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

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932 rows where agency_id = "FDA", document_type = "Notice" and posted_year = 2014 sorted by posted_date descending

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posted_year 1

  • 2014 · 932 ✖

document_type 1

  • Notice · 932 ✖

agency_id 1

  • FDA · 932 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2014-D-2254-0001 FDA None FDA-2014-D-2254 The Drug Supply Chain Security Act Implementation Product Tracing Requirements Compliance Policy Guidance for Industry Availability Notice Notice of Availability 2014-12-31T05:00:00Z 2014 12 2014-12-31T05:00:00Z   2024-11-12T05:33:45Z 2014-30608 1 0 090000648199bfdc
FDA-2014-N-1936-0002 FDA None FDA-2014-N-1936 Electronic Cigarettes and the Public Health Public Workshop Notice Meeting 2014-12-30T05:00:00Z 2014 12 2014-12-30T05:00:00Z   2015-03-04T12:21:12Z 2014-30450 0 0 0900006481999bbf
FDA-2007-D-0369-0310 FDA None FDA-2007-D-0369 Draft and Revised Draft Guidances for Industry Describing Product Specific Bioequivalence Recommendations Availability Notice Notice of Availability 2014-12-30T05:00:00Z 2014 12 2014-12-30T05:00:00Z 2015-03-03T04:59:59Z 2024-11-12T05:29:27Z 2014-30514 1 0 0900006481999bc7
FDA-2014-N-0797-0002 FDA None FDA-2014-N-0797 Agency Information Collection Activities; Submission for Office of Management and Budget Review Comment Request Guidance Medical Device ISO 13485 2003 Voluntary Audit Report Submission Pilot Program Notice 30 Day Proposed Information Collection 2014-12-30T05:00:00Z 2014 12 2014-12-30T05:00:00Z 2015-01-30T04:59:59Z 2014-12-30T17:02:11Z 2014-30513 0 0 0900006481999c8a
FDA-2014-N-1027-0003 FDA None FDA-2014-N-1027 Agency Information Collection Activities; Announcement of Office of Management and Budget Approval Infant Formula Recall Regulations Notice Notice of Approval 2014-12-30T05:00:00Z 2014 12 2014-12-30T05:00:00Z   2014-12-30T17:09:20Z 2014-30461 0 0 0900006481999d89
FDA-2014-D-2065-0001 FDA None FDA-2014-D-2065 Radiation Biodosimetry Devices Draft Guidance for Industry and Food and Drug Administration Staff Availability Notice Notice of Availability 2014-12-30T05:00:00Z 2014 12 2014-12-30T05:00:00Z 2015-03-31T03:59:59Z 2024-11-12T05:30:49Z 2014-30453 1 0 09000064819999f5
FDA-2014-N-0998-0002 FDA None FDA-2014-N-0998 Agency Information Collection Activities Submission for Office of Management and Budget Review Comment Request Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring Notice 30 Day Proposed Information Collection 2014-12-30T05:00:00Z 2014 12 2014-12-30T05:00:00Z 2015-01-30T04:59:59Z 2015-03-08T19:42:01Z 2014-30452 0 0 0900006481999bc3
FDA-2014-N-0001-0104 FDA None FDA-2014-N-0001 Science Board to the Food and Drug Administration Notice of Meeting Notice Public Meetings 2014-12-30T05:00:00Z 2014 12 2014-12-30T05:00:00Z   2014-12-30T15:34:56Z 2014-30516 0 0 0900006481999ad1
FDA-2011-N-0672-0003 FDA None FDA-2011-N-0672 Agency Information Collection Activities Proposed Collection Comment Request Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices Notice 60 Day Proposed Information Collection 2014-12-30T05:00:00Z 2014 12 2014-12-30T05:00:00Z 2015-03-03T04:59:59Z 2015-04-08T13:06:22Z 2014-30511 0 0 0900006481999b05
FDA-2014-N-0001-0105 FDA None FDA-2014-N-0001 Guidance: Advisory Committees; Filing of Closed Meeting Reports Notice Report Submissions 2014-12-30T05:00:00Z 2014 12 2014-12-30T05:00:00Z   2014-12-30T16:05:56Z 2014-30460 0 0 0900006481999b53
