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withdrawn,object_id FDA-2016-N-0124-0410,FDA,FDA-2016-N-0124,"Consumer Antiseptic Rub Final Rule; Finding of Ineligibility for Inclusion in Final Monograph Questions and Answers; Guidance for Industry; Small Entity Compliance Guide; Availability",Notice,Notice of Availability,2020-12-31T05:00:00Z,2020,12,2020-12-31T05:00:00Z,,2020-12-31T14:14:51Z,2020-28929,0,0,09000064849d654d FDA-2014-D-1804-0073,FDA,FDA-2014-D-1804,"Product Labeling for Laparoscopic Power Morcellators; Guidance for Industry and Food and Drug Administration Staff; Availability",Notice,Notice of Availability,2020-12-30T05:00:00Z,2020,12,2020-12-30T05:00:00Z,,2020-12-30T13:31:56Z,2020-28816,0,0,09000064849d16c7 FDA-2018-N-3233-0002,FDA,FDA-2018-N-3233,"Request for Nominations for Voting Members on a Public Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee",Notice,Request for Nominations,2020-12-30T05:00:00Z,2020,12,2020-12-30T05:00:00Z,,2020-12-30T13:28:30Z,2020-28833,0,0,09000064849d18c9 FDA-2020-N-2246-0001,FDA,FDA-2020-N-2246,Fee Rates Under the Over-the-Counter Monograph Drug User Fee Program for Fiscal Year 2021,Notice,Announcement,2020-12-29T05:00:00Z,2020,12,2020-12-29T05:00:00Z,,2020-12-29T17:03:53Z,2020-28714,0,0,09000064849cfd28 FDA-2010-N-0493-0013,FDA,FDA-2010-N-0493,"Agency Information Collection Activities; Proposals, Submissions, and Approvals",Notice,Notice of Approval,2020-12-29T05:00:00Z,2020,12,2020-12-29T05:00:00Z,,2020-12-29T17:10:19Z,2020-28608,0,0,09000064849cfdc6 FDA-2017-N-2021-0007,FDA,FDA-2017-N-2021,"Agency Information Collection Activities; Proposals, Submissions, and Approvals",Notice,Notice of Approval,2020-12-29T05:00:00Z,2020,12,2020-12-29T05:00:00Z,,2020-12-29T17:10:55Z,2020-28608,0,0,09000064849cfe9f FDA-2017-N-1095-0009,FDA,FDA-2017-N-1095,"Agency Information Collection Activities; Proposals, Submissions, and Approvals",Notice,Notice of Approval,2020-12-29T05:00:00Z,2020,12,2020-12-29T05:00:00Z,,2020-12-29T17:12:08Z,2020-28608,0,0,09000064849cfe9d FDA-2012-N-0197-0010,FDA,FDA-2012-N-0197,"Agency Information Collection Activities; Proposals, Submissions, and Approvals",Notice,Notice of Approval,2020-12-29T05:00:00Z,2020,12,2020-12-29T05:00:00Z,,2020-12-29T17:12:34Z,2020-28608,0,0,09000064849cfe9c FDA-2011-N-0424-0011,FDA,FDA-2011-N-0424,"Agency Information Collection Activities; Proposals, Submissions, and Approvals",Notice,Notice of Approval,2020-12-29T05:00:00Z,2020,12,2020-12-29T05:00:00Z,,2020-12-29T17:11:23Z,2020-28608,0,0,09000064849cfe9e FDA-2020-N-2252-0001,FDA,FDA-2020-N-2252,Interim Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act; Public Meeting; Request for Comments,Notice,Request for Comments,2020-12-28T05:00:00Z,2020,12,2020-12-28T05:00:00Z,2021-03-30T03:59:59Z,2021-03-30T01:00:27Z,2020-28602,0,0,09000064849cc7ab FDA-2020-D-0530-0668,FDA,FDA-2020-D-0530,"Voluntary Disclosure of Sesame as an Allergen: Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request; Extension of Comment Period",Notice,Notice of Availability,2020-12-28T05:00:00Z,2020,12,2020-12-28T05:00:00Z,2021-02-26T04:59:59Z,2021-02-27T02:00:26Z,2020-28559,0,0,09000064849cc892 FDA-2017-D-4303-0003,FDA,FDA-2017-D-4303,Providing Regulatory Submissions in Electronic Format—Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling; Guidance for Industry; Availability,Notice,Notice of Availability,2020-12-28T05:00:00Z,2020,12,2020-12-28T05:00:00Z,,2020-12-28T16:56:08Z,2020-28560,0,0,09000064849cc7af