[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.

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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: 
[email protected].

SUPPLEMENTARY INFORMATION: On August 26, 2015, HHS/CDC published a 
notice in the Federal Register (80 FR 51811) announcing the overall 
reporting requirements of the National ART Surveillance System (NASS). 
The notice 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