[Federal Register Volume 64, Number 202 (Wednesday, October 20, 1999)]
[Notices]
[Pages 56507-56508]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-27306]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary, DHHS


Request for Nominations for the Secretary's Advisory Committee on 
Xenotransplantation

ACTION: Notice.

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SUMMARY: 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 establishment of the Secretary's 
Advisory Committee on Xenotransplantation (SACX) and is soliciting 
nominations for qualified individuals to serve on the SACX.

DATES: Nomination packages should be submitted to Dr. Mary Groesch, 
Office of Biotechnology Activities, Office of Science Policy, National 
Institutes of Health, 6000 Executive Boulevard, Suite 302, Bethesda, 
Maryland 20892-7010 by December 6, 1999.

FOR FURTHER INFORMATION CONTACT: Dr. Mary Groesch, Office of 
Biotechnology Activities, Office of Science Policy, National Institutes 
of Health, 6000 Executive Boulevard, Suite 302, Bethesda, Maryland 
20892-7010, telephone 301-496-0785, facsimile 301-496-9839, e-mail 
[email protected].

SUPPLEMENTARY INFORMATION:

Background

    Xenotransplantation involves use of live cells, tissues, or organs 
from a nonhuman animal source transplanted or implanted into a human or 
used for ex vivo contact with human body fluids, cells, tissues or 
organs that are subsequently given to a human recipient. Interest in 
xenotransplantation has been renewed by the continuing, critical 
shortage of donated human organs and by advances in immunology and in 
the biology of organ and tissue rejection. Xenotransplantation holds 
potential for the treatment of 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 research also poses certain challenges 
with respect to the potential for transmission of infectious agents 
from animal donors to human recipients.
    Public awareness and understanding of xenotransplantation is vital 
because the infectious disease risks posed by xenotransplantation could 
extend beyond the individual patients to the public at large. In 
addition to these safety issues, a number of individuals and groups 
have raised concerns about the implications of xenotransplantation for 
human rights, community interest and consent, social equity in access 
to novel biotechnologies, allocation of human allografts, and animal 
welfare. For all of these reasons, scientific review of and public 
discourse on

[[Page 56508]]

xenotransplantation research are critical and necessary.
    The Secretary, DHHS, has established the Secretary's Advisory 
Committee on Xenotransplantation to provide a forum for the discussion 
of, and public input on, these and other relevant issues.

Abridged Committee Charter

Purpose

    The DHHS 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 Secretary's Advisory Committee on Xenotransplantation 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.
     Review current and proposed xenotransplantation clinical 
trials. 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.
     Recommend to the Department, as needed, 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 15 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. Of the appointed members, at least one 
shall be a current member of the Xenotransplantation Subcommittee of 
the Food and Drug Administration (FDA) Biologic Response Modifiers 
Advisory Committee and at least one shall be a current member of the 
Centers for Disease Control and Prevention (CDC) Hospital Infection 
Control Practices Advisory Committee.
    In addition, the Committee shall include non-voting, ex officio 
members from relevant DHHS components, including the Office of the 
Secretary, CDC, FDA, Health Resources and Services Administration, 
National Institutes of Health and others as deemed appropriate by the 
Secretary or designee. As necessary, standing and ad hoc subcommittees 
composed of members of the parent committee may be established to 
perform specific functions within the Committee's jurisdiction.
    Members shall be invited to serve for overlapping four year terms; 
terms of more than two years are contingent upon the renewal of the 
Committee by appropriate action prior to its termination. The Committee 
shall be able to call upon special consultants, assemble ad hoc working 
groups and convene conferences and workshops as necessary to assist in 
the work of the Committee. Management and support services shall be 
provided by the Office of Science Policy, Office of the Director, 
National Institutes of Health, with direction and guidance from the 
Assistant Secretary for Health.

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. A Government official shall be 
present at all meetings. 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. Meetings shall be conducted, 
and records of the proceedings kept, as required by applicable laws and 
Departmental regulations.

Nominations

    DHHS will consider nominations of all qualified individuals. 
Committee members will have expertise in such fields 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. Optimally, a nomination package would 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 45 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.

    Dated: October 13, 1999.
David Satcher,
Assistant Secretary for Health and Surgeon General.
[FR Doc. 99-27306 Filed 10-19-99; 8:45 am]
BILLING CODE 4140-01-M