FDA-2020-N-1440-0001,FDA,FDA-2020-N-1440,Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments,Notice,Request for Comments,2020-12-28T05:00:00Z,2020,12,2020-12-28T05:00:00Z,2021-02-09T04:59:59Z,2021-02-10T02:00:46Z,2020-28558,0,0,09000064849cc88e FDA-2020-N-0008-0022,FDA,FDA-2020-N-0008,"Advisory Committee; Cellular, Tissue and Gene Therapies Advisory Committee; Renewal",Notice,Renewals,2020-12-28T05:00:00Z,2020,12,2020-12-28T05:00:00Z,,2020-12-28T16:53:17Z,2020-28561,0,0,09000064849cc890 FDA-2020-N-2272-0001,FDA,FDA-2020-N-2272,"Hospira, Inc., et al.; Withdrawal of Approval of 27 New Drug Applications",Notice,Withdrawal,2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T15:00:57Z,2020-28346,0,0,09000064849c0835 FDA-2010-N-0155-0253,FDA,FDA-2010-N-0155,Agency Information Collection Activities; Proposed Collection; Comment Request; Veterinary Feed Directive,Notice,60 Day Proposed Information Collection,2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,2021-02-23T04:59:59Z,2020-12-23T15:07:58Z,2020-28353,0,0,09000064849c0f93 FDA-2020-N-2267-0001,FDA,FDA-2020-N-2267,"Endo Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug Application for OPANA (Oxymorphone Hydrochloride) Extended-Release Tablets",Notice,Withdrawal,2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T15:11:29Z,2020-28283,0,0,09000064849c0fe7 FDA-2014-N-0386-0005,FDA,FDA-2014-N-0386,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Orphan Drugs,Notice,30 Day Proposed Information Collection,2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,2021-01-23T04:59:59Z,2021-01-23T02:02:30Z,2020-28349,0,0,09000064849c0f39 FDA-2010-N-0161-0012,FDA,FDA-2010-N-0161,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export of Food and Drug Administration-Regulated Products: Export Certificates,Notice,30 Day Proposed Information Collection,2020-12-21T05:00:00Z,2020,12,2020-12-21T05:00:00Z,2021-01-21T04:59:59Z,2020-12-21T13:22:19Z,2020-28064,0,0,09000064849ae940 FDA-2020-N-1866-0002,FDA,FDA-2020-N-1866,"Wockhardt Ltd., et al.; Withdrawal of Approval of Nine Abbreviated New Drug Applications; Correction",Notice,Correction,2020-12-21T05:00:00Z,2020,12,2020-12-21T05:00:00Z,,2020-12-21T13:44:00Z,2020-28081,0,0,09000064849aef3a FDA-2020-P-1650-0003,FDA,FDA-2020-P-1650,"Determination That DOBUTREX (Dobutamine Hydrochloride), Equivalent 12.5 Milligram Base/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness",Notice,Determinations,2020-12-21T05:00:00Z,2020,12,2020-12-21T05:00:00Z,,2020-12-21T13:53:01Z,2020-28080,0,0,09000064849aefda FDA-2018-N-0417-0003,FDA,FDA-2018-N-0417,"Request for Nominations of Voting Members on a Public Advisory Committee; National Mammography Quality Assurance Advisory Committee",Notice,Advisory Committee,2020-12-21T05:00:00Z,2020,12,2020-12-21T05:00:00Z,,2020-12-21T13:33:01Z,2020-28054,0,0,09000064849aeb78 FDA-2020-N-0001-0007,FDA,FDA-2020-N-0001,"Scientific and Ethical Considerations for the Inclusion of Pregnant Women in Clinical Trials; Public Meeting",Notice,Public Meetings,2020-12-21T05:00:00Z,2020,12,2020-12-21T05:00:00Z,,2020-12-21T13:28:07Z,2020-28069,0,0,09000064849ae945 FDA-2020-N-2217-0001,FDA,FDA-2020-N-2217,Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drugs for Investigational Use,Notice,60 Day Proposed Information Collection,2020-12-21T05:00:00Z,2020,12,2020-12-21T05:00:00Z,2021-02-20T04:59:59Z,2021-02-20T02:00:29Z,2020-28068,0,0,09000064849aef84 FDA-2014-N-1072-0011,FDA,FDA-2014-N-1072,"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Participation in Food and Drug Administration Fellowship and