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

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

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

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Suggested facets: subtype, posted_month, posted_date (date), comment_start_date (date), comment_end_date (date), last_modified (date)

posted_year 1

  • 2019 · 45 ✖

document_type 1

  • Proposed Rule · 45 ✖

agency_id 1

  • FDA · 45 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2008-P-0086-0030 FDA FDA-2008-P-0086 Cheeses and Related CheeseProducts; Proposal To Permit the Use of Ultrafiltered Milk; Reopening the Comment Period Proposed Rule Reopening of Comment Period 2019-12-30T05:00:00Z 2019 12 2019-12-30T05:00:00Z   2020-04-15T20:32:35Z 2019-28145 0 0 0900006484256f2a
FDA-2019-N-5711-0001 FDA FDA-2019-N-5711 Importation of Prescription Drugs Proposed Rule Amendment 2019-12-23T05:00:00Z 2019 12 2019-12-23T05:00:00Z 2020-03-10T03:59:59Z 2022-01-18T02:00:13Z 2019-27474 0 0 090000648424842c
FDA-2019-N-3101-0001 FDA FDA-2019-N-3101 Revised Procedures for the Announcement of Approvals and Denials of Premarket Approval Applications and Humanitarian Device Exemption Applications Proposed Rule Amendment 2019-12-17T05:00:00Z 2019 12 2019-12-17T05:00:00Z 2020-03-03T04:59:59Z 2020-03-04T02:02:53Z 2019-27045 0 0 090000648421ceeb
FDA-2017-F-4399-0010 FDA FDA-2017-F-4399 Zinpro Corp.; Filing of Food Additive Petition (Animal Use) Proposed Rule Amendment 2019-11-29T05:00:00Z 2019 11 2019-11-29T05:00:00Z 2019-12-31T04:59:59Z 2020-01-01T02:02:15Z 2019-25903 0 0 09000064841c8875
FDA-2019-F-5401-0001 FDA FDA-2019-F-5401 Alzchem Trostberg GmbH; Filing of Food Additive Petition (Animal Use) Proposed Rule Amendment 2019-11-29T05:00:00Z 2019 11 2019-11-29T05:00:00Z   2019-11-29T19:16:58Z 2019-25904 0 0 09000064841c88e2
FDA-2019-N-2854-0663 FDA FDA-2019-N-2854 Premarket Tobacco Product Applications and Recordkeeping Requirements; Reopening of the Comment Period Proposed Rule Reopening of Comment Period 2019-11-26T05:00:00Z 2019 11 2019-11-26T05:00:00Z 2019-12-17T04:59:59Z 2019-12-18T02:01:22Z 2019-25675 0 0 09000064841b74c6
FDA-2019-N-3065-0484 FDA FDA-2019-N-3065 Tobacco Products; Required Warnings for Cigarette Packages and Advertisements; Additional Materials; Reopening of the Comment Period Proposed Rule Reopening of Comment Period 2019-11-12T05:00:00Z 2019 11 2019-11-12T05:00:00Z 2019-11-28T04:59:59Z 2019-11-12T15:05:34Z 2019-24511 0 0 09000064841433d1
FDA-2019-N-3325-0001 FDA FDA-2019-N-3325 Laboratory Accreditation for Analyses of Foods Proposed Rule Advance Notice of Proposed Rulemaking (ANPRM) 2019-11-04T05:00:00Z 2019 11 2019-11-04T05:00:00Z 2020-07-07T03:59:59Z 2020-07-08T01:02:34Z 2019-23870 0 0 090000648411a07f
FDA-2016-D-2343-0070 FDA FDA-2016-D-2343 Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability Proposed Rule GDL Guidance 2019-10-07T04:00:00Z 2019 10 2019-10-07T04:00:00Z 2020-02-05T04:59:59Z 2024-05-31T13:17:40Z 2019-21643 0 0 09000064840489c1
FDA-2019-F-3911-0001 FDA FDA-2019-F-3911 Evonik Corp.; Filing of Food Additive Petition (Animal Use) Proposed Rule Notice of Proposed Rulemaking (NPRM) 2019-10-01T04:00:00Z 2019 10 2019-10-01T04:00:00Z   2019-10-01T12:34:28Z 2019-20958 0 0 0900006483ff2174
