Assisted Reproductive Technology (ART) Success Rates Reporting and Data Validation Procedures, 53253-53256 [2018-22991]
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Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Notices
This is a revised Information
Collection Request (ICR) supporting a
broader group of employers to access
the updated and pilot tested Scorecard,
a web-based worksite organizational
assessment, to regularly assess their
workplace health programs and
practices. Scorecard users will create a
user account, complete the online
assessment and receive an immediate
feedback report that summarizes the
current status of their worksite health
program; identifies gaps in current
programming; benchmarks individual
employer results against other users of
the system; and provides access to
worksite health tools and resources to
address employer gaps and priority
program areas.
of the strategies and interventions
contained in the questions has been
completed. This will streamline future
information collection and minimize
additional response time.
CDC will continue to provide
outreach to, and register approximately
800 employers per year to use the online
Scorecard survey in their workplace
health program assessment, planning,
and implementation efforts, which is
open to employers of all sizes, industry
sectors, and geographic locations across
the country. OMB approval is requested
for three years. Participation is
voluntary and there are no costs to
respondents other than their time.
The updated Scorecard is based on a
2017 pilot test to determine the validity
and reliability involving 89 employers
(each represented by two knowledgeable
employees) who completed the survey
and follow-up telephone interviews to
gather general impressions of the
Scorecard—particularly the new
modules—and also to discuss items
where there were discrepancies (and
items that were left blank) to understand
the respondent’s interpretation and
perspective of their answers to these
questions. The revised instrument
includes some reorganization of the
instrument and minor revisions,
particularly to the new modules/
questions, to better explain and define
the context, concepts, or administration
ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hrs)
Total burden
(in hrs)
Form name
Employers .........................................
CDC Worksite Health ScoreCard
Registration.
CDC Worksite Health Scorecard .....
800
1
5/60
67
800
1
45/60
600
...........................................................
........................
........................
........................
667
Total ...........................................
Jeffrey M. Zirger,
Acting Chief, Information Collection Review
Office, Office of Scientific Integrity, Office
of the Associate Director for Science, Office
of the Director, Centers for Disease Control
and Prevention.
Department of Health and
Human Services (HHS), Centers for
Disease Control and Prevention (CDC).
ACTION: Notice of availability.
to include the footnotes to identify
clinics selected by CDC to participate in
the validation process of the National
ART Surveillance System (NASS) data
and: (a) Do participate, (b) do participate
and have major data discrepancies
identified through this process, or (c)
decline to participate in the data
validation process. This notice responds
to the comments received in response to
the notice published on May 31, 2018
and announces the availability of the
revised process for ART Success Rates
Reporting and plans for revising Data
Validation Procedures.
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
NE, Mailstop F–74, Atlanta, Georgia
30341. Telephone: (770) 488–5200;
email: ARTinfo@cdc.gov.
On May 31, 2018, the Centers
for Disease Control and Prevention
(CDC) in the Department of Health and
Human Services (HHS) requested
comments on a plan to (1) revise the
definition and characterization of
Assisted Reproductive Technology
(ART) success rates and (2) introduce
clinic validation footnotes for the
annual ART Fertility Clinic Success
Rates Report. In the plan, CDC proposed
Public Comment Summary and
Responses
CDC received three public comments
to the docket. One comment was
considered nonsubstantive because it
was outside the scope of the docket. A
second comment was supportive of
CDC’s planned approach for revising the
definition of success rates and
introducing clinic validation footnotes.
The third comment contained concerns
[FR Doc. 2018–22940 Filed 10–19–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2018–0054]
Assisted Reproductive Technology
(ART) Success Rates Reporting and
Data Validation Procedures
AGENCY:
SUMMARY:
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about CDC’s planned clinic validation
footnotes and the approach to clinic
validation, and requested a clarification
of the reporting requirements of embryo
banking cycles. These suggestions, as
well as CDC’s responses, are included
below:
1. ART success rates reporting: One
commenter asked that CDC provide
more details about reporting
requirements of embryo banking cycles.
Response: CDC thanks the commenter
for this request. Egg/embryo banking
cycles intended for pregnancy in the
short term include cycles initiated with
the intent of cryopreserving all eggs/
embryos for subsequent transfers within
12 months. Egg/embryo banking cycles
intended for pregnancy in the long term
(often referred to as fertility
preservation) include cycles where the
patient did not start any transfer cycles
within the 12 month period following
the date on which the intended retrieval
cycle started and one of the following:
(1) The cycle intent was long term (>12
months) banking for fertility
preservation prior to gonadotoxic
medical treatments; or (2) The cycle
intent was long term (>12 months)
banking for other reasons and (a) at least
one egg was retrieved, and (b) at least
one egg or embryo was frozen. Specifics
about the reporting process and
requirements are described in
‘‘Reporting of Pregnancy Success Rates
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Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Notices
from Assisted Reproductive Technology
(ART) Programs’’ (80 FR 51811).
