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75 rows where docket_id = "FDA-2008-N-0163" sorted by posted_date descending

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posted_year 7

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  • 2010 4
  • 2014 3
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  • 2013 1

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  • Supporting & Related Material 51
  • Other 20
  • Rule 3
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agency_id 1

  • FDA 75
id agency_id docket_id title document_type subtype posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id
FDA-2008-N-0163-0309 FDA None FDA-2008-N-0163 Partial Petition Approval and Denial Response Letter from FDA CDRH to Citizens for Health et al (Swankin and Turner) Other Partial Petition Approval and Denial 2015-01-27T05:00:00Z 2015 1 2015-01-27T05:00:00Z   2015-01-27T23:07:55Z   0 0 09000064819e30bc
FDA-2008-N-0163-0308 FDA None FDA-2008-N-0163 Denial Response Letter from FDA CDRH to Mothers Against Mercury (Titus Hillis Reynolds Love, Dickman & McCalmon, and Reeves & Associates) Other Denial of Petition 2015-01-27T05:00:00Z 2015 1 2015-01-27T05:00:00Z   2015-01-27T23:26:56Z   0 0 09000064819e3436
FDA-2008-N-0163-0307 FDA None FDA-2008-N-0163 Attachment Lorscheider, et al Mercury Exposure From Silver Tooth Fillings: Emerging Evidence Questions a Traditional Dental Paradigm re DAMS Intl - Comment FDA-2008-N-0163-0233 and FDA-2008-N-0163-0232 Supporting & Related Material Background Material 2014-12-01T05:00:00Z 2014 12     2014-12-01T21:49:53Z   0 0 09000064806a9ab5
FDA-2008-N-0163-0305 FDA None FDA-2008-N-0163 Letter from Titus Hills Reynolds Love Dickman & McCalmon re Conversion to Citizen Petition of the September 3, 2009 Petition for Reconsideration Other Letter(s) 2014-06-20T04:00:00Z 2014 6 2014-06-20T04:00:00Z   2014-10-15T21:39:00Z   0 0 090000648175888c
FDA-2008-N-0163-0306 FDA None FDA-2008-N-0163 Letter from Citizens for Health, et al (Swankin & Turner) re Conversion to Citizen Petition of the September 3, 2009 Petition for Reconsideration Other Letter(s) 2014-06-20T04:00:00Z 2014 6 2014-06-20T04:00:00Z   2014-10-15T23:32:20Z   0 0 090000648175888d
FDA-2008-N-0163-0304 FDA None FDA-2008-N-0163 Moms Against Mercury, et al. - Supplement Other Supplement (SUP) 2013-04-23T04:00:00Z 2013 4 2013-04-23T04:00:00Z   2013-04-23T17:53:07Z   0 0 0900006481220d56
FDA-2008-N-0163-0300 FDA None FDA-2008-N-0163 Reference 4 - Henry Schein Inc. Q2 2009 Earnings Call Transcript - [Citizens for Health, et al. - Petition for Reconsideration] Supporting & Related Material Petition 2012-09-22T04:00:00Z 2012 9     2012-09-22T17:30:12Z   0 0 0900006480a244fa
FDA-2008-N-0163-0303 FDA None FDA-2008-N-0163 Reference 2 - Richardson, et al, Mercury Vapour (Hgº): Continuing Toxicological Uncertainties, and Establishing a Canadian Reference Exposure Level - [Mom's Against Mercury, et al. - Petition for Reconsideration] Supporting & Related Material Petition 2012-09-22T04:00:00Z 2012 9     2012-09-22T17:30:12Z   0 0 0900006480a24910
FDA-2008-N-0163-0297 FDA None FDA-2008-N-0163 Reference 1 - Mundy, New FDA Chief Must Divest Several Stock, Fund Holdings - [Citizens for Health, et al (Swankin & Turner) - Petition for Reconsideration] Supporting & Related Material Petition 2012-09-22T04:00:00Z 2012 9     2012-09-22T17:30:11Z   0 0 0900006480a23fa2