Traineeship Programs",Notice,30 Day Proposed Information Collection,2020-12-18T05:00:00Z,2020,12,2020-12-18T05:00:00Z,2021-01-20T04:59:59Z,2020-12-18T14:46:28Z,2020-27963,0,0,09000064849a75bd FDA-2020-N-1359-0021,FDA,FDA-2020-N-1359,"Sugars That Are Metabolized Differently Than Traditional Sugars; Extension of Comment Period",Notice,Extension of Comment Period,2020-12-18T05:00:00Z,2020,12,2020-12-18T05:00:00Z,2020-10-20T03:59:59Z,2020-12-18T14:50:26Z,2020-27749,0,0,09000064849a7689 FDA-2020-N-0026-0008,FDA,FDA-2020-N-0026,Issuance of Priority Review Voucher: Rare Pediatric Disease Product,Notice,General Notice,2020-12-17T05:00:00Z,2020,12,2020-12-17T05:00:00Z,,2020-12-17T18:16:44Z,2020-27760,0,0,09000064849a4513 FDA-2013-N-0520-0011,FDA,FDA-2013-N-0520,Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Prohibited From Use in Animal Food or Feed,Notice,60 Day Proposed Information Collection,2020-12-17T05:00:00Z,2020,12,2020-12-17T05:00:00Z,2021-02-17T04:59:59Z,2020-12-17T18:14:11Z,2020-27746,0,0,09000064849a43f7 FDA-2020-D-2214-0001,FDA,FDA-2020-D-2214,Dry Eye: Developing Drugs for Treatment; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2020-12-17T05:00:00Z,2020,12,2020-12-17T05:00:00Z,2021-03-18T03:59:59Z,2022-09-12T19:47:56Z,2020-27762,0,0,09000064849a4491 FDA-2019-D-3679-0014,FDA,FDA-2019-D-3679,Interacting With the Food and Drug Administration on Complex Innovative Trial Designs for Drugs and Biological Products; Guidance for Industry; Availability,Notice,Notice of Availability,2020-12-17T05:00:00Z,2020,12,2020-12-17T05:00:00Z,,2020-12-17T19:10:20Z,2020-27813,0,0,09000064849a443c FDA-2020-N-0026-0007,FDA,FDA-2020-N-0026,Issuance of Priority Review Voucher; Rare Pediatric Disease Product,Notice,General Notice,2020-12-17T05:00:00Z,2020,12,2020-12-17T05:00:00Z,,2020-12-17T16:38:06Z,2020-27778,0,0,09000064849a448f FDA-2018-N-0074-0005,FDA,FDA-2018-N-0074,Agency Information Collection Activities; Proposed Collection; Comment Request; State Enforcement Notifications,Notice,60 Day Proposed Information Collection,2020-12-17T05:00:00Z,2020,12,2020-12-17T05:00:00Z,2021-02-17T04:59:59Z,2020-12-17T18:08:40Z,2020-27748,0,0,09000064849a43bc FDA-2014-D-1167-0021,FDA,FDA-2014-D-1167,Controlled Correspondence Related to Generic Drug Development; Guidance for Industry; Availability,Notice,Notice of Availability,2020-12-17T05:00:00Z,2020,12,2020-12-17T05:00:00Z,,2020-12-17T19:19:44Z,2020-27810,0,0,09000064849a4518 FDA-2020-N-2197-0001,FDA,FDA-2020-N-2197,"VistaPharm, Inc., et al.; Withdrawal of Approval of 10 Abbreviated New Drug Applications",Notice,Withdrawal,2020-12-11T05:00:00Z,2020,12,2020-12-11T05:00:00Z,,2020-12-11T14:19:32Z,2020-27303,0,0,0900006484998516 FDA-2015-D-3787-0015,FDA,FDA-2015-D-3787,Electromagnetic Compatibility of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment Period,Notice,Extension of Comment Period,2020-12-11T05:00:00Z,2020,12,2020-12-11T05:00:00Z,2021-02-17T04:59:59Z,2020-12-11T14:25:30Z,2020-27350,0,0,09000064849985cd FDA-2019-D-1650-0008,FDA,FDA-2019-D-1650,Performance Criteria for Safety and Performance Based Pathway; Guidances for Industry and Food and Drug Administration Staff; Availability,Notice,Notice of Availability,2020-12-11T05:00:00Z,2020,12,2020-12-11T05:00:00Z,,2020-12-11T13:54:17Z,2020-27248,0,0,0900006484998722 FDA-2019-D-1647-0005,FDA,FDA-2019-D-1647,Performance Criteria for Safety and Performance Based Pathway; Guidances for Industry and Food and Drug Administration Staff; Availability,Notice,Notice of