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withdrawn,object_id FDA-2008-D-0659-0034,FDA,FDA-2008-D-0659,"Guidance for Industry Current Good Tissue Practice and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products; Availability",Notice,Notice of Availability,2011-12-30T05:00:00Z,2011,12,2011-12-30T05:00:00Z,,2024-11-11T21:35:46Z,2011-33572,1,0,0900006480f8b716 FDA-2011-N-0002-0153,FDA,FDA-2011-N-0002,Oncologic Drugs Advisory Committee; Notice of Meeting,Notice,Meeting,2011-12-30T05:00:00Z,2011,12,2011-12-30T05:00:00Z,,2011-12-30T14:13:50Z,2011-33552,0,0,0900006480f8b71a FDA-2011-N-0002-0155,FDA,FDA-2011-N-0002,Oncologic Drugs Advisory Committee; Notice of Meeting,Notice,Meeting,2011-12-30T05:00:00Z,2011,12,2011-12-30T05:00:00Z,,2011-12-30T14:38:03Z,2011-33548,0,0,0900006480f8b7c4 FDA-2011-D-0868-0001,FDA,FDA-2011-D-0868,Draft Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices; Availability,Notice,Notice of Availability,2011-12-30T05:00:00Z,2011,12,2011-12-30T05:00:00Z,2012-03-30T03:59:59Z,2020-04-29T00:35:05Z,2011-33550,0,0,0900006480f8b728 FDA-2011-N-0827-0001,FDA,FDA-2011-N-0827,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Labeling Requirements for Blood and Blood Components, Including Source Plasma; Revisions",Notice,General Notice,2011-12-30T05:00:00Z,2011,12,2011-12-30T05:00:00Z,2012-02-29T04:59:59Z,2011-12-30T14:28:59Z,2011-33555,0,0,0900006480f8b750 FDA-2009-N-0247-0300,FDA,FDA-2009-N-0247,Report on Good Guidance Practices Improving Efficiency and Transparency; Availability,Notice,Availability of Document,2011-12-30T05:00:00Z,2011,12,2011-12-30T05:00:00Z,2012-02-29T04:59:59Z,2011-12-30T14:36:05Z,2011-33573,0,0,0900006480f8b7c2 FDA-2011-N-0002-0154,FDA,FDA-2011-N-0002,Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting,Notice,Meeting,2011-12-30T05:00:00Z,2011,12,2011-12-30T05:00:00Z,,2011-12-30T14:26:10Z,2011-33561,0,0,0900006480f8b74c FDA-2008-P-0555-0004,FDA,FDA-2008-P-0555,Determinations that Drugs Were Not Withdrawn from Sale for Reasons of Safety or Effectiveness: HYCODAN,Notice,General Notice,2011-12-30T05:00:00Z,2011,12,2011-12-30T05:00:00Z,,2011-12-30T13:50:53Z,2011-33549,0,0,0900006480f8b709 FDA-2011-D-0872-0001,FDA,FDA-2011-D-0872,Draft Guidance for Industry on Use of Histology in Biomarker Qualification Studies; Availabilty,Notice,Notice of Availability,2011-12-30T05:00:00Z,2011,12,2011-12-30T05:00:00Z,2012-03-30T03:59:59Z,2013-11-23T02:02:25Z,2011-33553,0,0,0900006480f8b6cb FDA-2011-N-0619-0002,FDA,FDA-2011-N-0619,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Medical Devices; Humanitarian Use Devices",Notice,General Notice,2011-12-30T05:00:00Z,2011,12,2011-12-30T05:00:00Z,2012-01-31T04:59:59Z,2011-12-30T13:41:14Z,2011-33551,0,0,0900006480f8b6e5 FDA-2011-N-0345-0003,FDA,FDA-2011-N-0345,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Experimental Study on Consumer Responses to Nutrition Facts Labels, etc.",Notice,General Notice,2011-12-29T05:00:00Z,2011,12,2011-12-29T05:00:00Z,2012-01-31T04:59:59Z,2014-06-14T01:03:15Z,2011-33303,0,0,0900006480f8abb7 FDA-2011-D-0652-0001,FDA,FDA-2011-D-0652,"Draft Guidances for Industry and Staff; Availability: 510(k) Program, Evaluating Substantial Equivalence in Premarket Notifications; Availability",Notice,Notice of Availability,2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,2012-04-27T03:59:59Z,2012-05-25T02:00:27Z,2011-33232,0,0,0900006480f8a26b FDA-2011-N-0912-0001,FDA,FDA-2011-N-0912,Communications and Activities: