05-5671. Office of the Director, National Institutes of Health; Amended Notice-Request for Public Comment

Notice is hereby given of a change in the submission date of public comments. Comments will be accepted until April 10, 2005, instead of March 31, 2005, as published in the Federal Register on March 9, 2005, 70 FR 4568.

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 issued 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 [amended to April 10, 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.

A 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 [phone] or by e-mailing Marcy Groesch at [e-mail].

Contact Person: March Groesch, Executive Director, Secretary's Advisory Committee on Xenotransplantation, Office of Biotechnology Activities, Rockledge I, Room 750, Bethesda, MD 20892, [phone].

(Catalogue of Federal Domestic Assistance Program Nos. 93.14, Intramural Research Training Award; 93.187, Undergraduate Scholarship Program for Individuals from Disadvantages 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 16, 2005.

LaVerne Y. Stringfield,

Director, Office of Federal Advisory Committee Policy.