Reporting of Pregnancy Success Rates From Assisted Reproductive Technology (ART) Programs; Proposed Modifications to Data Collection Fields and Data Validation Procedures; Final Notice, 70189-70191 [2024-19392]
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Federal Register / Vol. 89, No. 168 / Thursday, August 29, 2024 / Notices
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SUMMARY:
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70189
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[FR Doc. 2024–19442 Filed 8–28–24; 8:45 am]
BILLING CODE 6820–EP–P
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
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services.
ACTION: General notice.
AGENCY:
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).
SUMMARY:
E:\FR\FM\29AUN1.SGM
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70190
Federal Register / Vol. 89, No. 168 / Thursday, August 29, 2024 / Notices
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: ARTinfo@cdc.gov.
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.
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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
VerDate Sep<11>2014
19:16 Aug 28, 2024
Jkt 262001
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
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
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 nonsubstantive 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
E:\FR\FM\29AUN1.SGM
29AUN1
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Federal Register / Vol. 89, No. 168 / Thursday, August 29, 2024 / Notices
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.
VerDate Sep<11>2014
19:16 Aug 28, 2024
Jkt 262001
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
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Fmt 4703
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70191
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]
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information collection by selecting
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for Public Comments’’ or by using the
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E:\FR\FM\29AUN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 168 (Thursday, August 29, 2024)]
[Notices]
[Pages 70189-70191]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19392]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: [email protected].
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
