83_FR_53457 83 FR 53253 - Assisted Reproductive Technology (ART) Success Rates Reporting and Data Validation Procedures

83 FR 53253 - Assisted Reproductive Technology (ART) Success Rates Reporting and Data Validation Procedures

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 83, Issue 204 (October 22, 2018)

Page Range53253-53256
FR Document2018-22991

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.

Federal Register, Volume 83 Issue 204 (Monday, October 22, 2018)
[Federal Register Volume 83, Number 204 (Monday, October 22, 2018)]
[Notices]
[Pages 53253-53256]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-22991]


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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: ARTinfo@cdc.gov.

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



                                                                                    Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Notices                                                                                                 53253

                                                 This is a revised Information                                             The updated Scorecard is based on a                                        of the strategies and interventions
                                               Collection Request (ICR) supporting a                                    2017 pilot test to determine the validity                                     contained in the questions has been
                                               broader group of employers to access                                     and reliability involving 89 employers                                        completed. This will streamline future
                                               the updated and pilot tested Scorecard,                                  (each represented by two knowledgeable                                        information collection and minimize
                                               a web-based worksite organizational                                      employees) who completed the survey                                           additional response time.
                                               assessment, to regularly assess their                                    and follow-up telephone interviews to
                                                                                                                                                                                                        CDC will continue to provide
                                               workplace health programs and                                            gather general impressions of the
                                               practices. Scorecard users will create a                                 Scorecard—particularly the new                                                outreach to, and register approximately
                                               user account, complete the online                                        modules—and also to discuss items                                             800 employers per year to use the online
                                               assessment and receive an immediate                                      where there were discrepancies (and                                           Scorecard survey in their workplace
                                               feedback report that summarizes the                                      items that were left blank) to understand                                     health program assessment, planning,
                                               current status of their worksite health                                  the respondent’s interpretation and                                           and implementation efforts, which is
                                               program; identifies gaps in current                                      perspective of their answers to these                                         open to employers of all sizes, industry
                                               programming; benchmarks individual                                       questions. The revised instrument                                             sectors, and geographic locations across
                                               employer results against other users of                                  includes some reorganization of the                                           the country. OMB approval is requested
                                               the system; and provides access to                                       instrument and minor revisions,                                               for three years. Participation is
                                               worksite health tools and resources to                                   particularly to the new modules/                                              voluntary and there are no costs to
                                               address employer gaps and priority                                       questions, to better explain and define                                       respondents other than their time.
                                               program areas.                                                           the context, concepts, or administration

                                                                                                                       ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                                                                  Average
                                                                                                                                                                                                    Number of
                                                                                                                                                                         Number of                                              burden per              Total burden
                                                           Type of respondent                                                Form name                                                            responses per
                                                                                                                                                                        respondents                                              response                 (in hrs)
                                                                                                                                                                                                    respondent                    (in hrs)

                                               Employers .........................................       CDC Worksite Health ScoreCard                                                   800                           1                      5/60                67
                                                                                                          Registration.
                                                                                                         CDC Worksite Health Scorecard .....                                             800                           1                    45/60                600

                                                     Total ...........................................   ...........................................................   ........................   ........................   ........................            667



