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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

579 rows where agency_id = "FDA", document_type = "Notice" and posted_year = 2003 sorted by posted_date descending

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posted_year 1

  • 2003 · 579 ✖

document_type 1

  • Notice · 579 ✖

agency_id 1

  • FDA · 579 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id
FDA-2003-D-0244-0001 FDA Draft Guidance for Industry: Clozapine Tablets: In Vivo Bioequivalence and In Vitro Dissolution Testing, Revision FDA-2003-D-0244 FDA Notice NAD-Notice of Availability of Data 2003-12-30T05:00:00Z 2003 12 2003-12-30T05:00:00Z 2004-03-02T04:59:59Z 2008-04-12T00:55:07Z   0 0 090000648048ecd0
FDA-2003-N-0096-0001 FDA Revision of the Requirements for Spore-Forming Microorganisms FDA-2003-N-0096 Revision of the Requirements for Spore-Forming Microorganisms Notice NPR-Notice of Proposed Rule-Making 2003-12-30T05:00:00Z 2003 12 2003-12-30T05:00:00Z 2004-03-16T04:59:59Z 2025-06-19T09:00:11Z 03-31919 0 0 09000064804838aa
FDA-2002-D-0022-0004 FDA Medical Devices; Chemical Indicators Premarket Notification FDA-2002-D-0022 FDA Notice NAD-Notice of Availability of Data 2003-12-30T05:00:00Z 2003 12 2003-12-19T05:00:00Z 2004-12-20T04:59:59Z 2008-04-12T01:16:13Z   0 0 0900006480488e14
FDA-2000-N-0139-0002 FDA Changes to an Approved NDA or ANDA; Agency Information Collection FDA-2000-N-0139 Agency Information Collection Activities; Comment Request; Guidance for Industry-Changes to an Approved New Drug Application or Abbreviated New Drug Application Notice General Notice 2003-12-30T05:00:00Z 2003 12 2003-12-19T05:00:00Z 2004-02-18T04:59:59Z 2025-06-12T20:08:33Z 03-31412 0 0 09000064804d0bb0
FDA-2003-D-0428-0001 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 2003-12-30T05:00:00Z 2003 12 2003-12-19T05:00:00Z 2004-12-20T04:59:59Z 2008-04-12T00:55:43Z   0 0 09000064804a21c9
FDA-2003-N-0096-0002 FDA Revision of the Requirements for Spore-Forming Microorganisms FDA-2003-N-0096 Revision of the Requirements For Spore-Forming Microorganisms; Companion to Direct Final Rule Notice Notice of Final Rule 2003-12-30T05:00:00Z 2003 12 2003-12-30T05:00:00Z 2004-03-16T04:59:59Z 2025-06-18T19:14:55Z 03-31918 0 0 09000064804838f1
FDA-2002-D-0023-0004 FDA Human Dura Mater; Class II Special Controls Guidance FDA-2002-D-0023 FDA Notice NAD-Notice of Availability of Data 2003-12-18T05:00:00Z 2003 12 2003-12-17T05:00:00Z 2004-12-19T04:59:59Z 2008-04-12T01:16:14Z   0 0 0900006480488ef4
FDA-2002-D-0023-0005 FDA Human Dura Mater; Class II Special Controls Guidance FDA-2002-D-0023 FDA Notice NAD-Notice of Availability of Data 2003-12-18T05:00:00Z 2003 12 2003-12-17T05:00:00Z 2004-12-19T04:59:59Z 2008-04-12T01:16:14Z   0 0 0900006480488ef6
FDA-2002-N-0064-0003 FDA Neurological Devices; Classification of Human Dura Mater FDA-2002-N-0064 Neurological Devices; Classification of Human Dura Mater Notice Notice of Final Rule 2003-12-18T00:00:00Z 2003 12 2003-12-18T05:00:00Z   2025-05-13T07:52:58Z 03-31174 0 0 090000648048c4de
FDA-2003-D-0186-0005 FDA Food and Cosmetic Security Guidances FDA-2003-D-0186 FDA Notice NAD-Notice of Availability of Data 2003-12-17T05:00:00Z 2003 12 2003-12-17T05:00:00Z   2008-04-12T00:54:52Z   0 0 090000648048a872
FDA-2002-N-0064-0002 FDA Neurological Devices; Classification of Human Dura Mater FDA-2002-N-0064 Neurological Devices; Classification of Human Dura Mater Notice Notice of Final Rule 2003-12-17T05:00:00Z 2003 12 2003-12-18T05:00:00Z   2025-05-13T07:51:26Z 03-31174 0 0 090000648048c4db
FDA-2003-D-0186-0004 FDA Food and Cosmetic Security Guidances FDA-2003-D-0186 FDA Notice NAD-Notice of Availability of Data 2003-12-17T05:00:00Z 2003 12 2003-12-17T05:00:00Z   2008-04-12T00:54:52Z   0 0 090000648048a86f
FDA-2000-N-0224-0004 FDA Human Prescripton Drugs/Biologics in Electronic Format - CLOSED FDA-2000-N-0224 Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format; Notice of Approval Notice Notice of Approval 2003-12-16T05:00:00Z 2003 12 2003-12-16T05:00:00Z   2015-12-09T14:52:39Z   0 0 09000064804d542a
FDA-2003-N-0383-0001 FDA Premarket Notification Submission 510(K), FDA-2003-N-0383 Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification Submissions Notice 60 Day Proposed Information Collection 2003-12-16T05:00:00Z 2003 12 2003-12-16T05:00:00Z 2004-02-18T04:59:59Z 2025-06-23T18:52:24Z 03-30964 0 0 090000648049a1f9