FDA-2008-N-0163-0302 FDA None FDA-2008-N-0163 Reference 1 - Laks, Assessment of Chronic Mercury Exposure Within the U.S. Population, National Health and Nutrition Examination Survey, 1999-2006 - [Mom's Against Mercury, et al. - Petition for Reconsideration] Supporting & Related Material Petition 2012-09-22T04:00:00Z 2012 9     2012-09-22T17:30:12Z   0 0 0900006480a24788
FDA-2008-N-0163-0301 FDA None FDA-2008-N-0163 Reference 12 - Mundy, et al, FDA Scientists Ask Obama to Restructure Drug Agency - [Citizens for Health, et al. - Petition for Reconsideration] Supporting & Related Material Petition 2012-09-22T04:00:00Z 2012 9     2012-09-22T17:30:12Z   0 0 0900006480a24612
FDA-2008-N-0163-0299 FDA None FDA-2008-N-0163 Reference 3 - Settlement Agreement for Moms Against Mercury, et al. v. Andrew von Eschenbach, et al., Civ. No. 07-2332 (ESH/JMF) (D.D.C.) (filed Dec. 28, 2007) re Petition for Reconsideration Citizens for Health, et al See FDA-2009-P-0609-0001 Supporting & Related Material Background Material 2012-09-22T04:00:00Z 2012 9     2014-10-08T17:19:01Z   0 0 0900006480a244f7
FDA-2008-N-0163-0298 FDA None FDA-2008-N-0163 Reference 2 - Wall Street Journal, FDA's Hamburg, Husband Have Health-Related Wealth - [Citizens for Health, et al. - Petition for Reconsideration] Supporting & Related Material Petition 2012-09-22T04:00:00Z 2012 9     2012-09-22T17:30:11Z   0 0 0900006480a24043
FDA-2008-N-0163-0296 FDA None FDA-2008-N-0163 Center for Device and Radiological Health to James M. Love - Letter Other LET-Letter 2010-08-26T04:00:00Z 2010 8 2010-08-26T04:00:00Z   2013-08-11T01:36:45Z   0 0 0900006480b3bda1
FDA-2008-N-0163-0295 FDA None FDA-2008-N-0163 Response Letter from Center for Device and Radiological Health to Swankin & Turner Other Letter(s) 2010-08-26T04:00:00Z 2010 8 2010-08-26T04:00:00Z   2014-10-07T20:02:14Z   0 0 0900006480b3bd9e
FDA-2008-N-0163-0294 FDA None FDA-2008-N-0163 Dental Devices: Classification of Dental Amalgam, Reclassification of Dental Mercury, Designation of Special Controls for Dental Amalgam, Mercury, and Amalgam Alloy; Technical Amendment Rule NFR-Notice of Final Rule 2010-06-11T04:00:00Z 2010 6     2011-06-11T16:27:42Z 2010-14083 0 0 0900006480b002a6
FDA-2008-N-0163-0293 FDA None FDA-2008-N-0163 OMB Review, Executive Order 12866, Regulatory Policy and Management Staff Note to the Division of Dockets Management, March 22, 2010" - [Dental Device: Classification of the Dental Amalgam, Reclassification of Dental Mercury, Designation of Special Controls for Dental Amalgam, Mercury, and Amalgam Alloy; Final Rule, August 4, 2009] - Reference Other REF-Reference 2010-03-31T04:00:00Z 2010 3 2010-03-31T04:00:00Z   2013-08-11T01:33:22Z   0 0 0900006480ac77e7
FDA-2008-N-0163-0280 FDA None FDA-2008-N-0163 Reference 13 - Mundy, FDA Chief Eyes Device Group - [Citizens for Health, et al. - Petition for Reconsideration] Supporting & Related Material PRC-Petition for Reconsideration (Supporting and Related Material) 2009-09-22T04:00:00Z 2009 9     2012-09-22T17:35:23Z   0 0 0900006480a24613
FDA-2008-N-0163-0273 FDA None FDA-2008-N-0163 Reference 5 - Consumers for Dental Choice FDA, June 9, 2009 re: Concerns About Mercury Amalgam Regulation and Your Henry Schein Board Membership - [Citizens for Health, et al. - Petition for Reconsideration] Supporting & Related Material PRC-Petition for Reconsideration (Supporting and Related Material) 2009-09-22T04:00:00Z 2009 9     2012-09-22T17:33:48Z   0 0 0900006480a2452b
