{"database": "openregs", "table": "documents", "is_view": false, "human_description_en": "where agency_id = \"FDA\", document_type = \"Notice\" and posted_year = 2018 sorted by posted_date descending", "rows": [["FDA-2017-E-6016-0006", "FDA", "FDA-2017-E-6016", "Determination of Regulatory Review Period for Purposes of Patent\nExtension; PARSABIV", "Notice", "Determinations", "2018-12-31T05:00:00Z", 2018, 12, "2018-12-31T05:00:00Z", "2019-02-27T04:59:59Z", "2019-01-09T02:01:46Z", "2018-28221", 0, 0, "09000064839d2140"], ["FDA-2017-E-6017-0006", "FDA", "FDA-2017-E-6017", "Determination of Regulatory Review Period for Purposes of Patent\nExtension; PARSABIV", "Notice", "Determinations", "2018-12-31T05:00:00Z", 2018, 12, "2018-12-31T05:00:00Z", "2019-02-27T04:59:59Z", "2018-12-31T23:00:56Z", "2018-28221", 0, 0, "09000064839d2141"], ["FDA-2017-E-6708-0006", "FDA", "FDA-2017-E-6708", "Determinations of Regulatory Review Periods for Purposes of Patent Extensions: RYDAPT", "Notice", "Determinations", "2018-12-31T05:00:00Z", 2018, 12, "2018-12-31T05:00:00Z", "2019-06-27T03:59:59Z", "2024-03-07T21:12:00Z", "2018-28216", 0, 0, "09000064839d2146"], ["FDA-2017-E-6701-0006", "FDA", "FDA-2017-E-6701", "Determinations of Regulatory Review Periods for Purposes of Patent Extensions: RYDAPT", "Notice", "Determinations", "2018-12-31T05:00:00Z", 2018, 12, "2018-12-31T05:00:00Z", "2019-06-27T03:59:59Z", "2024-03-07T21:19:56Z", "2018-28216", 0, 0, "09000064839d2147"], ["FDA-2007-D-0369-0459", "FDA", "FDA-2007-D-0369", "Product-Specific Guidance for Linaclotide; Draft Guidance for\nIndustry", "Notice", "Notice of Availability", "2018-12-28T05:00:00Z", 2018, 12, "2018-12-28T05:00:00Z", "2019-02-27T04:59:59Z", "2019-02-27T02:04:39Z", "2018-28213", 0, 0, "09000064839cbf71"], ["FDA-2017-E-6003-0006", "FDA", "FDA-2017-E-6003", "Determination of Regulatory Review Period for Purposes of Patent\nExtension; PARSABIV", "Notice", "Determinations", "2018-12-28T05:00:00Z", 2018, 12, "2018-12-28T05:00:00Z", "2019-02-27T04:59:59Z", "2018-12-31T21:10:48Z", "2018-28221", 0, 0, "09000064839cbe98"], ["FDA-2018-D-4662-0001", "FDA", "FDA-2018-D-4662", "International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IV", "Notice", "Notice of Availability", "2018-12-28T05:00:00Z", 2018, 12, "2018-12-28T05:00:00Z", "2019-02-27T04:59:59Z", "2019-01-14T19:29:13Z", "2018-28219", 0, 0, "09000064839cbf33"], ["FDA-2018-N-3037-0002", "FDA", "FDA-2018-N-3037", "Agency Information Collection Activities; Submission for Office of\nManagement and Budget Review; Comment Request; Generic Clearance\nfor Quantitative Testing for the Development of Food and Drug\nAdministration Communications", "Notice", "30 Day Proposed Information Collection", "2018-12-28T05:00:00Z", 2018, 12, "2018-12-28T05:00:00Z", "2019-01-29T04:59:59Z", "2019-01-10T02:46:59Z", "2018-28252", 0, 0, "09000064839cbd39"], ["FDA-2017-E-6736-0005", "FDA", "FDA-2017-E-6736", "Determination of Regulatory Review Period for Purposes of Patent\nExtension; XERMELO", "Notice", "Determinations", "2018-12-28T05:00:00Z", 2018, 12, "2018-12-28T05:00:00Z", "2019-02-27T04:59:59Z", "2018-12-31T21:26:53Z", "2018-28218", 0, 0, "09000064839cbee3"], ["FDA-2012-N-0197-0005", "FDA", "FDA-2012-N-0197", "Agency Information Collection Activities; Proposed Collection;\nComment Request; Medical Devices; Shortages Data Collection System", "Notice", "Request for Comments", "2018-12-28T05:00:00Z", 2018, 12, "2018-12-28T05:00:00Z", "2019-02-27T04:59:59Z", "2018-12-31T20:58:41Z", "2018-28235", 0, 0, "09000064839cbe96"], ["FDA-2017-E-6002-0006", "FDA", "FDA-2017-E-6002", "Determination of Regulatory Review Period for Purposes of Patent\nExtension; RUBRACA", "Notice", "Determinations", "2018-12-28T05:00:00Z", 2018, 12, "2018-12-28T05:00:00Z", "2019-02-27T04:59:59Z", "2018-12-31T21:05:16Z", "2018-28217", 0, 0, "09000064839cbe97"], ["FDA-2012-N-0536-0008", "FDA", "FDA-2012-N-0536", "Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Cover Sheet, Form FDA 3601", "Notice", "60 Day Proposed