2. Clinic data validation and
footnotes: A commenter expressed
concern that discrepancies identified
during on-site data validation would not
be corrected prior to publication of the
ART Fertility Clinic Success Rates
Report. The commenter suggested that
instead of including a footnote,
identification of erroneous data (such as
an incorrect number of reported cycles
or pregnancy outcomes) should result in
removing clinic success rates from ART
Fertility Clinic Success Rates Report,
and that erroneous data should not be
included with data from other clinics.
The commenter was also concerned that
random selection of clinics under the
current CDC validation system does not
identify systematic reporting errors. The
commenter suggested that targeted
selection of clinics based on reporting
characteristics that predict erroneously
inflated ART success rates is a better
approach to identify systematic
reporting errors. Finally, the commenter
was concerned that validation footnotes
and the appendix may not be easily
understood by the patients.
Response: CDC thanks the commenter
for expressing these concerns and for
providing suggestions to improve
reporting. CDC is considering these
concerns and reviewing options for
future years’ data validation. CDC is
withdrawing its pending proposal for
data validation footnotes (83 FR 25009).
If CDC determines that changes in data
validation selection processes and/or
footnotes are advisable, proposed
changes will be published in the
Federal Register for public comment.
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Appendix—Notice for Assisted
Reproductive Technology (ART)
Success Rates Reporting:
A. Background
Section 2(a) of Public Law 102–493
(42 U.S.C. 263a–1(a)), the Fertility
Clinic Success Rate and Certification
Act of 1992 (FCSRCA), requires that
each assisted reproductive technology
(ART) program report annually to the
Secretary of the Department of Health
and Human Services through the
Centers for Disease Control and
Prevention (CDC) pregnancy success
rates achieved through assisted
reproductive technology. The FCSRCA
also requires CDC to annually publish
and distribute to the public reported
pregnancy success rates for each ART
clinic. According to the FCSRCA, the
definitions of pregnancy success rates
should be developed in consultation
with appropriate consumer and
professional organizations, should take
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into account the effect on success rates
of age, diagnosis, and other significant
factors, and should include the live
birth rate per attempted ovarian
stimulation procedure and the live birth
rate per successful oocyte retrieval.
Specifics about the reporting process
and requirements are described in
‘‘Reporting of Pregnancy Success Rates
from Assisted Reproductive Technology
(ART) Programs’’ (August 26, 2015; 80
FR (51811–51819)). Specifics about the
definition and characterization of ART
success rates were last described in
‘‘Reporting of Pregnancy Success Rates
from Assisted Reproductive Technology
Programs’’ (February 5, 2004; 69 FR
(5548–5550)). Success rates for fresh,
nondonor cycles were defined as: 1. The
rate of pregnancy after completion of
ART according to the number of all
ovarian stimulation or monitoring
procedures; 2. the rate of live birth after
completion of ART according to the
number of all ovarian stimulation or
monitoring procedures, the number of
oocyte retrieval processes, and the
number of embryo (or zygote or oocyte)
transfer procedures; 3. the rate of
singleton live birth after completion of
ART according to the number of all
ovarian stimulation or monitoring
procedures and the number of embryo
(or zygote or oocyte) transfer
procedures. Success rates for cycles
using thawed embryos and cycles using
donor oocytes or embryos were defined
as: 4. the rate of live birth after
completion of ART according to the
number of embryo (or zygote or oocyte)
transfer procedures; 5. the rate of
singleton live birth after completion of
ART according to the number of embryo
(or zygote or oocyte) transfer
procedures.
Effective for reporting year 2017, CDC
is implementing substantial changes to
the definition and characterization of
ART success rates due to changes in
clinical practice and more variation in
treatment options, including
improvements in cryopreservation
resulting in more segmentation of
typical treatment cycles. The field of
ART is moving toward the calculation
and reporting of cumulative success
rates where data collection systems can
collect successes over all embryo
transfers from a single oocyte retrieval
or across several oocyte retrievals and
embryo transfers. After consultation
with consumer and professional
organizations with expertise in ART,
CDC will begin cumulative ART success
rates reporting in reporting year 2017.
The ART success rates described in this
Federal Register notice shall replace
those previously described in 2004.
