[Code of Federal Regulations]
[Title 45, Volume 1, Parts 1 to 199]
[Revised as of October 1, 2000]
From the U.S. Government Printing Office via GPO Access
[CITE: 45CFR46.203]

[Page 118]
 
                        TITLE 45--PUBLIC WELFARE
 
                           AND HUMAN SERVICES
 
PART 46--PROTECTION OF HUMAN SUBJECTS--Table of Contents
 
 Subpart B--Additional Protections Pertaining to Research, Development, 
 and Related Activities Involving Fetuses, Pregnant Women, and Human In 
                           Vitro Fertilization
 
Sec. 46.203  Definitions.

    As used in this subpart:
    (a) Secretary means the Secretary of Health and Human Services and 
any other officer or employee of the Department of Health and Human 
Services to whom authority has been delegated.
    (b) Pregnancy encompasses the period of time from confirmation of 
implantation (through any of the presumptive signs of pregnancy, such as 
missed menses, or by a medically acceptable pregnancy test), until 
expulsion or extraction of the fetus.
    (c) Fetus means the product of conception from the time of 
implantation (as evidenced by any of the presumptive signs of pregnancy, 
such as missed menses, or a medically acceptable pregnancy test), until 
a determination is made, following expulsion or extraction of the fetus, 
that it is viable.
    (d) Viable as it pertains to the fetus means being able, after 
either spontaneous or induced delivery, to survive (given the benefit of 
available medical therapy) to the point of independently maintaining 
heart beat and respiration. The Secretary may from time to time, taking 
into account medical advances, publish in the Federal Register 
guidelines to assist in determining whether a fetus is viable for 
purposes of this subpart. If a fetus is viable after delivery, it is a 
premature infant.
    (e) Nonviable fetus means a fetus ex utero which, although living, 
is not viable.
    (f) Dead fetus means a fetus ex utero which exhibits neither 
heartbeat, spontaneous respiratory activity, spontaneous movement of 
voluntary muscles, nor pulsation of the umbilical cord (if still 
attached).
    (g) In vitro fertilization means any fertilization of human ova 
which occurs outside the body of a female, either through admixture of 
donor human sperm and ova or by any other means.

[40 FR 33528, Aug. 8, 1975, as amended at 43 FR 1759, Jan. 11, 1978]