[Federal Register Volume 88, Number 227 (Tuesday, November 28, 2023)]
[Notices]
[Pages 83131-83133]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-26137]


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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; Request for Comment

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 (CDC) in the 
Department of Health and Human Services (HHS) announces the opening of 
a docket to obtain comment on and review of proposed modifications to 
data collection fields for reporting of pregnancy success rates from 
assisted reproductive technology (ART) programs and proposed 
modifications to data validation procedures. This reporting is required 
by the Fertility Clinic Success Rate and Certification Act of 1992 
(FCSRCA).

DATES: Written comments must be received on or before January 29, 2024.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2023-
0093 by either of the methods listed below.
    Do not submit comments by email. CDC does not accept comments by 
email.
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

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     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; Attention: Assisted Reproductive Technology 
Surveillance and Research Team.
    Instructions: All submissions received must include the agency name 
and Docket Number. All relevant comments received will be posted 
without change to http://regulations.gov, including any personal 
information provided. For access to the docket to read background 
documents or comments received, go to http://www.regulations.gov.

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:

Public Participation

    Interested persons or organizations are invited to participate by 
submitting written views, recommendations, and data. In addition, CDC 
invites comments specifically on the following modifications to (1) 
data collection fields for reporting of pregnancy success rates from 
assisted reproductive technology (ART) programs; and (2) data 
validation procedures regarding the following proposals in this 
document:
     CDC proposal to remove the requirement for clinics to 
report dosage information for fertility medications including 
Clomiphene, Letrozole, and long-acting FSH.
     CDC proposal to remove the requirement for clinics to 
report information on research cycle study type.
     CDC proposal to add the requirement for clinics to report 
date of cryopreservation for fresh embryos.
     CDC proposal not to pursue targeted validation of clinics 
and identification of major data discrepancies.
    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. 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. Do not submit comments by 
email. CDC does not accept comments by email.

Background

    On August 26, 2015, HHS/CDC published a notice in the Federal 
Register (80 FR 51811) announcing the overall reporting requirements of 
the National ART Surveillance System. This notice described who shall 
report to HHS/CDC the process for reporting by each ART program; the 
data to be reported; the process for external validation of clinic 
data; and the contents of the published reports. CDC has obtained 
approval from the Office of Management and Budget under the Paperwork 
Reduction Act to collect this information which is needed to determine 
the annual pregnancy success rates for each clinic that provides ART 
services. This data collection is approved under OMB Control Number 
0920-0556, expiration date: December 31, 2024. CDC subsequently 
published a notice in the Federal Register on clarifications and 
modifications on December 15, 2016 (81 FR 90854), and a notice on 
clarifications and corrections on November 5, 2019 (84 FR 59625). In 
2021, CDC published a notice in the Federal Register (86 FR 20496) on 
changes to data validation of ART clinics. Subsequently, CDC published 
a notice in the Federal Register on June 10, 2022 (87 FR 35555) that 
added data collection fields and modified reporting requirements. The 
purpose of the subject notice is to (1) update data collection fields 
to reflect changes in ART practice that may impact pregnancy success 
rates; and (2) update the ART data validation process. This notice 
provides opportunity for public review and comment for the proposed 
modifications to data collection fields and data validation procedures.

Proposed Modifications to Data Collection Fields

    CDC is currently collecting information on Clomiphene dosage, 
Letrozole dosage, and other oral medication dosage (80 FR 51811; 
Section III ``What to Report'': F ``Stimulation and Retrieval''). 
Clomiphene and Letrozole are established treatment options for 
ovulation induction and may be administered based on patient 
diagnostics to increase the chances of ovulation and pregnancy. Other 
oral medications such as insulin-sensitizing agents may be used in 
specific groups of patients. Therefore, it is important to monitor the 
type of medication used, and CDC will continue to collect information 
on whether Clomiphene, Letrozole or other oral medication were used. 
However, dosage regimens for these medications follow established 
guidelines and are less likely to show variability in how they are 
administered. Given these treatment protocols, collection of these data 
can be streamlined. In addition, CDC is currently collecting dosage 
information on long-acting follicle stimulating hormone (FSH) 
medication. Since this medication is no longer used in ART practice, 
CDC proposes discontinuing the collection of information on this 
medication. Therefore, CDC proposes to remove the requirement for ART 
clinics to report associated dosage information related to (1) 
Clomiphene, Letrozole, or other oral medication; and (2) long-acting 
FSH. Deletion: Clomiphene dosage (Total mgs), Letrozole dosage (Total 
mgs), other oral medication dosage, long-acting FSH (Total mgs).
    CDC is currently collecting information on the type of research 
cycle performed by ART clinics (80 FR 51811; Section III ``What to 
Report'': G ``Laboratory Information''). Only a small number of 
research cycles are reported to CDC each year (i.e., 10 cycles in 
reporting year 2019, 7 cycles in reporting year 2020, and 0 cycles in 
reporting year 2021). CDC will continue to collect information on 
whether a cycle can be classified as a research cycle. CDC proposes to 
remove the requirement for clinics to report the research cycle study 
type, as only a small number of research cycles are performed each 
year. Deletion: Research cycle study type--if the cycle was a research 
cycle. This deletion will apply to all data fields for research study 
types: Device study, Protocol study, Pharmaceutical study, Laboratory 
technique, Other research.
    CDC is currently collecting information on fresh and frozen-embryo 
transfer procedures (80 FR 51811; Section III ``What to Report'': H 
``Transfer Information''). Embryo stage at the time of transfer is an 
important predictor of pregnancy success rates. For fresh-embryo 
transfer procedures, embryo stage can be determined by calculating the 
difference between the date of transfer and the date of oocyte 
retrieval. Both dates are currently collected. However, if fresh 
embryos were cryopreserved instead of being

[[Page 83133]]

utilized for a fresh transfer, the date of cryopreservation is not 
currently collected. In recent years, frozen-embryo transfers have 
become more prevalent as they may improve pregnancy success rates in 
certain groups of ART patients. For frozen-embryo transfers, the date 
at which fresh embryos were cryopreserved (with the date of oocyte 
retrieval) can be used to determine the stage of the embryo at the time 
of cryopreservation, which is an important predictor of ART success. 
Therefore, CDC proposes to add the date of fresh-embryo 
cryopreservation to the currently collected information as it will 
allow classification of embryo stage for frozen-embryo transfers and 
improve the reporting of factors that impact ART success rates. 
Addition: Date fresh embryos were cryopreserved--this date is to be 
reported for all frozen-embryo transfers.

Proposed Modifications to Data Validation Procedures

    Pursuant to the previous FRN notice (86 FR 20496), CDC proposed to 
conduct targeted validation of ART clinics to better capture systematic 
reporting errors by assessing certain reporting characteristics that 
may predict erroneously inflated ART success rates. In addition, CDC 
proposed to remove a clinic's reported success rates from the annual 
ART reports if major data discrepancies were identified. Identifying 
major data discrepancies would require the review of a larger number of 
clinic records at select clinics, thereby increasing data collection 
burden for clinics. Given the additional burden, CDC will not pursue 
implementation of targeted validation of ART clinics and identification 
of major discrepancies during data validation. CDC will continue to 
calculate discrepancy rates for key variables and provide feedback to 
clinics to improve the reporting of data used to report success rates 
as described in the FRN 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 the FRN notice (86 FR 20496).

Tiffany Brown,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2023-26137 Filed 11-27-23; 8:45 am]
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