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B. ART Procedures Among Patients
Using Their Own Oocytes
ART success rates for ART procedures
among all patients using their own eggs
are defined as:
1. The rate of live birth or singleton
live birth resulting from the transfer of
oocytes retrieved from the patient in the
year prior to the reporting year or from
the transfer of embryos created from
oocytes retrieved from the patient in the
year prior to the reporting year. For the
purpose of this definition, transfer
procedures must have started within 12
months of the start of the retrieval
procedure. Oocytes must have been
retrieved in the year prior to the
reporting year in order to allow a full
year to perform transfers of the retrieved
oocytes (either in the prior reporting
year or in the current reporting year).
The live birth rate and singleton live
birth rate will be presented according to
the number of:
a. All ovarian stimulation or
monitoring procedures started from the
year prior to the reporting year with the
intent to retrieve oocytes from the
patient.
b. All ovarian stimulation or
monitoring procedures started in the
year prior to the reporting year with the
intent to retrieve oocytes from the
patient in which at least one oocyte was
retrieved.
c. All transfer procedures of at least
one oocyte retrieved from the patient in
the year prior to the reporting year, or
of at least one embryo created from an
oocyte retrieved from the patient in the
year prior to the reporting year. For the
purpose of this definition, egg or
embryo transfer procedures must have
started within 12 months of the start of
the retrieval procedure.
2. The number of ovarian stimulation
or monitoring procedures started in the
year prior to the reporting year with the
intent to retrieve oocytes from the
patient presented according to the
number of:
a. Live births resulting from all
transfers of at least one oocyte retrieved
from the patient in the year prior to the
reporting year, or transfers of at least
one embryo created from an oocyte
retrieved from the patient in the year
prior to the reporting year. For the
purpose of this definition, egg or
embryo transfer procedures must have
started within 12 months of the start of
the retrieval procedure.
Other rates for ART procedures
among all patients using their own eggs
are defined as follows (and may be
provided publically at the ART
program’s discretion)—
3. The rate of cancellation,
implantation, pregnancy, live birth,
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singleton live birth, multiple live birth,
twin live birth, triplet or higher order
live birth, preterm live birth, low
birthweight live birth or term, normal
birthweight and singleton live birth
resulting from the transfer of oocytes
retrieved from the patient in the year
prior to the reporting year or the transfer
of embryos created from oocytes
retrieved from the patient in the year
prior to the reporting year. For the
purpose of this definition, transfer
procedures must have started within 12
months of the start of the retrieval
procedure. These other rates may be
presented according to the number of:
a. All ovarian stimulation or
monitoring procedures started in the
year prior to the reporting year with the
intent to retrieve oocytes from the
patient.
b. All ovarian stimulation or
monitoring procedures started in the
year prior to the reporting year with the
intent to retrieve oocytes from the
patient in which at least one oocyte was
retrieved.
c. All transfer procedures of at least
one oocyte retrieved from the patient in
the year prior to the reporting year, or
of at least one embryo created from an
oocyte retrieved from the patient in the
year prior to the reporting year. For the
purpose of this definition, egg or
embryo transfer procedures must have
started within 12 months of the start of
the retrieval procedure.
d. All first, second, third, or more
transfer procedures after retrieval of at
least one oocyte from the patient in the
year prior to the reporting year, or of at
least one embryo created from an oocyte
retrieved from the patient in the year
prior to the reporting year. For the
purpose of this definition, egg or
embryo transfer procedures must have
started within 12 months of the start of
the retrieval procedure.
Rates for ART procedures among new
ART patients (i.e. patients that have
never had a prior ART cycle ever) using
their own oocytes are defined as—
4. The rate of live birth resulting from
the transfer of oocytes or embryos from
all first intended oocyte retrievals
presented according to the number of:
a. ART patients who reported at the
start of the retrieval procedure that they
had no prior ART stimulations and no
prior frozen ART procedures. For the
purpose of this definition, the retrieval
procedure must have started in the year
prior to the reporting year.
5. The rate of live birth resulting from
the transfer of oocytes or embryos from
all first or second intended oocyte
retrievals presented according to the
number of:
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a. ART patients who reported at the
start of the retrieval procedure that they
had no prior ART stimulations and no
prior frozen ART procedures. For the
purpose of this definition, the retrieval
procedure must have started in the year
prior to the reporting year.
6. The rate of live birth resulting from
the transfer of oocytes or embryos from
all intended oocyte retrievals presented
according to the number of:
a. ART patients who reported at the
start of the retrieval procedure that they
had no prior ART stimulations and no
prior frozen ART procedures. For the
purpose of this definition, the retrieval
procedure must have started in the year
prior to the reporting year.
