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withdrawn,object_id FDA-2016-D-2335-0731,FDA,FDA-2016-D-2335,Use of the Term Healthy in the Labeling of Human Food Products; Request for Information and Comments; Extension of Comment Period,Proposed Rule,Extension of Comment Period,2016-12-30T05:00:00Z,2016,12,2016-12-30T05:00:00Z,2017-04-27T03:59:59Z,2017-04-27T13:02:53Z,2016-31734,0,0,090000648244128d FDA-2016-F-3880-0002,FDA,FDA-2016-F-3880,"Novus International, Inc.; Filing of Food Additive Petition (Animal Use); Reopening of the Comment Period",Proposed Rule,Reopening of Comment Period,2016-12-30T05:00:00Z,2016,12,2016-12-30T05:00:00Z,2017-01-31T04:59:59Z,2017-01-31T14:01:36Z,2016-31606,0,0,090000648244128b FDA-2012-D-1002-0009,FDA,FDA-2012-D-1002,Questions and Answers Regarding Food Facility Registration (Seventh Edition); Revised Draft Guidance for Industry; Availability,Proposed Rule,GDL Guidance,2016-12-27T05:00:00Z,2016,12,2016-12-27T05:00:00Z,2017-03-28T03:59:59Z,2017-03-28T01:02:30Z,2016-31193,0,0,090000648243741c FDA-2013-E-0474-0007,FDA,FDA-2013-E-0474,Notice of Determination from U.S. Patent and Trademark Office to the FDA CDER,Proposed Rule,Notice of Extension,2016-12-20T05:00:00Z,2016,12,2016-12-20T05:00:00Z,,2016-12-20T15:51:09Z,,0,0,090000648242a23d FDA-2016-N-3464-0001,FDA,FDA-2016-N-3464,"List of Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act",Proposed Rule,Notice of Proposed Rulemaking (NPRM),2016-12-16T05:00:00Z,2016,12,2016-12-16T05:00:00Z,2017-03-17T03:59:59Z,2017-08-05T01:02:50Z,2016-30109,0,0,090000648241437d FDA-1998-N-0880-1914,FDA,FDA-1998-N-0880,Medical Devices; Sunlamp Products Performance Standard; Request for Comments and Information; Extension of Comment Period,Proposed Rule,Extension of Comment Period,2016-12-05T05:00:00Z,2016,12,1999-05-04T04:00:00Z,1999-07-10T03:59:59Z,2018-04-09T18:16:37Z,99–11121,0,0,09000064805a1a1f FDA-2005-N-0343-0037,FDA,FDA-2005-N-0343,April 10 2006 Federal Register for Medical Gas Containers and Closures_ Current Good Manufacturing Practice Requirements(1),Proposed Rule,Notice of Proposed Rulemaking (NPRM),2016-11-18T05:00:00Z,2016,11,2016-11-18T05:00:00Z,,2016-11-18T18:34:55Z,,0,0,09000064823a2e3b FDA-2008-N-0622-0002,FDA,FDA-2008-N-0622,Withdrawal of Two Proposed Rules,Proposed Rule,Withdrawal,2016-11-14T05:00:00Z,2016,11,2016-11-14T05:00:00Z,,2016-11-14T19:03:23Z,2016-27329,0,0,0900006482393688 FDA-2014-F-0452-0002,FDA,FDA-2014-F-0452,"Novus International, Inc.; Filing of Food Additive Petition (Animal Use)",Proposed Rule,Notice of Proposed Rulemaking (NPRM),2016-11-08T05:00:00Z,2016,11,2016-11-08T05:00:00Z,2016-12-09T04:59:59Z,2016-11-26T02:01:39Z,2016-26922,0,0,090000648237b7b6 FDA-2016-N-2938-0001,FDA,FDA-2016-N-2938,"Reference Amount Customarily Consumed for Flavored Nut Butter Spreads and Products That Can Be Used To Fill Cupcakes and Other Desserts, in the Labeling of Human Food Products; Request for Information and Comments",Proposed Rule,Request for