                                               Jeffrey M. Zirger,                                                       to include the footnotes to identify                                          about CDC’s planned clinic validation
                                               Acting Chief, Information Collection Review                              clinics selected by CDC to participate in                                     footnotes and the approach to clinic
                                               Office, Office of Scientific Integrity, Office                           the validation process of the National                                        validation, and requested a clarification
                                               of the Associate Director for Science, Office                            ART Surveillance System (NASS) data                                           of the reporting requirements of embryo
                                               of the Director, Centers for Disease Control                             and: (a) Do participate, (b) do participate                                   banking cycles. These suggestions, as
                                               and Prevention.
                                                                                                                        and have major data discrepancies                                             well as CDC’s responses, are included
                                               [FR Doc. 2018–22940 Filed 10–19–18; 8:45 am]                             identified through this process, or (c)                                       below:
                                               BILLING CODE 4163–18–P                                                   decline to participate in the data                                               1. ART success rates reporting: One
                                                                                                                        validation process. This notice responds                                      commenter asked that CDC provide
                                                                                                                        to the comments received in response to                                       more details about reporting
                                               DEPARTMENT OF HEALTH AND                                                 the notice published on May 31, 2018                                          requirements of embryo banking cycles.
                                               HUMAN SERVICES                                                           and announces the availability of the                                            Response: CDC thanks the commenter
                                                                                                                        revised process for ART Success Rates                                         for this request. Egg/embryo banking
                                               Centers for Disease Control and                                                                                                                        cycles intended for pregnancy in the
                                               Prevention                                                               Reporting and plans for revising Data
                                                                                                                        Validation Procedures.                                                        short term include cycles initiated with
                                               [Docket No. CDC–2018–0054]                                               FOR FURTHER INFORMATION CONTACT:                                              the intent of cryopreserving all eggs/
                                                                                                                        Jeani Chang, Division of Reproductive                                         embryos for subsequent transfers within
                                               Assisted Reproductive Technology                                                                                                                       12 months. Egg/embryo banking cycles
                                                                                                                        Health, National Center for Chronic
                                               (ART) Success Rates Reporting and                                                                                                                      intended for pregnancy in the long term
                                                                                                                        Disease Prevention and Health
                                               Data Validation Procedures                                                                                                                             (often referred to as fertility
                                                                                                                        Promotion, Centers for Disease Control
                                               AGENCY: Department of Health and                                         and Prevention, 4770 Buford Highway                                           preservation) include cycles where the
                                               Human Services (HHS), Centers for                                        NE, Mailstop F–74, Atlanta, Georgia                                           patient did not start any transfer cycles
                                               Disease Control and Prevention (CDC).                                    30341. Telephone: (770) 488–5200;                                             within the 12 month period following
                                                                                                                        email: ARTinfo@cdc.gov.                                                       the date on which the intended retrieval
                                               ACTION: Notice of availability.
                                                                                                                                                                                                      cycle started and one of the following:
                                               SUMMARY:   On May 31, 2018, the Centers                                  Public Comment Summary and                                                    (1) The cycle intent was long term (>12
                                               for Disease Control and Prevention                                       Responses                                                                     months) banking for fertility
                                               (CDC) in the Department of Health and                                      CDC received three public comments                                          preservation prior to gonadotoxic
                                               Human Services (HHS) requested                                           to the docket. One comment was                                                medical treatments; or (2) The cycle
daltland on DSKBBV9HB2PROD with NOTICES




                                               comments on a plan to (1) revise the                                     considered nonsubstantive because it                                          intent was long term (>12 months)
                                               definition and characterization of                                       was outside the scope of the docket. A                                        banking for other reasons and (a) at least
                                               Assisted Reproductive Technology                                         second comment was supportive of                                              one egg was retrieved, and (b) at least
                                               (ART) success rates and (2) introduce                                    CDC’s planned approach for revising the                                       one egg or embryo was frozen. Specifics
                                               clinic validation footnotes for the                                      definition of success rates and                                               about the reporting process and
                                               annual ART Fertility Clinic Success                                      introducing clinic validation footnotes.                                      requirements are described in
                                               Rates Report. In the plan, CDC proposed                                  The third comment contained concerns                                          ‘‘Reporting of Pregnancy Success Rates


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                                               53254                        Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Notices

