60-day Federal Register Notice

Attachment B2. Program Response to Comments to 60 Day FRN
Comments in response to the Federal Register Notice
A 60-day Notice was published in the Federal Register on April 5, 2024, Vol. 89, No. 67, pp. 24005-24007
with the title Proposed Data Collection Submitted for Public Comment and Recommendations
(Attachment B1). CDC received two comments related to this notice (Attachment B2). CDC did not
provide a response to one comment because it fell outside the scope of this information collection. The
other comment was supportive of the data collection and provided feedback on enhancing the quality,
utility, and clarity of the information to be collected.
Comments

Date Received by CDC

CDC’s Response

A comment submitted by
Jean Publie.

04/06/2024

No reply (outside scope of project).

06/04/2024

CDC thanks the commenters for their comments. CDC
currently collects race and ethnicity data for both intended
parents as well as for oocyte sources and pregnancy carriers
to ensure consistency in demographic data collection. CDC
will amend the data collection to align with revised SPD15 and HHS Sexual Orientation and Gender Identity
questions after clinics have a chance to be notified of these
proposed changes per FCSRA. CDC agrees that
improvements can be made in the collection of other
demographic variables such as educational attainment,
income, and insurance or payment type.
However, additional data collection by CDC is undertaken
after careful estimations of extra burden on clinics.

The commenter
suggested that data
collection was not
necessary and a waste of
federal funds

Comment submitted
jointly by Dr. Tierney,
Dr. Jacobsen, and Dr.
Leyser-Whalen.
The commenters
suggested improvements
in race and ethnicity data
collection for both
patients and gestational
carriers, and also
suggested additional data
collection elements
related to social
determinants of health
such as educational
attainment, income, and
insurance or payment
type to capture
inequalities in utilization
and outcomes of ART
treatments. Additionally,
the commenters
suggested that
percentages be replaced
with numbers in the
reports for fertility
preservation by patient
age, and also requested
that clinic data tables in
excel spreadsheets are
archived as was done
previously.

CDC thanks the commenters for their comments and notes
the commenters’ feedback regarding these reporting
improvements. CDC will consider measures that improve
the practical utility of the information collected and
disseminated, while protecting confidentiality of patients.

The commenters
expressed appreciation of
the ART Fertility Clinic
and National Summary
Report.

PUBLIC SUBMISSION

As of: 6/24/24, 8:23 AM
Received: April 08, 2024
Status: Posted
Posted: April 09, 2024
Tracking No. lur-l81e-sess
Comments Due: June 05, 2024
Submission Type: Web

Docket: CDC-2024-0025
Assisted Reproductive Technology (ART) Program Reporting System
Comment On: CDC-2024-0025-0001
Assisted Reproductive Technology (ART) Program Reporting System
Document: CDC-2024-0025-0002
Comment from publie, jean

Submitter Information
Name: jean publie
Address:
flemington, NJ, 08822
Email: jeanpublic1@gmail.com
Phone: 800-000-0000

General Comment
i totally oppose billions of dollars going to this sneaky operation with its closed
meetings and failure to report to the us public via foia,this regulatgory agency is a
sneaky closed shop that has been causing fertility problems with bad vaccineis and
drugs for years and we need to stop their regulatory authority. all of them bounce back
and forth between bigpharma and the govt jobs for more and more money and they
seem to have no real connection to doing right by ghe public. they have taken actions
which have been negative for the us public imo i do not think this close connection
with this field isnecessary art all and believe itis a waste of our total tax dollars. it
needs to be shut down. this collection is not necessary and tells us noting valuable that
we need. this agency has been out of control for the last 25 years always asking for
more and more money with zero accountability for results. resutls dont count. just
more money for these useless mostly animal abusers. we shoudl shut down all animal

research by these sadists imo. the grade i wuold give this group is f minus or zero for
its work.

June 4, 2024

Dr. Katherine I. Tierney
Assistant Professor of Sociology
Western Michigan University
1903 West Michigan Avenue
Kalamazoo, Michigan 49008
Dr. Heather Jacobson
Professor of Sociology and Department Chair
University of Texas at Arlington
601 S. Nedderman Drive
Arlington, Texas 76019
Dr. Ophra Leyser-Whalen
Associate Professor of Sociology
University of Texas at El Paso
500 W. University Ave.
El Paso, TX 79968
RE: CDC, Assisted Reproductive Technology (ART) Program Reporting System

