{"database": "openregs", "table": "documents", "is_view": false, "human_description_en": "where agency_id = \"FDA\", document_type = \"Notice\" and posted_year = 2017 sorted by posted_date descending", "rows": [["FDA-2017-D-6564-0001", "FDA", "FDA-2017-D-6564", "Best Practices for Communication Between Investigational New Drug\nApplication Sponsors and the Food and Drug Administration; Guidance for Industry and Review Staff; Availability", "Notice", "Notice of Availability", "2017-12-29T05:00:00Z", 2017, 12, "2017-12-29T05:00:00Z", null, "2017-12-29T14:28:34Z", "2017-28139", 0, 0, "0900006482d832c0"], ["FDA-2017-D-6530-0001", "FDA", "FDA-2017-D-6530", "Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products; Draft Guidance for Industry; Availability", "Notice", "Notice of Availability", "2017-12-29T05:00:00Z", 2017, 12, "2017-12-29T05:00:00Z", "2018-03-30T03:59:59Z", "2018-03-28T01:02:41Z", "2017-28140", 0, 0, "0900006482d832bd"], ["FDA-2001-N-0437-0004", "FDA", "FDA-2001-N-0437", "Agency Information Collection Activities; Announcement of OMB Approval; Current Good Manufacturing Practice Regulations for Medicated Feeds", "Notice", "Notice of Approval", "2017-12-28T05:00:00Z", 2017, 12, null, null, "2024-11-25T16:30:52Z", "01\u201325763", 0, 0, "09000064804e8894"], ["FDA-2017-N-6778-0001", "FDA", "FDA-2017-N-6778", "Fostering Medical Innovation: Case for Quality Voluntary Medical Device\nManufacturing and Product Quality Pilot Program", "Notice", "Announcement", "2017-12-28T05:00:00Z", 2017, 12, "2017-12-28T05:00:00Z", null, "2017-12-28T14:57:25Z", "2017-28044", 0, 0, "0900006482d7a81e"], ["FDA-2001-N-0437-0002", "FDA", "FDA-2001-N-0437", "Agency Information Collection Activities; Submission for OMB Review; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds", "Notice", "30 Day Proposed Information Collection", "2017-12-28T05:00:00Z", 2017, 12, "2001-06-15T04:00:00Z", "2001-07-17T03:59:59Z", "2024-11-25T16:25:48Z", "01-15081", 0, 0, "09000064804e8892"], ["FDA-2017-N-6888-0001", "FDA", "FDA-2017-N-6888", "Neurological Devices Panel of the Medical Devices Advisory Committee;\nNotice of Meeting", "Notice", "Meeting", "2017-12-28T05:00:00Z", 2017, 12, "2017-12-28T05:00:00Z", null, "2017-12-28T15:06:19Z", "2017-27974", 0, 0, "0900006482d7a869"], ["FDA-2001-N-0437-0001", "FDA", "FDA-2001-N-0437", "Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds", "Notice", "60 Day Proposed Information Collection", "2017-12-28T05:00:00Z", 2017, 12, "2001-02-09T05:00:00Z", "2001-04-11T03:59:59Z", "2024-11-25T16:21:13Z", "01-3416", 0, 0, "09000064804e8891"], ["FDA-2017-D-6784-0001", "FDA", "FDA-2017-D-6784", "Implementation of Pathogen Reduction Technology in the Manufacture of Blood Components in Blood Establishments: Questions and Answers; Draft Guidance for Industry; Availability", "Notice", "Notice of Availability", "2017-12-27T05:00:00Z", 2017, 12, "2017-12-27T05:00:00Z", "2018-03-28T03:59:59Z", "2018-03-29T01:05:21Z", "2017-28043", 0, 0, "0900006482d76311"], ["FDA-2015-E-2655-0006", "FDA", "FDA-2015-E-2655", "Determination of Regulatory Review Period for Purposes of Patent Extension; ZYKADIA", "Notice", "Determinations", "2017-12-26T05:00:00Z", 2017, 12, "2017-12-26T05:00:00Z", "2018-02-27T04:59:59Z", "2017-12-26T16:01:36Z", "2017-27745", 0, 0, "0900006482d72685"], ["FDA-2015-E-2597-0007", "FDA", "FDA-2015-E-2597", "Determination of Regulatory Review Period for Purposes of Patent Extension; SIVEXTRO", "Notice", "Determinations", "2017-12-26T05:00:00Z", 2017, 12, "2017-12-26T05:00:00Z", "2018-02-27T04:59:59Z", "2024-02-27T14:24:20Z", "2017-27684", 0, 0, "0900006482d727c1"], ["FDA-2014-N-2294-0005", "FDA", "FDA-2014-N-2294", "Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Evaluation of the \nFood and Drug Administration's `Fresh Empire' Multicultural Youth Tobacco Prevention Campaign", "Notice", "60 Day Proposed Information Collection", "2017-12-26T05:00:00Z", 2017, 12, "2017-12-26T05:00:00Z", "2018-02-27T04:59:59Z", "2018-03-15T16:37:13Z", "2017-27712", 0, 0, "0900006482d72988"], ["FDA-2015-D-1245-0019", "FDA", "FDA-2015-D-1245", "Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System; Guidance for