Information Collection", "2018-12-28T05:00:00Z", 2018, 12, "2018-12-28T05:00:00Z", "2019-02-27T04:59:59Z", "2019-07-17T12:49:50Z", "2018-28220", 0, 0, "09000064839cc098"], ["FDA-2017-E-6700-0006", "FDA", "FDA-2017-E-6700", "Determinations of Regulatory Review Periods for Purposes of Patent Extensions: RYDAPT", "Notice", "Determinations", "2018-12-28T05:00:00Z", 2018, 12, "2018-12-28T05:00:00Z", "2019-06-27T03:59:59Z", "2024-03-07T21:04:21Z", "2018-28216", 0, 0, "09000064839cbfba"], ["FDA-2018-N-1989-0001", "FDA", "FDA-2018-N-1989", "Ranjan Bhandari: Debarment Order", "Notice", "Statutory Debarment", "2018-12-27T05:00:00Z", 2018, 12, "2018-12-27T05:00:00Z", null, "2018-12-31T20:39:45Z", "2018-27951", 0, 0, "09000064839c8820"], ["FDA-2018-N-4428-0001", "FDA", "FDA-2018-N-4428", "Agency Information Collection Activities; Proposed Collection;\nComment Request; Medicated Feed Mill License Application", "Notice", "60 Day Proposed Information Collection", "2018-12-26T05:00:00Z", 2018, 12, "2018-12-26T05:00:00Z", "2019-02-26T04:59:59Z", "2019-01-10T02:17:47Z", "2018-27812", 0, 0, "09000064839c4daf"], ["FDA-2017-D-3001-0235", "FDA", "FDA-2017-D-3001", "Modified Risk Tobacco Product Applications for IQOS System With Marlboro Heatsticks, IQOS System With Marlboro Smooth Menthol\nHeatsticks, and IQOS System With Marlboro Fresh Menthol Heatsticks\nSubmitted by Philip Morris Products S.A.", "Notice", "Announcement", "2018-12-26T05:00:00Z", 2018, 12, "2018-12-26T05:00:00Z", "2019-02-12T04:59:59Z", "2019-02-27T02:06:18Z", "2018-27807", 0, 0, "09000064839c4e5f"], ["FDA-2017-E-5040-0006", "FDA", "FDA-2017-E-5040", "Determination of Regulatory Review Period for Purposes of Patent\nExtension; ADLYXIN", "Notice", "Determinations", "2018-12-26T05:00:00Z", 2018, 12, "2018-12-26T05:00:00Z", "2019-02-26T04:59:59Z", "2019-01-10T02:33:03Z", "2018-27805", 0, 0, "09000064839c4db3"], ["FDA-2018-D-4455-0001", "FDA", "FDA-2018-D-4455", "Developing and Submitting Proposed Draft Guidance Relating to Patient\nExperience Data; Draft Guidance for Industry and Other Stakeholders;\nAvailability", "Notice", "Notice of Availability", "2018-12-21T05:00:00Z", 2018, 12, "2018-12-21T05:00:00Z", "2019-03-22T03:59:59Z", "2019-03-23T01:00:52Z", "2018-27657", 0, 0, "09000064839be12e"], ["FDA-2016-D-4308-0021", "FDA", "FDA-2016-D-4308", "Labeling of Red Blood Cell Units With Historical Antigen Typing Results;\nGuidance for Industry; Availability", "Notice", "Notice of Availability", "2018-12-21T05:00:00Z", 2018, 12, "2018-12-21T05:00:00Z", null, "2018-12-21T14:24:57Z", "2018-27654", 0, 0, "09000064839be0a5"], ["FDA-2017-E-3592-0005", "FDA", "FDA-2017-E-3592", "Determination of Regulatory Review Period for Purposes of Patent\nExtension; ABSORB GT1 BIORESORBABLE SCAFFOLD", "Notice", "Determinations", "2018-12-21T05:00:00Z", 2018, 12, "2018-12-21T05:00:00Z", "2019-06-20T03:59:59Z", "2019-03-02T02:06:18Z", "2018-27678", 0, 0, "09000064839be9b4"], ["FDA-2018-N-3552-0015", "FDA", "FDA-2018-N-3552", "Agency Information Collection Activities; Submission for Office of\nManagement and Budget Review; Comment Request; Experimental\nStudy of Cigarette Warnings", "Notice", "30 Day Proposed Information Collection", "2018-12-21T05:00:00Z", 2018, 12, "2018-12-21T05:00:00Z", "2019-01-23T04:59:59Z", "2019-01-23T02:00:31Z", "2018-27658", 0, 0, "09000064839be141"], ["FDA-2013-N-0520-0006", "FDA", "FDA-2013-N-0520", "Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed", "Notice", "60 Day Proposed Information Collection", "2018-12-21T05:00:00Z", 2018, 12, "2018-12-21T05:00:00Z", "2019-02-20T04:59:59Z", "2019-01-30T02:07:32Z", "2018-27656", 0, 0, "09000064839be0b7"], ["FDA-2017-E-3616-0005", "FDA", "FDA-2017-E-3616", "Determination of Regulatory Review Period for Purposes of Patent\nExtension; ABSORB GT1 BIORESORBABLE SCAFFOLD", "Notice", "Determinations", "2018-12-21T05:00:00Z", 2018, 12, "2018-12-21T05:00:00Z", "2019-06-20T03:59:59Z", "2019-03-02T02:07:21Z", "2018-27678", 0, 