II 110th CONGRESS 1st Session S. 30 IN THE SENATE OF THE UNITED STATES March 29, 2007 Mr. Coleman (for himself and Mr. Isakson) introduced the following bill; which was read twice and ordered held at the desk A BILL To intensify research to derive human pluripotent stem cell lines.

1.

Short title

This Act may be cited as the Hope Offered through Principled and Ethical Stem Cell Research Act or the HOPE Act.

2.

Purposes

It is the purpose of this Act to— (1)intensify research that may result in improved understanding of or treatments for diseases and other adverse health conditions; and (2)promote the derivation of pluripotent stem cell lines without the creation of human embryos for research purposes and without the destruction or discarding of, or risk of injury to, a human embryo or embryos other than those that are naturally dead.

3.

Human pluripotent stem cell research

Part H of title IV of the Public Health Service Act (42 U.S.C. 289 et seq.) is amended by inserting after section 498C the following:

498D.

Human pluripotent stem cell research

(a)

In general

The Secretary shall conduct and support basic and applied research to develop techniques for the isolation, derivation, production, or testing of stem cells, including pluripotent stem cells that have the flexibility of embryonic stem cells (whether or not they have an embryonic source), that may result in improved understanding of or treatments for diseases and other adverse health conditions, provided that the isolation, derivation, production, or testing of such cells will not involve— (1)the creation of a human embryo or embryos for research purposes; or (2)the destruction or discarding of, or risk of injury to, a human embryo or embryos other than those that are naturally dead. (b)

Guidelines

Not later than 90 days after the date of the enactment of this section, the Secretary, after consultation with the Director of NIH, shall issue final guidelines that— (1)provide guidance concerning the next steps required for additional research, which shall include a determination of the extent to which specific techniques may require additional animal research to ensure that any research involving human cells using these techniques would clearly be consistent with the standards established under subsection (a); (2)prioritize research with the greatest potential for near-term clinical benefit; (3)consistent with standards established under subsection (a), take into account techniques outlined by the President’s Council on Bioethics and any other appropriate techniques and research; and (4)in the case of research involving stem cells from a naturally dead embryo, require assurances from grant applicants that no alteration of the timing, methods, or procedures used to create, maintain, or intervene in the development of a human embryo was made solely for the purpose of deriving the stem cells. (c)

Reporting requirements

Not later than January 1 of each year, the Secretary shall prepare and submit to the appropriate committees of the Congress a report describing the activities carried out under this section during the fiscal year, including a description of the research conducted under this section. (d)

Rule of construction

Nothing in this section shall be construed as altering the policy in effect on the date of enactment of this section regarding the eligibility of stem cell lines for funding by the National Institutes of Health. (e)

Authorization of appropriations

There is authorized to be appropriated such sums as may be necessary to carry out this section. (f)

Definitions

In this section: (1)

Naturally dead

The term naturally dead means having naturally and irreversibly lost the capacity for integrated cellular division, growth, and differentiation that is characteristic of an organism, even if some cells of the former organism may be alive in a disorganized state. (2)

Human embryo or embryos

The term human embryo or embryos includes any organism, not protected as a human subject under part 46 of title 45, Code of Federal Regulations, as of the date of enactment of this section, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells. (3)

Risk of injury

The term risk of injury means subjecting a human embryo or embryos to risk of injury or death greater than that allowed for research on fetuses in utero under section 46.204(b) of title 45, Code of Federal Regulations, and section 498(b) of this Act.

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4.

National Amniotic and Placental Stem Cell Bank

(a)

In general

The Secretary of Health and Human Services shall enter into a contract with the Institute of Medicine for the conduct of a study to recommend an optimal structure for an amniotic and placental stem cell bank program and to address pertinent issues to maximize the potential of such technology, including collection, storage, standards setting, information sharing, distribution, reimbursement, research, and outcome measures. In conducting such study, the Institute should receive input from relevant experts including the existing operators of federal tissue bank programs and the biomedical research programs within the Department of Defense. (b)

Report

Not later than 180 days after the date of enactment of this Act, the Institute of Medicine shall complete the study under subsection (a) and submit to the Secretary of Health and Human Services and the appropriate committees of Congress a report on the results of such study.