{"database": "openregs", "table": "documents", "is_view": false, "human_description_en": "where agency_id = \"FDA\", document_type = \"Notice\" and posted_year = 2021 sorted by posted_date descending", "rows": [["FDA-2021-N-0341-0005", "FDA", "FDA-2021-N-0341", "Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals", "Notice", "Notice of Approval", "2021-12-30T05:00:00Z", 2021, 12, "2021-12-30T05:00:00Z", null, "2021-12-30T14:29:28Z", "2021-28362", 0, 0, "0900006484f005d4"], ["FDA-2015-N-1837-0011", "FDA", "FDA-2015-N-1837", "Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals", "Notice", "Notice of Approval", "2021-12-30T05:00:00Z", 2021, 12, "2021-12-30T05:00:00Z", null, "2021-12-30T14:29:00Z", "2021-28362", 0, 0, "0900006484f005d5"], ["FDA-2020-N-1307-0024", "FDA", "FDA-2020-N-1307", "Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals", "Notice", "Notice of Approval", "2021-12-30T05:00:00Z", 2021, 12, "2021-12-30T05:00:00Z", null, "2021-12-30T14:32:10Z", "2021-28362", 0, 0, "0900006484f005cf"], ["FDA-2021-N-0356-0003", "FDA", "FDA-2021-N-0356", "Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals", "Notice", "Notice of Approval", "2021-12-30T05:00:00Z", 2021, 12, "2021-12-30T05:00:00Z", null, "2021-12-30T14:31:08Z", "2021-28362", 0, 0, "0900006484f005d1"], ["FDA-2018-N-1857-0012", "FDA", "FDA-2018-N-1857", "Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals", "Notice", "Notice of Approval", "2021-12-30T05:00:00Z", 2021, 12, "2021-12-30T05:00:00Z", null, "2021-12-30T14:30:05Z", "2021-28362", 0, 0, "0900006484f005d3"], ["FDA-2011-D-0147-0039", "FDA", "FDA-2011-D-0147", "Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals", "Notice", "Notice of Approval", "2021-12-30T05:00:00Z", 2021, 12, "2021-12-30T05:00:00Z", null, "2021-12-30T14:30:37Z", "2021-28362", 0, 0, "0900006484f005d2"], ["FDA-2012-N-0536-0016", "FDA", "FDA-2012-N-0536", "Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals", "Notice", "Notice of Approval", "2021-12-30T05:00:00Z", 2021, 12, "2021-12-30T05:00:00Z", null, "2021-12-30T14:25:40Z", "2021-28362", 0, 0, "0900006484f003cd"], ["FDA-2014-N-1048-0011", "FDA", "FDA-2014-N-1048", "Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals", "Notice", "Notice of Approval", "2021-12-30T05:00:00Z", 2021, 12, "2021-12-30T05:00:00Z", null, "2022-08-24T14:18:15Z", "2021-28362", 0, 0, "0900006484f005d0"], ["FDA-2013-N-1529-0026", "FDA", "FDA-2013-N-1529", "Agency Information Collection\nActivities; Submission for Office of\nManagement and Budget Review;\nComment Request; Reclassification\nPetitions for Medical Devices", "Notice", "30 Day Proposed Information Collection", "2021-12-29T05:00:00Z", 2021, 12, "2021-12-29T05:00:00Z", "2022-01-29T04:59:59Z", "2021-12-29T17:25:49Z", "2021-28299", 0, 0, "0900006484effa24"], ["FDA-2013-N-1529-0027", "FDA", "FDA-2013-N-1529", "Agency Information Collection\nActivities; Submission for Office of\nManagement and Budget Review;\nComment Request; Reclassification\nPetitions for Medical Devices", "Notice", "30 Day Proposed Information Collection", "2021-12-29T05:00:00Z", 2021, 12, "2021-12-29T05:00:00Z", "2022-01-29T04:59:59Z", "2022-01-29T02:00:36Z", "2021-28305", 0, 0, "0900006484effb4a"], ["FDA-2012-P-1189-0015", "FDA", "FDA-2012-P-1189", "Canned Tuna Deviating From the Standard of Identity; Amendment of Temporary Marketing Permits", "Notice", "General Notice", "2021-12-28T05:00:00Z", 2021, 12, "2021-12-28T05:00:00Z", null, "2021-12-28T17:40:01Z", "2021-28164", 0, 0, "0900006484efed05"], ["FDA-2021-N-1252-0001", "FDA", "FDA-2021-N-1252", "Panray Corp. Sub Ormont Drug and Chemical Co., Inc., et al.; Proposal To Withdraw Approval of Three New Drug Applications; Opportunity for a Hearing", "Notice", "Withdrawal", "2021-12-27T05:00:00Z", 2021, 12, "2021-12-27T05:00:00Z", "2022-02-26T04:59:59Z", "2021-12-27T14:24:54Z", "2021-27946", 0, 0, "0900006484efd6cc"], ["FDA-2021-D-0367-0001", "FDA", "FDA-2021-D-0367", "Compliance Policy Guide Sec. 540.525\nScombrotoxin (Histamine)-Forming\nFish and Fishery