Off-Label Uses of Marketed Products and Use of Products Not Yet Legally Marketed,Notice,General Notice,2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,2012-03-28T03:59:59Z,2012-05-04T12:01:27Z,2011-33188,0,0,0900006480f8a26a FDA-2011-N-0002-0152,FDA,FDA-2011-N-0002,"Meetings: Cellular, Tissue, and Gene Therapies Advisory Committee",Notice,Meeting,2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,,2011-12-28T20:10:31Z,2011-33220,0,0,0900006480f8a239 FDA-2011-D-0893-0001,FDA,FDA-2011-D-0893,Draft Guidances for Industry and Staff; Availability: Center for Devices and Radiological Health Appeals Processes,Notice,Notice of Availability,2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,2012-04-27T03:59:59Z,2014-01-13T17:39:02Z,2011-33230,0,0,0900006480f8a2c3 FDA-2010-D-0313-0017,FDA,FDA-2010-D-0313,"Guidance for Industry: Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation; Availability",Notice,Notice of Availability,2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,,2024-11-07T01:39:58Z,2011-33292,1,0,0900006480f8a23c FDA-2011-N-0002-0151,FDA,FDA-2011-N-0002,Requests for Nominations: Voting Members on Public Advisory Panels or Committees,Notice,General Notice,2011-12-27T05:00:00Z,2011,12,2011-12-27T05:00:00Z,,2011-12-27T16:38:57Z,2011-33060,0,0,0900006480f898b3 FDA-2011-N-0915-0001,FDA,FDA-2011-N-0915,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products, etc.",Notice,General Notice,2011-12-27T05:00:00Z,2011,12,2011-12-27T05:00:00Z,2012-02-28T04:59:59Z,2011-12-27T16:45:58Z,2011-33140,0,0,0900006480f89156 FDA-2011-D-0787-0003,FDA,FDA-2011-D-0787,"Draft Guidance for Industry and Staff; Availability: Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human Studies",Notice,Notice of Extension,2011-12-27T05:00:00Z,2011,12,2011-12-27T05:00:00Z,2012-03-10T04:59:59Z,2011-12-27T16:55:21Z,2011-33142,0,0,0900006480f89d41 FDA-2011-D-0790-0004,FDA,FDA-2011-D-0790,"Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Staff; Availability: Decisions for Investigational Device Exemption Clinical Investigations",Notice,Notice of Extension,2011-12-27T05:00:00Z,2011,12,2011-12-27T05:00:00Z,2012-03-10T04:59:59Z,2011-12-27T17:03:18Z,2011-33141,0,0,0900006480f89877 FDA-2011-N-0002-0150,FDA,FDA-2011-N-0002,Requests for Nominations: Food Advisory Committee Voting Members,Notice,General Notice,2011-12-27T05:00:00Z,2011,12,2011-12-27T05:00:00Z,,2011-12-27T16:32:38Z,2011-33108,0,0,0900006480f89874 FDA-2011-N-0002-0149,FDA,FDA-2011-N-0002,Endocrinologic and Metabolic Drugs Advisory Committee Meeting,Notice,Meeting,2011-12-27T05:00:00Z,2011,12,2011-12-27T05:00:00Z,,2011-12-27T16:27:31Z,2011-33059,0,0,0900006480f89822 FDA-1977-N-0014-1438,FDA,FDA-1977-N-0014,Withdrawal of Notices of Opportunity for a Hearing: Penicillin and Tetracycline Used in Animal Feed,Notice,Withdrawal,2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,,2019-04-09T18:17:07Z,2011-32775,0,0,0900006480f87dc5 FDA-2011-N-0508-0002,FDA,FDA-2011-N-0508,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Blood Establishment Registration and Product Listing",Notice,General Notice,2011-12-22T05:00:00Z,2011,12,,,2011-12-22T17:02:14Z,2011-32777,0,0,0900006480f87cba FDA-1977-N-0019-0067,FDA,FDA-1977-N-0019,Withdrawal of Notices of Opportunity for a Hearing; Penicillin and Tetracycline Used in Animal Feed,Notice,Withdrawal,2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,,2019-04-25T18:21:26Z,2011-32775,0,0,0900006480f87c5a FDA-1977-N-0022-0146,FDA,FDA-1977-N-0022,Withdrawal