[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]


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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: [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]
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