Products\u2014\nDecomposition and Histamine;\nAvailability", "Notice", "Notice of Availability", "2021-12-27T05:00:00Z", 2021, 12, "2021-12-27T05:00:00Z", "2022-02-26T04:59:59Z", "2022-03-15T15:47:30Z", "2021-28053", 0, 0, "0900006484efd850"], ["FDA-2019-D-2330-0034", "FDA", "FDA-2019-D-2330", "Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers; Guidance for Industry; Availability", "Notice", "Notice of Availability", "2021-12-27T05:00:00Z", 2021, 12, "2021-12-27T05:00:00Z", null, "2021-12-27T14:29:13Z", "2021-28051", 0, 0, "0900006484efd807"], ["FDA-2020-D-1118-0006", "FDA", "FDA-2020-D-1118", "Non-Clinical and Clinical Investigation\nof Devices Used for the Treatment of\nBenign Prostatic Hyperplasia;\nGuidance for Industry and Food and\nDrug Administration Staff; Availability", "Notice", "Notice of Availability", "2021-12-27T05:00:00Z", 2021, 12, "2021-12-27T05:00:00Z", null, "2021-12-27T14:34:07Z", "2021-27919", 0, 0, "0900006484efd897"], ["FDA-2021-D-0980-0002", "FDA", "FDA-2021-D-0980", "Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability", "Notice", "Notice of Availability", "2021-12-23T05:00:00Z", 2021, 12, "2021-12-23T05:00:00Z", "2022-03-25T03:59:59Z", "2023-11-16T22:21:11Z", "2021-27812", 0, 0, "0900006484ee208a"], ["FDA-2021-D-0996-0002", "FDA", "FDA-2021-D-0996", "Technical Considerations for Medical Devices With Physiologic Closed-Loop Control Technology; Draft Guidance for Industry and Food and Drug Administration Staff; Availability", "Notice", "Notice of Availability", "2021-12-23T05:00:00Z", 2021, 12, "2021-12-23T05:00:00Z", null, "2021-12-23T14:34:15Z", "2021-27825", 0, 0, "0900006484ee7f1d"], ["FDA-2019-D-5606-0004", "FDA", "FDA-2019-D-5606", "Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use- Premarket Notification (510(k))\nSubmissions; Guidance for Industry and Food and Drug Administration Staff; Availability", "Notice", "Notice of Availability", "2021-12-23T05:00:00Z", 2021, 12, "2021-12-23T05:00:00Z", null, "2021-12-23T14:01:37Z", "2021-27823", 0, 0, "0900006484ee7f15"], ["FDA-2021-D-1149-0001", "FDA", "FDA-2021-D-1149", "Transition Plan for Medical Devices Issued Emergency Use Authorizations During the Coronavirus Disease 2019 Public Health Emergency; Draft Guidance for Industry and Food and Drug Administration Staff;  Availability; Agency Information Collection Activities; Proposed Collection; Comment Request", "Notice", "Notice of Availability", "2021-12-23T05:00:00Z", 2021, 12, "2021-12-23T05:00:00Z", null, "2022-04-02T23:44:43Z", "2021-27891", 0, 0, "0900006484ee7e2c"], ["FDA-2018-N-4206-0004", "FDA", "FDA-2018-N-4206", "Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Small Business Qualification and Certification", "Notice", "60 Day Proposed Information Collection", "2021-12-23T05:00:00Z", 2021, 12, "2021-12-23T05:00:00Z", "2022-02-23T04:59:59Z", "2022-02-23T02:00:25Z", "2021-27889", 0, 0, "0900006484ee7e8c"], ["FDA-2021-D-1118-0001", "FDA", "FDA-2021-D-1118", "Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 Public Health Emergency; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request", "Notice", "Notice of Availability", "2021-12-23T05:00:00Z", 2021, 12, "2021-12-23T05:00:00Z", null, "2022-02-02T02:00:22Z", "2021-27892", 0, 0, "0900006484ee7e8e"], ["FDA-2021-D-1128-0001", "FDA", "FDA-2021-D-1128", "Digital Health Technologies for Remote Data Acquisition in Clinical Investigations; Draft Guidance for\nIndustry, Investigators, and Other Stakeholders; Availability", "Notice", "Notice of Availability", "2021-12-23T05:00:00Z", 2021, 12, "2021-12-23T05:00:00Z", null, "2021-12-23T14:24:00Z", "2021-27894", 0, 0, "0900006484ee7ee5"], ["FDA-2018-N-1967-0005", "FDA", "FDA-2018-N-1967", "Agency Information Collection Activities; Submission for Office of Management and Budget Review;\nComment Request; Biosimilars User Fee Program", "Notice", "30 Day Proposed Information Collection", "2021-12-22T05:00:00Z", 2021, 12, "2021-12-22T05:00:00Z", "2022-01-22T04:59:59Z", "2021-12-22T13:37:54Z", "2021-27680", 0, 