To prohibit human cloning and protect stem cell research.

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Human Cloning Ban and Stem Cell 
Research Protection Act of 2005''.

SEC. 2. PURPOSES.

    It is the purpose of this Act to prohibit human cloning and to 
protect important areas of medical research, including stem cell 
research.

                 TITLE I--PROHIBITION ON HUMAN CLONING

SEC. 101. PROHIBITION ON HUMAN CLONING.

    (a) In General.--The Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 301 et seq.) is amended by adding at the end the following:

               ``CHAPTER X--PROHIBITION ON HUMAN CLONING

``SEC. 1001. PROHIBITION ON HUMAN CLONING.

    ``(a) Definitions.--In this section:
            ``(1) Human cloning.--The term `human cloning' means 
        implanting or attempting to implant the product of nuclear 
        transplantation into a uterus or the functional equivalent of a 
        uterus.
            ``(2) Human somatic cell.--The term `human somatic cell' 
        means any human cell other than a haploid germ cell.
            ``(3) Nuclear transplantation.--The term `nuclear 
        transplantation' means transferring the nucleus of a human 
        somatic cell into an oocyte from which the nucleus or all 
        chromosomes have been or will be removed or rendered inert.
            ``(4) Nucleus.--The term `nucleus' means the cell structure 
        that houses the chromosomes.
            ``(5) Oocyte.--The term `oocyte' means the female germ 
        cell, the egg.
            ``(6) Unfertilized blastocyst.--The term `unfertilized 
        blastocyst' means an intact cellular structure that is the 
        product of nuclear transplantation. Such term shall not be 
        construed to include any biological product derived from an 
        intact cellular structure that is the product of nuclear 
        transplantation, including stem cells, other cells, and 
        cellular structures.
    ``(b) Prohibitions on Human Cloning.--It shall be unlawful for any 
person or other legal entity, public or private--
            ``(1) to conduct or attempt to conduct human cloning;
            ``(2) to ship the product of nuclear transplantation in 
        interstate or foreign commerce for the purpose of human cloning 
        in the United States or elsewhere; or
            ``(3) to export to a foreign country an unfertilized 
        blastocyst if such country does not prohibit human cloning.
    ``(c) Protection of Research.--Nothing in this section shall be 
construed to restrict practices not expressly prohibited in this 
section.
    ``(d) Right of Action.--Nothing in this section shall be construed 
to give any individual or person a private right of action.''.
    (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 paragraph (1), (2), or (3) of section 
1001(b) (relating to human cloning).''.
            (2) Criminal penalties.--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 following:
            ``(7) Notwithstanding subsection (a), any person who 
        violates section 301(hh) shall be imprisoned not more than 10 
        years and fined in accordance with title 18, United States 
        Code, or both.''.
            (3) Civil penalties.--Section 303 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 333) is amended by adding at 
        the end:
    ``(g)(1) Any person who violates section 301(hh) 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 three times the amount of the 
        gross pecuniary gain resulting from the violation.
    ``(2) Paragraphs (3) through (5) of subsection (f) apply with 
respect to a civil penalty under this subsection to the same extent and 
in the same manner as such paragraphs (3) through (5) apply with 
respect to a civil penalty under subsection (f).''.
            (4) Forfeiture.--Section 303 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 333), as amended by paragraph (3), is 
        amended by adding at the end the following:
    ``(h) Any property, real or personal, derived from or used to 
commit a violation or attempted violation of section 301(hh), or any 
property traceable to such property, shall be subject to forfeiture to 
the United States in accordance with the procedures set forth in 
chapter 46 of title 18, United States Code.''.

SEC. 102. OVERSIGHT REPORTS ON ACTIONS TO ENFORCE CERTAIN PROHIBITIONS.

    (a) Report on Actions by Secretary of HHS to Enforce Prohibition on 
Human Cloning.--Not later than 1 year after the date of the enactment 
of this Act, the Secretary of Health and Human Services shall prepare 
and submit to the Committee on the Judiciary of the Senate and the 
Committee on Energy and Commerce of the House of Representatives a 
report that--
            (1) describes the actions taken by the Secretary to enforce 
        the provisions of chapter X of the Federal Food, Drug, and 
        Cosmetic Act (as added by section 101);
            (2) describes the personnel and resources the Secretary has 
        utilized to enforce the provisions of such chapter; and
            (3) contains a list of violations, if any, of the 
        provisions of such chapter.
    (b) Report on Coordination of Enforcement Actions Among Federal, 
State, and Local Governments With Respect to Human Cloning.--
            (1) Report.--Not later than 1 year after the date of the 
        enactment of this Act, the Secretary of Health and Human 
        Services shall prepare and submit to the Committee on the 
        Judiciary of the Senate and the Committee on Energy and 
        Commerce of the House of Representatives a report that--
                    (A) describes how the Secretary coordinates the 
                enforcement of violations of section 301(hh) of the 
                Federal Food, Drug, and Cosmetic Act (as added by 
                section 101) with enforcement actions taken by State or 
                local government law enforcement officials with respect 
                to similar State laws relating to human cloning; and
                    (B) describes the status and disposition of--
                            (i) Federal appellate litigation with 
                        respect to such section 301(hh) and State 
                        appellate litigation with respect to similar 
                        State laws relating to human cloning; and
                            (ii) civil litigation, including actions to 
                        appoint guardians, related to human cloning.
            (2) Definition.--In this subsection, the term ``similar 
        State law relating to human cloning'' means a State or local 
        law that provides for the imposition of criminal penalties on 
        individuals who are determined to be conducting or attempting 
        to conduct human cloning (as defined in section 1001 of the 
        Federal Food, Drug, and Cosmetic Act (as added by section 
        101)).
    (c) Report on International Laws Relating to Human Cloning.--Not 
later than 1 year after the date of the enactment of this Act, the 
Secretary of Health and Human Services shall prepare and submit to the 
Congress a report that--
            (1) describes the laws adopted by foreign countries related 
        to human cloning;
            (2) describes the actions taken by the chief law 
        enforcement officer in each foreign country that has enacted a 
        law described in paragraph (1) to enforce such law; and
            (3) describes the multilateral efforts of the United 
        Nations and elsewhere to ban human cloning.