FDA-2002-N-0233-0083 FDA Bioterrorism; Prior Notice of Imported Food Shipments FDA-2002-N-0233 FDA Notice NAD-Notice of Availability of Data 2003-12-16T05:00:00Z 2003 12 2003-12-12T05:00:00Z 2004-12-17T04:59:59Z 2008-04-12T01:23:40Z   0 0 0900006480498809
FDA-2003-N-0157-0004 FDA Submitting & Reviewing Complete Responses for Clinical Holds FDA-2003-N-0157 Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry: Submitting and Reviewing Complete Responses to Clinical Holds Notice Notice of Approval 2003-12-16T05:00:00Z 2003 12     2025-02-27T17:09:04Z 03-30963 0 0 0900006480487917
FDA-2003-D-0435-0001 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 Sec. 110.3 10 - “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 2003-12-15T05:00:00Z 2003 12 2003-12-15T05:00:00Z   2009-03-10T21:04:02Z   0 0 09000064804a234b
FDA-2002-N-0233-0081 FDA Bioterrorism; Prior Notice of Imported Food Shipments FDA-2002-N-0233 FDA Notice NAD-Notice of Availability of Data 2003-12-15T05:00:00Z 2003 12 2003-12-12T05:00:00Z   2008-04-12T01:23:22Z   0 0 0900006480498804
FDA-2002-N-0323-0076 FDA Bioterrorism Preparedness; Registration of Food Facilities FDA-2002-N-0323 Small Entity Compliance Guides on Registration of Food Facilities and Prior Notice of Imported Food Notice NAD-Notice of Availability of Data 2003-12-15T05:00:00Z 2003 12 2003-12-12T05:00:00Z   2009-10-27T19:46:17Z   0 0 09000064804a09c9
FDA-2003-N-0301-0001 FDA Certain Antibiotic New Animal Drug Products and Use Combinations Subject to Listings in New Animal Drug Regulations; Notice of Opportunity for Hearing; Bacitracin methylene disalicylate single-ingredient Type A Medicated articles FDA-2003-N-0301 FDA Notice NPH-Notice of Opportunity of Hearing 2003-12-12T05:00:00Z 2003 12 2003-08-05T04:00:00Z 2003-09-09T03:59:59Z 2008-04-12T01:00:02Z   0 0 0900006480493d43
FDA-2003-N-0102-0003 FDA Certain Antibiotic New Animal Drug Products and Use Combinations Subject to Listings in New Animal Drug Regulations; Notice of Opportunity for Hearing; Oxytetracycline and neomycin fixed-combination Type A medicated articles FDA-2003-N-0102 Certain Antibiotic New Animal Drug Products and Use Combinations Subject to Listings in New Animal Drug Regulations; Notice of Opportunity for Hearing; Correction Notice NCR-Notice of Correction 2003-12-12T05:00:00Z 2003 12 2003-08-05T04:00:00Z 2003-11-07T04:59:59Z 2009-08-10T22:30:15Z   0 0 09000064804840c3
FDA-2003-N-0162-0001 FDA Certain Antibiotic New Animal Drug Products and Use Combinations Subject to Listings in New Animal Drug Regulations; Notice of Opportunity for Hearing; Combination drug Type B and Type C medicated feeds for poultry containing bacitracin zinc FDA-2003-N-0162 Certain Antibiotic New Animal Drug Products and Use Combinations Subject to Listings in the New Animal Drug Regulations; Drug Efficacy Study Implementation; Notice of Opportunity for Hearing Notice Notice of Opportunity of Hearing 2003-12-12T05:00:00Z 2003 12     2025-03-14T14:16:37Z 03-20241 0 0 0900006480488554
FDA-2003-N-0301-0002 FDA Certain Antibiotic New Animal Drug Products and Use Combinations Subject to Listings in New Animal Drug Regulations; Notice of Opportunity for Hearing; Bacitracin methylene disalicylate single-ingredient Type A Medicated articles FDA-2003-N-0301 FDA Notice NCR-Notice of Correction 2003-12-12T05:00:00Z 2003 12 2003-08-05T04:00:00Z 2003-11-07T04:59:59Z 2008-04-12T01:00:02Z   0 0 0900006480493da5
FDA-2003-N-0300-0001 FDA Certain Antibiotic New Animal Drug Products and Use Combinations Subject to Listings in New Animal Drug Regulations; Notice of Opportunity for Hearing; Combination drug Type B and Type C medicated feeds for poultry containing nicarbazin FDA-2003-N-0300 Certain Antibiotic New Animal Drug Products and Use Combinations Subject to Listings in the New Animal Drug Regulations; Drug Efficacy Study Implementation; Notice of Opportunity for Hearing Notice Notice of Opportunity of Hearing 2003-12-12T05:00:00Z 2003 12     2025-03-13T19:16:21Z 03-20241 0 0 0900006480493c5c
FDA-2003-N-0102-0001 FDA Certain Antibiotic New Animal Drug Products and Use Combinations Subject to Listings in New Animal Drug Regulations; Notice of Opportunity for Hearing; Oxytetracycline and neomycin fixed-combination Type A medicated articles FDA-2003-N-0102 Certain Antibiotic New Animal Drug Products and Use Combinations Subject to Listings in New Animal Drug Regulations; Notice of Opportunity for Hearing Notice NPH-Notice of Opportunity of Hearing 2003-12-12T05:00:00Z 2003 12 2003-08-05T04:00:00Z 2003-09-09T03:59:59Z 2009-08-10T22:27:34Z   0 0 090000648048405a
