Notice2022-12528
Reporting of Pregnancy Success Rates from Assisted Reproductive Technology (ART) Programs; Proposed Additional Data Collection Fields and Modified Reporting Requirements; Final Notice
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Published
June 10, 2022
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 additional data fields and modified reporting requirements for Assisted Reproductive Technology (ART) programs pursuant to the Fertility Clinic Success Rate and Certification Act of 1992 (FCSRCA). This notice also responds to public comments received in response to CDC's 2019 request for comment.
Full Text
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<title>Federal Register, Volume 87 Issue 112 (Friday, June 10, 2022)</title>
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[Federal Register Volume 87, Number 112 (Friday, June 10, 2022)]
[Notices]
[Pages 35555-35557]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-12528]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2019-0103]
Reporting of Pregnancy Success Rates from Assisted Reproductive
Technology (ART) Programs; Proposed Additional Data Collection Fields
and Modified Reporting Requirements; Final Notice
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
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 additional data fields and modified reporting requirements
for Assisted Reproductive Technology (ART) programs pursuant to the
Fertility Clinic Success Rate and Certification Act of 1992 (FCSRCA).
This notice also responds to public comments received in response to
CDC's 2019 request for comment.
DATES: The requirements for the additional data fields and modified
reporting requirements will be implemented for reporting year 2021.
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#236271774a4d454c634047400d444c55"><span class="__cf_email__" data-cfemail="abeaf9ffc2c5cdc4ebc8cfc885ccc4dd">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: On November 6, 2019, CDC published a notice
in the Federal Register (84 FR 59814) requesting comments on a plan
proposing that ART programs collect additional information, listed
below.
(i) For intended parents who are not oocyte source or pregnancy
carriers under Section A (Patient Demographic Information): race/
ethnicity.
(ii) For oocyte donors under Section D (Oocyte Source and Carrier
Information): height, weight, smoking history, and other key pregnancy,
diagnostic, and reproductive history (including number of prior
pregnancies [ectopic, spontaneous abortions]; number of prior births
[full term, preterm, live births, stillbirths]; history of prior ART
cycles [fresh, frozen]; maximum follicle-stimulating hormone (FSH)
level [value in mIU/mL]; and most recent anti-m[uuml]llerian hormone
(AMH) level [value in ng/mL, date]).
(iii) For both fresh embryo transfers and thawed embryo transfers,
under Section H (Transfer Information): clinic names if oocyte
retrievals took place in a clinic different from the one performing the
transfer.
CDC also proposed changes in reporting responsibilities when
multiple ART programs were involved in performing one cycle (such as
different ART programs responsible for ovarian stimulation, oocyte
retrieval, and/or embryo transfer), moving the reporting obligations
from the ART program that accepts responsibility for embryo culture to
the ART program that directs the clinical management of the cycle.
Public Comment Summary and Responses
CDC received three comments (two comments from researchers and one
from the Society for Assisted Reproductive Technology) in response to
its request for comment. Summaries of these comments and CDC's
responses are provided below.
1. One commenter cautioned that embryos shipped between centers
often arrive without retrieval information, such as dates of retrieval.
The commenter was otherwise supportive of collecting additional
information for embryos shipped from different centers, as it would
improve the accuracy of calculating cumulative success rates.
Response: CDC thanks the commenter for providing this comment.
Accurate documentation of oocyte retrieval dates is important for
establishing cumulative
[[Page 35556]]
success rates. No changes were made to the reporting requirement.
2. A second commenter suggested using the term ``intended parents''
rather than ``patients'' for people who are not using their own oocytes
or carrying a pregnancy. The commenter supported collection of
additional information for oocyte donors and suggested expanding data
collection to reflect changes in ART practice by collecting additional
information (such as reproductive health and history, demographics, and
detailed information on prior ART treatments) for all people involved
in an ART cycle, including both intended parents and gestational
carriers. The commenter also proposed that independent egg freezing
clinics or companies that are not affiliated with ART clinics should be
required to report their data. Finally, the commenter had many
suggestions for improving the data collected by the Society for
Assisted Reproductive Technology.
Response: CDC thanks the commenter for these suggestions. CDC
agrees that the suggested terminology (``intended parents'') is more
accurate. No changes were made to the reporting requirements based on
these comments; however, CDC will adopt the term ``intended parents''
where appropriate.
Any practice, program, or clinic providing ART services (such as
egg freezing) is required to report its data to CDC whether or not it
is affiliated with an ART clinic. Specifics about the reporting process
and requirements are described in ``Reporting of Pregnancy Success
Rates from Assisted Reproductive Technology (ART) Programs'' (80 FR
51811). Therefore, no changes to the reporting requirements are needed
based on these comments.
3. A third commenter expressed concerns about the burden of
additional data collection on reporting clinics. The commenter also
noted that additional variables related to egg donors may not have an
impact on pregnancy outcomes, which is the primary focus of FCSRCA.
Additionally, the commenter noted that CDC's plan to collect
information on race/ethnicity for intended parents using donor oocytes
and gestational carriers was mainly for research purposes, as these
variables have no biological effect on pregnancy outcomes.
