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

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735 rows where agency_id = "FDA", document_type = "Notice" and posted_year = 2009 sorted by posted_date descending

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posted_year 1

  • 2009 · 735 ✖

document_type 1

  • Notice · 735 ✖

agency_id 1

  • FDA · 735 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-N-0546-0009 FDA FDA-2008-N-0546 Agency Information Collection Activities; Proposed Collection; Comment Request; Pet Food Early Warning Recall Rational Questionnaire as Part of the MedWatchPlus Notice N-Notice 2009-12-30T05:00:00Z 2009 12 2009-12-30T05:00:00Z 2010-01-30T04:59:59Z 2009-12-30T17:57:40Z E9-30872 0 0 0900006480a741c2
FDA-2009-N-0664-0131 FDA FDA-2009-N-0664 Medical Device Interoperability; Public Workshop Notice NM-Notice of Meeting 2009-12-30T05:00:00Z 2009 12 2009-12-30T05:00:00Z   2009-12-30T17:44:57Z E9-30871 0 0 0900006480a740cd
FDA-2009-N-0664-0130 FDA FDA-2009-N-0664 Advisory Committees; Tentative Schedule of Meetings for 2010 Notice N-Notice 2009-12-30T05:00:00Z 2009 12 2009-12-30T05:00:00Z   2009-12-30T17:39:27Z E9-30973 0 0 0900006480a74087
FDA-2009-N-0664-0132 FDA FDA-2009-N-0664 Second Annual Sentinel Initiative Public Workshop Notice NM-Notice of Meeting 2009-12-30T05:00:00Z 2009 12 2009-12-30T05:00:00Z   2009-12-30T17:49:10Z E9-30971 0 0 0900006480a740d2
FDA-2009-D-0591-0001 FDA FDA-2009-D-0591 Guidance to Pharmacies on Advance Compounding of Tamiflu Oral Suspension to Provide for Multiple Prescriptions;Availability Notice NAD-Notice of Availability of Data 2009-12-29T05:00:00Z 2009 12 2009-12-29T05:00:00Z   2009-12-29T14:32:34Z E9-30750 0 0 0900006480a7313d
FDA-2009-D-0600-0001 FDA FDA-2009-D-0600 Draft Guidance for Industry on Tobacco Health Document Submission; Availability Notice Notice of Availability 2009-12-28T05:00:00Z 2009 12 2009-12-28T05:00:00Z 2010-01-23T04:59:59Z 2016-09-09T14:32:45Z E9-30657 0 0 0900006480a72053
FDA-2009-N-0664-0129 FDA FDA-2009-N-0664 Gastrointestinal Drugs Advisory Committee Notice of Meeting Notice NM-Notice of Meeting 2009-12-23T05:00:00Z 2009 12 2009-12-23T05:00:00Z   2009-12-23T19:25:45Z E9-30442 0 0 0900006480a704a2
FDA-2008-D-0399-0006 FDA FDA-2008-D-0399 International Conference on Harmonisation: Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions Annex 5: Disintegration Test General Chapter Notice NAD-Notice of Availability of Data 2009-12-23T05:00:00Z 2009 12 2009-12-23T05:00:00Z   2009-12-23T19:06:42Z E9-30441 0 0 0900006480a70631
FDA-2009-D-0013-0004 FDA FDA-2009-D-0013 International Conference on Harmonisation: Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions Notice NAD-Notice of Availability of Data 2009-12-22T05:00:00Z 2009 12 2009-12-22T05:00:00Z   2009-12-22T16:28:44Z E9-30326 0 0 0900006480a6f728
FDA-2009-D-0588-0001 FDA FDA-2009-D-0588 Guidance for Industry on the Timeframe for Submission of Tobacco Health Documents; Availability Notice NAD-Notice of Availability of Data 2009-12-21T05:00:00Z 2009 12 2009-12-21T05:00:00Z   2009-12-22T15:59:22Z E9-30297 0 0 0900006480a6ef9e
FDA-2003-M-0501-0001 FDA Express & Express2 Monorail & Over-the-Wire Coronary Stent FDA-2003-M-0501 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice N-Notice 2009-12-18T05:00:00Z 2009 12 2009-12-18T05:00:00Z   2025-04-16T19:38:47Z 03-27119 0 0 09000064804a2b25
FDA-2009-N-0575-0001 FDA FDA-2009-N-0575 Meetings: Incorporation of New Science Into Regulatory Decisionmaking Within the Center for Devices and Radiological Health Notice NM-Notice of Meeting 2009-12-18T05:00:00Z 2009 12 2009-12-18T05:00:00Z 2010-02-25T04:59:59Z 2009-12-18T15:14:35Z E9-30114 0 0 0900006480a6de81
