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

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67 rows where agency_id = "FDA", document_type = "Proposed Rule" and posted_year = 2018 sorted by posted_date descending

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posted_year 1

  • 2018 · 67 ✖

document_type 1

  • Proposed Rule · 67 ✖

agency_id 1

  • FDA · 67 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2018-N-2727-0011 FDA FDA-2018-N-2727 Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations; Extension of Comment Period Proposed Rule Extension of Comment Period 2018-12-20T05:00:00Z 2018 12 2018-12-20T05:00:00Z 2019-02-14T04:59:59Z 2019-02-15T02:02:47Z 2018-27519 0 0 09000064839b9103
FDA-2018-N-3952-0057 FDA FDA-2018-N-3952 Eliminating Youth Electronic Cigarette and Other Tobacco Product Use: The Role for Drug Therapies; New Date for Public Hearing; Request for Comments Proposed Rule Request for Comment 2018-12-18T05:00:00Z 2018 12 2018-12-18T05:00:00Z 2019-02-02T04:59:59Z 2019-02-09T02:03:39Z 2018-27352 0 0 09000064839a99b2
FDA-2013-N-0500-0140 FDA FDA-2013-N-0500 Withdrawal of Proposed Rule on Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products Proposed Rule Withdrawal 2018-12-14T05:00:00Z 2018 12 2018-12-14T05:00:00Z   2018-12-14T14:36:07Z 2018-27098 0 0 09000064839936bc
FDA-2018-C-4464-0001 FDA FDA-2018-C-4464 Impossible Foods, Inc.; Filing of Color Additive Petition Proposed Rule Petition 2018-12-13T05:00:00Z 2018 12 2018-12-13T05:00:00Z   2019-07-01T18:26:28Z 2018-26949 0 0 090000648398ed83
FDA-2018-N-2732-0001 FDA FDA-2018-N-2732 Definition of the Term ‘‘Biological Product’’ Proposed Rule Notice of Proposed Rulemaking (NPRM) 2018-12-12T05:00:00Z 2018 12 2018-12-12T05:00:00Z 2019-02-26T04:59:59Z 2019-02-26T02:03:21Z 2018-26840 0 0 0900006483987cd9
FDA-2018-N-0236-0001 FDA FDA-2018-N-0236 Medical Device De Novo Classification Process Proposed Rule Notice of Proposed Rulemaking (NPRM) 2018-12-07T05:00:00Z 2018 12 2018-12-07T05:00:00Z 2019-03-08T04:59:59Z 2019-03-09T02:01:03Z 2018-26378 0 0 090000648395870c
FDA-2018-N-2727-0001 FDA FDA-2018-N-2727 Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations Proposed Rule Notice of Proposed Rulemaking (NPRM) 2018-11-15T05:00:00Z 2018 11 2018-11-15T05:00:00Z 2019-01-15T04:59:59Z 2019-01-15T02:01:45Z 2018-24822 0 0 09000064838d9668
FDA-2018-F-3757-0001 FDA FDA-2018-F-3757 Flexible Vinyl Alliance; Filing of Food Additive Petition Proposed Rule Petition 2018-11-14T05:00:00Z 2018 11 2018-11-14T05:00:00Z 2019-01-15T04:59:59Z 2019-01-15T02:01:48Z 2018-24657 0 0 09000064838d4d64
FDA-2018-N-3952-0001 FDA FDA-2018-N-3952 Eliminating Youth Electronic Cigarette and Other Tobacco Product Use: The Role for Drug Therapies; Public Hearing; Request for Comments Proposed Rule Notice of Hearing 2018-11-05T05:00:00Z 2018 11 2018-11-05T05:00:00Z   2019-01-10T02:03:18Z 2018-24126 0 0 09000064838988db
