Reporting of Pregnancy Success Rates From Assisted Reproductive Technology (ART) Programs; Clarifications and Corrections, 59625-59627 [2019-24043]
Download as PDF
<![CDATA[
Federal Register / Vol. 84, No. 214 / Tuesday, November 5, 2019 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
the aggregation and analysis of patient
safety events.
The Patient Safety Act authorizes the
listing of PSOs, which are entities or
component organizations whose
mission and primary activity are to
conduct activities to improve patient
safety and the quality of health care
delivery.
HHS issued the Patient Safety Rule to
implement the Patient Safety Act.
AHRQ administers the provisions of the
Patient Safety Act and Patient Safety
Rule relating to the listing and operation
of PSOs. The Patient Safety Rule
authorizes AHRQ to list as a PSO an
entity that attests that it meets the
statutory and regulatory requirements
for listing. A PSO can be ‘‘delisted’’ if
it is found to no longer meet the
requirements of the Patient Safety Act
and Patient Safety Rule, when a PSO
chooses to voluntarily relinquish its
status as a PSO for any reason, or when
a PSO’s listing expires. Section 3.108(d)
of the Patient Safety Rule requires
AHRQ to provide public notice when it
removes an organization from the list of
PSOs.
AHRQ has accepted a notification of
proposed voluntary relinquishment
from Symbria SAFE, a component entity
of Symbria Inc., to voluntarily
relinquish its status as a PSO.
Accordingly, Symbria SAFE, P0146, was
delisted effective at 12:00 Midnight ET
(2400) on October 31, 2019.
Symbria SAFE has patient safety work
product (PSWP) in its possession. The
PSO will meet the requirements of
section 3.108(c)(2)(i) of the Patient
Safety Rule regarding notification to
providers that have reported to the PSO
and of section 3.108(c)(2)(ii) regarding
disposition of PSWP consistent with
section 3.108(b)(3). According to section
3.108(b)(3) of the Patient Safety Rule,
the PSO has 90 days from the effective
date of delisting and revocation to
complete the disposition of PSWP that
is currently in the PSO’s possession.
More information on PSOs can be
obtained through AHRQ’s PSO website
at https://www.pso.ahrq.gov.
Virginia Mackay-Smith,
Associate Director.
[FR Doc. 2019–24152 Filed 11–4–19; 8:45 am]
BILLING CODE 4160–90–P
VerDate Sep<11>2014
16:34 Nov 04, 2019
Jkt 250001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Meeting of the National Advisory
Council for Healthcare Research and
Quality
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Notice of public meeting.
AGENCY:
This notice announces a
meeting of the National Advisory
Council for Healthcare Research and
Quality.
DATES: The meeting will be held on
Thursday, November 21, 2019, from
8:30 a.m. to 12:00 p.m.
ADDRESSES: The meeting will be held at
AHRQ, 5600 Fishers Lane, Rockville,
Maryland, 20857.
FOR FURTHER INFORMATION CONTACT:
Jaime Zimmerman, Designated
Management Official, at the Agency for
Healthcare Research and Quality, 5600
Fishers Lane, Mail Stop 06E37A,
Rockville, Maryland 20857, (301) 427–
1456. For press-related information,
please contact Bruce Seeman at (301)
427–1998 or Bruce.Seeman@
AHRQ.hhs.gov.
If sign language interpretation or other
reasonable accommodation for a
disability is needed, please contact the
Food and Drug Administration (FDA)
Office of Equal Employment
Opportunity and Diversity Management
on (301) 827–4840, no later than
Thursday, November 7, 2019. The
agenda, roster, and minutes will be
available from Ms. Heather Phelps,
Committee Management Officer, Agency
for Healthcare Research and Quality,
5600 Fishers Lane, Rockville, Maryland
20857. Ms. Phelps’ phone number is
(301) 427–1128.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Purpose
In accordance with section 10(a) of
the Federal Advisory Committee Act, 5
U.S.C. App., this notice announces a
meeting of the National Advisory
Council for Healthcare Research and
Quality (the Council). The Council is
authorized by Section 941 of the Public
Health Service Act, 42 U.S.C. 299c. In
accordance with its statutory mandate,
the Council is to advise the Secretary of
the Department of Health and Human
Services and the Director of AHRQ on
matters related to AHRQ’s conduct of its
mission including providing guidance
on (A) priorities for health care research,
(B) the field of health care research
including training needs and
PO 00000
Frm 00014
Fmt 4703
Sfmt 4703
59625
information dissemination on health
care quality and (C) the role of the
Agency in light of private sector activity
and opportunities for public private
partnerships. The Council is composed
of members of the public, appointed by
the Secretary, and Federal ex-officio
members specified in the authorizing
legislation.
