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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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1,014 rows where agency_id = "FDA", document_type = "Notice" and posted_year = 2016 sorted by posted_date descending

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posted_year 1

  • 2016 · 1,014 ✖

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  • Notice · 1,014 ✖

agency_id 1

  • FDA · 1,014 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-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-2015-D-0025-0015 FDA FDA-2015-D-0025 Medical Device Accessories—Describing 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   2016-12-30T14:17:49Z 2016-31669 0 0 0900006482441379
FDA-2013-N-0879-0004 FDA FDA-2013-N-0879 Agency Information Collection Activities; Submission for Office of Management 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-D-4318-0001 FDA FDA-2016-D-4318 Compounding and Repackaging of Radiopharmaceuticals by State- Licensed Nuclear Pharmacies and Federal Facilities; Draft Guidance for Industry; Availability Notice Notice of Availability 2016-12-29T05:00:00Z 2016 12 2016-12-29T05:00:00Z   2016-12-29T14:29:37Z 2016-31513 0 0 090000648243d2fb
FDA-2000-D-0103-0009 FDA Botanical Drug Development 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   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   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 Applications and Two Abbreviated New Drug Applications Notice Withdrawal 2016-12-29T05:00:00Z 2016 12 2016-12-29T05:00:00Z   2016-12-29T15:02:22Z 2016-31625 0 0 090000648243d2a9
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   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   2016-12-29T14:18:33Z 2016-31511 0 0 090000648243d24e
FDA-2016-D-0269-0112 FDA FDA-2016-D-0269 Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability Notice Notice of Availability 2016-12-29T05:00:00Z 2016 12 2016-12-29T05:00:00Z   2016-12-29T14:33:49Z 2016-31607 0 0 090000648243d35a
FDA-2016-D-4317-0001 FDA FDA-2016-D-4317 Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities; Draft Guidance for Industry; Availability Notice Notice of Availability 2016-12-29T05:00:00Z 2016 12 2016-12-29T05:00:00Z   2016-12-29T14:53:06Z 2016-31512 0 0 090000648243d4ab
FDA-2016-N-0001-0129 FDA FDA-2016-N-0001 Identification and Characterization of the Infectious Disease Risks of Human Cells, Tissues, and Cellular and Tissue-Based Products; Public Workshop Notice Public Meetings 2016-12-29T05:00:00Z 2016 12 2016-12-29T05:00:00Z   2016-12-29T14:11:28Z 2016-31628 0 0 090000648243d171
FDA-2014-D-1953-0002 FDA FDA-2014-D-1953 Providing Regulatory Submissions in Electronic Format—Submission of Manufacturing Establishment Information; Draft Guidance for Industry; Availability Notice   2016-12-29T00:00:00Z 2016 12     2019-05-22T14:57:37Z   0 1 090000648243d173
FDA-2016-E-1179-0006 FDA FDA-2016-E-1179 Determinations of Regulatory Review Periods for Purposes of Patent Extensions: IMLYGIC Notice Determinations 2016-12-28T05:00:00Z 2016 12 2016-12-28T05:00:00Z 2017-06-27T03:59:59Z 2016-12-28T14:27:41Z 2016-31322 0 0 090000648243a972
FDA-2016-E-1182-0006 FDA FDA-2016-E-1182 Determinations of Regulatory Review Periods for Purposes of Patent Extensions: IMLYGIC Notice Determinations 2016-12-28T05:00:00Z 2016 12 2016-12-28T05:00:00Z 2017-06-27T03:59:59Z 2016-12-28T14:20:56Z 2016-31322 0 0 0900006482439ffb