FDA-2009-D-0574-0001 FDA FDA-2009-D-0574 International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions Notice NAD-Notice of Availability of Data 2009-12-17T05:00:00Z 2009 12 2009-12-17T05:00:00Z 2010-02-17T04:59:59Z 2009-12-17T20:33:56Z E9-29988 0 0 0900006480a6ca37
FDA-2009-F-0570-0001 FDA FDA-2009-F-0570 Lallemand, Inc.; Filing of Food Additive Petition Notice NFL-Notice of Filing 2009-12-17T05:00:00Z 2009 12 2009-12-17T05:00:00Z   2009-12-17T19:55:48Z E9-29961 0 0 0900006480a6c9d7
FDA-2009-N-0664-0127 FDA FDA-2009-N-0664 Oncologic Drugs Advisory Committee; Notice of Meeting Notice NM-Notice of Meeting 2009-12-17T05:00:00Z 2009 12 2009-12-17T05:00:00Z   2009-12-17T19:59:52Z E9-29989 0 0 0900006480a6ca01
FDA-2009-D-0573-0001 FDA FDA-2009-D-0573 International Conference on Harmonisation; Draft Guidance on Addendum to International Conference on Harmonisation S6 Notice NAD-Notice of Availability of Data 2009-12-17T05:00:00Z 2009 12 2009-12-17T05:00:00Z 2010-02-02T04:59:59Z 2009-12-17T20:30:17Z E9-29991 0 0 0900006480a6ca36
FDA-2009-N-0665-0074 FDA FDA-2009-N-0665 New Animal Drugs for Use in Animal Feeds; Ractopamine; Tylosin Notice Notice of Final Rule 2009-12-17T05:00:00Z 2009 12 2009-12-17T05:00:00Z   2013-07-09T16:15:47Z E9-29998 0 0 0900006480a6ca39
FDA-2009-N-0664-0128 FDA FDA-2009-N-0664 Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance and Good Clinical Practices; Public Workshop Notice NM-Notice of Meeting 2009-12-17T05:00:00Z 2009 12 2009-12-17T05:00:00Z   2009-12-17T20:10:36Z E9-30017 0 0 0900006480a6ca05
FDA-2009-D-0579-0001 FDA FDA-2009-D-0579 International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Notice NAD-Notice of Availability of Data 2009-12-17T05:00:00Z 2009 12 2009-12-17T05:00:00Z 2010-02-17T04:59:59Z 2009-12-17T19:32:00Z E9-29990 0 0 0900006480a6c715
FDA-2009-N-0665-0071 FDA FDA-2009-N-0665 New Animal Drugs; Change of Sponsor; Ketamine - Final Rule Notice Notice of Final Rule 2009-12-16T05:00:00Z 2009 12 2009-12-16T05:00:00Z   2014-07-11T16:32:48Z E9-29888 0 0 0900006480a6bb3c
FDA-2009-N-0665-0072 FDA FDA-2009-N-0665 Implantation or Injectable Dosage Form New Animal Drugs; Florfenicol Notice Notice of Final Rule 2009-12-16T05:00:00Z 2009 12 2009-12-16T05:00:00Z   2013-07-09T16:24:11Z E9-29875 0 0 0900006480a6bb82
FDA-1981-D-0064-0001 FDA DEFECT ACTION LEVELS FOR HISTAMINE IN TUNA FDA-1981-D-0064 DEFECT ACTION LEVELS FOR HISTAMINE IN TUNA; AVAILABILITY OF GUIDE Notice Notice of Data Availability 2009-12-14T05:00:00Z 2009 12 2009-12-14T05:00:00Z   2026-01-30T22:34:45Z   0 0 09000064805af3df
FDA-2009-N-0293-0001 FDA FDA-2009-N-0293 Peter Xuong Lam: Debarment Order Notice N-Notice 2009-12-14T05:00:00Z 2009 12     2009-12-14T16:56:58Z E9-29715 0 0 0900006480a6a1b2
FDA-1995-D-0298-0001 FDA Decomposition & Histamine-Raw,Frozen Tuna & Mahi-Mahi; Avail FDA-1995-D-0298 Notice of Availability of Data - NAD Notice NAD-Notice of Availability of Data 2009-12-14T05:00:00Z 2009 12 2009-12-14T05:00:00Z 1995-09-06T03:59:59Z 2009-12-14T17:42:41Z   0 0 09000064805998f0
FDA-2009-N-0665-0067 FDA FDA-2009-N-0665 New Animal Drugs; Change of Sponsor; Azaperone Notice Notice of Final Rule 2009-12-11T05:00:00Z 2009 12 2009-12-11T05:00:00Z   2013-07-09T18:17:50Z E9-29494 0 0 0900006480a692a1
FDA-2008-N-0424-0004 FDA FDA-2008-N-0424 Postmarketing Safety Reporting for Combination Products; Extension of Comment Period Notice NPR-Notice of Proposed Rule-Making 2009-12-11T05:00:00Z 2009 12 2009-12-11T05:00:00Z 2010-01-30T04:59:59Z 2011-06-11T16:27:47Z E9-29493 0 0 0900006480a692a4