0, "09000064839be0db"], ["FDA-2018-N-4465-0001", "FDA", "FDA-2018-N-4465", "Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Detention and Banned Medical Devices", "Notice", "60 Day Proposed Information Collection", "2018-12-21T05:00:00Z", 2018, 12, "2018-12-21T05:00:00Z", "2019-02-20T04:59:59Z", "2018-12-21T14:22:29Z", "2018-27655", 0, 0, "09000064839be279"], ["FDA-2017-D-5966-0012", "FDA", "FDA-2017-D-5966", "Breakthrough Devices Program; Guidance for Industry and Food and\nDrug Administration Staff; Availability", "Notice", "Notice of Availability", "2018-12-19T05:00:00Z", 2018, 12, "2018-12-19T05:00:00Z", null, "2024-11-12T22:53:05Z", "2018-27433", 1, 0, "09000064839b2697"], ["FDA-2018-N-4627-0001", "FDA", "FDA-2018-N-4627", "Intent To Consider the Appropriate Classification of Hyaluronic Acid Intraarticular Products Intended for the Treatment of Pain in Osteoarthritis of the Knee Based on Scientific Evidence", "Notice", "Announcement", "2018-12-18T05:00:00Z", 2018, 12, "2018-12-18T05:00:00Z", null, "2018-12-18T13:45:44Z", "2018-27351", 0, 0, "09000064839a90fa"], ["FDA-2015-N-3454-0005", "FDA", "FDA-2015-N-3454", "Manufacturing Site Change Supplements: Content and Submission; Guidance for Industry and Food and Drug Administration Staff; Availability", "Notice", "Notice of Availability", "2018-12-17T05:00:00Z", 2018, 12, "2018-12-17T05:00:00Z", null, "2024-11-12T22:52:38Z", "2018-27237", 1, 0, "090000648399ce78"], ["FDA-2018-D-4115-0001", "FDA", "FDA-2018-D-4115", "Clarification of Radiation Control Regulations for Manufacturers of\nDiagnostic X-Ray Equipment; Draft Guidance for Industry and Food and\nDrug Administration Staff; Availability", "Notice", "Notice of Availability", "2018-12-17T05:00:00Z", 2018, 12, "2018-12-17T05:00:00Z", "2019-02-16T04:59:59Z", "2024-11-12T22:52:39Z", "2018-27236", 1, 0, "090000648399cd0c"], ["FDA-2018-D-3984-0001", "FDA", "FDA-2018-D-3984", "Data Integrity and Compliance With Drug CGMP: Questions and Answers;\nGuidance for Industry; Availability", "Notice", "Notice of Availability", "2018-12-13T05:00:00Z", 2018, 12, "2018-12-13T05:00:00Z", null, "2024-11-12T22:53:26Z", "2018-26957", 1, 0, "090000648398ee6f"], ["FDA-2018-N-4609-0001", "FDA", "FDA-2018-N-4609", "Issuance of Priority Review Voucher; Rare Pediatric Disease Product", "Notice", "Announcement", "2018-12-13T05:00:00Z", 2018, 12, "2018-12-13T05:00:00Z", null, "2018-12-13T14:58:17Z", "2018-27043", 0, 0, "090000648398eddc"], ["FDA-2018-N-4416-0001", "FDA", "FDA-2018-N-4416", "Allied Pharma, Inc., et al.; Withdrawal of Approval of Nine Abbreviated New\nDrug Applications", "Notice", "Withdrawal", "2018-12-13T05:00:00Z", 2018, 12, "2018-12-13T05:00:00Z", null, "2018-12-13T15:05:59Z", "2018-26947", 0, 0, "090000648398eddd"], ["FDA-2018-P-1734-0004", "FDA", "FDA-2018-P-1734", "Determination That IC\u2013GREEN (Indocyanine Green for Injection), 10\nMilligrams/Vial, 40 Milligrams/Vial, and 50 Milligrams/Vial Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness", "Notice", "Determinations", "2018-12-13T05:00:00Z", 2018, 12, "2018-12-13T05:00:00Z", null, "2018-12-13T14:47:12Z", "2018-26975", 0, 0, "090000648398ec98"], ["FDA-2011-D-0611-0065", "FDA", "FDA-2011-D-0611", "New and Revised Draft Q&As on Biosimilar Development and the\nBiologics Price Competition and Innovation Act (Revision 2); Draft\nGuidance for Industry; Availability", "Notice", "Notice of Availability", "2018-12-12T05:00:00Z", 2018, 12, "2018-12-12T05:00:00Z", "2019-02-12T04:59:59Z", "2019-11-18T16:51:35Z", "2018-26852", 0, 0, "0900006483987c81"], ["FDA-2015-D-4750-0021", "FDA", "FDA-2015-D-4750", "The \u2018\u2018Deemed to be a License\u2019\u2019 Provision of the BPCI Act: Questions and Answers; Draft Guidance for Industry; Availability; Request for Comments on Preliminary List of Affected Applications", "Notice", "Notice of Availability", "2018-12-12T05:00:00Z", 2018, 12, "2018-12-12T05:00:00Z", "2019-02-12T04:59:59Z", "2024-11-12T22:51:55Z", "2018-26855", 1, 0, "0900006483987c31"], ["FDA-2015-D-4750-0020", "FDA", "FDA-2015-D-4750", "Interpretation of