Industry; Availability", "Notice", "Notice of Availability", "2017-12-26T05:00:00Z", 2017, 12, "2017-12-26T05:00:00Z", null, "2017-12-26T16:51:11Z", "2017-27786", 0, 0, "0900006482d727c5"], ["FDA-2015-E-2582-0007", "FDA", "FDA-2015-E-2582", "Determination of Regulatory Review Period for Purposes of Patent Extension; STRIVERDI RESPIMAT", "Notice", "Determinations", "2017-12-26T05:00:00Z", 2017, 12, "2017-12-26T05:00:00Z", "2018-02-27T04:59:59Z", "2017-12-26T16:25:50Z", "2017-27710", 0, 0, "0900006482d727f7"], ["FDA-2014-N-1069-0004", "FDA", "FDA-2014-N-1069", "Agency Information Collection Activities; Proposed Collection; Comment Request; Blood Establishment Registration and Product Listing, Form FDA 2830", "Notice", "60 Day Proposed Information Collection", "2017-12-26T05:00:00Z", 2017, 12, "2017-12-26T05:00:00Z", "2018-02-27T04:59:59Z", "2017-12-26T16:35:03Z", "2017-27757", 0, 0, "0900006482d728a4"], ["FDA-2015-E-2656-0006", "FDA", "FDA-2015-E-2656", "Determination of Regulatory Review Period for Purposes of Patent Extension; ZYKADIA", "Notice", "Determinations", "2017-12-26T05:00:00Z", 2017, 12, "2017-12-26T05:00:00Z", "2018-02-27T04:59:59Z", "2017-12-26T16:07:16Z", "2017-27745", 0, 0, "0900006482d732f2"], ["FDA-2012-D-0307-0010", "FDA", "FDA-2012-D-0307", "Amendment to \u2018\u2018Revised Preventive Measures To Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry;\u2019\u2019 Draft Guidance for Industry; Availability", "Notice", "Notice of Availability", "2017-12-22T05:00:00Z", 2017, 12, "2017-12-22T05:00:00Z", "2018-03-23T03:59:59Z", "2018-01-06T02:01:16Z", "2017-27569", 0, 0, "0900006482d56ac6"], ["FDA-1995-D-0288-0002", "FDA", "FDA-1995-D-0288", "Chemistry, Manufacturing, and Controls Changes to an Approved\nApplication: Certain Biological Products; Draft Guidance for Industry;\nAvailability", "Notice", "Notice of Availability", "2017-12-22T05:00:00Z", 2017, 12, "2017-12-22T05:00:00Z", "2018-03-23T03:59:59Z", "2018-03-23T13:00:58Z", "2017-27589", 0, 0, "0900006482d56bc8"], ["FDA-2017-N-6395-0001", "FDA", "FDA-2017-N-6395", "Request for Nominations of Members for the Clinical Trials Transformation Initiative/Food and Drug Administration Patient  Engagement Collaborative", "Notice", "Request for Nominations", "2017-12-22T05:00:00Z", 2017, 12, "2017-12-22T05:00:00Z", null, "2017-12-22T14:08:24Z", "2017-27538", 0, 0, "0900006482d56c24"], ["FDA-2017-N-1277-0001", "FDA", "FDA-2017-N-1277", "Debarment Orders: Keith J. Pierce", "Notice", "Notice of Action Taken", "2017-12-21T05:00:00Z", 2017, 12, "2017-12-21T05:00:00Z", null, "2017-12-21T14:54:02Z", "2017-27485", 0, 0, "0900006482d48cd1"], ["FDA-2017-D-6380-0001", "FDA", "FDA-2017-D-6380", "Clarification of Orphan Designation of Drugs and Biologics for Pediatric\nSubpopulations of Common Diseases; Draft Guidance for Industry;\nAvailability", "Notice", "Notice of Availability", "2017-12-20T05:00:00Z", 2017, 12, "2017-12-20T05:00:00Z", "2018-01-20T04:59:59Z", "2018-01-20T02:02:49Z", "2017-27435", 0, 0, "0900006482d3f50b"], ["FDA-2017-D-6580-0001", "FDA", "FDA-2017-D-6580", "Drug Products Labeled as Homeopathic; Draft Guidance for Food\nand Drug Administration Staff and Industry; Availability", "Notice", "Notice of Availability", "2017-12-20T05:00:00Z", 2017, 12, "2017-12-20T05:00:00Z", "2018-03-21T03:59:59Z", "2018-03-21T13:00:23Z", "2017-27157", 0, 0, "0900006482d3e121"], ["FDA-2011-N-0075-0006", "FDA", "FDA-2011-N-0075", "Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Good Laboratory \nPractice Regulations for Nonclinical Studies", "Notice", "30 Day Proposed Information Collection", "2017-12-19T05:00:00Z", 2017, 12, "2017-12-19T05:00:00Z", "2018-01-19T04:59:59Z", "2017-12-19T15:36:36Z", "2017-27255", 0, 0, "0900006482d3ab7d"], ["FDA-2017-N-6716-0001", "FDA", "FDA-2017-N-6716", "New Insights for Product Development and Bioequivalence Assessments of Generic Orally Inhaled and Nasal Drug Products; Public Workshop; Request for Comments", "Notice", "Announcement", "2017-12-19T05:00:00Z", 2017, 12, "2017-12-19T05:00:00Z", "2018-02-15T04:59:59Z", "2018-02-15T02:03:48Z", "2017-27279", 0, 0, "0900006482d3ae6f"], ["FDA-2017-N-4678-0001", "FDA", "FDA-2017-N-4678", "Modified Risk Tobacco Product