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

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720 rows where agency_id = "FDA", document_type = "Notice" and posted_year = 2012 sorted by posted_date descending

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posted_year 1

  • 2012 · 720 ✖

document_type 1

  • Notice · 720 ✖

agency_id 1

  • FDA · 720 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2011-N-0899-0003 FDA FDA-2011-N-0899 Finding of no Significant Impact for Genetically Engineered Atlantic Salmon (AquAdvantage Salmon) Notice Availability of Document 2012-12-27T05:00:00Z 2012 12 2012-12-27T05:00:00Z 2013-04-27T03:59:59Z 2014-11-14T03:06:12Z   0 0 090000648119d263
FDA-2011-N-0899-0001 FDA FDA-2011-N-0899 Draft Environmental Assessment and Preliminary Finding of No Significant Impact Concerning a Genetically Engineered Atlantic Salmon; Availability Notice General Notice 2012-12-26T05:00:00Z 2012 12 2012-12-26T05:00:00Z 2013-02-15T04:59:59Z 2014-08-21T13:21:56Z 2012-31118 0 0 090000648119a623
FDA-2012-N-0176-0004 FDA FDA-2012-N-0176 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Experimental Study; Examination of Corrective Direct-to-Consumer Television Advertising Notice General Notice 2012-12-26T05:00:00Z 2012 12 2012-12-26T05:00:00Z   2012-12-28T16:20:17Z 2012-31028 0 0 090000648119a713
FDA-2012-N-0001-0153 FDA FDA-2012-N-0001 Public Workshops: Minimal Residual Disease Notice Meeting 2012-12-26T05:00:00Z 2012 12 2012-12-26T05:00:00Z   2012-12-26T16:07:03Z 2012-31043 0 0 090000648119a540
FDA-2010-D-0643-0051 FDA FDA-2010-D-0643 Draft Guidances for Industry; Availability, etc.: Electronic Source Data in Clinical Investigations; Correction Notice Correction 2012-12-26T05:00:00Z 2012 12 2012-12-26T05:00:00Z   2012-12-26T15:59:59Z 2012-31027 0 0 0900006481199d80
FDA-2012-N-0001-0154 FDA FDA-2012-N-0001 Public Workshops on Minimal Residual Disease Notice Meeting 2012-12-26T05:00:00Z 2012 12 2012-12-26T05:00:00Z   2012-12-26T16:13:42Z 2012-31044 0 0 090000648119a75b
FDA-2011-N-0899-0002 FDA FDA-2011-N-0899 Draft Environmental Assessment for Genetically Engineered Atlantic Salmon (AquAdvantage Salmon) Notice Availability of Environmental Assessment 2012-12-26T05:00:00Z 2012 12 2012-12-26T05:00:00Z 2013-04-27T03:59:59Z 2015-04-11T02:05:38Z   0 0 090000648119a936
FDA-2012-N-1181-0001 FDA FDA-2012-N-1181 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Medicated Feed Mill License Application; Extension Notice Notice of Extension 2012-12-21T05:00:00Z 2012 12 2012-12-21T05:00:00Z 2013-02-20T04:59:59Z 2013-01-09T03:07:26Z 2012-30738 0 0 09000064811954b9
FDA-2002-N-0106-0003 FDA Proposal to Debar Baldev Raj Bhutani/Notice of Opportunity for Hearing FDA-2002-N-0106 Denial of Hearing on Application for Special Termination of Debarment: Baldev Raj Bhutani Notice Notice of Final Rule 2012-12-21T05:00:00Z 2012 12     2012-12-21T14:50:12Z 2012-30709 0 0 09000064811954bc
FDA-2010-D-0482-0033 FDA FDA-2010-D-0482 Guidances for Industry and Investigators; on Safety Reporting Requirements for Investigational New Drug Applications and Bioavailability/ Bioequivalence Studies, and a Small Entity Compliance Guide; Availability Notice Notice of Availability 2012-12-20T05:00:00Z 2012 12 2012-12-20T05:00:00Z   2019-08-22T20:02:45Z 2012-30651 0 0 0900006481193abb
FDA-2012-N-0548-0086 FDA FDA-2012-N-0548 Drug Safety and Risk Management Advisory Committee Notice of Meeting Notice Meeting 2012-12-19T05:00:00Z 2012 12 2012-12-19T05:00:00Z 2013-02-02T04:59:59Z 2013-05-24T01:03:08Z 2012-30517 0 0 09000064811924c9