0, "0900006484ee0c68"], ["FDA-2021-P-0923-0004", "FDA", "FDA-2021-P-0923", "Determination That ANTIZOL (Fomepizole) Injection, 1.5 Grams/1.5 Milliliters, Was Not Withdrawn From\nSale for Reasons of Safety or Effectiveness", "Notice", "Determinations", "2021-12-22T05:00:00Z", 2021, 12, "2021-12-22T05:00:00Z", null, "2021-12-22T13:22:01Z", "2021-27699", 0, 0, "0900006484ee09d0"], ["FDA-2021-D-0756-0001", "FDA", "FDA-2021-D-0756", "Validation and Verification of Analytical Testing Methods Used for Tobacco Products; Draft Guidance for Industry; Availability; Request for Comments", "Notice", "Notice of Availability", "2021-12-22T05:00:00Z", 2021, 12, "2021-12-22T05:00:00Z", "2022-02-23T04:59:59Z", "2022-09-02T01:00:54Z", "2021-27719", 0, 0, "0900006484ee0b8d"], ["FDA-2021-P-0375-0006", "FDA", "FDA-2021-P-0375", "Determination That Alcohol and Dextrose Injection, 5 Milliliters/100 Milliliters, 5 Grams/100 Milliliters; and\n10 Milliliters/100 Milliliters, 5 Grams/100 Milliliters, Were Withdrawn From Sale for Reasons of Safety or\nEffectiveness", "Notice", "Determinations", "2021-12-22T05:00:00Z", 2021, 12, "2021-12-22T05:00:00Z", null, "2021-12-22T13:26:27Z", "2021-27696", 0, 0, "0900006484ee0a01"], ["FDA-2021-D-0548-0011", "FDA", "FDA-2021-D-0548", "Data Standards for Drug and BiologicalProduct Submissions Containing Real-\nWorld Data; Draft Guidance for Industry; Availability; Extension of Comment Period", "Notice", "Extension of Comment Period", "2021-12-21T05:00:00Z", 2021, 12, "2021-12-21T05:00:00Z", "2022-02-05T04:59:59Z", "2022-02-05T02:00:49Z", "2021-27521", 0, 0, "0900006484ed8389"], ["FDA-2021-N-1212-0001", "FDA", "FDA-2021-N-1212", "Wound Healing Scientific Workshop; Public Workshop; Request for Comments", "Notice", "Request for Comments", "2021-12-20T05:00:00Z", 2021, 12, "2021-12-20T05:00:00Z", "2022-06-29T03:59:59Z", "2022-06-29T01:00:38Z", "2021-27459", 0, 0, "0900006484ed6200"], ["FDA-2021-D-0241-0001", "FDA", "FDA-2021-D-0241", "Inspection of Injectable Products for Visible Particulates; Draft Guidance for Industry; Availability", "Notice", "Notice of Availability", "2021-12-17T05:00:00Z", 2021, 12, "2021-12-17T05:00:00Z", "2022-02-16T04:59:59Z", "2022-03-13T00:07:08Z", "2021-27351", 0, 0, "0900006484ed1d58"], ["FDA-2019-N-3926-0005", "FDA", "FDA-2019-N-3926", "Request for Nominations for Voting Members on Public Advisory Panels of the Medical Devices Advisory Committee", "Notice", "Request for Nominations", "2021-12-17T05:00:00Z", 2021, 12, "2021-12-17T05:00:00Z", "2022-02-16T04:59:59Z", "2021-12-17T17:01:39Z", "2021-27376", 0, 0, "0900006484ed13d2"], ["FDA-2013-N-1425-0198", "FDA", "FDA-2013-N-1425", "Agency Information Collection Activities; Proposed Collection; Comment Request; Mitigation Strategies To Protect Food Against\nIntentional Adulteration", "Notice", "60 Day Proposed Information Collection", "2021-12-17T05:00:00Z", 2021, 12, "2021-12-17T05:00:00Z", "2022-02-16T04:59:59Z", "2022-08-22T17:54:47Z", "2021-27285", 0, 0, "0900006484ed1e30"], ["FDA-2021-D-0997-0001", "FDA", "FDA-2021-D-0997", "Referencing the Definition of \u2018\u2018Device\u2019\u2019 in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents; Draft Guidance for Industry and Food and Drug Administration Staff; Availability", "Notice", "Notice of Availability", "2021-12-16T05:00:00Z", 2021, 12, "2021-12-16T05:00:00Z", "2022-02-15T04:59:59Z", "2022-02-12T02:00:16Z", "2021-27266", 0, 0, "0900006484ecfac6"], ["FDA-2021-N-0505-0002", "FDA", "FDA-2021-N-0505", "Julia Fees: Final Debarment Order", "Notice", "General Notice", "2021-12-15T05:00:00Z", 2021, 12, "2021-12-15T05:00:00Z", null, "2021-12-15T16:12:55Z", "2021-27056", 0, 0, "0900006484ecae26"], ["FDA-2021-N-0346-0002", "FDA", "FDA-2021-N-0346", "Jeffrey A. Styron: Final Debarment\nOrder", "Notice", "General Notice", "2021-12-15T05:00:00Z", 2021, 12, "2021-12-15T05:00:00Z", null, "2021-12-15T16:18:20Z", "2021-27053", 0, 0, "0900006484ecb00b"], ["FDA-2018-N-3758-0009", "FDA", "FDA-2018-N-3758", "Agency Information Collection\nActivities; Proposed Collection;\nComment