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

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

536 rows where agency_id = "FDA", document_type = "Notice" and posted_year = 2004 sorted by posted_date descending

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posted_year 1

  • 2004 · 536 ✖

document_type 1

  • Notice · 536 ✖

agency_id 1

  • FDA · 536 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2004-D-0118-0007 FDA Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: External Penile Rigidity Devices FDA-2004-D-0118 FDA Notice NAD-Notice of Availability of Data 2004-12-28T05:00:00Z 2004 12 2004-12-27T05:00:00Z 2005-12-29T04:59:59Z 2008-04-12T00:34:19Z   0 0 090000648046fb09
FDA-2004-N-0308-0010 FDA Agency Information Collection Activities: Proposed Collection; Comment Request; Infant Feeding Practices Study II FDA-2004-N-0308 Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Infant Feeding Practices Study II Notice Notice of Approval 2004-12-28T05:00:00Z 2004 12     2025-04-09T20:03:59Z 04-28136 0 0 0900006480472ecd
FDA-2003-D-0031-0010 FDA Guidance for Industry on Pharmacogenomic Data Submissions FDA-2003-D-0031 FDA Notice NAL-Notice of Approval 2004-12-28T05:00:00Z 2004 12 2004-12-23T05:00:00Z   2008-04-12T00:54:06Z   0 0 09000064804815bc
FDA-2004-D-0373-0001 FDA Guidance for Industry and FDA Staff on Class II Special Controls Guidance Document: Assisted Reproduction Laser Systems; Availability FDA-2004-D-0373 FDA Notice NAD-Notice of Availability of Data 2004-12-28T05:00:00Z 2004 12 2004-12-28T05:00:00Z 2005-12-29T04:59:59Z 2008-04-12T00:36:00Z   0 0 0900006480473721
FDA-2004-N-0569-0017 FDA Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting FDA-2004-N-0569 FDA Notice NEC-Notice of Extension 2004-12-28T05:00:00Z 2004 12 2004-12-27T05:00:00Z 2005-02-02T04:59:59Z 2008-04-12T00:46:19Z   0 0 0900006480483331
FDA-2004-N-0254-0001 FDA Agency Information Collection Activities: Proposed Collection; Comment Request; Exports: Notification and Recordkeeping Requirements FDA-2004-N-0254 Agency Information Collection Activities; Proposed Collection; Comment Request; Exports: Notification and Recordkeeping Requirements Notice 60 Day Proposed Information Collection 2004-12-28T00:00:00Z 2004 12 2004-12-27T05:00:00Z 2005-02-26T04:59:59Z 2025-05-13T19:08:00Z 04-28137 0 0 0900006480471b8b
FDA-2004-N-0054-0001 FDA Agency Information Collection Activities; Proposed Collection; MedWatch: The FDA Medical Products Reporting Program; Comment Request FDA-2004-N-0054 Agency Information Collection Activities; Proposed Collection; Comment Request; MedWatch: Food and Drug Administration Medical Products Reporting Program Notice 60 Day Proposed Information Collection 2004-12-28T00:00:00Z 2004 12 2004-12-27T05:00:00Z 2005-02-26T04:59:59Z 2025-05-13T09:00:41Z 04-28138 0 0 090000648046e8f4
FDA-2004-N-0497-0001 FDA Medical Devices; Obstetrical and Gynecological Devices; Classification of the Assisted Reproduction Laser System FDA-2004-N-0497 Medical Devices; Obstetrical and Gynecological Devices; Classification of the Assisted Reproduction Laser System Notice Notice of Final Rule 2004-12-28T00:00:00Z 2004 12     2025-05-12T19:12:18Z 04-28251 0 0 09000064804766b6
FDA-2004-D-0182-0001 FDA Draft Guidance for Industry on ANDAs: Pharmaceutical Solid Polymorphism; Chemistry, Manufacturing, and Controls Information FDA-2004-D-0182 FDA Notice NAD-Notice of Availability of Data 2004-12-27T05:00:00Z 2004 12 2004-12-20T05:00:00Z 2005-03-22T04:59:59Z 2008-04-12T00:34:48Z   0 0 0900006480470214
FDA-2004-M-0072-0001 FDA Premarket Approval for Sculptra - P030050 FDA-2004-M-0072 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applicatio11 Notice Notice of Data Availability 2004-12-23T05:00:00Z 2004 12 2004-12-14T05:00:00Z   2025-08-01T22:43:29Z 04-27387 0 0 090000648046ed12
FDA-2002-N-0153-0104 FDA Bioterrorism; Establishment & Maintenance of Records FDA-2002-N-0153 Notice; public meeting on final rule. Notice NM-Notice of Meeting 2004-12-23T05:00:00Z 2004 12 2004-12-06T05:00:00Z   2009-08-18T14:10:53Z   0 0 09000064804933ed
FDA-2002-N-0153-0105 FDA Bioterrorism; Establishment & Maintenance of Records FDA-2002-N-0153 Final Rule - Establishment and Maintenance of Records Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (pp 1-100) Notice NFR-Notice of Final Rule 2004-12-23T05:00:00Z 2004 12 2004-12-06T05:00:00Z   2009-08-18T14:21:36Z   0 0 09000064804933f0