                                               from Assisted Reproductive Technology                   into account the effect on success rates              B. ART Procedures Among Patients
                                               (ART) Programs’’ (80 FR 51811).                         of age, diagnosis, and other significant              Using Their Own Oocytes
                                                  2. Clinic data validation and                        factors, and should include the live                     ART success rates for ART procedures
                                               footnotes: A commenter expressed                        birth rate per attempted ovarian                      among all patients using their own eggs
                                               concern that discrepancies identified                   stimulation procedure and the live birth              are defined as:
                                               during on-site data validation would not                rate per successful oocyte retrieval.                    1. The rate of live birth or singleton
                                               be corrected prior to publication of the                   Specifics about the reporting process              live birth resulting from the transfer of
                                               ART Fertility Clinic Success Rates                      and requirements are described in                     oocytes retrieved from the patient in the
                                               Report. The commenter suggested that                    ‘‘Reporting of Pregnancy Success Rates                year prior to the reporting year or from
                                               instead of including a footnote,                        from Assisted Reproductive Technology                 the transfer of embryos created from
                                               identification of erroneous data (such as               (ART) Programs’’ (August 26, 2015; 80                 oocytes retrieved from the patient in the
                                               an incorrect number of reported cycles                  FR (51811–51819)). Specifics about the                year prior to the reporting year. For the
                                               or pregnancy outcomes) should result in                 definition and characterization of ART                purpose of this definition, transfer
                                               removing clinic success rates from ART                  success rates were last described in                  procedures must have started within 12
                                               Fertility Clinic Success Rates Report,                  ‘‘Reporting of Pregnancy Success Rates                months of the start of the retrieval
                                               and that erroneous data should not be                   from Assisted Reproductive Technology                 procedure. Oocytes must have been
                                               included with data from other clinics.                  Programs’’ (February 5, 2004; 69 FR                   retrieved in the year prior to the
                                               The commenter was also concerned that                   (5548–5550)). Success rates for fresh,                reporting year in order to allow a full
                                               random selection of clinics under the                   nondonor cycles were defined as: 1. The               year to perform transfers of the retrieved
                                               current CDC validation system does not                  rate of pregnancy after completion of                 oocytes (either in the prior reporting
                                               identify systematic reporting errors. The               ART according to the number of all                    year or in the current reporting year).
                                               commenter suggested that targeted                       ovarian stimulation or monitoring                     The live birth rate and singleton live
                                               selection of clinics based on reporting                 procedures; 2. the rate of live birth after           birth rate will be presented according to
                                               characteristics that predict erroneously                completion of ART according to the                    the number of:
                                               inflated ART success rates is a better                  number of all ovarian stimulation or                     a. All ovarian stimulation or
                                               approach to identify systematic                         monitoring procedures, the number of                  monitoring procedures started from the
                                               reporting errors. Finally, the commenter                oocyte retrieval processes, and the                   year prior to the reporting year with the
                                               was concerned that validation footnotes                 number of embryo (or zygote or oocyte)                intent to retrieve oocytes from the
                                               and the appendix may not be easily                      transfer procedures; 3. the rate of                   patient.
                                               understood by the patients.                             singleton live birth after completion of                 b. All ovarian stimulation or
                                                  Response: CDC thanks the commenter                   ART according to the number of all                    monitoring procedures started in the
                                               for expressing these concerns and for                   ovarian stimulation or monitoring                     year prior to the reporting year with the
                                               providing suggestions to improve                        procedures and the number of embryo                   intent to retrieve oocytes from the
                                               reporting. CDC is considering these                     (or zygote or oocyte) transfer                        patient in which at least one oocyte was
                                               concerns and reviewing options for                      procedures. Success rates for cycles                  retrieved.
                                               future years’ data validation. CDC is                   using thawed embryos and cycles using                    c. All transfer procedures of at least
                                               withdrawing its pending proposal for                    donor oocytes or embryos were defined                 one oocyte retrieved from the patient in
                                               data validation footnotes (83 FR 25009).                as: 4. the rate of live birth after                   the year prior to the reporting year, or
                                               If CDC determines that changes in data                  completion of ART according to the                    of at least one embryo created from an
                                               validation selection processes and/or                   number of embryo (or zygote or oocyte)                oocyte retrieved from the patient in the
                                               footnotes are advisable, proposed                                                                             year prior to the reporting year. For the
                                                                                                       transfer procedures; 5. the rate of
                                               changes will be published in the                                                                              purpose of this definition, egg or
                                                                                                       singleton live birth after completion of
                                               Federal Register for public comment.                                                                          embryo transfer procedures must have
                                                                                                       ART according to the number of embryo
                                                                                                                                                             started within 12 months of the start of
                                               Appendix—Notice for Assisted                            (or zygote or oocyte) transfer
                                                                                                                                                             the retrieval procedure.
                                               Reproductive Technology (ART)                           procedures.                                              2. The number of ovarian stimulation
                                               Success Rates Reporting:                                   Effective for reporting year 2017, CDC             or monitoring procedures started in the
                                                                                                       is implementing substantial changes to                year prior to the reporting year with the
                                               A. Background                                           the definition and characterization of                intent to retrieve oocytes from the
                                                  Section 2(a) of Public Law 102–493                   ART success rates due to changes in                   patient presented according to the
                                               (42 U.S.C. 263a–1(a)), the Fertility                    clinical practice and more variation in               number of:
                                               Clinic Success Rate and Certification                   treatment options, including                             a. Live births resulting from all
                                               Act of 1992 (FCSRCA), requires that                     improvements in cryopreservation                      transfers of at least one oocyte retrieved
                                               each assisted reproductive technology                   resulting in more segmentation of                     from the patient in the year prior to the
                                               (ART) program report annually to the                    typical treatment cycles. The field of                reporting year, or transfers of at least
                                               Secretary of the Department of Health                   ART is moving toward the calculation                  one embryo created from an oocyte
                                               and Human Services through the                          and reporting of cumulative success                   retrieved from the patient in the year
                                               Centers for Disease Control and                         rates where data collection systems can               prior to the reporting year. For the
                                               Prevention (CDC) pregnancy success                      collect successes over all embryo                     purpose of this definition, egg or
                                               rates achieved through assisted                         transfers from a single oocyte retrieval              embryo transfer procedures must have
                                               reproductive technology. The FCSRCA                     or across several oocyte retrievals and               started within 12 months of the start of
                                               also requires CDC to annually publish                   embryo transfers. After consultation                  the retrieval procedure.
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                                               and distribute to the public reported                   with consumer and professional                           Other rates for ART procedures
                                               pregnancy success rates for each ART                    organizations with expertise in ART,                  among all patients using their own eggs
                                               clinic. According to the FCSRCA, the                    CDC will begin cumulative ART success                 are defined as follows (and may be
                                               definitions of pregnancy success rates                  rates reporting in reporting year 2017.               provided publically at the ART
                                               should be developed in consultation                     The ART success rates described in this               program’s discretion)—
                                               with appropriate consumer and                           Federal Register notice shall replace                    3. The rate of cancellation,
                                               professional organizations, should take                 those previously described in 2004.                   implantation, pregnancy, live birth,