7. The number of ovarian stimulation
or monitoring procedures started in the
year prior to the reporting year with the
intent to retrieve oocytes from the
patient presented according to the
number of:
a. ART patients who reported at the
start of the retrieval procedure that they
had no prior ART stimulations and no
prior frozen ART procedures.
8. The number of transfer procedures
of at least one oocyte retrieved from the
patient in the year prior to the reporting
year, or of at least one embryo created
from an oocyte retrieved from the
patient in the year prior to the reporting
year presented according to the number
of:
a. Ovarian stimulation or monitoring
procedures started in the year prior to
the reporting year with the intent to
retrieve oocytes from the patient. For
the purpose of this definition, egg or
embryo transfer procedures must have
started within 12 months of the start of
the retrieval procedure. Also, ART
patients must have reported at the start
of the retrieval procedure that they had
no prior ART stimulations and no prior
frozen ART procedures.
C. ART Procedures Among Patients
Using Oocytes or Embryos From a Donor
Success rates for ART procedures
among patients using oocytes or
embryos from a donor are defined as—
9. The rate of live birth or singleton
live birth presented according to the
number of:
a. Transfer procedures of at least one
donor egg, embryo created from a donor
egg, or donated embryo started in the
current reporting year.
Other rates for ART procedures
among patients using oocytes or
embryos from a donor are defined as
follows (and may be provided publically
at the ART program’s discretion):
10. The rate of cancellation,
implantation, pregnancy, live birth,
singleton live birth, multiple live birth,
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twin live birth, triplet or higher order
live birth, preterm live birth, low
birthweight live birth, or term, normal
birthweight and singleton live birth
presented according to the number of:
a. ART procedures to prepare a
patient (recipient) for the transfer of at
least one donor egg, embryo created
from a donor egg, or donated embryo,
started in the current reporting year.
b. Transfer procedures of at least one
donor egg, embryo created from a donor
egg, or donated embryo started in the
current reporting year.
D. ART Procedures Among All Patients
and All Cycle Types
At the discretion of the ART program,
ART reporting also may include:
11. The number, average number or
percentage of ART procedures or ART
patients with certain characteristics,
such as:
a. Patient characteristics (e.g. patient
age or reason for ART).
b. ART procedure characteristics (e.g.
type of treatment (fertility preservation,
short term banking, in vitro fertilization,
gamete intrafallopian transfer, zygote
intrafallopian transfer), stimulation
protocol, source of the oocytes or
embryos (patient or donor), the state of
the oocytes or embryos (fresh or frozen),
the intent of the procedure, the use of
prenatal genetic diagnosis or screening,
the use of intracytoplasmic sperm
injection, the use of assisted hatching,
the use of a gestational carrier, the stage
of the embryo at transfer, or the number
of embryos transferred).
All ART patient and procedure
characteristics, ART success rates, and
other rates for patients using their own
oocytes as well as for patients using
oocytes or embryos from a donor may be
stratified by CDC by factors thought to
influence the outcome of an ART
procedure.
12. Factors for stratification may
include:
a. Characteristics of the ART patient
such as patient age or reason for ART.
b. Characteristics of the ART
procedure such as type of treatment
(fertility preservation, short term
banking, in vitro fertilization, gamete
intrafallopian transfer, zygote
intrafallopian transfer), stimulation
protocol, the source of the oocytes or
embryos (patient or donor), the state of
the oocytes or embryos (fresh or frozen),
the intent of the procedure, the use of
prenatal genetic diagnosis or screening,
the use of intracytoplasmic sperm
injection, the use of assisted hatching,
the use of a gestational carrier, the stage
of the embryo at transfer, or the number
of embryos transferred.
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Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Notices
Dated: October 17, 2018.
Sandra Cashman,
Executive Secretary, Centers for Disease
Control and Prevention.
[FR Doc. 2018–22991 Filed 10–19–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Mine Safety and Health Research
Advisory Committee (MSHRAC)
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of meeting.
AGENCY:
In accordance with the
Federal Advisory Committee Act, the
CDC announces the following meeting
for the Mine Safety and Health Research
Advisory Committee (MSHRAC). This
meeting is open to the public, limited
only by the space available. The meeting
room accommodates approximately 38
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or by phone, please contact Marie
Chovanec by email at MChovanec@
cdc.gov or by phone at 412–386–5302 at
least 5 business days in advance of the
meeting.
DATES: The meeting will be held on
November 29, 2018, 8 a.m.–4 p.m., MST
and on November 30, 2018, 8 a.m.–12
p.m. MST.
