[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]



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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]
 BILLING CODE 4163-18-P