<enum>I</enum><header>Prohibition on human cloning</header> <section id="H2CE1663AF1B646D68EFB45941FAE7D7B"><enum>101.</enum><header>Prohibition on human cloning</header> <subsection id="HCD9AEE72F6894A93BE8E003F78EDC96"><enum>(a)</enum><header>In general</header><text>The Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/301">21 U.S.C. 301 et seq.</external-xref>) is amended by adding at the end the following:</text> <quoted-block style="OLC" id="H393A6622E10345CEA0762B6D7460B11B" display-inline="no-display-inline"> <chapter id="H3AB0444EA6D347D6A400351CA9DE2C80"><enum>X</enum><header>Prohibition on Human Cloning</header> <section id="HD7582C09B7084ED1855F5E3F7BEECE00"><enum>1001.</enum><header>Prohibition on human cloning</header> <subsection id="H84D63ED711D34BD5AA12CCA7FCA601CD"><enum>(a)</enum><header>Definitions</header><text>In this section:</text> <paragraph id="H9C2AD606D66C4B88BB89B57D238BED14"><enum>(1)</enum><header>Human cloning</header><text>The term <term>human cloning</term> means implanting or attempting to implant the product of nuclear transplantation into a uterus or the functional equivalent of a uterus.</text></paragraph> <paragraph id="HA9488DA934E6447DA3DA5C654947EC42"><enum>(2)</enum><header>Human somatic cell</header><text>The term <term>human somatic cell</term> means any human cell other than a haploid germ cell.</text></paragraph> <paragraph id="HFEF4115F50AC4C4CAEF7B0E3AE10999E"><enum>(3)</enum><header>Nuclear transplantation</header><text>The term <term>nuclear transplantation</term> 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.</text></paragraph> <paragraph id="H9E76A825D1DF46F4A9ADC1DB61AF70EB"><enum>(4)</enum><header>Nucleus</header><text>The term <term>nucleus</term> means the cell structure that houses the chromosomes.</text></paragraph> <paragraph id="H3EAB9A54FFEA4691AA00701457037DB0"><enum>(5)</enum><header>Oocyte</header><text>The term <term>oocyte</term> means the female germ cell, the egg.</text></paragraph> <paragraph id="H81CCC00984FA4EB296AB519289208F1"><enum>(6)</enum><header>Unfertilized blastocyst</header><text display-inline="yes-display-inline">The term <term>unfertilized blastocyst</term> 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.</text></paragraph></subsection> <subsection id="HF4EE8396CF884C67B3AE0051821B467C"><enum>(b)</enum><header>Prohibitions on human cloning</header><text>It shall be unlawful for any person or other legal entity, public or private—</text> <paragraph id="HB55A12919A844EAE8BFCC641C3B1803F"><enum>(1)</enum><text>to conduct or attempt to conduct human cloning;</text></paragraph> <paragraph id="HEF99812B0B1E40C685A7539CD4DA7106"><enum>(2)</enum><text>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</text></paragraph> <paragraph id="H0AA13CF207F94EC5873B00F219DA705D"><enum>(3)</enum><text>to export to a foreign country an unfertilized blastocyst if such country does not prohibit human cloning.</text></paragraph></subsection> <subsection id="H7F700D81D6994EDC9130F2D5D8F14912"><enum>(c)</enum><header>Protection of research</header><text>Nothing in this section shall be construed to restrict practices not expressly prohibited in this section.</text></subsection> <subsection id="HD09CC845DF2B4A0C94DFD27160D96BA0"><enum>(d)</enum><header>Right of action</header><text>Nothing in this section shall be construed to give any individual or person a private right of action.</text></subsection> </section></chapter><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="H0BA202F616E642DDADBE3D14DDB5F4E2"><enum>(b)</enum><header>Prohibited Acts</header> <paragraph id="H1C3DFB9E322E45FCAFEFA223C4195D6"><enum>(1)</enum><header>In general</header><text>Section 301 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/331">21 U.S.C. 331</external-xref>) is amended by adding at the end the following:</text> <quoted-block style="OLC" id="H1CC760DB3AED43578D7F247BB7B4AC13" display-inline="no-display-inline"> <subsection id="H1A18A6CC42AD4B5B9B0693B2DB00737C"><enum>(hh)</enum><text>The violation of paragraph (1), (2), or (3) of section 1001(b) (relating to human cloning).</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph> <paragraph id="H22A2092959BF4312866B7410BD149D4D"><enum>(2)</enum><header>Criminal penalties</header><text>Section 303(b) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/333">21 U.S.C. 333(b)</external-xref>) is amended by adding at the end the following:</text> <quoted-block style="OLC" id="H5A50E6A454CD4F8CB1F492A8C1CEEE31" display-inline="no-display-inline"> <paragraph id="H956198343824452ABF8F193076B900D7"><enum>(7)</enum><text>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.