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

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51 rows where agency_id = "FDA", document_type = "Rule" and posted_year = 2019 sorted by posted_date descending

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posted_year 1

  • 2019 · 51 ✖

document_type 1

  • Rule · 51 ✖

agency_id 1

  • FDA · 51 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-D-1459-0047 FDA FDA-2018-D-1459 Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed at One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, Dual- Column Labeling, and Miscellaneous Topics; Guidance for Industry; Availability Rule Notice of Interim Rule 2019-12-31T05:00:00Z 2019 12 2019-12-31T05:00:00Z   2019-12-31T15:10:26Z 2019-27868 0 0 090000648425d410
FDA-2017-N-1129-0057 FDA FDA-2017-N-1129 Medical Devices; Exemptions From Premarket Notification for Class I and Class II Devices Rule Final Rule 2019-12-30T05:00:00Z 2019 12 2019-12-30T05:00:00Z   2019-12-30T16:00:40Z 2019-27394 0 0 090000648425877b
FDA-2017-N-1610-0002 FDA FDA-2017-N-1610 Medical Devices; Exemptions From Premarket Notification for Class I and Class II Devices Rule Final Rule 2019-12-30T05:00:00Z 2019 12 2019-12-30T05:00:00Z   2019-12-30T16:04:58Z 2019-27394 0 0 0900006484256f8e
FDA-2014-N-1209-0315 FDA FDA-2014-N-1209 Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Devices Intended To Treat Anxiety and/ or Insomnia; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Devices Intended To Treat Depression Rule Final Rule 2019-12-20T05:00:00Z 2019 12 2019-12-20T05:00:00Z   2019-12-20T13:47:06Z 2019-27295 0 0 0900006484240022
FDA-2018-C-4464-0019 FDA FDA-2018-C-4464 Listing of Color Additives Exempt From Certification; Soy Leghemoglobin Rule Final Rule 2019-12-19T05:00:00Z 2019 12 2019-12-19T05:00:00Z   2019-12-19T15:01:44Z 2019-27173 0 0 0900006484235cb1
FDA-2018-N-0628-0020 FDA FDA-2018-N-0628 Medical Device Submissions: Amending Premarket Regulations That Require Multiple Copies and Specify Paper Copies To Be Required in Electronic Format Rule Final Rule 2019-12-16T05:00:00Z 2019 12 2019-12-16T05:00:00Z   2019-12-16T16:22:23Z 2019-27047 0 0 090000648421276f
FDA-2017-N-6924-0015 FDA FDA-2017-N-6924 Regulation Requiring an Approved New Drug Application for Drugs Sterilized by Irradiation Rule Final Rule 2019-12-16T05:00:00Z 2019 12 2019-12-16T05:00:00Z   2019-12-16T16:15:20Z 2019-27046 0 0 0900006484212728
FDA-2019-N-2484-0001 FDA FDA-2019-N-2484 Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Continuous Glucose Monitor Data Management System Rule Final Rule 2019-10-29T04:00:00Z 2019 10 2019-10-29T04:00:00Z   2019-10-30T14:25:27Z 2019-23471 0 0 0900006484103fca
FDA-2011-F-0171-0421 FDA FDA-2011-F-0171 Food Labeling: Calorie Labeling of Articles of Food Sold From Certain Vending Machines; Front of Package Type Size Rule Final Rule 2019-10-28T04:00:00Z 2019 10 2019-10-28T04:00:00Z   2019-10-28T12:36:01Z 2019-23276 0 0 09000064840fee46
FDA-2019-N-4328-0001 FDA FDA-2019-N-4328 Medical Devices; Ear, Nose, and Throat Devices; Classification of the Self-Fitting Air-Conduction Hearing Aid Rule Final Rule 2019-10-28T04:00:00Z 2019 10 2019-10-28T04:00:00Z   2019-10-28T13:29:13Z 2019-23464 0 0 09000064840ff050
FDA-2019-N-2675-0001 FDA FDA-2019-N-2675 Medical Devices; Physical Medicine Therapeutic Devices; Classification of the Internal Therapeutic Massager Rule Final Rule 2019-10-25T04:00:00Z 2019 10 2019-10-25T04:00:00Z   2019-10-25T13:37:03Z 2019-23304 0 0 09000064840f8d85
