documents
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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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| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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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docket_id TEXT REFERENCES dockets(id),
title TEXT,
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