Response: CDC thanks the commenter for providing their feedback.
Since the proposed additional information related to egg donors is
already collected during the time of egg retrieval, CDC will instead
link the information collected during egg retrieval from the clinic
that performed the egg retrieval with information reported during donor
egg or embryo transfer from the ART clinic performing the transfer.
This can be achieved by transmitting the cycle identification number
from the clinic that collected the donor egg to the clinic that
provides care to the donor egg recipient. This will allow utilization
of the data that are already collected to avoid additional burden on
clinics. The details of the proposed linkage plan will be published
separately in a different Federal Register notice before
implementation.
CDC notes the commenter's feedback regarding collecting information
on race/ethnicity for a small group of intended parents that do not use
their own eggs or carry a pregnancy. Other demographic information such
as date of birth, sex, and residency status are currently collected for
this group; however, information on race/ethnicity is currently only
collected for oocyte sources and pregnancy carriers. Collecting
information on race/ethnicity for both intended parents that do not use
their own eggs or carry pregnancy, and for oocyte sources and pregnancy
carriers, ensures consistency in demographic data collection. CDC also
believes that this information allows the pregnancy success rates to
reflect a complete set of demographics for intended parents and will
help better understand disparities in utilization of ART services.
Please see the revised Appendix below for the new requirements.
Appendix--Notice for Reporting of Pregnancy Success Rates From Assisted
Reproductive Technology (ART) Programs; Additional Data Collection
Fields and Modified Reporting Requirements:
A. Background
On August 26, 2015, CDC published a notice in the Federal
Register (80 FR 51811) announcing the overall reporting requirements
of the National ART Surveillance System (NASS). The notice described
who shall report to HHS/CDC; the process for reporting by each ART
program; the data to be reported; and the contents of the published
reports. This data collection is approved under Office of Management
and Budget Control Number 0920-0556, expiration date: 12/31/2024.
The purpose of this notice published June 10, 2022 is to apply
consistent data collection requirements to various treatment
options, including certain rare situations, to improve quality of
data. Effective for reporting year 2021, CDC is implementing the
following changes to its data collection.
Section III. What to Report
Section A. Patient Demographic Information
Addition (for Intended Parents Who Are Not Oocyte Source or Pregnancy
Carrier)
In addition to collecting information on race and ethnicity for
oocyte source, sperm source, and pregnancy carrier as part of the
current data collection system, CDC will also collect race and
ethnicity information for intended parents who do not use their own
oocytes (use donor eggs) and do not carry the pregnancy (use
gestational carrier). Specifically, this information will include
(i) Ethnicity (Hispanic, non-Hispanic, Refused, Unknown) and (ii)
Race (White, Black, Asian, Native Hawaiian/Pacific Islander,
American Indian or Alaska Native, Refused, Unknown). CDC has added
these questions to the patient profile in the beginning of the
questionnaire to ensure consistency in demographic data collected
and to allow the pregnancy success rates to reflect a complete set
of demographics for intended parents. To reduce the reporting
burden, the system has been designed to pre-fill race/ethnicity of
oocyte source, sperm source, or pregnancy carrier, if previously
reported.
Section D. Oocyte Source and Carrier Information
Addition (for Oocyte Donors)
CDC has replaced its original plan to add several new data
collection fields for oocyte donors which were to be obtained
directly from ART programs. Instead, CDC plans to use the oocyte
donor cycle identifying information to link and retrieve information
about oocyte donors collected at the time of egg retrieval. When
applicable, oocyte donor cycle identifying information will be
transferred from the program involved in egg retrieval to the
program involved in subsequent use of donor eggs. The details of the
proposed linkage plan and the timeline for implementation of this
plan will be published in a separate Federal Register notice before
implementation.
Section H. Transfer Information
Addition (if Oocyte Retrieval Was Not Conducted at the Same Clinic as
Transfer)
CDC will collect the name of the clinic in which the previous
egg retrieval occurred for all fresh embryo transfers and thawed
embryo transfers if the retrieval and transfer were completed at
different clinics. Oocyte retrieval dates are already being
collected for all transferred embryos.
Reporting Requirement Modification
Section I. Who Reports
Sub-Section C. Reporting Responsibilities of ART Program
Modification (if More Than One Program is Involved in One Cycle)
Multiple ART programs involved in one cycle -- Different ART
programs responsible for ovarian stimulation, oocyte retrieval, and/
or embryo transfer.
The following updated guidelines shall be used:
a. The requirement to report cycles lies with the ART program
that directs the
[[Page 35557]]
clinical management of the cycle, which would include (but is not
limited to) multiple aspects of the treatment such as patient
selection, pre-treatment counseling and selection of the specific
treatment protocol. The ART programs involved must have a method in
place to ensure that these cycles can be prospectively reported by
the ART program required to report them. In addition, all canceled
cycles must be reported by the same ART program.
b. Cycles involving previously cryopreserved oocytes/embryos are
to be reported by the ART program that accepts responsibility for
thawing the oocytes/embryos.
Dated: June 7, 2022.
Angela K. Oliver,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2022-12528 Filed 6-9-22; 8:45 am]
BILLING CODE 4163-18-P
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