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                                                                            Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Notices                                            53255

                                               singleton live birth, multiple live birth,                 a. ART patients who reported at the                twin live birth, triplet or higher order
                                               twin live birth, triplet or higher order                start of the retrieval procedure that they            live birth, preterm live birth, low
                                               live birth, preterm live birth, low                     had no prior ART stimulations and no                  birthweight live birth, or term, normal
                                               birthweight live birth or term, normal                  prior frozen ART procedures. For the                  birthweight and singleton live birth
                                               birthweight and singleton live birth                    purpose of this definition, the retrieval             presented according to the number of:
                                               resulting from the transfer of oocytes                  procedure must have started in the year                  a. ART procedures to prepare a
                                               retrieved from the patient in the year                  prior to the reporting year.                          patient (recipient) for the transfer of at
                                               prior to the reporting year or the transfer                6. The rate of live birth resulting from           least one donor egg, embryo created
                                               of embryos created from oocytes                         the transfer of oocytes or embryos from               from a donor egg, or donated embryo,
                                               retrieved from the patient in the year                  all intended oocyte retrievals presented              started in the current reporting year.
                                               prior to the reporting year. For the                    according to the number of:                              b. Transfer procedures of at least one
                                               purpose of this definition, transfer                       a. ART patients who reported at the                donor egg, embryo created from a donor
                                               procedures must have started within 12                  start of the retrieval procedure that they            egg, or donated embryo started in the
                                               months of the start of the retrieval                    had no prior ART stimulations and no                  current reporting year.
                                               procedure. These other rates may be                     prior frozen ART procedures. For the
                                                                                                       purpose of this definition, the retrieval             D. ART Procedures Among All Patients
                                               presented according to the number of:
                                                                                                       procedure must have started in the year               and All Cycle Types
                                                  a. All ovarian stimulation or
                                               monitoring procedures started in the                    prior to the reporting year.                             At the discretion of the ART program,
                                               year prior to the reporting year with the                  7. The number of ovarian stimulation               ART reporting also may include:
                                               intent to retrieve oocytes from the                     or monitoring procedures started in the                  11. The number, average number or
                                               patient.                                                year prior to the reporting year with the             percentage of ART procedures or ART
                                                  b. All ovarian stimulation or                        intent to retrieve oocytes from the                   patients with certain characteristics,
                                               monitoring procedures started in the                    patient presented according to the                    such as:
                                               year prior to the reporting year with the               number of:                                               a. Patient characteristics (e.g. patient
                                               intent to retrieve oocytes from the                        a. ART patients who reported at the                age or reason for ART).
                                               patient in which at least one oocyte was                start of the retrieval procedure that they               b. ART procedure characteristics (e.g.
                                               retrieved.                                              had no prior ART stimulations and no                  type of treatment (fertility preservation,
                                                  c. All transfer procedures of at least               prior frozen ART procedures.                          short term banking, in vitro fertilization,
                                               one oocyte retrieved from the patient in                   8. The number of transfer procedures               gamete intrafallopian transfer, zygote
                                               the year prior to the reporting year, or                of at least one oocyte retrieved from the             intrafallopian transfer), stimulation
                                               of at least one embryo created from an                  patient in the year prior to the reporting            protocol, source of the oocytes or
                                               oocyte retrieved from the patient in the                year, or of at least one embryo created               embryos (patient or donor), the state of
                                               year prior to the reporting year. For the               from an oocyte retrieved from the                     the oocytes or embryos (fresh or frozen),
                                               purpose of this definition, egg or                      patient in the year prior to the reporting            the intent of the procedure, the use of
                                               embryo transfer procedures must have                    year presented according to the number                prenatal genetic diagnosis or screening,
                                               started within 12 months of the start of                of:                                                   the use of intracytoplasmic sperm
                                                                                                          a. Ovarian stimulation or monitoring
                                               the retrieval procedure.                                                                                      injection, the use of assisted hatching,