Dear CDC:
Thank you for the opportunity to comment on the Assisted Reproductive Technology (ART)
Program Reporting System. This comment responds to the identified issue of “enhanc[ing] the
quality, utility, and clarity of the information to be collected.”
As professors and social scientists researching assisted reproduction, we utilize the Centers for
Disease Control and Prevention’s Assisted Reproductive Technology Fertility Clinic and National
Summary Report that is generated via the ART Program Reporting System in our research. This
report and the available datasets are a primary data source for statistics to understand the scope
and practice of ART in the U.S. We write to express our support for this vitally important
continued data collection. Specifically, these are the only high-quality, publicly available data on
ART success rates and births in the U.S. Although information on ART use is collected on the
U.S. birth certificate, several studies have shown that birth certificate data underreport ART
births (e.g., Cohen et al. 2014; Moaddab et al. 2016; Thoma et al. 2014; Tierney & Cai 2019).
Further, the vital statistics datasets are often difficult for the general public to access due to the
size of the data files, which necessitates the use of specialized software. In addition, based on
historical studies (Stephen et al. 2016), demographic projections (Tierney 2022), and ongoing
delays to first births (e.g., Osterman et al. 2024), we believe demand for ART will only increase.

Therefore, continued collection and reporting on these data is necessary to both inform patientclients and enhance population level research on ART.
We would like to communicate our appreciation for the improvements made over the years to
data collection efforts and the presentation of the generated data in the ART Fertility Clinic and
National Summary Report. This includes the change begun with the 2021 report of including
numbers of patients receiving ART treatments, in addition to the number of ART cycles. We
appreciate the attention to this data collection and would like to make four specific suggestions
for continued improvement.
1) While demographic data are collected, expanding the patient demographic data that are
made available and easily accessible in the national summary report and dataset would
not only assist social scientists studying ART but would also help provide more
transparent data to patient-clients about ART accessibility. We make the following
specific recommendations related to demographic data collection/reporting:
a. Improvements to Race/Ethnicity Reporting– given the well documented disparities
in ART access and outcomes by racial/ethnic groups, efforts to address the known
quality issues in the reporting of race/ethnicity (as reported by Wellons et al.
2012) is needed both for patient-clients searching for care and to improve
population-level research on these inequalities. Furthermore, reporting easily
accessible demographic information on gestational carriers would provide muchneeded data for researchers.
b. Improvements to Age Reporting—first, in the reports, most data charts are
displayed only by age groups, which obscures the overall rates. Thus, we believe
adding a summary of aggregated data in the consumer-facing reports would be
useful. At the same time, datasets provided to researchers, or geared toward
clinicians, should include more detailed information of outcomes by age. More
detailed age reporting would also be valuable to consumers as they seek to make
informed medical decisions, and to clinicians counseling patients. Therefore,
reporting of these data by single year of age or with more clearly bounded age
groups would enhance their utility. For example, many outcomes are reported for
individuals under 35 and over 40. However, for quantitative research, such
“unbounded” numbers require researchers to make assumptions about the
population at-risk. Therefore, specifying the lower and upper bounds of these
ranges would enable more accurate inferences. Importantly, we believe that such
detailed age data should only be reported at the national level to help safeguard
individuals’ privacy.
c. Addition of Indicators of Socioeconomic Status (SES)—another area of inequality
in ART utilization and outcomes is related to SES. As policy contexts for
mandated coverage continue to change, information on social class (such as
income, educational attainment, or insurance or payment type) would represent a
critical expansion in the ability of researchers to understand access to ART care
and inequalities in ART by SES.
2) Certain language choices could be updated and/or modified:

a. The term “gender” is used in reports when referring to “sex.”
b. The term “people” could replace “women” to be more gender inclusive.
c. While an explanation for the use of the term “cycle” is provided, referring to
procedures as cycles may prove confusing for readers of the national reports,
especially for patient-clients.
3) The percentages provided in the tables in the National and Clinic reports (e.g., the
percentage of cycles for fertility preservation by patient age in the “Characteristics of
ART Cycles” section) are easily interpretable and of use for patient-clients. However, for
the research-oriented dataset, we would strongly advise directly reporting the underlying
numbers (e.g., number of cycles for fertility preservation in each age group). Such an
adjustment would allow researchers to transparently create their own measures without
the need for “back-calculations,” which introduces error.
4) Starting with the 2019 data on the Archived ART website
(https://www.cdc.gov/art/reports/archive.html), the presentation of clinic data on the
EXCEL spreadsheet for each year changed, such as the “Clinic Table Data Records” no
longer being available. The consistency of those data from 1995 forward is helpful for
researchers studying changes and trends in ART-providing clinics. We suggest
reintroducing the Clinic Table Data Records in the archived data and making efforts to
harmonize the national data reporting across years to the extent possible.
In summary, the ART data collection and high-quality reports made available via the CDC are
vital for researchers studying assisted reproduction in the U.S. and useful for patient-clients and
those providing services and support to them. Our comments here reflect suggestions for
improvement based on our experiences using the data. Thank you for the opportunity to make
comments.
Sincerely,
Dr. Tierney, Dr. Jacobson, Dr. Leyser-Whalen

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