{"database": "openregs", "table": "documents", "is_view": false, "human_description_en": "where agency_id = \"FDA\" and posted_year = 2016 sorted by posted_date descending", "rows": [["FDA-2016-D-2335-0731", "FDA", "FDA-2016-D-2335", "Use of the Term Healthy in the Labeling of Human Food Products; Request for Information and Comments; Extension of Comment Period", "Proposed Rule", "Extension of Comment Period", "2016-12-30T05:00:00Z", 2016, 12, "2016-12-30T05:00:00Z", "2017-04-27T03:59:59Z", "2017-04-27T13:02:53Z", "2016-31734", 0, 0, "090000648244128d"], ["FDA-2014-N-1205-0019", "FDA", "FDA-2014-N-1205", "Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems", "Rule", "Final Rule", "2016-12-30T05:00:00Z", 2016, 12, "2016-12-30T05:00:00Z", null, "2016-12-30T14:11:28Z", "2016-31670", 0, 0, "0900006482441325"], ["FDA-2014-N-1205-0027", "FDA", "FDA-2014-N-1205", "Reference 9 - DeIure 2012 Posterior lumbar fusion by peek rods in degenerative spine: preliminary report on 30 cases re Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems", "Supporting & Related Material", "Background Material", "2016-12-30T05:00:00Z", 2016, 12, null, null, "2016-12-30T15:24:47Z", null, 0, 0, "0900006482441a70"], ["FDA-2014-N-1205-0028", "FDA", "FDA-2014-N-1205", "Reference  10 - Ormond 2016 Polyetheretherketone (PEEK) Rods in Lumbar Spine Degenerative Disease A Case Series re Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems", "Supporting & Related Material", "Background Material", "2016-12-30T05:00:00Z", 2016, 12, null, null, "2016-12-30T15:24:50Z", null, 0, 0, "0900006482441a76"], ["FDA-2011-D-0376-2012", "FDA", "FDA-2011-D-0376", "Attachment 1 Comments from Various Organization in Reference to New Dietary Ingredient Notifications and Related Issues re: Comment from Thorne Research", "Supporting & Related Material", "Background Material", "2016-12-30T05:00:00Z", 2016, 12, null, null, "2016-12-30T16:17:33Z", null, 0, 0, "0900006482441f42"], ["FDA-2013-N-1155-0004", "FDA", "FDA-2013-N-1155", "Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling Regulations", "Notice", "60 Day Proposed Information Collection", "2016-12-30T05:00:00Z", 2016, 12, "2016-12-30T05:00:00Z", "2017-03-01T04:59:59Z", "2017-04-26T12:10:50Z", "2016-31733", 0, 0, "0900006482441427"], ["FDA-2011-F-0172-0620", "FDA", "FDA-2011-F-0172", "Food Labeling:Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments Final Regulatory Impact Analysis\nFDA\u20132011\u2013F\u20130172", "Supporting & Related Material", "Background Material", "2016-12-30T05:00:00Z", 2016, 12, null, null, "2016-12-30T14:42:43Z", null, 0, 0, "0900006482441831"], ["FDA-2016-N-0124-0256", "FDA", "FDA-2016-N-0124", "Advice Letter from FDA CDER to American Chemistry Council", "Supporting & Related Material", "Letter", "2016-12-30T05:00:00Z", 2016, 12, null, null, "2016-12-30T18:09:27Z", null, 0, 0, "0900006482442593"], ["FDA-2011-F-0172-0619", "FDA", "FDA-2011-F-0172", "Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Extension of Compliance Date", "Rule", "Final Rule", "2016-12-30T05:00:00Z", 2016, 12, "2016-12-30T05:00:00Z", null, "2016-12-30T13:58:42Z", "2016-31597", 0, 0, "09000064824412de"], ["FDA-2014-N-1205-0025", "FDA", "FDA-2014-N-1205", "Reference 7 - Athanasakopoulos 2013 Posterior Spinal Fusion Using Pedicle Screws re Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems", "Supporting & Related Material", "Background Material", "2016-12-30T05:00:00Z", 2016, 12, null, null, "2016-12-30T15:24:41Z", null, 0, 0, "0900006482441a6d"], ["FDA-2014-N-1205-0030", "FDA", "FDA-2014-N-1205", "Reference  