FDA-2008-N-0163-0275 FDA None FDA-2008-N-0163 Reference 7 - Consumers for Dental Choice Acting FDA Chief Counsel, July 9, 2009 - [Citizens for Health, et al. - Petition for Reconsideration] Supporting & Related Material PRC-Petition for Reconsideration (Supporting and Related Material) 2009-09-22T04:00:00Z 2009 9     2012-09-22T17:34:16Z   0 0 0900006480a24534
FDA-2008-N-0163-0278 FDA None FDA-2008-N-0163 Reference 10 - Landers, American Medical News, Jan. 14, 2008, Questioning Kids - [Citizens for Health, et al. - Petition for Reconsideration] Supporting & Related Material PRC-Petition for Reconsideration (Supporting and Related Material) 2009-09-22T04:00:00Z 2009 9     2012-09-22T17:32:44Z   0 0 0900006480a2460e
FDA-2008-N-0163-0281 FDA None FDA-2008-N-0163 Reference 14 - Dickinson, A 'Shocking' Decision - Bias Seen in Dental Amalgams Rule - [Citizens for Health, et al. - Petition for Reconsideration] Supporting & Related Material PRC-Petition for Reconsideration (Supporting and Related Material) 2009-09-22T04:00:00Z 2009 9     2012-09-22T17:35:38Z   0 0 0900006480a24614
FDA-2008-N-0163-0286 FDA None FDA-2008-N-0163 Reference 19 - Dickinson, FDA Blinks, Modifies Mercury Amalgam Website, August 11, 2009 - [Citizens for Health, et al. - Petition for Reconsideration] Supporting & Related Material PRC-Petition for Reconsideration (Supporting and Related Material) 2009-09-22T04:00:00Z 2009 9     2012-09-22T17:37:31Z   0 0 0900006480a24781
FDA-2008-N-0163-0290 FDA None FDA-2008-N-0163 Acknowledgement Letter to Swankin & Turner Other ACK-Acknowledgement Letter 2009-09-22T04:00:00Z 2009 9 2009-09-22T04:00:00Z   2014-10-07T19:49:33Z   0 0 0900006480a23f8b
FDA-2008-N-0163-0288 FDA None FDA-2008-N-0163 Reference 21 - Dickinson, FDA Amalgam Science Called 'Absurd' in New Experts Attack, August 5, 2009 - [Citizens for Health, et al. - Petition for Reconsideration] Supporting & Related Material PRC-Petition for Reconsideration (Supporting and Related Material) 2009-09-22T04:00:00Z 2009 9     2012-09-22T17:38:31Z   0 0 0900006480a24784
FDA-2008-N-0163-0279 FDA None FDA-2008-N-0163 Reference 11 - Janis, Baltimore City Paper, Feb. 8, 2006, Q+A, Dr. Joshua Sharfstein - [Citizens for Health, et al. - Petition for Reconsideration] Supporting & Related Material PRC-Petition for Reconsideration (Supporting and Related Material) 2009-09-22T04:00:00Z 2009 9     2012-09-22T17:35:10Z   0 0 0900006480a24611
FDA-2008-N-0163-0291 FDA None FDA-2008-N-0163 Moms Against Mercury, et al. - Petition for Reconsideration Other Citizen Petition 2009-09-22T04:00:00Z 2009 9 2009-09-22T04:00:00Z   2015-01-28T12:42:07Z   0 0 0900006480a24048
FDA-2008-N-0163-0285 FDA None FDA-2008-N-0163 Reference 18 - CFSAN/Office of Cosmetics and Colors, Ingredients Prohibited and Restricted by FDA Regulations - [Citizens for Health, et al. - Petition for Reconsideration] Supporting & Related Material PRC-Petition for Reconsideration (Supporting and Related Material) 2009-09-22T04:00:00Z 2009 9     2012-09-22T17:36:40Z   0 0 0900006480a24780
FDA-2008-N-0163-0289 FDA None FDA-2008-N-0163 Reference 22 - Dickinson, Hamburg Recuses Herself from Dental Mercury Rulemaking, July 14, 2009 - [Citizens for Health, et al. - Petition for Reconsideration] Supporting & Related Material PRC-Petition for Reconsideration (Supporting and Related Material) 2009-09-22T04:00:00Z 2009 9     2012-09-22T17:38:45Z   0 0 0900006480a24785
FDA-2008-N-0163-0277 FDA None FDA-2008-N-0163 Reference 9 - FDA, Chief Counsel Response to Consumer for Dental Choices, Julu 8, 2009 - [Citizens for Health, et al. - Petition for Reconsideration] Supporting & Related Material PRC-Petition for Reconsideration (Supporting and Related Material) 2009-09-22T04:00:00Z 2009 9     2012-09-22T17:34:40Z   0 0 0900006480a2457d
