01-2669. Notice of Meeting: Secretary's Advisory Committee on Xenotransplantation

Pursuant to Public Law 92-463, notice is hereby given of the first meeting of the Secretary's Advisory Committee on Xenotransplantation (SACX), Department of Health and Human Services (DHHS). The meeting will be held from 8 a.m. to 5 p.m. on February 20-21, 2001, at the DoubleTree Rockville Hotel, 1750 Rockville Pike, MD 20852. The meeting will be open to the public; however, seating is limited and pre-registration is encouraged (see below). The first SACX meeting will be primarily for orientation and organizational purposes. There will also be a limited period of time provided for public comment; interested individuals should contact the SACX Executive Director (see below).

Under authority of 42 U.S.C. 217a, section 222 of the Public Health Service Act, as amended, the DHHS established the SACX to advise and make recommendations to the Secretary, through the Assistant Secretary for Health, on all aspects of the scientific development and clinical application of xenotransplantation. The SACX is directed to advise DHHS on the current state of knowledge regarding xenotransplantation; identify and discuss the medical, public health, scientific, ethical, legal and/or socioeconomic issues raised by xenotransplantation clinical research; advise DHHS on the potential for transmission of infectious diseases as a consequence of xenotransplantation; recommend, as needed, changes to the PHS Guideline on Infectious Disease Issues in Xenotransplantation; and discuss additional issues, including international policies and developments, that are relevant to xenotransplantation.

The SACX is composed of 18 voting, non-governmental experts in relevant medical, scientific, and professional fields such 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. Of the appointed members, at least one is a current member of the Food and Drug Administration (FDA) Biologic Response Modifiers Advisory Committee and of the Centers for Disease Control and Prevention (CDC) Healthcare Infection Control Practices Advisory Committee. The SACX also includes non-voting, ex officio members from relevant DHHS components, including the Office of the Secretary, CDC, FDA, Health Resources and Services Administration, and the National Institutes of Health.

The draft meeting agenda and roster will be available at http://www4.od.nih.gov/​oba/​Sacx.htm in February. For pre-registration, please contact Technical Resources International (Sharon Leeney) at 301-564-6400. Individuals who wish to provide public comments or who plan to attend the meeting and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the SACX Executive Director, Dr. Mary Groesch, by telephone at 301-496-0785 or email at [e-mail]. The SACX office is located at 6750 Rockledge Drive, Suite 750, MSC 7985, Bethesda, MD 20892-7985.

Dated: January 19, 2001.

LaVerne Y. Stringfield,

Director, Office of Federal Advisory Committee Policy.