  TITLE II--ETHICAL REQUIREMENTS FOR NUCLEAR TRANSPLANTATION RESEARCH

SEC. 201. ETHICAL REQUIREMENTS FOR NUCLEAR TRANSPLANTATION RESEARCH.

    Title IV of the Public Health Service Act (42 U.S.C. 281 et seq.) 
is amended by adding at the end the following:

  ``PART J--ETHICAL REQUIREMENTS FOR NUCLEAR TRANSPLANTATION RESEARCH

``SEC. 499A. ETHICAL REQUIREMENTS FOR NUCLEAR TRANSPLANTATION RESEARCH, 
              INCLUDING INFORMED CONSENT, INSTITUTIONAL REVIEW BOARD 
              REVIEW, AND PROTECTION FOR SAFETY AND PRIVACY.

    ``(a) Definitions.--
            ``(1) In general.--The definitions contained in section 
        1001(a) of the Federal Food, Drug, and Cosmetic Act shall apply 
        for purposes of this section.
            ``(2) Other definitions.--In this section:
                    ``(A) Donating.--The term `donating' means giving 
                without receiving valuable consideration.
                    ``(B) Fertilization.--The term `fertilization' 
                means the fusion of an oocyte containing a haploid 
                nucleus with a male gamete (sperm cell).
                    ``(C) Valuable consideration.--The term `valuable 
                consideration' does not include reasonable payments--
                            ``(i) associated with the transportation, 
                        processing, preservation, or storage of a human 
                        oocyte or of the product of nuclear 
                        transplantation research; or
                            ``(ii) to compensate a donor of one or more 
                        human oocytes for the time or inconvenience 
                        associated with such donation.
    ``(b) Applicability of Federal Ethical Standards to Nuclear 
Transplantation Research.--Research involving nuclear transplantation 
shall be conducted in accordance with subpart A of part 46 of title 45, 
or parts 50 and 56 of title 21, Code of Federal Regulations (as in 
effect on the date of the enactment of the Human Cloning Ban and Stem 
Cell Research Protection Act of 2005), as applicable.
    ``(c) Prohibition on Conducting Nuclear Transplantation on 
Fertilized Eggs.--A somatic cell nucleus shall not be transplanted into 
a human oocyte that has undergone or will undergo fertilization.
    ``(d) Fourteen-Day Rule.--An unfertilized blastocyst shall not be 
maintained more than 14 days from its first cell division, not counting 
any time during which it is stored at temperatures less than zero 
degrees centigrade.
    ``(e) Voluntary Donation of Oocytes.--
            ``(1) Informed consent.--In accordance with subsection (b), 
        an oocyte may not be used in nuclear transplantation research 
        unless such oocyte shall have been donated voluntarily by and 
        with the informed consent of the woman donating the oocyte.
            ``(2) Prohibition on purchase or sale.--No human oocyte or 
        unfertilized blastocyst may be acquired, received, or otherwise 
        transferred for valuable consideration if the transfer affects 
        interstate commerce.
    ``(f) Separation of in Vitro Fertilization Laboratories From 
Locations at Which Nuclear Transplantation Is Conducted.--Nuclear 
transplantation may not be conducted in the same laboratory or other 
physical facility in which human oocytes are subject to assisted 
reproductive technology treatments or procedures.
    ``(g) Civil Penalties.--Whoever intentionally violates any 
provision of subsections (b) through (f) shall be subject to a civil 
penalty in an amount that is appropriate for the violation involved, 
but not more than $250,000.''.

Summary: Human Cloning Ban and Stem Cell Research Protection Act of 2005 - Amends the Federal Food, Drug, and Cosmetic Act to prohibit: (1) conducting or attempting to conduct human cloning; (2) shipping the product of nuclear transplantation in interstate or foreign commerce for the purpose of human cloning in the United States or elsewhere; or (3) exporting to a foreign country an unfertilized blastocyst if such country does not prohibit human cloning. Sets forth criminal and civil penalties for violations.

Requires the Secretary of Health and Human Services to report to the relevant congressional committees on: (1) actions taken to enforce such prohibitions; (2) coordination of Federal, State, and local enforcement; and (3) international laws relating to human cloning. Amends the Public Health Service Act to require research involving nuclear transplantation to be conducted in accordance with applicable Federal regulations regarding the protection of human subjects and Institutional Review Boards. Prohibits: (1) a somatic cell nucleus from being transplanted into a human oocyte (egg) that has undergone or will undergo fertilization; (2) an unfertilized blastocyst from being maintained after more than 14 days from its first cell division, not counting storage times at temperatures less than zero degrees centigrade; (3) an oocyte from being used in nuclear transplantation research unless donated voluntarily with the donor's informed consent; (4) a human oocyte or unfertilized blastocyst from being acquired, received, or transferred for valuable consideration in interstate commerce; and (5) nuclear transplantation in a laboratory in which human oocytes are subject to assisted reproductive technology treatments or procedures. Sets forth civil penalties for violations.