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

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127 rows where agency_id = "FDA", document_type = "Rule" and posted_year = 2016 sorted by posted_date descending

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posted_year 1

  • 2016 · 127 ✖

document_type 1

  • Rule · 127 ✖

agency_id 1

  • FDA · 127 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2014-N-1205-0019 FDA FDA-2014-N-1205 Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems Rule Final Rule 2016-12-30T05:00:00Z 2016 12 2016-12-30T05:00:00Z   2016-12-30T14:11:28Z 2016-31670 0 0 0900006482441325
FDA-2011-F-0172-0619 FDA FDA-2011-F-0172 Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Extension of Compliance Date Rule Final Rule 2016-12-30T05:00:00Z 2016 12 2016-12-30T05:00:00Z   2016-12-30T13:58:42Z 2016-31597 0 0 09000064824412de
FDA-2016-N-1555-0007 FDA FDA-2016-N-1555 Refuse to Accept Procedures for Premarket Tobacco Product Submissions Rule Final Rule 2016-12-29T05:00:00Z 2016 12 2016-12-29T05:00:00Z   2016-12-29T15:14:13Z 2016-31370 0 0 090000648243d41a
FDA-2016-N-0002-0034 FDA FDA-2016-N-0002 Oral Dosage Form New Animal Drugs; Approval of New Animal Drug Applications Rule Final Rule 2016-12-27T05:00:00Z 2016 12 2016-12-27T05:00:00Z   2016-12-27T15:20:22Z 2016-31084 0 0 0900006482437617
FDA-2016-N-0002-0033 FDA FDA-2016-N-0002 New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications Rule Withdrawal 2016-12-27T05:00:00Z 2016 12 2016-12-27T05:00:00Z   2016-12-27T14:40:37Z 2016-31082 0 0 09000064824374ac
FDA-2016-N-0002-0032 FDA FDA-2016-N-0002 New Animal Drugs for Use in Animal Feed; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications Rule Final Rule 2016-12-27T05:00:00Z 2016 12 2016-12-27T05:00:00Z   2016-12-27T13:37:48Z 2016-31083 0 0 090000648243727b
FDA-2015-F-4282-0002 FDA FDA-2015-F-4282 Food Additives Permitted in Feed and Drinking Water of Animals; Feed Grade Sodium Formate Rule Correction 2016-12-27T05:00:00Z 2016 12 2016-12-27T05:00:00Z 2017-01-27T04:59:59Z 2016-12-27T15:16:43Z 2016-31079 0 0 0900006482437611
FDA-2016-N-4165-0001 FDA FDA-2016-N-4165 Medical Devices: Neurological Devices; Classification of the Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment Rule Final Rule 2016-12-23T05:00:00Z 2016 12 2016-12-23T05:00:00Z   2016-12-23T14:39:36Z 2016-31007 0 0 0900006482433e5d
FDA-2008-N-0424-0019 FDA FDA-2008-N-0424 Postmarketing Safety Reporting for Combination Products Rule Final Rule 2016-12-20T05:00:00Z 2016 12 2016-12-20T05:00:00Z   2016-12-20T15:03:50Z 2016-30485 0 0 0900006482429777
FDA-2015-N-0701-0022 FDA FDA-2015-N-0701 General Hospital and Personal Use Devices: Renaming of Pediatric Hospital Bed Classification and Designation of Special Controls for Pediatric Medical Crib; Classification of Medical Bassinet Rule Final Rule 2016-12-19T05:00:00Z 2016 12 2016-12-19T05:00:00Z   2016-12-19T15:38:25Z 2016-30193 0 0 090000648242398e
FDA-2015-N-5017-0173 FDA FDA-2015-N-5017 Banned Devices; Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove Rule Final Rule 2016-12-19T05:00:00Z 2016 12 2016-12-19T05:00:00Z   2016-12-19T15:09:59Z 2016-30382 0 0 0900006482423312
FDA-2013-P-0047-0005 FDA FDA-2013-P-0047 Food Labeling: Health Claims; Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease Rule Interim Final Rule 2016-12-19T05:00:00Z 2016 12 2016-12-19T05:00:00Z 2017-03-07T04:59:59Z 2017-03-07T14:00:52Z 2016-29997 0 0 09000064824233a7
