Pursuant to the Federal Advisory Committee Act (FACA), as amended (5 U.S.C. Appendix 2), the Department of Health and Human Services (DHHS) is announcing the renewal of the charter for the Secretary's Advisory Committee on Xenotransplantation (SACX) and is soliciting nominations for qualified individuals to serve on the SACX.
Nomination packages should be submitted to Dr. Mary Groesch, Office of Biotechnology Activities, Office of Science Policy, National Institutes of Health, 6705 Rockledge Drive, Suite 750, Bethesda, Maryland 20892-7985 by October 16, 2003.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Dr. Mary Groesch, Office of Biotechnology Activities, Office of Science Policy, National Institutes of Health, 6705 Rockledge Drive, Suite 750, Bethesda, Maryland 20892-7985, telephone 301-496-0785, facsimile 301-496-9839, e-mail <email@example.com>. Information about the SACX can also be accessed at <http://www4.od.nih.gov/oba/Sacx.htm>.End Further Info End Preamble Start Supplemental Information
In the U.S., clinical xenotransplantation is an experimental procedure that involves the transplantation, implantation, or infusion into a human recipient of either (a) live cells, tissues, or organs from a nonhuman animal source; or (b) human body fluids, cells, tissues or organs that have had ex vivo contact with live nonhuman animal cells, tissues, or organs. Interest in xenotransplantation has been renewed by the continuing, critical shortage of donated human organs and tissues and by advances in immunology and in the biology of organ and tissue rejection.
Xenotransplantation holds potential for the development of new treatments for a wide range of conditions and disorders, including diabetes, Parkinson's disease, intractable pain, and other diseases involving tissue destruction and organ failure. However, xenotransplantation also raises an important public health issue—the recognized (but unquantified) risk of transmitting infectious agents from animal tissues to human recipients of xenotransplantation products, and subsequently to their close contacts and the public at large. Public awareness and understanding of xenotransplantation is important because the infectious disease risks posed by xenotransplantation could extend beyond the individual recipients. In addition to this public health issue, xenotransplantation raises an array of complex scientific, medical, ethical, and social issues. The Secretary, DHHS, established the SACX to provide a forum for the discussion of, and public input on, these and other relevant issues. The Committee was initially chartered in 1999 and has convened for five meetings since February, 2001. An abridged charter is included in this notice to provide an overview of the Committee purpose, function, and structure.
Abridged Committee Charter
Purpose. The Department of Health and Human Services has a vital role in safeguarding public health while fostering the development of promising strategies to treat tissue destruction, organ failure and other public health needs. The Secretary's Advisory Committee on Xenotransplantation considers the full range of complex scientific, medical, social, and ethical issues and the public health concerns raised by xenotransplantation, including ongoing and proposed protocols, and makes recommendations to the Secretary on policy and procedures. The recommendations of the Committee will facilitate DHHS efforts to develop an integrated approach to addressing emerging public health issues in xenotransplantation.
Function. The SACX shall advise the Secretary, through the Assistant Secretary for Health, on all aspects of the scientific development and clinical application of xenotransplantation. The Committee's charge includes the following activities:
- Advise the Department on the current state of knowledge regarding xenotransplantation.
- Be informed about current and proposed xenotransplantation clinical trials in order to identify and discuss the medical, scientific, ethical, legal, and/or socioeconomic issues raised by these clinical trials.
- Advise the Department on the potential for transmission of infectious diseases as a consequence of xenotransplantation.
- Advise the Department on policies relevant to xenotransplantation, including the need for changes to the PHS Guideline on Infectious Disease Issues in Xenotransplantation.
- Discuss additional scientific, medical, public health, ethical, legal and socioeconomic issues, including international policies and developments, that are relevant to xenotransplantation.
Structure. The Committee shall consist of 18 voting members, including the Chair, appointed by the Secretary or designee. Members shall be selected by the Secretary, or designee, from authorities knowledgeable in such fields as xenotransplantation, epidemiology, virology, microbiology, infectious diseases, molecular biology, veterinary medicine, immunology, transplantation surgery, public health, applicable law, bioethics, social sciences, psychology, patient advocacy, and animal welfare. Members shall be invited to serve for overlapping four year terms; terms of more than two years are contingent Start Printed Page 54230upon the renewal of the Committee by appropriate action prior to its termination. Members may serve after the expiration of their term until their successors have taken office.
Meetings. Meetings shall be held approximately three times per year at the call of the Chair with the advance approval of a Government official who shall also approve the agenda. Meetings shall be open to the public except as determined otherwise by the Secretary or designee; notice of all meetings shall be provided to the public.
Compensation. Members shall be paid at a rate not to exceed the daily equivalent of the rate in effect for Executive Level IV of the Executive Schedule for each day they are engaged in the performance of their duties as members of the Committee. Members shall receive per diem and travel expenses as authorized by section 5703, Title 5 U.S.C., as amended, for persons employed intermittently in the Government service. Members who are officers or employees of the United States shall not receive compensation for service on the Committee.
Termination Date. Unless renewed by appropriate action prior to its expiration, the Secretary's Advisory Committee on Xenotransplantation shall terminate on July 10, 2005.
Additional information about the SACX, including the complete charter, is available at http://www4.od.nih.gov/oba/Sacx.htm.
DHHS will consider nominations of all qualified individuals. Committee members will have expertise in fields such as xenotransplantation, epidemiology, virology, microbiology, infectious diseases, molecular biology, veterinary medicine, immunology, transplantation surgery, public health, law, bioethics, social sciences, psychology, patient advocacy, and animal welfare. Individuals may nominate themselves or other individuals, and professional associations and other organizations may nominate individuals. DHHS has a strong interest in ensuring that women, minority groups, and physically challenged individuals are adequately represented on the Committee and, therefore, encourages nominations of qualified candidates from these groups. DHHS also encourages geographic diversity in the composition of the Committee.
A nomination package should include the following information for each nominee: (1) A letter of nomination stating the name, affiliation, and contact information for the nominee, the basis for the nomination (i.e., what specific attributes recommend him/her for service in this capacity), and the nominee's field(s) of expertise; (2) a biographical sketch of the nominee and a copy of his or her curriculum vitae; and (3) the name, return address, and daytime telephone number at which the nominator can be contacted. Except for self-nominations, a nomination package should also include a statement by the nominee that he/she is willing to accept an appointment to Committee membership. All nomination information should be provided in a single, complete package within 30 days of the publication of this notice. The nomination letter should bear an original signature; facsimile transmissions or copies cannot be accepted. All nominations for membership should be sent to Dr. Mary Groesch at the address provided above.
DHHS will use the nomination package only for the purpose of considering nominees for appointment to the committee. However, portions of the nomination package may be publicly disclosed to the extent required by law in response to requests under the Freedom of Information Act, (5 U.S.C. 522), regardless of whether the nominee is appointed to the committee.Start Signature
Dated: September 10, 2003.
Cristina V. Beato,
Acting Assistant Secretary for Health.
[FR Doc. 03-23552 Filed 9-15-03; 8:45 am]
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