FDA-2008-N-0163-0292 FDA None FDA-2008-N-0163 Acknowledgement Letter to Titus Hillis Reynolds Love et al. - Correction Other CR-Correction 2009-09-22T04:00:00Z 2009 9 2009-09-22T04:00:00Z   2014-10-15T21:15:59Z   0 0 0900006480a29859
FDA-2008-N-0163-0276 FDA None FDA-2008-N-0163 Reference 8 - FDA, Chief Counsel Response to Consumer for Dental Choice, July 24, 2009 - [Citizens for Health, et al. - Petition for Reconsideration] Supporting & Related Material PRC-Petition for Reconsideration (Supporting and Related Material) 2009-09-22T04:00:00Z 2009 9     2012-09-22T17:34:29Z   0 0 0900006480a2457b
FDA-2008-N-0163-0274 FDA None FDA-2008-N-0163 Reference 6 - Consumers for Dental Choice to the FDA Commissioner, July 1, 2009 re: Requesting Your Response to our Concerns About Mercury Amalgam Regulation and Your Henry Schein Board Membership - [Citizens for Health, et al. - Petition for Reconsideration] Supporting & Related Material PRC-Petition for Reconsideration (Supporting and Related Material) 2009-09-22T04:00:00Z 2009 9     2012-09-22T17:34:03Z   0 0 0900006480a24531
FDA-2008-N-0163-0282 FDA None FDA-2008-N-0163 Reference 15 - Thimersosal in Vaccines Questions and Answers, How Does FDA Evaluate Vaccines to Make Sure They are Safe? - [Citizens for Health, et al. - Petition for Reconsideration] Supporting & Related Material PRC-Petition for Reconsideration (Supporting and Related Material) 2009-09-22T04:00:00Z 2009 9     2012-09-22T17:35:58Z   0 0 0900006480a24615
FDA-2008-N-0163-0283 FDA None FDA-2008-N-0163 Reference 16 - FDA Veterinary Newsletter 2002 Volume XVI, No. IV, Nationwide Recall of Miracle Leg Paint - [Citizens for Health, et al. - Petition for Reconsideration] Supporting & Related Material PRC-Petition for Reconsideration (Supporting and Related Material) 2009-09-22T04:00:00Z 2009 9     2012-09-22T17:36:13Z   0 0 0900006480a24616
FDA-2008-N-0163-0287 FDA None FDA-2008-N-0163 Reference 20 - Dickinson, Experts Fault FDA's Dental Amalgam Rulemaking, August 3, 2009 - [Citizens for Health, et al. - Petition for Reconsideration] Supporting & Related Material PRC-Petition for Reconsideration (Supporting and Related Material) 2009-09-22T04:00:00Z 2009 9     2012-09-22T17:38:00Z   0 0 0900006480a24783
FDA-2008-N-0163-0284 FDA None FDA-2008-N-0163 Reference 17 - What You Need to Know About Mercury in Fish and Shellfish, March 2004 - [Citizens for Health, et al. - Petition for Reconsideration] Supporting & Related Material PRC-Petition for Reconsideration (Supporting and Related Material) 2009-09-22T04:00:00Z 2009 9     2012-09-22T17:36:27Z   0 0 0900006480a24617
FDA-2008-N-0163-0272 FDA None FDA-2008-N-0163 Citizens for Health, et al (Swankin & Turner) - Petition for Reconsideration Other Petition for Reconsideration 2009-09-22T04:00:00Z 2009 9 2009-09-22T04:00:00Z   2015-01-28T12:42:43Z   0 0 0900006480a1d1bc
FDA-2008-N-0163-0271 FDA None FDA-2008-N-0163 American Dental Association (ADA) to the Commissioner, FDA - Letter Other LET-Letter 2009-09-02T04:00:00Z 2009 9 2009-09-02T04:00:00Z   2013-07-27T22:53:08Z   0 0 0900006480a1616f
FDA-2008-N-0163-0270 FDA None FDA-2008-N-0163 Attachment Solving The Puzzle of Mystery Syndromes re Mary Davis, DAMS, Intl. - Comment FDA-2008-N-0163-0216 Supporting & Related Material Background Material 2009-08-27T04:00:00Z 2009 8     2014-12-01T22:34:13Z   0 0 09000064806a1c50