FDA-2002-N-0153-0106 FDA Bioterrorism; Establishment & Maintenance of Records FDA-2002-N-0153 Final Rule - Establishment and Maintenance of Records Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (pp 201-300) Notice NFR-Notice of Final Rule 2004-12-23T05:00:00Z 2004 12 2004-12-06T05:00:00Z   2009-08-18T14:25:30Z   0 0 09000064804933f3
FDA-2004-M-0325-0001 FDA P040008 - VIDAS TPSA assay, Approved 7/8/04 FDA-2004-M-0325 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Data Availability 2004-12-23T05:00:00Z 2004 12 2004-12-14T05:00:00Z   2025-08-01T21:25:35Z 04-27387 0 0 09000064804730d8
FDA-2004-M-0071-0001 FDA P970043/S015- LADARVision 4000 Excimer Laser System, Approved 6/29/04 FDA-2004-M-0071 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Data Availability 2004-12-23T05:00:00Z 2004 12 2004-12-14T05:00:00Z   2025-07-29T23:29:00Z 04-27387 0 0 090000648046ecfe
FDA-2004-M-0138-0001 FDA P030054 - St. Jude Medical Epic HF System, Approved 6/30/04 FDA-2004-M-0138 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Application Notice Notice of Data Availability 2004-12-23T05:00:00Z 2004 12 2004-12-14T05:00:00Z   2025-07-30T00:17:04Z 04-27387 0 0 090000648046fde8
FDA-2004-M-0516-0001 FDA P030044 - DakoCytomation EGFR pharmDx, Approved 2/12/04 FDA-2004-M-0516 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Application Notice Notice of Data Availability 2004-12-23T05:00:00Z 2004 12 2004-12-14T05:00:00Z   2025-08-05T23:47:06Z 04-27387 0 0 0900006480477cb7
FDA-2004-M-0512-0001 FDA P020023 - Restylane Injectable Gel FDA-2004-M-0512 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applicatio Notice Notice of Data Availability 2004-12-23T05:00:00Z 2004 12 2004-12-14T05:00:00Z   2025-07-29T22:10:36Z 04-27387 0 0 0900006480477c56
FDA-2004-M-0196-0001 FDA P020030 - Stelid II steroid eluting pacing leads, Approved 6/17/04 FDA-2004-M-0196 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Data Availability 2004-12-23T05:00:00Z 2004 12 2004-12-14T05:00:00Z   2025-07-29T22:58:57Z 04-27387 0 0 0900006480470b87
FDA-2004-M-0075-0001 FDA Premarket Approval for ImageChecker CT CAD Software System - Model LN-1000 by R2 Technology, Inc., Approved 7/8/04 (P030012) FDA-2004-M-0075 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Data Availability 2004-12-23T05:00:00Z 2004 12 2004-12-14T05:00:00Z   2025-08-01T17:53:40Z 04-27387 0 0 090000648046ed44
FDA-2004-M-0563-0001 FDA Premarket Approval for CureLight BroadBand by PhotoCure ASA (Model CureLight 01), P010061, Approved 7/28/04 FDA-2004-M-0563 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Data Availability 2004-12-23T05:00:00Z 2004 12 2004-12-14T05:00:00Z   2025-08-01T22:08:53Z 04-27387 0 0 09000064804815c2
FDA-2004-G-0002-0001 FDA Draft Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 FDA-2004-G-0002 Draft Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Availability Notice Notice of Data Availability 2004-12-23T05:00:00Z 2004 12 2004-12-09T05:00:00Z 2005-01-25T04:59:59Z 2025-11-14T10:00:23Z 04-26931 0 0 090000648046a701
FDA-2003-F-0457-0001 FDA Increase the Maximum Permitted Energy Level of X-rays FDA-2003-F-0457 FDA Notice NFR-Notice of Final Rule 2004-12-23T05:00:00Z 2004 12 2004-12-22T05:00:00Z   2008-04-12T00:57:04Z   0 0 09000064804a26a0
FDA-2004-D-0122-0001 FDA Guidance for Small Business Entities on Labeling Over-the-Counter Human Drug Products; Availability FDA-2004-D-0122 Draft Compliance Guidance for Small Business Entities on Labeling Over-the-Counter Human Drug Products; Availability Notice NAD-Notice of Availability of Data 2004-12-23T05:00:00Z 2004 12 2004-12-08T05:00:00Z 2005-02-08T04:59:59Z 2009-05-11T15:38:00Z   0 0 090000648046fbbc
FDA-2002-N-0153-0108 FDA Bioterrorism; Establishment & Maintenance of Records FDA-2002-N-0153 Final Rule - Establishment and Maintenance of Records Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (pp 101-200) Notice NFR-Notice of Final Rule 2004-12-23T05:00:00Z 2004 12 2004-12-06T05:00:00Z   2009-08-18T14:28:56Z   0 0 09000064804933f9
FDA-2004-M-0393-0001 FDA P030024 - Vitros Immunodiagnostic Products Anti-HBc Reagent Pack and Vitros Immunodiagnostic Products Anti-HBc Calibrator, Approved 3/4/04 FDA-2004-M-0393 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Data Availability 2004-12-23T05:00:00Z 2004 12 2004-12-14T05:00:00Z   2025-08-01T18:58:41Z 04-27387 0 0 0900006480474397