FDA-2018-D-3631-0147 FDA FDA-2018-D-3631 Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Draft Guidance for Industry; Public Meetings; Request for Comments Proposed Rule Request for Comment 2018-11-01T04:00:00Z 2018 11 2018-11-01T04:00:00Z 2019-04-23T03:59:59Z 2019-04-24T01:01:36Z 2018-23868 0 0 090000648387abb1
FDA-2018-F-3932-0001 FDA FDA-2018-F-3932 Bonamar Corp.; Filing of Food Additive Petition Proposed Rule Petition 2018-11-01T04:00:00Z 2018 11 2018-11-01T04:00:00Z   2018-11-01T14:51:33Z 2018-23946 0 0 090000648387ac15
FDA-2016-N-2491-0024 FDA FDA-2016-N-2491 Withdrawal of the Laser Products; Proposed Amendment to Performance Standard and the Electronic Submission of Labeling for Certain Home-Use Medical Devices Proposed Rule Withdrawal 2018-11-01T04:00:00Z 2018 11 2018-11-01T04:00:00Z   2018-11-01T14:37:41Z 2018-23916 0 0 090000648387ac10
FDA-2011-N-0070-0036 FDA FDA-2011-N-0070 Withdrawal of the Laser Products; Proposed Amendment to Performance Standard and the Electronic Submission of Labeling for Certain Home-Use Medical Devices Proposed Rule Withdrawal 2018-11-01T04:00:00Z 2018 11 2018-11-01T04:00:00Z   2018-11-01T14:57:50Z 2018-23916 0 0 090000648387bc4a
FDA-2014-F-1184-0003 FDA FDA-2014-F-1184 Zinpro Corp.; Filing of Food Additive Petition (Animal Use) Proposed Rule Notice of Proposed Rulemaking (NPRM) 2018-10-30T04:00:00Z 2018 10 2018-10-30T04:00:00Z   2018-10-30T13:53:00Z 2018-23672 0 0 09000064838687c9
FDA-2015-F-2712-0002 FDA FDA-2015-F-2712 Adisseo France S.A.S.; Filing of Food Additive Petition (Animal Use) Proposed Rule Notice of Proposed Rulemaking (NPRM) 2018-10-30T04:00:00Z 2018 10 2018-10-30T04:00:00Z   2018-10-30T13:43:52Z 2018-23671 0 0 0900006483868425
FDA-2018-D-3631-0001 FDA FDA-2018-D-3631 Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Draft Guidance for Industry; Availability Proposed Rule GDL Guidance 2018-10-22T04:00:00Z 2018 10 2018-10-22T04:00:00Z 2019-04-23T03:59:59Z 2019-04-24T01:03:00Z 2018-23006 0 0 0900006483837cda
FDA-2018-D-3583-0001 FDA FDA-2018-D-3583 Guide To Minimize Food Safety Hazards of Fresh-Cut Produce: Draft Guidance for Industry; Availability Proposed Rule GDL Guidance 2018-10-22T04:00:00Z 2018 10 2018-10-22T04:00:00Z 2019-04-23T03:59:59Z 2019-04-24T01:04:57Z 2018-23005 0 0 0900006483837d0c
FDA-2018-F-3347-0001 FDA FDA-2018-F-3347 Kemin Industries, Inc.; Filing of Food Additive Petition (Animal Use) Proposed Rule Petition 2018-10-02T04:00:00Z 2018 10 2018-10-02T04:00:00Z 2018-11-02T03:59:59Z 2018-10-27T01:03:26Z 2018-21395 0 0 0900006483789fcf
FDA-2005-N-0033-0014 FDA Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants FDA-2005-N-0033 Use of Materials Derived From Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants; Reporting Information Regarding Falsification of Data Proposed Rule Withdrawal 2018-09-28T04:00:00Z 2018 9 2018-09-28T04:00:00Z   2018-10-23T15:00:58Z 2018-21133 0 0 090000648377f0ce