FDA-2014-N-2214-0001 FDA None FDA-2014-N-2214 Next Generation Sequencing Diagnostic Tests Public Workshop Request for Comments Notice Request for Comments 2014-12-29T05:00:00Z 2014 12 2014-12-29T05:00:00Z 2015-03-21T03:59:59Z 2015-03-22T02:01:51Z 2014-30308 0 0 0900006481995ff6
FDA-2014-N-2104-0001 FDA None FDA-2014-N-2104 Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Ebola Zaire Virus; Availability Notice Notice of Availability 2014-12-24T05:00:00Z 2014 12 2014-12-24T05:00:00Z   2014-12-24T19:05:36Z 2014-30108 0 0 09000064819914d1
FDA-2010-N-0155-0207 FDA None FDA-2010-N-0155 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Veterinary Feed Directive Notice 30 Day Proposed Information Collection 2014-12-24T05:00:00Z 2014 12 2014-12-24T05:00:00Z 2015-01-24T04:59:59Z 2015-01-08T03:01:55Z 2014-30157 0 0 090000648199147f
FDA-2014-D-1461-0003 FDA None FDA-2014-D-1461 Rare Pediatric Disease Priority Review Vouchers; Extension of Comment Period Notice Extension of Comment Period 2014-12-24T05:00:00Z 2014 12 2014-12-24T05:00:00Z 2015-02-17T04:59:59Z 2015-03-25T02:02:24Z 2014-30154 0 0 09000064819914d2
FDA-2014-N-0001-0103 FDA None FDA-2014-N-0001 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting Notice Public Meetings 2014-12-24T05:00:00Z 2014 12     2014-12-24T17:20:01Z 2014-30149 0 0 0900006481991291
FDA-2007-D-0369-0309 FDA None FDA-2007-D-0369 Bioequivalence Recommendations for Methylphenidate Hydrochloride Extended-Release Oral Suspension; Draft Guidance for Industry; Availability Notice Notice of Availability 2014-12-24T05:00:00Z 2014 12 2014-12-24T05:00:00Z 2015-02-24T04:59:59Z 2015-02-24T03:14:02Z 2014-30109 0 0 09000064819910d4
FDA-2014-D-1696-0001 FDA None FDA-2014-D-1696 Minimal Manipulation of Human Cells Tissues and Cellular and Tissue Based Products Draft Guidance for Industry and Food and Drug Administration Staff Availability Notice Notice of Availability 2014-12-23T05:00:00Z 2014 12 2014-12-23T05:00:00Z 2015-02-24T04:59:59Z 2015-02-25T03:05:07Z 2014-30011 0 0 090000648198eace
FDA-2008-D-0588-0003 FDA None FDA-2008-D-0588 Compliance Policy Guide Sec. 540.700 Labeling of Processed and Blended Seafood Products Made Primarily With Fish Protein Availability Notice Notice of Availability 2014-12-23T05:00:00Z 2014 12 2014-12-23T05:00:00Z   2024-11-12T05:32:10Z 2014-30015 1 0 090000648198e78d
FDA-2014-N-1076-0002 FDA None FDA-2014-N-1076 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guidance for Industry on Formal Dispute Resolution--Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice Notice 30 Day Proposed Information Collection 2014-12-23T05:00:00Z 2014 12 2014-12-23T05:00:00Z 2015-01-23T04:59:59Z 2015-03-09T11:23:38Z 2014-29917 0 0 090000648198e9c6
FDA-2014-N-1104-0003 FDA None FDA-2014-N-1104 Agency Information Collection Activities Announcement of Office of Management and Budget Approval State Petitions for Exemption From Preemption Notice Notice of Approval 2014-12-23T05:00:00Z 2014 12 2014-12-23T05:00:00Z   2014-12-23T16:22:55Z 2014-30012 0 0 090000648198eb22
FDA-2009-D-0268-0011 FDA None FDA-2009-D-0268 Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration Guidance for Industry Availability Notice Notice of Availability 2014-12-23T05:00:00Z 2014 12 2014-12-23T05:00:00Z   2014-12-23T14:58:05Z 2014-29988 0 0 090000648198e9cb
