[Federal Register Volume 84, Number 215 (Wednesday, November 6, 2019)]
[Notices]
[Pages 59814-59815]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24174]
[[Page 59814]]
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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;
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), located
within the Department of Health and Human Services (HHS), announces the
opening of a public docket to obtain comment and review of proposed
additional data collection fields and reporting requirement
modification for reporting of pregnancy success rates from assisted
reproductive technology (ART) programs. 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 6, 2020.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2019-
0103 by any of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Mail: Division of Reproductive Health, National Center for Chronic
Disease Prevention and Health Promotion, Centers for Disease Control
and Prevention, Mailstop S107-2, 4770 Buford Hwy. NE, Atlanta, Georgia
30341-3724. Attention: Assisted Reproduction Technology Surveillance
and Research Team.
FOR FURTHER INFORMATION CONTACT: Jeani Chang, Division of Reproductive
Health, National Center for Chronic Disease Prevention and Health
Promotion, Centers for Disease Control and Prevention, 4770 Buford
Highway, MS-C107-2, Atlanta, Georgia 30341. Phone: (770) 488-6355.
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 proposed additional data collection
fields and reporting requirement modification for reporting of
pregnancy success rates from assisted reproductive technology (ART)
programs.
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. Therefore, 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. CDC will
carefully consider all comments submitted.
Background
On August 26, 2015, HHS/CDC published a notice in the Federal
Register (80 FR 51811) (Current Notice) 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. CDC has already 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: 08/31/2021. This information includes
clinical information pertaining to the ART procedure, outcome
information on resultant pregnancies and births, and information on
factors that may affect outcomes, such as patient demographics, medical
history, and infertility diagnosis. The purpose of this notice
published [current date] is to apply consistent data collection
requirements to various treatment options, including certain rare
situations to improve quality of data. This notice provides opportunity
for public review and comment for the proposed additional data
collection fields.
Proposed Additional Data Collection Fields
Section III. What to Report
Section A. Patient Demographic Information
CDC is currently collecting information on race/ethnicity for
oocyte source and pregnancy carrier. In the rare situation when a
patient is not using her own oocytes (uses donor eggs) and does not
carry the pregnancy (uses gestational carrier), the current data
collection system will not capture patient race/ethnicity. CDC proposes
adding these questions to the patient profile in the beginning of the
questionnaire to help better understand the demographic profile of all
ART users and accurately assess ART success rates in this rare
situation. To reduce the reporting burden, the system will then pre-
fill race/ethnicity of oocyte source, sperm source, or gestational
carrier, if applicable.
Addition (for Patients Who Are Not Oocyte Source or Pregnancy Carrier)
Ethnicity (Hispanic, non-Hispanic, Refused, Unknown); Race (White,
Black, Asian, Native Hawaiian/Pacific Islander, American Indian or
Alaska Native, Refused, Unknown).
Section D. Oocyte Source and Carrier Information
CDC is currently collecting information on height, weight, smoking
history, prior ART cycles, diagnostic tests, and the pregnancy history
of a patient. However, this information is important regardless of
oocyte source to better understand the role of these factors on ART
success rates. CDC proposes adding these questions to the donor oocyte
source profile.
Addition (for Oocyte Donors)
Height; Weight; History of Smoking; History of Prior Pregnancies
and Births (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 FSH
Level (value in mIU/mL); Most Recent AMH Level (value in ng/mL, date).
Section H. Transfer Information
CDC is currently collecting the date of any previous oocyte
retrieval that contributed to a reported embryo transfer cycle to allow
for details of previous retrievals to be linked to current transfers.
However, this information is only collected if egg retrieval and
transfer occur in the same clinic. It is important to link retrievals
and transfers whether the retrieval and
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transfer occurred in the same clinic or when oocytes were retrieved in
an ART clinic that is different from the ART clinic where the current
transfer is taking place. Collection of the clinic name in which the
previous retrieval took place (if different from the clinic performing
the transfer) will allow for more complete linkage of embryo transfers
to egg retrievals. This information will allow for a better
understanding of the cumulative success rates over multiple ART
treatment cycles. CDC therefore proposes adding this information for
current fresh embryo transfers or thawed embryo transfers if the
retrieval and transfer did not occur in the same clinic.
Addition (if Oocyte Retrieval Was Not Conducted at the Same Clinic as
Transfer)
1. Fresh Embryo Transfer
Name of clinic if different from where oocyte retrieval took place.
2. Thawed Embryo Transfer
Name of clinic if different from where oocyte retrieval took place.
Proposed Reporting Requirement Modifications:
Section I. Who Reports
Sub-Section C. Reporting Responsibilities of ART Program
CDC currently requires that, when multiple programs are involved in
one cycle, the requirement to report cycles lies with the ART program
that accepts responsibility for the embryo culture or thawing the
oocytes or embryos. However, when clinics are contracting with external
embryo laboratories, these laboratories may not be recognizable to the
consumer. Therefore, we are proposing to change the requirement to
report cycles to the ART program that directs the clinical management
of the cycle. Both current and modified guidelines are provided below.
Current: Multiple ART programs involved in one cycle--Different ART
programs responsible for ovarian stimulation, oocyte retrieval, and/or
embryo transfer.
The following guidelines should be used:
a. The requirement to report cycles lies with the ART program that
accepts responsibility for the embryo culture. 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 ART program
accepting responsibility for the embryo culture.
b. Cycles involving previously cryopreserved oocytes/embryos are to
be reported by the ART program that accepts responsibility for thawing
the oocytes/embryos.
Modification (to ensure more accurate reporting by modifying
reporting responsibilities when 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 guidelines should be used:
a. The requirement to report cycles lies with the ART program that
directs the 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: October 31, 2019.
Sandra Cashman,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2019-24174 Filed 11-5-19; 8:45 am]
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