FDA-2007-N-0465-0028 FDA FDA-2007-N-0465 Label Requirement for Food That Has Been Refused Admission Into the United States Proposed Rule Withdrawal 2018-09-28T04:00:00Z 2018 9 2018-09-28T04:00:00Z   2018-10-23T15:19:14Z 2018-21145 0 0 090000648377f5a2
FDA-2008-N-0115-0050 FDA FDA-2008-N-0115 Use of Materials Derived From Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants; Reporting Information Regarding Falsification of Data Proposed Rule Withdrawal 2018-09-28T04:00:00Z 2018 9 2018-09-28T04:00:00Z   2018-10-23T15:02:03Z 2018-21133 0 0 090000648378011d
FDA-2018-N-3074-0001 FDA FDA-2018-N-3074 Ophthalmic Devices; Reclassification of Ultrasound Cyclodestructive Device Proposed Rule Notice of Proposed Rulemaking (NPRM) 2018-09-25T04:00:00Z 2018 9 2018-09-25T04:00:00Z 2018-11-27T04:59:59Z 2024-05-20T14:09:47Z 2018-20763 0 0 090000648376da40
FDA-2018-F-3230-0001 FDA FDA-2018-F-3230 Oakshire Naturals LP; Filing of Food Additive Petition Proposed Rule Petition 2018-09-18T04:00:00Z 2018 9 2018-09-18T04:00:00Z   2018-09-18T13:56:42Z 2018-20217 0 0 090000648370f6f9
FDA-2018-N-1622-0001 FDA FDA-2018-N-1622 Public Information Proposed Rule Notice of Proposed Rulemaking (NPRM) 2018-09-13T04:00:00Z 2018 9 2018-09-13T04:00:00Z 2018-11-14T04:59:59Z 2018-11-15T02:05:24Z 2018-19864 0 0 09000064836e6056
FDA-2018-N-0628-0001 FDA FDA-2018-N-0628 Medical Device Submissions: Amending Premarket Regulations That Require Multiple Copies and Specify Paper Copies To Be Allowed in Electronic Format Proposed Rule Notice of Proposed Rulemaking (NPRM) 2018-09-13T04:00:00Z 2018 9 2018-09-13T04:00:00Z 2018-12-13T04:59:59Z 2018-12-12T02:03:47Z 2018-19865 0 0 09000064836e65a5
FDA-2017-N-6924-0001 FDA FDA-2017-N-6924 Repeal of Regulation Requiring an Approved New Drug Application for Drugs Sterilized by Irradiation Proposed Rule Notice of Proposed Rulemaking (NPRM) 2018-09-12T04:00:00Z 2018 9 2018-09-12T04:00:00Z 2018-11-14T04:59:59Z 2018-11-08T02:00:28Z 2018-19845 0 0 09000064836df353
FDA-2012-D-1002-0017 FDA FDA-2012-D-1002 Supplemental Questions and Answers Regarding Food Facility Registration; Draft Guidance for Industry; Availability Proposed Rule GDL Guidance 2018-08-20T04:00:00Z 2018 8 2018-08-20T04:00:00Z 2018-10-20T03:59:59Z 2018-10-20T01:02:34Z 2018-17852 0 0 09000064836374ca
FDA-2018-N-3066-0001 FDA FDA-2018-N-3066 Medical Devices: Classification of Accessories Distinct from Other Devices; Proposed List of Accessories Suitable for Class I; Request for Comments Proposed Rule Request for Comment 2018-08-17T04:00:00Z 2018 8 2018-08-17T04:00:00Z 2018-10-17T03:59:59Z 2018-10-17T01:07:07Z 2018-17731 0 0 0900006483630814
FDA-2018-N-2610-0001 FDA FDA-2018-N-2610 Future Format of the National Drug Code; Public Hearing; Request for Comments Proposed Rule Request for Comment 2018-08-07T04:00:00Z 2018 8 2018-08-07T04:00:00Z 2019-01-06T04:59:59Z 2019-01-31T02:07:01Z 2018-16807 0 0 09000064835e0f0a