of Notices of Opportunity for a Hearing: Penicillin and Tetracycline Used in Animal Feed,Notice,Withdrawal,2011-12-22T05:00:00Z,2011,12,,,2011-12-22T16:45:03Z,2011-32775,0,0,0900006480f87ea8 FDA-2011-N-0511-0002,FDA,FDA-2011-N-0511,"Agency Information Collection Activities; Proposals, Submissions, andApprovals: Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components, etc.",Notice,General Notice,2011-12-22T05:00:00Z,2011,12,,,2011-12-22T14:02:15Z,2011-32778,0,0,0900006480f87c31 FDA-2011-N-0908-0001,FDA,FDA-2011-N-0908,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Establishment and Operation of Clinical Trial Data Monitoring Committees",Notice,General Notice,2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,2012-02-22T04:59:59Z,2011-12-22T17:04:41Z,2011-32776,0,0,0900006480f87d15 FDA-1977-N-0224-0138,FDA,FDA-1977-N-0224,Withdrawal of Notices of Opportunity for a Hearing: Penicillin and Tetracycline Used in Animal Feed,Notice,Withdrawal,2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,,2019-04-29T15:42:47Z,2011-32775,0,0,0900006480f87ed5 FDA-2011-N-0411-0003,FDA,FDA-2011-N-0411,"Withdrawal of Approval of 70 New Drug Applications and 97 Abbreviated New Drug Applications: Bristol-Myers Squibb Co., et al.; Correction",Notice,Correction,2011-12-22T05:00:00Z,2011,12,,,2011-12-22T17:07:37Z,2011-32822,0,0,0900006480f87d1a FDA-2011-N-0902-0001,FDA,FDA-2011-N-0902,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Prescription Drug Product Labeling; Medication Guide Requirements",Notice,60 Day Proposed Information Collection,2011-12-21T05:00:00Z,2011,12,2011-12-21T05:00:00Z,2012-02-22T04:59:59Z,2011-12-21T21:40:13Z,2011-32548,0,0,0900006480f87038 FDA-2011-N-0656-0002,FDA,FDA-2011-N-0656,Animal Drug User Fee Act; Reopening of Comment Period,Notice,Notice of Extension,2011-12-21T05:00:00Z,2011,12,2011-12-21T05:00:00Z,2013-01-16T04:59:59Z,2013-01-16T03:07:49Z,2011-32567,0,0,0900006480f87129 FDA-2011-N-0842-0001,FDA,FDA-2011-N-0842,Gluten in Drug Products,Notice,General Notice,2011-12-21T05:00:00Z,2011,12,2011-12-21T05:00:00Z,2012-03-21T03:59:59Z,2011-12-21T21:31:22Z,2011-32551,0,0,0900006480f87037 FDA-2011-N-0655-0003,FDA,FDA-2011-N-0655,Animal Generic Drug User Fee Act; Reopening of Comment Period,Notice,Notice of Extension,2011-12-21T05:00:00Z,2011,12,2011-12-21T05:00:00Z,2013-01-16T04:59:59Z,2012-12-11T03:01:51Z,2011-32565,0,0,0900006480f8703b FDA-2010-N-0381-0051,FDA,FDA-2010-N-0381,Meetings: Generic Drug User Fee; Correction,Notice,General Notice,2011-12-21T05:00:00Z,2011,12,2011-12-21T05:00:00Z,,2011-12-21T22:13:01Z,2011-32562,0,0,0900006480f870d0 FDA-2011-N-0885-0001,FDA,FDA-2011-N-0885,Rare Disease Patient Advocacy Day Meeting,Notice,Meeting,2011-12-20T05:00:00Z,2011,12,2011-12-20T05:00:00Z,,2011-12-20T14:44:21Z,2011-32436,0,0,0900006480f8650c FDA-2011-N-0849-0001,FDA,FDA-2011-N-0849,Establishing Timeframes for Implementation of Product Safety Labeling Changes,Notice,General Notice,2011-12-20T05:00:00Z,2011,12,2011-12-20T05:00:00Z,2012-02-22T04:59:59Z,2011-12-20T15:14:43Z,2011-32438,0,0,0900006480f8652b FDA-2011-N-0002-0148,FDA,FDA-2011-N-0002,"Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice; Public Workshop",Notice,Meeting,2011-12-20T05:00:00Z,2011,12,2011-12-20T05:00:00Z,,2011-12-20T16:34:16Z,2011-32435,0,0,0900006480f864d2 FDA-2011-D-0476-0009,FDA,FDA-2011-D-0476,Guidance for Industry and Staff; Availability: Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices,Notice,Notice of