FDA-2019-N-2711-0001 FDA FDA-2019-N-2711 Medical Devices; Orthopedic Devices; Classification of Orthopedic Surgical Instrumentation Designed for Osteochondral Implants With Press-Fit Fixation Rule Final Rule 2019-10-25T04:00:00Z 2019 10 2019-10-25T04:00:00Z   2019-10-25T12:57:01Z 2019-23307 0 0 09000064840f8c14
FDA-2019-N-0002-0003 FDA FDA-2019-N-0002 New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor's Name and Address Rule Final Rule 2019-10-07T04:00:00Z 2019 10 2019-10-07T04:00:00Z   2019-10-07T13:53:21Z 2019-21514 0 0 0900006484048afc
FDA-2019-N-0002-0002 FDA FDA-2019-N-0002 New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of Sponsors’ Names and Addresses Rule Final Rule 2019-08-09T04:00:00Z 2019 8 2019-08-09T04:00:00Z   2019-08-09T12:45:08Z 2019-16884 0 0 0900006483e1d816
FDA-2019-N-0002-0001 FDA FDA-2019-N-0002 New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications Rule Withdrawal 2019-08-09T04:00:00Z 2019 8 2019-08-09T04:00:00Z   2019-08-09T12:41:49Z 2019-16885 0 0 0900006483e1d71a
FDA-2018-C-4464-0002 FDA FDA-2018-C-4464 Listing of Color Additives Exempt From Certification; Soy Leghemoglobin Rule Final Rule 2019-08-01T04:00:00Z 2019 8 2019-08-01T04:00:00Z 2019-09-04T03:59:59Z 2019-09-05T01:06:25Z 2019-16374 0 0 0900006483dddc38
FDA-2011-N-0921-19183 FDA FDA-2011-N-0921 Ext 002 standards-produce-extension-compliance-dates-subparte-FRIA-document re Extension of Compliance Dates Rule Final Rule 2019-07-24T04:00:00Z 2019 7 2019-07-24T04:00:00Z   2019-07-24T13:46:00Z   0 0 0900006483db0cd3
FDA-2011-N-0921-19181 FDA FDA-2011-N-0921 Ext 000 List of references Rule Final Rule 2019-07-24T04:00:00Z 2019 7 2019-07-24T04:00:00Z   2019-07-24T13:43:41Z   0 0 0900006483db0cd1
FDA-2011-N-0921-19182 FDA FDA-2011-N-0921 Ext 001 Produce Final RIA-10-28-2015 CLEAN_508ED re Extension of Compliance Dates Rule Final Rule 2019-07-24T04:00:00Z 2019 7 2019-07-24T04:00:00Z   2019-07-24T13:45:26Z   0 0 0900006483db0cd2
FDA-2012-N-1067-0018 FDA FDA-2012-N-1067 New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food Rule Final Rule 2019-07-11T04:00:00Z 2019 7 2019-07-11T04:00:00Z   2019-07-11T14:44:25Z 2019-14098 0 0 0900006483d7d205
FDA-2016-N-2378-0004 FDA FDA-2016-N-2378 Internal Agency Review of Decisions; Requests for Supervisory Review of Certain Decisions Made by the Center for Devices and Radiological Health Rule Final Rule 2019-07-02T04:00:00Z 2019 7 2019-07-02T04:00:00Z   2019-07-02T19:10:21Z 2019-14096 0 0 0900006483d55e8e
FDA-2018-D-0671-0005 FDA FDA-2018-D-0671 Determining the Number of Employees for Purposes of the "Small Business" Definition (Current Good Manufacturing Practices and Preventive Controls Regulations for Human and Animal Food): Guidance for Industry; Availability Rule Notice of Interim Rule 2019-06-21T04:00:00Z 2019 6 2019-06-21T04:00:00Z   2019-06-27T15:14:22Z 2019-13223 0 0 0900006483d2f681
FDA-2019-D-2011-0001 FDA FDA-2019-D-2011 Guidance: Section 503A Bulks List Final Rule Questions and Answers; Small Entity Compliance Guide; Availability Rule Final Rule 2019-05-24T04:00:00Z 2019 5 2019-05-24T04:00:00Z   2019-05-24T16:35:25Z 2019-10953 0 0 0900006483cc3e2e
FDA-2018-N-3066-0010 FDA FDA-2018-N-3066 Medical Devices; Classification of Accessories Distinct From Other Devices; Finalized List of Accessories Suitable for Class I; Correction Rule Correction 2019-05-20T04:00:00Z 2019 5 2019-05-20T04:00:00Z   2019-05-20T14:29:46Z 2019-10399 0 0 0900006483ca0d2c