FDA-2011-N-0146-0241 FDA FDA-2011-N-0146 Amendments to Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications to Provide for User Fee Program Rule Final Rule 2016-12-14T05:00:00Z 2016 12 2016-12-14T05:00:00Z   2016-12-14T14:53:56Z 2016-30033 0 0 09000064824074c7
FDA-2005-N-0464-0238 FDA Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs; Correction Rule Final Rule 2016-12-13T05:00:00Z 2016 12 2016-12-13T05:00:00Z   2016-12-13T14:31:48Z 2016-29774 0 0 09000064823fed93
FDA-2015-N-2737-0002 FDA FDA-2015-N-2737 Medical Devices: Neurological Devices; Classification of the Computerized Cognitive Assessment Aid for Concussion Rule Final Rule 2016-12-06T05:00:00Z 2016 12 2016-12-06T05:00:00Z   2016-12-06T15:07:02Z 2016-29134 0 0 09000064823e337c
FDA-2015-F-2337-0003 FDA FDA-2015-F-2337 Food Additives: Permitted in Feed and Drinking Water of Animals; Guanidinoacetic Acid Rule Final Rule 2016-11-30T05:00:00Z 2016 11 2016-11-30T05:00:00Z 2016-12-31T04:59:59Z 2016-12-05T02:00:16Z 2016-28754 0 0 09000064823cb5aa
FDA-2016-N-1896-0011 FDA FDA-2016-N-1896 New Animal Drugs for Use in Animal Feed; Category Definitions; Confirmation of Effective Date Rule Direct Final Rule 2016-11-29T05:00:00Z 2016 11 2016-11-29T05:00:00Z   2016-11-29T15:59:47Z 2016-28607 0 0 09000064823c5fbb
FDA-2016-N-1487-0022 FDA FDA-2016-N-1487 Submission of Food and Drug Administration Import Data in the Automated Commercial Environment Rule Final Rule 2016-11-29T05:00:00Z 2016 11 2016-11-29T05:00:00Z   2016-11-29T16:07:38Z 2016-28582 0 0 09000064823c5ff3
FDA-2000-N-0011-0010 FDA Uniform Compliance Date for Food Labeling Regulations FDA-2000-N-0011 Uniform Compliance Date for Food Labeling Regulations Rule Direct Final Rule 2016-11-25T05:00:00Z 2016 11 2016-11-25T05:00:00Z 2017-01-25T04:59:59Z 2017-01-25T02:00:12Z 2016-28333 0 0 09000064823bed7c
FDA-2016-N-0543-0013 FDA FDA-2016-N-0543 Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications Rule Direct Final Rule 2016-11-23T05:00:00Z 2016 11 2016-11-23T05:00:00Z   2016-11-23T14:57:20Z 2016-28120 0 0 09000064823b9aa7
FDA-2011-F-0172-0616 FDA FDA-2011-F-0172 21 CFR Part 101 Food Labeling CFR Correction Rule Correction 2016-11-23T05:00:00Z 2016 11 2016-11-23T05:00:00Z   2016-11-24T05:34:01Z 2016-28363 0 0 09000064823b5f24
FDA-2011-F-0172-0618 FDA FDA-2011-F-0172 21 CFR Part 101 Food Labeling CFR Correction Rule Correction 2016-11-23T05:00:00Z 2016 11 2016-11-23T05:00:00Z   2016-11-24T05:42:56Z 2016-28364 0 0 09000064823b9b36
FDA-2011-F-0172-0617 FDA FDA-2011-F-0172 21 CFR Part 101 Food Labeling CFR Correction Rule Correction 2016-11-23T05:00:00Z 2016 11 2016-11-23T05:00:00Z   2016-11-24T05:39:35Z 2016-28367 0 0 09000064823b9aa6
FDA-2016-F-1153-0004 FDA FDA-2016-F-1153 Indirect Food Additives: Paper and Paperboard Components Rule Direct Final Rule 2016-11-22T05:00:00Z 2016 11 2016-11-22T05:00:00Z 2016-12-23T04:59:59Z 2016-12-22T02:01:54Z 2016-28116 0 0 09000064823ad1ec
FDA-2005-N-0343-0036 FDA Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements FDA-2005-N-0343 Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements Rule Correction 2016-11-18T05:00:00Z 2016 11 2016-11-18T05:00:00Z   2016-11-18T18:23:52Z 2016-27838 0 0 09000064823a092d