11 - Yang 2014 Short term outcome of posterior dynamic stabilization system in degenerative lumbar diseases re Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems", "Supporting & Related Material", "Background Material", "2016-12-30T05:00:00Z", 2016, 12, null, null, "2016-12-30T15:24:57Z", null, 0, 0, "0900006482441a7a"], ["FDA-2014-N-1205-0024", "FDA", "FDA-2014-N-1205", "Reference 6 - Gornet 2011 Biomechanical Assessment of a PEEK Rod System for Semi-Rigid Fixation of Lumbar Fusion Constructs re Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems", "Supporting & Related Material", "Background Material", "2016-12-30T05:00:00Z", 2016, 12, null, null, "2016-12-30T15:24:37Z", null, 0, 0, "0900006482441a6b"], ["FDA-2014-N-1205-0029", "FDA", "FDA-2014-N-1205", "Reference 10.1 - Ormond 2012 Polyetheretherketone (PEEK) Rods in Lumbar Spine Degenerative Disease: A Case Series re Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems", "Supporting & Related Material", "Background Material", "2016-12-30T05:00:00Z", 2016, 12, null, null, "2016-12-30T15:24:53Z", null, 0, 0, "0900006482441a79"], ["FDA-2015-N-0101-1319", "FDA", "FDA-2015-N-0101", "Advice Letter from FDA CDER to American Chemistry Council", "Other", "Letter(s)", "2016-12-30T05:00:00Z", 2016, 12, "2016-12-30T05:00:00Z", null, "2016-12-30T18:11:04Z", null, 0, 0, "0900006482442595"], ["FDA-2016-F-3880-0002", "FDA", "FDA-2016-F-3880", "Novus International, Inc.; Filing of Food Additive Petition (Animal Use);\nReopening of the Comment Period", "Proposed Rule", "Reopening of Comment Period", "2016-12-30T05:00:00Z", 2016, 12, "2016-12-30T05:00:00Z", "2017-01-31T04:59:59Z", "2017-01-31T14:01:36Z", "2016-31606", 0, 0, "090000648244128b"], ["FDA-2014-N-1205-0021", "FDA", "FDA-2014-N-1205", "Reference 3 - Qi 2013 Comparative effectiveness of PEEK rods versus titanium alloy rods in lumbar fusion: A preliminary report re Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems", "Supporting & Related Material", "Background Material", "2016-12-30T05:00:00Z", 2016, 12, null, null, "2016-12-30T15:24:27Z", null, 0, 0, "0900006482441a68"], ["FDA-2014-N-1205-0022", "FDA", "FDA-2014-N-1205", "Reference 4 - Sengupta 2013 The Comprehensive Biomechanics and Load-Sharing of Semirigid PEEK and Semirigid Posterio Dynamic Stabilizations Systems re Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems", "Supporting & Related Material", "Background Material", "2016-12-30T05:00:00Z", 2016, 12, null, null, "2016-12-30T15:24:30Z", null, 0, 0, "0900006482441a69"], ["FDA-2014-N-1205-0026", "FDA", "FDA-2014-N-1205", "Reference 8 - Colangeli 2015 Polyetheretherketone (PEEK) rods: short-term results in lumbar spine degenerative disease re Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems", "Supporting & Related Material", "Background Material", "2016-12-30T05:00:00Z", 2016, 12, null, null, "2016-12-30T15:24:44Z", null, 0, 0, "0900006482441a6e"], ["FDA-2015-D-0025-0015", "FDA", "FDA-2015-D-0025", "Medical Device Accessories\u2014Describing Accessories and Classification Pathway for New Accessory Types; Guidance for Industry and Food and Drug Administration Staff; Availability", "Notice", "Notice of Availability", "2016-12-30T05:00:00Z", 2016, 12, "2016-12-30T05:00:00Z", null, "2016-12-30T14:17:49Z", "2016-31669", 0, 0, "0900006482441379"], ["FDA-2015-D-0025-0016", "FDA", "FDA-2015-D-0025", "Medical Device Accessories \u2013 Describing Accessories and Classification Pathway for New Accessory Types Guidance for Industry and Food and Drug Administration