FDA-2010-N-0067-0003 FDA FDA-2010-N-0067 Pharmaceutical Science and Clinical Pharmacology Advisory Committee; Notice of Meeting; Correction Notice Correction 2016-12-28T05:00:00Z 2016 12 2016-12-28T05:00:00Z   2016-12-28T14:16:07Z 2016-31391 0 0 0900006482439e88
FDA-2016-E-1181-0006 FDA FDA-2016-E-1181 Determinations of Regulatory Review Periods for Purposes of Patent Extensions: IMLYGIC Notice Determinations 2016-12-28T05:00:00Z 2016 12 2016-12-28T05:00:00Z 2017-06-27T03:59:59Z 2016-12-28T14:27:57Z 2016-31322 0 0 090000648243a973
FDA-2015-D-5105-0057 FDA FDA-2015-D-5105 Postmarket Management of Cybersecurity in Medical Devices; Guidance for Industry and Food and Drug Administration; Availability Notice Notice of Availability 2016-12-28T05:00:00Z 2016 12 2016-12-28T05:00:00Z   2016-12-28T14:24:37Z 2016-31406 0 0 090000648243a197
FDA-2016-N-4187-0001 FDA FDA-2016-N-4187 Coordinated Registry Network for Devices Used for Acute Ischemic Stroke Intervention; Public Workshop; Request for Comments Notice Public Meetings 2016-12-27T05:00:00Z 2016 12 2016-12-27T05:00:00Z 2017-03-03T04:59:59Z 2017-03-03T02:01:15Z 2016-31143 0 0 090000648243741a
FDA-2016-N-0001-0128 FDA FDA-2016-N-0001 Psychopharmacologic Drugs Advisory Committee; Notice of Meeting Notice Meeting 2016-12-27T05:00:00Z 2016 12 2016-12-27T05:00:00Z   2016-12-27T13:46:42Z 2016-31144 0 0 09000064824373d0
FDA-2016-D-1495-0014 FDA FDA-2016-D-1495 Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions; Guidance for Industry and Food and Drug Administration Staff; Availability Notice Notice of Availability 2016-12-27T05:00:00Z 2016 12 2016-12-27T05:00:00Z   2016-12-27T15:04:22Z 2016-31145 0 0 0900006482437595
FDA-2012-N-1021-0033 FDA FDA-2012-N-1021 Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal Year 2017 Proposed Guidance Development Notice Announcement 2016-12-23T05:00:00Z 2016 12 2016-12-23T05:00:00Z 2017-02-22T04:59:59Z 2019-10-15T14:26:03Z 2016-31006 0 0 0900006482433eae
FDA-2016-N-4342-0001 FDA FDA-2016-N-4342 Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Participation in the Food and Drug Administration Regulatory Science Student Internship Program Notice 60 Day Proposed Information Collection 2016-12-23T05:00:00Z 2016 12 2016-12-23T05:00:00Z 2017-02-22T04:59:59Z 2016-12-23T14:37:29Z 2016-30967 0 0 0900006482433da8
FDA-2016-N-4319-0001 FDA FDA-2016-N-4319 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Unique Device Identification System Notice 30 Day Proposed Information Collection 2016-12-23T05:00:00Z 2016 12 2016-12-23T05:00:00Z 2017-01-24T04:59:59Z 2016-12-23T14:30:43Z 2016-30966 0 0 0900006482433811
FDA-2007-D-0369-0399 FDA FDA-2007-D-0369 Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry; Availability Notice Notice of Availability 2016-12-23T05:00:00Z 2016 12 2016-12-23T05:00:00Z 2017-02-22T04:59:59Z 2017-03-08T02:01:43Z 2016-30984 0 0 09000064824338b3
FDA-2004-N-0451-0040 FDA Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards FDA-2004-N-0451 Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 046 Notice Announcement 2016-12-23T05:00:00Z 2016 12 2016-12-23T05:00:00Z   2016-12-23T14:47:43Z 2016-31008 0 0 0900006482433ef3
FDA-2016-N-2474-0002 FDA FDA-2016-N-2474 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reporting Associated With Designated New Animal Drugs for Minor Use and Minor Species Notice 30 Day Proposed Information Collection 2016-12-22T05:00:00Z 2016 12 2016-12-22T05:00:00Z 2017-01-24T04:59:59Z 2016-12-22T14:46:45Z 2016-30770 0 0 090000648243058b