FDA-2016-N-1555-0006 FDA FDA-2016-N-1555 Refuse To Accept Procedures for Premarket Tobacco Product Submissions; Withdrawal Rule Direct Final Rule 2016-11-16T05:00:00Z 2016 11 2016-11-16T05:00:00Z   2016-11-16T16:03:10Z 2016-27456 0 0 0900006482398c71
FDA-2011-N-0697-0005 FDA FDA-2011-N-0697 Amendments to Regulations on Citizen Petitions, Petitions for Stay of Action, and Submission of Documents to Dockets Rule Correction 2016-11-08T05:00:00Z 2016 11 2016-11-08T05:00:00Z   2016-11-08T13:57:09Z 2016-26912 0 0 090000648237b6dd
FDA-2012-N-0222-0002 FDA FDA-2012-N-0222 Revision of Organization and Conforming Changes to Regulation Rule Direct Final Rule 2016-11-07T05:00:00Z 2016 11 2016-11-07T05:00:00Z   2016-11-07T14:37:34Z 2016-26799 0 0 09000064823779b9
FDA-2016-F-0821-0002 FDA FDA-2016-F-0821 Listing of Color Additives Exempt From Certification; Titanium Dioxide and Listing of Color Additives Subject to Certification; [Phthalocyaninato (2-)] Copper Rule Direct Final Rule 2016-11-01T04:00:00Z 2016 11 2016-11-01T04:00:00Z 2016-12-02T04:59:59Z 2016-12-02T02:00:29Z 2016-26310 0 0 090000648236253f
FDA-2015-N-1355-0003 FDA FDA-2015-N-1355 Use of Ozone-Depleting Substances Rule Direct Final Rule 2016-10-26T04:00:00Z 2016 10 2016-10-26T04:00:00Z 2016-12-28T04:59:59Z 2016-12-28T02:02:24Z 2016-25851 0 0 090000648234d51a
FDA-2016-N-3287-0001 FDA FDA-2016-N-3287 Medical Devices: Ear, Nose, and Throat Devices; Classification of the Eustachian Tube Balloon Dilation System Rule Final Rule 2016-10-24T04:00:00Z 2016 10 2016-10-24T04:00:00Z   2016-10-24T14:08:20Z 2016-25602 0 0 09000064823432a8
FDA-2016-N-2829-0001 FDA FDA-2016-N-2829 Medical Devices: Physical Medicine Devices; Classification of the Upper Extremity Prosthesis Including a Simultaneously Powered Elbow and/or Shoulder With Greater Than Two Simultaneous Powered Degrees of Freedom and Controlled by Non-Implanted Electrical Components Rule Final Rule 2016-10-18T04:00:00Z 2016 10 2016-10-18T04:00:00Z   2016-10-18T13:58:20Z 2016-25001 0 0 090000648230f555
FDA-2016-N-2766-0001 FDA FDA-2016-N-2766 Medical Devices; Cardiovascular Devices; Classification of the Apical Closure Device Rule Final Rule 2016-10-17T04:00:00Z 2016 10 2016-10-17T04:00:00Z   2016-10-17T13:50:52Z 2016-25002 0 0 0900006482303698
FDA-2016-N-2518-0001 FDA FDA-2016-N-2518 Medical Devices: Custom Devices; Technical Amendment Rule Final Rule 2016-10-12T04:00:00Z 2016 10 2016-10-12T04:00:00Z   2016-10-12T14:10:29Z 2016-24438 0 0 09000064822e6fe5
FDA-1999-N-0194-0009 FDA Additions to the List of Drug Products Have Been Withdrawn FDA-1999-N-0194 Additions to the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness Rule Final Rule 2016-10-07T04:00:00Z 2016 10 2000-01-04T05:00:00Z 2000-03-21T04:59:59Z 2024-10-28T16:55:00Z 00-76 0 0 09000064822aa00d
FDA-2011-N-0830-0022 FDA FDA-2011-N-0830 Abbreviated New Drug Applications and 505(b)(2) Applications Rule Final Rule 2016-10-06T04:00:00Z 2016 10 2016-10-06T04:00:00Z   2016-10-06T15:06:45Z 2016-22690 0 0 090000648229ee69
FDA-2016-P-1026-0006 FDA FDA-2016-P-1026 Medical Devices; Exemption From Premarket Notification: Method, Metallic Reduction, Glucose (Urinary, Nonquantitative) Test System in a Reagent Tablet Format Rule Final Rule 2016-10-04T04:00:00Z 2016 10 2016-10-04T04:00:00Z   2016-10-04T16:10:04Z 2016-23899 0 0 0900006482291406