Availability,2011-12-20T05:00:00Z,2011,12,2011-12-20T05:00:00Z,,2012-03-24T19:36:40Z,2011-32437,0,0,0900006480f86544 FDA-2011-N-0002-0147,FDA,FDA-2011-N-0002,Advisory Committees Meeting,Notice,General Notice,2011-12-20T05:00:00Z,2011,12,2011-12-20T05:00:00Z,,2011-12-20T14:30:40Z,2011-32469,0,0,0900006480f86432 FDA-2011-F-0765-0001,FDA,FDA-2011-F-0765,Filings of Food Additive Petitions: Nexira,Notice,Notice of Filing,2011-12-20T05:00:00Z,2011,12,2011-12-20T05:00:00Z,,2011-12-20T15:06:51Z,2011-32542,0,0,0900006480f864a8 FDA-2011-N-0883-0001,FDA,FDA-2011-N-0883,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products",Notice,General Notice,2011-12-19T05:00:00Z,2011,12,2011-12-19T05:00:00Z,2012-02-18T04:59:59Z,2011-12-19T14:24:12Z,2011-32397,0,0,0900006480f858fa FDA-2011-D-0817-0001,FDA,FDA-2011-D-0817,"Draft Guidance for Industry and Food and Drug Administration Staff, Availability: Evaluation of Sex Differences in Medical Device Clinical Studies",Notice,Notice of Availability,2011-12-19T05:00:00Z,2011,12,2011-12-19T05:00:00Z,2012-03-20T03:59:59Z,2011-12-19T15:02:25Z,2011-32368,0,0,0900006480f859d0 FDA-2011-N-0230-0011,FDA,FDA-2011-N-0230,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Examination of Online Direct-to-Consumer Prescription Drug Promotion",Notice,General Notice,2011-12-19T05:00:00Z,2011,12,2011-12-19T05:00:00Z,2012-01-19T04:59:59Z,2012-03-24T19:36:35Z,2011-32275,0,0,0900006480f858fb FDA-2011-P-0578-0003,FDA,FDA-2011-P-0578,"Determinations: BRETYLIUM TOSYLATE Injection, 50 Milligrams/Milliliter Not Withdrawn From Sale for Reasons of Safety or Effectiveness",Notice,General Notice,2011-12-19T05:00:00Z,2011,12,2011-12-19T05:00:00Z,,2011-12-19T14:30:56Z,2011-32367,0,0,0900006480f859b0 FDA-2011-N-0002-0145,FDA,FDA-2011-N-0002,Anesthetic and Analgesic Drug Products Advisory Committee Meeting,Notice,Meeting,2011-12-16T05:00:00Z,2011,12,2011-12-16T05:00:00Z,,2011-12-16T18:16:47Z,2011-32206,0,0,0900006480f84680 FDA-2011-N-0002-0146,FDA,FDA-2011-N-0002,Pediatric Advisory Committee Meeting,Notice,Meeting,2011-12-16T05:00:00Z,2011,12,2011-12-16T05:00:00Z,,2011-12-16T18:22:13Z,2011-32205,0,0,0900006480f8475c FDA-2011-N-0867-0001,FDA,FDA-2011-N-0867,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Experimental Study on PublicDisplay of Lists of Harmful and Potentially Harmful Tobacco Constituents",Notice,General Notice,2011-12-14T05:00:00Z,2011,12,2011-12-14T05:00:00Z,2012-02-14T04:59:59Z,2011-12-14T14:27:48Z,2011-32026,0,0,0900006480f82439 FDA-2011-N-0535-0002,FDA,FDA-2011-N-0535,"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body",Notice,General Notice,2011-12-14T05:00:00Z,2011,12,,,2014-11-14T17:18:58Z,2011-32025,0,0,0900006480f823fd FDA-2011-N-0813-0001,FDA,FDA-2011-N-0813,Quantitative Summary of the Benefits and Risks of Prescription Drugs - A Literature Review; Availability,Notice,General Notice,2011-12-13T05:00:00Z,2011,12,2011-12-13T05:00:00Z,2012-02-14T04:59:59Z,2011-12-13T15:03:29Z,2011-31931,0,0,0900006480f8128e FDA-2011-D-0847-0001,FDA,FDA-2011-D-0847,Draft Guidance for Industry and Staff; Availability Humanitarian Use Device Designations,Notice,Notice of Availability,2011-12-13T05:00:00Z,2011,12,2011-12-13T05:00:00Z,,2011-12-13T14:32:48Z,2011-31867,0,0,0900006480f812ab FDA-2011-N-0457-0003,FDA,FDA-2011-N-0457,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Experimental Study of Comparative Direct-to-Consumer Advertising",Notice,General Notice,2011-12-09T05:00:00Z,2011,12,,,2011-12-09T15:51:40Z,2011-31609,0,0,0900006480f7ed8a