FDA-2003-N-0102-0002 FDA Certain Antibiotic New Animal Drug Products and Use Combinations Subject to Listings in New Animal Drug Regulations; Notice of Opportunity for Hearing; Oxytetracycline and neomycin fixed-combination Type A medicated articles FDA-2003-N-0102 See FDA-2003-N-0102-0001 Notice NPH-Notice of Opportunity of Hearing 2003-12-12T05:00:00Z 2003 12 2003-08-05T04:00:00Z 2003-09-09T03:59:59Z 2009-08-10T22:32:45Z   0 0 09000064804840a6
FDA-2000-N-0224-0002 FDA Human Prescripton Drugs/Biologics in Electronic Format - CLOSED FDA-2000-N-0224 Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format; Final Rule Notice Notice of Final Rule 2003-12-12T05:00:00Z 2003 12 2003-12-09T05:00:00Z   2015-11-17T15:33:29Z   0 0 09000064804d5428
FDA-2003-N-0162-0002 FDA Certain Antibiotic New Animal Drug Products and Use Combinations Subject to Listings in New Animal Drug Regulations; Notice of Opportunity for Hearing; Combination drug Type B and Type C medicated feeds for poultry containing bacitracin zinc FDA-2003-N-0162 Certain Antibiotic New Animal Drug Products and Use Combinations Subject to Listings in the New Animal Drug Regulations; Drug Efficacy Study Implementation; Notice of Opportunity for Hearing; Correction Notice Correction 2003-12-12T05:00:00Z 2003 12 2003-10-07T04:00:00Z 2003-11-07T04:59:59Z 2025-03-14T14:23:01Z 03-25343 0 0 09000064804885a9
FDA-2003-N-0208-0003 FDA Electronic Records;Electronic Signatures;Agency Information FDA-2003-N-0208 Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Electronic Records; Electronic Notice Notice of Approval 2003-12-12T05:00:00Z 2003 12     2025-02-25T16:12:07Z 03-29071 0 0 090000648048bd0c
FDA-2003-N-0300-0002 FDA Certain Antibiotic New Animal Drug Products and Use Combinations Subject to Listings in New Animal Drug Regulations; Notice of Opportunity for Hearing; Combination drug Type B and Type C medicated feeds for poultry containing nicarbazin FDA-2003-N-0300 Certain Antibiotic New Animal Drug Products and Use Combinations Subject to Listings in the New Animal Drug Regulations; Drug Efficacy Study Implementation; Notice of Opportunity for Hearing; Correction Notice Correction 2003-12-12T05:00:00Z 2003 12 2003-08-05T04:00:00Z 2003-11-07T04:59:59Z 2025-03-13T19:30:24Z 03-25343 0 0 0900006480493c7d
FDA-1978-N-0027-0075 FDA Skin Protectant Drugs for O. T. C. Human Use FDA-1978-N-0027 Skin Protectant Drug Products for Over-the-Counter Human Use; Final Monograph; Technical Amendment Notice Notice of Final Rule 2003-12-09T05:00:00Z 2003 12 2003-12-09T05:00:00Z 2004-02-10T04:59:59Z 2019-08-01T14:04:49Z 03-30394 0 0 0900006480560e40
FDA-2003-N-0251-0008 FDA Inspection by Accredited Persons Under MDUFMA FDA-2003-N-0251 Agency Information Collection Activities; Announcement of the Office of Management and Budget Approval; Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002 Notice General Notice 2003-12-09T05:00:00Z 2003 12     2025-02-25T12:43:16Z 03-30534 0 0 090000648048f647
FDA-2003-N-0195-0001 FDA Error: The requested URL was not found, or cannot be served at this time. Oracle Reports Server CGI - Report Job has terminated with error. Reports Server Replies: REP-1401: 'cf_remarksformula': Fatal PL/SQL error occurred. ORA-06502: PL/SQL: numeric or value error Amending the MedWatch Forms to Collect Postmarketing Adverse Event Data Relating to Race and Ethnicity FDA-2003-N-0195 Amending the MedWatch Forms to Collect Postmarketing Adverse Event Data Relating to Race and Ethnicity Notice Request for Comments 2003-12-09T05:00:00Z 2003 12 2003-12-08T05:00:00Z 2004-02-07T04:59:59Z 2025-06-19T09:00:11Z 03-30300 0 0 090000648048b34f
FDA-2003-N-0439-0001 FDA Agency Information Collection Activities: Proposed Collection; Comment Request; Hazard Analysis and Critical Control Point (HAACP); Procedures for the Safe and Sanitary Processing and Importing b Recordkeeping Requirements for Processors of Fruit and Vegetable Juices FDA-2003-N-0439 Agency Information Collection Activities: Proposed Collection; Comment Request; Hazard Analysis and Critical Control Point; Procedures for the Safe and Sanitary Processing and Importing of Juice Notice 60 Day Proposed Information Collection 2003-12-09T05:00:00Z 2003 12 2003-12-08T05:00:00Z 2004-02-07T04:59:59Z 2025-06-19T09:00:11Z 03-30302 0 0 09000064804a23ed