FDA-2018-N-2689-0001 FDA FDA-2018-N-2689 Facilitating Competition and Innovation in the Biological Products Marketplace; Public Hearing; Request for Comments Proposed Rule Notice of Hearing 2018-07-25T04:00:00Z 2018 7 2018-07-25T04:00:00Z 2018-09-22T03:59:59Z 2018-10-11T01:31:25Z 2018-15859 0 0 0900006483554ac4
FDA-2014-F-2307-0003 FDA FDA-2014-F-2307 Humic Product Trade Association; Withdrawal of Food Additive Petition (Animal Use) Proposed Rule Withdrawal 2018-07-19T04:00:00Z 2018 7 2018-07-19T04:00:00Z   2018-07-19T13:34:40Z 2018-15394 0 0 090000648351f9f4
FDA-1992-N-0455-0001 FDA Regulation for Substances Used In Food-Contact Articles - Closed FDA-1992-N-0455 Food Additives; Threshold of Regulation for Substances Used in Food-Contact Articles Proposed Rule Notice of Proposed Rulemaking (NPRM) 2018-07-13T04:00:00Z 2018 7 1993-10-12T04:00:00Z 1993-12-14T04:59:59Z 2018-07-14T01:05:30Z 1993-24940 0 0 0900006480532844
FDA-1992-N-0455-0019 FDA Regulation for Substances Used In Food-Contact Articles - Closed FDA-1992-N-0455 Food Additives; Threshold of Regulation for Substances Used In Food-Contact Articles; Extension of Comment Period Proposed Rule Notice of Extension 2018-07-13T04:00:00Z 2018 7 2018-07-13T04:00:00Z 1994-02-12T04:59:59Z 2018-07-14T01:07:27Z 1993-30426 0 0 090000648053284b
FDA-2011-F-0171-0291 FDA FDA-2011-F-0171 Food Labeling: Calorie Labeling of Articles of Food Sold From Certain Vending Machines; Front of Package Type Size Proposed Rule Notice of Proposed Rulemaking (NPRM) 2018-07-12T04:00:00Z 2018 7 2018-07-12T04:00:00Z 2018-09-26T03:59:59Z 2018-09-26T01:04:47Z 2018-14906 0 0 09000064834d7dd7
FDA-2018-N-2309-0001 FDA FDA-2018-N-2309 The Food and Drug Administration Predictive Toxicology Roadmap and Its Implementation; Public Hearing; Request for Comments Proposed Rule Request for Comment 2018-06-29T04:00:00Z 2018 6 2018-06-29T04:00:00Z 2018-10-13T03:59:59Z 2018-10-14T01:02:31Z 2018-14052 0 0 0900006483478bc3
FDA-2017-N-6565-15120 FDA FDA-2017-N-6565 Regulation of Flavors in Tobacco Products; Extension of Comment Period Proposed Rule Extension of Comment Period 2018-06-08T04:00:00Z 2018 6     2018-06-08T17:07:42Z 2018-12369 0 0 0900006483398c5a
FDA-2017-N-6107-3431 FDA FDA-2017-N-6107 Regulation of Premium Cigars; Extension of Comment Period Proposed Rule Extension of Comment Period 2018-06-08T04:00:00Z 2018 6 2018-06-08T04:00:00Z   2018-07-16T08:46:00Z 2018-12367 0 0 0900006483398bd2
FDA-2017-N-6189-0650 FDA FDA-2017-N-6189 Tobacco Product Standard for Nicotine Level of Combusted Cigarettes; Extension of Comment Period Proposed Rule Extension of Comment Period 2018-06-08T04:00:00Z 2018 6 2018-06-08T04:00:00Z   2018-07-16T08:46:05Z 2018-12368 0 0 09000064833985aa
FDA-2004-N-0191-0005 FDA Definition of Primary Mode of Action of A Combination Product FDA-2004-N-0191 Product Jurisdiction: Correction Proposed Rule Correction 2018-06-07T04:00:00Z 2018 6 2018-06-07T04:00:00Z 2018-07-17T03:59:59Z 2025-04-11T18:29:27Z 2018-12201 0 0 090000648336367b