FDA-2008-N-0163-0269 FDA None FDA-2008-N-0163 Reference 3 - [FDA-2008-N-0163-0004] FDA Update/Review of Potential Adverse Health Risks Associated With Exposure to Mercury in Dental Amalgam Supporting & Related Material BKG-Background Material 2009-08-24T04:00:00Z 2009 8     2009-08-24T22:33:18Z   0 0 09000064805f1545
FDA-2008-N-0163-0260 FDA None FDA-2008-N-0163 Reference 15a - "Integrated Risk Information System (IRIS) Screening-Level Literature Review" - [Dental Devices: Classification of Encapsulated Amalgam Alloy and Dental Mercury and Reclassification of Dental Mercury; Issuance of Special Controls for Amalgam Alloy; Final Rule] Supporting & Related Material BKG-Background Material 2009-08-04T04:00:00Z 2009 8     2009-08-04T19:21:36Z   0 0 09000064809ff76b
FDA-2008-N-0163-0264 FDA None FDA-2008-N-0163 Reference 77 - "...Agency's Analysis of its NEPA Obligations for the Classification of Dental Amalgam, Reclassification of Dental Mercury... Memorandum July 28, 2009" - [Dental Devices: Classification of Encapsulated Amalgam Alloy and Dental Mercury and Reclassification of Dental Mercury; Issuance of Special Controls for Amalgam Alloy; Final Rule] Supporting & Related Material BKG-Background Material 2009-08-04T04:00:00Z 2009 8     2009-08-04T19:23:20Z   0 0 0900006480a0036f
FDA-2008-N-0163-0253 FDA None FDA-2008-N-0163 Reference 4 - "Update Statement by the U. S. Public Health Service on the Safety of Dental Amalgam" - [Dental Devices: Classification of Encapsulated Amalgam Alloy and Dental Mercury and Reclassification of Dental Mercury; Issuance of Special Controls for Amalgam Alloy; Final Rule] Supporting & Related Material BKG-Background Material 2009-08-04T04:00:00Z 2009 8     2009-08-04T19:17:54Z   0 0 09000064809ff65c
FDA-2008-N-0163-0258 FDA None FDA-2008-N-0163 Reference 13 - "Life Science Research Office Report: The Potential Health Effects of Dental Amalgam, July 2004" - [Dental Devices: Classification of Encapsulated Amalgam Alloy and Dental Mercury and Reclassification of Dental Mercury; Issuance of Special Controls for Amalgam Alloy; Final Rule] Supporting & Related Material BKG-Background Material 2009-08-04T04:00:00Z 2009 8     2009-08-04T19:20:07Z   0 0 09000064809ff68e
FDA-2008-N-0163-0261 FDA None FDA-2008-N-0163 Reference 15b - "Measurement of Hand Tremor Induced by Industrial Exposure to Metallic Mercury" - [Dental Devices: Classification of Encapsulated Amalgam Alloy and Dental Mercury and Reclassification of Dental Mercury; Issuance of Special Controls for Amalgam Alloy; Final Rule] Supporting & Related Material BKG-Background Material 2009-08-04T04:00:00Z 2009 8     2009-08-04T19:22:07Z   0 0 09000064809ff76e
FDA-2008-N-0163-0267 FDA None FDA-2008-N-0163 Reference 86 - "Estimated Pregnancy Rates by Outcome for the United States, 1990-2004, National Vital Statistics Reports, CDC, April 14, 2008 " - [Dental Devices: Classification of Encapsulated Amalgam Alloy and Dental Mercury and Reclassification of Dental Mercury; Issuance of Special Controls for Amalgam Alloy; Final Rule] Supporting & Related Material BKG-Background Material 2009-08-04T04:00:00Z 2009 8     2009-08-04T19:23:54Z   0 0 0900006480a003c2
FDA-2008-N-0163-0268 FDA None FDA-2008-N-0163 Reference 88 - "Preliminary Estimates: Labeling and Related Testing Costs for Medical Glove Manufacturers, Eastern Research Group Memorandum, January 18, 1999" - [Dental Devices: Classification of Encapsulated Amalgam Alloy and Dental Mercury and Reclassification of Dental Mercury; Issuance of Special Controls for Amalgam Alloy; Final Rule] Supporting & Related Material BKG-Background Material 2009-08-04T04:00:00Z 2009 8     2009-08-04T19:24:02Z   0 0 0900006480a003c8