FDA-2004-M-0515-0001 FDA P030026 - Vitros Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Vitros Immunodiagnostic Products Anti-HBc IgM Calibrator FDA-2004-M-0515 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applicatio11 Notice Notice of Data Availability 2004-12-23T05:00:00Z 2004 12 2004-12-14T05:00:00Z   2025-08-04T20:22:21Z 04-27387 0 0 0900006480477c92
FDA-2004-M-0078-0001 FDA P030025 - TAXUS Express2 Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire), Approved 3/4/04 FDA-2004-M-0078 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Data Availability 2004-12-23T05:00:00Z 2004 12 2004-12-14T05:00:00Z   2025-08-05T00:10:21Z 04-27387 0 0 090000648046ed79
FDA-2002-N-0153-0107 FDA Bioterrorism; Establishment & Maintenance of Records FDA-2002-N-0153 Final Rule - Establishment and Maintenance of Records Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (pp 301-344) Notice NFR-Notice of Final Rule 2004-12-23T05:00:00Z 2004 12 2004-12-06T05:00:00Z   2009-08-18T14:32:34Z   0 0 09000064804933f6
FDA-2003-M-0456-0001 FDA PMA Cypher Sirolimus-Eluting Coronary Stent on the Raptor FDA-2003-M-0456 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Approval 2004-12-23T05:00:00Z 2004 12 2004-12-14T05:00:00Z   2025-04-14T14:01:44Z   0 0 09000064804a2682
FDA-2004-P-0084-0001 FDA Cottage Cheese Deviating from Identity Standard; Temporary Permit for Market Testing FDA-2004-P-0084 Notice of Temporary Permit Notice N-Notice 2004-12-23T05:00:00Z 2004 12 2004-12-08T05:00:00Z 2004-12-10T04:59:59Z 2025-03-21T21:54:45Z 69FR71418 0 0 090000648046ee04
FDA-2004-M-0077-0001 FDA P040012 - ACCULINK Carotid Stent System and RX ACCULIN Carotid Stent System, Approved 8/30/04 FDA-2004-M-0077 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Data Availability 2004-12-23T05:00:00Z 2004 12 2004-12-14T05:00:00Z   2025-08-04T22:26:11Z 04-27387 0 0 090000648046ed6a
FDA-2004-M-0197-0001 FDA P030010 - Siemens Mammomat Novation Full Field Digital Mammography System, Approved 8/20/04 FDA-2004-M-0197 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Data Availability 2004-12-23T05:00:00Z 2004 12 2004-12-14T05:00:00Z   2025-08-04T21:55:14Z 04-27387 0 0 0900006480470b95
FDA-2004-M-0198-0001 FDA H030009 - Vertical Expandable Prosthetic Titanium Rib (VEPTR), approved August 24, 2004 FDA-2004-M-0198 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Data Availability 2004-12-23T05:00:00Z 2004 12 2004-12-14T05:00:00Z   2025-08-05T21:14:54Z 04-27387 0 0 0900006480470ba2
FDA-2004-M-0140-0001 FDA P010012/S026 - CONTAK CD (Model 1823), CONTAK CD 2 (Models H115 and H119), RENEWAL (Model H135), RENEWAL 3 (Models H170, H175, H177, and H179), Approved 9/14/04 FDA-2004-M-0140 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Application Notice Notice of Data Availability 2004-12-23T05:00:00Z 2004 12 2004-12-14T05:00:00Z   2025-08-05T22:33:49Z 04-27387 0 0 090000648046fe0c
FDA-2004-N-0311-0001 FDA Agency Information Collection Activities: Proposed Collection; Comment Request; Experimental Study of Health Claims on Food Packages FDA-2004-N-0311 Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Health Claims on Food Packages Notice 60 Day Proposed Information Collection 2004-12-21T05:00:00Z 2004 12 2004-12-10T05:00:00Z 2005-02-09T04:59:59Z 2025-06-04T23:03:14Z 04-27119 0 0 0900006480472f08
FDA-2004-N-0435-0001 FDA Medical Devices; General Hospital and Personal Use Devices; Classification of Implantable Radiofrequency Transponder System for Patient Identification and Health Information FDA-2004-N-0435 Medical Devices; General Hospital and Personal Use Devices; Classification of Implantable Radiofrequency Transponder System for Patient Identification and Health Information Notice Notice of Final Rule 2004-12-21T05:00:00Z 2004 12     2025-09-26T23:21:09Z 04-27077 0 0 090000648047496c
FDA-1993-F-0015-0001 FDA Safe use of Source of Fast (high energy) Neutrons FDA-1993-F-0015 Irradiation in the Production, Processing, and Handling of Food; Final rule Notice Notice of Final Rule 2004-12-21T05:00:00Z 2004 12 2004-12-21T05:00:00Z 2005-01-22T04:59:59Z 2016-02-16T22:00:55Z   0 0 09000064804fa56b
FDA-2004-D-0247-0001 FDA Guidance for Industry and Food and Drug Administration; Class II Special Controls Guidance Document: Implantable Radiofrequency Transponder System for Patient Identification and Health Information FDA-2004-D-0247 FDA Notice NAD-Notice of Availability of Data 2004-12-21T05:00:00Z 2004 12 2004-12-10T05:00:00Z 2005-12-13T04:59:59Z 2008-04-12T00:35:26Z   0 0 0900006480471af9