FDA-2018-N-1553-0001 FDA FDA-2018-N-1553 Radiology Devices; Reclassification of Medical Image Analyzers Proposed Rule Notice of Proposed Rulemaking (NPRM) 2018-06-04T04:00:00Z 2018 6 2018-06-04T04:00:00Z 2018-08-04T03:59:59Z 2018-08-03T01:11:21Z 2018-11880 0 0 090000648332f8fa
FDA-2015-F-3663-0014 FDA FDA-2015-F-3663 Grocery Manufacturers Association; Denial of Food Additive Petition Proposed Rule Denial 2018-05-21T04:00:00Z 2018 5 2018-05-21T04:00:00Z 2018-06-21T03:59:59Z 2018-06-19T01:03:40Z 2018-10715 0 0 09000064832a0740
FDA-2004-N-0191-0004 FDA Definition of Primary Mode of Action of A Combination Product FDA-2004-N-0191 Product Jurisdiction Proposed Rule Notice of Proposed Rulemaking (NPRM) 2018-05-15T04:00:00Z 2018 5 2018-05-15T04:00:00Z 2018-07-17T03:59:59Z 2025-04-11T18:28:38Z 2018-10321 0 0 09000064832686f5
FDA-1977-N-0025-0231 FDA Internal, Analgesic, Antipyretic & Antirheumatic Drug Products - OPEN FDA-1977-N-0025 Tentative Final Monographs: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Partial Withdrawal Proposed Rule Withdrawal 2018-05-14T04:00:00Z 2018 5 2018-05-14T04:00:00Z   2018-05-14T20:35:15Z 2018-10194 0 0 0900006483262e32
FDA-2018-D-0075-0083 FDA FDA-2018-D-0075 The Declaration of Added Sugars on Honey, Maple Syrup, and Certain Cranberry Products: Draft Guidance for Industry; Extension of Comment Period Proposed Rule Extension of Comment Period 2018-04-25T04:00:00Z 2018 4 2018-04-25T04:00:00Z 2018-06-16T03:59:59Z 2018-05-11T01:05:40Z 2018-08603 0 0 09000064831c0e39
FDA-2018-C-1007-0002 FDA FDA-2018-C-1007 Aker BioMarine; Filing of Color Additive Petition Proposed Rule Petition 2018-04-09T04:00:00Z 2018 4 2018-04-09T04:00:00Z 2018-05-10T03:59:59Z 2018-05-10T01:02:04Z 2018-07155 0 0 09000064830dd241
FDA-2018-N-1214-0001 FDA FDA-2018-N-1214 Medical Gas Regulation; Public Workshop; Request for Comments Proposed Rule Request for Comment 2018-03-29T04:00:00Z 2018 3 2018-03-29T04:00:00Z 2018-08-10T03:59:59Z 2024-11-07T01:23:47Z 2018-06251 1 0 0900006483061a32
FDA-2017-N-6107-0001 FDA FDA-2017-N-6107 Regulation of Premium Cigars Proposed Rule Advance Notice of Proposed Rulemaking (ANPRM) 2018-03-26T04:00:00Z 2018 3 2018-03-26T04:00:00Z 2018-06-26T03:59:59Z 2018-04-28T01:03:00Z 2018-06047 0 0 090000648304d9a4
FDA-2017-N-6565-0001 FDA FDA-2017-N-6565 Regulation of Flavors in Tobacco Products Proposed Rule Advance Notice of Proposed Rulemaking (ANPRM) 2018-03-21T04:00:00Z 2018 3 2018-03-21T04:00:00Z 2018-07-20T03:59:59Z 2024-05-30T01:03:28Z 2018-05655 0 0 09000064830358de
FDA-2008-N-0424-0022 FDA FDA-2008-N-0424 Postmarketing Safety Reporting for Combination Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Proposed Rule GDL Guidance 2018-03-21T04:00:00Z 2018 3 2018-03-21T04:00:00Z 2018-06-20T03:59:59Z 2018-03-21T13:13:54Z 2018-05687 0 0 09000064830356f0
FDA-2018-D-0671-0001 FDA FDA-2018-D-0671 Determining the Number of Employees for Purposes of the ‘‘Small Business’’ Definition in Parts 117 and 507: Draft Guidance for Industry; Availability Proposed Rule GDL Guidance 2018-03-20T04:00:00Z 2018 3 2018-03-20T04:00:00Z 2018-05-22T03:59:59Z 2018-03-22T13:00:37Z 2018-05705 0 0 090000648302a4c1
