>Federal Register, Volume 89 Issue 168 (Thursday, August 29, 2024)</title>
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[Federal Register Volume 89, Number 168 (Thursday, August 29, 2024)]
[Notices]
[Pages 70189-70191]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-19392]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2023-0093]
Reporting of Pregnancy Success Rates From Assisted Reproductive
Technology (ART) Programs; Proposed Modifications to Data Collection
Fields and Data Validation Procedures; Final Notice
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services.
ACTION: General notice.
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SUMMARY: The Centers for Disease Control and Prevention (CDC) within
the Department of Health and Human Services (HHS) announces revised
plans for data collection fields for reporting of pregnancy success
rates from assisted reproductive technology (ART) programs and for data
validation procedures. This reporting is required by the Fertility
Clinic Success Rate and Certification Act of 1992 (FCSRCA).
[[Page 70190]]
This notice also responds to public comments received in response to
CDC's 2023 request for comment in a Federal Register notice.
DATES: The requirements for the additional data fields and validation
requirements will be implemented for reporting year 2025.
FOR FURTHER INFORMATION CONTACT: Mithi Sunderam, 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. Telephone:
1-800-232-4636; email: <a href="/cdn-cgi/l/email-protection#145546407d7a727b547770773a737b62"><span class="__cf_email__" data-cfemail="763724221f1810193615121558111900">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: On November 28, 2023, CDC published a notice
in Federal Register (88 FR 83131) requesting comments on a plan that
proposed modifications to (1) data collection fields for reporting of
pregnancy success rates from assisted reproductive technology (ART)
programs; and (2) data validation procedures. Proposed modifications
were the following:
(i) Remove the requirement for clinics to report dosage information
for fertility medications including Clomiphene, Letrozole, and long-
acting follicle stimulating hormone (FSH).
(ii) Remove the requirement for clinics to report information on
research cycle study type.
(iii) Add the requirement for clinics to report date of
cryopreservation for fresh embryos.
(iv) Not to pursue targeted validation of clinics and
identification of major data discrepancies.
Public Comment Summary and Responses
CDC received seven public comments to the docket. One comment was
outside the scope of the docket. Summaries of the six other comments
and CDC's responses are provided below.
Proposed Modifications to Data Collection Fields
I. CDC proposal to remove the requirement for clinics to report
dosage information for fertility medications, including Clomiphene,
Letrozole, other oral medications, and long-acting follicle stimulating
hormone: One commenter agreed, two commenters did not comment on this
proposed change, and three commenters did not agree to the proposed
change. Of those who did not agree, one commenter suggested that CDC
should not stop collecting information on long-acting FSH medications
as it may be the preferred approach to stimulating egg follicles among
egg donors. Another commenter who disagreed suggested that many
outcomes and side effects are dosage dependent, and CDC should not
remove the requirement to report dosage. A third commenter who also
disagreed suggested that follicle stimulating hormone medications have
documented risks such as ovarian hyperstimulation and risks to both
mother and infants such as ectopic pregnancy and birth defects.
Response: CDC thanks the commenters for providing these comments.
CDC notes there may be variation in the type and dosage of medication
used to stimulate follicular development, including the use of
Clomiphene, Letrozole, and other oral medications. Established
treatment protocols and dosage of medication may, on occasion, vary by
patient and cycle type and may impact pregnancy success rates.
Based on these comments, CDC will not make proposed changes to
remove the requirement for clinics to report dosage information for
fertility medications, including Clomiphene, Letrozole, other oral
medications described in Federal Register notice (88 FR 83131).
However, CDC will stop collecting information on the use and dosage of
long-acting FSH medications as they are not approved for use in the
United States.
II. CDC proposal to remove the requirement for clinics to report
information on research cycle study type: Among the six commenters, one
commenter agreed, one commenter did not comment, and four commenters
disagreed on this proposed change. Two of the commenters who disagreed
stated that the low number of research cycles performed is not a
justification for removing this reporting requirement. Two other
commenters that disagreed noted the need for more regulation of
research cycles as well as follow up of outcomes for patients and
infants.
Response: CDC thanks the commenters for providing these comments.
CDC proposed to remove the requirement for clinics to report
information on the type of research cycle, not the requirement to
report information on research cycles in general. CDC will continue to
collect information on whether a research cycle was performed as
described in the requirements for reporting of pregnancy success rates
(80 FR 51811). Additional information on research cycle study type is
not necessary.
Therefore, proposed changes to remove the requirement to report
research cycle study type as described in Federal Register notice (88
FR 83131) will be made.
III. CDC proposal to add the requirement for clinics to report the
date of cryopreservation for fresh embryos: Two commenters agreed, two
commenters did not have any comments on this proposed change, one
commenter suggested additional information should be provided on the
need for this additional data collection, and one commenter had non-
substantive responses to this CDC proposal. One commenter who agreed
cautioned that the date of embryo cryopreservation could be captured
only for the first time that an embryo was thawed but not if the embryo
was refrozen again after additional culturing such as in some cases
when performing pre-implantation genetic testing (PGT).
Response: CDC thanks the commenters for providing these comments.
