[Federal Register Volume 87, Number 112 (Friday, June 10, 2022)]
[Notices]
[Pages 35555-35557]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-12528]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: [email protected].

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