FDA-1977-N-0018-0091 FDA Over-the-Counter Internal Analgesic, Antipyretic & Antirheumatic Products: OPEN FDA-1977-N-0018 Drug Products for the Treatment and/or Prevention of Nocturnal Leg Muscle Cramps for Over-the-Counter Human Use; Final Rule Notice Notice of Final Rule 2012-12-19T05:00:00Z 2012 12 2012-12-19T05:00:00Z   2018-12-26T13:27:13Z 94-20449 0 0 09000064805d9854
FDA-2012-N-0976-0002 FDA FDA-2012-N-0976 Agency Information Collection Activities Proposals, Submissions, and Approvals: Emergency Use Authorization of Medical Products Notice 30 Day Proposed Information Collection 2012-12-19T05:00:00Z 2012 12     2016-03-04T13:00:50Z 2012-30513 0 0 0900006481192371
FDA-2012-N-1202-0001 FDA FDA-2012-N-1202 Comprehensive Assessment of the Process for the Review of Device Submissions; Request for Comments Notice General Notice 2012-12-19T05:00:00Z 2012 12 2012-12-19T05:00:00Z 2013-02-05T04:59:59Z 2013-02-05T03:01:42Z 2012-30511 0 0 0900006481192403
FDA-2012-D-1168-0001 FDA FDA-2012-D-1168 Draft Guidances for Industry Providing Submissions in Electronic Format- Summary Level Clinical Site Data for Center for Drug Evaluation and Research's Inspection Planning; Availability Notice Notice of Availability 2012-12-19T05:00:00Z 2012 12 2012-12-19T05:00:00Z 2013-02-20T04:59:59Z 2013-02-20T03:08:53Z 2012-30510 0 0 09000064811922f2
FDA-1999-D-4090-0001 FDA Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer FDA-1999-D-4090 Medical Devices; Guidance Document for Premarket Notification Submissions for the Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer, and Nitrogen Dioxide Analyzer; Availability Notice Notice of Data Availability 2012-12-19T05:00:00Z 2012 12 2012-12-19T05:00:00Z 2000-04-25T03:59:59Z 2025-07-24T18:56:49Z 00-1535 0 0 09000064804f5f16
FDA-2012-N-1172-0001 FDA FDA-2012-N-1172 Impact of Approved Drug Labeling on Chronic Opioid Therapy: Public Hearings Request for Comments Notice Hearings 2012-12-19T05:00:00Z 2012 12 2012-12-19T05:00:00Z 2013-04-09T03:59:59Z 2013-04-17T01:04:39Z 2012-30516 0 0 090000648119224c
FDA-2012-D-1197-0001 FDA FDA-2012-D-1197 Draft Guidance for Industry on Certification of Designated Medical Gases; Availability Notice Notice of Availability 2012-12-18T05:00:00Z 2012 12 2012-12-18T05:00:00Z 2013-02-20T04:59:59Z 2013-02-09T03:01:18Z 2012-30382 0 0 0900006481190823
FDA-2012-D-1145-0001 FDA FDA-2012-D-1145 Draft Guidances for Industry on Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products; Availability Notice Notice of Availability 2012-12-17T05:00:00Z 2012 12 2012-12-17T05:00:00Z 2013-02-16T04:59:59Z 2013-02-15T03:02:38Z 2012-30274 0 0 090000648118f64f
FDA-2012-D-1003-0001 FDA FDA-2012-D-1003 Small Entity Compliance Guide: What You Need to Know About Registration of Food Facilities; Availability Notice Notice of Availability 2012-12-17T05:00:00Z 2012 12 2012-12-17T05:00:00Z   2012-12-17T16:14:51Z 2012-30327 0 0 090000648118f8e1
FDA-2012-N-1167-0001 FDA FDA-2012-N-1167 Proposals to Withdraw Approvals of New Animal Drug Applications: Ag-Mark, Inc., et al.; Opportunity for Hearing Notice General Notice 2012-12-17T05:00:00Z 2012 12 2012-12-17T05:00:00Z   2012-12-17T16:30:35Z 2012-30089 0 0 090000648118f699
FDA-2004-D-0298-0006 FDA Compliance Policy Guide Sec. 400.210 Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs, Availability FDA-2004-D-0298 Compliance Policy Guide: Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs; Notice to Extend Expiration Date Notice Notice of Availability 2012-12-17T05:00:00Z 2012 12 2012-12-17T05:00:00Z   2012-12-17T14:58:49Z 2012-30297 0 0 090000648118f615
FDA-2007-D-0369-0097 FDA FDA-2007-D-0369 Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability Notice Notice of Availability 2012-12-17T05:00:00Z 2012 12 2012-12-17T05:00:00Z 2013-02-16T04:59:59Z 2013-02-16T03:01:24Z 2012-30308 0 0 090000648118f5a2