FDA-2016-P-0159-0007 FDA FDA-2016-P-0159 Medical Devices; Exemption From Premarket Notification; Method, Metallic Reduction, Glucose (Urinary, Nonquantitative) Test System in a Reagent Tablet Format Rule Final Rule 2016-10-04T04:00:00Z 2016 10 2016-10-04T04:00:00Z   2016-10-04T15:42:52Z 2016-23901 0 0 09000064822912df
FDA-2014-F-0988-0003 FDA FDA-2014-F-0988 Food Additives: Permitted in Feed and Drinking Water of Animals; Feed Grade Sodium Formate Rule Final Rule 2016-09-30T04:00:00Z 2016 9 2016-09-30T04:00:00Z 2016-11-01T03:59:59Z 2016-10-05T01:00:45Z 2016-23671 0 0 0900006482284a3e
FDA-2016-N-2677-0001 FDA FDA-2016-N-2677 Medical Devices: Neurological Devices; Classification of the Evoked Photon Image Capture Device Rule Final Rule 2016-09-30T04:00:00Z 2016 9 2016-09-30T04:00:00Z   2016-09-30T13:32:56Z 2016-23633 0 0 090000648228499e
FDA-2016-N-0002-0030 FDA FDA-2016-N-0002 New Animal Drugs: Approval of New Animal Drug Applications; Change of Sponsor's Address Rule Final Rule 2016-09-30T04:00:00Z 2016 9 2016-09-30T04:00:00Z   2016-09-30T13:43:41Z 2016-23230 0 0 0900006482284ad3
FDA-2016-N-2656-0001 FDA FDA-2016-N-2656 Medical Devices; Ophthalmic Devices; Classification of Strabismus Detection Device Rule Final Rule 2016-09-22T04:00:00Z 2016 9 2016-09-22T04:00:00Z   2016-09-22T13:55:13Z 2016-22801 0 0 0900006482239eee
FDA-2016-N-2562-0001 FDA FDA-2016-N-2562 Medical Devices: General and Plastic Surgery Devices; Classification of Magnetic Surgical Instrument System Rule Final Rule 2016-09-21T04:00:00Z 2016 9 2016-09-21T04:00:00Z   2016-09-21T15:37:42Z 2016-22709 0 0 0900006482234401
FDA-1996-F-0288-0003 FDA Safe use of dimethyl 1,4-cyclohexanedicarboxylate as a monomer - CLOSED FDA-1996-F-0288 Indirect Food Additives: Adhesives and Components of Coatings Rule Final Rule 2016-09-21T04:00:00Z 2016 9 2016-09-21T04:00:00Z 1996-09-17T03:59:59Z 2016-09-21T13:13:41Z 1996-20858 0 0 0900006480504a32
FDA-2011-N-0920-2051 FDA FDA-2011-N-0920 Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals; Definition of Qualified Auditor; Announcement of Effective Date Rule Final Rule 2016-09-19T04:00:00Z 2016 9 2016-09-19T04:00:00Z   2016-09-19T13:18:08Z 2016-22494 0 0 09000064822261bf
FDA-2011-N-0922-0555 FDA FDA-2011-N-0922 Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals; Definition of Qualified Auditor; Announcement of Effective Date Rule Final Rule 2016-09-19T04:00:00Z 2016 9 2016-09-19T04:00:00Z   2016-09-19T13:20:44Z 2016-22494 0 0 09000064822269c3
FDA-2016-N-0002-0029 FDA FDA-2016-N-0002 New Animal Drugs for Use in Animal Feeds: Chlortetracycline and Sulfamethazine; Chlortetracycline, Procaine Penicillin, and Sulfamethazine Rule Final Rule 2016-09-14T04:00:00Z 2016 9 2016-09-14T04:00:00Z   2016-09-14T13:59:59Z 2016-21985 0 0 090000648220a1e1
FDA-2016-N-1745-0001 FDA FDA-2016-N-1745 Maximum Civil Money Penalty Amounts; Technical Amendment Rule Final Rule 2016-09-09T04:00:00Z 2016 9 2016-09-09T04:00:00Z   2016-09-09T14:20:41Z 2016-21705 0 0 09000064821e7622
FDA-1997-N-0020-0183 FDA Substances Generally Recognized as Safe (GRAS) - Closed FDA-1997-N-0020 Substances Generally Recognized as Safe Rule Correction 2016-09-08T04:00:00Z 2016 9 2016-09-08T04:00:00Z   2016-09-08T13:30:11Z C1-2016-19164 0 0 09000064821e0d81
FDA-1975-N-0012-0651 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Rule Final Rule 2016-09-06T04:00:00Z 2016 9 2016-09-06T04:00:00Z 2019-04-04T03:59:59Z 2019-04-03T01:05:19Z 2016-21337 0 0 09000064821d2e5a