Comment,2016-11-02T04:00:00Z,2016,11,2016-11-02T04:00:00Z,2017-01-04T04:59:59Z,2017-01-18T02:00:32Z,2016-26407,0,0,090000648236930c FDA-2016-D-2841-0001,FDA,FDA-2016-D-2841,"Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing the FDA Food Safety Modernization Act: Guidance for Industry; Availability",Proposed Rule,GDL Guidance,2016-10-31T04:00:00Z,2016,10,2016-10-31T04:00:00Z,2017-05-02T03:59:59Z,2017-05-02T01:00:50Z,2016-26245,0,0,090000648235df5e FDA-2010-N-0548-0124,FDA,FDA-2010-N-0548,Good Laboratory Practice for Nonclinical Laboratory Studies; Extension of Comment Period,Proposed Rule,Extension of Comment Period,2016-10-31T04:00:00Z,2016,10,2016-10-31T04:00:00Z,2017-01-22T04:59:59Z,2017-01-28T02:02:11Z,2016-26244,0,0,090000648235e57d FDA-2012-N-1067-0008,FDA,FDA-2012-N-1067,New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food,Proposed Rule,Amendment,2016-10-28T04:00:00Z,2016,10,2016-10-28T04:00:00Z,2016-12-28T04:59:59Z,2016-12-28T02:01:08Z,2016-26043,0,0,090000648235adde FDA-2015-N-1355-0004,FDA,FDA-2015-N-1355,Use of Ozone-Depleting Substances,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2016-10-26T04:00:00Z,2016,10,2016-10-26T04:00:00Z,2016-12-28T04:59:59Z,2016-12-01T14:00:46Z,2016-25850,0,0,090000648234d577 FDA-2015-N-1355-0005,FDA,FDA-2015-N-1355,Use of Ozone-Depleting Substances,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2016-10-26T04:00:00Z,2016,10,2016-10-26T04:00:00Z,2016-12-28T04:59:59Z,2017-01-31T02:02:25Z,2016-25852,0,0,090000648234d5d1 FDA-2016-N-2462-0001,FDA,FDA-2016-N-2462,"Amendments to the Regulation Regarding the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness",Proposed Rule,Amendment,2016-10-18T04:00:00Z,2016,10,2016-10-18T04:00:00Z,2017-01-04T04:59:59Z,2016-12-29T14:00:42Z,2016-25005,0,0,090000648230f5e5 FDA-2016-N-2491-0001,FDA,FDA-2016-N-2491,Electronic Submission of Labeling for Certain Home-Use Medical Devices,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2016-10-17T04:00:00Z,2016,10,2016-10-17T04:00:00Z,2017-01-18T04:59:59Z,2017-01-18T02:01:20Z,2016-25026,0,0,0900006482303611 FDA-2016-C-2767-0001,FDA,FDA-2016-C-2767,Wm. Wrigley Jr. Company; Filing of Color Additive Petition,Proposed Rule,Petition,2016-10-07T04:00:00Z,2016,10,2016-10-07T04:00:00Z,,2016-10-07T13:55:46Z,2016-24208,0,0,09000064822a9fb7 FDA-2014-F-0988-0004,FDA,FDA-2014-F-0988,BASF Corp.; Filing of Food Additive Petition (Animal Use),Proposed Rule,Petition,2016-09-30T04:00:00Z,2016,9,2016-09-30T04:00:00Z,2016-11-01T03:59:59Z,2016-10-05T01:02:15Z,2016-23645,0,0,0900006482284bd0 FDA-2016-D-2335-0001,FDA,FDA-2016-D-2335,"Use of the Term ‘‘Healthy’’ in the Labeling of Human Food Products; Request for Information and Comments",Proposed Rule,Request for Comment,2016-09-28T04:00:00Z,2016,9,2016-09-28T04:00:00Z,2017-01-27T04:59:59Z,2017-01-27T14:01:54Z,2016-23365,0,0,090000648227b22f FDA-1976-N-0031-0027,FDA,FDA-1976-N-0031,"Notice of Proposed Rule re Over-The-Counter Drugs; Establishment of a Monograph for OTC Cold, Cough, Allergy, Bronchodilator and Antiasthmatic Products (Page 324 -423)