Applications: Applications for Six Camel Snus Smokeless Tobacco Products Submitted by R.J. Reynolds Tobacco Company; Availability", "Notice", "Announcement", "2017-12-19T05:00:00Z", 2017, 12, "2017-12-19T05:00:00Z", "2020-12-31T04:59:59Z", "2021-01-01T02:01:53Z", "2017-27246", 0, 0, "0900006482d3ab2c"], ["FDA-2011-N-0672-0006", "FDA", "FDA-2011-N-0672", "Agency Information Collection Activities; Proposed Collection; Comment Request; Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices", "Notice", "60 Day Proposed Information Collection", "2017-12-19T05:00:00Z", 2017, 12, "2017-12-19T05:00:00Z", "2018-02-21T04:59:59Z", "2018-03-13T15:58:17Z", "2017-27276", 0, 0, "0900006482d3aebe"], ["FDA-2017-D-6535-0001", "FDA", "FDA-2017-D-6535", "Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research; Draft Guidance for Industry and Food and Drug Administration \nStaff; Availability", "Notice", "Notice of Availability", "2017-12-19T05:00:00Z", 2017, 12, "2017-12-19T05:00:00Z", "2018-03-20T03:59:59Z", "2018-03-20T01:03:43Z", "2017-27275", 0, 0, "0900006482d3ac76"], ["FDA-2017-N-6356-0001", "FDA", "FDA-2017-N-6356", "Investigational In Vitro Diagnostics Used in Clinical Investigations of\nTherapeutic Products; Draft Guidance for Industry, Food and Drug\nAdministration Staff, Sponsors, and Institutional Review Boards;  Availability", "Notice", "Notice of Availability", "2017-12-18T05:00:00Z", 2017, 12, "2017-12-18T05:00:00Z", "2018-03-20T03:59:59Z", "2018-03-20T13:01:12Z", "2017-27155", 0, 0, "0900006482d30343"], ["FDA-2017-D-0759-0001", "FDA", "FDA-2017-D-0759", "Drug Products, Including Biological Products, That Contain Nanomaterials; Draft Guidance for Industry; Availability", "Notice", "Notice of Availability", "2017-12-18T05:00:00Z", 2017, 12, "2017-12-18T05:00:00Z", "2018-03-20T03:59:59Z", "2018-03-20T01:02:36Z", "2017-27133", 0, 0, "0900006482d2f9b8"], ["FDA-2017-D-6765-0001", "FDA", "FDA-2017-D-6765", "Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability", "Notice", "Notice of Availability", "2017-12-18T05:00:00Z", 2017, 12, "2017-12-18T05:00:00Z", "2018-03-20T03:59:59Z", "2018-03-21T01:01:16Z", "2017-27132", 0, 0, "0900006482d30212"], ["FDA-2017-D-6752-0001", "FDA", "FDA-2017-D-6752", "Information Requests and Discipline Review Letters Under the Generic Drug User Fee Amendments; Draft Guidance for Industry; Availability", "Notice", "Notice of Availability", "2017-12-18T05:00:00Z", 2017, 12, "2017-12-18T05:00:00Z", "2018-02-17T04:59:59Z", "2018-02-17T02:02:50Z", "2017-27124", 0, 0, "0900006482d30211"], ["FDA-2017-D-6617-0001", "FDA", "FDA-2017-D-6617", "Developing Targeted Therapies in Low-Frequency Molecular Subsets of a\nDisease; Draft Guidance for Industry; Availability", "Notice", "Notice of Availability", "2017-12-18T05:00:00Z", 2017, 12, "2017-12-18T05:00:00Z", "2018-02-17T04:59:59Z", "2018-02-17T02:01:16Z", "2017-27156", 0, 0, "0900006482d3028d"], ["FDA-2017-D-6702-0001", "FDA", "FDA-2017-D-6702", "The Least Burdensome Provisions: Concept and Principles; Draft Guidance for Industry and Food and Drug Administration Staff; Availability", "Notice", "Notice of Availability", "2017-12-15T05:00:00Z", 2017, 12, "2017-12-15T05:00:00Z", "2018-02-14T04:59:59Z", "2018-01-24T02:04:12Z", "2017-26987", 0, 0, "0900006482d1290f"], ["FDA-2017-N-0809-0005", "FDA", "FDA-2017-N-0809", "Issuance of Priority Review Voucher; Rare Pediatric Disease Product", "Notice", "Announcement", "2017-12-15T05:00:00Z", 2017, 12, "2017-12-15T05:00:00Z", null, "2017-12-15T15:25:40Z", "2017-27049", 0, 0, "0900006482d126f3"], ["FDA-2011-N-0362-0008", "FDA", "FDA-2011-N-0362", "Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals", "Notice", "60 Day Proposed Information Collection", "2017-12-14T05:00:00Z", 2017, 12, "2017-12-14T05:00:00Z", "2018-02-13T04:59:59Z", "2017-12-14T17:26:03Z", "2017-26932", 0, 0, "0900006482d08dcb"], ["FDA-2015-D-4562-0024", "FDA", "FDA-2015-D-4562", "Public Workshop on Safety Assessment for Investigational New Drug Safety Reporting; Correction", "Notice", "Correction", "2017-12-14T05:00:00Z", 2017, 12, "2017-12-14T05:00:00Z", null, "2017-12-14T17:33:45Z", "2017-26938", 0, 0, "0900006482d08e78"], ["FDA-2017-N-6312-0001", "FDA", "FDA-2017-N-6312", "Patient-Focused