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph> <paragraph id="H775EB01409554AADAF6EAACCAB4D079D"><enum>(3)</enum><header>Civil Penalties</header><text>Section 303 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/333">21 U.S.C. 333</external-xref>) is amended by adding at the end:</text> <quoted-block style="OLC" id="H637744F5D77F4EA9B450C76E6BDD915C" display-inline="no-display-inline"> <subsection id="H567E3DBE4E8946008491348F0888BB99"><enum>(g)(1)</enum><text>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—</text> <paragraph id="H8E4876CF67024717BFAD9CE4F62EC952"><enum>(A)</enum><text>$10,000,000; or</text></paragraph> <paragraph id="HC8AAD8E560FA4A26A2297DE204179487"><enum>(B)</enum><text display-inline="yes-display-inline">an amount equal to three times the amount of the gross pecuniary gain resulting from the violation.</text></paragraph> <paragraph id="H8B259790AA884E7B86833DFDF1163E47" indent="up1"><enum>(2)</enum><text>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).</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph> <paragraph id="H0872B2D9A3AC401C9000AC9754E4CE6"><enum>(4)</enum><header>Forfeiture</header><text>Section 303 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/333">21 U.S.C. 333</external-xref>), as amended by paragraph (3), is amended by adding at the end the following:</text> <quoted-block style="OLC" id="H5E6B4543658C434C8801E929B9756200" display-inline="no-display-inline"> <subsection id="HFD21F22FF5004CC28091A0FFD107ED5"><enum>(h)</enum><text display-inline="yes-display-inline">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 <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/18/46">chapter 46</external-xref> of title 18, United States Code.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection></section> <section id="H0C56E72FD2554359A1B4137DC24332AA"><enum>102.</enum><header>Oversight reports on actions to enforce certain prohibitions</header> <subsection id="H2409B3C05F364330BE85BDA047007969"><enum>(a)</enum><header>Report on actions by Secretary of HHS to enforce prohibition on human cloning</header><text>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—</text> <paragraph id="H6598BAE5862849A6B5912EBE7C8C8BCC"><enum>(1)</enum><text>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);</text></paragraph> <paragraph id="HD10E5AE63CDA4EAE91E5C3B483AB30B2"><enum>(2)</enum><text>describes the personnel and resources the Secretary has utilized to enforce the provisions of such chapter; and</text></paragraph> <paragraph id="HF1222AD9B75D47A4BA68A338E3244946"><enum>(3)</enum><text>contains a list of violations, if any, of the provisions of such chapter.</text></paragraph></subsection> <subsection id="H00E84BDBAC664E23B50982F471921114"><enum>(b)</enum><header>Report on coordination of enforcement actions among Federal, State, and local governments with respect to human cloning</header> <paragraph id="H92598A5F7BB74347B6AAA7949E36CCD6"><enum>(1)</enum><header>Report</header><text>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—</text> <subparagraph id="H45FFDDEA9EC040A79967D8042D5E0406"><enum>(A)</enum><text>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</text></subparagraph> <subparagraph id="H3E7E2694ED094DFFB500D3A200B3D752"><enum>(B)</enum><text>describes the status and disposition of—</text> <clause id="H1397AA9A68C84F87BAE2BC6451491EEE"><enum>(i)</enum><text>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</text></clause> <clause id="H0B71B88DA6EA4937B434F604C4F8AF86"><enum>(ii)</enum><text>civil litigation, including actions to appoint guardians, related to human cloning.</text></clause></subparagraph></paragraph> <paragraph id="H7EAB2E186039421AA7278000A1623589"><enum>(2)</enum><header>Definition</header><text>In this subsection, the term <term>similar State law relating to human cloning</term> 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)).</text></paragraph> </subsection> <subsection id="HF306D2C60C0343D097B1C1DFD63F5DBF"><enum>(c)</enum><header>Report on international laws relating to human cloning</header><text>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—</text> <paragraph id="H0C0DCB0FB2364179B85D624F549EACC9"><enum>(1)</enum><text>describes the laws adopted by foreign countries related to human cloning;</text></paragraph> <paragraph id="H3B6678CC4B494499ABEC447000547FF9"><enum>(2)</enum><text>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</text></paragraph> <paragraph id="H670B7E9D625B47C2BFC63152F9B71812"><enum>(3)</enum><text>describes the multilateral efforts of the United Nations and elsewhere to ban human cloning.</text></paragraph></subsection></section>