FDA-2019-N-2854-0001 FDA FDA-2019-N-2854 Premarket Tobacco Product Applications and Recordkeeping Requirements Proposed Rule Notice of Proposed Rulemaking (NPRM) 2019-09-25T04:00:00Z 2019 9 2019-09-25T04:00:00Z 2019-12-17T04:59:59Z 2019-12-18T02:00:32Z 2019-20315 0 0 0900006483fc33e2
FDA-2019-N-0463-0001 FDA FDA-2019-N-0463 Addition of a New Method for the Analysis of Sulfites in Foods Proposed Rule Amendment 2019-09-17T04:00:00Z 2019 9 2019-09-17T04:00:00Z 2019-10-18T03:59:59Z 2019-09-26T01:02:20Z 2019-19862 0 0 0900006483f861a0
FDA-2019-N-3631-0001 FDA FDA-2019-N-3631 Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies; Public Hearing; Request for Comments Proposed Rule Notice of Hearing 2019-09-11T04:00:00Z 2019 9 2019-09-11T04:00:00Z 2020-01-22T04:59:59Z 2020-01-23T02:00:47Z 2019-19643 0 0 0900006483f36791
FDA-2018-N-4845-0001 FDA FDA-2018-N-4845 Amendments to the 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) 2019-09-05T04:00:00Z 2019 9 2019-09-05T04:00:00Z 2019-12-05T04:59:59Z 2019-12-06T02:01:33Z 2019-18951 0 0 0900006483eed96e
FDA-1998-N-1001-0002 FDA Amend the final monograph for (OTC) Ophthalmic Drug Products FDA-1998-N-1001 Ophthalmic Drug Products for Over-The-Counter Human Use; Proposed Amendment of Final Monograph Proposed Rule Notice of Proposed Rulemaking (NPRM) 2019-08-26T04:00:00Z 2019 8 2019-08-26T04:00:00Z 1998-05-24T03:59:59Z 2019-08-26T19:16:37Z 98-4531 0 0 09000064805a28d5
FDA-2019-N-2514-0025 FDA FDA-2019-N-2514 Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics To Treat Pain and Addiction; Public Hearing; Correction Proposed Rule Correction 2019-08-22T04:00:00Z 2019 8 2019-08-22T04:00:00Z   2019-08-22T13:40:07Z 2019-18090 0 0 0900006483e8c3b6
FDA-2019-N-3065-0001 FDA FDA-2019-N-3065 Tobacco Products; Required Warnings for Cigarette Packages and Advertisements Proposed Rule Notice of Proposed Rulemaking (NPRM) 2019-08-16T04:00:00Z 2019 8 2019-08-16T04:00:00Z 2019-11-28T04:59:59Z 2019-11-29T02:00:38Z 2019-17481 0 0 0900006483e5f2f7
FDA-2019-F-3519-0001 FDA FDA-2019-F-3519 Kellogg Company; Filing of Food Additive Petition Proposed Rule Petition 2019-08-12T04:00:00Z 2019 8 2019-08-12T04:00:00Z   2019-08-12T15:16:10Z 2019-17056 0 0 0900006483e2d684
FDA-2019-D-0892-0023 FDA FDA-2019-D-0892 The Use of an Alternate Name for Potassium Chloride in Food Labeling; Draft Guidance for Industry; Extension of Comment Period Proposed Rule Extension of Comment Period 2019-07-10T04:00:00Z 2019 7 2019-07-10T04:00:00Z 2019-09-18T03:59:59Z 2019-09-19T01:04:17Z 2019-14666 0 0 0900006483d74b33
FDA-2019-N-1363-0001 FDA FDA-2019-N-1363 Biologics License Applications and Master Files Proposed Rule Notice of Proposed Rulemaking (NPRM) 2019-06-28T04:00:00Z 2019 6 2019-06-28T04:00:00Z 2019-08-28T03:59:59Z 2019-08-28T01:03:12Z 2019-13753 0 0 0900006483d4af9c
FDA-2019-N-2514-0001 FDA FDA-2019-N-2514 Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction Proposed Rule Public Hearing 2019-06-21T04:00:00Z 2019 6 2019-06-21T04:00:00Z 2019-11-19T04:59:59Z 2019-11-23T02:00:56Z 2019-13219 0 0 0900006483d2f7ad
FDA-2016-N-3818-0068 FDA FDA-2016-N-3818 Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports; Extension of Comment Period Proposed Rule Extension of Comment Period 2019-06-13T04:00:00Z 2019 6 2019-06-13T04:00:00Z 2019-07-18T03:59:59Z 2019-06-13T21:14:01Z 2019-12478 0 0 0900006483d0d911
FDA-2019-D-0892-0001 FDA FDA-2019-D-0892 The Use of an Alternate Name for Potassium Chloride in Food Labeling; Draft Guidance for Industry; Availability Proposed Rule GDL Guidance 2019-05-20T04:00:00Z 2019 5 2019-05-20T04:00:00Z 2019-07-20T03:59:59Z 2019-07-11T01:05:50Z 2019-10401 0 0 0900006483ca0db2