FDA-1998-D-0025-0036 FDA Section 121 Positron Emission Tomography (PET) FDAMA FDA-1998-D-0025 Guidance on Current Good Manufacturing Practice for Positron Emission Tomography Drugs; Availability Notice NAD-Notice of Availability of Data 2009-12-10T05:00:00Z 2009 12 2009-12-10T05:00:00Z   2024-11-12T04:49:38Z E9-29286 1 0 0900006480a6845a
FDA-2004-N-0449-0003 FDA Current Good Manufacturing Practice for Positron Emission Tomography Drugs FDA-2004-N-0449 Current Good Manufacturing Practice for Positron Emission Tomography Drugs; Final Rule Notice Notice of Final Rule 2009-12-10T05:00:00Z 2009 12 2009-12-10T05:00:00Z   2015-12-10T15:21:51Z E9-29285 0 0 0900006480a6840e
FDA-2009-N-0561-0001 FDA FDA-2009-N-0561 Electronic Margin of Safety and NonClinical Toxicology Study Data Submission; Notice of Pilot Project Notice N-Notice 2009-12-10T05:00:00Z 2009 12 2009-12-10T05:00:00Z 2010-03-11T04:59:59Z 2009-12-10T15:35:48Z E9-29419 0 0 0900006480a684bb
FDA-2006-D-0362-0005 FDA Guidance for Industry on Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims FDA-2006-D-0362 Guidance for Industry on Patient-Reported Outcome Measures: Use in Medical Product Development To Support Labeling Claims; Availability Notice NAD-Notice of Availability of Data 2009-12-09T05:00:00Z 2009 12 2009-12-09T05:00:00Z   2009-12-09T17:15:22Z E9-29273 0 0 0900006480a66be8
FDA-2009-N-0569-0001 FDA FDA-2009-N-0569 Approved Tobacco Retailer Training Program; Request for Comments Notice N-Notice 2009-12-09T05:00:00Z 2009 12 2009-12-09T05:00:00Z 2010-01-09T04:59:59Z 2010-01-20T17:06:47Z E9-29288 0 0 0900006480a66b8a
FDA-2009-N-0664-0126 FDA FDA-2009-N-0664 Meetings: Anesthetic and Life Support Drugs Advisory Committee Notice NM-Notice of Meeting 2009-12-08T05:00:00Z 2009 12 2009-12-08T05:00:00Z   2009-12-08T15:43:55Z E9-29211 0 0 0900006480a66771
FDA-2009-N-0664-0125 FDA FDA-2009-N-0664 Meetings: Oncologic Drugs Advisory Committee Notice N-Notice 2009-12-08T05:00:00Z 2009 12 2009-12-08T05:00:00Z   2009-12-08T15:45:20Z E9-29208 0 0 0900006480a66745
FDA-2009-F-0525-0001 FDA FDA-2009-F-0525 Filing of Food Additive Petition (Animal Use) Kemira Oyj; Formic Acid Notice NFL-Notice of Filing 2009-12-07T05:00:00Z 2009 12 2009-12-07T05:00:00Z 2010-01-07T04:59:59Z 2009-12-07T16:23:09Z E9-29049 0 0 0900006480a64b02
FDA-2009-D-0539-0001 FDA FDA-2009-D-0539 Draft Guidance for Industry on Assay Development for Immunogenicity Testing of Therapeutic Proteins; Availability Notice Notice of Availability 2009-12-04T05:00:00Z 2009 12 2009-12-04T05:00:00Z 2010-02-03T04:59:59Z 2016-04-11T14:24:08Z E9-28960 0 0 0900006480a62b67
FDA-2009-D-0542-0001 FDA FDA-2009-D-0542 Draft Guidance for Industry: Factors That Distinguish Liquid Dietary Supplements From Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods; Availability Notice NAD-Notice of Availability of Data 2009-12-04T05:00:00Z 2009 12 2009-12-04T05:00:00Z 2010-02-03T04:59:59Z 2009-12-04T16:37:20Z E9-28926 0 0 0900006480a62af4
FDA-2008-P-0560-0004 FDA FDA-2008-P-0560 Determination That MESANTOIN (Mephenytoin) Tablets, 100 Milligrams, was not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice N-Notice 2009-12-03T05:00:00Z 2009 12 2009-12-03T05:00:00Z   2009-12-03T16:23:23Z E9-28872 0 0 0900006480a62024
FDA-2008-P-0330-0004 FDA FDA-2008-P-0330 Determination That ABILIFY DISCMELT (Aripiprazole) Orally Disintegrating Tablets, 20 Milligrams and 30 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice N-Notice 2009-12-03T05:00:00Z 2009 12 2009-12-03T05:00:00Z   2009-12-03T16:28:45Z E9-28871 0 0 0900006480a6203c