II. Agenda
On Thursday, November 21, 2019, the
Council meeting will convene at 8:30
a.m., with the call to order by the
Council Chair and approval of previous
Council summary notes. The meeting is
open to the public and will be available
via webcast at
www.webconferences.com/ahrq. The
meeting will begin with an update on
AHRQ’s budget, programs and
initiatives. The agenda will also include
a discussion about the challenges and
opportunities to leverage AHRQ’s CDS
Connect to improve care and a
conversation about the gaps and
opportunities for improving care, with a
focus on social determinants of health.
The meeting will adjourn at 12:00 p.m.
The final agenda will be available on the
AHRQ website at www.AHRQ.gov no
later than Thursday, November 14,
2019.
Dated: October 30, 2019.
Virginia L. Mackay-Smith,
Associate Director.
[FR Doc. 2019–24081 Filed 11–4–19; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Reporting of Pregnancy Success Rates
From Assisted Reproductive
Technology (ART) Programs;
Clarifications and Corrections
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
The Centers for Disease
Control and Prevention (CDC), located
within the Department of Health and
Human Services (HHS), announces
clarifications for and correction to
certain data collection fields,
terminology, and definitions used 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).
SUMMARY:
E:\FR\FM\05NON1.SGM
05NON1
59626
Federal Register / Vol. 84, No. 214 / Tuesday, November 5, 2019 / Notices
(Embryo banking from autologous
oocytes, embryo banking from donor
oocytes, autologous oocyte, donor
oocyte).
These clarifications and
corrections will be implemented
January 1, 2020.
DATES:
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:
ARTinfo@cdc.gov.
SUPPLEMENTARY INFORMATION: On August
26, 2015, HHS/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 current notice, published
November 5, 2019, includes
clarifications for some variables and
definitions to improve quality of data.
Corrections were made to align with
current terminology. These
clarifications and corrections will be
helpful by clarifying reporting
requirements in certain unique
situations and updating terminology to
align with current practice. This notice
includes the current guidance and
definitions that will be implemented
starting January 1, 2020.
Clarifications and Corrections
Section II. When and How To Report
khammond on DSKJM1Z7X2PROD with NOTICES
Section A. Reporting Activities
Current: All cycle data must be
reported prospectively, i.e., reporting of
initial cycle intent and select patient
details is required within four days of
cycle initiation.
Clarification (to improve the quality of
data by clarifying prospective reporting
requirements for natural cycles and
frozen cycles; effective January 1, 2020):
All cycle data must be reported
prospectively, i.e., reporting of initial
cycle intent and select patient details is
required: (a) At least one day prior to
oocyte retrieval for all natural cycles
using fresh embryos created from fresh
eggs; (b) at least one day prior to thaw
for all frozen oocyte or frozen embryo
cycles; and (c) within four days of cycle
initiation for all other cycles.
Section B. Cycle Information
Current: Intended banking type
(Embryo banking, autologous oocyte
banking, donor oocyte banking).
Clarification (to differentiate oocyte
source for banking cycles; effective
January 1, 2020): Intended banking type
VerDate Sep<11>2014
16:34 Nov 04, 2019
Jkt 250001
Section C. Patient History
Current: Number of Prior ART cycles
(Fresh & Frozen).
Clarification (to clarify question
applicability; effective January 1, 2020):
Number of Prior ART cycles started
with the intent to transfer oocytes or
embryos.
Section F. Stimulation and Retrieval
Current: Date of retrieval.
Clarification (to clarify the definition
for different treatment protocols;
effective January 1, 2020): In general,
each retrieval should be reported as its
own cycle. This includes egg retrievals
for fertility preservation cycles (e.g., for
cancer patients). In the case of
continuous stimulation or dual
stimulation to maximize the number of
eggs retrieved in the shortest possible
time, the cycle start date for the
subsequent retrieval will be the day that
stimulation medication was restarted
after the trigger was administered for the
previous egg retrieval; if the stimulation
medication was never stopped,
stimulation start will be the day after
the previous egg retrieval.