FDA-1998-F-0011-0001 FDA Formaldehyde Treated oilseed meal and fats for dairy & beef FDA-1998-F-0011 FDA Notice NFR-Notice of Final Rule 2003-12-08T05:00:00Z 2003 12 2003-11-20T05:00:00Z 2004-01-21T04:59:59Z 2008-05-16T21:24:31Z   0 0 0900006480559553
FDA-2003-N-0042-0003 FDA Environmental Impact Considerations; Agency Information Collection FDA-2003-N-0042 Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Environmental Impact Considerations Notice Notice of Approval 2003-12-08T05:00:00Z 2003 12     2025-02-25T18:00:54Z 03-29068 0 0 0900006480481755
FDA-2002-D-0222-0003 FDA Stability Data Pack for Registration Climatic Zones lll & IV FDA-2002-D-0222 FDA Notice NAD-Notice of Availability of Data 2003-12-08T05:00:00Z 2003 12 2003-11-20T05:00:00Z   2008-04-12T01:17:30Z   0 0 0900006480497115
FDA-1993-D-0019-0002 FDA Stability Testing of Biotechnological/Biological Products FDA-1993-D-0019 FDA Notice NAD-Notice of Availability of Data 2003-12-08T05:00:00Z 2003 12 2003-11-21T05:00:00Z   2008-05-16T23:22:51Z   0 0 09000064804faa28
FDA-2000-D-0075-0002 FDA Voluntary Labeling for Bioengineered Foods FDA-2000-D-0075 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Suggested Documentation for Substantiating Whether Foods Have or Have Not Been Developed Using Bioengineering; Withdrawal Notice NWL-Notice of Withdrawl 2003-12-08T05:00:00Z 2003 12 2003-11-20T05:00:00Z   2010-04-28T20:00:53Z   0 0 09000064804b7783
FDA-2003-N-0027-0003 FDA Using FDA forms 3503/3504 submissions Petitions,Food/color FDA-2003-N-0027 Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Submission of Petitions: Food Additive, Color Additive (Including Labeling), and Generally Recognized as Safe Affirmation; and Electronic Submission Using FDA Forms 3503 and 3504 Notice Notice of Approval 2003-12-05T05:00:00Z 2003 12     2025-02-26T13:28:41Z 03-30029 0 0 0900006480481418
FDA-2003-E-0329-0005 FDA Patent Extension for Strattera (atomoxetine hydrochloride), 5,658,590 FDA-2003-E-0329 Determination of Regulatory Review Period for Purposes of Patent Extension; STRATTERA Notice General Notice 2003-12-05T05:00:00Z 2003 12 2003-12-03T05:00:00Z   2025-10-28T17:50:57Z 03-30028 0 0 0900006480495953
FDA-2003-N-0239-0001 FDA Civil Money Penalties Hearings; Maximum Penalty Amounts & Compliance with the Federal Civil Penalties Inflation Adjustment Act FDA-2003-N-0239 Civil Money Penalties Hearings; Maximum Penalty Amounts and Compliance With the Federal Civil Penalties Inflation Adjustment Act Notice NPR-Notice of Proposed Rule-Making 2003-12-03T05:00:00Z 2003 12 2003-12-01T05:00:00Z 2004-02-18T04:59:59Z 2025-03-13T12:54:50Z 03-29741 0 0 090000648048e6d6
FDA-2003-D-0038-0001 FDA Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Dental Precious Metal Alloys and Class II Special Controls Guidance Document: Dental Base Metal Alloys FDA-2003-D-0038 FDA Notice NAD-Notice of Availability of Data 2003-12-03T05:00:00Z 2003 12 2003-11-28T05:00:00Z   2008-04-12T00:54:16Z   0 0 09000064804816dc
FDA-2003-N-0158-0004 FDA Agency Information Collection Activities; Submission for OMB Review; Comment Request; Agreement for Shipment of Devices for Sterilization FDA-2003-N-0158 Agency Information Collection Activities; Announcement of OMB Approval; Agreement for Shipment of Devices for Sterilization Notice Notice of Approval 2003-12-03T05:00:00Z 2003 12     2025-03-03T20:41:36Z 03-29745 0 0 0900006480487a38
FDA-2003-N-0395-0003 FDA Agency Information Collection Activities: Proposed Collection; Comment Request; Export of Medical Devices; Foreign Letters of Approval FDA-2003-N-0395 Agency Information Collection Activities; Announcement of OMB Approval; Export of Medical Devices-Foreign Letters of Approval Notice Notice of Approval 2003-12-03T05:00:00Z 2003 12     2025-03-04T15:19:44Z 03-29743 0 0 09000064804a1950
FDA-2003-N-0052-0001 FDA Dental Devices; Gold Based Alloys, Precious Metal Alloys, and Base Metal Alloys; Designation of Special Controls FDA-2003-N-0052 Dental Devices; Gold Based Alloys, Precious Metal Alloys, and Base Metal Alloys; Designation of Special Controls Notice NPR-Notice of Proposed Rule-Making 2003-12-03T05:00:00Z 2003 12 2003-12-01T05:00:00Z 2004-03-02T04:59:59Z 2025-06-10T09:00:17Z 03-29739 0 0 0900006480481a12
FDA-2003-E-0262-0004 FDA Patent Extension for Deramaxx (deracoxib), 5,521,207, Substituted Pyrazolyl Benzenesulfonamide for the treatment of inflammation FDA-2003-E-0262 Determination of Regulatory Review Period for Purposes of Patent Extension; DERAMAXX Notice General Notice 2003-12-03T05:00:00Z 2003 12 2003-12-01T05:00:00Z   2025-10-23T23:36:46Z 03-29742 0 0 090000648049048b