Availability,2020-12-11T05:00:00Z,2020,12,2020-12-11T05:00:00Z,,2020-12-11T13:51:06Z,2020-27248,0,0,0900006484998515 FDA-2019-N-4203-0033,FDA,FDA-2019-N-4203,"Advisory Committee; Bone, Reproductive and Urologic Drugs Advisory Committee; Renewal",Notice,Advisory Committee,2020-12-11T05:00:00Z,2020,12,2020-12-11T05:00:00Z,,2020-12-11T14:22:38Z,2020-27289,0,0,0900006484998591 FDA-2020-D-0064-0005,FDA,FDA-2020-D-0064,Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe Notices; Guidance for Industry; Availability,Notice,Notice of Availability,2020-12-11T05:00:00Z,2020,12,2020-12-11T05:00:00Z,,2020-12-11T13:31:44Z,2020-27256,0,0,0900006484998048 FDA-2020-N-2226-0001,FDA,FDA-2020-N-2226,Cheese Products Deviating from Identity Standard; Temporary Permit for Market Testing,Notice,General Notice,2020-12-11T05:00:00Z,2020,12,2020-12-11T05:00:00Z,,2020-12-11T13:46:57Z,2020-27197,0,0,0900006484998093 FDA-2019-D-1652-0008,FDA,FDA-2019-D-1652,Performance Criteria for Safety and Performance Based Pathway; Guidances for Industry and Food and Drug Administration Staff; Availability,Notice,Notice of Availability,2020-12-11T05:00:00Z,2020,12,2020-12-11T05:00:00Z,,2020-12-11T13:52:37Z,2020-27248,0,0,0900006484998721 FDA-2010-D-0529-0033,FDA,FDA-2010-D-0529,Qualification Process for Drug Development Tools; Guidance for Industry; Availability; Correction,Notice,Notice of Availability,2020-12-11T05:00:00Z,2020,12,2020-12-11T05:00:00Z,,2020-12-11T13:39:39Z,2020-27288,0,0,090000648499804d FDA-2020-N-2196-0001,FDA,FDA-2020-N-2196,"Allergan Pharmaceuticals International, Ltd.; Withdrawal of Approval of a New Drug Application for ASACOL (Mesalamine) Delayed-Release Tablets, 400 Milligrams",Notice,Withdrawal,2020-12-10T05:00:00Z,2020,12,2020-12-10T05:00:00Z,,2020-12-10T12:59:11Z,2020-27082,0,0,0900006484995521 FDA-2020-N-2227-0001,FDA,FDA-2020-N-2227,Food and Drug Administration FiscalbYear 2020 Performance Review Board,Notice,Announcement,2020-12-10T05:00:00Z,2020,12,2020-12-10T05:00:00Z,,2020-12-10T12:50:15Z,2020-27123,0,0,090000648499376c FDA-2014-N-1076-0007,FDA,FDA-2014-N-1076,"Agency Information Collection Activities; Proposed Co llection; Comment Request; Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice",Notice,60 Day Proposed Information Collection,2020-12-09T05:00:00Z,2020,12,2020-12-09T05:00:00Z,2021-02-09T04:59:59Z,2020-12-09T13:49:47Z,2020-27060,0,0,090000648498fb9a FDA-2020-D-0770-0001,FDA,FDA-2020-D-0770,Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2020-12-09T05:00:00Z,2020,12,2020-12-09T05:00:00Z,,2021-03-15T21:11:29Z,2020-27057,0,0,090000648498fbf4 FDA-2014-D-0622-0020,FDA,FDA-2014-D-0622,Best Practices in Developing Proprietary Names for Human Prescription Drug Products; Guidance for Industry; Availability,Notice,Notice of Availability,2020-12-09T05:00:00Z,2020,12,2020-12-09T05:00:00Z,,2020-12-09T13:40:47Z,2020-27058,0,0,090000648498fb58 FDA-2020-N-0026-0006,FDA,FDA-2020-N-0026,Issuance of Priority Review Voucher; Rare Pediatric Disease Product,Notice,Announcement,2020-12-07T05:00:00Z,2020,12,2020-12-07T05:00:00Z,,2020-12-07T16:10:20Z,2020-26801,0,0,0900006484989f80 FDA-2019-N-5900-0012,FDA,FDA-2019-N-5900,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Endorser Status and Explicitness of Payment in Directto-Consumer Promotion,Notice,30 Day Proposed Information Collection,2020-12-07T05:00:00Z,2020,12,2020-12-07T05:00:00Z,2021-01-07T04:59:59Z,2020-12-08T02:00:52Z,2020-26799,0,0,0900006484989f3f FDA-2018-N-1768-0002,FDA,FDA-2018-N-1768,"Advisory Committee; Pharmacy Compounding Advisory Committee; Renewal",Notice,Committee