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

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

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posted_year 1

  • 2016 · 77 ✖

document_type 1

  • Proposed Rule · 77 ✖

agency_id 1

  • FDA · 77 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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FDA FDA-2012-D-1002 Questions and Answers Regarding Food Facility Registration (Seventh Edition); Revised Draft Guidance for Industry; Availability Proposed Rule GDL Guidance 2016-12-27T05:00:00Z 2016 12 2016-12-27T05:00:00Z 2017-03-28T03:59:59Z 2017-03-28T01:02:30Z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 Sunlamp Products Performance Standard 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 Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 Sterility Requirements for Inhalation Solution Products- CLOSED 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 Maltodextrin; Proposed Affirmation of GRAS Status as Direct Human Food Ingredient - CLOSED 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 GRAS STATUS OF ETHYL ACRYLATE AND METHYL ACRYLATE 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 Oral Health Care Drug Product; Oral Antiseptic Drug Products 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 O. T. C. Antiemetic - Closed 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 OTC Topical Antimicrobial Drug Products - OPEN 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 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 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 BIOLOGICAL PRODUCTS; REPORTING OF ERROR & ACCIDENTS MANUFACTURING 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

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