FDA-2011-N-0769-0001,FDA,FDA-2011-N-0769,Notice of Listing of Members of the Food and Drug Administration’s Senior Executive Service Performance Review Board Members,Notice,General Notice,2011-12-09T05:00:00Z,2011,12,2011-12-09T05:00:00Z,,2011-12-09T15:56:13Z,2011-31579,0,0,0900006480f7edc4 FDA-2010-N-0381-0048,FDA,FDA-2010-N-0381,Generic Drug User Fee; Public Meeting,Notice,Meeting,2011-12-08T05:00:00Z,2011,12,2011-12-08T05:00:00Z,2012-01-07T04:59:59Z,2011-12-08T14:13:25Z,2011-31630,0,0,0900006480f7df83 FDA-2011-N-0326-0024,FDA,FDA-2011-N-0326,Recommendations for User Fee Programs: Biosimilar and Interchangeable Biological Product Applications for Fiscal Years 2013 Through 2017; Meeting,Notice,Public Meetings,2011-12-07T05:00:00Z,2011,12,2011-12-07T05:00:00Z,2012-01-07T04:59:59Z,2012-03-24T19:31:36Z,2011-31499,0,0,0900006480f7d578 FDA-2011-N-0608-0009,FDA,FDA-2011-N-0608,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: MedWatch; Medical Products Reporting Program",Notice,General Notice,2011-12-07T05:00:00Z,2011,12,2011-12-07T05:00:00Z,,2012-03-24T19:36:39Z,2011-31341,0,0,0900006480f7d55c FDA-2011-N-0858-0001,FDA,FDA-2011-N-0858,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Experimental Study on Comparing Data Obtained From Landline Telephone and Cell Phone Surveys",Notice,General Notice,2011-12-07T05:00:00Z,2011,12,2011-12-07T05:00:00Z,2012-02-07T04:59:59Z,2011-12-07T21:23:02Z,2011-31389,0,0,0900006480f7d579 FDA-2011-N-0824-0001,FDA,FDA-2011-N-0824,Regulatory Site Visit Training Program,Notice,General Notice,2011-12-06T05:00:00Z,2011,12,2011-12-06T05:00:00Z,2011-01-06T04:59:59Z,2011-12-13T16:56:03Z,2011-31152,0,0,0900006480f7c5aa FDA-2011-D-0464-0034,FDA,FDA-2011-D-0464,Draft Guidance for Industry and Staff; Availability: Content of Investigational Device Exemption and Premarket Approval Applications for Artificial Pancreas Device Systems,Notice,Notice of Availability,2011-12-06T05:00:00Z,2011,12,2011-12-06T05:00:00Z,,2011-12-06T14:16:35Z,2011-31214,0,0,0900006480f7c57a FDA-2010-P-0176-0086,FDA,FDA-2010-P-0176,"SEDASYS Computer-Assisted Personalized Sedation System: Ethicon Endo-Surgery, Inc. Petition for Review of Denial of Premarket Approval; Meeting Cancellation",Notice,General Notice,2011-12-05T05:00:00Z,2011,12,2011-12-05T05:00:00Z,,2011-12-05T14:42:36Z,2011-31105,0,0,0900006480f7b64c FDA-2011-N-0826-0001,FDA,FDA-2011-N-0826,Determinations That Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness: DEMULEN 1/50-28 (Ethinyl Estradiol; Ethynodiol Diacetate) Tablet and Four Other Drug Products,Notice,General Notice,2011-12-05T05:00:00Z,2011,12,2011-12-05T05:00:00Z,,2011-12-05T14:36:14Z,2011-31146,0,0,0900006480f7b5b9 FDA-2011-D-0800-0001,FDA,FDA-2011-D-0800,Draft Guidance for Industry; Availability: Regulatory Classification of Pharmaceutical Co-Crystals,Notice,Notice of Availability,2011-12-02T05:00:00Z,2011,12,2011-12-02T05:00:00Z,2012-03-02T04:59:59Z,2011-12-02T14:13:26Z,2011-31022,0,0,0900006480f7a304 FDA-2011-N-0005-0003,FDA,FDA-2011-N-0005,Memorandum of Understanding,Notice,General Notice,2011-12-01T05:00:00Z,2011,12,2011-12-01T05:00:00Z,,2011-12-02T13:26:22Z,2011-30911,0,0,0900006480f792d5 FDA-2011-N-0327-0002,FDA,FDA-2011-N-0327,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Generic Clearance for Collection of Qualitative Feedback on FDA Service Delivery",Notice,Notice of Approval,2011-12-01T05:00:00Z,2011,12,2011-12-01T05:00:00Z,,2012-03-24T19:30:21Z,2011-30877,0,0,0900006480f79309 