the \u2018\u2018Deemed To Be a License\u2019\u2019 Provision of the Biologics\nPrice Competition and Innovation Act of 2009; Guidance for Industry;\nAvailability", "Notice", "Notice of Availability", "2018-12-12T05:00:00Z", 2018, 12, "2018-12-12T05:00:00Z", null, "2018-12-12T15:17:09Z", "2018-26854", 0, 0, "0900006483987aea"], ["FDA-2011-D-0611-0064", "FDA", "FDA-2011-D-0611", "Biosimilars: Questions and Answers on Biosimilar Development and the\nBiologics Price Competition and Innovation Act of 2009; Guidance for\nIndustry; Availability", "Notice", "Notice of Availability", "2018-12-12T05:00:00Z", 2018, 12, "2018-12-12T05:00:00Z", null, "2018-12-12T15:04:52Z", "2018-26853", 0, 0, "0900006483987c7c"], ["FDA-2018-D-4267-0001", "FDA", "FDA-2018-D-4267", "Biomarker Qualification: Evidentiary Framework; Draft Guidance for\nIndustry and Food and Drug Administration Staff; Availability", "Notice", "Notice of Availability", "2018-12-12T05:00:00Z", 2018, 12, "2018-12-12T05:00:00Z", "2019-02-12T04:59:59Z", "2019-02-24T17:01:16Z", "2018-26900", 0, 0, "090000648398820d"], ["FDA-2014-D-0779-0023", "FDA", "FDA-2014-D-0779", "Current Good Manufacturing Practice\u2014Guidance for Human Drug\nCompounding Outsourcing Facilities Under Section 503B of the FD&C Act; Draft Guidance for Industry; Availability", "Notice", "Notice of Availability", "2018-12-11T05:00:00Z", 2018, 12, "2018-12-11T05:00:00Z", "2019-02-12T04:59:59Z", "2019-08-20T19:41:28Z", "2018-26724", 0, 0, "0900006483980a94"], ["FDA-2018-N-1990-0001", "FDA", "FDA-2018-N-1990", "Su-Chiao Kuo: Debarment Order", "Notice", "Statutory Debarment", "2018-12-11T05:00:00Z", 2018, 12, "2018-12-11T05:00:00Z", null, "2018-12-11T14:02:34Z", "2018-26778", 0, 0, "090000648398098c"], ["FDA-2018-N-4162-0001", "FDA", "FDA-2018-N-4162", "The Tobacco Products Scientific Advisory Committee; Notice of Meeting", "Notice", "Meeting", "2018-12-11T05:00:00Z", 2018, 12, "2018-12-11T05:00:00Z", null, "2018-12-11T14:12:45Z", "2018-26721", 0, 0, "0900006483980a59"], ["FDA-2018-N-4087-0001", "FDA", "FDA-2018-N-4087", "The Food and Drug Administration\u2019s Proposed Current Good Manufacturing Practice Policies for Outsourcing Facilities: Considerations Regarding Access to Office Stock; Public Meeting; Request for Comments", "Notice", "Request for Comments", "2018-12-11T05:00:00Z", 2018, 12, "2018-12-11T05:00:00Z", "2019-06-22T03:59:59Z", "2019-06-22T01:02:43Z", "2018-26725", 0, 0, "0900006483980af7"], ["FDA-2018-N-1994-0001", "FDA", "FDA-2018-N-1994", "David J. Fishman: Debarment Order", "Notice", "Statutory Debarment", "2018-12-11T05:00:00Z", 2018, 12, "2018-12-11T05:00:00Z", null, "2018-12-11T14:17:32Z", "2018-26722", 0, 0, "0900006483980a95"], ["FDA-2018-N-4395-0001", "FDA", "FDA-2018-N-4395", "Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments", "Notice", "Request for Comments", "2018-12-10T05:00:00Z", 2018, 12, "2018-12-10T05:00:00Z", "2019-02-12T04:59:59Z", "2019-02-13T02:04:02Z", "2018-26626", 0, 0, "0900006483973414"], ["FDA-2015-N-2126-0016", "FDA", "FDA-2015-N-2126", "Agency Information Collection Activities; Submission for Office of\nManagement and Budget Review; Comment Request; Food and Drug\nAdministration\u2019s Research and Evaluation Survey for the Public\nEducation Campaign on Tobacco Among the Lesbian Gay Bisexual\nTransgender Community", "Notice", "30 Day Proposed Information Collection", "2018-12-07T05:00:00Z", 2018, 12, "2018-12-07T05:00:00Z", "2019-01-08T04:59:59Z", "2019-01-08T02:04:10Z", "2018-26555", 0, 0, "090000648395870a"], ["FDA-2018-N-4000-0001", "FDA", "FDA-2018-N-4000", "Framework for a Real-World Evidence Program; Availability", "Notice", "Notice of Availability", "2018-12-07T05:00:00Z", 2018, 12, "2018-12-07T05:00:00Z", "2019-02-06T04:59:59Z", "2024-11-12T22:49:40Z", "2018-26546", 1, 0, "0900006483958758"], ["FDA-2012-N-0961-0010", "FDA", "FDA-2012-N-0961", "Agency Information Collection Activities; Submission for Office of\nManagement and Budget Review; Comment Request; Environmental\nImpact