FDA-2012-D-1002-0001 FDA FDA-2012-D-1002 Guidances for Industry: Questions and Answers Regarding Food Facility Registration (Fifth Edition) Notice Notice of Availability 2012-12-17T05:00:00Z 2012 12 2012-12-17T05:00:00Z   2012-12-17T15:24:50Z 2012-30328 0 0 090000648118f692
FDA-2012-N-1203-0001 FDA FDA-2012-N-1203 Agency Information Collection Activities; Proposed Collection; Comment Request; Information to Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements Notice 60 Day Proposed Information Collection 2012-12-17T05:00:00Z 2012 12 2012-12-17T05:00:00Z 2013-02-16T04:59:59Z 2016-01-07T12:43:50Z 2012-30275 0 0 090000648118f53f
FDA-2012-N-0001-0151 FDA FDA-2012-N-0001 Pulmonary-Allergy Drugs Advisory Committee Notice Meeting 2012-12-14T05:00:00Z 2012 12 2012-12-14T05:00:00Z   2012-12-14T14:00:46Z 2012-30171 0 0 090000648118c473
FDA-2012-N-0711-0001 FDA FDA-2012-N-0711 Establishments of Dockets: Risk Assessment for Establishing Food Allergen Thresholds; Request for Comments Notice   2012-12-14T05:00:00Z 2012 12 2012-12-14T05:00:00Z 2013-02-13T04:59:59Z 2013-03-06T03:02:08Z 2012-30123 0 0 090000648118c624
FDA-2012-N-0001-0150 FDA FDA-2012-N-0001 Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Correction Notice Correction 2012-12-13T05:00:00Z 2012 12 2012-12-13T05:00:00Z   2012-12-13T18:54:38Z 2012-30024 0 0 090000648118b131
FDA-2012-D-1005-0001 FDA FDA-2012-D-1005 Draft Guidances for Industry on Safety Considerations for Product Design to Minimize Medication Errors; Availability Notice Notice of Availability 2012-12-13T05:00:00Z 2012 12 2012-12-13T05:00:00Z 2013-02-12T04:59:59Z 2013-02-12T03:01:51Z 2012-30034 0 0 090000648118af95
FDA-2012-D-1161-0001 FDA FDA-2012-D-1161 Draft Guidances for Industry and Food and Drug Administration Staff; Design Considerations for Devices Intended for Home Use; Availability Notice Notice of Availability 2012-12-13T05:00:00Z 2012 12 2012-12-13T05:00:00Z 2013-03-14T03:59:59Z 2013-03-23T02:01:36Z 2012-30033 0 0 090000648118af5f
FDA-2012-D-0429-0006 FDA FDA-2012-D-0429 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Meetings With Industry and Investigators on the Research and Development of Tobacco Products Notice 30 Day Proposed Information Collection 2012-12-13T05:00:00Z 2012 12 2012-12-13T05:00:00Z 2013-01-15T04:59:59Z 2015-09-08T13:34:31Z 2012-30057 0 0 090000648118b0e3
FDA-2011-N-0568-0004 FDA FDA-2011-N-0568 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Experimental Study; Disease Information in Branded Promotional Material Notice Notice of Approval 2012-12-12T05:00:00Z 2012 12 2012-12-12T05:00:00Z   2012-12-12T14:11:15Z 2012-29931 0 0 090000648118881d
FDA-2012-D-0530-0019 FDA FDA-2012-D-0530 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guidance on Medical Devices; Pre-Submission Program and Meetings with FDA Staff Notice 30 Day Proposed Information Collection 2012-12-11T05:00:00Z 2012 12 2012-12-11T05:00:00Z 2013-01-11T04:59:59Z 2015-11-12T13:04:02Z 2012-29788 0 0 090000648118589b
FDA-2010-N-0304-0001 FDA FDA-2010-N-0304 Debarment Orders: Susan F. Knott; Denial of Hearing Notice Notice of Denial 2012-12-11T05:00:00Z 2012 12 2012-12-11T05:00:00Z   2012-12-11T14:56:16Z 2012-29782 0 0 0900006481185ab3
FDA-2012-N-0001-0149 FDA FDA-2012-N-0001 Cellular, Tissue, and Gene Therapies Advisory Committee Meeting Notice Meeting 2012-12-10T05:00:00Z 2012 12 2012-12-10T05:00:00Z   2012-12-10T14:45:28Z 2012-29706 0 0 090000648118457e