FDA-2011-N-0400-0038,FDA,FDA-2011-N-0400,"Approaches to Reducing Sodium Consumption; Establishment of Dockets: Request for Comments, Data, and Information; Extension of Comment Period",Notice,Notice of Extension,2011-11-30T05:00:00Z,2011,11,2011-11-30T05:00:00Z,2012-01-28T04:59:59Z,2015-01-28T03:03:16Z,2011-30865,0,0,0900006480f76cbd FDA-1986-P-0011-0002,FDA,FDA-1986-P-0011,Petitions Requesting Exclusivety for Certain Chlorhexidine Gluconate Products,Notice,Notice of Filing,2011-11-30T05:00:00Z,2011,11,2011-11-30T05:00:00Z,,2011-11-30T17:28:21Z,,0,0,090000648050d94c FDA-2009-N-0264-0002,FDA,FDA-2009-N-0264,Authorization of Emergency Use; Availability: Doxycycline Hyclate Tablet Emergency Kits for Eligible United States Postal Service Participants and Their Household Members,Notice,General Notice,2011-11-28T05:00:00Z,2011,11,2011-11-28T05:00:00Z,,2012-03-24T19:36:39Z,2011-30450,0,0,0900006480f744ac FDA-2011-N-0828-0001,FDA,FDA-2011-N-0828,"Withdrawals of Approval of New Drug Applications: MYLOTARG, Wyeth Pharmaceuticals, Inc.",Notice,Withdrawal,2011-11-28T05:00:00Z,2011,11,2011-11-28T05:00:00Z,,2011-11-28T15:27:07Z,2011-30473,0,0,0900006480f74426 FDA-2009-D-0386-0009,FDA,FDA-2009-D-0386,"Guidance for Industry and Staff; Availability: Establishing Performance Characteristics of In Vitro Diagnostic Devices for the Detection, etc., of Human Papillomaviruses",Notice,Notice of Availability,2011-11-28T05:00:00Z,2011,11,2011-11-28T05:00:00Z,,2015-07-29T16:44:35Z,2011-30552,0,0,0900006480f743be FDA-2011-N-0002-0143,FDA,FDA-2011-N-0002,"Nominations for Voting Members on Public Advisory Committee, Science Board",Notice,General Notice,2011-11-28T05:00:00Z,2011,11,2011-11-28T05:00:00Z,,2011-11-28T14:19:43Z,2011-30415,0,0,0900006480f743ed FDA-2011-D-0799-0001,FDA,FDA-2011-D-0799,"Draft Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples From Donors of Whole Blood and Blood Components, Including Source Plasma, to Reduce the Risk of Transmission of Hepatitis B Virus",Notice,Notice of Availability,2011-11-28T05:00:00Z,2011,11,2011-11-28T05:00:00Z,2012-01-28T04:59:59Z,2015-04-03T22:40:47Z,2011-30449,0,0,0900006480f74467 FDA-2011-N-0002-0144,FDA,FDA-2011-N-0002,Science Board to the Food and Drug Administration Meeting,Notice,Meeting,2011-11-28T05:00:00Z,2011,11,2011-11-28T05:00:00Z,,2011-11-28T14:25:12Z,2011-30416,0,0,0900006480f743bc FDA-2005-D-0086-0005,FDA,FDA-2005-D-0086,Guidance for Industry; Availability: Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals,Notice,Notice of Availability,2011-11-28T05:00:00Z,2011,11,2011-11-28T05:00:00Z,,2011-11-28T15:40:22Z,2011-30474,0,0,0900006480f743db FDA-2011-P-0488-0003,FDA,FDA-2011-P-0488,"Determination That Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness: TAXOTERE (Docetaxel) Injection, 40 Milligrams/Milliliter",Notice,General Notice,2011-11-28T05:00:00Z,2011,11,2011-11-28T05:00:00Z,,2011-11-28T14:59:00Z,2011-30472,0,0,0900006480f74452 FDA-2011-N-0231-0004,FDA,FDA-2011-N-0231,"Agency Information Collection Activities; Proposals, Submissions, and Approvals",Notice,Notice of Approval,2011-11-25T05:00:00Z,2011,11,2011-11-25T05:00:00Z,,2011-11-25T14:16:51Z,2011-30326,0,0,0900006480f73634 FDA-2011-N-0841-0001,FDA,FDA-2011-N-0841,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Food Safety Modernization Act; Economic Hardship Fee Reduction Guidance",Notice,General Notice,2011-11-25T05:00:00Z,2011,11,2011-11-25T05:00:00Z,2011-12-16T04:59:59Z,2011-11-25T14:12:21Z,2011-30471,0,0,0900006480f735ce