ADDRESSES: University of Arizona,
ENR2 Building, Room S215, 1064 E.
Lowell Street, Tucson, AZ 85721 United
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FOR FURTHER INFORMATION CONTACT:
Jeffrey H. Welsh, Designated Federal
Officer, MSHRAC, NIOSH, CDC, 626
Cochrans Mill Road, Pittsburgh, PA
15236, telephone 412–386–4040; email
juw5@cdc.gov.
SUPPLEMENTARY INFORMATION:
Purpose: This committee is charged
with providing advice to the Secretary,
Department of Health and Human
Services; the Director, CDC; and the
Director, NIOSH, on priorities in mine
safety and health research, including
grants and contracts for such research,
30 U.S.C. 812(b)(2), Section 102(b)(2).
Matters to be Considered: The agenda
will include discussions on mining
safety and health research projects and
outcomes, including real-time DPM
monitor; industrial minerals sector
research priorities; MSHRAC metal
mine automation workgroup report;
cemented backfill research; recent
research in coal mine explosion and fire
prevention; engaging in the miner
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SUMMARY:
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health program; stability evaluation of
active gas wells in longwall abutment
pillars; and durable support for western
US underground metal mines. The
meeting will also include updates from
the NIOSH Associate Director for
Mining, the Spokane Mining Research
Division, and the Pittsburgh Mining
Research Division. Agenda items are
subject to change as priorities dictate.
The Chief Operating Officer, Centers
for Disease Control and Prevention, has
been delegated the authority to sign
Federal Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Sherri Berger,
Chief Operating Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2018–22988 Filed 10–19–18; 8:45 am]
BILLING CODE 4163–19–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–19–18UF]
Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled Assessment of
Evidence to Inform Standards that
Ensure Turnout Gear Remains
Protective Throughout Its Lifecycle to
the Office of Management and Budget
(OMB) for review and approval. CDC
previously published a ‘‘Proposed Data
Collection Submitted for Public
Comment and Recommendations’’
notice on April 12, 2018 to obtain
comments from the public and affected
agencies. CDC received one comment
related to the previous notice. This
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comments.
CDC will accept all comments for this
proposed information collection project.
The Office of Management and Budget
is particularly interested in comments
that:
(a) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
(b) Evaluate the accuracy of the
agencies estimate of the burden of the
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proposed collection of information,
including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected;
(d) Minimize the burden of the
collection of information on those who
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use of appropriate automated,
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(e) Assess information collection
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To request additional information on
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Proposed Project
Evidence to Inform Standards that
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Background and Brief Description
Turnout gear is a type of personal
protective equipment used by the 1.1
million U.S. fire fighters to shield the
body from carcinogens, flames, heat,
and chemical/biological agents. It serves
as a barrier to external hazards while
simultaneously allowing for the escape
of metabolic heat to prevent elevated
core body temperatures. To provide the
necessary performance characteristics,
turnout gear design is complex,
consisting of three major layers that
work as a composite—a thermal liner, a
moisture barrier, and an outer shell.
Consensus standards provide
performance requirements and
retirement criteria for turnout gear. The
retirement criteria is based on visual
inspections and a 10-year age cap with
visual inspection being less effective for
the moisture barrier and thermal liner
layers. Recent data of turnout gear
donated from fire departments
demonstrates that turnout gear from 2 to
10 years old was unable to meet all
performance requirements. Thus, under
the current retirement criteria, turnout
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[Federal Register Volume 83, Number 204 (Monday, October 22, 2018)]
[Notices]
[Pages 53253-53256]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22991]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2018-0054]
Assisted Reproductive Technology (ART) Success Rates Reporting
and Data Validation Procedures
AGENCY: Department of Health and Human Services (HHS), Centers for
Disease Control and Prevention (CDC).
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: On May 31, 2018, the Centers for Disease Control and
Prevention (CDC) in the Department of Health and Human Services (HHS)
requested comments on a plan to (1) revise the definition and
characterization of Assisted Reproductive Technology (ART) success
rates and (2) introduce clinic validation footnotes for the annual ART
Fertility Clinic Success Rates Report. In the plan, CDC proposed to
include the footnotes to identify clinics selected by CDC to
participate in the validation process of the National ART Surveillance
System (NASS) data and: (a) Do participate, (b) do participate and have
major data discrepancies identified through this process, or (c)
decline to participate in the data validation process. This notice
responds to the comments received in response to the notice published
on May 31, 2018 and announces the availability of the revised process
for ART Success Rates Reporting and plans for revising Data Validation
Procedures.
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 NE, Mailstop F-74, Atlanta, Georgia 30341. Telephone: (770)
488-5200; email: [email protected].