FDA-2008-N-0163-0259 FDA None FDA-2008-N-0163 Reference 14 - "Toxicological Profile for Mercury " - [Dental Devices: Classification of Encapsulated Amalgam Alloy and Dental Mercury and Reclassification of Dental Mercury; Issuance of Special Controls for Amalgam Alloy; Final Rule] Supporting & Related Material BKG-Background Material 2009-08-04T04:00:00Z 2009 8     2009-08-04T19:20:50Z   0 0 09000064809ff691
FDA-2008-N-0163-0257 FDA None FDA-2008-N-0163 Reference 12 - "Dental Amalgam and Alternative Restorative Materials: An Update Report to the Environment Health Policy Committee, September 1997" - [Dental Devices: Classification of Encapsulated Amalgam Alloy and Dental Mercury and Reclassification of Dental Mercury; Issuance of Special Controls for Amalgam Alloy; Final Rule] Supporting & Related Material BKG-Background Material 2009-08-04T04:00:00Z 2009 8     2009-08-04T19:19:50Z   0 0 09000064809ff68b
FDA-2008-N-0163-0262 FDA None FDA-2008-N-0163 Reference 52 - U.S. Environmental Protection Agency (EPA) - "Integrated Risk Information System (IRIS) Screening-Level Literature Review--Mercuric Chloride, 2002" - [Dental Devices: Classification of Encapsulated Amalgam Alloy and Dental Mercury and Reclassification of Dental Mercury; Issuance of Special Controls for Amalgam Alloy; Final Rule] Supporting & Related Material BKG-Background Material 2009-08-04T04:00:00Z 2009 8     2009-08-04T19:22:33Z   0 0 09000064809ffa77
FDA-2008-N-0163-0252 FDA None FDA-2008-N-0163 Reference 3 - "Dental Amalgam: A Scientific Review and Recommended Public Health Service Strategy for Research, Education and Regulation, January 1993" - [Dental Devices: Classification of Encapsulated Amalgam Alloy and Dental Mercury and Reclassification of Dental Mercury; Issuance of Special Controls for Amalgam Alloy; Final Rule] Supporting & Related Material BKG-Background Material 2009-08-04T04:00:00Z 2009 8     2009-08-04T19:17:00Z   0 0 09000064809ff659
FDA-2008-N-0163-0250 FDA None FDA-2008-N-0163 Dental Devices: Classification of Dental Amalgam, Reclassification of Dental Mercury, Designation of Special Controls for Dental Amalgam, Mercury, and Amalgam Alloy; Final Rule Rule NFR-Notice of Final Rule 2009-08-04T04:00:00Z 2009 8 2009-08-04T04:00:00Z   2011-06-11T16:27:42Z E9-18447 0 0 0900006480a00973
FDA-2008-N-0163-0256 FDA None FDA-2008-N-0163 Reference 11 - "Addendum to the Dental Amalgam White Paper: Response to 2006 Joint Advisory Panel Comments and Recommendations, Final White Paper, July 2009" - [Dental Devices: Classification of Encapsulated Amalgam Alloy and Dental Mercury and Reclassification of Dental Mercury; Issuance of Special Controls for Amalgam Alloy; Final Rule] Supporting & Related Material BKG-Background Material 2009-08-04T04:00:00Z 2009 8     2009-08-04T19:19:16Z   0 0 09000064809ff681
FDA-2008-N-0163-0251 FDA None FDA-2008-N-0163 Reference List - [Dental Devices: Classification of Encapsulated Amalgam Alloy and Dental Mercury and Reclassification of Dental Mercury; Issuance of Special Controls for Amalgam Alloy; Final Rule] Supporting & Related Material BKG-Background Material 2009-08-04T04:00:00Z 2009 8     2009-08-04T18:45:00Z   0 0 09000064809ff491