FDA-2009-N-0554-0001 FDA FDA-2009-N-0554 Agency Information Collection Activities; Proposed Collection; Comment Request; Manufactured Food Regulatory Program Standards Notice N-Notice 2009-12-02T05:00:00Z 2009 12 2009-12-02T05:00:00Z 2010-02-02T04:59:59Z 2009-12-02T20:33:26Z E9-28834 0 0 0900006480a61db7
FDA-1982-P-0018-0393 FDA Reclassify Electroconvulsive Therapy (ECT) Section 513(E)-CLOSED FDA-1982-P-0018 Reclassify of Electroconvulsive Therapy Device Notice Notice of Intent 2009-12-02T05:00:00Z 2009 12 2009-12-02T05:00:00Z 1983-06-07T03:59:59Z 2024-12-17T14:01:40Z 83-8595 0 0 0900006480a61b8f
FDA-1982-P-0018-0400 FDA Reclassify Electroconvulsive Therapy (ECT) Section 513(E)-CLOSED FDA-1982-P-0018 Withdrawal of Certain Proposed Rules and Other Proposed Actions Notice Withdrawal 2009-12-02T05:00:00Z 2009 12 2009-12-02T05:00:00Z   2025-01-07T16:11:00Z 04-26234 0 0 0900006480a61cb3
FDA-1982-P-0018-0399 FDA Reclassify Electroconvulsive Therapy (ECT) Section 513(E)-CLOSED FDA-1982-P-0018 Withdrawal of Certain Proposed Rules and Other Proposed Actions; Notice of Intent Notice Notice of Intent 2009-12-02T05:00:00Z 2009 12 2009-12-02T05:00:00Z 2003-07-22T03:59:59Z 2025-01-07T15:49:26Z 03-9865 0 0 0900006480a61caf
FDA-2009-D-0466-0001 FDA FDA-2009-D-0466 Draft Compliance Policy Guide Sec. 527.300 Dairy Products-Microbial Contaminants and Alkaline Phosphatase Activity (Compliance Policy Guide 7106.08); Availability Notice NAD-Notice of Availability of Data 2009-12-01T05:00:00Z 2009 12 2009-12-01T05:00:00Z 2010-02-02T04:59:59Z 2009-12-01T17:53:51Z E9-28756 0 0 0900006480a60f4f
FDA-2009-D-0524-0024 FDA FDA-2009-D-0524 Guidance for Industry on Listing of Ingredients in Tobacco Products; Availability Notice Notice of Availability 2009-12-01T05:00:00Z 2009 12 2009-12-01T05:00:00Z   2016-10-06T15:58:32Z E9-28747 0 0 0900006480a60dfe
FDA-2007-D-0369-0033 FDA FDA-2007-D-0369 Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability Notice NAD-Notice of Availability of Data 2009-12-01T05:00:00Z 2009 12 2009-12-01T05:00:00Z 2010-02-02T04:59:59Z 2024-11-12T04:48:26Z E9-28593 1 0 0900006480a60ef1
FDA-2009-N-0220-0009 FDA FDA-2009-N-0220 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Studies of Nutrition Symbols on Food Packages Notice N-Notice 2009-12-01T05:00:00Z 2009 12     2009-12-01T17:36:23Z E9-28699 0 0 0900006480a60eea
FDA-2009-N-0664-0124 FDA FDA-2009-N-0664 Meetings: Pediatric Advisory Committee; Correction Notice NCR-Notice of Correction 2009-11-30T05:00:00Z 2009 11 2009-11-30T05:00:00Z   2009-11-30T15:10:02Z E9-28448 0 0 0900006480a6026c
FDA-2009-D-0563-0001 FDA FDA-2009-D-0563 Draft Guidance for Industry and Food and Drug Administration Staff; Preliminary Timetable for the Review of Applications for Modified Risk Tobacco Products Under the Federal Food, Drug, and Cosmetic Act; Availability Notice NAD-Notice of Availability of Data 2009-11-27T05:00:00Z 2009 11 2009-11-27T05:00:00Z 2010-02-26T04:59:59Z 2009-11-27T16:13:56Z E9-28515 0 0 0900006480a5f56b
FDA-2009-N-0664-0123 FDA FDA-2009-N-0664 Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting Notice NM-Notice of Meeting 2009-11-27T05:00:00Z 2009 11 2009-11-27T05:00:00Z   2009-11-27T15:43:51Z E9-28302 0 0 0900006480a5f50d
FDA-2008-D-0413-0015 FDA FDA-2008-D-0413 Guidance for Industry on Residual Solvents in Drug Products Marketed in the United States; Availability Notice Notice of Availability 2009-11-25T05:00:00Z 2009 11 2009-11-25T05:00:00Z   2020-05-11T22:59:33Z E9-28247 0 0 0900006480a5e954