FDA-1980-N-0220-0003 FDA GRAS STATUS OF ETHYL ACRYLATE AND METHYL ACRYLATE FDA-1980-N-0220 GRAS Status of Ethyl Acrylate and Methyl Acrylate Rule Final Rule 2016-09-06T04:00:00Z 2016 9 2016-09-06T04:00:00Z 1983-03-18T04:59:59Z 2016-09-06T14:48:19Z   0 0 09000064805bda78
FDA-2005-N-0464-0234 FDA Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs Rule Final Rule 2016-08-31T04:00:00Z 2016 8 2016-08-31T04:00:00Z   2016-08-31T14:21:07Z 2016-20471 0 0 09000064821b68af
FDA-2016-N-0002-0019 FDA FDA-2016-N-0002 New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of Sponsor's Name and Address; Change of Sponsor's Address Rule Correction 2016-08-29T04:00:00Z 2016 8 2016-08-29T04:00:00Z   2016-08-29T15:36:17Z 2016-19914 0 0 09000064821a8156
FDA-2016-N-0002-0018 FDA FDA-2016-N-0002 New Animal Drugs for Use in Animal Feed; Withdrawal of Approval of a New Animal Drug Application Rule Withdrawal 2016-08-29T04:00:00Z 2016 8 2016-08-29T04:00:00Z   2016-08-29T15:26:57Z 2016-19915 0 0 09000064821a7b65
FDA-2016-N-0011-0004 FDA FDA-2016-N-0011 Food Labeling: Technical Amendments Rule Correction 2016-08-29T04:00:00Z 2016 8 2016-08-29T04:00:00Z   2016-08-29T15:32:12Z 2016-19925 0 0 09000064821a7beb
FDA-2011-N-0922-0554 FDA FDA-2011-N-0922 The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules Rule Final Rule 2016-08-24T04:00:00Z 2016 8 2016-08-24T04:00:00Z   2016-08-24T15:40:21Z 2016-20176 0 0 0900006482198510
FDA-2016-N-1896-0002 FDA FDA-2016-N-1896 New Animal Drugs for Use in Animal Feed; Category Definitions Rule Direct Final Rule 2016-08-24T04:00:00Z 2016 8 2016-08-24T04:00:00Z 2016-11-08T04:59:59Z 2016-11-08T02:01:08Z 2016-20148 0 0 09000064821977aa
FDA-2011-N-0921-19134 FDA FDA-2011-N-0921 The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules Rule Final Rule 2016-08-24T04:00:00Z 2016 8 2016-08-24T04:00:00Z   2017-11-16T02:05:03Z 2016-20176 0 0 090000648219850f
FDA-2011-N-0920-2050 FDA FDA-2011-N-0920 The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules Rule Final Rule 2016-08-24T04:00:00Z 2016 8 2016-08-24T04:00:00Z   2016-08-24T15:34:58Z 2016-20176 0 0 090000648219850e
FDA-2011-N-0143-0389 FDA FDA-2011-N-0143 The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules Rule Final Rule 2016-08-24T04:00:00Z 2016 8 2016-08-24T04:00:00Z   2016-08-24T14:45:36Z 2016-20176 0 0 0900006482197984
FDA-1997-N-0020-0126 FDA Substances Generally Recognized as Safe (GRAS) - Closed FDA-1997-N-0020 Substances Generally Recognized as Safe Rule Final Rule 2016-08-17T04:00:00Z 2016 8 2016-08-17T04:00:00Z 2016-10-18T03:59:59Z 2016-10-18T01:02:39Z 2016-19164 0 0 090000648217cf8f
FDA-2016-N-1943-0001 FDA FDA-2016-N-1943 New Animal Drug Applications; Contents of Notice of Opportunity for a Hearing; Correction Rule Final Rule 2016-08-11T04:00:00Z 2016 8 2016-08-11T04:00:00Z   2016-08-11T15:28:44Z 2016-18809 0 0 090000648216d9bd
FDA-2016-N-0011-0003 FDA FDA-2016-N-0011 Regulatory Hearing Before the Food and Drug Administration; General Provisions; Technical Amendment Rule Final Rule 2016-08-11T04:00:00Z 2016 8 2016-08-11T04:00:00Z   2016-08-11T15:24:16Z 2016-18787 0 0 090000648216d9bc