FDA-2019-C-1782-0001 FDA FDA-2019-C-1782 CooperVision, Inc.; Filing of Color Additive Petition Proposed Rule Petition 2019-05-08T04:00:00Z 2019 5 2019-05-08T04:00:00Z   2019-05-08T13:39:36Z 2019-09411 0 0 0900006483c43a7a
FDA-2019-N-1250-0001 FDA FDA-2019-N-1250 General and Plastic Surgery Devices; Reclassification of Certain Surgical Staplers Proposed Rule Amendment 2019-04-24T04:00:00Z 2019 4 2019-04-24T04:00:00Z 2019-06-25T03:59:59Z 2019-06-25T01:01:16Z 2019-08260 0 0 0900006483be9aa2
FDA-2015-F-0537-0053 FDA FDA-2015-F-0537 Natural Resources Defense Council et al.: Response to the Objections and Denial of the Requests for a Public Hearing Proposed Rule Denial 2019-04-24T04:00:00Z 2019 4 2019-04-24T04:00:00Z   2019-04-24T15:54:26Z 2019-08262 0 0 0900006483be9aef
FDA-2018-D-2074-0001 FDA FDA-2018-D-2074 Initiation of Voluntary Recalls Draft Guidance for Industry and Food and Drug Administration Staff; Availability Proposed Rule GDL Guidance 2019-04-24T04:00:00Z 2019 4 2019-04-24T04:00:00Z 2019-06-25T03:59:59Z 2019-06-25T01:01:12Z 2019-08198 0 0 0900006483be94d9
FDA-1978-N-0018-1649 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Sunscreen Drug Products for Over-the-Counter Human Use; Correction Proposed Rule Correction 2019-04-18T04:00:00Z 2019 4 2019-04-18T04:00:00Z 2019-06-28T03:59:59Z 2024-04-16T20:27:21Z 2019-07712 0 0 0900006483bb94cb
FDA-1978-N-0018-1648 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Sunscreen Drug Products for Over-the-Counter Human Use; Extension of Comment Period Proposed Rule Extension of Comment Period 2019-04-18T04:00:00Z 2019 4 2019-04-18T04:00:00Z 2019-06-28T03:59:59Z 2019-09-24T01:03:41Z 2019-07710 0 0 0900006483bb93d6
FDA-2019-N-1132-0001 FDA FDA-2019-N-1132 The Future of Insulin Biosimilars: Increasing Access and Facilitating the Efficient Development of Biosimilar and Interchangeable Insulin Products; Public Hearing; Request for Comments Proposed Rule Request for Comment 2019-04-03T04:00:00Z 2019 4 2019-04-03T04:00:00Z 2019-06-01T03:59:59Z 2019-06-26T01:02:18Z 2019-06438 0 0 0900006483b5e6e5
FDA-2018-N-1815-0001 FDA FDA-2018-N-1815 Beverages: Bottled Water Proposed Rule Notice of Proposed Rulemaking (NPRM) 2019-04-03T04:00:00Z 2019 4 2019-04-03T04:00:00Z 2019-06-04T03:59:59Z 2019-06-05T01:02:17Z 2019-06201 0 0 0900006483b5e4c0
FDA-2019-N-1482-0001 FDA FDA-2019-N-1482 Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived Compounds; Public Hearing; Request for Comments Proposed Rule Request for Comment 2019-04-03T00:00:00Z 2019 4 2019-04-03T00:00:00Z   2025-05-14T18:16:19Z 2019-06436 0 0 0900006483b5e3f8
FDA-2016-N-3818-0001 FDA FDA-2016-N-3818 Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports Proposed Rule Notice of Proposed Rulemaking (NPRM) 2019-04-02T04:00:00Z 2019 4 2019-04-02T04:00:00Z 2019-07-18T03:59:59Z 2019-07-19T01:00:36Z 2019-05787 0 0 0900006483b571a6
FDA-2018-N-4757-0001 FDA FDA-2018-N-4757 Revocation of the Test for Mycoplasma Proposed Rule Notice of Proposed Rulemaking (NPRM) 2019-04-02T04:00:00Z 2019 4 2019-04-02T04:00:00Z 2019-06-18T03:59:59Z 2019-06-14T01:01:26Z 2019-06188 0 0 0900006483b571a2