",Proposed Rule,Notice of Proposed Rulemaking (NPRM),2016-09-26T04:00:00Z,2016,9,2016-09-26T04:00:00Z,1976-12-09T04:59:59Z,2016-09-26T18:16:23Z,,0,0,0900006481e508da FDA-1976-N-0031-0028,FDA,FDA-1976-N-0031,"Notice of Proposed Rule re Over-The-Counter Drugs; Establishment of a Monograph for OTC Cold, Cough, Allergy, Bronchodilator and Antiasthmatic Products (Part 926-940)
",Proposed Rule,Notice of Proposed Rulemaking (NPRM),2016-09-26T04:00:00Z,2016,9,2016-09-26T04:00:00Z,1976-12-09T04:59:59Z,2016-09-26T18:26:14Z,,0,0,0900006481e4f035 FDA-1996-N-0274-0001,FDA,FDA-1996-N-0274,Sterility Requirements for Inhalation Solution Products,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2016-09-21T04:00:00Z,2016,9,1997-09-23T04:00:00Z,1997-12-23T04:59:59Z,2017-04-12T16:36:07Z,1997–25130,0,0,09000064805044ca FDA-2016-C-2570-0001,FDA,FDA-2016-C-2570,"McCormick & Company, Inc.; Filing of Color Additive Petition",Proposed Rule,Petition,2016-09-16T04:00:00Z,2016,9,2016-09-16T04:00:00Z,,2016-09-16T13:20:27Z,2016-22289,0,0,0900006482218420 FDA-1980-N-0272-0013,FDA,FDA-1980-N-0272,Maltodextrin; Proposed Affirmation of GRAS Status as Direct Human Food Ingredient,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2016-09-14T04:00:00Z,2016,9,1982-08-20T04:00:00Z,1982-10-20T03:59:59Z,2019-08-21T17:45:38Z,82-22488,0,0,09000064805bddb9 FDA-1980-N-0220-0001,FDA,FDA-1980-N-0220,"Ethyl Acrylate and Methyl Acrylate; Proposed Removal from GRAS Status as Indirect Human Food Ingredients",Proposed Rule,Notice of Proposed Rulemaking (NPRM),2016-09-06T04:00:00Z,2016,9,2016-09-06T04:00:00Z,1982-08-08T03:59:59Z,2016-09-06T14:41:49Z,,0,0,09000064805bda77 FDA-2016-N-1149-0001,FDA,FDA-2016-N-1149,Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products; Public Hearing; Request for Comments,Proposed Rule,Notice of Hearing,2016-09-01T04:00:00Z,2016,9,2016-09-01T04:00:00Z,2017-04-20T03:59:59Z,2017-04-21T01:02:02Z,2016-21062,0,0,09000064821bd14a FDA-1981-N-0042-0002,FDA,FDA-1981-N-0042,Oral Health Care Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Oral Antiseptic Drug Products,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2016-08-25T04:00:00Z,2016,8,1994-02-09T05:00:00Z,1994-08-09T03:59:59Z,2016-09-17T18:58:24Z,94-2262,0,0,09000064805af28a FDA-2011-N-0079-0006,FDA,FDA-2011-N-0079,Disqualification of a Clinical Investigator,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2016-08-24T04:00:00Z,2016,8,2016-08-24T04:00:00Z,2016-11-23T04:59:59Z,2016-08-26T01:01:20Z,2016-19876,0,0,0900006482197a70 FDA-2010-N-0548-0088,FDA,FDA-2010-N-0548,Good Laboratory Practice for Nonclinical Laboratory Studies,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2016-08-24T04:00:00Z,2016,8,2016-08-24T04:00:00Z,2016-11-23T04:59:59Z,2016-11-12T02:00:31Z,2016-19875,0,0,09000064821977f2 FDA-2016-N-1896-0001,FDA,FDA-2016-N-1896,New Animal Drugs for Use in Animal Feed; Category