FDA-2014-D-2275-0001 FDA FDA-2014-D-2275 Lead in Cosmetic Lip Products and Externally Applied Cosmetics: Recommended Maximum Level; Draft Guidance for Industry; Availability Notice Notice of Availability 2016-12-22T05:00:00Z 2016 12 2016-12-22T05:00:00Z   2016-12-22T14:49:34Z 2016-30781 0 0 0900006482430288
FDA-2010-N-0597-0005 FDA FDA-2010-N-0597 Agency Information Collection Activities; Proposed Collection; Comment Request; Index of Legally Marketed Unapproved New Animal Drugs for Minor Species Notice 60 Day Proposed Information Collection 2016-12-21T05:00:00Z 2016 12 2016-12-21T05:00:00Z 2017-02-22T04:59:59Z 2017-02-08T14:02:51Z 2016-30676 0 0 090000648242d101
FDA-2016-N-4320-0001 FDA FDA-2016-N-4320 Sun Pharmaceutical Industries, Inc.; Withdrawal of Approval of 28 Abbreviated New Drug Applications Notice Withdrawal 2016-12-20T05:00:00Z 2016 12 2016-12-20T05:00:00Z   2016-12-20T14:56:31Z 2016-30623 0 0 09000064824290f9
FDA-2016-D-0620-0003 FDA FDA-2016-D-0620 Question-Based Review for the Chemistry, Manufacturing, and Controls Technical Section of Animal Drug Applications; Guidance for Industry; Availability Notice Notice of Availability 2016-12-20T05:00:00Z 2016 12 2016-12-20T05:00:00Z   2016-12-20T14:52:21Z 2016-30613 0 0 09000064824290f3
FDA-2016-E-0626-0006 FDA FDA-2016-E-0626 Determinations of Regulatory Review Periods for Purposes of Patent Extensions: COSENTYX Notice Determinations 2016-12-20T05:00:00Z 2016 12 2016-12-20T05:00:00Z 2017-06-20T03:59:59Z 2016-12-20T14:49:29Z 2016-30528 0 0 09000064824290f2
FDA-2016-N-0969-0003 FDA FDA-2016-N-0969 Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Zika Virus; Availability Notice Announcement 2016-12-20T05:00:00Z 2016 12 2016-12-20T05:00:00Z   2016-12-20T14:59:56Z 2016-30532 0 0 090000648242960c
FDA-2012-N-0873-0007 FDA FDA-2012-N-0873 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2016-12-19T05:00:00Z 2016 12 2016-12-19T05:00:00Z   2016-12-19T15:45:14Z 2016-30351 0 0 09000064824264ce
FDA-2016-N-1593-0002 FDA FDA-2016-N-1593 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2016-12-19T05:00:00Z 2016 12 2016-12-19T05:00:00Z   2016-12-19T15:47:32Z 2016-30351 0 0 09000064824264d5
FDA-2015-N-2406-0009 FDA FDA-2015-N-2406 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2016-12-19T05:00:00Z 2016 12 2016-12-19T05:00:00Z   2016-12-19T15:48:15Z 2016-30351 0 0 09000064824264d6
FDA-2013-N-0450-0006 FDA FDA-2013-N-0450 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2016-12-19T05:00:00Z 2016 12 2016-12-19T05:00:00Z   2016-12-19T15:48:56Z 2016-30351 0 0 09000064824264f0
FDA-2011-N-0830-0030 FDA FDA-2011-N-0830 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2016-12-19T05:00:00Z 2016 12 2016-12-19T05:00:00Z   2016-12-19T15:32:16Z 2016-30351 0 0 0900006482423485
FDA-2013-N-0093-0010 FDA FDA-2013-N-0093 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2016-12-19T05:00:00Z 2016 12 2016-12-19T05:00:00Z   2016-12-19T15:47:08Z 2016-30351 0 0 09000064824264d4
FDA-2015-E-3157-0005 FDA FDA-2015-E-3157 Determination of Regulatory Review Period for Purposes of Patent Extension; TRULICITY Notice Determinations 2016-12-19T05:00:00Z 2016 12 2016-12-19T05:00:00Z 2017-06-20T03:59:59Z 2016-12-19T15:35:53Z 2016-30399 0 0 0900006482423949
FDA-2013-N-0242-0009 FDA FDA-2013-N-0242 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2016-12-19T05:00:00Z 2016 12 2016-12-19T05:00:00Z   2016-12-19T15:46:13Z 2016-30351 0 0 09000064824264d1