Renewal,2020-12-04T05:00:00Z,2020,12,2020-12-04T05:00:00Z,,2020-12-04T14:09:26Z,2020-26696,0,0,0900006484985b73 FDA-2020-N-2216-0001,FDA,FDA-2020-N-2216,"Revocation of Authorizations of Emergency Use of Certain Medical Devices During COVID–19; Availability",Notice,Announcement,2020-12-04T05:00:00Z,2020,12,2020-12-04T05:00:00Z,,2020-12-04T13:25:15Z,2020-26697,0,0,0900006484985a7a FDA-2017-N-6397-0010,FDA,FDA-2017-N-6397,"Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Calorie Labeling of Articles of Food in Vending Machines and Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments",Notice,60 Day Proposed Information Collection,2020-12-04T05:00:00Z,2020,12,2020-12-04T05:00:00Z,2021-02-03T04:59:59Z,2021-01-26T02:01:19Z,2020-26695,0,0,0900006484985c24 FDA-2019-D-4739-0016,FDA,FDA-2019-D-4739,"Requesting FDA Feedback on Combination Products; Guidance for Industry and FDA Staff; Availability",Notice,Notice of Availability,2020-12-04T05:00:00Z,2020,12,2020-12-04T05:00:00Z,,2020-12-04T14:14:50Z,2020-26700,0,0,0900006484985b24 FDA-2017-D-5739-0009,FDA,FDA-2017-D-5739,"Formal Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants of Complex Products Under Generic Drug User Fee Amendments; Guidance for Industry; Availability; Correction",Notice,Notice of Availability,2020-12-04T05:00:00Z,2020,12,2020-12-04T05:00:00Z,,2020-12-04T13:53:26Z,2020-26691,0,0,0900006484985c2a FDA-2017-P-5787-0235,FDA,FDA-2017-P-5787,Petition Supplement 2 Post-Finasteride Syndrome Foundation,Notice,Background Material,2020-12-03T05:00:00Z,2020,12,,,2020-12-03T17:17:17Z,,0,0,0900006484984494 FDA-2017-P-5787-0234,FDA,FDA-2017-P-5787,Petition Supplement 1 Post-Finasteride Syndrome Foundation,Notice,Background Material,2020-12-03T05:00:00Z,2020,12,,,2020-12-03T17:16:41Z,,0,0,0900006484984493 FDA-2020-N-2242-0001,FDA,FDA-2020-N-2242,"Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments",Notice,Public Hearings,2020-12-03T05:00:00Z,2020,12,2020-12-03T05:00:00Z,2020-12-17T04:59:59Z,2020-12-18T02:00:39Z,2020-26704,0,0,090000648498419b FDA-2011-N-0016-0013,FDA,FDA-2011-N-0016,"Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals",Notice,Notice of Approval,2020-12-02T05:00:00Z,2020,12,2020-12-02T05:00:00Z,,2020-12-02T15:02:15Z,2020-26571,0,0,09000064849819f5 FDA-2010-N-0622-0011,FDA,FDA-2010-N-0622,"Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals",Notice,Notice of Approval,2020-12-02T05:00:00Z,2020,12,2020-12-02T05:00:00Z,,2020-12-02T15:04:53Z,2020-26571,0,0,09000064849819f3 FDA-2009-N-0501-0023,FDA,FDA-2009-N-0501,"Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals",Notice,Notice of Approval,2020-12-02T05:00:00Z,2020,12,2023-04-04T04:00:00Z,,2023-04-04T15:33:25Z,2020-26571,0,0,09000064849819f8 FDA-2019-N-6098-0009,FDA,FDA-2019-N-6098,"Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals",Notice,Notice of Approval,2020-12-02T05:00:00Z,2020,12,2020-12-02T05:00:00Z,,2020-12-02T14:46:49Z,2020-26571,0,0,09000064849819f6 FDA-1987-P-0074-0007,FDA,FDA-1987-P-0074,"Canned Pacific Salmon Deviating From Identity Standard; Amendment of Temporary Marketing Permit",Notice,Correction,2020-12-02T05:00:00Z,2020,12,2020-12-02T05:00:00Z,,2020-12-02T14:37:41Z,2020-26533,0,0,0900006484981905 FDA-2010-N-0190-0004,FDA,FDA-2010-N-0190,"Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Requirements",Notice,60 Day Proposed Information Collection,2020-12-02T05:00:00Z,2020,12,2020-12-02T05:00:00Z,2021-02-02T04:59:59Z,2021-02-02T02:00:58Z,2020-26537,0,0,0900006484981343 