81 FR 90854 - Reporting of Pregnancy Success Rates From Assisted Reproductive Technology (ART) Programs; Clarifications and Modifications

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

Federal Register Volume 81, Issue 241 (December 15, 2016)

Page Range		90854-90854
FR Document		2016-30145

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces clarification and modification of certain definitions used for reporting of pregnancy success rates from assisted reproductive technology (ART) programs as required by the Fertility Clinic Success Rate and Certification Act of 1992 (FCSRCA). These clarifications and modifications are based on inquiries and comments to CDC after the publication of the Final Notice on August 26, 2015. All comments were reviewed and carefully considered in developing the final definition to better assist ART clinics in reporting accurate data to CDC.

Federal Register, Volume 81 Issue 241 (Thursday, December 15, 2016)

[Federal Register Volume 81, Number 241 (Thursday, December 15, 2016)]
[Notices]
[Page 90854]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-30145]


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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 Modifications

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 
clarification and modification of certain definitions used for 
reporting of pregnancy success rates from assisted reproductive 
technology (ART) programs as required by the Fertility Clinic Success 
Rate and Certification Act of 1992 (FCSRCA). These clarifications and 
modifications are based on inquiries and comments to CDC after the 
publication of the Final Notice on August 26, 2015. All comments were 
reviewed and carefully considered in developing the final definition to 
better assist ART clinics in reporting accurate data to CDC.

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-74, Atlanta, Georgia 30341. Phone: (770) 488-6370. 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 describes 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 notice includes clarification and modification of certain 
definitions used for reporting of pregnancy success rates from assisted 
reproductive technology (ART) programs, reporting requirements and 
responsibilities, and data validation.

Clarification and Modification:

Section J. Definitions

    Current: Gestational carrier (sometimes referred to as a 
gestational surrogate)--A woman who gestates an embryo that did not 
develop from her oocyte, with the expectation of returning the infant 
to its intended parent(s). NOTE: For female same sex couples, the woman 
who will carry the pregnancy should be identified as the patient and a 
separate cycle should be reported if donor oocytes are used, even if 
the patient's partner is the source of the oocytes. If a gestational 
carrier is used, one cycle is reported for fresh embryo cycle; two 
cycles should be reported for frozen embryo cycle (one for the oocyte 
retrieval and one for the embryo transfer).
    Modification: Gestational carrier--A woman who gestates an embryo 
that did not develop from her oocyte, with the expectation of returning 
the infant to its intended parent(s). If a gestational carrier is used, 
one cycle should be reported for fresh oocyte cycles; at least two 
cycles should be reported for fresh embryos created from frozen/thawed 
oocytes or frozen/thawed embryos (one for the oocyte retrieval and one 
for each cycle conducted with the intent to transfer). NOTE: For female 
same sex couples, if one partner will carry the pregnancy, the partner 
who will carry the pregnancy should be identified as the patient.
    Current: Oligospermia--Semen with a low concentration of sperm. 
Severe oligospermia is defined by <5 million spermatozoa per mL; 
moderate is defined by 5-15 million spermatozoa per mL.
    Modification: Oligozoospermia--Semen with a low concentration of 
sperm. Severe oligozoospermia is defined by <5 million spermatozoa per 
mL; moderate is defined by 5-15 million spermatozoa per mL.
    Addition: Minimal stimulation protocol--generally includes the use 
of oral medications, such as clomiphene citrate, followed by a low dose 
of injectable gonadotropin and an hCG trigger shot or just the hCG 
trigger shot.
    Addition: Cigarette smoking--Includes smoking of combustible 
tobacco products, such as cigarettes, cigars, cigarillos and little 
cigars; does not include electronic cigarettes.

    Dated: December 12, 2016.
Sandra Cashman,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2016-30145 Filed 12-14-16; 8:45 am]
BILLING CODE 4163-18-P