Drug Development: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data; Public Workshop; Request for Comments", "Notice", "Request for Comments", "2017-12-14T05:00:00Z", 2017, 12, "2017-12-14T05:00:00Z", "2018-05-19T03:59:59Z", "2018-04-10T01:05:05Z", "2017-26978", 0, 0, "0900006482d08e7c"], ["FDA-2011-N-0279-0007", "FDA", "FDA-2011-N-0279", "Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Marketing Act of 1987; Administrative  Procedures, Policies, and Requirements", "Notice", "60 Day Proposed Information Collection", "2017-12-14T05:00:00Z", 2017, 12, "2017-12-14T05:00:00Z", "2018-02-13T04:59:59Z", "2017-12-14T17:20:49Z", "2017-26933", 0, 0, "0900006482d084dd"], ["FDA-2017-N-5925-0011", "FDA", "FDA-2017-N-5925", "21st Century Cures Act: Announcing the Establishment of the Susceptibility Test Interpretive Criteria Website", "Notice", "Announcement", "2017-12-13T05:00:00Z", 2017, 12, "2017-12-13T05:00:00Z", null, "2017-12-13T17:37:08Z", "2017-26790", 0, 0, "0900006482d01f46"], ["FDA-2017-N-6455-0001", "FDA", "FDA-2017-N-6455", "Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Consultation Procedures: Foods Derived From New Plant Varieties", "Notice", "60 Day Proposed Information Collection", "2017-12-13T05:00:00Z", 2017, 12, "2017-12-13T05:00:00Z", "2018-02-13T04:59:59Z", "2018-02-13T02:05:45Z", "2017-26794", 0, 0, "0900006482d01f45"], ["FDA-2017-D-6352-0001", "FDA", "FDA-2017-D-6352", "Gluten in Drug Products and Associated Labeling Recommendations; Draft Guidance for Industry; Availability", "Notice", "Guidance", "2017-12-13T05:00:00Z", 2017, 12, "2017-12-13T05:00:00Z", "2018-02-13T04:59:59Z", "2018-02-13T14:00:38Z", "2017-26828", 0, 0, "0900006482d01f79"], ["FDA-2017-D-6554-0001", "FDA", "FDA-2017-D-6554", "Guidance: Refuse to File-New Drug Application and Biologics License Application Submissions to the Center for Drug Evaluation and Research", "Notice", "Guidance", "2017-12-13T05:00:00Z", 2017, 12, "2017-12-13T05:00:00Z", "2018-02-13T04:59:59Z", "2017-12-13T14:40:07Z", "2017-26791", 0, 0, "0900006482d01c53"], ["FDA-2014-N-0345-0007", "FDA", "FDA-2014-N-0345", "Agency Information Collection Activities; Submission for Office of\nManagement and Budget Review; Comment Request; Data To Support\nDrug Product Communications as Used by the Food and Drug\nAdministration", "Notice", "30 Day Proposed Information Collection", "2017-12-13T05:00:00Z", 2017, 12, "2017-12-13T05:00:00Z", "2018-01-13T04:59:59Z", "2017-12-13T17:25:59Z", "2017-26795", 0, 0, "0900006482d01f42"], ["FDA-2014-N-1030-0005", "FDA", "FDA-2014-N-1030", "Agency Information Collection Activities; Proposed Collection; Comment Request; Food Allergen Labeling and Reporting", "Notice", "60 Day Proposed Information Collection", "2017-12-12T05:00:00Z", 2017, 12, "2017-12-12T05:00:00Z", "2018-02-13T04:59:59Z", "2017-12-31T02:00:22Z", "2017-26690", 0, 0, "0900006482cfd0a6"], ["FDA-2012-N-1021-0038", "FDA", "FDA-2012-N-1021", "Notice to Public of Website Location of Center for Devices and Radiological Health Fiscal Year 2018 Proposed Guidance Development", "Notice", "Announcement", "2017-12-12T05:00:00Z", 2017, 12, "2017-12-12T05:00:00Z", "2018-02-13T04:59:59Z", "2018-02-13T02:02:29Z", "2017-26721", 0, 0, "0900006482cfd636"], ["FDA-1999-D-4079-0008", "FDA", "FDA-1999-D-4079", "Product Name Placement, Size, and Prominence in Promotional Labeling\nand Advertisements; Guidance for Industry; Availability", "Notice", "Notice of Availability", "2017-12-12T05:00:00Z", 2017, 12, "2017-12-12T05:00:00Z", null, "2017-12-12T18:36:42Z", "2017-26725", 0, 0, "0900006482cfd500"], ["FDA-2017-D-6528-0001", "FDA", "FDA-2017-D-6528", "Refusal of Inspection by a Foreign Food Establishment or Foreign  Government; Draft Guidance for Industry; Availability", "Notice", "Notice of Availability", "2017-12-12T05:00:00Z", 2017, 12, "2017-12-12T05:00:00Z", "2018-02-27T04:59:59Z", "2018-02-27T14:01:46Z", "2017-26692", 0, 0, "0900006482cfd503"], ["FDA-2017-N-6397-0001", "FDA", "FDA-2017-N-6397", "Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Calorie Labeling of Articles of Food in Vending Machines", "Notice", "60 Day Proposed Information