FDA-2013-N-1119-0015,FDA,FDA-2013-N-1119,"Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals",Notice,Notice of Approval,2020-12-02T05:00:00Z,2020,12,2020-12-02T05:00:00Z,,2020-12-02T14:52:37Z,2020-26571,0,0,090000648498138f FDA-2019-N-1845-0136,FDA,FDA-2019-N-1845,"Fixed-Quantity Unit-of-Use Blister-Packaging for Certain Immediate- Release Opioid Analgesics for Treatment of Acute Pain; Establishment of a Public Docket; Request for Comments; Reopening of the Comment Period and Provision of Additional Information and Analysis",Notice,Request for Comments,2020-12-01T05:00:00Z,2020,12,2020-12-01T05:00:00Z,2021-02-02T04:59:59Z,2021-02-02T02:00:58Z,2020-26504,0,0,090000648497f5d1 FDA-2020-D-1794-0001,FDA,FDA-2020-D-1794,"Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications; Draft Guidance for Industry; Availability",Notice,Notice of Availability,2020-12-01T05:00:00Z,2020,12,2020-12-01T05:00:00Z,2021-03-02T04:59:59Z,2021-03-02T02:00:56Z,2020-26510,0,0,090000648497f79e FDA-2011-N-0076-0013,FDA,FDA-2011-N-0076,"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Records; Electronic Signatures",Notice,30 Day Proposed Information Collection,2020-12-01T05:00:00Z,2020,12,2020-12-01T05:00:00Z,2021-01-01T04:59:59Z,2023-08-31T17:40:52Z,2020-26487,0,0,090000648497f743 FDA-2020-N-1671-0003,FDA,FDA-2020-N-1671,"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Good Laboratory Practice for Nonclinical Laboratory Studies",Notice,30 Day Proposed Information Collection,2020-12-01T05:00:00Z,2020,12,2020-12-01T05:00:00Z,2021-01-01T04:59:59Z,2020-12-01T15:39:21Z,2020-26502,0,0,090000648497f7a5 FDA-2020-N-1337-0003,FDA,FDA-2020-N-1337,John Kapoor: Final Debarment Order,Notice,Statutory Debarment,2020-11-30T05:00:00Z,2020,11,2020-11-30T05:00:00Z,,2020-11-30T13:47:21Z,2020-26262,0,0,090000648497c3e1 FDA-2019-N-4248-0002,FDA,FDA-2019-N-4248,Barry J. Cadden: Final Debarment Order,Notice,Statutory Debarment,2020-11-30T05:00:00Z,2020,11,2020-11-30T05:00:00Z,,2020-11-30T13:26:47Z,2020-26255,0,0,090000648497c22c FDA-2020-N-1255-0002,FDA,FDA-2020-N-1255,Tuan Anh Tran: Final Debarment Order,Notice,Statutory Debarment,2020-11-30T05:00:00Z,2020,11,2020-11-30T05:00:00Z,,2020-11-30T13:41:46Z,2020-26250,0,0,090000648497c353 FDA-2020-N-1347-0002,FDA,FDA-2020-N-1347,Michael L. Babich: Final Debarment Order,Notice,Statutory Debarment,2020-11-27T05:00:00Z,2020,11,2020-11-27T05:00:00Z,,2020-11-27T13:49:00Z,2020-26226,0,0,09000064849787fd FDA-2020-N-1736-0009,FDA,FDA-2020-N-1736,"Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial New Animal Drugs; Extension of Comment Period",Notice,Extension of Comment Period,2020-11-27T05:00:00Z,2020,11,2020-11-27T05:00:00Z,,2021-04-03T01:00:54Z,2020-26182,0,0,09000064849787ac FDA-2020-N-1898-0036,FDA,FDA-2020-N-1898,"Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments",Notice,Public Meetings,2020-11-27T05:00:00Z,2020,11,2020-11-27T05:00:00Z,2020-12-10T04:59:59Z,2020-12-11T02:00:44Z,2020-26229,0,0,0900006484978404 FDA-2016-D-4437-0005,FDA,FDA-2016-D-4437,"In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products; Guidance for Industry; Availability",Notice,Notice of Availability,2020-11-27T05:00:00Z,2020,11,2020-11-27T05:00:00Z,,2020-11-27T13:36:35Z,2020-26183,0,0,09000064849787ae FDA-2019-N-3077-0013,FDA,FDA-2019-N-3077,"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Obtaining Information To Understand Challenges and Opportunities Encountered by Compounding Outsourcing Facilities",Notice,30 Day Proposed Information