Notice2023-26137
Reporting of Pregnancy Success Rates From Assisted Reproductive Technology (ART) Programs; Proposed Modifications to Data Collection Fields and Data Validation Procedures; Request for Comment
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
November 28, 2023
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
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).
Full Text
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<title>Federal Register, Volume 88 Issue 227 (Tuesday, November 28, 2023)</title>
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[Federal Register Volume 88, Number 227 (Tuesday, November 28, 2023)]
[Notices]
[Pages 83131-83133]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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.
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">http://www.regulations.gov</a>.
Follow the instructions for submitting comments.
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<bullet> 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 <a href="http://regulations.gov">http://regulations.gov</a>, including any personal
information provided. For access to the docket to read background
documents or comments received, go to <a href="http://www.regulations.gov">http://www.regulations.gov</a>.
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#e1a0b3b5888f878ea1828582cf868e97"><span class="__cf_email__" data-cfemail="a8e9fafcc1c6cec7e8cbcccb86cfc7de">[email protected]</span></a>.
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:
<bullet> CDC proposal to remove the requirement for clinics to
report dosage information for fertility medications including
Clomiphene, Letrozole, and long-acting FSH.
<bullet> CDC proposal to remove the requirement for clinics to
report information on research cycle study type.
<bullet> CDC proposal to add the requirement for clinics to report
date of cryopreservation for fresh embryos.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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
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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]
BILLING CODE 4163-18-P
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