FDA-2018-N-3303-0001 FDA FDA-2018-N-3303 Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Standards for Diagnostic X-Ray, Laser and Ultrasonic Products Proposed Rule Notice of Proposed Rulemaking (NPRM) 2019-04-01T04:00:00Z 2019 4 2019-04-01T04:00:00Z 2019-07-02T03:59:59Z 2019-07-02T01:01:57Z 2019-05822 0 0 0900006483b51258
FDA-2013-N-0134-0006 FDA FDA-2013-N-0134 Mammography Quality Standards Act Proposed Rule Amendment 2019-03-28T04:00:00Z 2019 3 2019-03-28T04:00:00Z 2019-06-27T03:59:59Z 2019-07-03T01:05:03Z 2019-05803 0 0 0900006483b38569
FDA-2019-F-0670-0002 FDA FDA-2019-F-0670 Uralkali PSJ; Filing of Food Additive Petition Proposed Rule Notice of Proposed Rulemaking (NPRM) 2019-03-28T04:00:00Z 2019 3 2019-03-28T04:00:00Z 2019-04-30T03:59:59Z 2019-04-05T01:01:30Z 2019-05954 0 0 0900006483b38522
FDA-2017-F-0969-0002 FDA FDA-2017-F-0969 Food Additives Permitted in Feed and Drinking Water of Animals; Spent Bleaching Clay Proposed Rule Amendment 2019-03-19T04:00:00Z 2019 3 2019-03-19T04:00:00Z 2019-04-19T03:59:59Z 2019-04-19T01:00:27Z 2019-05103 0 0 0900006483aff21b
FDA-2018-D-1398-0025 FDA FDA-2018-D-1398 Mitigation Strategies To Protect Food Against Intentional Adulteration: Draft Guidance for Industry; Public Meeting; Request for Comments Proposed Rule Public Meeting 2019-03-19T04:00:00Z 2019 3 2019-03-19T04:00:00Z 2019-07-06T03:59:59Z 2019-07-06T01:00:39Z 2019-05149 0 0 0900006483afebda
FDA-2018-N-4394-0001 FDA FDA-2018-N-4394 Medical Devices; Exemption From Premarket Notification: Class II Devices; Flow Cytometer Instruments; Request for Comments Proposed Rule Request for Comment 2019-03-06T05:00:00Z 2019 3 2019-03-06T05:00:00Z 2019-05-07T03:59:59Z 2019-05-07T01:01:08Z 2019-03967 0 0 0900006483ac2460
FDA-1978-N-0018-0841 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Sunscreen Drug Products for Over-the-Counter Human Use Proposed Rule Notice of Proposed Rulemaking (NPRM) 2019-02-26T05:00:00Z 2019 2 2019-02-26T05:00:00Z 2019-05-29T03:59:59Z 2019-05-30T01:07:25Z 2019-03019 0 0 0900006483aa7022
FDA-2018-N-2727-0042 FDA FDA-2018-N-2727 Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations; Reopening of Comment Period Proposed Rule Extension of Comment Period 2019-02-25T05:00:00Z 2019 2 2019-02-25T05:00:00Z 2019-03-08T04:59:59Z 2019-03-09T02:02:09Z 2019-03195 0 0 0900006483aa313c
FDA-1976-N-0476-0426 FDA Good Laboratory Practice for Nonclinical Laboratory Studi- Open FDA-1976-N-0476 Nonclinical Laboratory Studies; Amendment of Good Laboratory Practice Regulations Proposed Rule Notice of Proposed Rulemaking (NPRM) 2019-01-30T05:00:00Z 2019 1 2019-01-30T05:00:00Z 1980-02-05T04:59:59Z 2019-01-30T19:00:27Z 79-36991 0 0 0900006480521aa5
FDA-1976-N-0476-0001 FDA Good Laboratory Practice for Nonclinical Laboratory Studi- Open FDA-1976-N-0476 Nonclinical Laboratory Studies Proposed Regulations for Good Laboratory Practice Regulations Proposed Rule Notice of Proposed Rulemaking (NPRM) 2019-01-29T05:00:00Z 2019 1 2019-01-29T05:00:00Z 1977-03-22T04:59:59Z 2019-01-29T15:28:47Z 76-34014 0 0 0900006480521944
FDA-1976-N-0476-0081 FDA Good Laboratory Practice for Nonclinical Laboratory Studi- Open FDA-1976-N-0476 Nonclinical Laboratory Studies, Proposed Regulations for Good Laboratory Practice; Correction Proposed Rule Correction 2019-01-29T05:00:00Z 2019 1 2019-01-29T05:00:00Z   2019-01-29T16:41:17Z 77-2405 0 0 090000648052195a

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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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