FDA-2000-N-0043-0006 FDA Presubmission Conferences - CLOSED FDA-2000-N-0043 Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Presubmission Conference; Notice Notice Notice of Approval 2004-12-14T05:00:00Z 2004 12 2004-12-14T05:00:00Z 2007-12-01T04:59:59Z 2025-06-11T23:20:18Z 04-27292 0 0 09000064804aefd9
FDA-2004-N-0380-0001 FDA Agency Information Collection Activities: Proposed Collection; Comment Request; Reports of Corrections and Removals FDA-2004-N-0380 Agency Information Collection Activities; Proposed Collection; Comment Request; Reports of Corrections and Removals Notice 60 Day Proposed Information Collection 2004-12-14T00:00:00Z 2004 12 2004-12-14T05:00:00Z 2005-02-15T04:59:59Z 2025-05-09T19:18:24Z 04-27293 0 0 090000648047381e
FDA-2004-N-0309-0001 FDA Agency Information Collection Activities: Proposed Collection; Comment Request; Medical Device Labeling Regulations FDA-2004-N-0309 Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Labeling Regulations Notice 60 Day Proposed Information Collection 2004-12-14T00:00:00Z 2004 12 2004-12-13T00:00:00Z 2005-02-15T04:59:59Z 2025-05-08T22:45:00Z 04-27333 0 0 0900006480472ed7
FDA-2004-N-0126-0001 FDA Fast Track Drug Development Programs: Designation, Development, and Application Review FDA-2004-N-0126 Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Fast Track Drug Development Programs-Designation, Development, and Application Review Notice 60 Day Proposed Information Collection 2004-12-14T00:00:00Z 2004 12 2004-12-13T00:00:00Z 2005-02-12T04:59:59Z 2025-05-09T22:28:44Z 04-27198 0 0 090000648046fcb5
FDA-1979-P-0027-0003 FDA Exempt Homoeopathic Drug Products from G. M. P. Regulations-CLOSED FDA-1979-P-0027 Withdrawal of Certain Proposed Rules and Other Proposed Actions Notice Withdrawal 2004-12-09T05:00:00Z 2004 12 2004-11-25T05:00:00Z   2019-09-19T15:43:56Z 04-26234 0 0 0900006480553955
FDA-1997-N-0057-0007 FDA Human Cellular and Tissue-Based Products FDA-1997-N-0057 Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products - Notice of Approval Notice NAL-Notice of Approval 2004-12-09T05:00:00Z 2004 12 2004-11-26T05:00:00Z   2010-10-07T14:26:29Z   0 0 09000064805d023e
FDA-1990-N-0016-0003 FDA Drug Labeling; Sodium Labeling For OTC Drugs FDA-1990-N-0016 FDA Notice NFR-Notice of Final Rule 2004-12-09T05:00:00Z 2004 12 2004-11-26T05:00:00Z   2008-05-16T23:47:49Z   0 0 0900006480528a8f
FDA-1985-N-0006-0005 FDA Hematology & Pathology DEV/PMA/Automoted Blood Cell Seper FDA-1985-N-0006 FDA Notice NWL-Notice of Withdrawl 2004-12-09T05:00:00Z 2004 12 2004-11-25T05:00:00Z   2008-05-30T22:53:05Z   0 0 09000064805b39f9
FDA-2004-D-0242-0001 FDA Guidance for Industry on the Role of HIV Drug Resistance Testing in Antiretroviral Drug Development FDA-2004-D-0242 FDA Notice NAD-Notice of Availability of Data 2004-12-09T05:00:00Z 2004 12 2004-11-29T05:00:00Z 2005-03-01T04:59:59Z 2008-04-12T00:35:21Z   0 0 09000064804719a3
FDA-2004-N-0379-0007 FDA Agency Information Collection Activities; Proposed Collection; Comment Request; , Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions Part 60 (21 CFR Part 60) FDA-2004-N-0379 Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions Notice Notice of Approval 2004-12-09T05:00:00Z 2004 12     2025-09-26T00:09:15Z 04-26270 0 0 0900006480473812
FDA-1980-N-0058-0015 FDA Deletion of GRAS Status of Caffeine FDA-1980-N-0058 FDA Notice NWL-Notice of Withdrawl 2004-12-09T05:00:00Z 2004 12 2004-11-25T05:00:00Z   2008-05-30T22:53:16Z   0 0 09000064805ba78a
FDA-2004-N-0050-0002 FDA Application for Participation in the Medical Device Fellowship Program FDA-2004-N-0050 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Participation in the Medical Device Fellowship Program Notice 30 Day Proposed Information Collection 2004-12-09T00:00:00Z 2004 12 2004-12-06T05:00:00Z 2005-01-06T04:59:59Z 2025-04-28T16:36:06Z 04-26672 0 0 090000648046e8b5
FDA-1977-N-0026-0008 FDA Gelatin; GRAS Status as Direct Human Food Ingredient FDA-1977-N-0026 Withdrawal of Certain Proposed Rules and Other Proposed Actions Notice Withdrawal 2004-12-08T05:00:00Z 2004 12 2004-11-25T05:00:00Z   2019-05-01T17:26:41Z 04-26234 0 0 09000064805da38c