109 HR 1822 IH: Human Cloning Ban and Stem Cell Research Protection Act of 2005 U.S. House of Representatives 2005-04-26 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

Short title

This Act may be cited as the

Human Cloning Ban and Stem Cell Research Protection Act of 2005

Purposes

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

<enum>I</enum><header>Prohibition on human cloning</header> <section id="H2CE1663AF1B646D68EFB45941FAE7D7B"><enum>101.</enum><header>Prohibition on human cloning</header> <subsection id="HCD9AEE72F6894A93BE8E003F78EDC96"><enum>(a)</enum><header>In general</header><text>The Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/301">21 U.S.C. 301 et seq.</external-xref>) is amended by adding at the end the following:</text> <quoted-block style="OLC" id="H393A6622E10345CEA0762B6D7460B11B" display-inline="no-display-inline"> <chapter id="H3AB0444EA6D347D6A400351CA9DE2C80"><enum>X</enum><header>Prohibition on Human Cloning</header> <section id="HD7582C09B7084ED1855F5E3F7BEECE00"><enum>1001.</enum><header>Prohibition on human cloning</header> <subsection id="H84D63ED711D34BD5AA12CCA7FCA601CD"><enum>(a)</enum><header>Definitions</header><text>In this section:</text> <paragraph id="H9C2AD606D66C4B88BB89B57D238BED14"><enum>(1)</enum><header>Human cloning</header><text>The term <term>human cloning</term> means implanting or attempting to implant the product of nuclear transplantation into a uterus or the functional equivalent of a uterus.</text></paragraph> <paragraph id="HA9488DA934E6447DA3DA5C654947EC42"><enum>(2)</enum><header>Human somatic cell</header><text>The term <term>human somatic cell</term> means any human cell other than a haploid germ cell.</text></paragraph> <paragraph id="HFEF4115F50AC4C4CAEF7B0E3AE10999E"><enum>(3)</enum><header>Nuclear transplantation</header><text>The term <term>nuclear transplantation</term> 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.</text></paragraph> <paragraph id="H9E76A825D1DF46F4A9ADC1DB61AF70EB"><enum>(4)</enum><header>Nucleus</header><text>The term <term>nucleus</term> means the cell structure that houses the chromosomes.</text></paragraph> <paragraph id="H3EAB9A54FFEA4691AA00701457037DB0"><enum>(5)</enum><header>Oocyte</header><text>The term <term>oocyte</term> means the female germ cell, the egg.</text></paragraph> <paragraph id="H81CCC00984FA4EB296AB519289208F1"><enum>(6)</enum><header>Unfertilized blastocyst</header><text display-inline="yes-display-inline">The term <term>unfertilized blastocyst</term> 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.</text></paragraph></subsection> <subsection id="HF4EE8396CF884C67B3AE0051821B467C"><enum>(b)</enum><header>Prohibitions on human cloning</header><text>It shall be unlawful for any person or other legal entity, public or private—</text> <paragraph id="HB55A12919A844EAE8BFCC641C3B1803F"><enum>(1)</enum><text>to conduct or attempt to conduct human cloning;</text></paragraph> <paragraph id="HEF99812B0B1E40C685A7539CD4DA7106"><enum>(2)</enum><text>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</text></paragraph> <paragraph id="H0AA13CF207F94EC5873B00F219DA705D"><enum>(3)</enum><text>to export to a foreign country an unfertilized blastocyst if such country does not prohibit human cloning.</text></paragraph></subsection> <subsection id="H7F700D81D6994EDC9130F2D5D8F14912"><enum>(c)</enum><header>Protection of research</header><text>Nothing in this section shall be construed to restrict practices not expressly prohibited in this section.</text></subsection> <subsection id="HD09CC845DF2B4A0C94DFD27160D96BA0"><enum>(d)</enum><header>Right of action</header><text>Nothing in this section shall be construed to give any individual or person a private right of action.</text></subsection> </section></chapter><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="H0BA202F616E642DDADBE3D14DDB5F4E2"><enum>(b)</enum><header>Prohibited Acts</header> <paragraph id="H1C3DFB9E322E45FCAFEFA223C4195D6"><enum>(1)</enum><header>In general</header><text>Section 301 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/331">21 U.S.C. 331</external-xref>) is amended by adding at the end the following:</text> <quoted-block style="OLC" id="H1CC760DB3AED43578D7F247BB7B4AC13" display-inline="no-display-inline"> <subsection id="H1A18A6CC42AD4B5B9B0693B2DB00737C"><enum>(hh)</enum><text>The violation of paragraph (1), (2), or (3) of section 1001(b) (relating to human cloning).