From: BULLELKMAN@aol.com Sent: Thursday, September 12, 2002 5:52 AM To: fdadockets@oc.fda.gov; rxf@cdrh.fda.gov Subject: Resending - More comments about Docket Number - #01N-0067 Subj: More comments about Docket Number - #01N-0067 Date: 6/18/2002 10:15:57 PM Pacific Standard Time From: BULLELKMAN To: JMS@CDRH.FDA.GOV, FDADockets@oc.fda.gov CC: brownchas@erols.com, bjones@cavitat.com, Fourpawsca, GRUFFY3 Dear Mr. Sheehan, I did receive your response regarding "comments". As staffs for the Docket Management Branch and your department of Regulation know that the topic of mercury dental fillings is very important to thousands of Americans. Thank you. In an earlier e-mail from me, you read the e-mails from people who know that their lives have been affected by mercury fillings and they shared the dangers of mercury dental fillings to human health. These Americans want to share with the FDA. These Americans know that this government agency works to protect Americans from products that can and do cause harm. I hope that you can do everything in your power to make all the e-mails and letters that the FDA receives for Docket Number 01N-0067 between the comment periods as "relevant". We think all of them are "relevant" to such an important topic of mercury dental fillings and the proposed ruling saying that mercury dental fillings are safe. People are sending e-mails and letters to the FDA because they want their voices heard on this important subject to say that mercury dental fillings are not safe. Thank you. When do you think FDA will reopen the comment period? Thank you, Mary Ann Newell Manager of the Files for Consumers for Dental Choice Subj: RE: More comments about Docket Number - #01N-0067 Date: 6/11/2002 4:54:48 AM Pacific Standard Time From: JMS@CDRH.FDA.GOV To: BULLELKMAN@aol.com Sent from the Internet (Details) Ms. Newell, "Comments" must be submitted in accordance with the procedures announced in the Federal Register. This includes the time-frames specified in the Federal Register. E-mails and letters sent to FDA and directed to the Dockets Management Branch within those time-frames are considered comments. E-mails and letters received outside of those time frames, if relevant, will become part of the administrative record and will receive appropriate consideration in the development of a final rule. I am appending a copy of our regulation on this subject at the end of this e-mail. The comment period on docket number 01N-0067 is now closed. FDA will reopen it soon. At that time, all interested person may submit comments in accordance with the procedures and timeframes announced in the notice reopening the comment period. Joseph M. Sheehan, Chief, Regulations Staff Phone 301-827-2974 Fax 301-594-4795 jms@cdrh.fda.gov TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 10--ADMINISTRATIVE PRACTICES AND PROCEDURES--Table of Contents Subpart B--General Administrative Procedures Sec. 10.40 Promulgation of regulations for the efficient enforcement of the law. (a) The Commissioner may propose and promulgate regulations for the efficient enforcement of the laws administered by FDA whenever it is necessary or appropriate to do so. The issuance, amendment, or revocation of a regulation may be initiated in any of the ways specified in Sec. 10.25. (1) This section applies to any regulation: (i) Not subject to Sec. 10.50 and part 12, or (ii) if it is subject to Sec. 10.50 and part 12, to the extent that those provisions make this section applicable. (2) A regulation proposed by an interested person in a petition submitted under Sec. 10.25(a) will be published in the Federal Register as a proposal if: (i) The petition contains facts demonstrating reasonable grounds for the proposal; and (ii) The petition substantially shows that the proposal is in the public interest and will promote the objectives of the act and the agency. (3) Two or more alternative proposed regulations may be published on the same subject to obtain comment on the different alternatives. (4) A regulation proposed by an interested person in a petition submitted under Sec. 10.25(a) may be published together with the Commissioner's preliminary views on the proposal and any alternative proposal. (b) Except as provided in paragraph (e) of this section, each regulation must be the subject of a notice of proposed rulemaking published in the Federal Register. (1) The notice will contain: (i) The name of the agency; (ii) The nature of the action, e.g., proposed rule, or notice; (iii) A summary in the first paragraph describing the substance of the document in easily understandable terms; (iv) Relevant dates, e.g., comment closing date, and proposed effective date(s); (v) The name, business address, and phone number of an agency contact person who can provide further information to the public about the notice; (vi) An address for submitting written comments; (vii) Supplementary information about the notice in the form of a preamble that summarizes the proposal and the facts and policy underlying it, includes references to all information on which the Commissioner relies for the proposal (copies or a full list of which are a part of the docket file on the matter in the office of the Dockets Management Branch), and cites the authority under which the regulation is proposed; (viii) Either the terms or substance of the proposed regulation or a description of the subjects and issues involved; (ix) A reference to the existence or lack of need for an environmental impact statement under Sec. 25.52 of this chapter; and (x) The docket number of the matter, which identifies the docket file established by the Dockets Management Branch for all relevant submissions. (2) The