FDA-2004-N-0125-0004 FDA Agency Information Collection Activities: Proposed Collection; Comment Request; Institutional Review Boards--Part 56 (21 CFR Part 56.115) FDA-2004-N-0125 Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Protection of Human Subjects; Recordkeeping Requirements for Institutional Review Boards Notice Notice of Approval 2004-12-07T05:00:00Z 2004 12     2025-04-08T20:09:25Z 04-26581 0 0 090000648046fca8
FDA-2004-D-0374-0001 FDA Draft Guidance for Industry on Recommended Approaches to Integration of Genetic Toxicology Study Results FDA-2004-D-0374 FDA Notice NAD-Notice of Availability of Data 2004-12-06T05:00:00Z 2004 12 2005-12-01T05:00:00Z 2005-02-01T04:59:59Z 2008-04-12T00:36:01Z   0 0 090000648047372b
FDA-2004-N-0252-0005 FDA Agency Information Collection Activities; Proposed Collection; Comment Request; Color Additive Certification Requests and Recordkeeping FDA-2004-N-0252 FDA Notice NAL-Notice of Approval 2004-12-06T05:00:00Z 2004 12 2004-11-30T05:00:00Z   2008-04-12T00:40:16Z   0 0 0900006480471b75
FDA-2004-D-0302-0001 FDA Guidance and Protocol for Industry and Food and Drug Administration Staff: Certification of Fish and Fishery Products for Export to the European Union and the European Free Trade Association FDA-2004-D-0302 FDA Notice NAD-Notice of Availability of Data 2004-12-06T05:00:00Z 2004 12 2004-11-26T05:00:00Z 2004-12-28T04:59:59Z 2008-04-12T00:35:46Z   0 0 0900006480472df0
FDA-2002-N-0276-0005 FDA Withdrawal of Certain Proposed Rules and Other Propose Actions FDA-2002-N-0276 FDA Notice NWL-Notice of Withdrawl 2004-12-06T05:00:00Z 2004 12 2004-11-25T05:00:00Z   2008-04-12T01:24:30Z   0 0 090000648049e5b3
FDA-2002-N-0106-0002 FDA Proposal to Debar Baldev Raj Bhutani/Notice of Opportunity for Hearing FDA-2002-N-0106 Baldev Raj Bhutani; Denial of Hearing; Final Debarment Order Notice ND-Notice of Denial 2004-12-06T05:00:00Z 2004 12     2010-08-26T20:13:38Z   0 0 090000648048f6f5
FDA-2004-N-0133-0001 FDA Beverages: Bottled Water FDA-2004-N-0133 FDA - Quality Standard Regulations for Arsenic in Bottled Water Notice NPR-Notice of Proposed Rule-Making 2004-12-06T05:00:00Z 2004 12 2004-11-26T05:00:00Z 2005-02-01T04:59:59Z 2009-07-28T13:44:43Z   0 0 090000648046fd7d
FDA-2004-D-0043-0001 FDA Proposed Referral Program from the Food and Drug Administration to the National Oceanic and Atmospheric Administration Seafood Inspection Program for the Certification of Live and Perishable Fish and Fishery Products for Export to the European Union and the European Free Trade Association FDA-2004-D-0043 Proposed Referral Program from the Food and Drug Administration to the National Oceanic and Atmospheric Administration Seafood Inspection Program for the Certification of Live and Perishable Fish and Fishery Products for Export to the European Union and the European Free Trade Association Notice NAD-Notice of Availability of Data 2004-12-06T05:00:00Z 2004 12 2004-11-26T05:00:00Z 2004-12-28T04:59:59Z 2009-01-16T21:42:57Z   0 0 090000648046adae
FDA-2004-N-0186-0001 FDA Agency Information Collection Activities: Proposed Collection; Comment Request; 2005 Food Safety Survey FDA-2004-N-0186 Agency Information Collection Activities; Proposed Collection; Comment Request; 2005 Food Safety Survey Notice 60 Day Proposed Information Collection 2004-12-06T00:00:00Z 2004 12 2004-12-02T05:00:00Z 2005-02-01T04:59:59Z 2025-05-10T01:14:49Z 04-26551 0 0 090000648047026b
FDA-2003-D-0375-0008 FDA Draft Guidance for Industry and FDA Staff; Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use; Availability FDA-2003-D-0375 FDA Notice NAD-Notice of Availability of Data 2004-12-03T05:00:00Z 2004 12 2004-11-29T05:00:00Z 2005-12-01T04:59:59Z 2008-04-12T00:55:38Z   0 0 09000064804993b7
FDA-2004-N-0381-0006 FDA Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary Registration of Cosmetic Product Establishments FDA-2004-N-0381 Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Voluntary Registration of Cosmetic Product Establishments Notice Notice of Availability 2004-12-03T05:00:00Z 2004 12     2025-04-02T18:45:59Z 04-26332 0 0 090000648047383b
FDA-2004-F-0069-0001 FDA Filing of Food Additive Petition (FAP 3M4744), provide for the safe use of ionizing radiation in the production of fully cooked shelf stable foods, including fully cooked multiple ingredient shelf stable foods, where the absorbed dose required to cause a 12 log reduction in Clostridium botulinum has been established FDA-2004-F-0069 Sterigenics International, Inc.; Filing of Food Additive Petition Notice Notice of Filing 2004-12-03T05:00:00Z 2004 12     2025-11-20T21:01:58Z 04-26334 0 0 090000648046ecec