FDA-2008-D-0031-0005 FDA FDA-2008-D-0031 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2016-12-19T05:00:00Z 2016 12 2016-12-19T05:00:00Z   2016-12-19T15:45:42Z 2016-30351 0 0 09000064824264d0
FDA-2013-N-0125-0024 FDA FDA-2013-N-0125 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2016-12-19T05:00:00Z 2016 12 2016-12-19T05:00:00Z   2016-12-19T15:46:41Z 2016-30351 0 0 09000064824264d3
FDA-2015-D-4361-0005 FDA FDA-2015-D-4361 Gifts to the Food and Drug Administration: Evaluation and Acceptance; Guidance for the Public and Food and Drug Administration; Availability Notice Notice of Availability 2016-12-16T05:00:00Z 2016 12 2016-12-16T05:00:00Z   2016-12-16T15:05:07Z 2016-30312 0 0 0900006482414334
FDA-2014-D-1352-0005 FDA FDA-2014-D-1352 International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Bioequivalence: Blood Level Bioequivalence Study; Guidance for Industry; Availability Notice Notice of Availability 2016-12-16T05:00:00Z 2016 12 2016-12-16T05:00:00Z   2016-12-16T15:12:36Z 2016-30309 0 0 0900006482414488
FDA-2016-N-3995-0001 FDA FDA-2016-N-3995 Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended To Treat, Diagnose, or Cure Notice 60 Day Proposed Information Collection 2016-12-16T05:00:00Z 2016 12 2016-12-16T05:00:00Z 2017-02-15T04:59:59Z 2016-12-16T15:15:37Z 2016-30243 0 0 0900006482414962
FDA-2015-D-0390-0025 FDA FDA-2015-D-0390 Use of Electronic Informed Consent—Questions and Answers; Guidance for Institutional Review Boards, Investigators, and Sponsors; Availability Notice Notice of Availability 2016-12-15T05:00:00Z 2016 12 2016-12-15T05:00:00Z   2016-12-15T15:09:26Z 2016-30146 0 0 090000648240b6b5
FDA-2013-N-0795-0005 FDA FDA-2013-N-0795 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Third-Party Review Under the Food and Drug Administration Modernization Act Notice 30 Day Proposed Information Collection 2016-12-15T05:00:00Z 2016 12 2016-12-15T05:00:00Z 2017-01-18T04:59:59Z 2016-12-15T14:59:29Z 2016-30113 0 0 090000648240b585
FDA-2016-N-4119-0001 FDA FDA-2016-N-4119 Food Safety Modernization Act Third-Party Certification Program User Fee Rate for Fiscal Year 2017 Notice Announcement 2016-12-14T05:00:00Z 2016 12 2016-12-14T05:00:00Z   2016-12-14T14:50:58Z 2016-30034 0 0 090000648240749a
FDA-2016-N-4198-0001 FDA FDA-2016-N-4198 Public Meeting on Patient-Focused Drug Development for Sarcopenia; Request for Comments Notice Request for Comments 2016-12-14T05:00:00Z 2016 12 2016-12-14T05:00:00Z 2017-06-07T03:59:59Z 2017-06-07T01:02:42Z 2016-29998 0 0 0900006482407424
FDA-2012-N-0477-0008 FDA FDA-2012-N-0477 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2016-12-14T05:00:00Z 2016 12 2016-12-14T05:00:00Z   2016-12-14T16:05:49Z 2016-30035 0 0 0900006482408288
FDA-2016-D-4120-0001 FDA FDA-2016-D-4120 Fruit Juice and Vegetable Juice as Color Additives in Food; Draft Guidance for Industry; Availability Notice Notice of Availability 2016-12-14T05:00:00Z 2016 12 2016-12-14T05:00:00Z 2017-02-14T04:59:59Z 2017-02-14T02:00:19Z 2016-29968 0 0 0900006482407498
FDA-2013-N-0662-0006 FDA FDA-2013-N-0662 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2016-12-14T05:00:00Z 2016 12 2016-12-14T05:00:00Z   2016-12-14T16:05:07Z 2016-30035 0 0 0900006482408286
FDA-2013-N-0519-0006 FDA FDA-2013-N-0519 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2016-12-14T05:00:00Z 2016 12 2016-12-14T05:00:00Z   2016-12-14T14:45:15Z 2016-30035 0 0 0900006482407453