FDA-2009-N-0288-0001 FDA FDA-2009-N-0288 Anthony W. Albanese: Debarment Order Notice N-Notice 2009-11-23T05:00:00Z 2009 11     2009-11-23T15:40:25Z E9-28084 0 0 0900006480a5c872
FDA-2009-N-0281-0001 FDA FDA-2009-N-0281 Niaja Kane: Debarment Order Notice N-Notice 2009-11-23T05:00:00Z 2009 11     2009-11-23T15:45:57Z E9-28083 0 0 0900006480a5c8d3
FDA-2009-N-0556-0001 FDA FDA-2009-N-0556 Agency Information Collection Activities; Proposed Collection; Comment Request; Records and Reports Concerning Experience WithApproved New Animal Drugs Notice N-Notice 2009-11-20T05:00:00Z 2009 11 2009-11-20T05:00:00Z 2009-12-22T04:59:59Z 2009-11-20T15:19:13Z E9-27956 0 0 0900006480a5b482
FDA-2008-D-0614-0004 FDA FDA-2008-D-0614 Guidance for Industry on Changes to Approved New Animal Drug Applications-New Animal Drug Applications Versus Category II SupplementalNew Animal Drug Applications; Availability Notice NAD-Notice of Availability of Data 2009-11-20T05:00:00Z 2009 11 2009-11-20T05:00:00Z   2024-11-07T22:11:17Z E9-27926 1 0 0900006480a5b4d9
FDA-2009-N-0665-0059 FDA FDA-2009-N-0665 Oral Dosage Form New Animal Drugs; Sulfadimethoxine - Final Rule Notice Notice of Final Rule 2009-11-20T05:00:00Z 2009 11     2014-01-08T12:43:29Z E9-27885 0 0 0900006480a5b477
FDA-2009-D-0533-0001 FDA FDA-2009-D-0533 Draft Guidance for Industry: Recommendations for the Assessment of Blood Donor Suitability, Blood Product Safety, and Preservation of the Blood Supply in Response to Pandemic (H1N1) 2009 Virus; Availability Notice NAD-Notice of Availability of Data 2009-11-19T05:00:00Z 2009 11 2009-11-19T05:00:00Z 2009-12-04T04:59:59Z 2009-11-19T15:09:58Z E9-27729 0 0 0900006480a5ab15
FDA-2009-N-0664-0121 FDA FDA-2009-N-0664 Vaccines and Related Biological Products Advisory Committee; Notice of Meeting Notice NM-Notice of Meeting 2009-11-19T05:00:00Z 2009 11 2009-11-19T05:00:00Z   2009-11-19T15:00:23Z E9-27728 0 0 0900006480a5aac9
FDA-2009-N-0664-0122 FDA FDA-2009-N-0664 Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting Notice NM-Notice of Meeting 2009-11-19T05:00:00Z 2009 11 2009-11-19T05:00:00Z   2009-11-19T15:04:24Z E9-27741 0 0 0900006480a5ab09
FDA-2009-N-0665-0057 FDA FDA-2009-N-0665 New Animal Drugs for Use in Animal Feeds; Melengestrol; Monensin Notice Notice of Final Rule 2009-11-19T05:00:00Z 2009 11 2009-11-19T05:00:00Z   2013-07-09T18:15:25Z E9-27744 0 0 0900006480a5ab33
FDA-2009-N-0143-1063 FDA FDA-2009-N-0143 Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting Notice NM-Notice of Meeting 2009-11-18T05:00:00Z 2009 11 2009-11-18T05:00:00Z 2009-11-28T04:59:59Z 2009-11-18T17:39:41Z E9-27718 0 0 0900006480a58ff2
FDA-2009-N-0251-0003 FDA FDA-2009-N-0251 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; User Fee Cover Sheet; Form FDA 3397 Notice N-Notice 2009-11-18T05:00:00Z 2009 11 2009-11-18T05:00:00Z   2009-11-18T17:12:14Z E9-27719 0 0 0900006480a59071
FDA-2009-N-0393-0007 FDA FDA-2009-N-0393 Acrylamide in Food; Request for Comments and for Scientific Data and Information; Extension of Comment Period Notice NEC-Notice of Extension 2009-11-18T05:00:00Z 2009 11 2009-11-18T05:00:00Z 2010-01-26T04:59:59Z 2009-11-18T19:44:04Z E9-27692 0 0 0900006480a58fc6
FDA-2009-N-0545-0001 FDA FDA-2009-N-0545 Agency Information Collection Activities; Proposed Collection; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing; Form FDA 3486 and Addendum 3486A Notice N-Notice 2009-11-18T05:00:00Z 2009 11 2009-11-18T05:00:00Z 2010-01-20T04:59:59Z 2009-11-18T19:42:09Z E9-27716 0 0 0900006480a58fc5