Request; Expanded Access\nto Investigational Drugs for Treatment\nUse", "Notice", "60 Day Proposed Information Collection", "2021-12-14T05:00:00Z", 2021, 12, "2021-12-14T05:00:00Z", "2022-02-15T04:59:59Z", "2023-04-27T14:49:59Z", "2021-26990", 0, 0, "0900006484ec65df"], ["FDA-2021-N-1287-0001", "FDA", "FDA-2021-N-1287", "Actavis LLC, et al.; Withdrawal of Approval of Six Abbreviated New Drug Applications", "Notice", "Withdrawal", "2021-12-13T05:00:00Z", 2021, 12, "2021-12-13T05:00:00Z", null, "2021-12-13T14:05:07Z", "2021-26892", 0, 0, "0900006484ec0819"], ["FDA-2020-D-1301-0006", "FDA", "FDA-2020-D-1301", "Q3C(R8) Impurities: Guidance for Residual Solvents; International Council for Harmonisation; Guidance for Industry; Availability", "Notice", "Notice of Availability", "2021-12-13T05:00:00Z", 2021, 12, "2021-12-13T05:00:00Z", null, "2021-12-13T14:32:26Z", "2021-26889", 0, 0, "0900006484ec09b9"], ["FDA-2021-D-0406-0001", "FDA", "FDA-2021-D-0406", "Bowel Cleansing for Colonoscopy: Efficacy and Safety Considerations for Developing New Products; Draft Guidance for Industry; Availability", "Notice", "Notice of Availability", "2021-12-13T05:00:00Z", 2021, 12, "2021-12-13T05:00:00Z", null, "2021-12-13T13:50:15Z", "2021-26923", 0, 0, "0900006484ec05aa"], ["FDA-2021-N-1285-0001", "FDA", "FDA-2021-N-1285", "Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments", "Notice", "Request for Comments", "2021-12-13T05:00:00Z", 2021, 12, "2021-12-13T05:00:00Z", "2022-02-10T04:59:59Z", "2022-02-10T02:00:38Z", "2021-26891", 0, 0, "0900006484ec07e5"], ["FDA-2021-D-0861-0001", "FDA", "FDA-2021-D-0861", "Cover Letter Attachments for Controlled Correspondences and Abbreviated New Drug Application Submissions; Draft Guidance for Industry; Availability", "Notice", "Notice of Availability", "2021-12-13T05:00:00Z", 2021, 12, "2021-12-13T05:00:00Z", null, "2021-12-13T14:27:05Z", "2021-26893", 0, 0, "0900006484ec08ed"], ["FDA-2020-D-2307-0052", "FDA", "FDA-2020-D-2307", "Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-\nMaking for Drug and Biological Products; Draft Guidance for Industry; Reopening of the Comment Period", "Notice", "Notice of Availability", "2021-12-10T05:00:00Z", 2021, 12, "2021-12-10T05:00:00Z", "2022-01-25T04:59:59Z", "2024-07-25T12:53:56Z", "2021-26699", 0, 0, "0900006484eb7ef1"], ["FDA-2021-D-1096-0001", "FDA", "FDA-2021-D-1096", "Chronic Rhinosinusitis With Nasal\nPolyps: Developing Drugs for\nTreatment; Draft Guidance for\nIndustry; Availability", "Notice", "Notice of Availability", "2021-12-10T05:00:00Z", 2021, 12, "2021-12-10T05:00:00Z", "2022-02-09T04:59:59Z", "2022-02-09T02:00:44Z", "2021-26733", 0, 0, "0900006484eb80f8"], ["FDA-2021-N-0918-0002", "FDA", "FDA-2021-N-0918", "Agency Information Collection\nActivities; Submission for Office of\nManagement and Budget Review;\nComment Request; Labeling\nRequirements for Prescription Drugs", "Notice", "30 Day Proposed Information Collection", "2021-12-10T05:00:00Z", 2021, 12, "2021-12-10T05:00:00Z", "2022-01-11T04:59:59Z", "2021-12-14T02:00:50Z", "2021-26730", 0, 0, "0900006484eb8075"], ["FDA-2017-D-2802-0016", "FDA", "FDA-2017-D-2802", "Chemistry, Manufacturing, and\nControls Postapproval Manufacturing\nChanges for Specified Biological\nProducts To Be Documented in Annual\nReports; Guidance for Industry;\nAvailability", "Notice", "Notice of Availability", "2021-12-10T05:00:00Z", 2021, 12, "2021-12-10T05:00:00Z", null, "2021-12-10T15:14:13Z", "2021-26734", 0, 0, "0900006484eb80f4"], ["FDA-2020-D-1518-0016", "FDA", "FDA-2020-D-1518", "Development of Anti-Infective Drug Products for the Pediatric Population; Guidance for Industry; Availability", "Notice", "Notice of Availability", "2021-12-10T05:00:00Z", 2021, 12, "2021-12-10T05:00:00Z", null, "2021-12-10T13:30:21Z", "2021-26737", 0, 0, "0900006484eb7f61"], ["FDA-2021-D-1214-0001", "FDA", "FDA-2021-D-1214", "Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry;\nAvailability", "Notice", "Notice of Availability", "2021-12-09T05:00:00Z", 2021, 