FDA-2009-N-0511-0006 FDA FDA-2009-N-0511 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2016-12-14T05:00:00Z 2016 12 2016-12-14T05:00:00Z   2016-12-14T16:02:32Z 2016-30035 0 0 090000648240823d
FDA-2013-N-0134-0005 FDA FDA-2013-N-0134 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2016-12-14T05:00:00Z 2016 12 2016-12-14T05:00:00Z   2016-12-14T16:02:06Z 2016-30035 0 0 090000648240823b
FDA-2013-N-0450-0005 FDA FDA-2013-N-0450 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2016-12-14T05:00:00Z 2016 12 2016-12-14T05:00:00Z   2016-12-14T16:05:28Z 2016-30035 0 0 0900006482408287
FDA-2013-N-0375-0005 FDA FDA-2013-N-0375 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2016-12-14T05:00:00Z 2016 12 2016-12-14T05:00:00Z   2016-12-14T16:01:21Z 2016-30035 0 0 0900006482408237
FDA-2013-N-0370-0005 FDA FDA-2013-N-0370 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2016-12-14T05:00:00Z 2016 12 2016-12-14T05:00:00Z   2016-12-14T16:01:43Z 2016-30035 0 0 0900006482408238
FDA-2011-N-0902-0009 FDA FDA-2011-N-0902 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2016-12-14T05:00:00Z 2016 12 2016-12-14T05:00:00Z   2016-12-14T16:04:45Z 2016-30035 0 0 0900006482408240
FDA-1997-N-0020-0194 FDA Substances Generally Recognized as Safe (GRAS) - Closed FDA-1997-N-0020 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2016-12-14T05:00:00Z 2016 12 2016-12-14T05:00:00Z   2016-12-14T16:04:21Z 2016-30035 0 0 090000648240823f
FDA-2015-D-4803-0030 FDA FDA-2015-D-4803 Public Notification of Emerging Postmarket Medical Device Signals (‘‘Emerging Signals’’); Guidance for Industry and Food and Drug Administration Staff; Availability Notice Notice of Availability 2016-12-14T05:00:00Z 2016 12 2016-12-14T05:00:00Z   2016-12-14T14:56:12Z 2016-29989 0 0 0900006482407d7e
FDA-2016-N-2836-0008 FDA FDA-2016-N-2836 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Donor Risk Assessment Questionnaire for the Food and Drug Administration/National Heart, Lung, and Blood Institute-Sponsored Transfusion-Transmissible Infections Monitoring System—Risk Factor Elicitation Notice 30 Day Proposed Information Collection 2016-12-13T05:00:00Z 2016 12 2016-12-13T05:00:00Z 2017-01-13T04:59:59Z 2019-12-27T18:27:32Z 2016-29814 0 0 09000064823fed94
FDA-2009-D-0508-0014 FDA FDA-2009-D-0508 Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishment; Guidance for Industry; Availability Notice Notice of Availability 2016-12-13T05:00:00Z 2016 12 2016-12-13T05:00:00Z   2016-12-13T14:22:26Z 2016-29776 0 0 09000064823fe52b
FDA-2016-E-0625-0005 FDA FDA-2016-E-0625 Determinations of Regulatory Review Periods for Purposes of Patent Extensions: NUCALA Notice Determinations 2016-12-13T05:00:00Z 2016 12 2016-12-13T05:00:00Z 2017-06-13T03:59:59Z 2016-12-13T14:24:15Z 2016-29838 0 0 09000064823fe725
FDA-2013-N-0764-0009 FDA FDA-2013-N-0764 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Feed Regulatory Program Standards Notice 30 Day Proposed Information Collection 2016-12-13T05:00:00Z 2016 12 2016-12-13T05:00:00Z 2017-01-13T04:59:59Z 2016-12-13T14:27:29Z 2016-29839 0 0 09000064823fed90
FDA-2016-P-1363-0005 FDA FDA-2016-P-1363 Determination That SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER (Sodium Chloride), Injectable, 234 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice Determinations 2016-12-12T05:00:00Z 2016 12 2016-12-12T05:00:00Z   2016-12-12T14:18:25Z 2016-29674 0 0 09000064823f9857