FDA-2009-N-0535-0001 FDA FDA-2009-N-0535 Agency Information Collection Activities; Proposed Collection; Comment Request; "Real Time" Surveys of Consumers Notice N-Notice 2009-11-18T05:00:00Z 2009 11 2009-11-18T05:00:00Z 2010-01-20T04:59:59Z 2009-11-18T17:17:04Z E9-27659 0 0 0900006480a59000
FDA-2009-N-0291-0002 FDA FDA-2009-N-0291 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infectious Disease Issues in Xenotransplantation Notice N-Notice 2009-11-18T05:00:00Z 2009 11 2009-11-18T05:00:00Z   2009-11-18T19:39:06Z E9-27658 0 0 0900006480a58ff1
FDA-2009-C-0543-0001 FDA FDA-2009-C-0543 Sauflon Pharmaceuticals Ltd.; Filing of Color Additive Petition Notice NFL-Notice of Filing 2009-11-18T05:00:00Z 2009 11 2009-11-18T05:00:00Z   2009-11-18T17:23:15Z E9-27629 0 0 0900006480a59037
FDA-2009-N-0664-0120 FDA FDA-2009-N-0664 Anti-Infective Drugs Advisory Committee; Amendment of Notice Notice N-Notice 2009-11-18T05:00:00Z 2009 11 2009-11-18T05:00:00Z   2009-11-18T17:43:36Z E9-27693 0 0 0900006480a59038
FDA-2009-N-0532-0001 FDA FDA-2009-N-0532 Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Nutrition Facts Label Formats Notice N-Notice 2009-11-18T05:00:00Z 2009 11 2009-11-18T05:00:00Z 2010-01-20T04:59:59Z 2009-11-18T19:40:46Z E9-27720 0 0 0900006480a58fea
FDA-2009-N-0667-0011 FDA FDA-2009-N-0667 Memorandum of Understanding Between the Food and Drug Administration and Waterfront Media Notice N-Notice 2009-11-18T05:00:00Z 2009 11 2009-11-18T05:00:00Z   2009-11-18T17:30:45Z E9-27630 0 0 0900006480a5904e
FDA-1998-P-0974-0002 FDA DIPRIVAN (propofol) Injectable Emulsion-CLOSED FDA-1998-P-0974 FDA/CDER - AstraZencea Pharmaceuticals LP - Withdrawl Notice NWL-Notice of Withdrawl 2009-11-17T05:00:00Z 2009 11 2009-11-17T05:00:00Z   2009-11-17T15:33:19Z   0 0 09000064805a24d1
FDA-1998-P-0974-0001 FDA DIPRIVAN (propofol) Injectable Emulsion-CLOSED FDA-1998-P-0974 Gensia Sicor Pharmaceutical Inc - Comment Notice N-Notice 2009-11-17T05:00:00Z 2009 11 2009-11-17T05:00:00Z   2013-07-27T21:47:33Z   0 0 09000064805a24c3
FDA-2009-N-0664-0118 FDA FDA-2009-N-0664 Oncologic Drugs Advisory Committee; Notice of Meeting Notice NM-Notice of Meeting 2009-11-17T05:00:00Z 2009 11     2009-11-17T17:38:38Z E9-27493 0 0 0900006480a593d0
FDA-2009-N-0664-0119 FDA FDA-2009-N-0664 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting Notice NM-Notice of Meeting 2009-11-17T05:00:00Z 2009 11     2009-11-17T17:42:04Z E9-27491 0 0 0900006480a5942c
FDA-2009-N-0664-0117 FDA FDA-2009-N-0664 Oncologic Drugs Advisory Committee; Notice of Meeting Notice NM-Notice of Meeting 2009-11-17T05:00:00Z 2009 11     2009-11-17T17:35:10Z E9-27490 0 0 0900006480a593f6
FDA-2009-N-0083-0012 FDA FDA-2009-N-0083 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Gluten-Free Labeling of Food Products Experimental Study Notice N-Notice 2009-11-17T05:00:00Z 2009 11     2009-11-17T17:30:25Z E9-27512 0 0 0900006480a593b2
FDA-2009-N-0664-0115 FDA FDA-2009-N-0664 Thermal Aspects of Radio Frequency Exposure; Public Workshop Notice NM-Notice of Meeting 2009-11-17T05:00:00Z 2009 11     2009-11-17T17:19:46Z E9-27513 0 0 0900006480a59359
FDA-2009-N-0664-0116 FDA FDA-2009-N-0664 National Mammography Quality Assurance Advisory Committee; Notice of Meeting Notice NM-Notice of Meeting 2009-11-17T05:00:00Z 2009 11     2009-11-17T17:23:57Z E9-27492 0 0 0900006480a5937c