FDA-2008-N-0424-0034 FDA FDA-2008-N-0424 Compliance Policy for Combination Product Postmarketing Safety Reporting; Immediately in Effect Guidance for Industry; Availability Rule Correction 2019-04-24T04:00:00Z 2019 4 2019-04-24T04:00:00Z   2019-07-23T11:14:49Z 2019-08284 0 0 0900006483be9a6e
FDA-2017-C-6238-0006 FDA FDA-2017-C-6238 Listing of Color Additives Exempt From Certification; Synthetic Iron Oxide; Confirmation of Effective Date Rule Confirmation of Effective Date 2019-04-18T04:00:00Z 2019 4 2019-04-18T04:00:00Z   2023-01-24T16:58:06Z 2019-07829 0 0 0900006483bb992d
FDA-2019-N-0647-0001 FDA FDA-2019-N-0647 Medical Devices; Anesthesiology Devices; Classification of the Ventilatory Electrical Impedance Tomograph Rule Final Rule 2019-04-15T04:00:00Z 2019 4 2019-04-15T04:00:00Z   2019-04-15T13:38:27Z 2019-07463 0 0 0900006483ba2974
FDA-2016-N-0124-0281 FDA FDA-2016-N-0124 Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use Rule Final Rule 2019-04-12T04:00:00Z 2019 4 2019-04-12T04:00:00Z   2019-04-12T13:14:40Z 2019-06791 0 0 0900006483b89f68
FDA-2018-N-3066-0009 FDA FDA-2018-N-3066 Medical Devices; Classification of Accessories Distinct From Other Devices; Finalized List of Accessories Suitable for Class I Rule Direct Final Rule 2019-04-12T04:00:00Z 2019 4 2019-04-12T04:00:00Z   2019-04-12T13:13:55Z 2019-07290 0 0 0900006483b89fcc
FDA-2018-N-0002-0006 FDA FDA-2018-N-0002 New Animal Drugs: Approval of New Animal Drug Applications; Changes of Sponsorship Rule Final Rule 2019-04-02T04:00:00Z 2019 4 2019-04-02T04:00:00Z   2019-04-02T13:09:20Z 2019-06136 0 0 0900006483b571a1
FDA-2017-N-7007-0009 FDA FDA-2017-N-7007 Removal of Certain Time of Inspection and Duties of Inspector Regulations for Biological Products Rule Final Rule 2019-04-02T04:00:00Z 2019 4 2019-04-02T04:00:00Z   2019-04-02T13:50:48Z 2019-06187 0 0 0900006483b57290
FDA-2011-N-0920-2067 FDA FDA-2011-N-0920 Implementing the Food and Drug Administration Food Safety Modernization Act; Technical Amendment Rule Final Rule 2019-04-02T04:00:00Z 2019 4 2019-04-02T04:00:00Z   2019-04-02T12:58:59Z 2019-06141 0 0 0900006483b5797c
FDA-2011-N-0922-0566 FDA FDA-2011-N-0922 Implementing the Food and Drug Administration Food Safety Modernization Act; Technical Amendment Rule Final Rule 2019-04-02T04:00:00Z 2019 4 2019-04-02T04:00:00Z   2019-04-02T12:58:03Z 2019-06141 0 0 0900006483b5714d
FDA-2011-N-0921-19180 FDA FDA-2011-N-0921 Implementing the Food and Drug Administration Food Safety Modernization Act; Technical Amendment Rule Final Rule 2019-04-02T04:00:00Z 2019 4 2019-04-02T04:00:00Z   2019-04-02T12:59:31Z 2019-06141 0 0 0900006483b57980
FDA-2017-C-1951-0234 FDA FDA-2017-C-1951 Reinstatement of Color Additive Listing for Lead Acetate Rule Final Rule 2019-04-01T04:00:00Z 2019 4 2019-04-01T04:00:00Z   2019-04-01T16:25:55Z 2019-06238 0 0 0900006483b5129d
FDA-2015-N-3785-0009 FDA FDA-2015-N-3785 Medical Devices; Orthopedic Devices; Classification of Posterior Cervical Screw Systems Rule Final Rule 2019-04-01T04:00:00Z 2019 4 2019-04-01T04:00:00Z   2019-04-01T16:22:28Z 2019-06024 0 0 0900006483b511b1
FDA-2011-N-0103-0021 FDA FDA-2011-N-0103 Microbiology Devices; Classification of In Vitro Diagnostic Devices for Bacillus Species Detection Rule Final Rule 2019-04-01T04:00:00Z 2019 4 2019-04-01T04:00:00Z   2019-04-01T15:56:15Z 2019-06026 0 0 0900006483b512a0
FDA-2019-N-1345-0001 FDA FDA-2019-N-1345 Medical Devices; Technical Amendment Rule Final Rule 2019-04-01T04:00:00Z 2019 4 2019-04-01T04:00:00Z   2019-04-01T16:27:11Z 2019-06139 0 0 0900006483b513f0