FDA-2003-F-0055-0001 FDA Food Additive Petition for Chlorine Dioxide (FAP 4A4751) proposing that food additive regulation 173.300 be amended. FDA-2003-F-0055 Vulcan Chemicals; Filing of Food Additive Petition Notice Notice of Filing 2003-12-03T05:00:00Z 2003 12 2003-12-01T05:00:00Z 2004-01-01T04:59:59Z 2025-11-03T20:00:57Z 03-29744 0 0 0900006480481a75
FDA-2002-D-0260-0003 FDA Dental Sonography and Jaw Tracking Devices FDA-2002-D-0260 FDA Notice NAD-Notice of Availability of Data 2003-12-02T05:00:00Z 2003 12 2003-12-01T05:00:00Z 2004-03-02T04:59:59Z 2008-04-12T01:17:35Z   0 0 090000648049c625
FDA-2003-E-0067-0004 FDA Patent Extension #5,420,319 for Eloxatin (oxaliplatin) FDA-2003-E-0067 Determination of Regulatory Review Period for Purposes of Patent Extension; ELOXATIN Notice General Notice 2003-12-02T05:00:00Z 2003 12 2003-12-02T05:00:00Z   2025-10-23T19:35:22Z 03-29928 0 0 0900006480481d4d
FDA-2002-N-0017-0002 FDA Dental Sonography Device & Jaw Tracking Device FDA-2002-N-0017 FDA Notice NFR-Notice of Final Rule 2003-12-02T05:00:00Z 2003 12 2003-12-01T05:00:00Z   2008-04-12T01:20:13Z   0 0 09000064804889a3
FDA-1999-N-0134-0114 FDA Public Health Impact of Foodborne Listeria Monocytogenes FDA-1999-N-0134 FDA Notice NCR-Notice of Correction 2003-12-02T05:00:00Z 2003 12 2003-12-01T05:00:00Z   2008-04-25T00:17:00Z   0 0 09000064804aeca6
FDA-2003-D-0373-0001 FDA Draft Guidance for Industry and FDA Staff; Premarket Submissions and Labeling Recommendations for Drugs of Abuse Screening Tests; Availability FDA-2003-D-0373 FDA Notice NAD-Notice of Availability of Data 2003-12-02T05:00:00Z 2003 12 2003-12-02T05:00:00Z 2004-03-02T04:59:59Z 2008-04-12T00:55:35Z   0 0 09000064804990be
FDA-1999-N-0134-0116 FDA Public Health Impact of Foodborne Listeria Monocytogenes FDA-1999-N-0134 FDA Notice NAD-Notice of Availability of Data 2003-12-02T05:00:00Z 2003 12 2003-12-01T05:00:00Z   2008-04-25T00:16:58Z   0 0 09000064804aecaa
FDA-2003-E-0061-0004 FDA Patent Extension for Invanz (ertapenem sodium), 5,478,820 FDA-2003-E-0061 Determination of Regulatory Review Period for Purposes of Patent Extension; INVANZ Notice General Notice 2003-12-02T05:00:00Z 2003 12 2003-12-02T05:00:00Z   2025-10-24T19:12:22Z 03-29929 0 0 0900006480481aed
FDA-2003-E-0261-0004 FDA Patent Extension for Lexapro (escitalopram oxalate), 34,712 FDA-2003-E-0261 Determination of Regulatory Review Period for Purposes of Patent Extension; LEXAPRO Notice General Notice 2003-12-02T05:00:00Z 2003 12 2003-12-02T05:00:00Z   2025-10-24T22:03:18Z 03-29927 0 0 0900006480490349
FDA-2003-D-0376-0001 FDA Bundling Multiple Devices in a Single Application; Draft Guidance for Industry and FDA; Availability FDA-2003-D-0376 FDA Notice NAD-Notice of Availability of Data 2003-11-28T05:00:00Z 2003 11 2003-11-25T05:00:00Z   2008-04-12T00:55:39Z   0 0 09000064804994a5
FDA-2002-E-0285-0002 FDA Patent Term Extension Application for XIGRIS No. 4,775,624 FDA-2002-E-0285 Determination of Regulatory Review Period for Purposes of Patent Extension; XIGRIS Notice General Notice 2003-11-28T05:00:00Z 2003 11 2003-11-25T05:00:00Z   2025-10-02T18:39:58Z 03-29333 0 0 090000648049ebf6
FDA-2003-E-0168-0003 FDA Patent Extension for Xigris (drotrecogin alpha), 4,775,624 and 5,009,889, and 5,681,932 FDA-2003-E-0168 Determination of Regulatory Review Period for Purposes of Patent Extension; XIGRIS Notice Determinations 2003-11-28T05:00:00Z 2003 11 2003-11-25T05:00:00Z   2025-10-27T18:41:47Z 03-29333 0 0 0900006480488d36
FDA-2003-N-0161-0026 FDA Obesity and Nutrition FDA-2003-N-0161 Food Labels, Packaging, Restaurants, and Weight Management; Public Workshop; Amendment of Notice Notice NM-Notice of Meeting 2003-11-28T05:00:00Z 2003 11 2003-11-19T05:00:00Z 2003-12-13T04:59:59Z 2009-11-21T23:14:33Z   0 0 090000648048807f
FDA-2003-N-0045-0001 FDA Food Labeling: Health Claims; Dietary Guidance FDA-2003-N-0045 FDA Notice NPR-Notice of Proposed Rule-Making 2003-11-28T05:00:00Z 2003 11 2003-11-25T05:00:00Z 2004-01-27T04:59:59Z 2008-04-12T00:58:08Z   0 0 09000064804817a5
FDA-2001-P-0123-0001 FDA Switch Status of Emergency Contraceptives from Rx to OTC FDA-2001-P-0123 FDA - Notice of Meeting Notice NM-Notice of Meeting 2003-11-28T05:00:00Z 2003 11 2003-11-24T05:00:00Z   2009-07-17T19:32:07Z   0 0 09000064804bcde3
