[Federal Register Volume 70, Number 45 (Wednesday, March 9, 2005)]
[Notices]
[Page 11680]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-4568]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Office of the Director, National Institutes of Health; Request 
for Public Comment on Draft Reports on Xenotransplantation

    The Secretary's Advisory Committee on Xenotransplantation (SACX) is 
requesting public comment on two draft reports on xenotransplantation. 
One is on the state of the science of xenotransplantation and the other 
is on informed consent issues in clinical trials involving 
xenotransplantation.
    Before the reports are finalized and transmitted to the Secretary, 
the SACX is requesting comments on the draft reports from members of 
the public. All public comments received will be considered in 
finalizing the reports. Comments should be submitted by March 31, 2005. 
Received comments will be available for public inspection at the NIH 
Office of Biotechnology Activities, Monday through Friday between the 
hours of 8:30 a.m. and 5 p.m., at the contact address noted below.
    Information: The Secretary's Advisory Committee on 
Xenotransplantation, Department of Health and Human Services, considers 
the scientific, medical, social, and ethical issues and the public 
health concerns raised by xenotransplantation and makes recommendations 
to the Secretary on policy and procedures. The Committee's charges 
include advising on the current state of knowledge regarding 
xenotransplantation and on the potential for transmission of infectious 
diseases as a consequence of xenotransplantation; and deliberating on 
medical, public health, ethical, legal and socioeconomic issues, 
including international policies and developments that are relevant to 
xenotransplantation.
    Overview of Drafts: The state of the science report addresses the 
scientific challenges in xenotransplantation, the infectious disease 
risks associated with xenotransplantation, public health concerns 
associated with xenotourism, knowledge gaps and resource limitations, 
and alternative strategies to xenotransplantation. The report also 
proposes a series of recommendations regarding these issues.
    The report on informed consent issues in clinical research 
involving xenotransplantation addresses the ethical foundations and 
functions of informed consent, components of informed consent, the 
informed consent process, informed consent forms, and special issues 
raised by xenotransplantation. The report proposes a series of 
recommendations regarding informed consent in xenotransplantation 
research.
    The full draft reports are available electronically at http://www4.od.nih.gov/oba/Sacx.htm. A paper or electronic copy can also be 
requested by calling the NIH Office of Biotechnology Activities at 
(301) 496-9838 or by e-mailing Mary Groesch at [email protected].
    Contact Person: Mary Groesch, Ph.D., Executive Director, 
Secretary's Advisory Committee on Xenotransplantation, Office of 
Biotechnology Activities, Rockledge I, Room 750, Bethesda, MD 20892. 
(301) 496-9838.

(Catalogue of Federal Domestic Assistance Program Nos. 93.14, 
Intramural Research Training Award; 93.187, Undergraduate 
Scholarship Program for Individuals from Disadvantaged Backgrounds; 
93.22, Clinical Research Loan Repayment Program for Individuals from 
Disadvantaged Backgrounds; 93.232, Loan Repayment Program for 
Research Generally; 93.39, Academic Research Enhancement Award; 
93.936, NIH Acquired Immunodeficiency Syndrome Research Loan 
Repayment Program, National Institutes of Health, HHS.)

    Dated: March 1, 2005.
LaVerne Y. Stringfield,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 05-4568 Filed 3-8-05; 8:45 am]
BILLING CODE 4140-01-M