FDA-2012-N-0001-0148 FDA FDA-2012-N-0001 Endocrinologic and Metabolic Drugs Advisory Committee Meeting Notice Meeting 2012-12-10T05:00:00Z 2012 12 2012-12-10T05:00:00Z   2012-12-10T14:41:31Z 2012-29650 0 0 0900006481184647
FDA-2012-N-0001-0147 FDA FDA-2012-N-0001 Neurological Devices Panel of Medical Devices Advisory Committee Meeting Notice Meeting 2012-12-07T05:00:00Z 2012 12 2012-12-07T05:00:00Z   2012-12-07T16:25:14Z 2012-29538 0 0 09000064811824e2
FDA-2012-N-0001-0146 FDA FDA-2012-N-0001 Requests for Nominations: Nonvoting Industry Representatives on Public Advisory Panels Notice General Notice 2012-12-07T05:00:00Z 2012 12 2012-12-07T05:00:00Z   2012-12-07T16:19:35Z 2012-29574 0 0 090000648118242a
FDA-2012-D-1086-0001 FDA FDA-2012-D-1086 Compliance Guidancesfor Small Business Entities; Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use; Availability Notice Notice of Availability 2012-12-06T05:00:00Z 2012 12 2012-12-06T05:00:00Z   2012-12-06T17:34:56Z 2012-29462 0 0 0900006481180cf4
FDA-2012-D-1135-0001 FDA FDA-2012-D-1135 Guidances for Industry on Limiting Use of Certain Phthalates as Excipients in Center for Drug Evaluation and Research-Regulated Products; Availability Notice Notice of Availability 2012-12-06T05:00:00Z 2012 12 2012-12-06T05:00:00Z   2012-12-06T17:25:38Z 2012-29461 0 0 0900006481180e50
FDA-2012-N-0813-0002 FDA FDA-2012-N-0813 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Applications for Approval to Market New Drug; Revision of Postmarketing Reporting Requirements; Discontinuance Notice General Notice 2012-12-05T05:00:00Z 2012 12 2012-12-05T05:00:00Z 2013-01-05T04:59:59Z 2012-12-05T14:50:06Z 2012-29327 0 0 090000648117f7fe
FDA-2012-N-0273-0006 FDA FDA-2012-N-0273 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Experimental Study of Graphic Cigarette Warning Labels Notice General Notice 2012-12-05T05:00:00Z 2012 12 2012-12-05T05:00:00Z 2013-01-05T04:59:59Z 2013-01-04T03:02:33Z 2012-29321 0 0 090000648117f804
FDA-2011-N-0655-0007 FDA FDA-2011-N-0655 Animal Generic Drug User Fee Act Public Meeting Notice Meeting 2012-12-05T05:00:00Z 2012 12 2012-12-05T05:00:00Z 2013-01-05T04:59:59Z 2013-01-05T03:04:18Z 2012-29499 0 0 090000648117eb49
FDA-2011-N-0656-0009 FDA FDA-2011-N-0656 Animal Drug User Fee Act Public Meeting Notice Meeting 2012-12-05T05:00:00Z 2012 12 2012-12-05T05:00:00Z 2013-01-05T04:59:59Z 2013-01-05T03:04:25Z 2012-29498 0 0 090000648117f67f
FDA-2012-N-1040-0002 FDA FDA-2012-N-1040 Antiseptic Patient Preoperative Skin Preparation Products; Public Hearing; Correction Notice Correction 2012-12-04T05:00:00Z 2012 12 2012-12-04T05:00:00Z   2012-12-05T21:36:18Z 2012-29166 0 0 090000648117e58b
FDA-2012-D-0081-0008 FDA FDA-2012-D-0081 Guidance on Investigational New Drug Applications for Positron Emission Tomography Drugs Notice Notice of Availability 2012-12-04T05:00:00Z 2012 12 2012-12-04T05:00:00Z   2012-12-04T16:52:03Z 2012-29163 0 0 090000648117e397
FDA-2012-D-0080-0004 FDA FDA-2012-D-0080 Guidance on Oversight of Positron Emission Tomography Drug Products - Questions and Answers Notice Notice of Availability 2012-12-04T05:00:00Z 2012 12 2012-12-04T05:00:00Z   2012-12-04T16:38:40Z 2012-29157 0 0 090000648117e3df
FDA-2012-N-0001-0145 FDA FDA-2012-N-0001 Requests for Nominations: Nonvoting Industry Representatives on the Device Good Manufacturing Practice Advisory Committee Notice General Notice 2012-12-04T05:00:00Z 2012 12 2012-12-04T05:00:00Z   2012-12-04T16:34:39Z 2012-29165 0 0 090000648117e51c
FDA-2010-N-0307-0004 FDA FDA-2010-N-0307 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Antiparasitic Drug and Resistance Survey Notice General Notice 2012-12-03T05:00:00Z 2012 12 2012-12-03T05:00:00Z 2013-02-02T04:59:59Z 2013-01-29T03:01:03Z 2012-29094 0 0 090000648117c781