FDA-2000-D-1542-0001 FDA Content/Format of NDA/ANDA for Certain Positron Emission FDA-2000-D-1542 Draft Guidance for Industry on the Content and Format of New Drug Applications and Abbreviated New Drug Applications for Certain Positron Emission Tomography Drug Products; Availability Notice NAD-Notice of Availability of Data 2009-11-16T05:00:00Z 2009 11 2009-11-16T05:00:00Z 2000-06-09T03:59:59Z 2009-11-16T19:37:14Z   0 0 09000064804f9074
FDA-1998-N-0872-0001 FDA Import for Export; Reporting & Recordkeeping Requirement FDA-1998-N-0872 Import for Export; Reporting and Recordkeeping Requirements for Unapproved or Violative Products Imported for Further Processing or Incorporation and Subsequent Export Notice Proposed Guidelines 2009-11-13T05:00:00Z 2009 11 1998-11-24T05:00:00Z 1999-02-09T04:59:59Z 2024-10-03T12:52:58Z 98-31351 0 0 09000064805a13c0
FDA-2008-N-0488-0025 FDA FDA-2008-N-0488 Medical Devices: Ophthalmic Devices; Laser-Assisted In Situ Keratomileusis (LASIK) Devices; Reopening of the Comment Period Notice N-Notice 2009-11-13T05:00:00Z 2009 11 2009-11-13T05:00:00Z 2010-11-16T04:59:59Z 2009-11-13T15:03:26Z E9-27222 0 0 0900006480a56cc2
FDA-2009-N-0292-0001 FDA FDA-2009-N-0292 Michelle Lynn Torgerson; Debarment Order Notice N-Notice 2009-11-13T05:00:00Z 2009 11 2009-11-13T05:00:00Z   2009-11-13T14:57:59Z E9-27223 0 0 0900006480a56c08
FDA-1998-N-0872-0002 FDA Import for Export; Reporting & Recordkeeping Requirement FDA-1998-N-0872 Import for Export; Reporting and Recordkeeping Requirements for Unapproved or Violative Products Imported for Further Processing or Incorporation and Subsequent Export; Marking Requirements for and Prohibitions on the Reimportation of Imported Food Products That Have Been Refused Admission Into the United States; Withdrawal Notice Withdrawal 2009-11-13T05:00:00Z 2009 11     2024-09-25T12:53:51Z 02-21264 0 0 09000064805a13ea
FDA-1998-D-0544-0001 FDA Modifications to Devices Subject to Premarket Approval FDA-1998-D-0544 Draft Modifications to Devices Subject to Premarket Approval - The PMA Supplement Decision Making Process; Availability Notice NAD-Notice of Availability of Data 2009-11-12T05:00:00Z 2009 11 2009-11-12T05:00:00Z 1998-11-05T04:59:59Z 2009-11-12T23:09:55Z   0 0 090000648059b513
FDA-2009-D-0508-0009 FDA FDA-2009-D-0508 Guidance for Industry on Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments; Availability Notice Notice of Availability 2009-11-12T05:00:00Z 2009 11 2009-11-12T05:00:00Z   2024-11-07T22:12:04Z E9-27182 1 0 0900006480a55f9e
FDA-1989-E-0386-0001 FDA Cytovene II, Patent Extension Application No. 4,423,050 FDA-1989-E-0386 Determination of Regulatory Review Period for Purposes of Patent Extenion; Cytovene Notice N-Notice 2009-11-12T05:00:00Z 2009 11 2009-11-12T05:00:00Z 1989-11-28T04:59:59Z 2009-11-12T22:48:06Z   0 0 090000648047a47c
FDA-2009-D-0528-0001 FDA FDA-2009-D-0528 International Conference on Harmonisation; Draft Guidance on E7 Studies in Support of Special Populations; Geriatrics; Questions and Answers; Availability Notice NAD-Notice of Availability of Data 2009-11-10T05:00:00Z 2009 11 2009-11-10T05:00:00Z 2010-01-12T04:59:59Z 2009-11-10T17:26:33Z E9-27000 0 0 0900006480a54e55
FDA-2009-N-0667-0009 FDA FDA-2009-N-0667 Memorandum of Understanding Between the Food and Drug Administration, United States Department of Health and Human Services and the National Oceanic and Atmospheric Administration, United States Department of Commerce Notice N-Notice 2009-11-10T05:00:00Z 2009 11     2009-11-10T17:42:24Z E9-27118 0 0 0900006480a54f06
FDA-2008-D-0233-0029 FDA FDA-2008-D-0233 Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion; Availability Notice NAD-Notice of Availability of Data 2009-11-09T05:00:00Z 2009 11 2009-11-09T05:00:00Z   2009-11-09T17:00:09Z E9-26870 0 0 0900006480a53fe0
