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Health Service Act (42 U.S.C. §§ 289 et seq.) instead of Title 18 of the United States Code.45 S. 658 includes a criminal penalty of imprisonment of not more than 10 years and a civil penalty of not less than $1 million. It requires GAO to conduct a study to assess the need (if any) for any changes of the prohibition on cloning in light of new developments in medical technology, the need for SCNT to produce medical advances, current public attitudes and prevailing ethical views on the use of SCNT and potential legal implications of research in SCNT. The study is to be completed within four years of enactment. S. 658 has been referred to the Senate Health, Education, Labor, and Pensions Committee.

S. 876 (Hatch), the Human Cloning Ban and Stem Cell Research Protection Act of 2005, was introduced on April 21, 2005. A similar bill, H.R. 1822 (Bono), the Human Cloning Ban and Stem Cell Research Protection Act of 2005, was introduced on April 26, 2005. S. 876 amends Title 18 of the United States Code and H.R. 1822 amends the Food, Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.).46 Both bills would ban human reproductive cloning but allow cloning for medical research purposes, including stem cell research. S. 876 and H.R. 1822 include a criminal penalty of imprisonment of not more than 10 years; S. 876 has a civil penalty of not less than $1 million, H.R. 1822 has a civil penalty not to exceed $10 million.

S. 876 requires the Comptroller General to prepare a series of four reports within one year of enactment. The first report describes the actions taken by the Attorney General to enforce the prohibition on human reproductive cloning, the personnel and resources used to enforce the prohibition, and a list of any violations of the prohibition. A second report describes similar state laws that prohibit human cloning and actions taken by the states’ attorney general to enforce the provisions of any similar state law along with a list of violations. A third report describes the coordination of enforcement actions among the federal, state and local governments. A fourth report describes laws adopted byforeign countries related to human cloning. H.R. 1822 requires a similar set of three reports to be prepared by the Secretary of Health and Human Services.

S. 876 and H.R. 1822 would amend the Public Health Service Act by requiring that human SCNT be conducted in accordance with the ethical requirements (such as informed consent, examination by an Institutional Review Board, and protections for safety and privacy) contained in subpart A of 45 C.F.R. Part 46,47 or Parts 50 and 56 of 21 C.F.R.48 S. 876 and H.R. 1822 have a prohibition on conducting SCNT on fertilized human eggs (oocytes), and both state that “unfertilized blastocysts” shall not be maintained after more than 14 days from its first cell division, aside from

45 By seeking to amend Title 18 of the U.S. Code rather than the Public Health Service Act, S. 658 would likely be subject to different committee jurisdiction.

46 Because they amend different titles of the U.S. Code, the bills would likely be subject to different committee jurisdiction.

47 This provision specifies protections due to human beings who participate in research conducted or supported by HHS and many other departments.

48 This provision specifies protections due to human beings who participate in research involved in testing a drug or medical device for FDA approval.

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