Public Comment Summary and Responses
CDC received three public comments to the docket. One comment was
considered nonsubstantive because it was outside the scope of the
docket. A second comment was supportive of CDC's planned approach for
revising the definition of success rates and introducing clinic
validation footnotes. The third comment contained concerns about CDC's
planned clinic validation footnotes and the approach to clinic
validation, and requested a clarification of the reporting requirements
of embryo banking cycles. These suggestions, as well as CDC's
responses, are included below:
1. ART success rates reporting: One commenter asked that CDC
provide more details about reporting requirements of embryo banking
cycles.
Response: CDC thanks the commenter for this request. Egg/embryo
banking cycles intended for pregnancy in the short term include cycles
initiated with the intent of cryopreserving all eggs/embryos for
subsequent transfers within 12 months. Egg/embryo banking cycles
intended for pregnancy in the long term (often referred to as fertility
preservation) include cycles where the patient did not start any
transfer cycles within the 12 month period following the date on which
the intended retrieval cycle started and one of the following: (1) The
cycle intent was long term (>12 months) banking for fertility
preservation prior to gonadotoxic medical treatments; or (2) The cycle
intent was long term (>12 months) banking for other reasons and (a) at
least one egg was retrieved, and (b) at least one egg or embryo was
frozen. Specifics about the reporting process and requirements are
described in ``Reporting of Pregnancy Success Rates
[[Page 53254]]
from Assisted Reproductive Technology (ART) Programs'' (80 FR 51811).
2. Clinic data validation and footnotes: A commenter expressed
concern that discrepancies identified during on-site data validation
would not be corrected prior to publication of the ART Fertility Clinic
Success Rates Report. The commenter suggested that instead of including
a footnote, identification of erroneous data (such as an incorrect
number of reported cycles or pregnancy outcomes) should result in
removing clinic success rates from ART Fertility Clinic Success Rates
Report, and that erroneous data should not be included with data from
other clinics. The commenter was also concerned that random selection
of clinics under the current CDC validation system does not identify
systematic reporting errors. The commenter suggested that targeted
selection of clinics based on reporting characteristics that predict
erroneously inflated ART success rates is a better approach to identify
systematic reporting errors. Finally, the commenter was concerned that
validation footnotes and the appendix may not be easily understood by
the patients.
Response: CDC thanks the commenter for expressing these concerns
and for providing suggestions to improve reporting. CDC is considering
these concerns and reviewing options for future years' data validation.
CDC is withdrawing its pending proposal for data validation footnotes
(83 FR 25009). If CDC determines that changes in data validation
selection processes and/or footnotes are advisable, proposed changes
will be published in the Federal Register for public comment.
Appendix--Notice for Assisted Reproductive Technology (ART) Success
Rates Reporting:
A. Background
Section 2(a) of Public Law 102-493 (42 U.S.C. 263a-1(a)), the
Fertility Clinic Success Rate and Certification Act of 1992 (FCSRCA),
requires that each assisted reproductive technology (ART) program
report annually to the Secretary of the Department of Health and Human
Services through the Centers for Disease Control and Prevention (CDC)
pregnancy success rates achieved through assisted reproductive
technology. The FCSRCA also requires CDC to annually publish and
distribute to the public reported pregnancy success rates for each ART
clinic. According to the FCSRCA, the definitions of pregnancy success
rates should be developed in consultation with appropriate consumer and
professional organizations, should take into account the effect on
success rates of age, diagnosis, and other significant factors, and
should include the live birth rate per attempted ovarian stimulation
procedure and the live birth rate per successful oocyte retrieval.
Specifics about the reporting process and requirements are
described in ``Reporting of Pregnancy Success Rates from Assisted
Reproductive Technology (ART) Programs'' (August 26, 2015; 80 FR
(51811-51819)). Specifics about the definition and characterization of
ART success rates were last described in ``Reporting of Pregnancy
Success Rates from Assisted Reproductive Technology Programs''
(February 5, 2004; 69 FR (5548-5550)). Success rates for fresh,
nondonor cycles were defined as: 1. The rate of pregnancy after
completion of ART according to the number of all ovarian stimulation or
monitoring procedures; 2. the rate of live birth after completion of
ART according to the number of all ovarian stimulation or monitoring
procedures, the number of oocyte retrieval processes, and the number of
embryo (or zygote or oocyte) transfer procedures; 3. the rate of
singleton live birth after completion of ART according to the number of
all ovarian stimulation or monitoring procedures and the number of
embryo (or zygote or oocyte) transfer procedures. Success rates for
cycles using thawed embryos and cycles using donor oocytes or embryos
were defined as: 4. the rate of live birth after completion of ART
according to the number of embryo (or zygote or oocyte) transfer
procedures; 5. the rate of singleton live birth after completion of ART
according to the number of embryo (or zygote or oocyte) transfer
procedures.