12, "2021-12-09T05:00:00Z", "2022-03-10T04:59:59Z", "2024-11-07T00:34:19Z", "2021-26640", 1, 0, "0900006484eb23b7"], ["FDA-2011-D-0125-0017", "FDA", "FDA-2011-D-0125", "Agency Information Collection Activities; Proposed Collection;\nComment Request; Guidance for Industry on Establishing that a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007", "Notice", "60 Day Proposed Information Collection", "2021-12-09T05:00:00Z", 2021, 12, "2021-12-09T05:00:00Z", "2022-02-08T04:59:59Z", "2021-12-09T14:32:05Z", "2021-26652", 0, 0, "0900006484eb237b"], ["FDA-2004-N-0451-0050", "FDA", "FDA-2004-N-0451", "Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 056", "Notice", "Announcement", "2021-12-09T05:00:00Z", 2021, 12, "2021-12-09T05:00:00Z", "2021-12-10T04:59:59Z", "2024-11-07T00:34:20Z", "2021-26635", 1, 0, "0900006484eb23ba"], ["FDA-2021-D-0373-0003", "FDA", "FDA-2021-D-0373", "Tobacco Product User Fees: Responses to Frequently Asked\nQuestions; Guidance for Industry; Availability", "Notice", "Notice of Availability", "2021-12-09T05:00:00Z", 2021, 12, "2021-12-09T05:00:00Z", null, "2021-12-09T13:52:03Z", "2021-26651", 0, 0, "0900006484eb24a7"], ["FDA-2021-N-1194-0001", "FDA", "FDA-2021-N-1194", "Fresenius Kabi Deutschland GmbH; Withdrawal of Approval of New Drug Application of Hydroxyethyl Starch", "Notice", "Withdrawal", "2021-12-09T05:00:00Z", 2021, 12, "2021-12-09T05:00:00Z", null, "2021-12-09T14:55:20Z", "2021-26648", 0, 0, "0900006484eb24ed"], ["FDA-2021-D-1139-0001", "FDA", "FDA-2021-D-1139", "Investigational New Drug Application Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Chemistry, Manufacturing, and Controls Recommendations, Guidance for Sponsor-Investigators; Draft Guidance for Industry; Availability", "Notice", "Notice of Availability", "2021-12-08T05:00:00Z", 2021, 12, "2021-12-08T05:00:00Z", null, "2021-12-08T14:15:39Z", "2021-26454", 0, 0, "0900006484eaee8c"], ["FDA-2021-D-1140-0001", "FDA", "FDA-2021-D-1140", "Investigational New Drug Application Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommendations; Draft Guidance for Sponsor-Investigators; Availability", "Notice", "Notice of Availability", "2021-12-08T05:00:00Z", 2021, 12, "2021-12-08T05:00:00Z", null, "2021-12-08T14:19:49Z", "2021-26453", 0, 0, "0900006484eaeede"], ["FDA-1975-N-0336-0115", "FDA", "FDA-1975-N-0336", "Pathibamate Tablets; Drugs for Human Use; Drug Efficacy Study Implementation; Withdrawal of Approval of New Drug Application", "Notice", "Withdrawal", "2021-12-07T05:00:00Z", 2021, 12, null, null, "2021-12-07T16:26:29Z", "52 FR 22687", 0, 0, "09000064805c7bff"], ["FDA-2018-N-0417-0005", "FDA", "FDA-2018-N-0417", "Request for Nominations of Voting\nMembers on a Public Advisory\nCommittee; National Mammography\nQuality Assurance Advisory\nCommittee", "Notice", "Request for Nominations", "2021-12-03T05:00:00Z", 2021, 12, "2021-12-03T05:00:00Z", null, "2021-12-03T16:25:28Z", "2021-26258", 0, 0, "0900006484e9c7d4"], ["FDA-2018-N-0417-0006", "FDA", "FDA-2018-N-0417", "Request for Nominations on the National Mammography Quality Assurance Advisory Committee", "Notice", "Request for Nominations", "2021-12-03T05:00:00Z", 2021, 12, "2021-12-03T05:00:00Z", null, "2021-12-03T16:43:54Z", "2021-26264", 0, 0, "0900006484e9c85b"], ["FDA-2011-N-0921-19184", "FDA", "FDA-2011-N-0921", "Agency Information Collection Activities; Proposed Collection; Comment Request; Standards for the\nGrowing, Harvesting, Packaging, and\nHolding of Produce for Human\nConsumption", "Notice", "60 Day Proposed Information Collection", "2021-12-03T05:00:00Z", 2021, 12, "2021-12-03T05:00:00Z", "2022-02-02T04:59:59Z", "2021-12-04T23:26:08Z", "2021-26261", 0, 0, "0900006484e9c823"], ["FDA-2012-N-0280-0010", "FDA", "FDA-2012-N-0280", "Agency Information Collection\nActivities; Proposed Collection;\nComment Request; Financial\nDisclosure by Clinical Investigators", "Notice", "60 Day Proposed Information Collection", "2021-12-02T05:00:00Z", 2021, 12, "2021-12-02T05:00:00Z", "2022-02-01T04:59:59Z", "2021-12-03T02:00:32Z", "2021-26182", 0, 