FDA-2016-N-1170-0004 FDA FDA-2016-N-1170 Standard Preparations, Limits of Potency, and Dating Period Limitations for Biological Products; Confirmation of Effective Date Rule Direct Final Rule 2016-08-08T04:00:00Z 2016 8 2016-08-08T04:00:00Z   2016-08-08T15:06:53Z 2016-18584 0 0 090000648215c467
FDA-2016-N-1555-0002 FDA FDA-2016-N-1555 Refuse To Accept Procedures for Premarket Tobacco Product Submissions Rule Direct Final Rule 2016-08-08T04:00:00Z 2016 8 2016-08-08T04:00:00Z 2016-10-25T03:59:59Z 2016-10-25T01:01:50Z 2016-18534 0 0 090000648215c46a
FDA-1984-G-0019-0106 FDA Affirmation of GRAS Status of Certain Enzymes - CLOSED FDA-1984-G-0019 Notice of Final Rule re Enzyme Preparations from Animal and Plant Sources; Affirmation of GRAS Status As Direct Food Ingredients Rule Final Rule 2016-08-03T04:00:00Z 2016 8 2016-08-03T04:00:00Z   2016-08-03T15:44:21Z   0 0 09000064805a7faf
FDA-2011-F-0171-0275 FDA FDA-2011-F-0171 Food Labeling; Calorie Labeling of Articles of Food in Vending Machines; Extension of Compliance Date Rule Final Rule 2016-08-01T04:00:00Z 2016 8 2016-08-01T04:00:00Z   2016-08-01T15:28:34Z 2016-18140 0 0 0900006482145644
FDA-2016-N-0011-0002 FDA FDA-2016-N-0011 Change of Address; Technical Amendment Rule Correction 2016-07-29T04:00:00Z 2016 7 2016-07-29T04:00:00Z   2016-07-29T13:34:14Z 2016-17658 0 0 0900006482138cf9
FDA-2014-N-0002-0085 FDA FDA-2014-N-0002 New Animal Drugs: Change of Sponsor Rule Final Rule 2016-07-26T04:00:00Z 2016 7 2016-07-26T04:00:00Z   2016-07-26T14:45:37Z 2016-17501 0 0 09000064821222dc
FDA-2000-N-0158-0064 FDA Revision of the Identification of the Ionotophoresis FDA-2000-N-0158 Physical Medicine Devices; Reclassification of Iontophoresis Device Intended for Any Other Purposes Rule Final Rule 2016-07-26T04:00:00Z 2016 7 2016-07-26T04:00:00Z   2016-07-26T14:37:46Z 2016-17609 0 0 09000064821222d9
FDA-2015-N-5052-0003 FDA FDA-2015-N-5052 Administrative Actions for Noncompliance; Lesser Administrative Actions; Confirmation of Effective Date Rule Confirmation of Effective Date 2016-07-21T04:00:00Z 2016 7 2016-07-21T04:00:00Z   2016-07-21T14:58:31Z 2016-17186 0 0 09000064820db930
FDA-2015-N-2819-0003 FDA FDA-2015-N-2819 Emergency Permit Control Regulations; Technical Amendments Rule Final Rule 2016-07-19T04:00:00Z 2016 7 2016-07-19T04:00:00Z 2016-08-19T03:59:59Z 2016-07-19T13:39:09Z 2016-16968 0 0 09000064820c9ed3
FDA-2013-N-0888-0002 FDA FDA-2013-N-0888 Food Additives Permitted for Direct Addition to Food for Human Consumption: Vitamin D2 and Vitamin D3 Rule Final Rule 2016-07-18T04:00:00Z 2016 7 2016-07-18T04:00:00Z 2016-08-18T03:59:59Z 2016-08-18T13:00:47Z 2016-16738 0 0 09000064820bfd4e
FDA-2002-N-0323-0233 FDA Bioterrorism Preparedness; Registration of Food Facilities FDA-2002-N-0323 Amendments to Registration of Food Facilities Rule Final Rule 2016-07-14T04:00:00Z 2016 7 2016-07-14T04:00:00Z   2016-07-14T14:06:03Z 2016-16531 0 0 09000064820accd2
FDA-2015-N-2103-0003 FDA FDA-2015-N-2103 Removal of Review and Reclassification Procedures for Biological Products Licensed Prior to July 1, 1972; Technical Amendment Rule Final Rule 2016-07-14T04:00:00Z 2016 7 2016-07-14T04:00:00Z   2016-07-14T14:09:33Z 2016-16637 0 0 09000064820accd6
FDA-2016-N-1813-0001 FDA FDA-2016-N-1813 Medical Devices: Gastroenterology-Urology Devices; Classification of the Metallic Biliary Stent System for Benign Strictures Rule Final Rule 2016-07-13T04:00:00Z 2016 7 2016-07-13T04:00:00Z   2016-07-13T14:15:21Z 2016-16530 0 0 09000064820a8a12