If a patient is having a second egg
retrieval due to a ‘‘failed trigger’’ (i.e.,
patient medication administration error
or poor response to the trigger that
results in unexpectedly low number of
eggs), the second trigger and retrieval
date would be used for reporting as part
of the first cycle. In this case, the
interval between the first and second
retrieval should not exceed 2 days. If the
interval exceeds 2 days, each retrieval
should be entered as its own cycle.
Section G. Laboratory Information
Current:
Indication for ICSI (Prior failed
fertilization, Poor fertilization, PGD or
PGS, Abnormal semen parameters,
Low oocyte yield, Laboratory routine,
Frozen cycle, Rescue ICSI, Other)
PGD (Pre-implantation genetic
diagnosis) or screening (PGS)
Reasons for PGD or PGS
Technique used for PGD or PGS
Correction (to update the terminology
for preimplantation genetic testing;
effective January 1, 2020):
Indication for ICSI (Prior failed
fertilization, Poor fertilization, PGT,
Abnormal semen parameters, Low
oocyte yield, Laboratory routine,
Frozen cycle, Rescue ICSI, Other)
PGT (Pre-implantation genetic testing)
Reasons for PGT
PO 00000
Frm 00015
Fmt 4703
Sfmt 4703
Technique used for PGT
Section H. Transfer Information
Current: Endometrial Thickness Prior
to Embryo Transfer.
Clarification (to clarify the timing of
measurement; effective January 1, 2020):
Most Recent Endometrial Thickness.
Section J. Definitions
Current: Cycle start date (cycle
initiation date)—
(1) For fresh embryo (both donor and
nondonor): The first day that
medication to stimulate follicular
development is given in a stimulated
cycle or the first day of menses in an
unstimulated cycle. For example:
a. The first day of gonadotropins in a
gonadotropin only cycle or in a long
suppression GnRH agonist-gonadotropin
cycle;
b. The first day of GnRH agonist in a
GnRH agonist flare-gonadotropin cycle;
c. The first day of clomiphene or
letrozole in a clomiphene/gonadotropin
cycle or a clomiphene only cycle;
d. The first day of natural menses or
withdrawal bleeding in an unstimulated
cycle.
(2) For fresh embryo donor cycles:
a. The first day exogenous sex steroids
are given to patient to prepare the
endometrium;
b. The first day of natural menses or
withdrawal bleeding in an unstimulated
cycle.
(3) For frozen embryo cycles (both
donor and non-donor):
a. The first day exogenous sex steroids
are given to prepare the endometrium;
b. The first day of natural menses or
withdrawal bleeding in an unstimulated
cycle.
(4) For oocyte/embryo banking cycles:
a. The first day of gonadotropins in a
gonadotropin only cycle or in a long
suppression GnRH agonist-gonadotropin
cycle;
b. The first day of GnRH agonist in a
GnRH agonist flare-gonadotropin cycle;
c. The first day of clomiphene or
letrozole in a clomiphene/gonadotropin
cycle or a clomiphene only cycle;
d. The first day of natural menses or
withdrawal bleeding in an unstimulated
cycle.
Clarification (to clarify the definition
for different types of cycles; effective
January 1, 2020): Cycle start date (cycle
initiation date)—
(1) For cycles using fresh embryos
created from fresh nondonor eggs: The
first day that medication to stimulate
follicular development is given in a
stimulated cycle or the first day of
menses in an unstimulated cycle. For
example:
a. The first day of gonadotropins in a
gonadotropin only cycle or in a long
E:\FR\FM\05NON1.SGM
05NON1
khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 84, No. 214 / Tuesday, November 5, 2019 / Notices
suppression GnRH agonist-gonadotropin
cycle;
b. The first day of GnRH agonist in a
GnRH agonist flare-gonadotropin cycle;
c. The first day of clomiphene or
letrozole in a clomiphene/gonadotropin
cycle or a clomiphene only cycle;
d. The first day of natural menses or
withdrawal bleeding in an unstimulated
cycle.
(2) For cycles using fresh embryos
created from fresh donor eggs:
a. The first day exogenous sex steroids
are given to patient to prepare the
endometrium;
b. The first day of natural menses or
withdrawal bleeding in an unstimulated
cycle.