Collection", "2017-12-12T05:00:00Z", 2017, 12, "2017-12-12T05:00:00Z", "2018-02-13T04:59:59Z", "2018-02-13T02:01:56Z", "2017-26672", 0, 0, "0900006482cfd54e"], ["FDA-2016-N-4487-0017", "FDA", "FDA-2016-N-4487", "Agency Information Collection Activities; Submission for Office of\nManagement and Budget Review; Comment Request; Consumer and\nHealthcare Professional Identification of and Responses to Deceptive\nPrescription Drug Promotion", "Notice", "30 Day Proposed Information Collection", "2017-12-12T05:00:00Z", 2017, 12, "2017-12-12T05:00:00Z", "2018-01-12T04:59:59Z", "2017-12-12T18:09:19Z", "2017-26704", 0, 0, "0900006482cfd550"], ["FDA-2011-N-0015-0005", "FDA", "FDA-2011-N-0015", "Agency Information Collection Activities; Submission for Office of\nManagement and Budget Review; Comment Request; Orphan Products\nDevelopment; Food and Drug Administration Orphan Drug Designation Request Form and The Common European Medicines Agency/\nFood and Drug Administration Form for Orphan Medicinal Product\nDesignation", "Notice", "30 Day Proposed Information Collection", "2017-12-12T05:00:00Z", 2017, 12, "2017-12-12T05:00:00Z", "2018-01-12T04:59:59Z", "2017-12-12T17:22:33Z", "2017-26669", 0, 0, "0900006482cfd0ff"], ["FDA-2013-N-0523-0007", "FDA", "FDA-2013-N-0523", "Agency Information Collection Activities: Submission for Office of\nManagement and Budget Review; Comment Request; Applications for\nFood and Drug Administration Approval To Market a New Drug", "Notice", "30 Day Proposed Information Collection", "2017-12-12T05:00:00Z", 2017, 12, "2017-12-12T05:00:00Z", "2018-01-12T04:59:59Z", "2018-01-11T14:01:28Z", "2017-26670", 0, 0, "0900006482cfce02"], ["FDA-2017-P-2659-0006", "FDA", "FDA-2017-P-2659", "Determination That NOROXIN (Norfloxacin) Tablets, 400 Milligrams,\nWas Not Withdrawn From Sale for Reasons of Safety or Effectiveness", "Notice", "Determinations", "2017-12-12T05:00:00Z", 2017, 12, "2017-12-12T05:00:00Z", null, "2017-12-12T18:27:25Z", "2017-26693", 0, 0, "0900006482cfd5ec"], ["FDA-2014-N-1072-0005", "FDA", "FDA-2014-N-1072", "Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for \nParticipation in Food and Drug Administration Fellowship Programs", "Notice", "30 Day Proposed Information Collection", "2017-12-11T05:00:00Z", 2017, 12, "2017-12-11T05:00:00Z", "2018-01-11T04:59:59Z", "2017-12-11T14:46:21Z", "2017-26543", 0, 0, "0900006482cf739c"], ["FDA-2009-D-0508-0017", "FDA", "FDA-2009-D-0508", "Registration and Product Listing for Owners and Operators of Domestic\nTobacco Product Establishments; Guidance for Industry; Availability", "Notice", "Notice of Availability", "2017-12-08T05:00:00Z", 2017, 12, "2017-12-08T05:00:00Z", null, "2017-12-08T15:42:30Z", "2017-26469", 0, 0, "0900006482cf29f2"], ["FDA-2017-D-6569-0001", "FDA", "FDA-2017-D-6569", "Clinical and Patient Decision Support Software; Draft Guidance for Industry and Food and Drug Administration Staff; Availability", "Notice", "Notice of Availability", "2017-12-08T05:00:00Z", 2017, 12, "2017-12-08T05:00:00Z", "2018-03-16T03:59:59Z", "2019-10-23T14:25:18Z", "2017-26439", 0, 0, "0900006482cf2a39"], ["FDA-2016-N-3083-0003", "FDA", "FDA-2016-N-3083", "Report on the Performance of Drug and Biologics Firms in Conducting\nPostmarketing Requirements and Commitments; Availability", "Notice", "Notice of Availability", "2017-12-08T05:00:00Z", 2017, 12, "2017-12-08T05:00:00Z", null, "2017-12-08T17:36:17Z", "2017-26470", 0, 0, "0900006482cf2abe"], ["FDA-2017-D-5767-0021", "FDA", "FDA-2017-D-5767", "Abbreviated New Drug Applications for Certain Highly Purified Synthetic\nPeptide Drug Products That Refer to Listed Drugs of Recombinant\nDeoxyribonucleic Acid Origin; Draft Guidance for Industry; Availability;\nExtension of Comment Period", "Notice", "Notice of Availability", "2017-12-08T05:00:00Z", 2017, 12, "2017-12-08T05:00:00Z", "2018-02-05T04:59:59Z", "2018-02-03T02:04:56Z", "2017-26436", 0, 0, "0900006482cf2a7a"], ["FDA-2016-D-2483-0019", "FDA", "FDA-2016-D-2483", "Software as a Medical Device: Clinical Evaluation; International Medical\nDevice Regulators Forum; Guidance for Industry and Food and Drug\nAdministration Staff; Availability", "Notice", "Notice of Availability", "2017-12-08T05:00:00Z", 