FDA-1998-D-0001-0001 FDA PMA/510(K)Expedited Review Guidance for Industry FDA-1998-D-0001 FDA Notice NAD-Notice of Availability of Data 2003-11-28T05:00:00Z 2003 11 2003-11-25T05:00:00Z   2008-05-16T21:17:53Z   0 0 09000064805585b6
FDA-1999-N-0069-0002 FDA Public Information Regulations FDA-1999-N-0069 Public Information Regulations; Correction Notice Correction 2003-11-28T05:00:00Z 2003 11     2024-10-21T18:57:38Z 03-28985 0 0 09000064804a6860
FDA-2003-D-0144-0009 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 2003-11-28T05:00:00Z 2003 11 2003-11-20T05:00:00Z 2004-01-21T04:59:59Z 2008-04-12T00:54:35Z   0 0 09000064804868b9
FDA-2003-N-0046-0001 FDA Electronic Submissions of Food Contact Notifications; Notice of Pilot Project FDA-2003-N-0046 Electronic Submissions of Food Contact Notifications; Notice of Pilot Project Notice General Notice 2003-11-28T05:00:00Z 2003 11 2003-11-26T05:00:00Z   2025-06-19T09:00:11Z 03-29462 0 0 0900006480481881
FDA-2003-E-0263-0003 FDA Patent extension ABILIFY (aripiprazole) Patent No. 5,006,528 FDA-2003-E-0263 Determination of Regulatory Review Period for Purposes of Patent Extension; ABILIFY Notice Determinations 2003-11-28T05:00:00Z 2003 11 2003-11-26T05:00:00Z   2025-10-23T17:25:51Z 03-29464 0 0 09000064804904a6
FDA-2003-D-0203-0001 FDA Guidance for Industry and FDA Staff; User Fees and Refunds for Premarket Approval Applications FDA-2003-D-0203 FDA Notice NAD-Notice of Availability of Data 2003-11-25T05:00:00Z 2003 11 2003-11-21T05:00:00Z   2008-04-12T00:54:59Z   0 0 090000648048b8ac
FDA-2003-N-0311-0002 FDA Agency Information Collection Activities: Proposed Collection; Comment Request; Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products FDA-2003-N-0311 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products Notice 30 Day Proposed Information Collection 2003-11-25T05:00:00Z 2003 11 2003-11-21T05:00:00Z 2003-12-25T04:59:59Z 2025-03-13T18:25:15Z 03-29195 0 0 0900006480494bd0
FDA-2003-N-0390-0001 FDA Agency Information Collection Activities; Proposed Collection; Comment Request; Focus Groups as Used by the Food and Drug Administration FDA-2003-N-0390 Agency Information Collection Activities; Proposed Collection; Comment Request; Focus Groups as Used by the Food and Drug Administration Notice 60 Day Proposed Information Collection 2003-11-25T05:00:00Z 2003 11 2003-11-24T05:00:00Z 2004-01-24T04:59:59Z 2025-06-17T22:09:36Z 03-29197 0 0 09000064804a1038
FDA-2002-N-0233-0040 FDA Bioterrorism; Prior Notice of Imported Food Shipments FDA-2002-N-0233 FDA Notice NCR-Notice of Correction 2003-11-21T05:00:00Z 2003 11 2003-11-06T05:00:00Z   2008-04-12T01:23:39Z   0 0 090000648049879f
FDA-2003-D-0037-0001 FDA Guidance for Industry: IRB Review of Stand-Alone HIPAA Authorizations; Availability FDA-2003-D-0037 FDA Notice NAD-Notice of Availability of Data 2003-11-21T05:00:00Z 2003 11 2003-11-06T05:00:00Z   2008-04-12T00:54:15Z   0 0 09000064804816c9
FDA-2002-N-0323-0034 FDA Bioterrorism Preparedness; Registration of Food Facilities FDA-2002-N-0323 Interim Final Regulations Implementing Title III, Subtitle A, of Public Health Security and Bioterrorism Preparedness and Response Act of 2002-Section 305: Registration of Food Facilities and Section 307: Prior Notice of Imported Food Shipments; Notice of Public Meeting; Correction Notice NCR-Notice of Correction 2003-11-21T05:00:00Z 2003 11 2003-11-06T05:00:00Z   2009-10-08T19:10:00Z   0 0 09000064804a0938
FDA-1996-D-0048-0002 FDA Impurities in new drug products guideline FDA-1996-D-0048 FDA Notice NAD-Notice of Availability of Data 2003-11-21T05:00:00Z 2003 11 2003-11-13T05:00:00Z   2008-05-16T22:15:27Z   0 0 09000064804fc7bc
FDA-1999-N-0134-0113 FDA Public Health Impact of Foodborne Listeria Monocytogenes FDA-1999-N-0134 FDA Notice NM-Notice of Meeting 2003-11-21T05:00:00Z 2003 11 2003-11-06T05:00:00Z   2008-04-25T00:16:59Z   0 0 09000064804aeca4
FDA-2003-N-0250-0001 FDA Agency Information Collection Activities: Proposed Collection; Comment Request; Mammography Facilities, Standards, and Lay Summaries for Patients FDA-2003-N-0250 Agency Information Collection Activities; Proposed Collection; Comment Request; Mammography Facilities, Standards, and Lay Summaries for Patients Notice 60 Day Proposed Information Collection 2003-11-21T05:00:00Z 2003 11 2003-11-07T05:00:00Z 2004-01-07T04:59:59Z 2025-06-16T20:03:20Z   0 0 090000648048f4d2