Considerations", "Notice", "30 Day Proposed Information Collection", "2018-12-07T05:00:00Z", 2018, 12, "2018-12-07T05:00:00Z", "2019-01-08T04:59:59Z", "2018-12-07T14:17:58Z", "2018-26556", 0, 0, "090000648395875c"], ["FDA-2018-D-3380-0001", "FDA", "FDA-2018-D-3380", "Developing and Labeling In vitro Companion Diagnostic Devices for a\nSpecific Group or Class of Oncology Therapeutic Products; Draft Guidance for Industry; Availability", "Notice", "Notice of Availability", "2018-12-07T05:00:00Z", 2018, 12, "2018-12-07T05:00:00Z", "2019-02-06T04:59:59Z", "2024-11-12T22:49:40Z", "2018-26554", 1, 0, "090000648395867c"], ["FDA-2018-N-3458-0001", "FDA", "FDA-2018-N-3458", "Food Handler Antiseptic Drug Products for Over-the-Counter Human\nUse; Request for Data and Information", "Notice", "Announcement", "2018-12-07T05:00:00Z", 2018, 12, "2018-12-07T05:00:00Z", "2019-02-06T04:59:59Z", "2019-03-05T09:05:43Z", "2018-26561", 0, 0, "090000648395878b"], ["FDA-2014-D-1814-0125", "FDA", "FDA-2014-D-1814", "Bacterial Risk Control Strategies for Blood Collection Establishments and\nTransfusion Services To Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Notice", "Notice of Availability", "2018-12-06T05:00:00Z", 2018, 12, "2018-12-06T05:00:00Z", "2019-02-05T04:59:59Z", "2019-02-05T02:02:20Z", "2018-26477", 0, 0, "090000648394cd15"], ["FDA-2017-E-3547-0006", "FDA", "FDA-2017-E-3547", "Determination of Regulatory Review Period for Purposes of Patent\nExtension; EXABLATE NEURO MODEL 4000 TYPE 1.0 SYSTEM", "Notice", "Determinations", "2018-12-04T05:00:00Z", 2018, 12, "2018-12-04T05:00:00Z", "2019-02-05T04:59:59Z", "2018-12-04T14:30:50Z", "2018-26282", 0, 0, "0900006483939723"], ["FDA-2017-E-3650-0006", "FDA", "FDA-2017-E-3650", "Determination of Regulatory Review Period for Purposes of Patent\nExtension; OCALIVA", "Notice", "Determinations", "2018-12-04T05:00:00Z", 2018, 12, "2018-12-04T05:00:00Z", "2019-02-05T04:59:59Z", "2018-12-04T14:17:27Z", "2018-26288", 0, 0, "0900006483939066"], ["FDA-2018-D-3632-0001", "FDA", "FDA-2018-D-3632", "Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment; Draft Guidance for Industry; Availability", "Notice", "Notice of Availability", "2018-12-04T05:00:00Z", 2018, 12, "2018-12-04T05:00:00Z", "2019-02-05T04:59:59Z", "2024-11-12T22:50:44Z", "2018-26333", 1, 0, "09000064839394fb"], ["FDA-2014-D-0609-0028", "FDA", "FDA-2014-D-0609", "Agency Information Collection Activities; Submission for Office of\nManagement and Budget Review; Comment Request; Drug Supply Chain\nSecurity Act Implementation: Identification of Suspect Product and\nNotification", "Notice", "30 Day Proposed Information Collection", "2018-12-04T05:00:00Z", 2018, 12, "2018-12-04T05:00:00Z", "2019-01-04T04:59:59Z", "2019-01-05T02:02:23Z", "2018-26295", 0, 0, "090000648393964c"], ["FDA-2015-N-3815-0004", "FDA", "FDA-2015-N-3815", "Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Submission of Medical Device Registration and Listing", "Notice", "60 Day Proposed Information Collection", "2018-12-04T05:00:00Z", 2018, 12, "2018-12-04T05:00:00Z", "2019-02-05T04:59:59Z", "2019-07-23T11:55:32Z", "2018-26303", 0, 0, "090000648393907f"], ["FDA-2017-D-5928-0007", "FDA", "FDA-2017-D-5928", "Post-Complete Response Letter Meetings Between the Food and Drug\nAdministration and Abbreviated New Drug Application Applicants Under\nGeneric Drug User Fee Amendments; Guidance for Industry; Availability", "Notice", "Notice of Availability", "2018-12-04T05:00:00Z", 2018, 12, "2018-12-04T05:00:00Z", null, "2022-10-05T19:15:10Z", "2018-26285", 0, 0, "0900006483939624"], ["FDA-2017-E-2801-0005", "FDA", "FDA-2017-E-2801", "Determination of Regulatory Review Period for Purposes of Patent\nExtension; ASPIRE ASSIST", "Notice", "Determinations", "2018-12-04T05:00:00Z", 2018, 12, "2018-12-04T05:00:00Z", "2019-02-05T04:59:59Z", "2019-01-30T02:06:05Z", "2018-26290", 0, 0, "09000064839394de"], ["FDA-2017-E-4282-0012", "FDA", "FDA-2017-E-4282", "Determination of Regulatory Review Period for Purposes of