C.F.R. » Title 45 » SUBCHAPTER A—GENERAL ADMINISTRATION › PART 46—PROTECTION OF HUMAN SUBJECTS › Subpart B—Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research

45 C.F.R. § 46.202

Definitions

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The definitions in § 46.102 of the pre-2018 Requirements and the 2018 Requirements, as applicable, shall be applicable to this subpart as well. In addition, as used in this subpart:

(a) Dead fetus means a fetus that exhibits neither heartbeat, spontaneous respiratory activity, spontaneous movement of voluntary muscles, nor pulsation of the umbilical cord.

(b) Delivery means complete separation of the fetus from the woman by expulsion or extraction or any other means.

(c) Fetus means the product of conception from implantation until delivery.

(d) Neonate means a newborn.

(e) Nonviable neonate means a neonate after delivery that, although living, is not viable.

(f) Pregnancy encompasses the period of time from implantation until delivery. A woman shall be assumed to be pregnant if she exhibits any of the pertinent presumptive signs of pregnancy, such as missed menses, until the results of a pregnancy test are negative or until delivery.

(g) 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.

(h) Viable, as it pertains to the neonate, means being able, after delivery, to survive (given the benefit of available medical therapy) to the point of independently maintaining heartbeat 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 neonate is viable for purposes of this subpart. If a neonate is viable then it may be included in research only to the extent permitted and in accordance with the requirements of the pre-2018 Requirements or the 2018 Requirements, as applicable, and subpart D of this part.

[66 FR 56778, Nov. 13, 2001, as amended at 89 FR 84825, Oct. 24, 2024]
Notes of Decisions
Cited in 5 cases, 2013–2017 · leading case: Real Alternatives, Inc. v. Secretary Department of Health & Human Services
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Real Alternatives, Inc. v. Secretary Department of Health & Human Services (2017) ca3 · cites it 2× “14 However, longstanding FDA regulations treat pregnancy as “the period of time from implantation until delivery,” 45 C.F.R. § 46.202 (f), and categorize drugs that may prevent implantation as contraceptives rather than as abortifacients.”
Burwell v. Hobby Lobby Stores, Inc. (2014) scotus “8611 (1997); 45 CFR § 46.202 (f) (2013), do not so classify them.”
Liberty University, Inc. v. Jacob Lew (2013) ca4 “” 45 C.F.R. 46.202(f) (2001). The forms of contraception that Plaintiffs now challenge, as they themselves recognize, do not act after implantation, so they do not terminate a "pregnancy” as defined in this regulation.”
Wheaton College v. Sylvia Mathews Burwell (2015) ca7 “” True, the government defines abortion as the termination of a pregnancy, and defines pregnancy as (beginning) the moment an embryo is implanted in the wall of the uterus (see 45 C.F.R. § 46.202 (f)), whereas Wheaton defines “conception,” which it regards as the first stage in…”
Louisiana College v. Sebelius (2014) lawd “8611 (1997); 45 CFR § 46.202 (f) (2013), do not so classify them.”
— 45 C.F.R. § 46.202(f) — 1 case
Liberty University, Inc. v. Jacob Lew (2013) ca4 “” 45 C.F.R. 46.202(f) (2001). The forms of contraception that Plaintiffs now challenge, as they themselves recognize, do not act after implantation, so they do not terminate a "pregnancy” as defined in this regulation.”
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