FDA-2003-P-0120-0002 FDA Request whether Cataflam (diclofenac Potassium) Tablets 25 mg (NDA 20-12) mfged by Novartis Pharmaceuticals Corporation, has been voluntarily withdrawn or withheld from sale for safety or effectiveness reasons. FDA-2003-P-0120 Notice of Determination Notice N-Notice 2003-11-18T05:00:00Z 2003 11 2003-11-18T05:00:00Z 2003-11-18T04:59:59Z 2024-10-30T21:35:20Z 68FR65074 0 0 0900006480485a41
FDA-2003-N-0317-0001 FDA Medical Devices; Effective Date of Requirement for Premarket Approval for Three Class III Preamendments Devices FDA-2003-N-0317 Medical Devices; Effective Date of Requirement for Premarket Approval for Three Class III Preamendments Devices Notice NPR-Notice of Proposed Rule-Making 2003-11-18T05:00:00Z 2003 11 2003-11-18T05:00:00Z 2004-02-18T04:59:59Z 2025-06-16T16:54:31Z 03-28741 0 0 09000064804953cb
FDA-2003-N-0319-0001 FDA Agency Information Collection Activities; Proposed Collection; Comment Request; Study to Measure the Compliance of Prescribers with the Contraindication of the Use of b Triptansb in Migraine Headache Patients with Vascular Disease FDA-2003-N-0319 Agency Information Collection Activities; Proposed Collection; Comment Request; Study to Measure the Compliance of Prescribers With the Contraindication of the Use of Triptans in Migraine Headache Patients With Vascular Disease Notice 60 Day Proposed Information Collection 2003-11-17T05:00:00Z 2003 11 2003-11-17T05:00:00Z 2004-01-17T04:59:59Z 2025-06-25T15:30:11Z   0 0 0900006480495652
FDA-2003-N-0310-0001 FDA Agency Emergency Processing Under OMB Review; Experimental Study of Health Claim Disclaimers on Foods FDA-2003-N-0310 Agency Emergency Processing Under Office of Management and Budget Review; Experimental Study of Health Claim Disclaimers on Foods Notice General Notice 2003-11-14T05:00:00Z 2003 11 2003-11-10T05:00:00Z 2003-12-11T04:59:59Z 2025-06-17T23:18:09Z 03-28196 0 0 0900006480494a8f
FDA-2003-D-0433-0001 FDA International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Studies to evaluate the safety of residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological ADI (VICH GL-36) Request for Comments; Availability FDA-2003-D-0433 FDA Notice NAD-Notice of Availability of Data 2003-11-13T05:00:00Z 2003 11 2003-11-12T05:00:00Z 2003-12-16T04:59:59Z 2008-04-12T00:55:51Z   0 0 09000064804a2315
FDA-2001-B-0228-0004 FDA Permitted Daily Exposures for two solvents, N-Methylpyrrolld FDA-2001-B-0228 FDA Notice NAD-Notice of Availability of Data 2003-11-13T05:00:00Z 2003 11 2003-11-12T05:00:00Z   2008-04-25T02:37:02Z   0 0 09000064804e59fc
FDA-2002-D-0091-0003 FDA Safety of Residues of Veterinary Drugs In Human Food FDA-2002-D-0091 FDA Notice NAD-Notice of Availability of Data 2003-11-13T05:00:00Z 2003 11 2003-11-12T05:00:00Z   2008-04-12T01:16:26Z   0 0 090000648048e1bd
FDA-2003-N-0382-0001 FDA Agency Information Collection Activities; Proposed Collection; Comment Request; Food Additive Petitions FDA-2003-N-0382 Agency Information Collection Activities; Proposed Collection; Comment Request; Food Additive Petitions Notice 60 Day Proposed Information Collection 2003-11-13T05:00:00Z 2003 11 2003-11-10T05:00:00Z 2004-01-13T04:59:59Z 2025-06-16T18:57:40Z 03-28252 0 0 090000648049a04b
FDA-2003-N-0094-0001 FDA Agency Emergency Processing Request Under OMB Review; Experimental Study of Trans Fat Claims on Foods FDA-2003-N-0094 Agency Emergency Processing Request Under OMB Review; Experimental Study of Trans Fat Claims on Foods Notice General Notice 2003-11-12T05:00:00Z 2003 11 2003-11-10T05:00:00Z 2003-12-11T04:59:59Z 2025-06-17T19:40:58Z 03-28194 0 0 0900006480483621
FDA-2003-N-0438-0001 FDA Agency Emergency Processing Request Under OMB Review; Experimental Study of Possible Footnotes and Cuing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosure on the Nutrition Facts Panel (NFP) FDA-2003-N-0438 Agency Emergency Processing Request Under Office of Management and Budget Review; Experimental Study of Possible Footnotes and Cuing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosure on the Nutrition Facts Panel Notice 30 Day Proposed Information Collection 2003-11-12T05:00:00Z 2003 11 2003-11-10T05:00:00Z 2003-12-11T04:59:59Z 2025-06-18T09:00:04Z 03-28195 0 0 09000064804a23bf
FDA-2003-D-0200-0001 FDA Compliance Program Guidance Manual 7371.009; BSE/Ruminant Feed Ban Inspections; Availability FDA-2003-D-0200 FDA Notice NAD-Notice of Availability of Data 2003-11-12T05:00:00Z 2003 11 2003-11-07T05:00:00Z   2008-04-12T00:54:56Z   0 0 090000648048b7fb
