Reporting of Pregnancy Success Rates From Assisted Reproductive Technology (ART) Programs; Clarifications and Modifications, 90854 [2016-30145]

Download as PDF 90854 Federal Register / Vol. 81, No. 241 / Thursday, December 15, 2016 / Notices FEDERAL RESERVE SYSTEM DEPARTMENT OF HEALTH AND HUMAN SERVICES Formations of, Acquisitions by, and Mergers of Bank Holding Companies Centers for Disease Control and Prevention The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below. The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States. Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than January 13, 2017. A. Federal Reserve Bank of Dallas (Robert L. Triplett III, Senior Vice President) 2200 North Pearl Street, Dallas, Texas 75201–2272: 1. Texas State Bankshares, Inc., Harlingen, Texas; to acquire Blanco National Holdings, Inc., and therefore indirectly acquire The Blanco National Bank, both of Blanco, Texas. Board of Governors of the Federal Reserve System, December 12, 2016. Yao-Chin Chao, Assistant Secretary of the Board. rmajette on DSK2TPTVN1PROD with NOTICES [FR Doc. 2016–30135 Filed 12–14–16; 8:45 am] 15:19 Dec 14, 2016 Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces 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. SUMMARY: 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 BILLING CODE 6210–01–P VerDate Sep<11>2014 Reporting of Pregnancy Success Rates From Assisted Reproductive Technology (ART) Programs; Clarifications and Modifications Jkt 241001 PO 00000 Frm 00083 Fmt 4703 Sfmt 9990 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 E:\FR\FM\15DEN1.SGM 15DEN1

Agencies

[Federal Register Volume 81, Number 241 (Thursday, December 15, 2016)]
[Notices]
[Page 90854]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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

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