Definitions,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2016-08-24T04:00:00Z,2016,8,2016-08-24T04:00:00Z,2016-11-08T04:59:59Z,2016-11-08T02:00:48Z,2016-20149,0,0,09000064821977a8 FDA-2016-F-1253-0379,FDA,FDA-2016-F-1253,"Breast Cancer Fund, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Clean Water Action, Consumer Federation of America, Earthjustice, Environmental Defense Fund, Improving Kids' Environment, Learning Disabilities Association of America, and Natural Resources Defense Council; Filing of Food Additive Petition; Reopening of Comment Period",Proposed Rule,Extension of Comment Period,2016-08-08T04:00:00Z,2016,8,2016-08-08T04:00:00Z,2016-09-20T03:59:59Z,2016-09-29T01:00:46Z,2016-18720,0,0,090000648215c49a FDA-2016-N-1555-0001,FDA,FDA-2016-N-1555,Refuse To Accept Procedures for Premarket Tobacco Product Submissions,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2016-08-08T04:00:00Z,2016,8,2016-08-08T04:00:00Z,2016-10-25T03:59:59Z,2016-10-25T01:02:13Z,2016-18533,0,0,090000648215c3da FDA-2016-N-1487-0001,FDA,FDA-2016-N-1487,Submission of Food and Drug Administration Import Data in the Automated Commercial Environment,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2016-07-01T04:00:00Z,2016,7,2016-07-01T04:00:00Z,2016-08-31T03:59:59Z,2016-09-01T01:00:41Z,2016-15684,0,0,0900006482080496 FDA-2016-F-1805-0001,FDA,FDA-2016-F-1805,"Society of the Plastics Industry, Inc.; Filing of Food Additive Petition",Proposed Rule,Petition,2016-06-30T04:00:00Z,2016,6,2016-06-30T04:00:00Z,2016-08-30T03:59:59Z,2016-08-19T01:00:42Z,2016-15474,0,0,090000648207c43c FDA-2016-N-0124-0001,FDA,FDA-2016-N-0124,"Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record",Proposed Rule,Notice of Proposed Rulemaking (NPRM),2016-06-30T04:00:00Z,2016,6,2016-06-30T04:00:00Z,2016-12-28T04:59:59Z,2024-11-11T21:26:44Z,2016-15410,1,0,090000648207c47e FDA-1978-N-1446-0001,FDA,FDA-1978-N-1446,"Proposal to Establish Monographs for OTC Laxative, Antidiarrheal, Emetic, and Antiemetic Products",Proposed Rule,Notice of Proposed Rulemaking (NPRM),2016-06-29T04:00:00Z,2016,6,1975-03-21T04:00:00Z,1975-04-21T03:59:59Z,2016-07-01T01:00:43Z,,0,0,09000064820500d4 FDA-1975-N-0016-0027,FDA,FDA-1975-N-0016,Proposal To Establish a Monograph for OTC Topical Antimicrobial Products: Page ( 1-100 ),Proposed Rule,Notice of Proposed Rulemaking (NPRM),2016-06-16T04:00:00Z,2016,6,2016-06-16T04:00:00Z,,2017-10-17T17:58:56Z,,0,0,09000064805c1f9d FDA-2016-F-1444-0001,FDA,FDA-2016-F-1444,Styrene Information and Research Center; Filing of Food Additive Petition,Proposed Rule,Petition,2016-06-15T04:00:00Z,2016,6,2016-06-15T04:00:00Z,2016-08-16T03:59:59Z,2016-08-16T01:01:05Z,2016-14107,0,0,090000648203d44c FDA-2016-F-1253-0004,FDA,FDA-2016-F-1253,"Breast Cancer Fund, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Clean Water Action, Consumer Federation of America, Earthjustice, Environmental Defense Fund, Improving Kids’ Environment, Learning Disabilities Association of America, and Natural Resources