FDA-2010-D-0350-0009,FDA,FDA-2010-D-0350,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Draft Guidance for Tobacco Retailers on Tobacco Retailer Training Programs",Notice,General Notice,2011-11-25T05:00:00Z,2011,11,2011-11-25T05:00:00Z,2012-01-25T04:59:59Z,2011-11-25T14:14:30Z,2011-30327,0,0,0900006480f73613 FDA-2011-N-0002-0142,FDA,FDA-2011-N-0002,Tobacco Products Scientific Advisory Committee; Notice of Meeting,Notice,Meeting,2011-11-23T05:00:00Z,2011,11,2011-11-23T05:00:00Z,,2011-11-23T14:55:39Z,2011-30163,0,0,0900006480f7209e FDA-2011-D-0784-0001,FDA,FDA-2011-D-0784,Draft Guidance for Industry on Evaluating Effectiveness of Anticoccidial Drugs in Food-Producing Animals; Availability,Notice,Notice of Availability,2011-11-23T05:00:00Z,2011,11,2011-11-23T05:00:00Z,2012-01-24T04:59:59Z,2011-11-23T14:58:01Z,2011-30149,0,0,0900006480f720d9 FDA-2011-N-0780-0001,FDA,FDA-2011-N-0780,"Bridging Idea Development Evaluation Assessment and Long-Term Initiative and Total Product Life Cycle, etc.; Correction",Notice,Correction,2011-11-23T05:00:00Z,2011,11,2011-11-23T05:00:00Z,,2011-11-23T15:03:50Z,2011-30145,0,0,0900006480f72512 FDA-2011-N-0439-0003,FDA,FDA-2011-N-0439,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Recall Regulations",Notice,General Notice,2011-11-23T05:00:00Z,2011,11,2011-11-23T05:00:00Z,2011-12-24T04:59:59Z,2011-11-23T14:52:38Z,2011-30146,0,0,0900006480f7209a FDA-2010-P-0176-0084,FDA,FDA-2010-P-0176,"SEDASYS Computer-Assisted Personalized Sedation System; Ethicon Endo-Surgery, Inc.'s Petition for Review of FDA's Denial of Premarket Approval - Notice of Meeting",Notice,Meeting,2011-11-21T05:00:00Z,2011,11,2011-11-21T05:00:00Z,2011-12-08T04:59:59Z,2011-11-28T15:18:41Z,2011-29888,0,0,0900006480f70910 FDA-2011-N-0557-0002,FDA,FDA-2011-N-0557,Advancing Regulatory Science for Highly Multiplexed Microbiology/Medical Countermeasure Devices; Public Meeting; Reopening of Comment Period,Notice,Extension of Comment Period,2011-11-21T05:00:00Z,2011,11,2011-11-21T05:00:00Z,2011-12-22T04:59:59Z,2012-01-26T22:58:19Z,2011-29937,0,0,0900006480f70972 FDA-2011-N-0002-0141,FDA,FDA-2011-N-0002,Gastroenterology and Urology Devices Panel of Medical Devices Advisory Committee Meeting,Notice,Meeting,2011-11-21T05:00:00Z,2011,11,2011-11-21T05:00:00Z,,2011-11-21T14:52:52Z,2011-29890,0,0,0900006480f70957 FDA-2011-N-0492-0002,FDA,FDA-2011-N-0492,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Class II Special Controls Guidance Document; Labeling for Natural Rubber Latex Condoms",Notice,30 Day Proposed Information Collection,2011-11-18T05:00:00Z,2011,11,2011-11-18T05:00:00Z,2011-12-20T04:59:59Z,2015-06-02T14:56:04Z,2011-29839,0,0,0900006480f6f613 FDA-2011-N-0410-0008,FDA,FDA-2011-N-0410,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Premarket Notification for a New Dietary Ingredient",Notice,Notice of Approval,2011-11-18T05:00:00Z,2011,11,2011-11-18T05:00:00Z,,2011-11-18T14:26:19Z,2011-29837,0,0,0900006480f6f554 FDA-2011-N-0099-0004,FDA,FDA-2011-N-0099,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Followup Study for Infant Feeding Practices Study II",Notice,Notice of Approval,2011-11-18T05:00:00Z,2011,11,2011-11-18T05:00:00Z,,2011-11-18T14:37:19Z,2011-29836,0,0,0900006480f6f604 FDA-2011-D-0074-0024,FDA,FDA-2011-D-0074,Guidance for Industry on Medication Guide Distribution Requirements and Inclusion of Medication Guides in Risk Evaluation and Mitigation Strategies; Availability,Notice,Notice of