2017, 12, "2017-12-08T05:00:00Z", null, "2017-12-08T16:20:53Z", "2017-26441", 0, 0, "0900006482cf2ac2"], ["FDA-2017-N-6607-0001", "FDA", "FDA-2017-N-6607", "Oncology Center of Excellence Listening Session; Public Meeting; Request for Comments", "Notice", "Request for Comments", "2017-12-08T05:00:00Z", 2017, 12, "2017-12-08T05:00:00Z", "2018-04-17T03:59:59Z", "2018-04-18T01:01:57Z", "2017-26440", 0, 0, "0900006482cf291f"], ["FDA-2017-D-6294-0001", "FDA", "FDA-2017-D-6294", "Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act; Draft Guidance for Industry and Food and Drug Administration Staff; Availability", "Notice", "Notice of Availability", "2017-12-08T05:00:00Z", 2017, 12, "2017-12-08T05:00:00Z", "2018-02-07T04:59:59Z", "2018-02-07T14:00:56Z", "2017-26442", 0, 0, "0900006482cf29f1"], ["FDA-2017-N-4301-0020", "FDA", "FDA-2017-N-4301", "Fostering Digital Health Innovation: Developing the Software  Precertification Program; Public Workshop; Request for Comments", "Notice", "Request for Comments", "2017-12-08T05:00:00Z", 2017, 12, "2017-12-08T05:00:00Z", null, "2024-11-07T01:13:10Z", "2017-26457", 1, 0, "0900006482cf2ac1"], ["FDA-2017-N-6313-0001", "FDA", "FDA-2017-N-6313", "Prescription Drug User Fee Act VI Commitment To Assess Current  Practices of the Food and Drug Administration and Sponsors in\nCommunicating During Investigational New Drug Development; Establishment of a Public Docket; Request for Comments", "Notice", "Request for Comments", "2017-12-08T05:00:00Z", 2017, 12, "2017-12-08T05:00:00Z", "2018-01-23T04:59:59Z", "2018-01-23T02:02:52Z", "2017-26437", 0, 0, "0900006482cf28d9"], ["FDA-2013-N-1161-0007", "FDA", "FDA-2013-N-1161", "Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Safety Survey", "Notice", "30 Day Proposed Information Collection", "2017-12-07T05:00:00Z", 2017, 12, "2017-12-07T05:00:00Z", "2018-01-09T04:59:59Z", "2018-01-09T02:02:16Z", "2017-26356", 0, 0, "0900006482ced75a"], ["FDA-2017-N-6476-0001", "FDA", "FDA-2017-N-6476", "Pediatric Rare Diseases-A Collaborative Approach for Drug Development Using Gaucher Disease as a Model; Draft Guidance for Industry; Availability", "Notice", "Notice of Availability", "2017-12-07T05:00:00Z", 2017, 12, "2017-12-07T05:00:00Z", "2018-02-06T04:59:59Z", "2018-02-06T02:04:23Z", "2017-26357", 0, 0, "0900006482ced510"], ["FDA-2009-D-0137-0045", "FDA", "FDA-2009-D-0137", "Use of Serological Tests to Reduce the Risk of Transmission of  Trypanosoma cruzi Infection in Blood and Blood Components; Guidance for Industry; Availability", "Notice", "Notice of Availability", "2017-12-06T05:00:00Z", 2017, 12, "2017-12-06T05:00:00Z", null, "2017-12-06T15:20:12Z", "2017-26226", 0, 0, "0900006482ce90a2"], ["FDA-2016-D-1159-0006", "FDA", "FDA-2016-D-1159", "Food and Drug Administration Categorization of Investigational Device Exemption Devices To Assist the Centers for Medicare and Medicaid\nServices With Coverage Decisions; Guidance for Sponsors, Clinical\nInvestigators, Industry, Institutional Review Boards, and Food and Drug\nAdministration Staff; Availability", "Notice", "Notice of Availability", "2017-12-05T05:00:00Z", 2017, 12, "2017-12-05T05:00:00Z", null, "2017-12-05T17:07:32Z", "2017-26195", 0, 0, "0900006482cdbd97"], ["FDA-2016-D-1210-0031", "FDA", "FDA-2016-D-1210", "Technical Considerations for Additive Manufactured Medical Devices;\nGuidance for Industry and Food and Drug Administration Staff; Availability", "Notice", "Notice of Availability", "2017-12-05T05:00:00Z", 2017, 12, "2017-12-05T05:00:00Z", null, "2017-12-05T17:11:51Z", "2017-26196", 0, 0, "0900006482cdbdfb"], ["FDA-2014-N-0192-0010", "FDA", "FDA-2014-N-0192", "Agency Information Collection Activities; Submission for Office of\nManagement and Budget Review; Comment Request; Establishing and\nMaintaining Lists of United States Manufacturers/Processors With\nInterest in Exporting Center for Food Safety and Applied Nutrition-Regulated Products to China", "Notice", "30 Day Proposed Information Collection", "2017-12-04T05:00:00Z", 2017, 12, "2017-12-04T05:00:00Z", "2018-01-04T04:59:59Z", "2017-12-04T15:41:41Z", "2017-26042", 0, 0, "0900006482cd3ca9"], ["FDA-2017-N-4853-0002", "FDA", "FDA-2017-N-4853", "Receipt