FDA-2017-N-6189-0001 FDA FDA-2017-N-6189 Tobacco Product Standard for Nicotine Level of Combusted Cigarettes Proposed Rule Advance Notice of Proposed Rulemaking (ANPRM) 2018-03-16T04:00:00Z 2018 3 2018-03-16T04:00:00Z 2018-06-15T03:59:59Z 2018-04-29T01:01:18Z 2018-05345 0 0 090000648301bf2e
FDA-2014-F-0469-0002 FDA FDA-2014-F-0469 Excentials B.V.; Withdrawal of Food Additive Petition (Animal Use) Proposed Rule Withdrawal 2018-03-12T04:00:00Z 2018 3 2018-03-12T04:00:00Z   2018-03-13T14:23:45Z 2018-04775 0 0 0900006482ffda8c
FDA-2018-C-0617-0002 FDA FDA-2018-C-0617 GW Cosmetics GmbH; Filing of Color Additive Petition Proposed Rule Petition 2018-03-07T05:00:00Z 2018 3 2018-03-07T05:00:00Z 2018-04-07T03:59:59Z 2018-04-06T01:04:20Z 2018-04619 0 0 0900006482fa1256
FDA-2018-D-0075-0001 FDA FDA-2018-D-0075 The Declaration of Added Sugars on Honey, Maple Syrup, and Certain Cranberry Products; Draft Guidance for Industry; Availability Proposed Rule GDL Guidance 2018-03-02T05:00:00Z 2018 3 2018-03-02T05:00:00Z 2018-05-02T03:59:59Z 2018-04-29T01:01:05Z 2018-04281 0 0 0900006482f8584a
FDA-2018-N-0128-0001 FDA FDA-2018-N-0128 Nicotine Steering Committee; Establishment of a Public Docket; Request for Comments Proposed Rule Request for Comment 2018-02-20T05:00:00Z 2018 2 2018-02-20T05:00:00Z 2018-04-17T03:59:59Z 2018-04-17T01:01:26Z 2018-03341 0 0 0900006482f453db
FDA-2017-N-6381-0001 FDA FDA-2017-N-6381 Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements Proposed Rule Notice of Proposed Rulemaking (NPRM) 2018-02-14T05:00:00Z 2018 2 2018-02-14T05:00:00Z 2018-05-01T03:59:59Z 2018-04-26T01:05:34Z 2018-02757 0 0 0900006482f30507
FDA-2017-N-7007-0002 FDA FDA-2017-N-7007 Removal of Certain Time of Inspection and Duties of Inspector Regulations for Biological Products; Companion to Direct Final Rule Proposed Rule Notice of Proposed Rulemaking (NPRM) 2018-01-26T05:00:00Z 2018 1 2018-01-26T05:00:00Z 2018-04-12T03:59:59Z 2018-04-13T01:01:40Z 2018-01467 0 0 0900006482e6bea2
FDA-2017-D-0397-0003 FDA FDA-2017-D-0397 Considerations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding Requirement in 21 CFR Part 112 or the Preventive Controls Requirements in Part 117 or 507; Draft Guidance for Industry; Availability Proposed Rule GDL Guidance 2018-01-25T05:00:00Z 2018 1 2018-01-25T05:00:00Z 2018-05-26T03:59:59Z 2018-01-25T23:07:09Z 2018-01296 0 0 0900006482e64592
FDA-2011-N-0143-0400 FDA FDA-2011-N-0143 Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: What You Need To Know About the Food and Drug Administration Regulation; Small Entity Compliance Guide; Availability Proposed Rule Notice of Proposed Rulemaking (NPRM) 2018-01-25T05:00:00Z 2018 1 2018-01-25T05:00:00Z   2018-01-26T17:52:44Z 2018-01300 0 0 0900006482e6458d