FDA-2000-D-0128-0003 FDA Assessment of Antimicrobial Susceptibility Devices FDA-2000-D-0128 Medical Devices: Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test Systems; Guidance for Industry and FDA; Availability Notice Notice of Availability 2016-12-12T05:00:00Z 2016 12 2016-12-12T05:00:00Z   2016-12-13T02:01:35Z   0 0 09000064823fc479
FDA-2016-D-3466-0001 FDA FDA-2016-D-3466 Immediately in Effect Guidance Document: Conditions for Sale for Air-Conduction Hearing Aids; Guidance for Industry and Food and Drug Administration Staff; Availability Notice Notice of Availability 2016-12-12T05:00:00Z 2016 12 2016-12-12T05:00:00Z   2016-12-12T13:46:11Z 2016-29724 0 0 09000064823f97ff
FDA-2016-D-1814-0001 FDA FDA-2016-D-1814 Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability Notice Notice of Availability 2016-12-09T05:00:00Z 2016 12 2016-12-09T05:00:00Z 2017-02-08T04:59:59Z 2017-02-08T02:04:29Z 2016-29587 0 0 09000064823f44a8
FDA-2014-D-0609-0022 FDA FDA-2014-D-0609 Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification; Guidance for Industry; Availability Notice Notice of Availability 2016-12-09T05:00:00Z 2016 12 2016-12-09T05:00:00Z   2025-04-01T16:32:50Z 2016-29588 0 0 09000064823f4a40
FDA-2016-N-4096-0001 FDA FDA-2016-N-4096 Final Assessment of the Program for Enhanced Review Transparency and Communication; Public Meeting and Establishment of Docket Notice Announcement 2016-12-09T05:00:00Z 2016 12 2016-12-09T05:00:00Z 2017-04-04T03:59:59Z 2017-04-04T13:00:45Z 2016-29589 0 0 09000064823f4bfc
FDA-2011-N-0146-0239 FDA FDA-2011-N-0146 Third-Party Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards; Guidance for Industry and Food and Drug Administration Staff; Availability Notice Notice of Availability 2016-12-07T05:00:00Z 2016 12 2016-12-07T05:00:00Z   2016-12-07T16:14:15Z 2016-29278 0 0 09000064823e6ef0
FDA-2016-E-0630-0005 FDA FDA-2016-E-0630 Determination of Regulatory Review Period for Purposes of Patent Extension; GARDASIL 9 Notice Determinations 2016-12-07T05:00:00Z 2016 12 2016-12-07T05:00:00Z 2017-02-07T04:59:59Z 2016-12-07T14:56:23Z 2016-29303 0 0 09000064823e7947
FDA-2016-N-3274-0001 FDA FDA-2016-N-3274 Posting Adverse Event Report Data Associated With Conventional Foods, Dietary Supplements, and Cosmetics on the Internet; Availability Notice Notice of Availability 2016-12-07T05:00:00Z 2016 12 2016-12-07T05:00:00Z   2016-12-07T14:52:14Z 2016-29277 0 0 09000064823e6fa0
FDA-2016-E-1102-0003 FDA FDA-2016-E-1102 Determination of Regulatory Review Period for Purposes of Patent Extension; GARDASIL 9 Notice Determinations 2016-12-07T05:00:00Z 2016 12 2016-12-07T05:00:00Z 2017-02-07T04:59:59Z 2016-12-07T14:55:45Z 2016-29303 0 0 09000064823e7105
FDA-2013-D-0117-0006 FDA FDA-2013-D-0117 Agency Information Collection Activities; Proposed Collection; Comment Request; Providing Information About Pediatric Uses of Medical Devices Notice 60 Day Proposed Information Collection 2016-12-05T05:00:00Z 2016 12 2016-12-05T05:00:00Z 2017-02-04T04:59:59Z 2016-12-05T16:11:40Z 2016-29105 0 0 09000064823ded6b
FDA-1999-D-1875-0024 FDA Use of Medicated Feeds for Minor Species FDA-1999-D-1875 Compliance Policy Guide Sec. 615.115 on Extralabel Use of Medicated Feeds for Minor Species; Availability Notice Notice of Availability 2016-12-05T05:00:00Z 2016 12 2016-12-05T05:00:00Z   2016-12-05T16:29:04Z 2016-29133 0 0 09000064823def04
FDA-2013-N-1089-0004 FDA FDA-2013-N-1089 Agency Information Collection Activities; Proposed Collection; Comment Request; Recommended Glossary and Educational Outreach To Support Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use Notice 60 Day Proposed Information Collection 2016-12-05T05:00:00Z 2016 12 2016-12-05T05:00:00Z 2017-02-04T04:59:59Z 2016-12-05T16:32:01Z 2016-29104 0 0 09000064823def94