Effective for reporting year 2017, CDC is implementing substantial
changes to the definition and characterization of ART success rates due
to changes in clinical practice and more variation in treatment
options, including improvements in cryopreservation resulting in more
segmentation of typical treatment cycles. The field of ART is moving
toward the calculation and reporting of cumulative success rates where
data collection systems can collect successes over all embryo transfers
from a single oocyte retrieval or across several oocyte retrievals and
embryo transfers. After consultation with consumer and professional
organizations with expertise in ART, CDC will begin cumulative ART
success rates reporting in reporting year 2017. The ART success rates
described in this Federal Register notice shall replace those
previously described in 2004.
B. ART Procedures Among Patients Using Their Own Oocytes
ART success rates for ART procedures among all patients using their
own eggs are defined as:
1. The rate of live birth or singleton live birth resulting from
the transfer of oocytes retrieved from the patient in the year prior to
the reporting year or from the transfer of embryos created from oocytes
retrieved from the patient in the year prior to the reporting year. For
the purpose of this definition, transfer procedures must have started
within 12 months of the start of the retrieval procedure. Oocytes must
have been retrieved in the year prior to the reporting year in order to
allow a full year to perform transfers of the retrieved oocytes (either
in the prior reporting year or in the current reporting year). The live
birth rate and singleton live birth rate will be presented according to
the number of:
a. All ovarian stimulation or monitoring procedures started from
the year prior to the reporting year with the intent to retrieve
oocytes from the patient.
b. All ovarian stimulation or monitoring procedures started in the
year prior to the reporting year with the intent to retrieve oocytes
from the patient in which at least one oocyte was retrieved.
c. All transfer procedures of at least one oocyte retrieved from
the patient in the year prior to the reporting year, or of at least one
embryo created from an oocyte retrieved from the patient in the year
prior to the reporting year. For the purpose of this definition, egg or
embryo transfer procedures must have started within 12 months of the
start of the retrieval procedure.
2. The number of ovarian stimulation or monitoring procedures
started in the year prior to the reporting year with the intent to
retrieve oocytes from the patient presented according to the number of:
a. Live births resulting from all transfers of at least one oocyte
retrieved from the patient in the year prior to the reporting year, or
transfers of at least one embryo created from an oocyte retrieved from
the patient in the year prior to the reporting year. For the purpose of
this definition, egg or embryo transfer procedures must have started
within 12 months of the start of the retrieval procedure.
Other rates for ART procedures among all patients using their own
eggs are defined as follows (and may be provided publically at the ART
program's discretion)--
3. The rate of cancellation, implantation, pregnancy, live birth,
[[Page 53255]]
singleton live birth, multiple live birth, twin live birth, triplet or
higher order live birth, preterm live birth, low birthweight live birth
or term, normal birthweight and singleton live birth resulting from the
transfer of oocytes retrieved from the patient in the year prior to the
reporting year or the transfer of embryos created from oocytes
retrieved from the patient in the year prior to the reporting year. For
the purpose of this definition, transfer procedures must have started
within 12 months of the start of the retrieval procedure. These other
rates may be presented according to the number of:
a. All ovarian stimulation or monitoring procedures started in the
year prior to the reporting year with the intent to retrieve oocytes
from the patient.
b. All ovarian stimulation or monitoring procedures started in the
year prior to the reporting year with the intent to retrieve oocytes
from the patient in which at least one oocyte was retrieved.
c. All transfer procedures of at least one oocyte retrieved from
the patient in the year prior to the reporting year, or of at least one
embryo created from an oocyte retrieved from the patient in the year
prior to the reporting year. For the purpose of this definition, egg or
embryo transfer procedures must have started within 12 months of the
start of the retrieval procedure.
d. All first, second, third, or more transfer procedures after
retrieval of at least one oocyte from the patient in the year prior to
the reporting year, or of at least one embryo created from an oocyte
retrieved from the patient in the year prior to the reporting year. For
the purpose of this definition, egg or embryo transfer procedures must
have started within 12 months of the start of the retrieval procedure.
Rates for ART procedures among new ART patients (i.e. patients that
have never had a prior ART cycle ever) using their own oocytes are
defined as--
4. The rate of live birth resulting from the transfer of oocytes or
embryos from all first intended oocyte retrievals presented according
to the number of:
a. ART patients who reported at the start of the retrieval
procedure that they had no prior ART stimulations and no prior frozen
ART procedures. For the purpose of this definition, the retrieval
procedure must have started in the year prior to the reporting year.