0, "0900006484e936d4"], ["FDA-2008-D-0530-0022", "FDA", "FDA-2008-D-0530", "Agency Information Collection Activities; Proposed Collection ;Comment Request; Tropical \n Disease Priority Review Vouchers", "Notice", "60 Day Proposed Information Collection", "2021-12-02T05:00:00Z", 2021, 12, "2021-12-02T05:00:00Z", "2022-02-01T04:59:59Z", "2022-08-22T17:58:57Z", "2021-26196", 0, 0, "0900006484e935d5"], ["FDA-2021-N-1145-0001", "FDA", "FDA-2021-N-1145", "Aurolife Pharma LLC, et al.; Withdrawal of Approval of Five Abbreviated New Drug Applications", "Notice", "Withdrawal", "2021-12-02T05:00:00Z", 2021, 12, "2021-12-02T05:00:00Z", null, "2021-12-02T18:58:52Z", "2021-26170", 0, 0, "0900006484e93612"], ["FDA-2021-N-1222-0001", "FDA", "FDA-2021-N-1222", "Agency Information Collection\nActivities; Proposed Collection;\nComment Request; Food Labeling:\nNotification Procedures for Statements\non Dietary Supplements", "Notice", "60 Day Proposed Information Collection", "2021-12-02T05:00:00Z", 2021, 12, "2021-12-02T05:00:00Z", "2022-02-01T04:59:59Z", "2021-12-02T18:51:32Z", "2021-26172", 0, 0, "0900006484e935d7"], ["FDA-2019-N-2809-0003", "FDA", "FDA-2019-N-2809", "Advisory Committee; Patient Engagement Advisory Committee; Renewal", "Notice", "Renewals", "2021-12-01T05:00:00Z", 2021, 12, "2021-12-01T05:00:00Z", null, "2021-12-01T14:57:52Z", "2021-26118", 0, 0, "0900006484e8f357"], ["FDA-2020-E-2224-0006", "FDA", "FDA-2020-E-2224", "Determination of Regulatory Review Period for Purposes of Patent Extension; ZEPZELCA", "Notice", "Determinations", "2021-11-30T05:00:00Z", 2021, 11, "2021-11-30T05:00:00Z", "2022-02-01T04:59:59Z", "2024-02-05T18:15:56Z", "2021-26009", 0, 0, "0900006484e8c17a"], ["FDA-2018-N-3233-0003", "FDA", "FDA-2018-N-3233", "Request for Nominations for Voting Members on a Public Advisory Committee; Technical Electronic\nProduct Radiation Safety Standards Committee", "Notice", "Call for Nominations", "2021-11-30T05:00:00Z", 2021, 11, "2021-11-30T05:00:00Z", null, "2021-11-30T17:39:03Z", "2021-26002", 0, 0, "0900006484e8bcf5"], ["FDA-2021-D-1146-0001", "FDA", "FDA-2021-D-1146", "Real-World Data: Assessing Registries To Support Regulatory Decision-Making for Drug and Biological\nProducts; Draft Guidance for Industry; Availability", "Notice", "Notice of Availability", "2021-11-30T05:00:00Z", 2021, 11, "2021-11-30T05:00:00Z", "2022-03-01T04:59:59Z", "2022-03-02T02:00:49Z", "2021-26006", 0, 0, "0900006484e8bbad"], ["FDA-2005-N-0101-0005", "FDA", "FDA-2005-N-0101", "Agency Information Collection Activities; Proposed Collections; Comment Request; Prescription Drug\nUser Fee Program", "Notice", "60 Day Proposed Information Collection", "2021-11-30T05:00:00Z", 2021, 11, "2021-11-30T05:00:00Z", "2022-02-01T04:59:59Z", "2021-12-01T16:11:24Z", "2021-26079", 0, 0, "0900006484e8bbb4"], ["FDA-2014-N-1721-0016", "FDA", "FDA-2014-N-1721", "Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Application Requirements", "Notice", "60 Day Proposed Information Collection", "2021-11-24T05:00:00Z", 2021, 11, "2021-11-24T05:00:00Z", "2022-01-25T04:59:59Z", "2023-03-14T21:05:23Z", "2021-25615", 0, 0, "0900006484e7b858"], ["FDA-2020-E-2122-0006", "FDA", "FDA-2020-E-2122", "Determination of Regulatory Review Period for Purposes of Patent Extension; TRODELVY", "Notice", "Determinations", "2021-11-24T05:00:00Z", 2021, 11, "2021-11-24T05:00:00Z", "2022-05-24T03:59:59Z", "2022-01-29T02:00:34Z", "2021-25612", 0, 0, "0900006484e7b859"], ["FDA-2021-N-0405-0002", "FDA", "FDA-2021-N-0405", "Maytee Lledo: Final Debarment Order", "Notice", "General Notice", "2021-11-23T05:00:00Z", 2021, 11, "2021-11-23T05:00:00Z", null, "2021-11-23T15:07:39Z", "2021-25589", 0, 0, "0900006484e7599d"], ["FDA-2018-N-4465-0004", "FDA", "FDA-2018-N-4465", "Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Detention and Banned Medical Devices", "Notice", "60 Day Proposed Information Collection", "2021-11-22T05:00:00Z", 2021, 11, "2021-11-22T05:00:00Z", "2022-01-22T04:59:59Z", "2021-11-27T02:00:35Z", "2021-25323", 0, 