To require implementation of the National Institutes of Health Guidelines for Research Using Human Pluripotent Stem Cells, and for other purposes.

August 2, 2001

Ms. DEGETTE (for herself and Mr. RAMSTAD) introduced the following bill; which was referred to the Committee on Energy and Commerce

To require implementation of the National Institutes of Health Guidelines for Research Using Human Pluripotent Stem Cells, and for other purposes.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the `Stem Cell Research for Patient Benefit Act of 2001'.

SEC. 2. IMPLEMENTATION OF NATIONAL INSTITUTES OF HEALTH GUIDELINES FOR RESEARCH USING HUMAN PLURIPOTENT STEM CELLS.

The Director of the National Institutes of Health shall conduct or support research using human pluripotent stem cells from embryos and fetal tissue in accordance with the National Institutes of Health Guidelines for Research Using Human Pluripotent Stem Cells, as published in the Federal Register on August 25, 2000 (65 FR 51976), and corrected on November 21, 2000 (65 FR 69951).

SEC. 3. STUDY ON STEM CELLS BY THE NATIONAL INSTITUTES OF HEALTH.

(a) IN GENERAL- The Director of the National Institutes of Health shall conduct a study on the following:

(1) The current state of knowledge about the following:

(A) Biological properties of stem cells obtained from embryos, fetal tissues, and adult tissues.

(B) Biological differences among stem cells obtained from embryos, fetal tissues, and adult tissues and the significance of these differences for research and medicine.

(C) Ability of stem cells to generate tissues, including neurons and heart, kidney, blood, and liver tissues, and the potential clinical uses of these tissues.

(2) Emerging stem cell applications.

(3) The effectiveness of the guidelines referred to in section 2.

(b) REPORT- Not later than 5 years after the date of the enactment of this Act, the Director of the National Institutes of Health shall submit a report describing the findings and conclusions of the study to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate.

SEC. 4. STUDY ON THERAPIES ADDRESSING IMMUNOLOGICAL REJECTION OF STEM CELLS AND DIFFERENTIATED CELLS AND TISSUE DERIVED FROM STEM CELLS.

(a) IN GENERAL- The Secretary of Health and Human Services (in this section referred to as the `Secretary') shall seek to enter into an agreement with the Institute of Medicine under which the Institute, taking into consideration the results of the study authorized by section 3, will conduct a study to--

(1) assess the current state of knowledge about therapies, including somatic cell nuclear transfer and therapies using pharmaceuticals, that may be used to address immunological rejection of stem cells and differentiated cells and tissue derived from stem cells;

(2) compare the potential therapeutic value of such therapies; and

(3) identify safeguards that could be implemented to prevent the use of human embryos created by somatic cell nuclear transfer for purposes other than the development of therapies for diseases.

(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 2 years after the date of the enactment of this Act, the study to be conducted under subsection (a) is completed and a report describing the findings and conclusions of the study is submitted to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate.

SEC. 5. BIOMEDICAL ADVISORY COMMISSION.

(a) ESTABLISHMENT- There is established a commission to be known as the Biomedical Advisory Commission (in this section referred to as the `Commission').

(b) DUTIES-

(1) STUDY- The Commission shall conduct studies on the following:

(A) Bioethical issues arising from research on human biology and applications of such research.

(B) Emerging biomedical research, including the ethical, social, legal, and regulatory issues concerning such research and its clinical applications.

(2) RECOMMENDATIONS- Based on the results of the study, the Commission shall formulate such recommendations as it considers appropriate with the goal of realizing the development of effective therapies as quickly as possible, taking into account the relevant ethical, social, legal, and regulatory considerations.

(c) MEMBERSHIP-

(1) APPOINTMENT- The Commission shall be composed of 13 members as follows:

(A) 1 member appointed by the President.

(B) 3 members appointed by the Speaker of the House of Representatives.

(C) 3 members appointed by the minority leader of the House of Representatives.

(D) 3 members appointed by the majority leader of the Senate.

(E) 3 members appointed by the minority leader of the Senate.

(2) QUALIFICATIONS- The members appointed under subparagraphs (B), (C), (D), and (E) of paragraph (1) shall include representatives from the legal, ethical, scientific, medical, patient, religious, and industry communities.

(3) CONSULTATION- All appointments under paragraph (1) shall be made in consultation with members of the communities referred to in paragraph (2).

(4) CHAIRPERSON- The Chairperson of the Commission shall be elected by a majority from among the members of the Commission.

(5) TERMS- Each member of the Commission shall be appointed for a term of 3 years and may be reappointed.

(6) VACANCIES- A vacancy in the Commission shall be filled in the manner in which the original appointment was made.

(d) MEETINGS- The Commission shall meet--

(1) at the call of the Chairperson; and

(2) at least 2 times but not more than 4 times each calendar year.

(e) COMPENSATION AND EXPENSES-

(1) COMPENSATION- Subject to paragraph (2), each member of the Commission shall be compensated at a rate equal to the daily equivalent of the annual rate of basic pay prescribed for level III of the Executive Schedule under section 5314 of title 5, United States Code, for each day (including travel time) during which such member is engaged in the performance of the duties of the Commission.

(2) PROHIBITION OF COMPENSATION OF FEDERAL EMPLOYEES- Members of the Commission who are full-time officers or employees of the United States or Members of Congress may not receive additional pay, allowances, or benefits by reason of their service on the Commission.

(3) TRAVEL EXPENSES- Each member of the Commission shall receive travel expenses, including per diem in lieu of subsistence, in accordance with applicable provisions under subchapter I of chapter 57 of title 5, United States Code, while away from the member's home or regular place of business in the performance of services for the Commission.

(f) EXECUTIVE DIRECTOR AND STAFF-

(1) EXECUTIVE DIRECTOR-

(A) APPOINTMENT- The Commission shall have an Executive Director who shall be appointed by the Secretary of Health and Human Services.

(B) PAY- The Executive Director shall be paid at a rate not to exceed the rate payable for level V of the Executive Schedule under section 5316 of title 5, United States Code.

(2) STAFF-

(A) APPOINTMENT- The Executive Director may appoint such additional personnel as the Executive Director sees fit.

(B) PAY- The staff of the Commission shall be paid in accordance with the provisions of chapter 51 and subchapter III of chapter 53 of title 5, United States Code, relating to classification and General Schedule pay rates.

(3) APPLICABILITY OF CERTAIN CIVIL SERVICE LAWS- The Executive Director and staff of the Commission shall be appointed subject to the provisions of title 5, United States Code, governing appointments in the competitive service.

(g) HEARINGS AND SESSIONS- The Commission may, for the purpose of carrying out this section, hold hearings, sit and act at times and places, take testimony, and receive evidence as the Commission considers appropriate.

(h) OBTAINING OFFICIAL DATA- The Commission may secure directly from any department or agency of the United States information (other than information required by any Federal statute to be kept confidential by such department or agency) necessary for the Commission to carry out its duties under this section. Upon request of the Commission, the head of that department or agency shall furnish such nonconfidential information to the Commission.

(i) ADMINISTRATIVE SUPPORT SERVICES- Upon the request of the Commission, the Administrator of General Services shall provide to the Commission, on a reimbursable basis, the administrative support services necessary for the Commission to carry out its responsibilities under this Act.

(j) CONTRACTS- To the extent or in the amounts provided in advance in appropriations Acts, the Commission may contract with and compensate government and private agencies or persons for supplies and services.

(k) REPORTS- The Commission may submit to the Congress and the President such reports as the Congress requests or the Commission considers appropriate.

(l) TERMINATION- The Commission terminates 30 days after the date that is 6 years after the date of the enactment of this Act.

END