From: BULLELKMAN@aol.com Sent: Thursday, September 12, 2002 5:17 AM To: fdadockets@oc.fda.gov; rxf@cdrh.fda.gov Subject: Resending - RE: Docket # 01N-0067 - AGAINST the FDA Rule on Mercury Dental Fi ll Subj: RE: Docket # 01N-0067 - AGAINST the FDA Rule on Mercury Dental Fi llings Date: 8/8/2002 5:29:18 AM Pacific Standard Time From: JMS@CDRH.FDA.GOV To: BULLELKMAN@aol.com, JMS@CDRH.FDA.GOV, FDADockets@oc.fda.gov, brownchas@erols.com CC: Fourpawsca@aol.com, GRUFFY3@aol.com Sent from the Internet (Details) Dear Ms. Newell, Please see this website for information on how to submit comments to FDA: http://www.fda.gov/opacom/backgrounders/voice.html As noted in this article, it is not necessary to include the docket number in a comment but FDA encourages including it because it expedites processing and minimizes the possibility of a mistake in filing. As also noted in this article, Federal Register documents are available from numerous sources. The Federal Register documents on amalgam are available at several places on FDA web sites. I entered the word "amalgam" in the search box on the Dockets web site and the first two documents listed were the notices reopening the comment period. These notices list the docket number and instructions for submitting comments. In addition, the people in Dockets Management Branch as well as other FDA employees will be glad to provide anyone a docket number upon request. It is not unusual that the amalgam docket is not included in the drop-down list of dockets on the Dockets page on the FDA web site. Due to limited resources, very few of the active dockets are listed there. As noted on the Dockets page where "Comment Periods Ending" are listed, the page is updated monthly (again due to limited resources). The amalgam docket was, in fact, closed from mid-May to mid-July. It is now reopened. The Dockets page will be updated shortly to reflect the reopening. The notice announcing the reopening is now available in several places on the FDA web sites. I hope that this has been helpful. Joseph M. Sheehan, Chief, Regulations Staff Phone 301-827-2974 Fax 301-594-4795 jms@cdrh.fda.gov -----Original Message----- From: BULLELKMAN@aol.com [mailto:BULLELKMAN@aol.com] Sent: Thursday, August 08, 2002 12:00 AM To: JMS@CDRH.FDA.GOV; fdadockets@oc.fda.gov; brownchas@erols.com Cc: Fourpawsca@aol.com; GRUFFY3@aol.com Subject: Docket # 01N-0067 - AGAINST the FDA Rule on Mercury Dental Fillings Dear Mr. Sheehan, You have been so helpful that I hope that you can help me understand a few "why"s about the FDA webpages. I have left you a voice mail message about these issues that I am going to state in my letter to you and the FDA docket. THANK YOU! COMMENT 1 : I know that the "U.S. Food and Drug Administration Docket Management Electronic Comment Submission Form", states "If your comments are NOT related to a docket listed below, you can e-mail your comments to E-mail or submit written comments to Dockets Management Branch, Food and Drug Administration, 5630 Fishers Lane, Room 1061, HFA-305, Rockville, MD 20852." Q1 - If concerned American citizen(s) heard about the FDA taking comments on mercury fillings, how would they easily find the important Docket Number #01N-0067 regarding mercury fillings? COMMENT 2: I feel that "U.S. Food and Drug Administration Docket Management Electronic Comment Submission Form" webpage, should tell the concerned citizen that they need to put the docket number on the top of their letter/e-mail. Remember, you kindly informed me of that in an e-mail that you sent to me dated 5/29/2002: You wrote "To assure that your comments are considered, you should send them to Dockets Management Branch at one of the given addresses and include Docket Number #01N-0067 at the top of the letter/e-mail." Q2. How would concerned citizens be assured that their comments were routed to the correct docket without putting the correct docket number on their letter/e-mail? COMMENT 3: I have a real concern when I viewed the FDA webpage titled "Select Docket for Comment". I realize the title says "What's New" with the "Docket Number" in left column and the "Title of Docket" in the right column. The list of "What's New" lists new dockets but also updated dockets. Q3. Why isn't Docket Docket Number #01N-0067 Reclassification of Dental Mercury listed on this webpage? COMMENT 4. I find it very disturbing that when you go to the "Dockets - Comment Period Ending (UPDATED MONTHLY)". 1. I did NOT find Docket Number - 01N-0067 Reclassification of Dental Mercury in the "SELECTED DOCKETS - COMMENT PERIOD'S ENDING for July, August , and September 2002". 2. I found Docket Number - 01N-0067 in the "SELECTED DOCKETS - COMMENT PERIODs CLOSED", in May 2002 01N-0067 Reclassification of Dental Mercury 05/21/02. BIG Q4: WHY? COMMENT 5: This comment is not directed at you, Mr. Sheehan but at the FDA's department of Center for Devices and Radiological Health. I wanted it to be noted that I and thousands of concerned dental consumers feel that the FDA's department of Center for Devices and Radiological Health is purposely "not listing" docket number - 01N-0067 to hide this important proposed ruling about mercury dental filling from the American public. We feel that the FDA's department of CDRH is hiding the truth from the American people just like the ADA. The ADA is hiding the truth from dental consumers by calling dental fillings - silver/amalgam fillings. The American dental consumer deserves the truth that a filling is 50% mercury and that mercury fillings have health risks. Mr. Sheehan, as you know I am working to protect your children and future grandchildren because you know if you and I did not work for protecting your children and future grandchildren, you know that the ADA is not and will not. Your children and future grandchildren need you as a hero. THANK YOU! I look forward to hearing from you soon regarding my questions. Thank you, Mary Ann Newell Manager of the Files for Consumers for Dental Choice