FDA-2016-N-1653-0001 FDA FDA-2016-N-1653 Medical Devices; Neurological Devices; Classification of the Thermal System for Insomnia Rule Final Rule 2016-07-11T04:00:00Z 2016 7 2016-07-11T04:00:00Z   2016-07-11T15:18:18Z 2016-16351 0 0 090000648209bdc6
FDA-2016-N-1618-0001 FDA FDA-2016-N-1618 Medical Devices: General and Plastic Surgery Devices; Classification of the Electrosurgical Device for Over-the-Counter Aesthetic Use Rule Final Rule 2016-06-29T04:00:00Z 2016 6 2016-06-29T04:00:00Z   2016-06-29T14:33:43Z 2016-15381 0 0 090000648207885d
FDA-2014-F-0232-0007 FDA FDA-2014-F-0232 Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate; Extension of the Comment Period Rule Extension of Comment Period 2016-06-27T04:00:00Z 2016 6 2016-06-27T04:00:00Z 2016-07-20T03:59:59Z 2016-06-27T14:06:26Z 2016-14932 0 0 090000648206ec50
FDA-2014-N-1484-0010 FDA FDA-2014-N-1484 Revisions to Exceptions Applicable to Certain Human Cells, Tissues, and Cellular and Tissue-Based Products Rule Final Rule 2016-06-22T04:00:00Z 2016 6 2016-06-22T04:00:00Z   2016-06-22T12:51:24Z 2016-14721 0 0 0900006482056e9b
FDA-2016-N-1318-0001 FDA FDA-2016-N-1318 Medical Devices; Obstetrical and Gynecological Devices; Classification of the Gynecologic Laparoscopic Power Morcellation Containment System Rule Direct Final Rule 2016-06-21T04:00:00Z 2016 6 2016-06-21T04:00:00Z   2016-06-21T14:44:11Z 2016-14627 0 0 0900006482053a5c
FDA-2013-N-0125-0016 FDA FDA-2013-N-0125 Use of Symbols in Labeling Rule Final Rule 2016-06-15T04:00:00Z 2016 6 2016-06-15T04:00:00Z   2016-06-15T14:38:00Z 2016-13989 0 0 090000648203d414
FDA-2016-N-1308-0001 FDA FDA-2016-N-1308 Medical Devices: Ophthalmic Devices; Classification of Nasolacrimal Compression Device Rule Final Rule 2016-06-10T04:00:00Z 2016 6 2016-06-10T04:00:00Z   2016-06-13T13:17:04Z 2016-13788 0 0 090000648202c0d8
FDA-2015-D-3539-0013 FDA FDA-2015-D-3539 Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability Rule Correction 2016-06-10T04:00:00Z 2016 6 2016-06-10T04:00:00Z   2016-06-10T19:21:24Z 2016-13798 0 0 090000648202c009
FDA-2016-N-0001-0069 FDA FDA-2016-N-0001 Advisory Committee; Transmissible Spongiform Encephalopathies Advisory Committee; Termination Rule Final Rule 2016-06-09T04:00:00Z 2016 6 2016-06-09T04:00:00Z   2016-06-09T14:38:10Z 2016-13705 0 0 0900006482025cd9
FDA-2016-N-0002-0012 FDA FDA-2016-N-0002 New Animal Drugs: Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship Rule Final Rule 2016-06-08T04:00:00Z 2016 6 2016-06-08T04:00:00Z   2016-06-08T14:03:11Z 2016-13517 0 0 090000648201e0ff
FDA-2016-N-0002-0011 FDA FDA-2016-N-0002 New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application Rule Withdrawal 2016-06-08T04:00:00Z 2016 6 2016-06-08T04:00:00Z   2016-06-08T13:29:59Z 2016-13518 0 0 090000648201df5b
FDA-2014-F-0232-0003 FDA FDA-2014-F-0232 Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate Rule Correction 2016-06-03T04:00:00Z 2016 6 2016-06-03T04:00:00Z 2016-07-06T03:59:59Z 2016-06-07T01:00:37Z 2016-13082 0 0 090000648200d008
FDA-2016-N-1268-0001 FDA FDA-2016-N-1268 Medical Devices: Ophthalmic Devices; Classification of the Diurnal Pattern Recorder System Rule Final Rule 2016-05-31T04:00:00Z 2016 5 2016-05-31T04:00:00Z   2016-05-31T13:15:49Z 2016-12683 0 0 0900006481fff5c5