FDA-2012-N-0477-0004 FDA FDA-2012-N-0477 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Investigational Device Exemptions Reports and Records Notice 30 Day Proposed Information Collection 2012-12-03T05:00:00Z 2012 12 2012-12-03T05:00:00Z 2013-01-03T04:59:59Z 2015-10-19T14:18:07Z 2012-29095 0 0 090000648117c85c
FDA-2012-D-1038-0001 FDA FDA-2012-D-1038 Draft Guidance for Industry; Availability: Preclinical Assessment of Investigational Cellular and Gene Therapy Products Notice Notice of Availability 2012-11-29T05:00:00Z 2012 11 2012-11-29T05:00:00Z 2012-02-28T04:59:59Z 2012-11-29T14:11:27Z 2012-28882 0 0 0900006481177429
FDA-2010-N-0099-0010 FDA FDA-2010-N-0099 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Revision of Requirements for Constituent Materials Notice General Notice 2012-11-29T05:00:00Z 2012 11 2012-11-29T05:00:00Z 2013-01-29T04:59:59Z 2012-11-29T14:03:07Z 2012-28907 0 0 09000064811773af
FDA-2012-N-0001-0144 FDA FDA-2012-N-0001 Orthopaedic and Rehabilitation Devices Panel of Medical Devices Advisory Committee Meeting Notice Meeting 2012-11-29T05:00:00Z 2012 11 2012-11-29T05:00:00Z   2012-11-29T13:58:43Z 2012-28855 0 0 09000064811773aa
FDA-2012-N-0386-0006 FDA FDA-2012-N-0386 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments, etc. Notice Notice of Approval 2012-11-28T05:00:00Z 2012 11 2012-11-28T05:00:00Z   2022-01-10T21:26:05Z 2012-28774 0 0 090000648117620b
FDA-2010-D-0276-0005 FDA FDA-2010-D-0276 Guidances for Industry: Enforcement Policy Concerning Rotational Warning Plans for Smokeless Tobacco Products; Withdrawal Notice Withdrawal 2012-11-28T05:00:00Z 2012 11 2012-11-28T05:00:00Z   2012-11-28T15:38:36Z 2012-28809 0 0 0900006481176269
FDA-2012-N-1154-0001 FDA FDA-2012-N-1154 Framework for Pharmacy Compounding; State and Federal Roles Meeting Notice Meeting 2012-11-28T05:00:00Z 2012 11 2012-11-28T05:00:00Z 2013-01-19T04:59:59Z 2013-02-02T03:02:14Z 2012-28786 0 0 09000064811762e8
FDA-2012-N-1134-0001 FDA FDA-2012-N-1134 Enforcement Action Dates: Sodium Nitrite Injection and Sodium Thiosulfate Injection Drug Products Labeled for Treatment of Cyanide Poisoning Notice General Notice 2012-11-28T05:00:00Z 2012 11 2012-11-28T05:00:00Z   2012-11-28T15:46:40Z 2012-28773 0 0 09000064811762a3
FDA-2012-N-1021-0001 FDA FDA-2012-N-1021 Medical Device User Fee and Modernization Act: Web Site Location of Fiscal Year 2013 Proposed Guidance Development Notice Notice of Intent 2012-11-26T05:00:00Z 2012 11 2012-11-26T05:00:00Z   2024-11-12T05:09:01Z 2012-28539 1 0 0900006481173246
FDA-2012-N-0001-0143 FDA FDA-2012-N-0001 Risk Communication Advisory Committee Meeting Notice Meeting 2012-11-26T05:00:00Z 2012 11 2012-11-26T05:00:00Z   2012-11-26T14:57:34Z 2012-28462 0 0 09000064811730ba
FDA-2011-D-0464-0045 FDA FDA-2011-D-0464 Guidances for Industry and Staff: Content of Investigational Device Exemption and Premarket Approval Applications for Artificial Pancreas Device Systems Notice Notice of Data Availability 2012-11-23T05:00:00Z 2012 11 2012-11-23T05:00:00Z   2024-11-12T05:10:22Z 2012-28339 1 0 09000064811718ac
FDA-2012-N-1090-0001 FDA FDA-2012-N-1090 Docket Establishment for Provisions of the Food and Drug Administration Safety and Innovation Act Related to Medical Gases Notice General Notice 2012-11-23T05:00:00Z 2012 11 2012-11-23T05:00:00Z 2013-11-26T04:59:59Z 2013-11-26T02:01:55Z 2012-28431 0 0 09000064811718ee
FDA-2012-D-1120-0001 FDA FDA-2012-D-1120 Draft Guidance for Industry on Vaginal Microbicides: Development for the Prevention of Human Immunodeficiency Virus Infection; Availability Notice Notice of Availability 2012-11-23T05:00:00Z 2012 11 2012-11-23T05:00:00Z 2013-02-22T04:59:59Z 2013-02-22T03:03:44Z 2012-28430 0 0 09000064811718a5