FDA-2017-D-5225-0003 FDA FDA-2017-D-5225 Foreign Supplier Verification Programs for Importers of Food for Humans and Animals; Draft Guidance for Industry; Availability Proposed Rule GDL Guidance 2018-01-25T05:00:00Z 2018 1 2018-01-25T05:00:00Z 2018-05-26T03:59:59Z 2023-01-11T19:13:39Z 2018-01297 0 0 0900006482e645c5
FDA-2017-D-6592-0002 FDA FDA-2017-D-6592 Application of the Foreign Supplier Verification Program Regulation to Importers of Grain Raw Agricultural Commodities: Guidance for Industry; Availability Proposed Rule GDL Guidance 2018-01-25T05:00:00Z 2018 1 2018-01-25T05:00:00Z   2018-01-25T23:19:32Z 2018-01298 0 0 0900006482e645c4
FDA-2016-D-2343-0042 FDA FDA-2016-D-2343 Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability Proposed Rule GDL Guidance 2018-01-25T05:00:00Z 2018 1 2018-01-25T05:00:00Z 2018-05-26T03:59:59Z 2024-05-31T13:17:23Z 2018-01299 0 0 0900006482e6461c
FDA-2017-N-5319-0007 FDA FDA-2017-N-5319 Devices Proposed for a New Use With an Approved, Marketed Drug; Public Hearing; Reopening of the Comment Period Proposed Rule Extension of Comment Period 2018-01-22T05:00:00Z 2018 1 2018-01-22T05:00:00Z 2018-02-22T04:59:59Z 2018-02-24T02:01:42Z 2018-00991 0 0 0900006482e3eea7
FDA-2016-D-3548-0001 FDA FDA-2016-D-3548 Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Proposed Rule GDL Guidance 2018-01-19T05:00:00Z 2018 1 2018-01-19T05:00:00Z 2018-03-21T03:59:59Z 2018-03-21T13:03:35Z 2018-00918 0 0 0900006482e2ebf3
FDA-2016-N-2378-0001 FDA FDA-2016-N-2378 Internal Agency Review of Decisions; Requests for Supervisory Review of Certain Decisions Made by Center for Devices and Radiological Health Proposed Rule Notice of Proposed Rulemaking (NPRM) 2018-01-17T05:00:00Z 2018 1 2018-01-17T05:00:00Z 2018-04-18T03:59:59Z 2018-04-18T01:04:11Z 2018-00646 0 0 0900006482e18ba5
FDA-2017-N-0763-0867 FDA FDA-2017-N-0763 Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease; Extension of Comment Period Proposed Rule Extension of Comment Period 2018-01-17T05:00:00Z 2018 1 2018-01-17T05:00:00Z 2018-03-20T03:59:59Z 2023-08-08T01:02:42Z 2018-00683 0 0 0900006482e18b55
FDA-2015-N-2002-2008 FDA FDA-2015-N-2002 Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ‘‘Intended Uses’’; Proposed Partial Delay of Effective Date Proposed Rule Notice of Proposed Rulemaking (NPRM) 2018-01-16T05:00:00Z 2018 1 2018-01-16T05:00:00Z 2018-02-06T04:59:59Z 2018-02-06T14:02:16Z 2018-00555 0 0 0900006482e0b3c7

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CREATE TABLE documents (
    id TEXT PRIMARY KEY,
    agency_id TEXT,
    docket_id TEXT REFERENCES dockets(id),
    title TEXT,
    document_type TEXT,
    subtype TEXT,
    posted_date TEXT,
    posted_year INTEGER,
    posted_month INTEGER,
    comment_start_date TEXT,
    comment_end_date TEXT,
    last_modified TEXT,
    fr_doc_num TEXT,
    open_for_comment INTEGER,
    withdrawn INTEGER,
    object_id TEXT
);
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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