proposal will provide 60 days for comment, although the Commissioner may shorten or lengthen this time period for good cause. In no event is the time for comment to be less than 10 days. (3) After publication of the proposed rule, any interested person may request the Commissioner to extend the comment period for an additional specified period by submitting a written request to the Dockets Management Branch stating the grounds for the request. The request is submitted under Sec. 10.35 but should be headed ``REQUEST FOR EXTENSION OF COMMENT PERIOD.'' (i) A request must discuss the reason comments could not feasibly be submitted within the time permitted, or that important new information will shortly be available, or that sound public policy otherwise supports an extension of the time for comment. The Commissioner may grant or deny the request or may grant an extension for a time period different from that requested. An extension may be limited to specific persons who have made and justified the request, but will ordinarily apply to all interested persons. (ii) A comment time extension of 30 days or longer will be published n the Federal Register and will be applicable to all interested persons. A comment time extension of less than 30 days will be the subject either of a letter or memorandum filed with the Dockets Management Branch or of a notice published in the Federal Register. (4) A notice of proposed rulemaking will request that four copies of all comments be submitted to the Dockets Management Branch, except that individuals may submit single copies. Comments will be stamped with the date of receipt and will be numbered chronologically. (5) Persons submitting comments critical of a proposed regulation are encouraged to include their preferred alternative wording. (c) After the time for comment on a proposed regulation has expired, the Commissioner will review the entire administrative record on the matter, including all comments and, in a notice published in the Federal Register, will terminate the proceeding, issue a new proposal, or promulgate a final regulation. (1) The quality and persuasiveness of the comments will be the basis for the Commissioner's decision. The number or length of comments will not ordinarily be a significant factor in the decision unless the number of comments is material where the degree of public interest is a legitimate factor for consideration. (2) The decision of the Commissioner on the matter will be based solely upon the administrative record. (3) A final regulation published in the Federal Register will have a preamble stating: (i) The name of the agency, (ii) the nature of the action e.g., final rule, notice, (iii) a summary first paragraph describing the substance of the document in easily understandable terms, (iv) relevant dates, e.g., the rule's effective date and comment closing date, if an opportunity for comment is provided, (v) the name, business address, and phone number of an agency contact person who can provide further information to the public about the notice, (vi) an address for the submission of written comments when they are permitted, (vii) supplementary information about the regulation in the body of the preamble that contains references to prior notices relating to the same matter and a summary of each type of comment submitted on the proposal and the Commissioner's conclusions with respect to each. The preamble is to contain a thorough and comprehensible explanation of the reasons for the Commissioner's decision on each issue. (4) The effective date of a final regulation may not be less than 30 days after the date of publication in the Federal Register, except for: (i) A regulation that grants an exemption or relieves a restriction; or (ii) A regulation for which the Commissioner finds, and states in the notice good cause for an earlier effective date. (d) The provisions for notice and comment in paragraphs (b) and (c) of this section apply only to the extent required by the Administrative Procedure Act (5 U.S.C. 551, 552, and 553). As a matter of discretion, however, the Commissioner may voluntarily follow those provisions in circumstances in which they are not required by the Administrative Procedure Act. (e) The requirements of notice and public procedure in paragraph (b) of this section do not apply in the following situations: (1) When the Commissioner determines for good cause that they are impracticable, unnecessary, or contrary to the public interest. In these cases, the notice promulgating the regulation will state the reasons for the determination, and provide an opportunity for comment to determine whether the regulation should subsequently be modified or revoked. A subsequent notice based on those comments may, but need not, provide additional opportunity for public comment. (2) Food additive and color additive petitions, which are subject to the provisions of Sec. 12.20(b)(2). (3) New animal drug regulations, which are promulgated under section 512(i) of the act. (f) In addition to the notice and public procedure required under paragraph (b) of this section, the Commissioner may also subject a proposed or final regulation, before or after publication in the Federal Register, to the following additional procedures: (1) Conferences, meetings, discussions, and correspondence under Sec. 10.65. (2) A hearing under parts 12, 13, 14, or 15. (3) A notice published in the Federal Register requesting information and views before the Commissioner determines whether to propose a regulation. (4) A draft of a proposed regulation placed on public display in the office of the Dockets Management Branch. If this procedure is used, the