FDA-2008-N-0163-0266 FDA None FDA-2008-N-0163 Reference 85 - "U.S. Agency for Toxic Substances and Disease Registry, ToxFAQs for Mercury, DHHS, April 1999" - [Dental Devices: Classification of Encapsulated Amalgam Alloy and Dental Mercury and Reclassification of Dental Mercury; Issuance of Special Controls for Amalgam Alloy; Final Rule] Supporting & Related Material BKG-Background Material 2009-08-04T04:00:00Z 2009 8     2009-08-04T19:23:43Z   0 0 0900006480a003ad
FDA-2008-N-0163-0254 FDA None FDA-2008-N-0163 Reference 6 - "The Safety of Dental Amalgam and Alternative Dental Restoration Materials for Patients and Users " - [Dental Devices: Classification of Encapsulated Amalgam Alloy and Dental Mercury and Reclassification of Dental Mercury; Issuance of Special Controls for Amalgam Alloy; Final Rule] Supporting & Related Material BKG-Background Material 2009-08-04T04:00:00Z 2009 8     2009-08-04T19:18:17Z   0 0 09000064809ff667
FDA-2008-N-0163-0265 FDA None FDA-2008-N-0163 Reference 82 - "Delta Dental Plans Association, Comment 0169, July24, 2008" - [Dental Devices: Classification of Encapsulated Amalgam Alloy and Dental Mercury and Reclassification of Dental Mercury; Issuance of Special Controls for Amalgam Alloy; Final Rule] Supporting & Related Material BKG-Background Material 2009-08-04T04:00:00Z 2009 8     2009-08-04T19:23:33Z   0 0 0900006480a0039a
FDA-2008-N-0163-0255 FDA None FDA-2008-N-0163 Reference 10 - "FDA Update/Review of Potential Adverse Health Risks Associated with Exposure to Mercury in Dental Amalgam, Draft White Paper, August 2006" - [Dental Devices: Classification of Encapsulated Amalgam Alloy and Dental Mercury and Reclassification of Dental Mercury; Issuance of Special Controls for Amalgam Alloy; Final Rule] Supporting & Related Material BKG-Background Material 2009-08-04T04:00:00Z 2009 8     2009-08-04T19:18:39Z   0 0 09000064809ff67e
FDA-2008-N-0163-0263 FDA None FDA-2008-N-0163 Reference 66 - "Transcript From Joint Meeting of Dental Products Panel and Central Nervous System Drugs Advisory Committee, September 6, 2006" - [Dental Devices: Classification of Encapsulated Amalgam Alloy and Dental Mercury and Reclassification of Dental Mercury; Issuance of Special Controls for Amalgam Alloy; Final Rule] Supporting & Related Material BKG-Background Material 2009-08-04T04:00:00Z 2009 8     2009-08-04T19:22:49Z   0 0 0900006480a00328
FDA-2008-N-0163-0249 FDA None FDA-2008-N-0163 Dental Devices: Classification of Dental Amalgam, Reclassification of Dental Mercury, Designation of Special Controls for Dental Amalgam, Mercury, and Amalgam Alloy Rule   2009-08-04T00:00:00Z 2009 8     2011-06-11T16:27:42Z   0 1 0900006480a007e1
FDA-2008-N-0163-0247 FDA None FDA-2008-N-0163 IAOMT to the Food & Drug Adminstration - Report Other RPT-Report (outside of agency unless indicated) 2008-08-14T04:00:00Z 2008 8 2008-08-14T04:00:00Z   2008-08-14T17:18:00Z   0 0 09000064806a95aa
FDA-2008-N-0163-0243 FDA None FDA-2008-N-0163 Freya Koss, PA Coalition for Mercury-Free Dentistry] - Supplement Other Supplement (SUP) 2008-08-10T04:00:00Z 2008 8 2008-08-10T04:00:00Z   2014-12-01T21:29:57Z   0 0 090000648069e176
FDA-2008-N-0163-0246 FDA None FDA-2008-N-0163 Attachment 2 [FDA-2008-N-0163-0124] - Tandvårdsskadeförbundet - Ann-Marie Lidmark]{"Are they really sick? A report on the ElectroSensitive and the Dental Materials Injured in Sweden"} - Comment Supporting & Related Material EREG-Electronic Regulation from Form Supporting and Related Material) 2008-08-10T04:00:00Z 2008 8     2008-08-10T20:12:34Z   0 0 09000064806890cf