</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph> <paragraph id="H22A2092959BF4312866B7410BD149D4D"><enum>(2)</enum><header>Criminal penalties</header><text>Section 303(b) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/333">21 U.S.C. 333(b)</external-xref>) is amended by adding at the end the following:</text> <quoted-block style="OLC" id="H5A50E6A454CD4F8CB1F492A8C1CEEE31" display-inline="no-display-inline"> <paragraph id="H956198343824452ABF8F193076B900D7"><enum>(7)</enum><text>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.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph> <paragraph id="H775EB01409554AADAF6EAACCAB4D079D"><enum>(3)</enum><header>Civil Penalties</header><text>Section 303 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/333">21 U.S.C. 333</external-xref>) is amended by adding at the end:</text> <quoted-block style="OLC" id="H637744F5D77F4EA9B450C76E6BDD915C" display-inline="no-display-inline"> <subsection id="H567E3DBE4E8946008491348F0888BB99"><enum>(g)(1)</enum><text>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—</text> <paragraph id="H8E4876CF67024717BFAD9CE4F62EC952"><enum>(A)</enum><text>$10,000,000; or</text></paragraph> <paragraph id="HC8AAD8E560FA4A26A2297DE204179487"><enum>(B)</enum><text display-inline="yes-display-inline">an amount equal to three times the amount of the gross pecuniary gain resulting from the violation.</text></paragraph> <paragraph id="H8B259790AA884E7B86833DFDF1163E47" indent="up1"><enum>(2)</enum><text>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).</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph> <paragraph id="H0872B2D9A3AC401C9000AC9754E4CE6"><enum>(4)</enum><header>Forfeiture</header><text>Section 303 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/333">21 U.S.C. 333</external-xref>), as amended by paragraph (3), is amended by adding at the end the following:</text> <quoted-block style="OLC" id="H5E6B4543658C434C8801E929B9756200" display-inline="no-display-inline"> <subsection id="HFD21F22FF5004CC28091A0FFD107ED5"><enum>(h)</enum><text display-inline="yes-display-inline">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 <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/18/46">chapter 46</external-xref> of title 18, United States Code.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection></section> <section id="H0C56E72FD2554359A1B4137DC24332AA"><enum>102.</enum><header>Oversight reports on actions to enforce certain prohibitions</header> <subsection id="H2409B3C05F364330BE85BDA047007969"><enum>(a)</enum><header>Report on actions by Secretary of HHS to enforce prohibition on human cloning</header><text>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—</text> <paragraph id="H6598BAE5862849A6B5912EBE7C8C8BCC"><enum>(1)</enum><text>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);</text></paragraph> <paragraph id="HD10E5AE63CDA4EAE91E5C3B483AB30B2"><enum>(2)</enum><text>describes the personnel and resources the Secretary has utilized to enforce the provisions of such chapter; and</text></paragraph> <paragraph id="HF1222AD9B75D47A4BA68A338E3244946"><enum>(3)</enum><text>contains a list of violations, if any, of the provisions of such chapter.</text></paragraph></subsection> <subsection id="H00E84BDBAC664E23B50982F471921114"><enum>(b)</enum><header>Report on coordination of enforcement actions among Federal, State, and local governments with respect to human cloning</header> <paragraph id="H92598A5F7BB74347B6AAA7949E36CCD6"><enum>(1)</enum><header>Report</header><text>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—</text> <subparagraph id="H45FFDDEA9EC040A79967D8042D5E0406"><enum>(A)</enum><text>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</text></subparagraph> <subparagraph id="H3E7E2694ED094DFFB500D3A200B3D752"><enum>(B)</enum><text>describes the status and disposition of—</text> <clause id="H1397AA9A68C84F87BAE2BC6451491EEE"><enum>(i)</enum><text>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</text></clause> <clause id="H0B71B88DA6EA4937B434F604C4F8AF86"><enum>(ii)</enum><text>civil litigation, including actions to appoint guardians, related to human cloning.</text></clause></subparagraph></paragraph> <paragraph id="H7EAB2E186039421AA7278000A1623589"><enum>(2)</enum><header>Definition</header><text>In this subsection, the term <term>similar State law relating to human cloning</term> 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)).</text></paragraph> </subsection> <subsection id="HF306D2C60C0343D097B1C1DFD63F5DBF"><enum>(c)</enum><header>Report on international laws relating to human cloning</header><text>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—</text> <paragraph id="H0C0DCB0FB2364179B85D624F549EACC9"><enum>(1)</enum><text>describes the laws adopted by foreign countries related to human cloning;</text></paragraph> <paragraph id="H3B6678CC4B494499ABEC447000547FF9"><enum>(2)</enum><text>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</text></paragraph> <paragraph id="H670B7E9D625B47C2BFC63152F9B71812"><enum>(3)</enum><text>describes the multilateral efforts of the United Nations and elsewhere to ban human cloning.