Collection,2020-11-25T05:00:00Z,2020,11,2020-11-25T05:00:00Z,2020-12-29T04:59:59Z,2020-12-27T02:02:12Z,2020-26066,0,0,0900006484975894 FDA-2020-N-1677-0005,FDA,FDA-2020-N-1677,"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recordkeeping and Reporting Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing Material From Cattle",Notice,30 Day Proposed Information Collection,2020-11-25T05:00:00Z,2020,11,2020-11-25T05:00:00Z,2020-12-29T04:59:59Z,2020-11-26T02:00:36Z,2020-26059,0,0,0900006484975e11 FDA-2009-N-0380-0012,FDA,FDA-2009-N-0380,"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Product Jurisdiction and Combination Products",Notice,30 Day Proposed Information Collection,2020-11-25T05:00:00Z,2020,11,2020-11-25T05:00:00Z,2020-12-29T04:59:59Z,2020-11-25T14:13:57Z,2020-26062,0,0,09000064849757af FDA-2017-D-5739-0007,FDA,FDA-2017-D-5739,"Formal Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants of Complex Products Under Generic Drug User Fee Amendments; Guidance for Industry; Availability",Notice,Notice of Availability,2020-11-25T05:00:00Z,2020,11,2020-11-25T05:00:00Z,,2020-11-25T14:24:31Z,2020-26050,0,0,0900006484975d73 FDA-2010-D-0529-0031,FDA,FDA-2010-D-0529,Qualification Process for Drug Development Tools; Guidance for Industry; Availability,Notice,Notice of Availability,2020-11-25T05:00:00Z,2020,11,2020-11-25T05:00:00Z,,2020-11-25T14:16:53Z,2020-26051,0,0,090000648497584a FDA-2020-Z-2200-0002,FDA,FDA-2020-Z-2200,Termination of the Food and Drug Administration's Unapproved Drugs Initiative,Notice,General Notice,2020-11-25T05:00:00Z,2020,11,2020-11-25T05:00:00Z,,2020-11-27T16:25:15Z,2020-26133,0,0,0900006484975dc2 FDA-2020-D-1848-0001,FDA,FDA-2020-D-1848,"Clinical Drug Interaction Studies With Combined Oral Contraceptives; Draft Guidance for Industry; Availability",Notice,Notice of Availability,2020-11-23T05:00:00Z,2020,11,2020-11-23T05:00:00Z,2021-02-23T04:59:59Z,2021-02-23T02:00:36Z,2020-25744,0,0,090000648497009b FDA-2018-D-1752-0028,FDA,FDA-2018-D-1752,"Public Availability of Lists of Retail Consignees To Effectuate Certain Human and Animal Food Recalls; Guidance for Industry and Food and Drug Administration Staff; Availability",Notice,Notice of Availability,2020-11-23T05:00:00Z,2020,11,2020-11-23T05:00:00Z,,2020-11-23T14:18:01Z,2020-25719,0,0,0900006484970634 FDA-2017-N-6455-0004,FDA,FDA-2017-N-6455,Agency Information Collection Activities; Proposed Collection; Comment Request; Consultation Procedures: Foods Derived From New Plant Varieties,Notice,60 Day Proposed Information Collection,2020-11-23T05:00:00Z,2020,11,2020-11-23T05:00:00Z,2021-01-23T04:59:59Z,2020-11-23T14:11:23Z,2020-25752,0,0,0900006484970095 FDA-2018-D-0943-0010,FDA,FDA-2018-D-0943,"Elemental Impurities in Animal Drug Products—Questions and Answers; Guidance for Industry; Availability",Notice,Notice of Availability,2020-11-23T05:00:00Z,2020,11,2020-11-23T05:00:00Z,,2020-11-23T14:16:00Z,2020-25726,0,0,0900006484970560 FDA-2020-D-2107-0001,FDA,FDA-2020-D-2107,"Cross Labeling Oncology Drugs in Combination Drug Regimens; Draft Guidance for Industry; Availability",Notice,Notice of Availability,2020-11-20T05:00:00Z,2020,11,2020-11-20T05:00:00Z,2021-01-20T04:59:59Z,2021-01-20T02:02:52Z,2020-25737,0,0,090000648496ac8d FDA-2020-N-1584-0002,FDA,FDA-2020-N-1584,"Authorization of Emergency Use of Certain Medical Devices During COVID–19; Availability",Notice,General Notice,2020-11-20T05:00:00Z,2020,11,2020-11-20T05:00:00Z,,2020-11-20T15:33:21Z,2020-25603,0,0,090000648496ac8a FDA-2011-D-0611-0081,FDA,FDA-2011-D-0611,Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the