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Sample of an Establishment NoticeA Sample of an Establishment Notice for a New Federal Advisory Committee (FACA). DEPARTMENT OF HEALTH AND HUMAN SERVICES AGENCY: Health Resources and Services Administration (HRSA), HHS. ACTION: Notice of establishment of the Advisory Council on Blood Stem Cell Transplantation and Solicitation of Nominations for Membership. SUMMARY: Pursuant to Public Law 109- 129, 42 U.S.C. 274k (section 379 of the Public Health Service Act, as amended) and the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), the Administrator, HRSA, announces the establishment of the Advisory Council on Blood Stem Cell Transplantation by the Secretary, HHS. The Council will advise the Secretary on proposed C.W. Bill Young Cell Transplantation Program policies and other such matters as the Secretary determines. Duration of this Council is for two years unless renewed by the Secretary, HHS. This notice also requests nominations for membership on the Council. DATES: Nominations for members must be received on or before February 22, 2007. ADDRESSES: All nominations should be submitted to the Executive Secretary, Advisory Council on Blood Stem Cell Transplantation, Healthcare Systems Bureau, HRSA, Parklawn Building, Room 12C-06, 5600 Fishers Lane, Rockville, Maryland 20857. Federal Express, Airborne, or UPS, mail delivery should be addressed to Executive Secretary, Advisory Council on Blood Stem Cell Transplantation, Healthcare Systems Bureau, HRSA, at the above address. FOR FURTHER INFORMATION CONTACT: Remy Aronoff, Executive Secretary, Advisory Council on Blood Stem Cell Transplantation, at (301) 443-3264 or email Remy.Aronoff@hrsa.hhs.gov or Robert Baitty, Director, Blood Stem Cell Transplantation Program, Division of Transplantation, at (301) 443-2612 or email Robert.Baitty@hrsa.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background and Authority Establishment of the Council implements a statutory requirement of the Stem Cell Therapeutic and Research Act of 2005 (Pub. L. 109-129). The Council is governed by the Federal Advisory Committee Act (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of advisory committees. The Advisory Council shall advise the Secretary and the Administrator, HRSA, on matters related to the activities of the C.W. Bill Young Cell Transplantation Program and the National Cord Blood Inventory Program. The Council shall, as requested by the Secretary, discuss and make recommendations regarding the C.W. Bill Young Cell Transplantation Program (Program). It shall provide a consolidated, comprehensive source of expert, unbiased analysis and recommendations to the Secretary on the latest advances in the science of blood stem cell transplantation. The Council shall advise, assist, consult and make recommendations, at the request of the Secretary, on broad Program policy in areas such as the necessary size and composition of the adult donor pool available through the Program and the composition of the National Cord Blood Inventory, requirements regarding informed consent for cord blood donation, accreditation requirements for cord blood banks, the scientific factors that define a cord blood unit as high quality, public and professional education to encourage the ethical recruitment of genetically diverse donors and ethical donation practices, criteria for selecting the appropriate blood stem source for transplantation, Program priorities, research priorities, and the scope and design of the Stem Cell Therapeutic Outcomes Database. It also shall, at the request of the Secretary, review and advise on issues relating more broadly to the field of blood stem cell transplantation, such as regulatory policy including compatibility of international regulations, and actions that may be taken by the State and Federal Governments and public and private insurers to increase donation and access to transplantation. The Advisory Council also shall make recommendations regarding research on emerging therapies using cells from bone marrow and cord blood. II. Structure The Council shall consist of up to 25 members, including the Chair. Members of the Advisory Council shall be chosen to ensure objectivity and balance, and reduce the potential for conflicts of interest. The Secretary shall establish bylaws and procedures to prohibit any member of the Advisory Council who has an employment, governance, or financial affiliation with a donor center, recruitment organization, transplant center, or cord blood bank from participating in any decision that materially affects the center, recruitment organization, transplant center, or cord blood bank; and to limit the number of members of the Advisory Council with any such affiliation. III. Compensation Members shall be paid at a rate of $200 for each day they are engaged in the performance of their duties as members of the Council. Members shall receive per diem and travel expenses as authorized by 5 U.S.C. 5703, as amended, for persons employed intermittently in the Government service. Members who are officers or employees of the United States Government shall not receive compensation for service on the Council. IV. Nominations HHS will consider nominations of all qualified individuals to ensure that the Advisory Council includes the areas of subject matter expertise noted above (see ''Structure''). Individuals may nominate themselves or other individuals, and professional associations and organizations may nominate one or more qualified persons for membership on the Advisory Council. Nominations shall state that the nominee is willing to serve as a member of the Council. Potential candidates will be asked to provide detailed information concerning financial interests, consultancies, research grants, and/or contracts that might be affected by recommendations of the Council to permit evaluation of possible sources of conflicts of interest. In addition, nominees will be asked to provide detailed information concerning any employment, governance, or financial affiliation with any donor centers, recruitment organizations, transplant centers, and/or cord blood banks. Dated: January 16, 2007. Elizabeth M. Duke,
Last Reviewed 7/3/2008
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