Defense Council; Filing of Food Additive Petition; Correction",Proposed Rule,Correction,2016-06-10T04:00:00Z,2016,6,2016-06-10T04:00:00Z,,2016-06-10T15:29:28Z,2016-13739,0,0,090000648202c03f FDA-2004-N-0258-0175,FDA,FDA-2004-N-0258,"Proposed Rules on Food Labeling: Revision of the Nutrition and Supplement Facts Labels and 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; Public Meeting",Proposed Rule,Public Meeting,2016-06-02T04:00:00Z,2016,6,2016-06-02T04:00:00Z,2014-08-02T03:59:59Z,2016-06-02T17:53:00Z,2014-12362,0,0,090000648171c5c8 FDA-2016-N-1111-0382,FDA,FDA-2016-N-1111,"Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior; Extension of Comment Period",Proposed Rule,Extension of Comment Period,2016-05-23T04:00:00Z,2016,5,2016-05-23T04:00:00Z,2016-07-26T03:59:59Z,2018-07-11T01:05:15Z,2016-12026,0,0,0900006481fe7441 FDA-2016-F-1253-0002,FDA,FDA-2016-F-1253,"Breast Cancer Fund, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Clean Water Action, Consumer Federation of America, Earthjustice, Environmental Defense Fund, Improving Kids’ Environment, Learning Disabilities Association of America, and Natural Resources Defense Council; Filing of Food Additive Petition",Proposed Rule,Petition,2016-05-20T04:00:00Z,2016,5,2016-05-20T04:00:00Z,2016-07-20T03:59:59Z,2022-05-06T16:04:50Z,2016-11866,0,0,0900006481fe3c96 FDA-2016-D-1164-0001,FDA,FDA-2016-D-1164,Qualified Facility Attestation Using Form FDA 3942a (for Human Food) or Form FDA 3942b (for Animal Food); Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request,Proposed Rule,GDL Guidance,2016-05-16T04:00:00Z,2016,5,2016-05-16T04:00:00Z,2016-11-15T04:59:59Z,2016-11-15T02:01:07Z,2016-11439,0,0,0900006481fd113b FDA-2015-D-2325-0001,FDA,FDA-2015-D-2325,Tobacco Product Master Files; Guidance for Industry; Availability,Proposed Rule,Request for Comment,2016-05-10T04:00:00Z,2016,5,2016-05-10T04:00:00Z,,2016-05-10T14:24:39Z,2016-10690,0,0,0900006481fbdb4d FDA-2015-D-2496-0001,FDA,FDA-2015-D-2496,Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request,Proposed Rule,Request for Comment,2016-05-10T04:00:00Z,2016,5,2016-05-10T04:00:00Z,2016-07-12T03:59:59Z,2016-07-22T15:20:45Z,2016-10687,0,0,0900006481fbd968 FDA-2014-N-0189-82903,FDA,FDA-2014-N-0189,"The Food and Drug Administration Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements; Small Entity Compliance Guide; Availability",Proposed Rule,GDL Guidance,2016-05-10T04:00:00Z,2016,5,2016-05-10T04:00:00Z,,2016-05-12T21:58:07Z,2016-10684,0,0,0900006481fbd9b4 FDA-2014-D-0917-0003,FDA,FDA-2014-D-0917,"Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products; Small Entity Compliance Guide; Availability",Proposed Rule,Request for Comment,2016-05-10T04:00:00Z,2016,5,2016-05-10T04:00:00Z,,2016-05-10T14:20:26Z,2016-10689,0,0,0900006481fbda57 FDA-2015-N-0797-0037,FDA,FDA-2015-N-0797,"The Food and Drug Administration Food Safety Modernization Act: Focus on Strategic Implementation of Prevention-Oriented Import Safety Programs; Public