90854 Federal Register / Vol. 81, No. 241 / Thursday, December 15, 2016 / Notices

FEDERAL RESERVE SYSTEM DEPARTMENT OF HEALTH AND parent(s). NOTE: For female same sex
HUMAN SERVICES couples, the woman who will carry the
Formations of, Acquisitions by, and pregnancy should be identified as the
Mergers of Bank Holding Companies Centers for Disease Control and patient and a separate cycle should be
Prevention reported if donor oocytes are used, even
The companies listed in this notice if the patient’s partner is the source of
have applied to the Board for approval, Reporting of Pregnancy Success Rates
From Assisted Reproductive the oocytes. If a gestational carrier is
pursuant to the Bank Holding Company used, one cycle is reported for fresh
Act of 1956 (12 U.S.C. 1841 et seq.) Technology (ART) Programs;
Clarifications and Modifications embryo cycle; two cycles should be
(BHC Act), Regulation Y (12 CFR part reported for frozen embryo cycle (one
225), and all other applicable statutes AGENCY: Centers for Disease Control and for the oocyte retrieval and one for the
and regulations to become a bank Prevention (CDC), Department of Health embryo transfer).
holding company and/or to acquire the and Human Services (HHS).
Modification: Gestational carrier—A
assets or the ownership of, control of, or ACTION: Notice.
woman who gestates an embryo that did
the power to vote shares of a bank or
SUMMARY: The Centers for Disease not develop from her oocyte, with the
bank holding company and all of the
Control and Prevention (CDC), located expectation of returning the infant to its
banks and nonbanking companies
within the Department of Health and intended parent(s). If a gestational
owned by the bank holding company, Human Services (HHS) announces carrier is used, one cycle should be
including the companies listed below. clarification and modification of certain reported for fresh oocyte cycles; at least
The applications listed below, as well definitions used for reporting of two cycles should be reported for fresh
as other related filings required by the pregnancy success rates from assisted embryos created from frozen/thawed
Board, are available for immediate reproductive technology (ART) oocytes or frozen/thawed embryos (one
inspection at the Federal Reserve Bank programs as required by the Fertility for the oocyte retrieval and one for each
indicated. The applications will also be Clinic Success Rate and Certification cycle conducted with the intent to
available for inspection at the offices of Act of 1992 (FCSRCA). These
transfer). NOTE: For female same sex
the Board of Governors. Interested clarifications and modifications are
couples, if one partner will carry the
persons may express their views in based on inquiries and comments to
CDC after the publication of the Final pregnancy, the partner who will carry
writing on the standards enumerated in the pregnancy should be identified as
the BHC Act (12 U.S.C. 1842(c)). If the Notice on August 26, 2015. All
comments were reviewed and carefully the patient.
proposal also involves the acquisition of
considered in developing the final Current: Oligospermia—Semen with a
a nonbanking company, the review also
definition to better assist ART clinics in low concentration of sperm. Severe
includes whether the acquisition of the
reporting accurate data to CDC. oligospermia is defined by <5 million
nonbanking company complies with the
FOR FURTHER INFORMATION CONTACT: spermatozoa per mL; moderate is
standards in section 4 of the BHC Act
Jeani Chang, Division of Reproductive defined by 5–15 million spermatozoa
(12 U.S.C. 1843). Unless otherwise
Health, National Center for Chronic per mL.
noted, nonbanking activities will be
Disease Prevention and Health Modification: Oligozoospermia—
conducted throughout the United States. Promotion, Centers for Disease Control Semen with a low concentration of
Unless otherwise noted, comments and Prevention, 4770 Buford Highway,
sperm. Severe oligozoospermia is
regarding each of these applications MS–74, Atlanta, Georgia 30341. Phone:
defined by <5 million spermatozoa per
must be received at the Reserve Bank (770) 488–6370. Email: artinfo@cdc.gov.
mL; moderate is defined by 5–15
indicated or the offices of the Board of SUPPLEMENTARY INFORMATION: On August
million spermatozoa per mL.
Governors not later than January 13, 26, 2015, HHS/CDC published a notice
2017. in the Federal Register (80 FR 51811) Addition: Minimal stimulation
announcing the overall reporting protocol—generally includes the use of
A. Federal Reserve Bank of Dallas
requirements of the National ART oral medications, such as clomiphene
(Robert L. Triplett III, Senior Vice
Surveillance System (NASS). The notice citrate, followed by a low dose of
President) 2200 North Pearl Street,
describes who shall report to HHS/CDC; injectable gonadotropin and an hCG
Dallas, Texas 75201–2272:
the process for reporting by each ART trigger shot or just the hCG trigger shot.
1. Texas State Bankshares, Inc., program; the data to be reported; and Addition: Cigarette smoking—
Harlingen, Texas; to acquire Blanco the contents of the published reports. Includes smoking of combustible
National Holdings, Inc., and therefore This notice includes clarification and
tobacco products, such as cigarettes,
indirectly acquire The Blanco National modification of certain definitions used
cigars, cigarillos and little cigars; does
Bank, both of Blanco, Texas. for reporting of pregnancy success rates
not include electronic cigarettes.
Board of Governors of the Federal Reserve from assisted reproductive technology
(ART) programs, reporting requirements Dated: December 12, 2016.
System, December 12, 2016.
and responsibilities, and data Sandra Cashman,
Yao-Chin Chao,
validation. Executive Secretary, Centers for Disease
Assistant Secretary of the Board.
Clarification and Modification: Control and Prevention.
[FR Doc. 2016–30135 Filed 12–14–16; 8:45 am]
[FR Doc. 2016–30145 Filed 12–14–16; 8:45 am]
rmajette on DSK2TPTVN1PROD with NOTICES

BILLING CODE 6210–01–P Section J. Definitions
BILLING CODE 4163–18–P
Current: Gestational carrier
(sometimes referred to as a gestational
surrogate)—A woman who gestates an
embryo that did not develop from her
oocyte, with the expectation of
returning the infant to its intended

VerDate Sep<11>2014 15:19 Dec 14, 2016 Jkt 241001 PO 00000 Frm 00083 Fmt 4703 Sfmt 9990 E:\FR\FM\15DEN1.SGM 15DEN1

Document Created: 2016-12-15 01:10:34
Document Modified: 2016-12-15 01:10:34

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
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-74, Atlanta, Georgia 30341. Phone: (770) 488-6370. Email: [email protected]
FR Citation		81 FR 90854

81 FR 90854 - Reporting of Pregnancy Success Rates From Assisted Reproductive Technology (ART) Programs; Clarifications and Modifications

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention

Federal Register Volume 81, Issue 241 (December 15, 2016)

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