                                                                                                       procedures started in the year prior to
                                                  d. All first, second, third, or more                                                                       the use of a gestational carrier, the stage
                                                                                                       the reporting year with the intent to
                                               transfer procedures after retrieval of at                                                                     of the embryo at transfer, or the number
                                                                                                       retrieve oocytes from the patient. For
                                               least one oocyte from the patient in the                                                                      of embryos transferred).
                                                                                                       the purpose of this definition, egg or
                                               year prior to the reporting year, or of at                                                                       All ART patient and procedure
                                                                                                       embryo transfer procedures must have
                                               least one embryo created from an oocyte                                                                       characteristics, ART success rates, and
                                                                                                       started within 12 months of the start of
                                               retrieved from the patient in the year                                                                        other rates for patients using their own
                                                                                                       the retrieval procedure. Also, ART
                                               prior to the reporting year. For the                                                                          oocytes as well as for patients using
                                                                                                       patients must have reported at the start
                                               purpose of this definition, egg or                                                                            oocytes or embryos from a donor may be
                                                                                                       of the retrieval procedure that they had
                                               embryo transfer procedures must have                                                                          stratified by CDC by factors thought to
                                                                                                       no prior ART stimulations and no prior
                                               started within 12 months of the start of                                                                      influence the outcome of an ART
                                                                                                       frozen ART procedures.
                                               the retrieval procedure.                                                                                      procedure.
                                                  Rates for ART procedures among new                   C. ART Procedures Among Patients                         12. Factors for stratification may
                                               ART patients (i.e. patients that have                   Using Oocytes or Embryos From a Donor                 include:
                                               never had a prior ART cycle ever) using                    Success rates for ART procedures                      a. Characteristics of the ART patient
                                               their own oocytes are defined as—                       among patients using oocytes or                       such as patient age or reason for ART.
                                                  4. The rate of live birth resulting from             embryos from a donor are defined as—                     b. Characteristics of the ART
                                               the transfer of oocytes or embryos from                    9. The rate of live birth or singleton             procedure such as type of treatment
                                               all first intended oocyte retrievals                    live birth presented according to the                 (fertility preservation, short term
                                               presented according to the number of:                   number of:                                            banking, in vitro fertilization, gamete
                                                  a. ART patients who reported at the                     a. Transfer procedures of at least one             intrafallopian transfer, zygote
                                               start of the retrieval procedure that they              donor egg, embryo created from a donor                intrafallopian transfer), stimulation
                                               had no prior ART stimulations and no                    egg, or donated embryo started in the                 protocol, the source of the oocytes or
                                               prior frozen ART procedures. For the                    current reporting year.                               embryos (patient or donor), the state of
                                               purpose of this definition, the retrieval                  Other rates for ART procedures                     the oocytes or embryos (fresh or frozen),
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                                               procedure must have started in the year                 among patients using oocytes or                       the intent of the procedure, the use of
                                               prior to the reporting year.                            embryos from a donor are defined as                   prenatal genetic diagnosis or screening,
                                                  5. The rate of live birth resulting from             follows (and may be provided publically               the use of intracytoplasmic sperm
                                               the transfer of oocytes or embryos from                 at the ART program’s discretion):                     injection, the use of assisted hatching,
                                               all first or second intended oocyte                        10. The rate of cancellation,                      the use of a gestational carrier, the stage
                                               retrievals presented according to the                   implantation, pregnancy, live birth,                  of the embryo at transfer, or the number
                                               number of:                                              singleton live birth, multiple live birth,            of embryos transferred.