Staff", "Other", "Guidance", "2016-12-30T05:00:00Z", 2016, 12, "2016-12-30T05:00:00Z", null, "2024-11-11T21:31:30Z", null, 1, 0, "09000064824410cc"], ["FDA-2014-N-1205-0020", "FDA", "FDA-2014-N-1205", "Reference 1 - Matsuzaki 1990 Problems and Solutions of Pedicle Screw Plate Fixation of Lumbar Spine re Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems", "Supporting & Related Material", "Background Material", "2016-12-30T05:00:00Z", 2016, 12, null, null, "2016-12-30T15:24:24Z", null, 0, 0, "0900006482441a67"], ["FDA-2014-N-1205-0023", "FDA", "FDA-2014-N-1205", "Reference 5 - Kurtz 2013 Retrieval analysis of PEEK rods for posterior fusion and motion preservation re Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems", "Supporting & Related Material", "Background Material", "2016-12-30T05:00:00Z", 2016, 12, null, null, "2016-12-30T15:24:34Z", null, 0, 0, "0900006482441a6a"], ["FDA-2016-P-4388-0004", "FDA", "FDA-2016-P-4388", "Citizen Petition Reference List Re. Citizen Petition from S. Varghese", "Supporting & Related Material", "Background Material", "2016-12-29T05:00:00Z", 2016, 12, null, null, "2016-12-29T17:34:01Z", null, 0, 0, "090000648243acf8"], ["FDA-2016-D-0269-0113", "FDA", "FDA-2016-D-0269", "Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry", "Other", "Guidance", "2016-12-29T05:00:00Z", 2016, 12, "2016-12-29T05:00:00Z", null, "2024-11-12T06:18:06Z", null, 1, 0, "090000648243ddab"], ["FDA-2013-N-0879-0004", "FDA", "FDA-2013-N-0879", "Agency Information Collection Activities; Submission for Office of\nManagement and Budget Review; Comment Request: Procedures for Safe and Sanitary Processing and Importing of Fish and Fishery Products", "Notice", "30 Day Proposed Information Collection", "2016-12-29T05:00:00Z", 2016, 12, "2016-12-29T05:00:00Z", "2017-01-31T04:59:59Z", "2017-01-31T02:00:17Z", "2016-31424", 0, 0, "090000648243d253"], ["FDA-2016-P-4388-0003", "FDA", "FDA-2016-P-4388", "Baker, a Pharmacological Review 2007 Re. Citizen Petition from S. Varghese", "Supporting & Related Material", "Background Material", "2016-12-29T05:00:00Z", 2016, 12, null, null, "2016-12-29T17:33:57Z", null, 0, 0, "090000648243acf7"], ["FDA-2016-D-4318-0001", "FDA", "FDA-2016-D-4318", "Compounding and Repackaging of Radiopharmaceuticals by State-\nLicensed Nuclear Pharmacies and Federal Facilities; Draft Guidance for\nIndustry; Availability", "Notice", "Notice of Availability", "2016-12-29T05:00:00Z", 2016, 12, "2016-12-29T05:00:00Z", null, "2016-12-29T14:29:37Z", "2016-31513", 0, 0, "090000648243d2fb"], ["FDA-2013-E-0397-0007", "FDA", "FDA-2013-E-0397", "Letter from U.S. Patent and Trademark Office", "Other", "Letter(s)", "2016-12-29T05:00:00Z", 2016, 12, "2016-12-29T05:00:00Z", null, "2016-12-29T17:24:51Z", null, 0, 0, "090000648243dfe0"], ["FDA-2016-V-4616-0002", "FDA", "FDA-2016-V-4616", "Acknowledgement Letter from FDA DDM to LASERSLIVE", "Other", "Acknowledgement Letter/Receipt", "2016-12-29T05:00:00Z", 2016, 12, "2016-12-29T05:00:00Z", null, "2016-12-29T22:41:32Z", null, 0, 0, "090000648243f2c9"], ["FDA-2016-V-4592-0002", "FDA", "FDA-2016-V-4592", "Acknowledgement Letter from FDA DDM to FOH Ninja", "Other", "Acknowledgement Letter/Receipt", "2016-12-29T05:00:00Z", 2016, 12, "2016-12-29T05:00:00Z", null, "2016-12-29T22:38:52Z", null, 0, 0, "090000648243c203"], ["FDA-2014-E-0265-0008", "FDA", "FDA-2014-E-0265", "Letter from U.S. Patent and Trademark Office", "Other", "Letter(s)", "2016-12-29T05:00:00Z", 2016, 12, "2016-12-29T05:00:00Z", null, "2016-12-29T17:00:31Z", null, 0, 