‘‘(2) The use of mitochondrial, cytoplasmic, or 
gene therapy. 
‘‘(3) The use of in vitro fertilization, the admin-
istration of fertility-enhancing drugs, or the use of 
other medical procedures (excluding those using 
human somatic cell nuclear transfer or the product 
thereof) to assist a woman in becoming or remaining 
pregnant. 
‘‘(4) The use of somatic cell nuclear transfer 
technology to clone or otherwise create animals other 
than humans. 
‘‘(5) Any other activity (including biomedical, 
microbiological, or agricultural research or practices) 
not expressly prohibited in subsection (a). 
‘‘(c) REGISTRATION.—
‘‘(1) IN
GENERAL.—Each individual who in-
tends to perform human somatic cell nuclear trans-
fer technology shall, prior to first performing such 
technology, register with the Secretary his or her 
name and place of business (except that, in the case 
of an individual who performed such technology be-
fore the date of the enactment of the Cloning Prohi-
bition Act of 2003, the individual shall so register 
not later than 60 days after such date). The Sec-
retary may by regulation require that the registra-
tion provide additional information regarding the 
identity and business locations of the individual, and 
information on the training and experience of the in-
dividual regarding the performance of such tech-
nology. 
‘‘(2) ATTESTATION BY RESEARCHER.—A reg-
istration under paragraph (1) shall include a state-
ment, signed by the individual submitting the reg-
istration, declaring that the individual is aware of 
the prohibitions described in subsection (a) and will 
not engage in any violation of such subsection. 
‘‘(3) CONFIDENTIALITY.—Information provided 
in a registration under paragraph (1) shall not be 
disclosed to the public by the Secretary except to the 
extent that—
‘‘(A) the individual submitting the reg-
istration has in writing authorized the disclo-
sure; or
‘‘(B) the disclosure does not identify such 
individual or any place of business of the indi-
vidual. 
‘‘(d) APPLICABILITY OF HUMAN SUBJECT PROTEC-
TION STANDARDS.—
‘‘(1) IN GENERAL.—Research involving human 
somatic cell nuclear transfer technology shall be con-
ducted in accordance with parts 50 and 56 of title 
21, Code of Federal Regulations, subject to para-
graph (2). Individuals whose cells are used for such 
research shall be considered human subjects for pur-
poses of such parts. 
‘‘(2) INFORMED CONSENT.—
‘‘(A) DONOR
OF
HUMAN
CELLS.—In re-
search involving human somatic cell nuclear 
transfer technology, human cells may be used 
only if, in addition to requirements that apply 
under parts 50 and 56 of title 21, Code of Fed-
eral Regulations, the individual who provides 
the cells makes a statement in writing, which is 
signed by the individual, declaring that—
‘‘(i) the individual donates the cells 
for purposes of such research; 
‘‘(ii) the individual understands that 
Federal law regulates such technology and 
establishes a crime relating to the use of 
the technology to initiate a pregnancy; and 
‘‘(iii) the individual does not intend 
for the cells to be used to initiate a preg-
nancy. 
‘‘(B) ATTESTATION BY RESEARCHERS.—In 
research involving human somatic cell nuclear
transfer technology, human cells may be used 
only if, in addition to requirements that apply 
under parts 50 and 56 of title 21, Code of Fed-
eral Regulations, the individual with the prin-
cipal responsibility for conducting the research 
makes a statement in writing, which is signed 
by the individual, declaring that the consent of 
the donor of the cells for the cells to be used 
in such research was obtained in accordance 
with this subsection. 
‘‘(e) PREEMPTION OF STATE LAW.—This section su-
persedes any State or local law that—
‘‘(1) establishes prohibitions, requirements, or 
authorizations regarding human somatic cell nuclear 
transfer technology that are different than, or in ad-
dition to, those established in subsection (a) or (c); 
or 
‘‘(2) with respect to humans, prohibits or re-
stricts research regarding or practices constituting—
‘‘(A) somatic cell nuclear transfer; 
‘‘(B) mitochondrial or cytoplasmic therapy; 
or 
‘‘(C) the cloning of molecules, DNA, cells, 
tissues, or organs;
except that this subsection does not apply to any State 
or local law that was in effect as of the day before the 
date of the enactment of the Cloning Prohibition Act of 
2003. 
‘‘(f) RIGHT OF ACTION.—This section may not be 
construed as establishing any private right of action. 
‘‘(g) DEFINITION.—For purposes of this section, the 
term ‘person’ includes governmental entities. 
‘‘(h) SUNSET.—This section and section 301(hh) do 
not apply to any activity described in subsection (a) that 
occurs on or after the expiration of the 10-year period be-
ginning on the date of the enactment of the Cloning Prohi-
bition Act of 2003.’’. 
(b) PROHIBITED ACTS.—
(1) IN GENERAL.—Section 301 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331) is 
amended by adding at the end the following: 
‘‘(hh) The violation of section 1001(a), or the failure 
to register in accordance with section 1001(c).’’. 
(2) CRIMINAL PENALTY.—Section 303(b) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
333(b)) is amended by adding at the end the fol-
lowing: 
‘‘(7) Notwithstanding subsection (a), any person who 
violates section 301(hh) shall be imprisoned not more than
10 years or fined in accordance with title 18, United 
States Code, or both.’’. 
(3) CIVIL PENALTIES.—Section 303 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 333) 
is amended by adding at the end the following: 
‘‘(h)(1) Any person who violates section 301(hh) or 
section 1001(d) shall be liable to the United States for 
a civil penalty in an amount not to exceed the greater of—
‘‘(A) $10,000,000; or 
‘‘(B) an amount equal to the amount of any 
gross pecuniary gain derived from such violation 
multiplied by 2. 
‘‘(2) Paragraphs (3) through (5) of subsection (g) 
apply with respect to a civil penalty under this subsection 
to the same extent and in the same manner as such para-
graphs (3) through (5) apply with respect to a civil penalty 
under subsection (g).’’. 
(4) FORFEITURE.—Section 303 of the Federal 
Food, Drug, and Cosmetic Act, as amended by para-
graph (3), is amended by adding at the end the fol-
lowing: 
‘‘(i) Any property, real or personal, derived from or 
used to commit a violation of section 301(hh), or any prop-
erty traceable to such property, shall be subject to for-
feiture to the United States.’’.
SEC. 3. STUDY BY INSTITUTE OF MEDICINE. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services (referred to in this section as the ‘‘Sec-
retary’’) shall request the Institute of Medicine to enter 
into an agreement with the Secretary under which such 
Institute conducts a study to—
(1) review the current state of knowledge about 
the biological properties of stem cells obtained from 
embryos, fetal tissues, and adult tissues; 
(2) evaluate the current state of knowledge 
about biological differences among stem cells ob-
tained from embryos, fetal tissues, and adult tissues 
and the consequences for research and medicine; and 
(3) assess what is currently known about the 
ability of stem cells to generate neurons, heart, kid-
ney, blood, liver and other tissues and the potential 
clinical uses of these tissues. 
(b) OTHER ENTITIES.—If the Institute of Medicine 
declines to conduct the study described in subsection (a), 
the Secretary shall enter into an agreement with another 
appropriate public or nonprofit private entity to conduct 
the study. 
(c) REPORT.—The Secretary shall ensure that, not 
later than three years after the date of the enactment of 
this Act, the study required in subsection (a) is completed 
and a report describing the findings made in the study
is submitted to the Committee on Energy and Commerce 
in the House of Representatives and the Committee on 
Health, Education, Labor, and Pensions in the Senate.
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