FDA-2012-N-1210-0875 FDA FDA-2012-N-1210 Food Labeling: Revision of the Nutrition and Supplement Facts Labels Rule Final Rule 2016-05-27T04:00:00Z 2016 5 2016-05-27T04:00:00Z   2016-05-27T13:43:41Z 2016-11867 0 0 0900006481ff9026
FDA-2004-N-0258-0136 FDA Food Labeling: Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes FDA-2004-N-0258 Food Labeling: Serving Sizes of Foods that Can Reasonably Be Consumed at One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments Rule Final Rule 2016-05-27T04:00:00Z 2016 5 2016-05-27T04:00:00Z   2016-05-27T13:27:03Z 2016-11865 0 0 0900006481ff8e48
FDA-2013-N-1425-0146 FDA FDA-2013-N-1425 Mitigation Strategies to Protect Food Against Intentional Adulteration Rule Final Rule 2016-05-27T04:00:00Z 2016 5 2016-05-27T04:00:00Z   2016-05-27T13:33:32Z 2016-12373 0 0 0900006481ff8ef6
FDA-2012-N-1173-0006 FDA FDA-2012-N-1173 Cardiovascular Devices: Reclassification of External Cardiac Compressor; Reclassification of Cardiopulmonary Resuscitation Aids Rule Final Rule 2016-05-25T04:00:00Z 2016 5 2016-05-25T04:00:00Z   2016-05-25T13:18:19Z 2016-12333 0 0 0900006481fee8b8
FDA-2012-N-0447-0108 FDA FDA-2012-N-0447 Antimicrobial Animal Drug Sales and Distribution Reporting Rule Final Rule 2016-05-11T04:00:00Z 2016 5 2016-05-11T04:00:00Z   2016-05-11T14:45:33Z 2016-11082 0 0 0900006481fc35b3
FDA-2012-N-0920-0016 FDA FDA-2012-N-0920 Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Cigars and Pipe Tobacco Rule Final Rule 2016-05-10T04:00:00Z 2016 5 2016-05-10T04:00:00Z   2016-05-10T14:09:40Z 2016-10688 0 0 0900006481fbd96d
FDA-2014-N-0189-82904 FDA FDA-2014-N-0189 Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products Rule Final Rule 2016-05-10T04:00:00Z 2016 5 2016-05-10T04:00:00Z   2016-06-07T20:40:11Z 2016-10685 0 0 0900006481fbdb9a
FDA-2016-N-1170-0001 FDA FDA-2016-N-1170 Standard Preparations, Limits of Potency, and Dating Period Limitations for Biological Products Rule Direct Final Rule 2016-05-04T04:00:00Z 2016 5 2016-05-04T04:00:00Z 2016-07-19T03:59:59Z 2016-05-09T15:35:55Z 2016-10385 0 0 0900006481fa86ef
FDA-2011-N-0921-19132 FDA FDA-2011-N-0921 Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Technical Amendment Rule Final Rule 2016-05-03T04:00:00Z 2016 5 2016-05-03T04:00:00Z   2016-05-03T19:09:16Z 2016-09768 0 0 0900006481fa3df4
FDA-2011-N-0143-0388 FDA FDA-2011-N-0143 Foreign Supplier Verification Programs for Importers of Food for Humans and Animals; Technical Amendment Rule Final Rule 2016-04-28T04:00:00Z 2016 4 2016-04-28T04:00:00Z   2016-05-05T22:21:34Z 2016-09784 0 0 0900006481f94d20
FDA-2016-N-0002-0010 FDA FDA-2016-N-0002 New Animal Drugs: Approval of New Animal Drug Applications; Changes of Sponsorship; Correction Rule Final Rule 2016-04-28T04:00:00Z 2016 4 2016-04-28T04:00:00Z   2016-04-28T16:16:35Z 2016-09865 0 0 0900006481f94e7f

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CREATE TABLE documents (
    id TEXT PRIMARY KEY,
    agency_id TEXT,
    docket_id TEXT REFERENCES dockets(id),
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    document_type TEXT,
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    posted_date TEXT,
    posted_year INTEGER,
    posted_month INTEGER,
    comment_start_date TEXT,
    comment_end_date TEXT,
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    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);
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