Meetings",Proposed Rule,Public Meeting,2016-05-09T04:00:00Z,2016,5,2016-05-09T04:00:00Z,,2016-05-09T14:33:12Z,2016-10799,0,0,0900006481fb6feb FDA-2011-F-0172-0613,FDA,FDA-2011-F-0172,"A Labeling Guide for Restaurants and Retail Establishments Selling Away- From-Home Foods—Part II (Menu Labeling Requirements in Accordance With the Patient Protection Affordable Care Act of 2010); Guidance for Industry; Availability",Proposed Rule,GDL Guidance,2016-05-05T04:00:00Z,2016,5,2016-05-05T04:00:00Z,,2016-05-05T14:52:44Z,2016-10462,0,0,0900006481fac540 FDA-2016-N-1170-0002,FDA,FDA-2016-N-1170,"Standard Preparations, Limits of Potency, and Dating Period Limitations for Biological Products; Companion to Direct Final Rule",Proposed Rule,Correction,2016-05-04T04:00:00Z,2016,5,2016-05-04T04:00:00Z,2016-07-19T03:59:59Z,2016-07-15T01:00:19Z,2016-10386,0,0,0900006481fa88d3 FDA-2016-F-1153-0001,FDA,FDA-2016-F-1153,3M Corporation; Filing of Food Additive Petition,Proposed Rule,Petition,2016-04-29T04:00:00Z,2016,4,2016-04-29T04:00:00Z,2016-06-29T03:59:59Z,2016-06-24T01:00:33Z,2016-09932,0,0,0900006481f9808f FDA-2016-N-1111-0001,FDA,FDA-2016-N-1111,"Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior",Proposed Rule,Notice of Proposed Rulemaking (NPRM),2016-04-25T04:00:00Z,2016,4,2016-04-25T04:00:00Z,2016-05-26T03:59:59Z,2016-05-28T20:58:34Z,2016-09433,0,0,0900006481f88fd3 FDA-2016-N-0436-0039,FDA,FDA-2016-N-0436,"Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third- Party Entities and Original Equipment Manufacturers; Extension of Comment Period",Proposed Rule,Extension of Comment Period,2016-04-25T04:00:00Z,2016,4,2016-04-25T04:00:00Z,2016-06-04T03:59:59Z,2016-06-10T01:00:31Z,2016-09443,0,0,0900006481f88f51 FDA-2014-D-1696-0053,FDA,FDA-2014-D-1696,"Draft Guidances Relating to the Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Extension of Comment Periods",Proposed Rule,Extension of Comment Period,2016-04-22T04:00:00Z,2016,4,2016-04-22T04:00:00Z,2016-09-28T03:59:59Z,2016-09-28T13:01:29Z,2016-09366,0,0,0900006481f83c8d FDA-2015-D-3581-0009,FDA,FDA-2015-D-3581,"Draft Guidances Relating to the Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Extension of Comment Periods",Proposed Rule,Extension of Comment Period,2016-04-22T04:00:00Z,2016,4,2016-04-22T04:00:00Z,2016-09-28T03:59:59Z,2016-10-22T01:01:26Z,2016-09366,0,0,0900006481f8312b FDA-2014-D-1584-0195,FDA,FDA-2014-D-1584,"Draft Guidances Relating to the Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Extension of Comment Periods",Proposed Rule,Extension of Comment Period,2016-04-22T04:00:00Z,2016,4,2016-04-22T04:00:00Z,2016-09-28T03:59:59Z,2016-09-28T13:01:46Z,2016-09366,0,0,0900006481f83c89 FDA-2014-D-1856-0086,FDA,FDA-2014-D-1856,"Draft Guidances Relating to the Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Extension of Comment Periods",Proposed Rule,Extension of Comment Period,2016-04-22T04:00:00Z,2016,4,2016-04-22T04:00:00Z,2016-09-28T03:59:59Z,2016-10-20T01:00:57Z,2016-09366,0,0,0900006481f83c8e