Patent\nExtension; TRULANCE", "Notice", "Determinations", "2018-12-04T05:00:00Z", 2018, 12, "2018-12-04T05:00:00Z", "2019-02-05T04:59:59Z", "2019-01-30T02:05:27Z", "2018-26289", 0, 0, "09000064839390a7"], ["FDA-2017-E-6604-0008", "FDA", "FDA-2017-E-6604", "Determination of Regulatory Review Period for Purposes of Patent\nExtension; KEVZARA", "Notice", "Determinations", "2018-11-30T05:00:00Z", 2018, 11, "2018-11-30T05:00:00Z", "2019-01-30T04:59:59Z", "2018-11-30T15:50:45Z", "2018-26033", 0, 0, "09000064839161bb"], ["FDA-2018-N-4131-0001", "FDA", "FDA-2018-N-4131", "Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Adverse Event Reports;\nElectronic Submissions", "Notice", "60 Day Proposed Information Collection", "2018-11-30T05:00:00Z", 2018, 11, "2018-11-30T05:00:00Z", "2019-01-30T04:59:59Z", "2019-01-30T02:09:21Z", "2018-26031", 0, 0, "0900006483915990"], ["FDA-2013-D-1445-0065", "FDA", "FDA-2013-D-1445", "Blood Glucose Monitoring Test Systems for Prescription Point-of-Care\nUse; Draft Guidance for Industry and Food and Drug Administration Staff;\nAvailability", "Notice", "Notice of Availability", "2018-11-30T05:00:00Z", 2018, 11, "2018-11-30T05:00:00Z", "2019-03-01T04:59:59Z", "2024-11-12T22:50:38Z", "2018-26034", 1, 0, "0900006483916275"], ["FDA-2017-E-6603-0007", "FDA", "FDA-2017-E-6603", "Determination of Regulatory Review Period for Purposes of Patent\nExtension; KEVZARA", "Notice", "Determinations", "2018-11-30T05:00:00Z", 2018, 11, "2018-11-30T05:00:00Z", "2019-01-30T04:59:59Z", "2018-11-30T15:52:08Z", "2018-26033", 0, 0, "09000064839191b0"], ["FDA-2018-N-4282-0001", "FDA", "FDA-2018-N-4282", "Endocrinologic and Metabolic Drugs Advisory Committee; Notice of\nMeeting; Establishment of a Public Docket; Request for Comments", "Notice", "Request for Comments", "2018-11-30T05:00:00Z", 2018, 11, "2018-11-30T05:00:00Z", "2019-01-17T04:59:59Z", "2019-01-18T02:00:40Z", "2018-25990", 0, 0, "090000648391601c"], ["FDA-2016-E-3305-0006", "FDA", "FDA-2016-E-3305", "Determination of Regulatory Review Period for Purposes of Patent\nExtension; PROVAYBLUE", "Notice", "Determinations", "2018-11-30T05:00:00Z", 2018, 11, "2018-11-30T05:00:00Z", "2019-01-30T04:59:59Z", "2019-01-30T02:13:15Z", "2018-26035", 0, 0, "0900006483916277"], ["FDA-2011-D-0597-0060", "FDA", "FDA-2011-D-0597", "Agency Information Collection Activities; Proposed Collection;\nComment Request; Oversight of Clinical Investigations: A Risk-Based\nApproach to Monitoring", "Notice", "60 Day Proposed Information Collection", "2018-11-30T05:00:00Z", 2018, 11, "2018-11-30T05:00:00Z", "2019-01-30T04:59:59Z", "2022-11-22T18:59:11Z", "2018-26032", 0, 0, "0900006483915d45"], ["FDA-2013-D-1446-0016", "FDA", "FDA-2013-D-1446", "Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use;\nDraft Guidance for Industry and Food and Drug Administration Staff;\nAvailability", "Notice", "Notice of Availability", "2018-11-30T05:00:00Z", 2018, 11, "2018-11-30T05:00:00Z", "2019-03-01T04:59:59Z", "2024-11-12T22:50:38Z", "2018-26028", 1, 0, "09000064839161bc"], ["FDA-2018-N-4227-0001", "FDA", "FDA-2018-N-4227", "Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting;\nEstablishment of a Public Docket; Request for Comments", "Notice", "Request for Comments", "2018-11-30T05:00:00Z", 2018, 11, "2018-11-30T05:00:00Z", "2019-01-11T04:59:59Z", "2018-12-28T02:03:16Z", "2018-25991", 0, 0, "09000064839159b7"], ["FDA-2018-N-4116-0001", "FDA", "FDA-2018-N-4116", "Bone, Reproductive and Urologic Drugs Advisory Committee; Notice of\nMeeting; Establishment of a Public Docket; Request for Comments", "Notice", "Request for Comments", "2018-11-30T05:00:00Z", 2018, 11, "2018-11-30T05:00:00Z", "2019-01-15T04:59:59Z", "2019-01-11T02:01:28Z", "2018-26029", 0, 0, "090000648391572a"], ["FDA-2007-D-0369-0456", "FDA", "FDA-2007-D-0369", "Product-Specific Guidances; Draft and Revised Draft Guidances for Industry;\nAvailability", "Notice", "Notice of Availability", "2018-11-29T05:00:00Z", 2018, 11, "2018-11-29T05:00:00Z", "2019-01-29T04:59:59Z", "2024-11-12T22:50:12Z", "2018-25950", 