of Notice That a Patent Infringement Complaint Was Filed Against a Biosimilar Applicant", "Notice", "General Notice", "2017-12-04T05:00:00Z", 2017, 12, "2017-12-04T05:00:00Z", null, "2017-12-04T15:24:30Z", "2017-26013", 0, 0, "0900006482cd3be6"], ["FDA-2017-N-6475-0001", "FDA", "FDA-2017-N-6475", "Food and Drug Administration Fiscal Year 2017 Performance Review Board\nMembers", "Notice", "Announcement", "2017-12-04T05:00:00Z", 2017, 12, "2017-12-04T05:00:00Z", null, "2017-12-04T15:53:13Z", "2017-26015", 0, 0, "0900006482cd4273"], ["FDA-2017-N-6286-0001", "FDA", "FDA-2017-N-6286", "Site Visit Training Program for Office of Pharmaceutical Quality Staff;\nInformation Available to Industry", "Notice", "Announcement", "2017-12-04T05:00:00Z", 2017, 12, "2017-12-04T05:00:00Z", "2018-02-03T04:59:59Z", "2018-01-31T02:00:58Z", "2017-26055", 0, 0, "0900006482cd3b8e"], ["FDA-2004-N-0451-0042", "FDA", "FDA-2004-N-0451", "Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 048", "Notice", "Announcement", "2017-12-04T05:00:00Z", 2017, 12, "2017-12-04T05:00:00Z", null, "2024-11-07T01:13:33Z", "2017-26043", 1, 0, "0900006482cd3cde"], ["FDA-2017-N-6591-0001", "FDA", "FDA-2017-N-6591", "Barr Laboratories, Inc. et al.; Withdrawal of Approval of 68 Abbreviated New Drug Applications", "Notice", "Withdrawal", "2017-12-01T05:00:00Z", 2017, 12, "2017-12-01T05:00:00Z", null, "2017-12-04T15:00:20Z", "2017-25920", 0, 0, "0900006482cc9bb9"], ["FDA-2017-N-6293-0001", "FDA", "FDA-2017-N-6293", "Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments", "Notice", "Request for Comments", "2017-12-01T05:00:00Z", 2017, 12, "2017-12-01T05:00:00Z", "2018-01-11T04:59:59Z", "2018-01-10T02:01:11Z", "2017-25911", 0, 0, "0900006482cc9c36"], ["FDA-2017-P-4027-0004", "FDA", "FDA-2017-P-4027", "Determination That METICORTEN (Prednisone) Tablets, 1 Milligram and 5\nMilligrams, Were Not Withdrawn From Sale for Reasons of Safety or\nEffectiveness", "Notice", "Determinations", "2017-12-01T05:00:00Z", 2017, 12, "2017-12-01T05:00:00Z", null, "2017-12-04T14:55:48Z", "2017-25900", 0, 0, "0900006482cc9ac1"], ["FDA-1996-N-0473-0002", "FDA", "FDA-1996-N-0473", "Gary D. Mays; Debarment Order", "Notice", "Notice of Final Rule", "2017-11-30T05:00:00Z", 2017, 11, null, null, "2017-11-30T14:55:57Z", "97-1784", 0, 0, "0900006480507b6b"], ["FDA-2015-E-3316-0006", "FDA", "FDA-2015-E-3316", "Determination of Regulatory Review Periods for Purposes of Patent Extension: ADVANTAME", "Notice", "Determinations", "2017-11-30T05:00:00Z", 2017, 11, "2017-11-30T05:00:00Z", "2018-01-30T04:59:59Z", "2017-11-30T15:57:22Z", "2017-25780", 0, 0, "0900006482cc09cd"], ["FDA-2015-E-3316-0007", "FDA", "FDA-2015-E-3316", "Determination of Regulatory Review Periods for Purposes of Patent Extension: ADVANTAME", "Notice", "Determinations", "2017-11-30T05:00:00Z", 2017, 11, "2017-11-30T05:00:00Z", "2018-01-30T04:59:59Z", "2017-11-30T15:59:10Z", "2017-25780", 0, 0, "0900006482cc2a5c"], ["FDA-2017-D-5570-0001", "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", "2017-11-29T05:00:00Z", 2017, 11, "2017-11-29T05:00:00Z", "2018-01-30T04:59:59Z", "2018-01-14T03:27:08Z", "2017-25775", 0, 0, "0900006482cbbc77"], ["FDA-2016-E-2181-0005", "FDA", "FDA-2016-E-2181", "Determination of Regulatory Review Period for Purposes of Patent\nExtension; XURIDEN", "Notice", "Determinations", "2017-11-29T05:00:00Z", 2017, 11, "2017-11-29T05:00:00Z", "2018-01-30T04:59:59Z", "2017-11-29T16:32:21Z", "2017-25770", 0, 0, "0900006482cbbcc8"], ["FDA-2016-E-2216-0005", "FDA", "FDA-2016-E-2216", "Determination of Regulatory Review Period for Purposes of Patent\nExtension; VELTASSA", "Notice", "Determinations", "2017-11-29T05:00:00Z", 2017, 11, "2017-11-29T05:00:00Z", "2018-01-30T04:59:59Z", "2017-11-29T16:39:29Z", "2017-25761", 0, 0, "0900006482cbbd77"], ["FDA-2009-N-0505-0011", "FDA", "FDA-2009-N-0505", "Agency Information Collection Activities; Submission for Office of\nManagement and Budget Review; Comment Request; Recordkeeping\nand Reporting Requirements for Human Food and Cosmetics  Manufactured From, Processed With, or Otherwise Containing Material From Cattle", "Notice", "30 Day Proposed Information