FDA-2012-N-1040-0001 FDA FDA-2012-N-1040 Antiseptic Patient Preoperative Skin Preparation Products Public Hearing Request for Comments Notice General Notice 2012-11-21T05:00:00Z 2012 11 2012-11-21T05:00:00Z 2013-02-13T04:59:59Z 2013-02-13T03:02:47Z 2012-28357 0 0 090000648116fd16
FDA-2011-D-0436-0026 FDA FDA-2011-D-0436 International Conference on Harmonisation; Guidance Availability: Q11 Development and Manufacture of Drug Substances Notice Notice of Availability 2012-11-20T05:00:00Z 2012 11 2012-11-20T05:00:00Z   2012-11-20T15:21:44Z 2012-28142 0 0 090000648116e95a
FDA-2012-D-0847-0001 FDA FDA-2012-D-0847 Draft Guidance for IRBs, Clinical Investigators, and Sponsors; Availability: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed Notice Notice of Availability 2012-11-20T05:00:00Z 2012 11 2012-11-20T05:00:00Z 2013-01-23T04:59:59Z 2013-01-25T03:01:05Z 2012-28149 0 0 090000648116eb29
FDA-2012-N-0001-0141 FDA FDA-2012-N-0001 Pulmonary-Allergy Drugs Advisory Committee Meeting Notice Meeting 2012-11-20T05:00:00Z 2012 11 2012-11-20T05:00:00Z   2012-11-20T14:27:36Z 2012-28205 0 0 090000648116e919
FDA-2012-N-0974-0001 FDA FDA-2012-N-0974 Requests for Comments: Development of Prioritized Therapeutic Area Data Standards Notice General Notice 2012-11-20T05:00:00Z 2012 11 2012-11-20T05:00:00Z 2013-01-23T04:59:59Z 2013-01-23T03:11:12Z 2012-28197 0 0 090000648116ead9
FDA-2012-N-0001-0142 FDA FDA-2012-N-0001 Pulmonary-Allergy Drugs Advisory Committee Meeting Notice Meeting 2012-11-20T05:00:00Z 2012 11 2012-11-20T05:00:00Z   2012-11-20T14:35:46Z 2012-28201 0 0 090000648116ebd5
FDA-2010-D-0643-0045 FDA FDA-2010-D-0643 Draft Guidances for Industry; Availability: Electronic Source Data in Clinical Investigations Notice Notice of Availability 2012-11-20T05:00:00Z 2012 11 2012-11-20T05:00:00Z 2013-03-27T03:59:59Z 2013-03-27T02:02:02Z 2012-28198 0 0 090000648116e9b5
FDA-2012-N-1131-0001 FDA FDA-2012-N-1131 Agency Information Collection Activities; Proposals, Submissions, and Approvals: New Animal Drug Applications and Supporting Regulations Notice General Notice 2012-11-20T05:00:00Z 2012 11 2012-11-20T05:00:00Z 2013-01-23T04:59:59Z 2012-11-20T14:44:54Z 2012-28199 0 0 090000648116eb64
FDA-2011-D-0784-0005 FDA FDA-2011-D-0784 Guidance for Industry; Availability: Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals Notice Notice of Availability 2012-11-20T05:00:00Z 2012 11 2012-11-20T05:00:00Z   2012-11-20T15:37:50Z 2012-28156 0 0 090000648116e9b3
FDA-2003-D-0033-0004 FDA Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Notification Submissions 510(k): Effect on FDA Review Clock and Performance Assessment FDA-2003-D-0033 Guidance for Industry and Food and Drug Administration Staff: Food and Drug Administration and Industry Actions on Premarket Notification Submissions: Effect on Food and Drug Administration Review Clock and Performance Assessment; Availability see FDA-2003-D_0033-0001 Notice Notice of Availability 2012-11-20T05:00:00Z 2012 11 2012-11-20T05:00:00Z   2022-10-06T19:14:43Z   0 0 090000648116e889
FDA-2012-N-1045-0001 FDA FDA-2012-N-1045 Medical Devices; Custom Devices; Request for Comments Notice General Notice 2012-11-19T05:00:00Z 2012 11 2012-11-19T05:00:00Z 2013-01-19T04:59:59Z 2013-01-25T03:01:08Z 2012-28042 0 0 090000648116c9ae
FDA-2012-N-0001-0140 FDA FDA-2012-N-0001 Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting Notice Meeting 2012-11-16T05:00:00Z 2012 11 2012-11-16T05:00:00Z   2012-11-16T15:08:09Z 2012-27934 0 0 0900006481168f6e