1, 0, "090000648390c07a"], ["FDA-2017-D-5625-0011", "FDA", "FDA-2017-D-5625", "Recommendations for Dual 510(k) and Clinical Laboratory Improvement\nAmendments Waiver by Application Studies; Draft Guidance for Industry\nand Food and Drug Administration Staff; Availability", "Notice", "Notice of Availability", "2018-11-29T05:00:00Z", 2018, 11, "2018-11-29T05:00:00Z", "2019-02-28T04:59:59Z", "2024-11-12T22:50:46Z", "2018-25960", 1, 0, "090000648390c0b9"], ["FDA-2017-D-5570-0012", "FDA", "FDA-2017-D-5570", "Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications for Manufacturers of In Vitro Diagnostic Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability", "Notice", "Notice of Availability", "2018-11-29T05:00:00Z", 2018, 11, "2018-11-29T05:00:00Z", "2019-02-28T04:59:59Z", "2024-11-12T22:50:46Z", "2018-25959", 1, 0, "090000648390c0fa"], ["FDA-2018-N-4337-0001", "FDA", "FDA-2018-N-4337", "Prescription Drug User Fee Act of 2017; Electronic Submissions and Data\nStandards; Announcement of Public Meeting; Request for Comments", "Notice", "Request for Comments", "2018-11-29T05:00:00Z", 2018, 11, "2018-11-29T05:00:00Z", "2019-04-11T03:59:59Z", "2019-04-03T01:05:21Z", "2018-25958", 0, 0, "090000648390c11d"], ["FDA-2018-N-1262-0003", "FDA", "FDA-2018-N-1262", "Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher", "Notice", "Announcement", "2018-11-23T05:00:00Z", 2018, 11, "2018-11-23T05:00:00Z", null, "2018-11-23T20:50:10Z", "2018-25480", 0, 0, "09000064838f5b5b"], ["FDA-2018-N-3522-4873", "FDA", "FDA-2018-N-3522", "Use of the Names of Dairy Foods in the Labeling of Plant-Based Products;\nExtension of Comment Period", "Notice", "Extension of Comment Period", "2018-11-21T05:00:00Z", 2018, 11, "2018-11-21T05:00:00Z", "2019-01-29T04:59:59Z", "2019-05-23T01:04:52Z", "2018-25347", 0, 0, "09000064838f185d"], ["FDA-2008-N-0500-0009", "FDA", "FDA-2008-N-0500", "Agency Information Collection Activities; Submission for Office of\nManagement and Budget Review; Comment Request; General Licensing\nProvisions; Requirements on Content and Format of Labeling for Human\nPrescription Drug and Biological Products", "Notice", "30 Day Proposed Information Collection", "2018-11-21T05:00:00Z", 2018, 11, "2018-11-21T05:00:00Z", "2018-12-22T04:59:59Z", "2018-11-21T13:19:42Z", "2018-25352", 0, 0, "09000064838f1a72"], ["FDA-2018-N-2027-0008", "FDA", "FDA-2018-N-2027", "Agency Information Collection Activities; Submission for Office of\nManagement and Budget Review; Comment Request; Survey of Current\nManufacturing Practices for the Cosmetics Industry", "Notice", "30 Day Proposed Information Collection", "2018-11-20T05:00:00Z", 2018, 11, "2018-11-20T05:00:00Z", "2018-12-21T04:59:59Z", "2018-12-21T02:03:49Z", "2018-25231", 0, 0, "09000064838ec722"], ["FDA-2018-N-3017-0001", "FDA", "FDA-2018-N-3017", "Prescription Drug-Use-Related Software; Establishment of a Public Docket; Request for Comments", "Notice", "Request for Comments", "2018-11-20T05:00:00Z", 2018, 11, "2018-11-20T05:00:00Z", "2019-04-30T03:59:59Z", "2019-06-18T18:50:27Z", "2018-25206", 0, 0, "09000064838ec2c9"], ["FDA-2012-N-0129-0013", "FDA", "FDA-2012-N-0129", "Agency Information Collection Activities; Submission for Office of\nManagement and Budget Review; Comment Request; General Licensing\nProvisions; Section 351(k) Biosimilar Applications", "Notice", "30 Day Proposed Information Collection", "2018-11-20T05:00:00Z", 2018, 11, "2018-11-20T05:00:00Z", "2018-12-21T04:59:59Z", "2018-11-20T14:24:41Z", "2018-25232", 0, 0, "09000064838ec50e"], ["FDA-2018-N-3771-0001", "FDA", "FDA-2018-N-3771", "Report on the Performance of Drug and Biologics Firms in Conducting\nPostmarketing Requirements and Commitments; Availability", "Notice", "Notice of Availability", "2018-11-19T05:00:00Z", 2018, 11, "2018-11-19T05:00:00Z", null, "2018-11-19T14:51:02Z", "2018-25128", 0, 0, "09000064838e674f"], ["FDA-2018-N-4142-0001", "FDA", "FDA-2018-N-4142", "Determination That REGITINE (Phentolamine Mesylate) Injection, 5\nMilligrams/Vial, and