5. The rate of live birth resulting from the transfer of oocytes or
embryos from all first or second intended oocyte retrievals presented
according to the number of:
a. ART patients who reported at the start of the retrieval
procedure that they had no prior ART stimulations and no prior frozen
ART procedures. For the purpose of this definition, the retrieval
procedure must have started in the year prior to the reporting year.
6. The rate of live birth resulting from the transfer of oocytes or
embryos from all intended oocyte retrievals presented according to the
number of:
a. ART patients who reported at the start of the retrieval
procedure that they had no prior ART stimulations and no prior frozen
ART procedures. For the purpose of this definition, the retrieval
procedure must have started in the year prior to the reporting year.
7. The number of ovarian stimulation or monitoring procedures
started in the year prior to the reporting year with the intent to
retrieve oocytes from the patient presented according to the number of:
a. ART patients who reported at the start of the retrieval
procedure that they had no prior ART stimulations and no prior frozen
ART procedures.
8. The number of transfer procedures of at least one oocyte
retrieved from the patient in the year prior to the reporting year, or
of at least one embryo created from an oocyte retrieved from the
patient in the year prior to the reporting year presented according to
the number of:
a. Ovarian stimulation or monitoring procedures started in the year
prior to the reporting year with the intent to retrieve oocytes from
the patient. For the purpose of this definition, egg or embryo transfer
procedures must have started within 12 months of the start of the
retrieval procedure. Also, ART patients must have reported at the start
of the retrieval procedure that they had no prior ART stimulations and
no prior frozen ART procedures.
C. ART Procedures Among Patients Using Oocytes or Embryos From a Donor
Success rates for ART procedures among patients using oocytes or
embryos from a donor are defined as--
9. The rate of live birth or singleton live birth presented
according to the number of:
a. Transfer procedures of at least one donor egg, embryo created
from a donor egg, or donated embryo started in the current reporting
year.
Other rates for ART procedures among patients using oocytes or
embryos from a donor are defined as follows (and may be provided
publically at the ART program's discretion):
10. The rate of cancellation, implantation, pregnancy, live birth,
singleton live birth, multiple live birth, twin live birth, triplet or
higher order live birth, preterm live birth, low birthweight live
birth, or term, normal birthweight and singleton live birth presented
according to the number of:
a. ART procedures to prepare a patient (recipient) for the transfer
of at least one donor egg, embryo created from a donor egg, or donated
embryo, started in the current reporting year.
b. Transfer procedures of at least one donor egg, embryo created
from a donor egg, or donated embryo started in the current reporting
year.
D. ART Procedures Among All Patients and All Cycle Types
At the discretion of the ART program, ART reporting also may
include:
11. The number, average number or percentage of ART procedures or
ART patients with certain characteristics, such as:
a. Patient characteristics (e.g. patient age or reason for ART).
b. ART procedure characteristics (e.g. type of treatment (fertility
preservation, short term banking, in vitro fertilization, gamete
intrafallopian transfer, zygote intrafallopian transfer), stimulation
protocol, source of the oocytes or embryos (patient or donor), the
state of the oocytes or embryos (fresh or frozen), the intent of the
procedure, the use of prenatal genetic diagnosis or screening, the use
of intracytoplasmic sperm injection, the use of assisted hatching, the
use of a gestational carrier, the stage of the embryo at transfer, or
the number of embryos transferred).
All ART patient and procedure characteristics, ART success rates,
and other rates for patients using their own oocytes as well as for
patients using oocytes or embryos from a donor may be stratified by CDC
by factors thought to influence the outcome of an ART procedure.
12. Factors for stratification may include:
a. Characteristics of the ART patient such as patient age or reason
for ART.
b. Characteristics of the ART procedure such as type of treatment
(fertility preservation, short term banking, in vitro fertilization,
gamete intrafallopian transfer, zygote intrafallopian transfer),
stimulation protocol, the source of the oocytes or embryos (patient or
donor), the state of the oocytes or embryos (fresh or frozen), the
intent of the procedure, the use of prenatal genetic diagnosis or
screening, the use of intracytoplasmic sperm injection, the use of
assisted hatching, the use of a gestational carrier, the stage of the
embryo at transfer, or the number of embryos transferred.
[[Page 53256]]
Dated: October 17, 2018.
Sandra Cashman,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2018-22991 Filed 10-19-18; 8:45 am]
BILLING CODE 4163-18-P
