[Federal Register Volume 68, Number 179 (Tuesday, September 16, 2003)]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 03-23552]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Request for Nominations for the Secretary's Advisory Committee on
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 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.
DATES: 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.
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
<firstname.lastname@example.org. Information about the SACX can also be
accessed at <http://www4.od.nih.gov/oba/Sacx.htm.
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
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:
[sbull] Advise the Department on the current state of knowledge
[sbull] 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
[sbull] Advise the Department on the potential for transmission of
infectious diseases as a consequence of xenotransplantation.
[sbull] Advise the Department on policies relevant to
xenotransplantation, including the need for changes to the PHS
Guideline on Infectious Disease Issues in Xenotransplantation.
[sbull] 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
upon 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.
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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