FDA-2016-N-2544-0002 FDA FDA-2016-N-2544 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device: Current Good Manufacturing Practice Quality System Regulations Notice 30 Day Proposed Information Collection 2016-12-05T05:00:00Z 2016 12 2016-12-05T05:00:00Z 2017-01-05T04:59:59Z 2016-12-05T16:16:22Z 2016-29028 0 0 09000064823dedfc
FDA-2016-E-0617-0005 FDA FDA-2016-E-0617 Determinations of Regulatory Review Periods for Purposes of Patent Extension: BEXSERO Notice Determinations 2016-12-05T05:00:00Z 2016 12 2016-12-05T05:00:00Z 2017-06-06T03:59:59Z 2016-12-05T16:32:55Z 2016-29025 0 0 09000064823e018b
FDA-2016-N-2896-0004 FDA FDA-2016-N-2896 Public Meeting on Pre-Market Evaluation of Abuse-Deterrent Properties of Opioid Drug Products; Extension of Comment Period Notice Extension of Comment Period 2016-12-05T05:00:00Z 2016 12 2016-12-05T05:00:00Z 2017-01-04T04:59:59Z 2017-01-04T02:00:17Z 2016-29097 0 0 09000064823ded68
FDA-2016-E-0619-0005 FDA FDA-2016-E-0619 Determinations of Regulatory Review Periods for Purposes of Patent Extension: BEXSERO Notice Determinations 2016-12-05T05:00:00Z 2016 12 2016-12-05T05:00:00Z 2017-06-06T03:59:59Z 2016-12-05T16:22:30Z 2016-29025 0 0 09000064823deeab
FDA-2009-D-0095-0015 FDA FDA-2009-D-0095 Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products—Content and Format; Guidance for Industry; Availability Notice Notice of Availability 2016-12-05T05:00:00Z 2016 12 2016-12-05T05:00:00Z   2016-12-05T16:25:46Z 2016-29125 0 0 09000064823deeb0
FDA-2009-D-0600-0019 FDA FDA-2009-D-0600 Health Document Submission Requirements for Tobacco Products; Guidance for Industry; Availability Notice Notice of Availability 2016-12-05T05:00:00Z 2016 12 2016-12-05T05:00:00Z   2016-12-05T15:39:55Z 2016-29117 0 0 09000064823ded63
FDA-2015-E-3159-0004 FDA FDA-2015-E-3159 Determination of Regulatory Review Period for Purposes of Patent Extension; TRUMENBA Notice Determinations 2016-12-02T05:00:00Z 2016 12 2016-12-02T05:00:00Z 2017-06-01T03:59:59Z 2016-12-02T17:20:09Z 2016-28916 0 0 09000064823db1ad
FDA-2016-E-0616-0005 FDA FDA-2016-E-0616 Determination of Regulatory Review Period for Purposes of Patent Extension; OPDIVO Notice Determinations 2016-12-02T05:00:00Z 2016 12 2016-12-02T05:00:00Z 2017-06-01T03:59:59Z 2016-12-02T17:04:55Z 2016-28917 0 0 09000064823da02e
FDA-2015-E-5107-0004 FDA FDA-2015-E-5107 Determination of Regulatory Review Period for Purposes of Patent Extension; TRESIBA Notice Determinations 2016-12-02T05:00:00Z 2016 12 2016-12-02T05:00:00Z 2017-06-01T03:59:59Z 2016-12-02T16:58:01Z 2016-28939 0 0 09000064823d9ecd
FDA-2015-E-3158-0004 FDA FDA-2015-E-3158 Determination of Regulatory Review Period for Purposes of Patent Extension; TRUMENBA Notice Determinations 2016-12-02T05:00:00Z 2016 12 2016-12-02T05:00:00Z 2017-06-01T03:59:59Z 2016-12-02T17:14:07Z 2016-28916 0 0 09000064823da076
FDA-2016-D-3969-0001 FDA FDA-2016-D-3969 Physiologically Based Pharmacokinetic Analyses--Format and Content; Draft Guidance for Industry; Availability Notice Notice of Availability 2016-12-02T05:00:00Z 2016 12 2016-12-02T05:00:00Z 2017-02-01T04:59:59Z 2017-02-01T02:02:41Z 2016-28971 0 0 09000064823da07b