FDA-2004-N-0312-0001 FDA Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Device Tracking FDA-2004-N-0312 Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Device Tracking Notice 60 Day Proposed Information Collection 2004-12-03T00:00:00Z 2004 12 2004-11-29T00:00:00Z 2005-02-01T04:59:59Z 2025-05-08T17:56:15Z 04-26331 0 0 0900006480472f1b
FDA-2004-P-0149-0004 FDA petitioner requests the Commissioner to determine that NDA 19-44, Sodium Bicarbonate Injection in PET Abboject Vials was not withdrawn for safety or effectiveness reasons FDA-2004-P-0149 Notice of Determination Notice N-Notice 2004-11-29T05:00:00Z 2004 11 2004-11-26T05:00:00Z 2004-11-30T04:59:59Z 2024-12-23T22:09:45Z 69FR69373 0 0 090000648046ff0b
FDA-2004-D-0046-0001 FDA Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Newborn Screening Test Systems for Amino Acids, Free Carnitine, and Acylcarnitines Using Tandem Mass Spectrometry FDA-2004-D-0046 FDA Notice NAD-Notice of Availability of Data 2004-11-24T05:00:00Z 2004 11 2004-11-23T05:00:00Z   2008-04-12T00:34:14Z   0 0 090000648046e86c
FDA-2003-D-0144-0012 FDA Draft Guidance for Industry on Continuous Marketing Applications: Pilot 2 - Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA FDA-2003-D-0144 FDA Notice N-Notice 2004-11-24T05:00:00Z 2004 11 2004-11-18T05:00:00Z 2005-11-22T04:59:59Z 2008-04-12T00:54:35Z   0 0 09000064804868c3
FDA-2004-D-0044-0001 FDA Guidance for Industry: Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use FDA-2004-D-0044 Draft Guidance for Industry: Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use; Availability Notice NAD-Notice of Availability of Data 2004-11-24T05:00:00Z 2004 11 2004-11-19T05:00:00Z 2005-01-25T04:59:59Z 2009-05-09T13:18:28Z   0 0 090000648046ae10
FDA-1997-N-0040-0004 FDA Current Good Tissue Practice for Mfrs. of Human Cellular FDA-1997-N-0040 Notice of Final Rule re Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments; Inspection and Enforcement (pages 201-285) Notice Notice of Final Rule 2004-11-24T05:00:00Z 2004 11 2004-11-18T05:00:00Z   2017-01-13T19:09:28Z   0 0 09000064805cfbe8
FDA-1997-N-0040-0002 FDA Current Good Tissue Practice for Mfrs. of Human Cellular FDA-1997-N-0040 Notice of Final Rule re Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments; Inspection and Enforcement Notice Notice of Final Rule 2004-11-24T05:00:00Z 2004 11 2004-11-18T05:00:00Z   2017-01-13T19:08:49Z   0 0 09000064805cfbe5
FDA-1997-N-0040-0003 FDA Current Good Tissue Practice for Mfrs. of Human Cellular FDA-1997-N-0040 Notice of Final Rule re Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments; Inspection and Enforcement (pages 201-285) Notice Notice of Final Rule 2004-11-24T05:00:00Z 2004 11 2004-11-18T05:00:00Z   2017-01-13T19:09:08Z   0 0 09000064805cfbe6
FDA-1997-N-0040-0001 FDA Current Good Tissue Practice for Mfrs. of Human Cellular FDA-1997-N-0040 Notice of Final Rule re Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments; Inspecition and Enforcement (pages 1-100) Notice Notice of Final Rule 2004-11-24T05:00:00Z 2004 11 2004-11-18T05:00:00Z   2017-01-13T19:08:25Z   0 0 09000064805cfb7b
FDA-2004-N-0319-0001 FDA Amendment to 25.34; Categorical Exclusions Environmental Assessment FDA-2004-N-0319 Environmental Assessment; Categorical Exclusions Notice NPR-Notice of Proposed Rule-Making 2004-11-24T00:00:00Z 2004 11 2004-11-24T05:00:00Z 2004-12-28T04:59:59Z 2025-05-06T16:48:44Z 04-25974 0 0 0900006480473022
FDA-2004-N-0297-0001 FDA Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of Newborn Screening Test Systems for Amino Acids, Free Carnitine, and Acylcarnitines Using Tandem Mass Spectrometry FDA-2004-N-0297 Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of Newborn Screening Test Systems for Amino Acids, Free Carnitine, and Acylcarnitines Using Tandem Mass Spectrometry Notice Notice of Final Rule 2004-11-24T00:00:00Z 2004 11     2025-05-07T18:48:22Z 04-25975 0 0 0900006480472d0c
FDA-2004-N-0313-0001 FDA Draft Risk Assessment of Streptogramin Resistance in Enterococcus Faecium Attributable to the Use of Streptogramins in Animals; Availability FDA-2004-N-0313 Draft Risk Assessment of Streptogramin Resistance in Enterococcus faecium Attributable to the Use of Streptogramins in Animals; Availability Notice Notice of Data Availability 2004-11-24T00:00:00Z 2004 11 2004-11-24T05:00:00Z 2005-01-25T04:59:59Z 2025-05-09T01:17:11Z 04-25979 0 0 0900006480472f2e