0, "090000648243db42"], ["FDA-2000-D-0103-0010", "FDA", "FDA-2000-D-0103", "Botanical Drug Development Guidance for Industry", "Other", "Guidance", "2016-12-29T05:00:00Z", 2016, 12, "2016-12-29T05:00:00Z", null, "2024-11-12T06:17:07Z", null, 1, 0, "090000648243ddaf"], ["FDA-2016-V-4616-0001", "FDA", "FDA-2016-V-4616", "Variance Application from LASERSLIVE", "Other", "Application for Variance (VAR)", "2016-12-29T05:00:00Z", 2016, 12, "2016-12-29T05:00:00Z", null, "2016-12-29T22:40:37Z", null, 0, 0, "090000648243f28d"], ["FDA-2013-E-0687-0007", "FDA", "FDA-2013-E-0687", "Letter from U.S. Patent and Trademark Office", "Other", "Letter(s)", "2016-12-29T05:00:00Z", 2016, 12, "2016-12-29T05:00:00Z", null, "2016-12-29T17:16:50Z", null, 0, 0, "090000648243df84"], ["FDA-2016-N-1555-0007", "FDA", "FDA-2016-N-1555", "Refuse to Accept Procedures for Premarket Tobacco Product Submissions", "Rule", "Final Rule", "2016-12-29T05:00:00Z", 2016, 12, "2016-12-29T05:00:00Z", null, "2016-12-29T15:14:13Z", "2016-31370", 0, 0, "090000648243d41a"], ["FDA-2000-D-0103-0009", "FDA", "FDA-2000-D-0103", "Botanical Drug Development; Guidance for Industry; Availability", "Notice", "Notice of Availability", "2016-12-29T05:00:00Z", 2016, 12, "2016-12-29T05:00:00Z", null, "2016-12-29T14:39:34Z", "2016-31627", 0, 0, "090000648243d468"], ["FDA-2009-D-0524-0032", "FDA", "FDA-2009-D-0524", "Listing of Ingredients in Tobacco Products; Revised Guidance for Industry; Availability", "Notice", "Notice of Availability", "2016-12-29T05:00:00Z", 2016, 12, "2016-12-29T05:00:00Z", null, "2016-12-29T15:34:59Z", "2016-31587", 0, 0, "090000648243d2a5"], ["FDA-2016-N-0002-0035", "FDA", "FDA-2016-N-0002", "Abbott Laboratories, et al.; Withdrawal of Approval of Four New Drug\nApplications and Two Abbreviated New Drug Applications", "Notice", "Withdrawal", "2016-12-29T05:00:00Z", 2016, 12, "2016-12-29T05:00:00Z", null, "2016-12-29T15:02:22Z", "2016-31625", 0, 0, "090000648243d2a9"], ["FDA-2016-P-4388-0005", "FDA", "FDA-2016-P-4388", "Loperamide Abuse and Dependence 2015 Re. Citizen Petition from S. Varghese", "Supporting & Related Material", "Background Material", "2016-12-29T05:00:00Z", 2016, 12, null, null, "2016-12-29T17:34:05Z", null, 0, 0, "090000648243acf9"], ["FDA-2016-P-4388-0006", "FDA", "FDA-2016-P-4388", "Loperamide Induced TDP, Re. Citizen Petition from S. Varghese", "Supporting & Related Material", "Background Material", "2016-12-29T05:00:00Z", 2016, 12, null, null, "2016-12-29T17:34:08Z", null, 0, 0, "090000648243acfa"], ["FDA-2016-N-3389-0394", "FDA", "FDA-2016-N-3389", "Request to Extend Comment Period from Grocery Manufacturers Association", "Other", "Electronic Regulation from Form", "2016-12-29T05:00:00Z", 2016, 12, "2016-12-29T05:00:00Z", null, "2016-12-29T17:19:26Z", null, 0, 0, "0900006482432fb6"], ["FDA-2016-D-4317-0002", "FDA", "FDA-2016-D-4317", "Draft Guidance for Compounding and Repackaging of Radiopharmaceuticals By Outsourcing Facilities Guidance for Industry", "Other", "Guidance", "2016-12-29T05:00:00Z", 2016, 12, "2016-12-29T05:00:00Z", "2017-02-28T04:59:59Z", "2019-08-21T15:09:05Z", null, 0, 0, "090000648243ddb2"], ["FDA-2016-V-4617-0001", "FDA", "FDA-2016-V-4617", "Variance Application from Redwolf Entertainment", "Other", "Application for Variance (VAR)", "2016-12-29T05:00:00Z", 2016, 12, "2016-12-29T05:00:00Z", null, "2016-12-29T23:09:01Z", null, 0, 0, "090000648243f1f6"], ["FDA-2016-D-2335-0730", "FDA", "FDA-2016-D-2335", "Request to Extend Comment Period from Herbalife International of America, Inc.", "Other", "Request for Extension", "2016-12-29T05:00:00Z", 2016, 