From: Heins, Jill [Jill.Heins@vetmedpub.com]
Sent: Tuesday, March 06, 2001 10:08 AM
To: 'fdadockets@oc.fda.gov'
Subject: Docket No. 00N-0989

March 6, 2001

Dockets Management Branch
Food and Drug Administration
5630 Fishers Lane
Room 10-61 HFA-305
Rockville, MD  20852


Re: Docket No. 00N-0989


I am would like to encourage you to support the proposed rule that would
provide public access to study design and safety information on new or
ongoing clinical trials involving gene therapy and xenotransplantation. Both
are potentially dangerous areas that the public should be fully informed
about. This proposed rule would bring gene therapy and xenotransplantation
in compliance with the same types of information already released to the
public by other government agencies.

Because of the grave public health risks, disclosure should include
additional information such as the names of the physicians conducting the
trials and the participating medical centers. The FDA must assume
responsibility for summarizing and distributing information submitted by the
research sponsors, rather than leave it to sponsor discretion.

Because of the public health risks, legal and ethical issues, enormous cost,
serious animal welfare concerns, and the failure to adequately assess other
alternatives, all xenotransplantation clinical trials should stop.
Moreover, the U.S. government should certainly not fund xenotransplantation
research.

Sincerely,


Jill M. Heins
7833 Garnett
Lenexa, KS  66214
jill.heins@vetmedpub.com