[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
groeschm@od.nih.gov.
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
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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