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                                               53256                        Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Notices

                                                 Dated: October 17, 2018.                              health program; stability evaluation of               proposed collection of information,
                                               Sandra Cashman,                                         active gas wells in longwall abutment                 including the validity of the
                                               Executive Secretary, Centers for Disease                pillars; and durable support for western              methodology and assumptions used;
                                               Control and Prevention.                                 US underground metal mines. The                         (c) Enhance the quality, utility, and
                                               [FR Doc. 2018–22991 Filed 10–19–18; 8:45 am]            meeting will also include updates from                clarity of the information to be
                                               BILLING CODE 4163–18–P                                  the NIOSH Associate Director for                      collected;
                                                                                                       Mining, the Spokane Mining Research                     (d) Minimize the burden of the
                                                                                                       Division, and the Pittsburgh Mining                   collection of information on those who
                                               DEPARTMENT OF HEALTH AND                                Research Division. Agenda items are                   are to respond, including, through the
                                               HUMAN SERVICES                                          subject to change as priorities dictate.              use of appropriate automated,
                                                                                                         The Chief Operating Officer, Centers                electronic, mechanical, or other
                                               Centers for Disease Control and                         for Disease Control and Prevention, has               technological collection techniques or
                                               Prevention                                              been delegated the authority to sign                  other forms of information technology,
                                                                                                       Federal Register notices pertaining to                e.g., permitting electronic submission of
                                               Mine Safety and Health Research                         announcements of meetings and other                   responses; and
                                               Advisory Committee (MSHRAC)                             committee management activities, for                    (e) Assess information collection
                                               AGENCY: Centers for Disease Control and                 both the Centers for Disease Control and              costs.
                                               Prevention (CDC), Department of Health                  Prevention and the Agency for Toxic
                                                                                                                                                               To request additional information on
                                               and Human Services (HHS).                               Substances and Disease Registry.
                                                                                                                                                             the proposed project or to obtain a copy
                                               ACTION: Notice of meeting.                              Sherri Berger,                                        of the information collection plan and
                                                                                                       Chief Operating Officer, Centers for Disease          instruments, call (404) 639–7570 or
                                               SUMMARY:   In accordance with the                       Control and Prevention.                               send an email to omb@cdc.gov. Direct
                                               Federal Advisory Committee Act, the                     [FR Doc. 2018–22988 Filed 10–19–18; 8:45 am]          written comments and/or suggestions
                                               CDC announces the following meeting                                                                           regarding the items contained in this
                                                                                                       BILLING CODE 4163–19–P
                                               for the Mine Safety and Health Research                                                                       notice to the Attention: CDC Desk
                                               Advisory Committee (MSHRAC). This                                                                             Officer, Office of Management and
                                               meeting is open to the public, limited                  DEPARTMENT OF HEALTH AND                              Budget, 725 17th Street NW,
                                               only by the space available. The meeting                HUMAN SERVICES                                        Washington, DC 20503 or by fax to (202)
                                               room accommodates approximately 38                                                                            395–5806. Provide written comments
                                               people. If you wish to attend in person                 Centers for Disease Control and                       within 30 days of notice publication.
                                               or by phone, please contact Marie                       Prevention
                                               Chovanec by email at MChovanec@                                                                               Proposed Project
                                                                                                       [30Day–19–18UF]
                                               cdc.gov or by phone at 412–386–5302 at                                                                          Evidence to Inform Standards that
                                               least 5 business days in advance of the                 Agency Forms Undergoing Paperwork                     Ensure Turnout Gear Remains
                                               meeting.                                                Reduction Act Review                                  Protective Throughout Its Lifecycle—
                                               DATES: The meeting will be held on                                                                            New—National Institute for
                                               November 29, 2018, 8 a.m.–4 p.m., MST                      In accordance with the Paperwork