(3) For cycles using frozen eggs or
frozen embryos (both donor and nondonor):
a. The first day exogenous sex steroids
are given to prepare the endometrium;
b. The first day of natural menses or
withdrawal bleeding in an unstimulated
cycle.
(4) For oocyte/embryo banking cycles:
a. The first day of gonadotropins in a
gonadotropin only cycle or in a long
suppression GnRH agonist-gonadotropin
cycle;
b. The first day of GnRH agonist in a
GnRH agonist flare-gonadotropin cycle;
c. The first day of clomiphene or
letrozole in a clomiphene/gonadotropin
cycle or a clomiphene only cycle;
d. The first day of natural menses or
withdrawal bleeding in an unstimulated
cycle.
Current: Preimplantation genetic
diagnosis (PGD)—Characterization of a
cell or cells from preimplanted embryos
from IVF cycles to determine the
presence or absence of a specific genetic
defect.
Preimplantation genetic screening
(PGS)—Characterization of a cell or cells
from preimplanted embryos from IVF
cycles to identify genetic abnormalities.
Correction (to update the terminology;
effective January 1, 2020):
Preimplantation genetic testing (PGT)—
Testing performed to analyze DNA from
oocytes or embryos for determining
genetic abnormalities, including
aneuploidies (PGT–A), monogenic/
single gene defects (PGT–M), and
chromosomal structural rearrangements
(PGT–SR).
Dated: October 30, 2019.
Sandra Cashman,
Executive Secretary, Centers for Disease
Control and Prevention.
[FR Doc. 2019–24043 Filed 11–4–19; 8:45 am]
BILLING CODE 4163–18–P
VerDate Sep<11>2014
16:34 Nov 04, 2019
Jkt 250001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Scholarships for
Disadvantaged Students, OMB No.
0915–0149—Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR have been provided to OMB.
OMB will accept further comments from
the public during the review and
approval period. OMB may act on
HRSA’s ICR only after the 30 day
comment period for this Notice has
closed.
DATES: Comments on this ICR should be
received no later than December 5,
2019.
ADDRESSES: Submit your comments,
including the ICR Title, to the desk
officer for HRSA, either by email to
OIRA_submission@omb.eop.gov or by
fax to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email Lisa
Wright-Solomon, the HRSA Information
Collection Clearance Officer at
paperwork@hrsa.gov or call (301) 443–
1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Scholarships for Disadvantaged
Students Program OMB No. 0915–
0149—Revision.
Abstract: HRSA seeks to update the
Scholarships for Disadvantaged
Students (SDS) program-specific form to
collect 3 years of student data instead of
1 year of student data from SDS program
applicants. This will assist the agency in
making funding decisions for SDS
program awards. The form will reflect
programmatic changes to the SDS
program, made after consideration of the
comments received in response to the
request for public comment, published
at 84 FR 23571, which will be finalized
in the forthcoming SDS Policy Change
Federal Register Notice.
Need and Proposed Use of the
Information: The purpose of the SDS
SUMMARY:
PO 00000
Frm 00016
Fmt 4703
Sfmt 4703
59627
Program is to make grant awards to
eligible schools to provide scholarships
to full-time, financially needy students
from disadvantaged backgrounds
enrolled in health professions programs.
To qualify for participation in the SDS
program, a school must be carrying out
a program for recruiting and retaining
students from disadvantaged
backgrounds, including students who
are members of racial and ethnic
minority groups (section 737(d)(1)(B) of
the Public Health Service (PHS) Act). To
meet this requirement, a school must
show that at least 20 percent of the
school’s full-time enrolled students and
graduates are from a disadvantaged
background. HRSA previously required
schools to demonstrate this percentage
by submitting 1 year of data; a school
must now provide this data for the most
recent 3 year period.1 The proposed
revisions to the SDS program-specific
form will require applicants to provide
the percentage of full-time enrolled
students and graduates from a
disadvantaged background over a 3-year
period, consistent with this policy
change.
An additional change to the SDS
program is that a 3 year average, instead
of a 1 year average, will be used to
calculate priority points, which are
provided to eligible schools based on
the proportion of graduating students
going into primary care, the proportion
of underrepresented minority students,
and the proportion of graduates working
in medically underserved communities
(section 737(c) of the PHS Act). The
proposed revisions to the SDS programspecific form will require applicants to
provide a 3 year average for these
percentages, consistent with this policy
change, as opposed to the 1 year of data
previously required.
