[Federal Register Volume 68, Number 179 (Tuesday, September 16, 2003)]
[Notices]
[Pages 54229-54230]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-23552]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


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 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 
<[email protected]. Information about the SACX can also be 
accessed at <http://www4.od.nih.gov/oba/Sacx.htm.

SUPPLEMENTARY INFORMATION:

Background

    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:
    [sbull] Advise the Department on the current state of knowledge 
regarding xenotransplantation.
    [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 
clinical trials.
    [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 
contingent

[[Page 54230]]

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.

Nominations

    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]
BILLING CODE 4140-01-P