FDA-2004-N-0390-0001 FDA Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance on Consultation Procedures; Foods Derived From New Plant Varieties FDA-2004-N-0390 Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Consultation Procedures; Foods Derived From New Plant Varieties Notice 60 Day Proposed Information Collection 2004-11-24T00:00:00Z 2004 11 2004-11-24T05:00:00Z 2005-01-25T04:59:59Z 2025-05-09T01:17:11Z 04-26048 0 0 09000064804742ad
FDA-2004-D-0179-0001 FDA Guidance for Industry on Changes to an Approved NDA or ANDA; Specifications Use of Enforcement Discretion for Compendial Changes FDA-2004-D-0179 FDA Notice NAD-Notice of Availability of Data 2004-11-23T05:00:00Z 2004 11 2004-11-22T05:00:00Z 2005-11-23T04:59:59Z 2008-04-12T00:34:45Z   0 0 09000064804701dc
FDA-1994-P-0043-0018 FDA Adopt Amendments Governing Health Claims & Nutrient Claims FDA-1994-P-0043 FDA Notice NEC-Notice of Extension 2004-11-19T05:00:00Z 2004 11 2004-11-17T05:00:00Z 2004-01-19T04:59:59Z 2008-05-16T23:21:16Z   0 0 09000064804ff51b
FDA-1995-P-0016-0008 FDA Implied Nutrient Content Claim 'Healthy' & Health Claims-CLOSED FDA-1995-P-0016 FDA Notice NEC-Notice of Extension 2004-11-19T05:00:00Z 2004 11 2004-11-17T05:00:00Z 2005-01-19T04:59:59Z 2008-05-16T23:06:37Z   0 0 0900006480558688
FDA-2004-D-0298-0001 FDA Compliance Policy Guide Sec. 400.210 Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs, Availability FDA-2004-D-0298 FDA Notice NAD-Notice of Availability of Data 2004-11-19T05:00:00Z 2004 11 2004-11-15T05:00:00Z 2004-11-16T04:59:59Z 2008-04-12T00:35:32Z   0 0 0900006480472d15
FDA-2004-F-0321-0005 FDA Filing of Food Additive Petition (FAP 4A4754) Food Additives Permitted in Food on an Interim Basis or in Contact With Food Pending Additional Study; Mannitol FDA-2004-F-0321 Food Additives Permitted in Food on an Interim Basis or in Contact With Food Pending Additional Study; Mannitol Notice Notice of Final Rule 2004-11-16T05:00:00Z 2004 11 2004-11-15T05:00:00Z 2004-12-16T04:59:59Z 2025-11-07T20:53:41Z 04-25243 0 0 09000064804730a7
FDA-2004-F-0321-0006 FDA Filing of Food Additive Petition (FAP 4A4754) Food Additives Permitted in Food on an Interim Basis or in Contact With Food Pending Additional Study; Mannitol FDA-2004-F-0321 Food Additives Permitted in Food on an Interim Basis or in Contact With Food Pending Additional Study; Mannitol Notice Notice of Final Rule 2004-11-16T05:00:00Z 2004 11 2004-11-15T05:00:00Z 2004-12-16T04:59:59Z 2025-11-07T20:56:51Z 04-25243 0 0 09000064804730a8
FDA-2000-N-0144-0001 FDA Reimportation of Imported Food Products Refused Admission FDA-2000-N-0144 Notice of Withdrawl Import for Export; Reporting and Record keeping Requirements for Unapproved or Violative Products Imported for Further Processing or Incorporation and Subsequent Export; Marking Requirement for and Prohibitions on the Re importation of Imported Food Products that have been Refused Admission into the United States. Notice Withdrawal 2004-11-16T05:00:00Z 2004 11 2002-08-21T04:00:00Z   2015-11-19T19:08:35Z   0 0 09000064804d0e41
FDA-2004-P-0088-0004 FDA requests that the commissioner of Food and Drug Admination determine that Astra Zenecal LP's Dyclone(dyclonine hydrochloride) Topical Solution 0.5% and 1.0%(NDA 9-925) was voluntarily withdrawn or withheld form sale for reasons other than safety or efficacy FDA-2004-P-0088 FDA Notice N-Notice 2004-11-16T05:00:00Z 2004 11 2004-11-15T05:00:00Z 2004-11-16T04:59:59Z 2024-12-04T21:35:42Z 67FR6264 0 0 090000648046ee58
FDA-2004-N-0389-0002 FDA Current Good Manufacturing Practice Regulations for Type A Medicated Articles, 21CFR Part 226 FDA-2004-N-0389 Agency Information Collection Activities: Submission for Office of Management and Budget Review; Comment Request, Current Good Manufacturing Practice Regulations for Type A Medicated Articles Notice 30 Day Proposed Information Collection 2004-11-10T05:00:00Z 2004 11 2004-11-10T05:00:00Z 2004-12-11T04:59:59Z 2025-04-22T20:17:56Z 04-24993 0 0 09000064804742a6
FDA-2003-N-0382-0005 FDA Agency Information Collection Activities; Proposed Collection; Comment Request; Food Additive Petitions FDA-2003-N-0382 Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Food Additive Petitions Notice Notice of Approval 2004-11-10T05:00:00Z 2004 11     2025-06-16T19:09:50Z 04-24992 0 0 090000648049a10a
