From: marc krimen [marcandklara@hotmail.com]
Sent: Friday, March 02, 2001 3:19 PM
To: fdadockets@oc.fda.gov
Subject: 00N-0989

I am writing to ask the FDA to approve docket # 00N-0989. 
    a.. This proposal only brings gene therapy and xenotransplantation in compliance with the same types of information already released to the public by other government agencies. 
    b.. Because of the grave public health risks, disclosure should include additional information such as physicians, medical centers, and so on. All information should be made public except trade secrets and patient identification. 
    c.. The FDA must assume the sole responsibility for summarizing and distributing information submitted by the research sponsor, rather than leave it to the sponsor’s discretion. 
    d.. Because of the pubic health risks, ethical issues, cost uncertainty, and the inability to adequately assess other alternatives, all xenotransplantation clinical trials should stop.