12, "2016-12-29T05:00:00Z", null, "2016-12-29T18:07:39Z", null, 0, 0, "0900006482432aa1"], ["FDA-2016-D-2495-0014", "FDA", "FDA-2016-D-2495", "Submission of Warning Plans for Cigars Guidance for Industry", "Other", "Guidance", "2016-12-29T05:00:00Z", 2016, 12, "2016-12-29T05:00:00Z", null, "2024-11-07T23:52:28Z", null, 1, 0, "090000648243da71"], ["FDA-2016-V-4592-0001", "FDA", "FDA-2016-V-4592", "Variance Application from FOH Ninja", "Other", "Application for Variance (VAR)", "2016-12-29T05:00:00Z", 2016, 12, "2016-12-29T05:00:00Z", null, "2016-12-29T22:38:47Z", null, 0, 0, "090000648243c201"], ["FDA-2014-E-0126-0011", "FDA", "FDA-2014-E-0126", "Letter from U.S. Patent and Trademark Office", "Other", "Letter(s)", "2016-12-29T05:00:00Z", 2016, 12, "2016-12-29T05:00:00Z", null, "2016-12-29T17:22:08Z", null, 0, 0, "090000648243dfb9"], ["FDA-2016-V-4617-0002", "FDA", "FDA-2016-V-4617", "Acknowledgement Letter from FDA DDM to Redwolf Entertainment", "Other", "Acknowledgement Letter/Receipt", "2016-12-29T05:00:00Z", 2016, 12, "2016-12-29T05:00:00Z", null, "2016-12-29T23:09:07Z", null, 0, 0, "090000648243f1f9"], ["FDA-2016-D-2495-0013", "FDA", "FDA-2016-D-2495", "Submission of Warning Plans for Cigars; Guidance for Industry; Availability", "Notice", "Notice of Availability", "2016-12-29T05:00:00Z", 2016, 12, "2016-12-29T05:00:00Z", null, "2016-12-29T14:48:32Z", "2016-31586", 0, 0, "090000648243d469"], ["FDA-2014-D-0234-0029", "FDA", "FDA-2014-D-0234", "Clinical Pharmacology Data To Support a Demonstration of Biosimilarity to a Reference Product; Guidance for Industry; Availability", "Notice", "Notice of Availability", "2016-12-29T05:00:00Z", 2016, 12, "2016-12-29T05:00:00Z", null, "2016-12-29T14:18:33Z", "2016-31511", 0, 0, "090000648243d24e"], ["FDA-2013-E-0968-0007", "FDA", "FDA-2013-E-0968", "Letter from U.S. Patent and Trademark Office", "Other", "Letter(s)", "2016-12-29T05:00:00Z", 2016, 12, "2016-12-29T05:00:00Z", null, "2016-12-29T17:27:19Z", null, 0, 0, "090000648243dfe2"], ["FDA-2013-E-0785-0007", "FDA", "FDA-2013-E-0785", "Letter from U.S. Patent and Trademark Office", "Other", "Letter(s)", "2016-12-29T05:00:00Z", 2016, 12, "2016-12-29T05:00:00Z", null, "2016-12-29T17:29:41Z", null, 0, 0, "090000648243dfe5"], ["FDA-2014-D-0234-0030", "FDA", "FDA-2014-D-0234", "Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product Guidance for Industry", "Other", "Guidance", "2016-12-29T05:00:00Z", 2016, 12, "2016-12-29T05:00:00Z", null, "2024-11-12T06:15:55Z", null, 1, 0, "090000648243d98f"], ["FDA-2016-D-4318-0002", "FDA", "FDA-2016-D-4318", "Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities Guidance for Industry\nDRAFT GUIDANCE", "Other", "Guidance", "2016-12-29T05:00:00Z", 2016, 12, "2016-12-29T05:00:00Z", "2017-02-28T04:59:59Z", "2024-11-12T06:15:53Z", null, 1, 0, "090000648243dd0f"], ["FDA-2013-E-1302-0007", "FDA", "FDA-2013-E-1302", "Letter from U.S. Patent and Trademark Office", "Other", "Letter(s)", "2016-12-29T05:00:00Z", 2016, 12, "2016-12-29T05:00:00Z", null, "2016-12-29T17:19:45Z", null, 0, 0, "090000648243dfb6"], ["FDA-2016-D-0269-0112", "FDA", "FDA-2016-D-0269", "Prescription Requirement Under Section 503A of the Federal Food,\nDrug, and Cosmetic Act; Guidance for Industry; Availability", "Notice", "Notice of Availability", "2016-12-29T05:00:00Z", 2016, 12, "2016-12-29T05:00:00Z", null, "2016-12-29T14:33:49Z", "2016-31607", 0, 0, "090000648243d35a"], ["FDA-2016-P-4388-0002", "FDA", "FDA-2016-P-4388", "Acknowledgment Letter from FDA DDM to Dr. S. 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