Biologics Price Competition and Innovation Act of 2009; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2020-11-20T05:00:00Z,2020,11,2020-11-20T05:00:00Z,2021-01-20T04:59:59Z,2021-01-21T02:00:45Z,2020-25606,0,0,090000648496ac54 FDA-2020-N-1394-0002,FDA,FDA-2020-N-1394,Richard M. Simon: Final Debarment Order,Notice,Statutory Debarment,2020-11-19T05:00:00Z,2020,11,2020-11-19T05:00:00Z,,2020-11-19T14:02:33Z,2020-25601,0,0,0900006484968606 FDA-2007-D-0369-0510,FDA,FDA-2007-D-0369,"Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability",Notice,Notice of Availability,2020-11-19T05:00:00Z,2020,11,2020-11-19T05:00:00Z,2021-01-20T04:59:59Z,2020-11-19T14:06:28Z,2020-25602,0,0,09000064849686e1 FDA-2013-N-1429-0020,FDA,FDA-2013-N-1429,"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act and Associated Fees",Notice,30 Day Proposed Information Collection,2020-11-18T05:00:00Z,2020,11,2020-11-18T05:00:00Z,2020-12-19T04:59:59Z,2023-07-20T14:23:39Z,2020-25411,0,0,0900006484966148 FDA-2020-D-1137-0060,FDA,FDA-2020-D-1137,Guidance Documents Related to Coronavirus Disease 2019; Availability,Notice,Notice of Availability,2020-11-18T05:00:00Z,2020,11,2020-11-18T05:00:00Z,,2021-04-03T01:00:48Z,2020-25399,0,0,0900006484966237 FDA-2013-D-0575-0040,FDA,FDA-2013-D-0575,Agency Information Collection Activities; Proposed Collection; Comment Request; Expedited Programs for Serious Conditions— Drugs and Biologics,Notice,60 Day Proposed Information Collection,2020-11-18T05:00:00Z,2020,11,2020-11-18T05:00:00Z,2021-01-20T04:59:59Z,2021-01-21T02:00:41Z,2020-25414,0,0,090000648496582e FDA-2007-D-0369-0508,FDA,FDA-2007-D-0369,Product-Specific Guidance for Tiotropium Bromide; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2020-11-18T05:00:00Z,2020,11,2020-11-18T05:00:00Z,2021-01-20T04:59:59Z,2021-01-16T02:01:08Z,2020-25412,0,0,09000064849661a3 FDA-2020-D-1138-0132,FDA,FDA-2020-D-1138,Guidance Documents Related to Coronavirus Disease 2019; Availability,Notice,Notice of Availability,2020-11-18T05:00:00Z,2020,11,2020-11-18T05:00:00Z,,2020-11-18T13:30:14Z,2020-25399,0,0,0900006484965ca4 FDA-2019-N-5843-0002,FDA,FDA-2019-N-5843,"Pharmacia and Upjohn Co., et al.; Withdrawal of Approval of 19 New Drug Applications; Correction",Notice,Correction,2020-11-18T05:00:00Z,2020,11,2020-11-18T05:00:00Z,,2020-11-18T13:15:03Z,2020-25413,0,0,09000064849661a2 FDA-2015-D-3787-0008,FDA,FDA-2015-D-3787,Electromagnetic Compatibility of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability,Notice,Notice of Availability,2020-11-17T05:00:00Z,2020,11,2020-11-17T05:00:00Z,2021-01-20T04:59:59Z,2021-01-15T02:01:09Z,2020-25306,0,0,0900006484963731 FDA-2020-N-2030-0001,FDA,FDA-2020-N-2030,Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Food and Drug Administration Approval To Market a New Drug,Notice,60 Day Proposed Information Collection,2020-11-16T05:00:00Z,2020,11,2020-11-16T05:00:00Z,2021-01-16T04:59:59Z,2020-11-16T13:30:51Z,2020-25239,0,0,0900006484960494 FDA-2019-D-3592-0010,FDA,FDA-2019-D-3592,"Certificates of Confidentiality; Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff; Availability",Notice,Notice of Availability,2020-11-16T05:00:00Z,2020,11,2020-11-16T05:00:00Z,,2020-11-16T13:40:06Z,2020-25238,0,0,0900006484960498 FDA-2009-D-0052-0016,FDA,FDA-2009-D-0052,"Documenting Electronic Data Files and Statistical Analysis Programs; Guidance for Industry; Availability",Notice,Notice of Availability,2020-11-13T05:00:00Z,2020,11,2020-11-13T05:00:00Z,,2020-11-13T15:21:33Z,2020-25131,0,0,090000648495bcbe