FDA-2019-D-1266-0001 FDA FDA-2019-D-1266 Produce Safety Rule: Enforcement Policy for Entities Growing, Harvesting, Packing, or Holding Hops, Wine Grapes, Pulse Crops, and Almonds; Guidance for Industry; Availability Rule Policy Statement 2019-03-28T04:00:00Z 2019 3 2019-03-28T04:00:00Z   2019-04-02T16:50:15Z 2019-05953 0 0 0900006483b37f47
FDA-2011-N-0921-19179 FDA FDA-2011-N-0921 Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Extension of Compliance Dates for Subpart E Rule Final Rule 2019-03-18T04:00:00Z 2019 3 2019-03-18T04:00:00Z   2019-03-18T14:05:36Z 2019-04652 0 0 0900006483af67e1
FDA-2019-N-0360-0001 FDA FDA-2019-N-0360 Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microorganisms and Associated Resistance Marker Nucleic Acids Directly in Respiratory Specimens Rule Final Rule 2019-03-14T04:00:00Z 2019 3 2019-03-14T04:00:00Z   2019-03-14T15:02:48Z 2019-04719 0 0 0900006483adea69
FDA-2019-N-0396-0001 FDA FDA-2019-N-0396 Medical Devices; Neurological Devices; Classification of the Transcranial Magnetic Stimulation System for Neurological and Psychiatric Disorders and Conditions Rule Final Rule 2019-03-14T04:00:00Z 2019 3 2019-03-14T04:00:00Z   2019-03-14T14:42:39Z 2019-04709 0 0 0900006483ade91a
FDA-2018-N-0002-0004 FDA FDA-2018-N-0002 New Animal Drugs; Withdrawal of Approval of New Animal Drug Application Rule Withdrawal 2019-03-13T04:00:00Z 2019 3 2019-03-13T04:00:00Z   2019-03-13T13:19:26Z 2019-04222 0 0 0900006483adaeb9
FDA-2018-N-0002-0005 FDA FDA-2018-N-0002 New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship Rule Final Rule 2019-03-13T04:00:00Z 2019 3 2019-03-13T04:00:00Z   2019-03-13T13:22:43Z 2019-04226 0 0 0900006483adaeba
FDA-2015-F-2712-0003 FDA FDA-2015-F-2712 Food Additives Permitted in Feed and Drinking Water of Animals; Selenomethionine Hyd Rule Final Rule 2019-03-06T05:00:00Z 2019 3 2019-03-06T05:00:00Z 2019-04-06T03:59:59Z 2019-03-14T01:03:57Z 2019-03909 0 0 0900006483ac2419
FDA-2019-N-0138-0001 FDA FDA-2019-N-0138 Medical Devices; Obstetrical and Gynecological Devices; Classification of the Software Application for Contraception Rule Final Rule 2019-03-06T05:00:00Z 2019 3 2019-03-06T05:00:00Z   2019-03-06T14:18:52Z 2019-04028 0 0 0900006483ac24f8
FDA-2019-N-0646-0001 FDA FDA-2019-N-0646 Change of Address; Technical Amendment Rule Final Rule 2019-02-28T05:00:00Z 2019 2 2019-02-28T05:00:00Z   2019-02-28T14:50:46Z 2019-03542 0 0 0900006483aaf4fd
FDA-2017-F-4511-0002 FDA FDA-2017-F-4511 Food Additives Permitted in Feed and Drinking Water of Animals; Gamma- Linolenic Acid Safflower Oil Rule Final Rule 2019-02-28T05:00:00Z 2019 2 2019-02-28T05:00:00Z 2019-04-02T03:59:59Z 2019-04-02T01:02:23Z 2019-03514 0 0 0900006483aaf556
FDA-2019-N-0142-0001 FDA FDA-2019-N-0142 Medical Devices; Dental Devices; Classification of the Auto Titration Device for Oral Appliances Rule Final Rule 2019-02-20T05:00:00Z 2019 2 2019-02-20T05:00:00Z   2019-02-20T16:30:49Z 2019-02824 0 0 0900006483a8fd76
FDA-2016-N-3464-0029 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 Rule Final Rule 2019-02-19T05:00:00Z 2019 2 2019-02-19T05:00:00Z   2019-02-19T14:46:18Z 2019-02367 0 0 0900006483a88bb0
FDA-1976-N-0476-0324 FDA Good Laboratory Practice for Nonclinical Laboratory Studi- Open FDA-1976-N-0476 Nonclinical Laboratory Studies, Good Laboratory Practice Regulations; Correction Rule Correction 2019-01-30T05:00:00Z 2019 1 2019-01-30T05:00:00Z   2019-01-30T15:15:55Z 79-9094 0 0 0900006480521a45

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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);