Commissioner shall publish an appropriate notice in the Federal Register stating that the document is available and specifying the time within which comments on the draft proposal may be submitted orally or in writing. (5) A revised proposal published in the Federal Register, which proposal is subject to all the provisions in this section relating to proposed regulations. (6) A tentative final regulation or tentative revised final regulation placed on public display in the office of the Dockets Management Branch and, if deemed desirable by the Commissioner, published in the Federal Register. If the tentative regulation is placed on display only, the Commissioner shall publish an appropriate notice in the Federal Register stating that the document is available and specifying the time within which comments may be submitted orally or in writing on the tentative final regulation. The Commissioner shall mail a copy of the tentative final regulation and the Federal Register notice to each person who submitted comments on the proposed regulation if one has been published. (7) A final regulation published in the Federal Register that provides an opportunity for the submission of further comments, in accordance with paragraph (e)(1) of this section. (8) Any other public procedure established in this chapter and expressly applicable to the matter. (g) The record of the administrative proceeding consists of all of the following: (1) If the regulation was initiated by a petition, the administrative record specified in Sec. 10.30(i). (2) If a petition for reconsideration or for a stay of action is filed, the administrative record specified in Secs. 10.33(k) and 10.35(h). (3) The proposed rule published in the Federal Register, including all information identified or filed by the Commissioner with the Dockets Management Branch on the proposal. (4) All comments received on the proposal, including all information submitted as a part of the comments. (5) The notice promulgating the final regulation, including all information identified or filed by the Commissioner with the Dockets Management Branch as part of the administrative record of the final regulation. (6) The transcripts, minutes of meetings, reports, Federal Register notices, and other documents resulting from the procedures specified in paragraph (f) of this section, but not the transcript of a closed portion of a public advisory committee meeting. (7) All documents submitted to the Dockets Management Branch under Sec. 10.65(h). (h) The record of the administrative proceeding closes on the date of publication of the final regulation in the Federal Register unless some other date is specified. Thereafter, any interested person may submit a petition for reconsideration under Sec. 10.33 or a petition for stay of action under Sec. 10.35. A person who wishes to rely upon information or views not included in the administrative record shall submit it to the Commissioner with a new petition to modify the final regulation. (i) The Dockets Management Branch shall maintain a chronological list of all regulations proposed and promulgated under this section and Sec. 10.50 (which list will not include regulations resulting from petitions filed and assigned a docket number under Sec. 10.30) showing- (1) The docket number (for a petition submitted directly to a center, the list also includes the number or other designation assigned by the center, e.g., the number assigned to a food additive petition); (2) The name of the petitioner, if any; (3) The subject matter involved; and (4) The disposition of the petition. [44 FR 22323, Apr. 13, 1979, as amended at 52 FR 36401, Sept. 29, 1987; 54 FR 9034, Mar. 3, 1989; 56 FR 13758, Apr. 4, 1991; 62 FR 40592, July 29, 1997; 66 FR 6468, Jan. 22, 2001; 66 FR 12848, Mar. 1, 2001] Effective Date Note: At 66 FR 12848, Mar. 1, 2001, Sec. 10.40 was amended in paragraph (g)(7) by removing ``Sec. 10.65(f)'' and by adding in its place ``Sec. 10.65(h)'', effective Jan. 22, 2001, to Apr. 22, 2001. -----Original Message----- From: BULLELKMAN@aol.com [mailto:BULLELKMAN@aol.com] Sent: Tuesday, June 11, 2002 1:23 AM To: JMS@CDRH.FDA.GOV; FDADockets@oc.fda.gov Cc: brownchas@erols.com; bjones@cavitat.com; Fourpawsca@aol.com; GRUFFY3@aol.com Subject: More comments about Docket Number - #01N-0067 Dear Mr.Sheehan, Per my voice mail message, I want to thank you for your quick reply back to me regarding Mr. Bob Jones' e-mail from Ms. Jennie C. Butler. Like I said in my voice mail to you, I work for a high tech company. When I share my work "lingo" with others, it is confusing to them. This is why it is important to know the terminology when we are working with different organizations both in the public and private sectors. I am confused by the word "comments" and I need help to please understand the FDA's meaning of the word "comments". 1. I thought when people send e-mails and letters to the FDA regarding Docket Number - #01N-0067 that the people are sending in "comments" to the FDA. Is that wrong? Thank you. 2. Another question, when I sent my e-mail to Docket Number #01N-0067 was I not sending my "comments" to the FDA. Is that right or is that wrong?? Thank you. 3. Another question, when I sent my personal two page story about how mercury fillings made me very ill, is that not consider "comments" to the FDA for Docket Number #01N-0067? Thank you. 4. Would you please tell me the FDA's definition of "comments" so I understand it? Thank you. I am looking forward to hearing from you so we are all are "on the same page" on the definition of "comments". Thank you. Thank you again, Mary Ann Newell Manager of the Files for Consumers for Dental Choice Phone - 360-694-5770