FDA-2002-P-0127-0003 FDA Delcobese Tablets and Capsules FDA-2002-P-0127 FDA Notice N-Notice 2003-11-12T05:00:00Z 2003 11 2003-11-07T05:00:00Z   2008-04-12T01:26:40Z   0 0 090000648049053d
FDA-1999-N-0098-0001 FDA Status reports/postmarketing studies-human drugs&biological FDA-1999-N-0098 Notice of Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; "Draft Guidance for Industry: Reports on the Status of Postmarketing Studies - Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 Notice N-Notice 2003-11-10T05:00:00Z 2003 11 2003-11-04T05:00:00Z 2003-12-06T04:59:59Z 2024-10-03T16:08:25Z 65FR64607 0 0 09000064804a6b1a
FDA-2002-P-0245-0002 FDA Requests FDA Determination regarding whether Wydase (Hyaluronidase) Inj. was withdrawn for Safety Reasons FDA-2002-P-0245 FDA Determination that Wydase (Hyaluronidase) Inj. was not Withdrawn for Safety or Effectiveness Reasons 68 FR 62810 Notice N-Notice 2003-11-10T05:00:00Z 2003 11 2003-11-05T05:00:00Z   2016-04-24T16:19:16Z 68 0 0 090000648049a9c3
FDA-2003-M-0216-0001 FDA P010052 - Diagnostic Products Corporation, IMMULITE?? Anti-HBs and IMMULITE?? 2000 Anti-HBs, Approved 7/22/02 FDA-2003-M-0216 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Data Availability 2003-11-10T05:00:00Z 2003 11 2003-11-05T05:00:00Z   2025-04-16T19:48:25Z 03-27882 0 0 090000648048c897
FDA-2003-N-0044-0005 FDA Risk Management Programs on the Practice of Pharmacy FDA-2003-N-0044 Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Impact of Risk Management Programs on the Practice of Pharmacy Notice Notice of Approval 2003-11-10T05:00:00Z 2003 11     2025-02-18T21:15:36Z 03-27881 0 0 0900006480481790
FDA-2000-D-0075-0001 FDA Voluntary Labeling for Bioengineered Foods FDA-2000-D-0075 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Suggested Documentation for Substantiating Whether Foods Have or Have Not Been Developed Using Bioengineering Notice N-Notice 2003-11-07T05:00:00Z 2003 11 2003-10-31T05:00:00Z 2003-12-02T04:59:59Z 2015-10-10T19:27:31Z   0 0 09000064804b0347
FDA-2003-D-0146-0001 FDA Guidance for Industry on Product Recalls, Including Removals and Corrections; Availability FDA-2003-D-0146 Guidance for Industry on Product Recalls, Including Removals and Corrections; Availability Notice NAD-Notice of Availability of Data 2003-11-07T05:00:00Z 2003 11 2003-11-07T05:00:00Z   2008-04-14T01:44:41Z   0 0 0900006480486c45
FDA-2003-D-0148-0001 FDA Class II Special Controls Guidance Document: Endotoxin Activity Assay FDA-2003-D-0148 FDA Notice NAD-Notice of Availability of Data 2003-11-07T05:00:00Z 2003 11 2003-10-30T05:00:00Z   2008-04-12T00:54:42Z   0 0 0900006480486e7e
FDA-2003-D-0148-0003 FDA Class II Special Controls Guidance Document: Endotoxin Activity Assay FDA-2003-D-0148 FDA Notice NFR-Notice of Final Rule 2003-11-07T05:00:00Z 2003 11 2003-10-30T05:00:00Z   2008-04-12T00:54:42Z   0 0 0900006480486ee1
FDA-2003-N-0156-0001 FDA Agency Information Collection Activities: Proposed Collection; Comment Request; Food Labeling Regulations FDA-2003-N-0156 Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling Regulations Notice 60 Day Proposed Information Collection 2003-11-07T05:00:00Z 2003 11 2003-10-31T05:00:00Z 2003-12-31T04:59:59Z 2025-06-16T23:47:37Z 03-27388 0 0 09000064804877fb
FDA-2003-N-0452-0001 FDA Agency Information Collection Activities; Proposed Collection; Comment Request; Certain Biologics Labeling FDA-2003-N-0452 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Certain Biologics Labeling Notice 60 Day Proposed Information Collection 2003-11-07T05:00:00Z 2003 11 2003-10-31T05:00:00Z 2003-12-02T04:59:59Z 2025-03-12T19:49:21Z 03-27389 0 0 09000064804a25cb
FDA-2003-D-0306-0001 FDA Guidance for Industry on Powder Blends and Finished Dosage Units -- Stratified In-Process Dosage Unit Sampling and Assessment FDA-2003-D-0306 Draft Guidance for Industry on Powder Blends and Finished Dosage Units Stratified In-Process Dosage Unit Sampling and Assessment Notice Notice of Availability 2003-11-07T05:00:00Z 2003 11 2003-11-07T05:00:00Z 2004-03-09T04:59:59Z 2014-07-15T17:55:28Z   0 0 0900006480494496
FDA-2003-D-0031-0001 FDA Guidance for Industry on Pharmacogenomic Data Submissions FDA-2003-D-0031 FDA Notice NAD-Notice of Availability of Data 2003-11-04T05:00:00Z 2003 11 2003-11-04T05:00:00Z 2004-01-06T04:59:59Z 2008-04-12T00:54:06Z   0 0 090000648048155f

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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);