FDA-2015-D-3719-0018,FDA,FDA-2015-D-3719,"Draft Guidances Relating to the Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Rescheduling of Public Hearing; Request for Comments",Proposed Rule,Notice of Hearing,2016-04-22T04:00:00Z,2016,4,2016-04-22T04:00:00Z,2016-09-28T03:59:59Z,2016-10-27T01:00:38Z,2016-09372,0,0,0900006481f831b9 FDA-2015-N-1260-0008,FDA,FDA-2015-N-1260,Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph Proposed Rule; Reopening of the Comment Period,Proposed Rule,Reopening of Comment Period,2016-04-18T04:00:00Z,2016,4,2016-04-18T04:00:00Z,2016-05-19T03:59:59Z,2016-05-18T22:00:30Z,2016-08888,0,0,0900006481f70598 FDA-2016-N-0543-0001,FDA,FDA-2016-N-0543,Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications,Proposed Rule,Amendment,2016-04-04T04:00:00Z,2016,4,2016-04-04T04:00:00Z,2016-06-04T03:59:59Z,2016-05-28T20:55:03Z,2016-07612,0,0,0900006481f2331f FDA-2015-N-5052-0002,FDA,FDA-2015-N-5052,Administrative Actions for Noncompliance; Lesser Administrative Actions,Proposed Rule,Amendment,2016-04-04T04:00:00Z,2016,4,2016-04-04T04:00:00Z,2016-06-21T03:59:59Z,2016-04-04T16:44:42Z,2016-07524,0,0,0900006481f23c5e FDA-2016-F-0821-0001,FDA,FDA-2016-F-0821,"Milton W. Chu, M.D.; Filing of Color Additive Petition",Proposed Rule,Petition,2016-03-22T04:00:00Z,2016,3,2016-03-22T04:00:00Z,,2016-03-22T13:16:05Z,2016-06397,0,0,0900006481ed5ea7 FDA-2015-N-5017-0001,FDA,FDA-2015-N-5017,"Banned Devices; Proposal To Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove",Proposed Rule,Notice of Proposed Rulemaking (NPRM),2016-03-22T04:00:00Z,2016,3,2016-03-22T04:00:00Z,2016-06-21T03:59:59Z,2016-06-21T13:00:21Z,2016-06360,0,0,0900006481ed5d78 FDA-2016-F-0784-0001,FDA,FDA-2016-F-0784,Global Nutrition International; Filing of Food Additive Petition (Animal Use),Proposed Rule,Petition,2016-03-21T04:00:00Z,2016,3,2016-03-21T04:00:00Z,,2016-03-21T15:07:44Z,2016-06199,0,0,0900006481ed240d FDA-2015-N-3785-0001,FDA,FDA-2015-N-3785,"Medical Devices; Orthopedic Devices; Classification of Posterior Cervical Screw Systems",Proposed Rule,Notice of Proposed Rulemaking (NPRM),2016-03-10T05:00:00Z,2016,3,2016-03-10T05:00:00Z,2016-06-09T03:59:59Z,2016-06-09T01:00:36Z,2016-05384,0,0,0900006481eb8198 FDA-2013-N-0402-0023,FDA,FDA-2013-N-0402,"Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives; Public Hearing; Request for Comments",Proposed Rule,Notice of Hearing,2016-03-09T05:00:00Z,2016,3,2016-03-09T05:00:00Z,,2024-11-12T05:59:06Z,2016-05221,1,0,0900006481eb47b7 FDA-2016-N-0436-0001,FDA,FDA-2016-N-0436,"Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third- Party Entities and Original Equipment Manufacturers; Request for Comments",Proposed Rule,Request for Comment,2016-03-04T05:00:00Z,2016,3,2016-03-04T05:00:00Z,2016-05-04T03:59:59Z,2016-05-06T19:00:24Z,2016-04700,0,0,0900006481ea097a FDA-2016-N-0400-0001,FDA,FDA-2016-N-0400,General and Plastic Surgery Devices; Reclassification of Blood