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

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837 rows where agency_id = "FDA", document_type = "Notice" and posted_year = 2011 sorted by posted_date descending

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posted_year 1

  • 2011 · 837 ✖

document_type 1

  • Notice · 837 ✖

agency_id 1

  • FDA · 837 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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FDA-2011-D-0868-0001 FDA FDA-2011-D-0868 Draft Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices; Availability Notice Notice of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 Penicillin in Animal Feeds - CLOSED 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 Penicillin-Containing Premixes 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 Tetracycline (Chlortetracycline & Oxytetracycline) Premixed 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 Tetracycline-Proposal to Revise Regulations 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 EXIDINE AEROSOL & EXIDINE SOLUTION 3 YRS EXCLUSIVITY 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 Draft Guidance for Industry on Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals; Availability 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

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CREATE TABLE documents (
    id TEXT PRIMARY KEY,
    agency_id TEXT,
    docket_id TEXT REFERENCES dockets(id),
    title TEXT,
    document_type TEXT,
    subtype TEXT,
    posted_date TEXT,
    posted_year INTEGER,
    posted_month INTEGER,
    comment_start_date TEXT,
    comment_end_date TEXT,
    last_modified TEXT,
    fr_doc_num TEXT,
    open_for_comment INTEGER,
    withdrawn INTEGER,
    object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);