FDA-2016-D-2635-0125 FDA FDA-2016-D-2635 The Judicious Use of Medically Important Antimicrobial Drugs in Food- Producing Animals; Establishing Appropriate Durations of Therapeutic Administration; Extension of Comment Period Notice Extension of Comment Period 2016-11-29T05:00:00Z 2016 11 2016-11-29T05:00:00Z 2017-03-14T03:59:59Z 2017-03-22T01:02:45Z 2016-28660 0 0 09000064823c5eee
FDA-2016-F-3880-0001 FDA FDA-2016-F-3880 Novus International, Inc.; Filing of Food Additive Petition (Animal Use); Correction Notice Correction 2016-11-29T05:00:00Z 2016 11 2016-11-29T05:00:00Z   2016-11-29T14:42:23Z 2016-28656 0 0 09000064823c5ea5
FDA-2014-D-2153-0012 FDA FDA-2014-D-2153 Mitigating the Risk of Cross-Contamination From Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes; Guidance for Industry and Food and Drug Administration Staff; Availability Notice Notice of Availability 2016-11-29T05:00:00Z 2016 11 2016-11-29T05:00:00Z   2016-11-29T15:27:12Z 2016-28604 0 0 09000064823c5eed
FDA-2016-N-0735-0026 FDA FDA-2016-N-0735 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Superimposed Text in Direct-to-Consumer Promotion of Prescription Drugs Notice 30 Day Proposed Information Collection 2016-11-29T05:00:00Z 2016 11 2016-11-29T05:00:00Z 2016-12-30T04:59:59Z 2016-12-02T02:01:55Z 2016-28733 0 0 09000064823c5eef
FDA-2013-D-0575-0033 FDA FDA-2013-D-0575 Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry on Expedited Programs for Serious Conditions—Drugs and Biologics Notice 60 Day Proposed Information Collection 2016-11-29T05:00:00Z 2016 11 2016-11-29T05:00:00Z 2017-01-31T04:59:59Z 2016-11-29T15:05:48Z 2016-28732 0 0 09000064823c5ea9
FDA-2015-E-4669-0004 FDA FDA-2015-E-4669 Determination of Regulatory Review Period for Purposes of Patent Extension; IXINITY Notice Determinations 2016-11-29T05:00:00Z 2016 11 2016-11-29T05:00:00Z 2017-05-31T03:59:59Z 2016-11-29T16:20:41Z 2016-28653 0 0 09000064823c693a
FDA-2011-N-0830-0029 FDA FDA-2011-N-0830 Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Abbreviated New Drug Applications and 505(b)(2) Applications Notice Notice of Approval 2016-11-29T05:00:00Z 2016 11 2016-11-29T05:00:00Z   2016-11-29T16:14:37Z 2016-28655 0 0 09000064823c607f
FDA-2015-E-4659-0004 FDA FDA-2015-E-4659 Determination of Regulatory Review Period for Purposes of Patent Extension; IXINITY Notice Determinations 2016-11-29T05:00:00Z 2016 11 2016-11-29T05:00:00Z 2017-05-31T03:59:59Z 2016-11-29T14:56:12Z 2016-28653 0 0 09000064823c5ea6
FDA-2010-N-0067-0002 FDA FDA-2010-N-0067 Pharmaceutical Science and Clinical Pharmacology Advisory Committee; Establishment of a Public Docket; Request for Comments; Notice of Meeting Notice Request for Comments 2016-11-29T05:00:00Z 2016 11 2016-11-29T05:00:00Z 2017-04-15T03:59:59Z 2017-04-15T01:02:05Z 2016-28605 0 0 09000064823c6040
FDA-2013-D-0349-0010 FDA FDA-2013-D-0349 Providing Postmarketing Periodic Safety Reports in the International Council for Harmonisation E2C(R2) Format (Periodic Benefit-Risk Evaluation Report); Guidance for Industry; Availability Notice Notice of Availability 2016-11-29T05:00:00Z 2016 11 2016-11-29T05:00:00Z   2016-11-29T15:53:39Z 2016-28606 0 0 09000064823c5f73

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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,
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    posted_date TEXT,
    posted_year INTEGER,
    posted_month INTEGER,
    comment_start_date TEXT,
    comment_end_date TEXT,
    last_modified TEXT,
    fr_doc_num TEXT,
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);
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);