Collection", "2017-11-29T05:00:00Z", 2017, 11, "2017-11-29T05:00:00Z", "2017-12-30T04:59:59Z", "2017-11-30T02:03:20Z", "2017-25767", 0, 0, "0900006482cbbc73"], ["FDA-2016-E-1292-0005", "FDA", "FDA-2016-E-1292", "Determination of Regulatory Review Period for Purposes of Patent\nExtension; REXULTI", "Notice", "Determinations", "2017-11-29T05:00:00Z", 2017, 11, "2017-11-29T05:00:00Z", "2018-01-30T04:59:59Z", "2017-11-29T16:37:58Z", "2017-25772", 0, 0, "0900006482cbbd2a"], ["FDA-2014-E-1653-0006", "FDA", "FDA-2014-E-1653", "Determination of Regulatory Review Period for Purposes of Patent\nExtension; SOLX SYSTEM", "Notice", "Determinations", "2017-11-29T05:00:00Z", 2017, 11, "2017-11-29T05:00:00Z", "2018-01-30T04:59:59Z", "2017-11-29T16:36:24Z", "2017-25773", 0, 0, "0900006482cbbd25"], ["FDA-2017-N-6373-0001", "FDA", "FDA-2017-N-6373", "Roxane Laboratories, Inc.; Withdrawal of Approval of a New Drug Application for ROXICODONE (Oxycodone Hydrochloride) Sustained-Release Tablets, 10 Milligrams and 30 Milligrams", "Notice", "Withdrawal", "2017-11-29T05:00:00Z", 2017, 11, "2017-11-29T05:00:00Z", null, "2017-11-29T16:30:15Z", "2017-25771", 0, 0, "0900006482cbbc78"], ["FDA-2017-D-5625-0001", "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", "2017-11-29T05:00:00Z", 2017, 11, "2017-11-29T05:00:00Z", "2018-01-30T04:59:59Z", "2018-01-14T03:27:10Z", "2017-25774", 0, 0, "0900006482cbbd24"], ["FDA-2016-E-0534-0006", "FDA", "FDA-2016-E-0534", "Determination of Regulatory Review Period for Purposes of Patent\nExtension; RAPIVAB", "Notice", "Determinations", "2017-11-28T05:00:00Z", 2017, 11, "2017-11-28T05:00:00Z", "2018-01-30T04:59:59Z", "2017-11-28T16:07:01Z", "2017-25676", 0, 0, "0900006482cb6df7"], ["FDA-2016-E-2374-0005", "FDA", "FDA-2016-E-2374", "Determination of Regulatory Review Period for Purposes of Patent  Extension; YONDELIS", "Notice", "Determinations", "2017-11-28T05:00:00Z", 2017, 11, "2017-11-28T05:00:00Z", "2018-01-30T04:59:59Z", "2017-11-28T15:55:11Z", "2017-25683", 0, 0, "0900006482cb669e"], ["FDA-2016-E-1195-0005", "FDA", "FDA-2016-E-1195", "Determination of Regulatory Review Period for Purposes of Patent\nExtension; Senza Spinal Cord Stimulation System", "Notice", "Determinations", "2017-11-28T05:00:00Z", 2017, 11, "2017-11-28T05:00:00Z", "2018-01-30T04:59:59Z", "2017-11-28T15:51:38Z", "2017-25684", 0, 0, "0900006482cb77b4"], ["FDA-2016-E-0533-0006", "FDA", "FDA-2016-E-0533", "Determination of Regulatory Review Period for Purposes of Patent\nExtension; RAPIVAB", "Notice", "Determinations", "2017-11-28T05:00:00Z", 2017, 11, "2017-11-28T05:00:00Z", "2018-01-30T04:59:59Z", "2017-11-28T16:07:34Z", "2017-25676", 0, 0, "0900006482cb8369"], ["FDA-2012-D-0384-0021", "FDA", "FDA-2012-D-0384", "Pediatric Information for X-Ray Imaging Device Premarket Notifications; Guidance for Industry and Food and Drug Administration Staff; Availability", "Notice", "Notice of Availability", "2017-11-28T05:00:00Z", 2017, 11, "2017-11-28T05:00:00Z", null, "2017-11-28T16:13:29Z", "2017-25632", 0, 0, "0900006482cb661a"], ["FDA-2016-E-1237-0005", "FDA", "FDA-2016-E-1237", "Determination of Regulatory Review Period for Purposes of Patent\nExtension; SAVAYSA", "Notice", "Determinations", "2017-11-28T05:00:00Z", 2017, 11, "2017-11-28T05:00:00Z", "2018-01-30T04:59:59Z", "2017-11-28T15:56:38Z", "2017-25703", 0, 0, "0900006482cb67b4"], ["FDA-2016-E-1534-0004", "FDA", "FDA-2016-E-1534", "Determination of Regulatory Review Period for Purposes of Patent\nExtension; Senza Spinal Cord Stimulation System", "Notice", "Determinations", "2017-11-28T05:00:00Z", 2017, 11, "2017-11-28T05:00:00Z", "2018-01-30T04:59:59Z", "2017-11-28T15:51:03Z", "2017-25684", 0, 0, "0900006482cb661f"], ["FDA-2016-E-0623-0005", "FDA", "FDA-2016-E-0623", "Determination of Regulatory Review Period for Purposes of Patent\nExtension; ZERBAXA", "Notice", "Determinations", "2017-11-28T05:00:00Z", 2017, 11, "2017-11-28T05:00:00Z", "2018-01-30T04:59:59Z", "2017-11-28T16:04:50Z", "2017-25682", 0, 0, "0900006482cb6dc0"], ["FDA-2017-N-0001-0042", "FDA", "FDA-2017-N-0001", "Weighing the Evidence: Variant Classification and Interpretation in\nPrecision Oncology; 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