FDA-2011-D-0164-0007 FDA FDA-2011-D-0164 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act Notice 30 Day Proposed Information Collection 2012-11-16T05:00:00Z 2012 11 2012-11-16T05:00:00Z 2012-12-18T04:59:59Z 2015-08-25T11:02:16Z 2012-27881 0 0 0900006481169eb1
FDA-2012-N-1037-0001 FDA FDA-2012-N-1037 Establishing a List of Qualifying Pathogens That Have the Potential To Pose a Serious Threat to Public Health; Public Hearing; Request for Comments Notice General Notice 2012-11-16T05:00:00Z 2012 11 2012-11-16T05:00:00Z 2013-01-26T04:59:59Z 2013-02-06T19:11:36Z 2012-27931 0 0 0900006481169eb7
FDA-2011-D-0799-0009 FDA FDA-2011-D-0799 Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and Blood Components, Including Source Plasma, to Reduce the Risk of Transmission of Hepatitis B Virus Notice Notice of Availability 2012-11-15T05:00:00Z 2012 11 2012-11-15T05:00:00Z   2015-04-03T22:43:21Z 2012-27783 0 0 0900006481168398
FDA-2012-N-1105-0001 FDA FDA-2012-N-1105 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Voluntary Hazard Analysis and Critical Control Point Manuals for Operators and Regulators of Retail and Food Service Establishments Notice General Notice 2012-11-15T05:00:00Z 2012 11 2012-11-15T05:00:00Z 2013-01-15T04:59:59Z 2012-11-20T03:01:35Z 2012-27721 0 0 0900006481168435
FDA-2012-N-1106-0001 FDA FDA-2012-N-1106 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors with Interest in Exporting to Chile Notice General Notice 2012-11-15T05:00:00Z 2012 11 2012-11-15T05:00:00Z 2013-01-15T04:59:59Z 2012-11-16T15:02:23Z 2012-27723 0 0 09000064811685f3
FDA-2012-N-1108-0001 FDA FDA-2012-N-1108 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Interstate Shellfish Dealer's Certificate Notice General Notice 2012-11-15T05:00:00Z 2012 11 2012-11-15T05:00:00Z 2013-01-15T04:59:59Z 2013-01-15T03:02:51Z 2012-27722 0 0 0900006481168396
FDA-1995-N-0031-0006 FDA OTC Bronchodilator Drug Products FDA-1995-N-0031 Compliance Guidance for Small Business Entities; Availability: Labeling for Bronchodilators; Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use Notice Notice of Availability 2012-11-15T05:00:00Z 2012 11 2012-11-15T05:00:00Z   2019-10-23T14:21:32Z 2012-27724 0 0 09000064811685ad
FDA-2012-N-0911-0001 FDA FDA-2012-N-0911 Privacy Act; Systems of Records Notice General Notice 2012-11-14T05:00:00Z 2012 11 2012-11-14T05:00:00Z 2013-01-01T04:59:59Z 2012-11-14T15:05:56Z 2012-27580 0 0 0900006481167317
FDA-2012-N-1093-0001 FDA FDA-2012-N-1093 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Food Additive Petitions and Investigational Food Additive Exemptions Notice 60 Day Proposed Information Collection 2012-11-13T05:00:00Z 2012 11 2012-11-13T05:00:00Z 2013-01-15T04:59:59Z 2015-10-08T15:14:55Z 2012-27485 0 0 0900006481165cf8
FDA-2012-D-1057-0001 FDA FDA-2012-D-1057 Draft Guidance for Industry and Staff; Availability: Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices Notice Notice of Availability 2012-11-09T05:00:00Z 2012 11 2012-11-09T05:00:00Z 2013-02-08T04:59:59Z 2013-02-09T03:01:18Z 2012-27340 0 0 0900006481164173
FDA-2012-N-0001-0139 FDA FDA-2012-N-0001 Anesthetic and Analgesic Drug Products Advisory Committee Meeting Notice Meeting 2012-11-09T05:00:00Z 2012 11 2012-11-09T05:00:00Z   2012-11-09T14:56:58Z 2012-27368 0 0 0900006481163fd8
FDA-2012-D-0848-0001 FDA FDA-2012-D-0848 Draft Compliance Policy Guide; Availability: Canned Ackee, Frozen Ackee, and Other Ackee Products-Hypoglycin A Toxin Notice Notice of Availability 2012-11-08T05:00:00Z 2012 11 2012-11-08T05:00:00Z 2013-01-08T04:59:59Z 2020-04-28T15:11:26Z 2012-27225 0 0 0900006481162986