Data Availability,2011-11-18T05:00:00Z,2011,11,2011-11-18T05:00:00Z,,2019-10-21T13:22:31Z,2011-29877,0,0,0900006480f6f567 FDA-2011-N-0802-0001,FDA,FDA-2011-N-0802,Role of Naloxone in OpioidOverdose Fatality Prevention; Workshop; Request for Comments,Notice,Meeting,2011-11-17T05:00:00Z,2011,11,2011-11-17T05:00:00Z,2012-06-13T03:59:59Z,2012-06-14T02:02:30Z,2011-29703,0,0,0900006480f6e632 FDA-2011-N-0805-0001,FDA,FDA-2011-N-0805,Dermatologic and Ophthalmic Drugs Advisory Committee; Noyice of Meeting,Notice,Meeting,2011-11-17T05:00:00Z,2011,11,2011-11-17T05:00:00Z,2012-03-06T04:59:59Z,2012-02-23T19:46:45Z,2011-29682,0,0,0900006480f6e6ba FDA-2011-N-0599-0002,FDA,FDA-2011-N-0599,"Report of Scientific and Medical Literature and Information on Non-Standardized Allergenic Extracts, etc.: Center for Biologics Evaluation and Research; Extension of Comment Period",Notice,Notice of Extension,2011-11-16T05:00:00Z,2011,11,2011-11-16T05:00:00Z,2012-04-26T03:59:59Z,2015-03-04T03:16:11Z,2011-29483,0,0,0900006480f6d690 FDA-2011-N-0402-0003,FDA,FDA-2011-N-0402,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: State Petitions for Exemption for Preemption",Notice,Notice of Approval,2011-11-16T05:00:00Z,2011,11,2011-11-16T05:00:00Z,,2011-11-16T22:02:22Z,2011-29511,0,0,0900006480f6d62e FDA-2011-N-0793-0001,FDA,FDA-2011-N-0793,Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Recall Authority,Notice,60 Day Proposed Information Collection,2011-11-16T05:00:00Z,2011,11,2011-11-16T05:00:00Z,2012-01-18T04:59:59Z,2015-03-04T12:38:03Z,2011-29512,0,0,0900006480f6d712 FDA-2011-D-0720-0003,FDA,FDA-2011-D-0720,"International Conference on Harmonisation: Electronic Transmission of Individual Case Safety Reports, etc., Correction",Notice,General Notice,2011-11-16T05:00:00Z,2011,11,2011-11-16T05:00:00Z,,2011-11-16T22:41:14Z,2011-29485,0,0,0900006480f6d72d FDA-2011-N-0425-0003,FDA,FDA-2011-N-0425,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Infant Formula Recall Regulations",Notice,Notice of Approval,2011-11-16T05:00:00Z,2011,11,2011-11-16T05:00:00Z,,2011-11-16T22:24:47Z,2011-29479,0,0,0900006480f6d6cf FDA-2011-N-0002-0140,FDA,FDA-2011-N-0002,Meetings: Neurological Devices Panel of the Medical Devices Advisory Committee,Notice,Meeting,2011-11-16T05:00:00Z,2011,11,2011-11-16T05:00:00Z,,2011-11-16T22:17:24Z,2011-29528,0,0,0900006480f6d6f4 FDA-2011-N-0377-0001,FDA,FDA-2011-N-0377,Scott S. Reuben: Debarment Order,Notice,Notice of Final Rule,2011-11-16T05:00:00Z,2011,11,2011-11-16T05:00:00Z,,2024-11-07T22:42:40Z,2011-29538,1,0,0900006480f6d781 FDA-2011-N-0555-0002,FDA,FDA-2011-N-0555,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Extralabel Drug Use in Animals",Notice,General Notice,2011-11-16T05:00:00Z,2011,11,2011-11-16T05:00:00Z,,2012-03-24T19:34:43Z,2011-29477,0,0,0900006480f6d747 FDA-2011-N-0781-0001,FDA,FDA-2011-N-0781,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Record Retention Requirements for Soy Protein and Risk of Coronary Heart Disease Health Claim",Notice,60 Day Proposed Information Collection,2011-11-16T05:00:00Z,2011,11,2011-11-16T05:00:00Z,2012-01-18T04:59:59Z,2015-03-04T03:09:21Z,2011-29478,0,0,0900006480f6d636 FDA-2011-P-0416-0003,FDA,FDA-2011-P-0416,"Determinations that Product was Not Withdrawn from Sale for Reasons of Safety or Effectiveness: TRAVATAN (Travoprost Ophthalmic Solution), 0.004 percent",Notice,General Notice,2011-11-16T05:00:00Z,2011,11,2011-11-16T05:00:00Z,,2011-11-16T22:11:54Z,2011-29484,0,0,0900006480f6d68f