CDC agrees that under certain circumstances, frozen embryos may be
thawed and refrozen for future use after additional days of culturing;
however, this is rare. The date of first cryopreservation provides a
good proxy of embryo stage even if the embryo was thawed and refrozen
for future use. It will allow classification of embryo stage for
frozen-embryo transfers and improve the reporting of factors that
impact ART success rates.
Based on these comments, CDC will add the date of fresh embryo
cryopreservation to the reporting requirements described in Federal
Register notice (88 FR 83131).
Proposed Modifications to Data Validation Procedures
CDC proposed not to pursue implementation of a plan to conduct
targeted validation of clinics and identification of major data
discrepancies as described in the Federal Register published on
November 28, 2023, (88 FR 83131) and to maintain validation procedures
described in Federal Register notice published on August 26, 2015 (80
FR 51811). One commenter agreed with all changes proposed by CDC but
did not have any specific comments regarding the modifications to data
validation procedures. Five commenters disagreed with this proposed
change stating that the validation process was necessary for data
accuracy. Of those who disagreed, one commenter noted that the proposed
changes would weaken the validation process and that patients deserved
to get accurate data from clinics. One commenter who disagreed noted
that validation was necessary to ensure clinics are not inflating
success rates. One commenter who disagreed noted
[[Page 70191]]
that data discrepancies could be misleading to the public. One
commenter suggested additional fields for targeted validation.
Response: CDC thanks the commenters for providing these comments
and notes their feedback and suggestions. CDC strives to provide
accurate data and maintains multiple mechanisms to ensure data
accuracy: conducting data checks for logical errors and inconsistencies
during the data entry stage, verification of data accuracy by clinics'
medical directors, and additional data checks for logical errors and
internal inconsistencies after submission. If any errors or
inconsistencies are identified during these stages, CDC's contractor
contacts the clinics and corrects the data.
In addition, CDC currently conducts annual site visits by selecting
5-10% of all reporting clinics and about 70-80 cycles per clinic for
data validation as described in Federal Register notice (80 FR 51811).
This data validation process involves comparing information for key
variables from a patient's medical record with the data submitted to
the National ART Surveillance System (NASS), the CDC data reporting
system for ART procedures. This information is used to calculate
discrepancy rates for these variables. Aggregate findings for validated
data fields from all ART programs participating in validation are
published annually. In addition, CDC will continue removing a clinic's
reported success rates from annual ART reports if the clinic was
selected for annual ART data validation but declined to participate, as
described in the changes to data validation process published in
Federal Register notice (86 FR 20496).
The targeted data validation and major discrepancy analysis were
additional mechanisms that CDC was considering identifying any
systematic problems that could cause data collection to be inconsistent
or incomplete. The commenters' suggestions will be taken under
consideration as CDC works toward further refining its data validation
process while balancing potential gains in accuracy with additional
burden to clinics. The details of any modifications to data validation
will be published in a separate Federal Register notice before
implementation.
At this time, changes proposed to data validation procedures
described in Federal Register notice published on November 28, 2023,
(88 FR 83131) will be made. Please see the revised Appendix below for
the new requirements.
Appendix--Notice for Reporting of Pregnancy Success Rates From Assisted
Reproductive Technology (ART) Programs--Modifications to Data
Collection Fields and Data Validation Procedures
The purpose of this notice published August 29, 2024 is to announce
revised data collection requirements and data validation procedures.
This data collection is approved under Office of Management and Budget
Control Number 0920-0556, expiration date: 12/31/2024. Effective for
reporting year 2025, CDC is implementing the following changes to its
data collection and data validation procedures.
Section III. What To Report
F. Stimulation and Retrieval
Deletion (if Medication Containing FSH Used)
CDC will remove the requirement for clinics to report dosage
information for long-acting FSH as described in Federal Register notice
88 FR 83131.
G. Laboratory Information
Deletion (if Cycle was a Research Cycle)
CDC will remove the requirement for clinics to report the research
cycle study type. This deletion will apply to all data fields for
research study types: Device study, Protocol study, Pharmaceutical
study, Laboratory technique, and Other research, as described in
Federal Register notice 88 FR 83131.
H. Transfer Information
Addition (if Frozen Embryos Were Transferred)
CDC will add the requirement for clinics to report date of fresh
embryo cryopreservation for all frozen embryo transfer procedures as
described in Federal Register notice 88 FR 83131.
Data Validation
CDC will not conduct targeted validation of clinics and
identification of major discrepancies during data validation, as
described in Federal Register notice 83 FR 25353. CDC will continue
conducting data validation using stratified random sampling of
reporting clinics to assess discrepancy rates for key variables that
are generalizable for all reporting clinics and provide feedback to
clinics to improve the reporting of data used to report success rates
as described in Federal Register notice 80 FR 51811. In addition, CDC
will continue removing a clinic's reported success rates from annual
ART reports if the clinic was selected for annual ART data validation
but declined to participate, as described in Federal Register notice 86
FR 20496.
Noah Aleshire,
Chief Regulatory Officer, Centers for Disease Control and Prevention.
[FR Doc. 2024-19392 Filed 8-28-24; 8:45 am]
BILLING CODE 4163-18-P
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