                                                                                                                                                             Occupational Safety and Health
                                               and on November 30, 2018, 8 a.m.–12                     Reduction Act of 1995, the Centers for
                                                                                                                                                             (NIOSH), Centers for Disease Control
                                               p.m. MST.                                               Disease Control and Prevention (CDC)
                                                                                                                                                             and Prevention (CDC).
                                                                                                       has submitted the information
                                               ADDRESSES: University of Arizona,
                                                                                                       collection request titled Assessment of               Background and Brief Description
                                               ENR2 Building, Room S215, 1064 E.
                                                                                                       Evidence to Inform Standards that
                                               Lowell Street, Tucson, AZ 85721 United                                                                          Turnout gear is a type of personal
                                                                                                       Ensure Turnout Gear Remains
                                               States.                                                                                                       protective equipment used by the 1.1
                                                                                                       Protective Throughout Its Lifecycle to
                                               FOR FURTHER INFORMATION CONTACT:                                                                              million U.S. fire fighters to shield the
                                                                                                       the Office of Management and Budget
                                               Jeffrey H. Welsh, Designated Federal                    (OMB) for review and approval. CDC                    body from carcinogens, flames, heat,
                                               Officer, MSHRAC, NIOSH, CDC, 626                        previously published a ‘‘Proposed Data                and chemical/biological agents. It serves
                                               Cochrans Mill Road, Pittsburgh, PA                      Collection Submitted for Public                       as a barrier to external hazards while
                                               15236, telephone 412–386–4040; email                    Comment and Recommendations’’                         simultaneously allowing for the escape
                                               juw5@cdc.gov.                                           notice on April 12, 2018 to obtain                    of metabolic heat to prevent elevated
                                               SUPPLEMENTARY INFORMATION:                              comments from the public and affected                 core body temperatures. To provide the
                                                 Purpose: This committee is charged                    agencies. CDC received one comment                    necessary performance characteristics,
                                               with providing advice to the Secretary,                 related to the previous notice. This                  turnout gear design is complex,
                                               Department of Health and Human                          notice serves to allow an additional 30               consisting of three major layers that
                                               Services; the Director, CDC; and the                    days for public and affected agency                   work as a composite—a thermal liner, a
                                               Director, NIOSH, on priorities in mine                  comments.                                             moisture barrier, and an outer shell.
                                               safety and health research, including                      CDC will accept all comments for this                Consensus standards provide
                                               grants and contracts for such research,                 proposed information collection project.              performance requirements and
                                               30 U.S.C. 812(b)(2), Section 102(b)(2).                 The Office of Management and Budget                   retirement criteria for turnout gear. The
                                                 Matters to be Considered: The agenda                  is particularly interested in comments                retirement criteria is based on visual
                                               will include discussions on mining                      that:                                                 inspections and a 10-year age cap with
                                               safety and health research projects and                    (a) Evaluate whether the proposed                  visual inspection being less effective for
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                                               outcomes, including real-time DPM                       collection of information is necessary                the moisture barrier and thermal liner
                                               monitor; industrial minerals sector                     for the proper performance of the                     layers. Recent data of turnout gear
                                               research priorities; MSHRAC metal                       functions of the agency, including                    donated from fire departments
                                               mine automation workgroup report;                       whether the information will have                     demonstrates that turnout gear from 2 to
                                               cemented backfill research; recent                      practical utility;                                    10 years old was unable to meet all
                                               research in coal mine explosion and fire                   (b) Evaluate the accuracy of the                   performance requirements. Thus, under
                                               prevention; engaging in the miner                       agencies estimate of the burden of the                the current retirement criteria, turnout


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Document Created: 2018-10-20 01:49:32
Document Modified: 2018-10-20 01:49:32
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
ContactJeani 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]
FR Citation83 FR 53253 

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