Likely Respondents: Institutions that
apply for SDS program awards.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
1 The SDS program will allow an exception for
newly established schools; that is, schools that have
not been in existence long enough to have three
years of enrollment and graduation data. However,
these schools will be required to demonstrate that
at least 20 percent of the school’s full-time students
are students from disadvantaged backgrounds, with
at least two years of student enrollment, and at least
one year of graduation data.
E:\FR\FM\05NON1.SGM
05NON1
]]>Agencies
[Federal Register Volume 84, Number 214 (Tuesday, November 5, 2019)]
[Notices]
[Pages 59625-59627]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24043]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Reporting of Pregnancy Success Rates From Assisted Reproductive
Technology (ART) Programs; Clarifications and Corrections
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC), located
within the Department of Health and Human Services (HHS), announces
clarifications for and correction to certain data collection fields,
terminology, and definitions used 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).
[[Page 59626]]
DATES: These clarifications and corrections will be implemented January
1, 2020.
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: On August 26, 2015, HHS/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 current notice, published
November 5, 2019, includes clarifications for some variables and
definitions to improve quality of data. Corrections were made to align
with current terminology. These clarifications and corrections will be
helpful by clarifying reporting requirements in certain unique
situations and updating terminology to align with current practice.
This notice includes the current guidance and definitions that will be
implemented starting January 1, 2020.
Clarifications and Corrections
Section II. When and How To Report
Section A. Reporting Activities
Current: All cycle data must be reported prospectively, i.e.,
reporting of initial cycle intent and select patient details is
required within four days of cycle initiation.
Clarification (to improve the quality of data by clarifying
prospective reporting requirements for natural cycles and frozen
cycles; effective January 1, 2020): All cycle data must be reported
prospectively, i.e., reporting of initial cycle intent and select
patient details is required: (a) At least one day prior to oocyte
retrieval for all natural cycles using fresh embryos created from fresh
eggs; (b) at least one day prior to thaw for all frozen oocyte or
frozen embryo cycles; and (c) within four days of cycle initiation for
all other cycles.
Section B. Cycle Information
Current: Intended banking type (Embryo banking, autologous oocyte
banking, donor oocyte banking).
Clarification (to differentiate oocyte source for banking cycles;
effective January 1, 2020): Intended banking type (Embryo banking from
autologous oocytes, embryo banking from donor oocytes, autologous
oocyte, donor oocyte).
Section C. Patient History
Current: Number of Prior ART cycles (Fresh & Frozen).
Clarification (to clarify question applicability; effective January
1, 2020): Number of Prior ART cycles started with the intent to
transfer oocytes or embryos.
Section F. Stimulation and Retrieval
Current: Date of retrieval.
Clarification (to clarify the definition for different treatment
protocols; effective January 1, 2020): In general, each retrieval
should be reported as its own cycle. This includes egg retrievals for
fertility preservation cycles (e.g., for cancer patients). In the case
of continuous stimulation or dual stimulation to maximize the number of
eggs retrieved in the shortest possible time, the cycle start date for
the subsequent retrieval will be the day that stimulation medication
was restarted after the trigger was administered for the previous egg
retrieval; if the stimulation medication was never stopped, stimulation
start will be the day after the previous egg retrieval.
If a patient is having a second egg retrieval due to a ``failed
trigger'' (i.e., patient medication administration error or poor
response to the trigger that results in unexpectedly low number of
eggs), the second trigger and retrieval date would be used for
reporting as part of the first cycle. In this case, the interval
between the first and second retrieval should not exceed 2 days. If the
interval exceeds 2 days, each retrieval should be entered as its own
cycle.
Section G. Laboratory Information
Current:
Indication for ICSI (Prior failed fertilization, Poor fertilization,
PGD or PGS, Abnormal semen parameters, Low oocyte yield, Laboratory
routine, Frozen cycle, Rescue ICSI, Other)
PGD (Pre-implantation genetic diagnosis) or screening (PGS)
Reasons for PGD or PGS
Technique used for PGD or PGS
Correction (to update the terminology for preimplantation genetic
testing; effective January 1, 2020):
Indication for ICSI (Prior failed fertilization, Poor fertilization,
PGT, Abnormal semen parameters, Low oocyte yield, Laboratory routine,
Frozen cycle, Rescue ICSI, Other)
PGT (Pre-implantation genetic testing)
Reasons for PGT
Technique used for PGT
Section H. Transfer Information
Current: Endometrial Thickness Prior to Embryo Transfer.