0, "0900006484e711e9"], ["FDA-1978-N-0018-15847", "FDA", "FDA-1978-N-0018", "Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-The-Counter Human Use; Over-The-Counter Monograph Proposed Order (OTC 000008) Extension of Comment Period", "Notice", "Extension of Comment Period", "2021-11-22T05:00:00Z", 2021, 11, "2021-11-22T05:00:00Z", "2021-12-28T04:59:59Z", "2021-12-25T02:00:48Z", "2021-25371", 0, 0, "0900006484e711a4"], ["FDA-2012-N-1021-0075", "FDA", "FDA-2012-N-1021", "Notice to Public of Website Location of\nCenter for Devices and Radiological\nHealth Fiscal Year 2022 Proposed\nGuidance Development", "Notice", "Correction", "2021-11-19T05:00:00Z", 2021, 11, "2021-11-19T05:00:00Z", null, "2021-11-19T16:21:42Z", "C1-2021-23392", 0, 0, "0900006484e655f2"], ["FDA-2009-D-0268-0024", "FDA", "FDA-2009-D-0268", "Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Labeling of Certain\nBeers Subject to the Labeling Jurisdiction of the Food and Drug Administration", "Notice", "30 Day Proposed Information Collection", "2021-11-19T05:00:00Z", 2021, 11, "2021-11-19T05:00:00Z", "2021-12-21T04:59:59Z", "2021-11-19T15:53:05Z", "2021-25300", 0, 0, "0900006484e66010"], ["FDA-2018-N-3404-0005", "FDA", "FDA-2018-N-3404", "Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Drug User Fee Program", "Notice", "60 Day Proposed Information Collection", "2021-11-19T05:00:00Z", 2021, 11, "2021-11-19T05:00:00Z", "2022-01-19T04:59:59Z", "2021-11-19T16:10:41Z", "2021-25294", 0, 0, "0900006484e65f35"], ["FDA-2021-N-1192-0001", "FDA", "FDA-2021-N-1192", "Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Generally Recognized as Safe: Notification Procedure", "Notice", "60 Day Proposed Information Collection", "2021-11-19T05:00:00Z", 2021, 11, "2021-11-19T05:00:00Z", "2022-01-19T04:59:59Z", "2022-01-19T02:00:28Z", "2021-25302", 0, 0, "0900006484e655f6"], ["FDA-2018-N-3031-0005", "FDA", "FDA-2018-N-3031", "Agency Information Collection Activities; Proposed Collection;\nComment Request; Tobacco Products, User Fees, Requirements for the\nSubmission of Data Needed To Calculate User Fees for Domestic\nManufacturers and Importers of Tobacco Products", "Notice", "60 Day Proposed Information Collection", "2021-11-19T05:00:00Z", 2021, 11, "2021-11-19T05:00:00Z", "2022-01-19T04:59:59Z", "2021-11-19T14:56:20Z", "2021-25306", 0, 0, "0900006484e65f9d"], ["FDA-2012-N-1021-0078", "FDA", "FDA-2012-N-1021", "Notice to Public of Website Location of\nCenter for Devices and Radiological\nHealth Fiscal Year 2022 Proposed\nGuidance Development", "Notice", "Correction", "2021-11-19T05:00:00Z", 2021, 11, "2021-11-19T05:00:00Z", null, "2021-12-02T17:57:56Z", "C1-2021-23", 0, 0, "0900006484e66067"], ["FDA-2019-E-5389-0006", "FDA", "FDA-2019-E-5389", "Determination of Regulatory Review Period for Purposes of Patent Extension; SUNOSI", "Notice", "Determinations", "2021-11-19T05:00:00Z", 2021, 11, "2021-11-19T05:00:00Z", "2022-05-19T03:59:59Z", "2021-11-19T16:16:11Z", "2021-25297", 0, 0, "0900006484e65e47"], ["FDA-2021-N-1195-0001", "FDA", "FDA-2021-N-1195", "Discovery Therapeutics, LLC, et al.; Withdrawal of Approval of 18 Abbreviated New Drug Applications", "Notice", "Withdrawal", "2021-11-18T05:00:00Z", 2021, 11, "2021-11-18T05:00:00Z", null, "2021-11-18T15:35:44Z", "2021-25111", 0, 0, "0900006484e5f2db"], ["FDA-1992-N-0011-0009", "FDA", "FDA-1992-N-0011", "Sanyasi Raju Kalidindi; Grant of Special Termination", "Notice", "Termination of Statutory Disbarment", "2021-11-16T05:00:00Z", 2021, 11, "2021-11-16T05:00:00Z", null, "2021-11-16T18:23:09Z", "2021-24973", 0, 0, "0900006484e4dfd1"], ["FDA-2020-E-2167-0006", "FDA", "FDA-2020-E-2167", "Determination of Regulatory Review Period for Purposes of Patent Extension; QINLOCK", "Notice", "Determinations", "2021-11-16T05:00:00Z", 2021, 11, "2021-11-16T05:00:00Z", "2022-01-19T04:59:59Z", "2021-11-16T18:16:22Z", "2021-24978", 0, 0, "0900006484e4dfcd"], ["FDA-2020-E-2168-0006", "FDA", "FDA-2020-E-2168", "Determination of Regulatory Review Period for Purposes of Patent Extension; QINLOCK", "Notice", "Determinations", "2021-11-16T05:00:00Z", 