From: S. Smith [Planmanagement@compuserve.com]
Sent: Tuesday, January 30, 2001 5:10 PM
To: fdadockets@oc.fda.gov
Subject: Docket 00n-0989

To: Dockets Management

From: Steve Smith
474 Poplar Avenue
Elmhurst, Illinois  60126

Date: 1-30-01

Re:  My comments to docket 004-0989


This proposed regulation is to make publicly available such information
regarding clinical trials and new drug/biologics research that is
heretofore not available to the public.

We believe this regulation is good.  We believe that it is good to make as
much information regarding such research as possible without making
research financially unfeasible for sponsor organizations.  

I am actively involved in various advocacy, education and research projects
 focused on helping patient/family communities with rare disorders.  I am
frequently leading discussions within some of these communities regarding
new drug development and regulatory policy.  My assessment of this new
regulation is that it is very good for patients and families.  I also find
that contacts in the pharmaceuticals industry would welcome this regulation
because it sets a level playing field requiring the disclosure of
information of benefit to patients.  

I estimate that support for this regulation would be nearly 100 percent
amongst the patients support groups with rare disorders currently waiting
for treatment, their physicians, and the research scientists currently
working on breakthrough treatments.

Steve Smith