Clarification (to clarify the timing of measurement; effective
January 1, 2020): Most Recent Endometrial Thickness.
Section J. Definitions
Current: Cycle start date (cycle initiation date)--
(1) For fresh embryo (both donor and nondonor): The first day that
medication to stimulate follicular development is given in a stimulated
cycle or the first day of menses in an unstimulated cycle. For example:
a. The first day of gonadotropins in a gonadotropin only cycle or
in a long suppression GnRH agonist-gonadotropin cycle;
b. The first day of GnRH agonist in a GnRH agonist flare-
gonadotropin cycle;
c. The first day of clomiphene or letrozole in a clomiphene/
gonadotropin cycle or a clomiphene only cycle;
d. The first day of natural menses or withdrawal bleeding in an
unstimulated cycle.
(2) For fresh embryo donor cycles:
a. The first day exogenous sex steroids are given to patient to
prepare the endometrium;
b. The first day of natural menses or withdrawal bleeding in an
unstimulated cycle.
(3) For frozen embryo cycles (both donor and non-donor):
a. The first day exogenous sex steroids are given to prepare the
endometrium;
b. The first day of natural menses or withdrawal bleeding in an
unstimulated cycle.
(4) For oocyte/embryo banking cycles:
a. The first day of gonadotropins in a gonadotropin only cycle or
in a long suppression GnRH agonist-gonadotropin cycle;
b. The first day of GnRH agonist in a GnRH agonist flare-
gonadotropin cycle;
c. The first day of clomiphene or letrozole in a clomiphene/
gonadotropin cycle or a clomiphene only cycle;
d. The first day of natural menses or withdrawal bleeding in an
unstimulated cycle.
Clarification (to clarify the definition for different types of
cycles; effective January 1, 2020): Cycle start date (cycle initiation
date)--
(1) For cycles using fresh embryos created from fresh nondonor
eggs: The first day that medication to stimulate follicular development
is given in a stimulated cycle or the first day of menses in an
unstimulated cycle. For example:
a. The first day of gonadotropins in a gonadotropin only cycle or
in a long
[[Page 59627]]
suppression GnRH agonist-gonadotropin cycle;
b. The first day of GnRH agonist in a GnRH agonist flare-
gonadotropin cycle;
c. The first day of clomiphene or letrozole in a clomiphene/
gonadotropin cycle or a clomiphene only cycle;
d. The first day of natural menses or withdrawal bleeding in an
unstimulated cycle.
(2) For cycles using fresh embryos created from fresh donor eggs:
a. The first day exogenous sex steroids are given to patient to
prepare the endometrium;
b. The first day of natural menses or withdrawal bleeding in an
unstimulated cycle.
(3) For cycles using frozen eggs or frozen embryos (both donor and
non-donor):
a. The first day exogenous sex steroids are given to prepare the
endometrium;
b. The first day of natural menses or withdrawal bleeding in an
unstimulated cycle.
(4) For oocyte/embryo banking cycles:
a. The first day of gonadotropins in a gonadotropin only cycle or
in a long suppression GnRH agonist-gonadotropin cycle;
b. The first day of GnRH agonist in a GnRH agonist flare-
gonadotropin cycle;
c. The first day of clomiphene or letrozole in a clomiphene/
gonadotropin cycle or a clomiphene only cycle;
d. The first day of natural menses or withdrawal bleeding in an
unstimulated cycle.
Current: Preimplantation genetic diagnosis (PGD)--Characterization
of a cell or cells from preimplanted embryos from IVF cycles to
determine the presence or absence of a specific genetic defect.
Preimplantation genetic screening (PGS)--Characterization of a cell
or cells from preimplanted embryos from IVF cycles to identify genetic
abnormalities.
Correction (to update the terminology; effective January 1, 2020):
Preimplantation genetic testing (PGT)--Testing performed to analyze DNA
from oocytes or embryos for determining genetic abnormalities,
including aneuploidies (PGT-A), monogenic/single gene defects (PGT-M),
and chromosomal structural rearrangements (PGT-SR).
Dated: October 30, 2019.
Sandra Cashman,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2019-24043 Filed 11-4-19; 8:45 am]
BILLING CODE 4163-18-P