</text></paragraph></subsection></section> <enum>II</enum><header>Ethical requirements for nuclear transplantation research</header> <section id="H5BB146C1AEFB4D6BB3004D31355C931E"><enum>201.</enum><header>Ethical requirements for nuclear transplantation research</header><text display-inline="no-display-inline">Title IV of the <act-name parsable-cite="PHSA">Public Health Service Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/281">42 U.S.C. 281 et seq.</external-xref>) is amended by adding at the end the following:</text> <quoted-block act-name="Public Health Service Act" id="HDD90BE2029B14CE19F9178B8A08D83E9"> <part id="H5689247CEADB435C84A7C51EBA704B59"><enum>J</enum><header>Ethical requirements for nuclear transplantation research</header> <section id="H94F2AE8DA7C34137ABC9395F1E593D32"><enum>499A.</enum><header>Ethical requirements for nuclear transplantation research, including informed consent, institutional review board review, and protection for safety and privacy</header> <subsection id="H010AC86F2BE8420888C9E8A2F4002B02"><enum>(a)</enum><header>Definitions</header> <paragraph id="H6245C0B7D83B48CB839BD28043FC4503"><enum>(1)</enum><header>In general</header><text>The definitions contained in section 1001(a) of the Federal Food, Drug, and Cosmetic Act shall apply for purposes of this section.</text></paragraph> <paragraph id="H5F304FFEC6CC4E87914E882272DC87BF"><enum>(2)</enum><header>Other definitions</header><text>In this section:</text> <subparagraph id="H8F3750939C8C4510ABA5E78BAAB1316"><enum>(A)</enum><header>Donating</header><text>The term <term>donating</term> means giving without receiving valuable consideration.</text></subparagraph> <subparagraph id="H4EE6C6BA9CB142768BB34E6DE1137283"><enum>(B)</enum><header>Fertilization</header><text>The term <term>fertilization</term> means the fusion of an oocyte containing a haploid nucleus with a male gamete (sperm cell).</text></subparagraph> <subparagraph id="HDBAA5A28BE8949E19800197872D0CFF1"><enum>(C)</enum><header>Valuable consideration</header><text>The term <term>valuable consideration</term> does not include reasonable payments—</text> <clause id="H8AC0A55CCECB4B79BF625C6F57F90089"><enum>(i)</enum><text>associated with the transportation, processing, preservation, or storage of a human oocyte or of the product of nuclear transplantation research; or</text></clause> <clause id="H9F93FDB6E429495182D4CB87993294C8"><enum>(ii)</enum><text>to compensate a donor of one or more human oocytes for the time or inconvenience associated with such donation.</text></clause></subparagraph></paragraph></subsection> <subsection id="H358FB50CB7C842A69E87BE77B3BFF8B1"><enum>(b)</enum><header>Applicability of Federal ethical standards to nuclear transplantation research</header><text>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.</text></subsection> <subsection id="HBEE128950C224B359DAD1F788B6BFF44"><enum>(c)</enum><header>Prohibition on conducting nuclear transplantation on fertilized eggs</header><text>A somatic cell nucleus shall not be transplanted into a human oocyte that has undergone or will undergo fertilization.</text></subsection> <subsection id="H3BA09B25884344FC818FB8AF70D59B31"><enum>(d)</enum><header>Fourteen-Day rule</header><text>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.</text></subsection> <subsection id="H05CE608A642C45C2A7BBE350047E8BE"><enum>(e)</enum><header>Voluntary donation of oocytes</header> <paragraph id="H325BBCFA43FF425E94CFC91FD33D1CA"><enum>(1)</enum><header>Informed consent</header><text>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.</text></paragraph> <paragraph id="H72D43A712CE04F088DD6B40008B7F0EB"><enum>(2)</enum><header>Prohibition on purchase or sale</header><text>No human oocyte or unfertilized blastocyst may be acquired, received, or otherwise transferred for valuable consideration if the transfer affects interstate commerce.</text></paragraph></subsection> <subsection id="H44BA76503D59472097C565005003942"><enum>(f)</enum><header>Separation of in vitro fertilization laboratories from locations at which nuclear transplantation is conducted</header><text>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.</text></subsection> <subsection id="HF2318554A2114E2D95E2C9278EF15C08"><enum>(g)</enum><header>Civil penalties</header><text>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.</text></subsection></section></part><after-quoted-block>.</after-quoted-block></quoted-block></section>