supervision of a certified health care provider (com-
monly referred to as the ‘‘in-person dispensing re-
quirement’’). 
(b) OTHER LIMITATIONS.—With respect to the appli-
cable risk evaluation and mitigation strategy under section 
505–1 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355–1) relating to an abortion drug, the Secretary 
of Health and Human Services, the Commissioner of Food 
and Drugs, or any other official within the Department 
of Health and Human Services— 
(1) may not reduce protections (including by 
means of any update) in such strategy until every 
State submits to the abortion surveillance system of 
the Centers for Disease Control and Prevention the 
abortion data collected in the aggregate from the 
States and entered into a standardized worksheet 
that includes questions on the variables specified in 
subsection (c); and 
(2) may not waive the requirement under such 
strategy that such drugs be dispensed in only clinics, 
medical offices, and hospitals by or under the super-
vision of a certified health care provider (commonly 
referred to as the ‘‘in-person dispensing require-
ment’’). 
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(c) MANDATORY VARIABLES.—The mandatory vari-
ables specified in this subsection shall be treated as man-
datory questions for purposes of section 1903(bb) of the 
Social Security Act (42 U.S.C. 1396b(bb)) and shall in-
clude the following: 
(1) Maternal age in years. 
(2) Gestational age in completed weeks at the 
time of abortion. 
(3) Maternal race. 
(4) Maternal ethnicity. 
(5) Maternal race by ethnicity. 
(6) The abortion method type. 
(7) Maternal marital status. 
(8) Previous pregnancies of the mother, includ-
ing the number of previous live births, the number 
of previous induced abortions, and the number of 
previous spontaneous abortions. 
(9) Maternal residence (State or county). 
(10) Whether the child survived the abortion. 
(11) Congenital anomalies. 
(d) DEFINITIONS.—In this section: 
(1) The term ‘‘abortion’’ means the use or pro-
vision of any instrument, medicine, drug, or any 
other substance or device— 
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(A) to intentionally kill the unborn child of 
a woman known to be pregnant; or 
(B) to intentionally terminate the preg-
nancy of a woman known to be pregnant, with 
an intention other than— 
(i) after viability to produce a live 
birth that, if premature, is medically indi-
cated, and to preserve the life and health 
of the child born alive; 
(ii) to treat an ectopic pregnancy; or 
(iii) to remove a dead unborn child. 
(2) The term ‘‘abortion drug’’ means any medi-
cine, drug, or any other substance or combination of 
drugs, medicine, or substances used for an abortion. 
(3) The term ‘‘certified health care provider’’ 
means a health care provider that has completed a 
Prescriber Agreement Form pursuant to the ele-
ments for safe use under the applicable risk evalua-
tion and mitigation strategy under section 505–1 of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355–1) relating to abortion drugs, under 
which the provider agrees to the following: 
(A) The provider has the following quali-
fications: 
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(i) Ability to assess the duration of 
pregnancy accurately. 
(ii) Ability to diagnose ectopic preg-
nancies. 
(iii) Ability to provide surgical inter-
vention in cases of incomplete abortion or 
severe bleeding, or to have made plans to 
provide such care through others, and abil-
ity to assure patient access to medical fa-
cilities equipped to provide blood trans-
fusions and resuscitation, if necessary. 
(B) The provider will follow the guidelines 
for use of mifepristone under the applicable risk 
evaluation and mitigation strategy under sec-
tion 505–1 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355–1) relating to 
abortion drugs. 
(4) The term ‘‘unborn child’’ means an indi-
vidual organism of the species homo sapiens, begin-
ning at fertilization, until the point of being born 
alive as defined in section 8(b) of title 18, United 
States Code. 
Æ 
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