FDA-2012-N-0001-0138 FDA FDA-2012-N-0001 Blood Products Advisory Committee Meeting Notice Meeting 2012-11-08T05:00:00Z 2012 11 2012-11-08T05:00:00Z   2012-11-08T15:21:39Z 2012-27323 0 0 0900006481162a70
FDA-2012-N-0001-0137 FDA FDA-2012-N-0001 Circulatory System Devices Panel of Medical Devices Advisory Committee Notice of Meeting Notice Meeting 2012-11-07T05:00:00Z 2012 11 2012-11-07T05:00:00Z   2012-11-24T03:00:49Z 2012-27068 0 0 09000064811613f0
FDA-2012-N-0001-0136 FDA FDA-2012-N-0001 Burkholderia; Exploring Current Issues and Identifying Regulatory Science Gaps Notice Meeting 2012-11-07T05:00:00Z 2012 11 2012-11-07T05:00:00Z   2012-11-07T14:29:08Z 2012-27146 0 0 09000064811613ec
FDA-2012-N-1075-0001 FDA FDA-2012-N-1075 Minimum Clinically Important Difference, Outcome Metric in Orthopaedic Device Science and Regulation Public Workshop Notice Meeting 2012-11-07T05:00:00Z 2012 11 2012-11-07T05:00:00Z   2012-11-07T14:50:40Z 2012-27147 0 0 09000064811614d6
FDA-2007-D-0433-0008 FDA FDA-2007-D-0433 Draft Guidances for Industry; Availability: Bioequivalence Recommendation for Lenalidomide Capsules Notice Notice of Availability 2012-11-06T05:00:00Z 2012 11 2012-11-06T05:00:00Z 2013-01-08T04:59:59Z 2013-01-08T03:27:42Z 2012-27004 0 0 090000648115f3c3
FDA-2012-N-0748-0005 FDA FDA-2012-N-0748 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Generic Drug User Fee Cover Sheet Notice 30 Day Proposed Information Collection 2012-11-06T05:00:00Z 2012 11 2012-11-06T05:00:00Z 2012-12-07T04:59:59Z 2015-06-02T15:42:23Z 2012-27003 0 0 090000648115f3c7
FDA-2012-N-0001-0135 FDA FDA-2012-N-0001 Cellular, Tissue and Gene Therapies Advisory Committee Meeting Notice General Notice 2012-10-30T04:00:00Z 2012 10 2012-10-30T04:00:00Z   2012-10-31T12:22:12Z 2012-26635 0 0 09000064811552e6
FDA-2012-N-0559-0003 FDA FDA-2012-N-0559 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation Notice 30 Day Proposed Information Collection 2012-10-29T04:00:00Z 2012 10 2012-10-29T04:00:00Z 2012-11-29T04:59:59Z 2015-09-22T11:05:31Z 2012-26494 0 0 090000648115435f
FDA-2012-N-0547-0005 FDA FDA-2012-N-0547 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Retail and Foodservice Facility Types Notice General Notice 2012-10-29T04:00:00Z 2012 10 2012-10-29T04:00:00Z 2012-11-29T04:59:59Z 2012-11-23T03:00:47Z 2012-26472 0 0 09000064811543e6
FDA-2009-F-0303-0004 FDA FDA-2009-F-0303 Filings of Food Additive Petitions: Ajinomoto Co., Inc.; Amendment Notice General Notice 2012-10-26T04:00:00Z 2012 10 2012-10-26T04:00:00Z 2012-11-27T04:59:59Z 2012-10-30T02:01:58Z 2012-26315 0 0 09000064811518f2
FDA-2012-N-0007-0005 FDA FDA-2012-N-0007 Generic Drug User Fee: Backlog Fee Rate for Fiscal Year 2013 Notice General Notice 2012-10-25T04:00:00Z 2012 10 2012-10-25T04:00:00Z   2012-10-25T16:40:46Z 2012-26257 0 0 090000648115020e
FDA-2012-N-0007-0004 FDA FDA-2012-N-0007 Generic Drug User Fee: Abbreviated New Drug Application, Prior Approval Supplement, and Drug Master File Fee Rates for Fiscal Year 2013 Notice General Notice 2012-10-25T04:00:00Z 2012 10 2012-10-25T04:00:00Z   2012-10-25T16:36:51Z 2012-26256 0 0 0900006481150373
FDA-2012-N-0001-0134 FDA FDA-2012-N-0001 Drug Safety and Risk Management Advisory Committee Meeting Notice Meeting 2012-10-24T04:00:00Z 2012 10 2012-10-24T04:00:00Z   2012-10-24T13:35:31Z 2012-26162 0 0 090000648114e4d3
FDA-2012-D-0585-0016 FDA FDA-2012-D-0585 Guidance for Industry: Necessity of Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories; Availability Notice Notice of Availability 2012-10-24T04:00:00Z 2012 10 2012-10-24T04:00:00Z   2012-10-24T13:47:42Z 2012-26239 0 0 090000648114e449

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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);