Lancets,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2016-03-03T05:00:00Z,2016,3,2016-03-03T05:00:00Z,2016-06-02T03:59:59Z,2016-06-02T13:00:23Z,2016-04578,0,0,0900006481e9bca4 FDA-2016-M-0035-0001,FDA,FDA-2016-M-0035,Effective Date of Requirement for Premarket Approval for Blood Lancets,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2016-03-03T05:00:00Z,2016,3,2016-03-03T05:00:00Z,2016-06-02T03:59:59Z,2016-06-02T01:01:08Z,2016-04579,0,0,0900006481e9bb71 FDA-2016-N-0406-0001,FDA,FDA-2016-N-0406,"Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories",Proposed Rule,Notice of Proposed Rulemaking (NPRM),2016-03-01T05:00:00Z,2016,3,2016-03-01T05:00:00Z,2016-06-01T03:59:59Z,2016-06-01T01:00:19Z,2016-04411,0,0,0900006481e951c9 FDA-2014-N-1021-0454,FDA,FDA-2014-N-1021,"Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods; Reopening of the Comment Period",Proposed Rule,Reopening of Comment Period,2016-02-23T05:00:00Z,2016,2,2016-02-23T05:00:00Z,2016-04-26T03:59:59Z,2016-04-27T19:01:09Z,2016-03716,0,0,0900006481e80444 FDA-2015-F-4317-0039,FDA,FDA-2015-F-4317,"Center for Science in the Public Interest, Natural Resources Defense Council, Center for Food Safety, Consumers Union, Improving Kids’ Environment, Center for Environmental Health, Environmental Working Group, Environmental Defense Fund, and James Huff; Filing of Food Additive Petition; Extension of Comment Period",Proposed Rule,Extension of Comment Period,2016-02-23T05:00:00Z,2016,2,2016-02-23T05:00:00Z,2016-05-04T03:59:59Z,2016-05-03T22:00:20Z,2016-03708,0,0,0900006481e80505 FDA-2014-N-1209-0001,FDA,FDA-2014-N-1209,Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Intended To Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Intended To Treat Depression,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2016-01-22T05:00:00Z,2016,1,2016-01-22T05:00:00Z,2016-04-22T03:59:59Z,2016-06-15T01:00:33Z,2016-01173,0,0,0900006481e2882d FDA-2014-N-1021-0098,FDA,FDA-2014-N-1021,"Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods; Reopening of the Comment Period",Proposed Rule,Extension of Comment Period,2016-01-22T05:00:00Z,2016,1,2016-01-22T05:00:00Z,2016-02-23T04:59:59Z,2016-02-23T05:00:49Z,2016-01177,0,0,0900006481e287e4 FDA-1997-N-0103-0001,FDA,FDA-1997-N-0103,Biological Products; Reporting of Errors and Accidents in Manufacturing; Proposed Rule,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2016-01-13T05:00:00Z,2016,1,1997-09-23T04:00:00Z,1997-12-23T04:59:59Z,2016-01-13T16:47:30Z,,0,0,09000064805d06a5 FDA-2015-F-4317-0001,FDA,FDA-2015-F-4317,"Center for Science in the Public Interest, Natural Resources Defense Council, Center for Food Safety, Consumers Union, Improving Kids’ Environment, Center for Environmental Health, Environmental Working Group, Environmental Defense Fund, and James Huff; Filing of Food Additive Petition",Proposed Rule,Notice of Proposed Rulemaking (NPRM),2016-01-04T05:00:00Z,2016,1,2016-01-04T05:00:00Z,2016-03-05T04:59:59Z,2016-03-04T17:00:48Z,2015-33011,0,0,0900006481de405d