2021, 11, "2021-11-16T05:00:00Z", "2022-01-19T04:59:59Z", "2021-11-16T18:18:00Z", "2021-24978", 0, 0, "0900006484e4ebd2"], ["FDA-2018-N-3353-0004", "FDA", "FDA-2018-N-3353", "Agency Information Collection Activities; Proposed Collection; Comment Request; Antimicrobial Animal Drug Distribution Reports and Recordkeeping", "Notice", "60 Day Proposed Information Collection", "2021-11-09T05:00:00Z", 2021, 11, "2021-11-09T05:00:00Z", "2022-01-11T04:59:59Z", "2021-11-09T14:51:54Z", "2021-24433", 0, 0, "0900006484e37a15"], ["FDA-2014-N-1960-0028", "FDA", "FDA-2014-N-1960", "Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; MedWatch: The Food and Drug Administration Medical Products Reporting Program", "Notice", "30 Day Proposed Information Collection", "2021-11-09T05:00:00Z", 2021, 11, "2021-11-09T05:00:00Z", "2021-12-10T04:59:59Z", "2021-12-10T02:00:46Z", "2021-24432", 0, 0, "0900006484e37ac8"], ["FDA-2020-E-2232-0006", "FDA", "FDA-2020-E-2232", "Determination of Regulatory Review Period for Purposes of Patent Extension; DOJOLVI", "Notice", "Determinations", "2021-11-09T05:00:00Z", 2021, 11, "2021-11-09T05:00:00Z", "2022-01-11T04:59:59Z", "2024-02-05T19:20:20Z", "2021-24435", 0, 0, "0900006484e37a46"], ["FDA-2020-E-2204-0006", "FDA", "FDA-2020-E-2204", "Determination of Regulatory Review Period for Purposes of Patent Extension; DOJOLVI", "Notice", "Determinations", "2021-11-09T05:00:00Z", 2021, 11, "2021-11-09T05:00:00Z", "2022-01-11T04:59:59Z", "2021-11-09T14:57:45Z", "2021-24435", 0, 0, "0900006484e37d4d"], ["FDA-2007-D-0369-0567", "FDA", "FDA-2007-D-0369", "Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability", "Notice", "Notice of Availability", "2021-11-09T05:00:00Z", 2021, 11, "2021-11-09T05:00:00Z", "2022-01-11T04:59:59Z", "2021-12-31T02:00:32Z", "2021-24431", 0, 0, "0900006484e37a93"], ["FDA-1996-D-0405-0010", "FDA", "FDA-1996-D-0405", "Compliance Policy Guide Sec. 110.100; Withdrawal of Guidance", "Notice", "Withdrawal", "2021-11-05T04:00:00Z", 2021, 11, "2021-11-05T04:00:00Z", null, "2021-11-05T17:24:38Z", "2021-24234", 0, 0, "0900006484e23a7d"], ["FDA-2021-N-0515-0002", "FDA", "FDA-2021-N-0515", "Agency Information Collection Activities; Submission for Office of\nManagement and Budget Review; Comment Request; Postmarketing Adverse Experience Reporting and Recordkeeping for Drug and Biological Products", "Notice", "30 Day Proposed Information Collection", "2021-11-05T04:00:00Z", 2021, 11, "2021-11-05T04:00:00Z", "2021-12-07T04:59:59Z", "2021-11-05T17:18:42Z", "2021-24236", 0, 0, "0900006484e23a30"], ["FDA-2020-E-1327-0006", "FDA", "FDA-2020-E-1327", "Determination of Regulatory Review Period for Purposes of Patent Extension; ADAKVEO", "Notice", "Determinations", "2021-11-04T04:00:00Z", 2021, 11, "2021-11-04T04:00:00Z", "2022-01-04T04:59:59Z", "2021-11-09T19:40:14Z", "2021-24070", 0, 0, "0900006484e18049"], ["FDA-2017-D-6784-0013", "FDA", "FDA-2017-D-6784", "Manufacture of Blood Components Using a Pathogen Reduction Device in Blood Establishments: Questions and Answers; Guidance for Industry; Availability", "Notice", "Notice of Availability", "2021-11-04T04:00:00Z", 2021, 11, "2021-11-04T04:00:00Z", null, "2021-11-09T17:41:05Z", "2021-24073", 0, 0, "0900006484e17ebf"], ["FDA-2020-E-2045-0006", "FDA", "FDA-2020-E-2045", "Determination of Regulatory Review Period for Purposes of Patent Extension; AKLIEF", "Notice", "Determinations", "2021-11-04T04:00:00Z", 2021, 11, "2021-11-04T04:00:00Z", "2022-01-04T04:59:59Z", "2021-11-09T19:54:35Z", "2021-24077", 0, 0, "0900006484e1b479"], ["FDA-2020-E-2042-0006", "FDA", "FDA-2020-E-2042", "Determination of Regulatory Review\nPeriod for Purposes of Patent\nExtension; AKLIEF", "Notice", "Determinations", "2021-11-04T04:00:00Z", 2021, 11, "2021-11-04T04:00:00Z", "2022-01-04T04:59:59Z", "2021-11-04T16:03:55Z", "2021-24077", 0, 0, "0900006484e1b478"], ["FDA-2020-E-2023-0005", "FDA", "FDA-2020-E-2023", "Determination of Regulatory Review Period for Purposes of Patent Extension; 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