FDA-2004-D-0353-0001 FDA Guidance for FDA Review Staff and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) FDA-2004-D-0353 FDA Notice NAD-Notice of Availability of Data 2004-11-10T05:00:00Z 2004 11 2004-11-08T05:00:00Z 2005-02-08T04:59:59Z 2008-04-12T00:35:51Z   0 0 090000648047353d
FDA-2004-D-0372-0001 FDA Draft Guidance for Industry on Development of Target Animal Safety and Effectiveness Data to Support Approval of Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) for use in Animals FDA-2004-D-0372 FDA Notice NAD-Notice of Availability of Data 2004-11-10T05:00:00Z 2004 11 2004-11-09T05:00:00Z 2005-01-30T04:59:59Z 2015-09-11T01:30:42Z   0 0 0900006480473706
FDA-2004-D-0303-0001 FDA Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act FDA-2004-D-0303 FDA Notice NAD-Notice of Availability of Data 2004-11-10T05:00:00Z 2004 11 2004-11-09T05:00:00Z 2005-01-11T04:59:59Z 2008-04-12T00:35:47Z   0 0 0900006480472e0f
FDA-2004-D-0303-0002 FDA Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act FDA-2004-D-0303 FDA Notice NAD-Notice of Availability of Data 2004-11-10T05:00:00Z 2004 11 2004-11-09T05:00:00Z 2005-01-11T04:59:59Z 2008-04-12T00:35:47Z   0 0 0900006480472e14
FDA-2003-D-0428-0006 FDA Compliance Policy Guide Sec.110.300 Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 FDA-2003-D-0428 FDA Notice NAD-Notice of Availability of Data 2004-11-10T05:00:00Z 2004 11 2004-11-04T05:00:00Z 2005-11-10T04:59:59Z 2008-04-12T00:55:43Z   0 0 09000064804a21da
FDA-2003-D-0435-0012 FDA Compliance Policy Guide Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 FDA-2003-D-0435 Compliance Policy Guide Regarding Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Availability Notice NAD-Notice of Availability of Data 2004-11-10T05:00:00Z 2004 11 2004-11-04T05:00:00Z   2009-03-12T20:30:30Z   0 0 09000064804a2361
FDA-2004-N-0307-0010 FDA Animal Models and Correlates of Protection for Plague Vaccines, Public Workshop FDA-2004-N-0307 FDA Notice NM-Notice of Meeting 2004-11-10T05:00:00Z 2004 11 2004-08-30T04:00:00Z   2008-04-12T00:40:50Z   0 0 0900006480472eae
FDA-2004-N-0038-0001 FDA Preparation for the International Conference on Harmonization Meetings in Yokohama, Japan: Public Meeting FDA-2004-N-0038 FDA Notice NM-Notice of Meeting 2004-11-10T05:00:00Z 2004 11 2004-09-30T04:00:00Z   2008-04-12T00:38:33Z   0 0 090000648046ac8e
FDA-2004-N-0259-0001 FDA Dietary Supplements; Regulatory Strategy for the Further Implementation and Enforcement of the Dietary Supplement Health and Education Act of 1994 FDA-2004-N-0259 Dietary Supplements; Strategy for the Further Implementation and Enforcement of the Dietary Supplement Health and Education Act of 1994; Availability Notice Notice of Data Availability 2004-11-10T00:00:00Z 2004 11 2004-11-09T05:00:00Z   2025-05-06T01:33:45Z 04-24870 0 0 0900006480472061
FDA-2004-N-0314-0001 FDA The Minor Use & Minor Species (MUMS) Animal Health Act FDA-2004-N-0314 The Minor Use and Minor Species Animal Health Act; Request for Comments Notice Request for Comments 2004-11-10T00:00:00Z 2004 11 2004-11-09T05:00:00Z 2005-01-11T04:59:59Z 2025-05-09T01:17:11Z 04-24880 0 0 0900006480472f57
FDA-2004-N-0068-0001 FDA Agency Information Collection Activities: Proposed Collection; Comment Request;New Animal Drugs For Investigational Use, 21 CFR Part 511 FDA-2004-N-0068 Agency Information Collection Activities: Proposed Collection; Comment Request; New Animal Drugs For Investigational Use Notice 60 Day Proposed Information Collection 2004-11-10T00:00:00Z 2004 11 2004-11-10T05:00:00Z 2005-01-11T04:59:59Z 2025-05-06T19:21:28Z 04-24991 0 0 090000648046ecde
FDA-2004-D-0040-0001 FDA Guidance for Industry on Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 Questions and Answers FDA-2004-D-0040 FDA Notice NAD-Notice of Availability of Data 2004-11-04T05:00:00Z 2004 11 2004-11-03T05:00:00Z 2005-02-06T04:59:59Z 2008-04-12T00:32:09Z   0 0 090000648046acf9
FDA-2000-N-0158-0002 FDA Revision of the Identification of the Ionotophoresis FDA-2000-N-0158 Medical Devices; Reclassification of the lontophoresis Device Notice Notice of Intent 2004-11-04T05:00:00Z 2004 11 2004-11-04T05:00:00Z 2005-02-03T04:59:59Z 2025-06-11T23:54:22Z 04-24591 0 0 09000064804d178a

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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);