FDA-2014-N-0001-0101 FDA None FDA-2014-N-0001 Vaccines and Related Biological Products Advisory Committee Notice of Meeting Notice Meeting 2014-12-22T05:00:00Z 2014 12 2014-12-22T05:00:00Z   2014-12-22T14:37:50Z 2014-29860 0 0 090000648198b2c1
FDA-2013-N-1504-0004 FDA None FDA-2013-N-1504 Independent Assessment of the Process for the Review of Device Submissions Final Implementation Plan Notice Availability of Environmental Assessment 2014-12-22T05:00:00Z 2014 12 2014-12-22T05:00:00Z   2014-12-22T14:19:33Z 2014-29800 0 0 090000648198ab1d
FDA-2014-D-1837-0001 FDA None FDA-2014-D-1837 Transfer of a Premarket Notification 510k Clearance Questions and Answers Draft Guidance for Industry and Food and Drug Administration Staff Availability Notice Notice of Availability 2014-12-22T05:00:00Z 2014 12 2014-12-22T05:00:00Z 2015-03-24T03:59:59Z 2015-03-24T02:04:37Z 2014-29832 0 0 090000648198b246
FDA-2008-N-0144-0012 FDA None FDA-2008-N-0144 Agency Information Collection Activities; Submission for Office of Management and Budget Review Comment Request Certification to Accompany Drug Biological Product and Device Applications or Submissions Notice 30 Day Proposed Information Collection 2014-12-19T05:00:00Z 2014 12 2014-12-19T05:00:00Z 2015-01-21T04:59:59Z 2014-12-19T21:02:38Z 2014-29752 0 0 0900006481985e03
FDA-2008-D-0128-0008 FDA None FDA-2008-D-0128 Serious Drug-Induced Liver Injury The Importance of Getting It Right How To Measure and Interpret Drug-Induced Liver Injury Information and Make Correct Diagnoses Public Conference Request for Comments Notice Notice of Conference 2014-12-19T05:00:00Z 2014 12 2014-12-19T05:00:00Z   2016-01-06T18:58:08Z 2014-29720 0 0 0900006481985fad
FDA-2012-D-1092-0004 FDA None FDA-2012-D-1092 Minimizing Risk for Children's Toy Laser Products Guidance for Industry and Food and Drug Administration Staff Availability Notice Notice of Availability 2014-12-19T05:00:00Z 2014 12 2014-12-19T05:00:00Z   2014-12-22T21:42:15Z 2014-29725 0 0 0900006481985ecb
FDA-2014-N-2137-0001 FDA None FDA-2014-N-2137 Public Meeting on Patient-Focused Drug Development for Breast Cancer Request for Comments Notice Request for Comments 2014-12-19T05:00:00Z 2014 12 2014-12-19T05:00:00Z 2015-06-03T03:59:59Z 2015-06-03T01:30:57Z 2014-29721 0 0 0900006481985d1e
FDA-2012-D-0097-0036 FDA None FDA-2012-D-0097 Providing Regulatory Submissions in Electronic Format Standardized Study Data Guidance for Industry Availability Notice Notice of Availability 2014-12-18T05:00:00Z 2014 12 2014-12-18T05:00:00Z   2014-12-18T16:26:29Z 2014-29608 0 0 09000064819823bb
FDA-2014-D-0313-0004 FDA None FDA-2014-D-0313 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff on Meetings With the Office of Orphan Products Development Notice 30 Day Proposed Information Collection 2014-12-18T05:00:00Z 2014 12 2014-12-18T05:00:00Z 2015-01-21T04:59:59Z 2015-07-09T14:25:12Z 2014-29612 0 0 0900006481982289
FDA-2011-N-0085-0005 FDA None FDA-2011-N-0085 Agency Information Collection Activities Submission for Office of Management and Budget Review Comment Request Guidance for Industry Cooperative Manufacturing Arrangements for Licensed Biologics Notice 30 Day Proposed Information Collection 2014-12-18T05:00:00Z 2014 12 2014-12-18T05:00:00Z 2015-01-21T04:59:59Z 2014-12-18T16:15:06Z 2014-29611 0 0 0900006481982302
FDA-2014-N-0996-0002 FDA None FDA-2014-N-0996 Agency Information Collection Activities; Submission for Office of Management and Budget Review Comment Request Guidance for Industry Fast Track Drug Development Programs Designation Development and Application Review Notice 30 Day Proposed Information Collection 2014-12-18T05:00:00Z 2014 12 2014-12-18T05:00:00Z 2015-01-21T04:59:59Z 2015-03-08T20:14:46Z 2014-29607 0 0 090000648198240f