Other Drug Products Were Not Withdrawn From\nSale for Reasons of Safety or Effectiveness", "Notice", "Determinations", "2018-11-19T05:00:00Z", 2018, 11, "2018-11-19T05:00:00Z", null, "2018-11-19T14:53:26Z", "2018-25187", 0, 0, "09000064838e67e8"], ["FDA-2018-M-2460-0002", "FDA", "FDA-2018-M-2460", "Medical Devices; Availability of Safety and Effectiveness Summaries for\nPremarket Approval Applications", "Notice", "Notice of Publication", "2018-11-16T05:00:00Z", 2018, 11, "2018-11-16T05:00:00Z", null, "2018-11-16T16:31:59Z", "2018-25071", 0, 0, "09000064838e0939"], ["FDA-2017-M-6984-0002", "FDA", "FDA-2017-M-6984", "Medical Devices; Availability of Safety and Effectiveness Summaries for\nPremarket Approval Applications", "Notice", "Notice of Publication", "2018-11-16T05:00:00Z", 2018, 11, "2018-11-16T05:00:00Z", null, "2018-11-16T16:17:27Z", "2018-25071", 0, 0, "09000064838dffb3"], ["FDA-2018-M-1791-0002", "FDA", "FDA-2018-M-1791", "Medical Devices; Availability of Safety and Effectiveness Summaries for\nPremarket Approval Applications", "Notice", "Notice of Publication", "2018-11-16T05:00:00Z", 2018, 11, "2018-11-16T05:00:00Z", null, "2018-11-16T16:28:18Z", "2018-25071", 0, 0, "09000064838e04d2"], ["FDA-2018-M-2461-0002", "FDA", "FDA-2018-M-2461", "Medical Devices; Availability of Safety and Effectiveness Summaries for\nPremarket Approval Applications", "Notice", "Notice of Publication", "2018-11-16T05:00:00Z", 2018, 11, "2018-11-16T05:00:00Z", null, "2018-11-16T16:32:24Z", "2018-25071", 0, 0, "09000064838e094e"], ["FDA-2018-M-3131-0002", "FDA", "FDA-2018-M-3131", "Medical Devices; Availability of Safety and Effectiveness Summaries for\nPremarket Approval Applications", "Notice", "Notice of Publication", "2018-11-16T05:00:00Z", 2018, 11, "2018-11-16T05:00:00Z", null, "2018-11-16T16:36:18Z", "2018-25071", 0, 0, "09000064838e09a3"], ["FDA-2018-N-4002-0001", "FDA", "FDA-2018-N-4002", "Electronic Submission of Adverse Event Reports to the Food and Drug\nAdministration Adverse Event Reporting System Using International\nCouncil for Harmonisation E2B(R3) Standards; Public Meetings; Request\nfor Comments", "Notice", "Request for Comments", "2018-11-16T05:00:00Z", 2018, 11, "2018-11-16T05:00:00Z", null, "2018-11-16T15:25:25Z", "2018-25063", 0, 0, "09000064838df0b4"], ["FDA-2018-M-0792-0002", "FDA", "FDA-2018-M-0792", "Medical Devices; Availability of Safety and Effectiveness Summaries for\nPremarket Approval Applications", "Notice", "Notice of Publication", "2018-11-16T05:00:00Z", 2018, 11, "2018-11-16T05:00:00Z", null, "2018-11-16T16:22:03Z", "2018-25071", 0, 0, "09000064838e0376"], ["FDA-2018-M-2883-0002", "FDA", "FDA-2018-M-2883", "Medical Devices; Availability of Safety and Effectiveness Summaries for\nPremarket Approval Applications", "Notice", "Notice of Publication", "2018-11-16T05:00:00Z", 2018, 11, "2018-11-16T05:00:00Z", null, "2018-11-16T16:33:59Z", "2018-25071", 0, 0, "09000064838e0952"], ["FDA-2018-M-2983-0002", "FDA", "FDA-2018-M-2983", "Medical Devices; Availability of Safety and Effectiveness Summaries for\nPremarket Approval Applications", "Notice", "Notice of Publication", "2018-11-16T05:00:00Z", 2018, 11, "2018-11-16T05:00:00Z", null, "2018-11-16T16:35:53Z", "2018-25071", 0, 0, "09000064838e09a2"], ["FDA-2018-M-2886-0002", "FDA", "FDA-2018-M-2886", "Medical Devices; Availability of Safety and Effectiveness Summaries for\nPremarket Approval Applications", "Notice", "Notice of Publication", "2018-11-16T05:00:00Z", 2018, 11, "2018-11-16T05:00:00Z", null, "2018-11-16T16:35:06Z", "2018-25071", 0, 0, "09000064838e09a0"], ["FDA-2018-M-1371-0002", "FDA", "FDA-2018-M-1371", "Medical Devices; Availability of Safety and Effectiveness Summaries for\nPremarket Approval Applications", "Notice", "Notice of Publication", "2018-11-16T05:00:00Z", 2018, 11, "2018-11-16T05:00:00Z", null, "2018-11-16T16:22:59Z", "2018-25071", 0, 0, "09000064838e0377"], ["FDA-2018-M-3505-0002", "FDA", "FDA-2018-M-3505", "Medical Devices; 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