From: BULLELKMAN@aol.com
Sent: Thursday, September 12, 2002 6:11 AM
To: fdadockets@oc.fda.gov; rxf@cdrh.fda.gov
Subject: Resend -Docket 01N-0067 New 60-day period - public comment:
reply & suggestions 

Subj:   New 60-day period for public comment: reply and suggestions 
Date:   5/21/2002 1:27:05 PM Pacific Standard Time
From:   brownchas@erols.com

To: JMS@CDRH.FDA.GOV, FDADockets@oc.fda.gov

CC: FourPawsCa@aol.com,  gruffy3@aol.com,  bullelkman@aol.com

Sent from the Internet (Details)




Joseph M. Sheehan, Chief
Regulations Staff
FDA

Dear Mr. Sheehan

    Thank you.  We appreciate the time to make comments that, we hope, will
benefit the FDA as well as the public.
    May I ask that you consider, in the notice, adding the following:
    -- Public hearings by the FDA
    -- An additional time period to rebutthe comments of other participants.
    The issue is quite contentious, and involves Congressional bills, state
legislative bills (and state laws already enacted). and intense debate
WITHIN dentistry.  We think it would be enlightening to the rule makers to
allow each side to rebut the other side's comments.

Charles G. Brown
Consumers for Dental Choice
May 21, 2002



-----Original Message-----
From: Sheehan, Joseph M. [mailto:JMS@CDRH.FDA.GOV]
Sent: Tuesday, May 21, 2002 3:17 PM
To: 'brownchas@erols.com'; Dockets, FDA
Cc: Rosie Cronin; sandy duffy; Mary Ann Newell
Subject: RE: 60-day extension for public comment

Mr. Brown,

What Dr. Runner told you is mostly accurate with some clarifications.  We
will need to reopen the comment period.  We expect to publish a Federal
Register notice in a few weeks and a new 60-day period will start at that
time.

I will let you know when that happens.

Joseph M. Sheehan,
Chief, Regulations StaffPhone 301-827-2974
Fax 301-594-4795
jms@cdrh.fda.gov



-----Original Message-----
From: Charles Brown [mailto:brownchas@erols.com]
Sent: Tuesday, May 21, 2002 3:02 PM
To: JMS@CDRH.FDA.GOV; fdadockets@oc.fda.gov
Cc: Rosie Cronin; sandy duffy; Mary Ann Newell
Subject: 60-day extension for public comment

Consumers for Dental Choice, Inc.

                                May 21,
2002, 2:45 pm
Mr. Joseph Sheehan
Regulations Staff
FDA            Via e-mail:  JMS@CDRH.fda.gov

cc:  Susan Runner, D.D.S., Branch Chief, Dental Devices, Division of Dental
Infection Control and General Hospital Devices, FDA        Via fax:
301.480-3002

cc:  fdadockets@oc.fda.gov  (the public record)

Re:  Docket # 01N-0067 - AGAINST the FDA Rule Re Mercury Dental Fillings

Dear Mr. Sheehan:

    I am counsel for Consumers for Dental Choice, Inc., an interested
party in
the proposed FDA regulation concerning mercury dental fillings (amalgam).

    Today, via telephone, Dr. Susan Runner informed Rosie Cronin of
Salem, New
Hampshire, then me separately, that the deadline for submitting comments has
been moved from today to sixty days hence.  Dr. Runner said she has been
internally informed, and that the matter would be published later in the
week.  As you know, we had asked for this extension.

    We thank you for undertaking this step.  The regulation has some
major
difficulties, and this will allow more comments from the public, such as the
scientific community, dentists (who are divided on the safety of mercury
fillings), consumers, and victims of mercury amalgam poisoning.

    A few moments ago, I left you a voice message on this continuance.
Of course, if my information is incorrect, please e-mail me / phone me at
once.
(E-address below; phone 202.462-8800, ext. 13; cell 202.210-0899).
Because, of course, if the information is not correct, we must submit our
comments today.  I have comments almost completed, but can provide a better
submission, and one with more precise citations, with this continuance.  We
will therefore not be making this submission today unless I hear from you.

Sincerely,


Charles G. Brown
1400 Sixteenth St., N.W., Suite 330
Washington, DC 20036-2215
Phone 202.462-8800.  Fax 202.265-6564
E:  brownchas@erols.com

cc:  Rosie Cronin