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withdrawn,object_id FDA-2014-N-1205-0019,FDA,FDA-2014-N-1205,"Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral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,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,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,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,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,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,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,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,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,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,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,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,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,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,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