FDA-2009-N-0506-0001 FDA FDA-2009-N-0506 Agency Information Collection Activities; Proposed Collection; Comment Request; Bar Code Label Requirement for Human Drug and Biological Products Notice N-Notice 2009-11-06T05:00:00Z 2009 11 2009-11-06T05:00:00Z 2010-01-06T04:59:59Z 2009-11-06T17:06:28Z E9-26850 0 0 0900006480a52a09
FDA-2009-D-0319-0001 FDA FDA-2009-D-0319 Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic 2009 H1N1 Tests for Use in the 2009 H1N1 Emergency; Availability Notice NAD-Notice of Availability of Data 2009-11-06T05:00:00Z 2009 11 2009-11-06T05:00:00Z   2009-11-06T17:16:29Z E9-26737 0 0 0900006480a52aac
FDA-2009-N-0507-0001 FDA FDA-2009-N-0507 Agency Information Collection Activities: Proposed Collection; Comment Request; Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format Notice N-Notice 2009-11-06T05:00:00Z 2009 11 2009-11-06T05:00:00Z 2010-01-06T04:59:59Z 2009-11-06T17:11:19Z E9-26760 0 0 0900006480a517ab
FDA-2009-D-0322-0001 FDA FDA-2009-D-0322 Draft Guidance for Industry on Dosage Delivery Devices for Over-The-Counter Liquid Drug Products; Availability Notice NAD-Notice of Availability of Data 2009-11-05T05:00:00Z 2009 11 2009-11-05T05:00:00Z 2010-02-04T04:59:59Z 2009-11-05T15:22:21Z E9-26531 0 0 0900006480a5173f
FDA-2009-N-0526-0001 FDA FDA-2009-N-0526 Safe Use Initiative; Availability of Information Notice N-Notice 2009-11-05T05:00:00Z 2009 11 2009-11-05T05:00:00Z   2024-11-07T22:08:15Z E9-26530 1 0 0900006480a517a4
FDA-2009-N-0667-0007 FDA FDA-2009-N-0667 Amendment to Memorandum of Understanding Between the Food and Drug Administration and WebMD, LLC Notice N-Notice 2009-11-05T05:00:00Z 2009 11 2009-11-05T05:00:00Z   2009-11-05T15:37:38Z E9-26674 0 0 0900006480a51786
FDA-2007-C-0044-0003 FDA FDA-2007-C-0044 Listing of Color Additives Exempt From Certification; Astaxanthin Dimethyldisuccinate Notice NFR-Notice of Final Rule 2009-11-05T05:00:00Z 2009 11 2009-11-05T05:00:00Z 2009-12-08T04:59:59Z 2026-01-08T20:58:38Z E9-26524 0 0 0900006480a51773
FDA-2009-D-0347-0010 FDA FDA-2009-D-0347 Draft Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Melons; Extension of Comment Period Notice NEC-Notice of Extension 2009-11-04T05:00:00Z 2009 11 2009-11-04T05:00:00Z 2010-01-05T04:59:59Z 2009-11-04T15:37:25Z E9-26638 0 0 0900006480a503a9
FDA-2009-D-0346-0013 FDA FDA-2009-D-0346 Draft Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Tomatoes; Extension of Comment Period Notice Extension of Comment Period 2009-11-04T05:00:00Z 2009 11 2009-11-04T05:00:00Z 2010-01-05T04:59:59Z 2019-02-28T14:03:35Z E9-26636 0 0 0900006480a503a3
FDA-2009-D-0348-0014 FDA FDA-2009-D-0348 Draft Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Leafy Greens; Extension of Comment Period Notice NEC-Notice of Extension 2009-11-04T05:00:00Z 2009 11 2009-11-04T05:00:00Z 2010-01-05T04:59:59Z 2009-11-04T15:39:48Z E9-26637 0 0 0900006480a503f7
FDA-2009-N-0519-0001 FDA FDA-2009-N-0519 Public Workshop: International Conference on Harmonisation S2 Genetic Toxicology Issues; Request for Comments Notice NM-Notice of Meeting 2009-11-03T05:00:00Z 2009 11 2009-11-03T05:00:00Z 2010-02-25T04:59:59Z 2009-11-03T18:30:17Z E9-26397 0 0 0900006480a4fe9e
FDA-2009-N-0523-0001 FDA FDA-2009-N-0523 Product Tracing Systems for Food; Public Meeting Notice NM-Notice of Meeting 2009-11-03T05:00:00Z 2009 11 2009-11-03T05:00:00Z 2010-03-05T04:59:59Z 2010-03-04T22:10:42Z E9-26479 0 0 0900006480a4fe7a

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