FDA-2008-N-0163-0245 FDA None FDA-2008-N-0163 Attachment 1 [FDA-2008-N-0163-0124 - Tandvårdsskadeförbundet - Ann-Marie Lidmark] - Comment Supporting & Related Material EREG-Electronic Regulation from Form Supporting and Related Material) 2008-08-10T04:00:00Z 2008 8     2008-08-10T20:12:33Z   0 0 09000064806890ce
FDA-2008-N-0163-0244 FDA None FDA-2008-N-0163 Freya Koss [FDA-2008-N-0163-0214] - PA Coalition for Mercury-Free Dentistry] - Supplement Other SUP-Supplement 2008-08-10T04:00:00Z 2008 8 2008-08-10T04:00:00Z   2013-07-27T22:19:44Z   0 0 090000648069e1fc
FDA-2008-N-0163-0242 FDA None FDA-2008-N-0163 Bob Reeves - Supplement Other SUP-Supplement 2008-08-09T04:00:00Z 2008 8 2008-08-09T04:00:00Z   2013-07-27T22:19:44Z   0 0 090000648069e21d
FDA-2008-N-0163-0238 FDA None FDA-2008-N-0163 Freya Koss Communication w/FDA - ELetter Other ELET-Electronic Letter 2008-08-09T04:00:00Z 2008 8 2008-08-09T04:00:00Z   2013-07-28T01:54:58Z   0 0 090000648069e1f6
FDA-2008-N-0163-0227 FDA None FDA-2008-N-0163 Laboratory Center Bremen - Supplement re FDA-2008-N-0163-0195 Other Supplement (SUP) 2008-08-01T04:00:00Z 2008 8 2008-08-01T04:00:00Z   2014-12-01T21:39:02Z   0 0 09000064806a0d52
FDA-2008-N-0163-0186 FDA None FDA-2008-N-0163 DAMS, Intl. - Addendum and Correction re FDA-2008-N-0163-0233 Supporting & Related Material Correction 2008-07-31T04:00:00Z 2008 7     2014-12-01T20:30:11Z   0 0 09000064806a0b27
FDA-2008-N-0163-0207 FDA None FDA-2008-N-0163 Laboratory Center Bremen - Supplement re FDA-2008-N-0163-0195 Supporting & Related Material Background Material 2008-07-31T04:00:00Z 2008 7     2014-12-01T21:41:58Z   0 0 090000648069ccae
FDA-2008-N-0163-0104 FDA None FDA-2008-N-0163 Tom McGuire, DDS to the Division of Dockets Management - Letter Other LET-Letter 2008-07-22T04:00:00Z 2008 7 2008-07-22T04:00:00Z   2008-08-10T15:44:12Z   0 0 090000648068b1ef
FDA-2008-N-0163-0001 FDA None FDA-2008-N-0163 Dental Devices: Classification of Encapsulated Amalgam Alloy and Dental Mercury and Reclassification of Dental Mercury; Issuance of Special Controls for Amalgam Alloy; Reopening of Comment Period Proposed Rule NPR-Notice of Proposed Rule-Making 2008-04-28T04:00:00Z 2008 4 2008-04-28T04:00:00Z 2008-07-29T03:59:59Z 2014-12-02T03:03:13Z 08-01187 0 0 0900006480537ef9
FDA-2008-N-0163-0003 FDA None FDA-2008-N-0163 Dental Devices: Classification of Dental Amalgam and Reclassification of Dental Mercury; Issuance of Special Controls for Amalgam Alloy References Supporting & Related Material BKG- Background Material (internal references) 2008-04-28T04:00:00Z 2008 4     2008-04-29T03:04:08Z   0 0 0900006480529b70
FDA-2008-N-0163-0004 FDA None FDA-2008-N-0163 Reference 3 - FDA Update/Review of Potential Adverse Health Risks Associated With Exposure to Mercury in Dental Amalgam Supporting & Related Material   2008-04-28T00:00:00Z 2008 4     2008-08-10T17:22:20Z   0 1 0900006480534c54

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CREATE TABLE documents (
    id TEXT PRIMARY KEY,
    agency_id TEXT,
    docket_id TEXT REFERENCES dockets(id),
    title TEXT,
    document_type TEXT,
    subtype TEXT,
    posted_date TEXT,
    posted_year INTEGER,
    posted_month INTEGER,
    comment_start_date TEXT,
    comment_end_date TEXT,
    last_modified TEXT,
    fr_doc_num TEXT,
    open_for_comment INTEGER,
    withdrawn INTEGER,
    object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;
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