FDA-2014-N-2033-0001 FDA None FDA-2014-N-2033 Agency Information Collection Activities; Proposed Collection Comment Request; Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice and Retail Food Stores Facility Types Notice 60 Day Proposed Information Collection 2014-12-17T05:00:00Z 2014 12 2014-12-17T05:00:00Z 2015-02-18T04:59:59Z 2014-12-17T14:23:44Z 2014-29478 0 0 090000648197e869
FDA-2014-N-0809-0002 FDA None FDA-2014-N-0809 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requirements for Submission of Bioequivalence Data Notice Request for Comments 2014-12-16T05:00:00Z 2014 12 2014-12-16T05:00:00Z 2015-01-16T04:59:59Z 2014-12-16T16:18:37Z 2014-29425 0 0 090000648197bbaf
FDA-2014-D-1842-0001 FDA None FDA-2014-D-1842 Crabmeat--Fresh and Frozen--Adulteration With Filth, Involving the Presence of Escherichia coli; Compliance Policy Guide; Draft Guidance for Food and Drug Administration Staff; Availability Notice Notice of Availability 2014-12-16T05:00:00Z 2014 12 2014-12-16T05:00:00Z 2015-02-18T04:59:59Z 2014-12-16T17:39:16Z 2014-29314 0 0 090000648197badf
FDA-2014-N-1697-0002 FDA None FDA-2014-N-1697 Privacy Act of 1974; Report of a New System of Records; Food and Drug Administration Commissioning of State and Local Officials; Correction Notice Correction 2014-12-16T05:00:00Z 2014 12 2014-12-16T05:00:00Z 2015-01-23T04:59:59Z 2014-12-16T15:41:51Z 2014-29424 0 0 090000648197ba94
FDA-2014-N-1409-0002 FDA None FDA-2014-N-1409 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Records and Reports Concerning Experiences With Approved New Animal Drugs: Adverse Event Reports Notice Request for Comments 2014-12-16T05:00:00Z 2014 12 2014-12-16T05:00:00Z 2015-01-16T04:59:59Z 2014-12-16T16:31:29Z 2014-29426 0 0 090000648197c119
FDA-2014-N-0987-0006 FDA None FDA-2014-N-0987 Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications Notice 60 Day Proposed Information Collection 2014-12-12T05:00:00Z 2014 12 2014-12-12T05:00:00Z 2014-10-01T03:59:59Z 2014-12-13T03:07:08Z 2014-18195 0 0 0900006481973c49
FDA-2014-N-2076-0001 FDA None FDA-2014-N-2076 Agency Information Collection Activities; Proposed Collection; Comment Request; Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Restaurant Facility Types Notice 60 Day Proposed Information Collection 2014-12-11T05:00:00Z 2014 12 2014-12-11T05:00:00Z 2015-02-10T04:59:59Z 2014-12-15T03:01:30Z 2014-29065 0 0 090000648196da00
FDA-2014-N-1960-0001 FDA None FDA-2014-N-1960 Agency Information Collection Activities; Proposed Collection; Comment Request; MedWatch: The Food and Drug Administration Medical Products Reporting Program Notice 60 Day Proposed Information Collection 2014-12-11T05:00:00Z 2014 12 2014-12-11T05:00:00Z 2015-02-10T04:59:59Z 2015-02-10T03:01:31Z 2014-29064 0 0 090000648196db4e
FDA-2008-P-0320-0004 FDA None FDA-2008-P-0320 Determination That PFIZERPEN (Penicillin G Potassium) Injection, 1 Million Units/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice Determinations 2014-12-11T05:00:00Z 2014 12 2014-12-11T05:00:00Z   2014-12-11T21:23:52Z 2014-29034 0 0 090000648196daf6
FDA-2007-D-0369-0308 FDA None FDA-2007-D-0369 Bioequivalence Recommendations for Budesonide Extended-Release Tablets; Draft Guidance for Industry; Availability Notice Notice of Availability 2014-12-11T05:00:00Z 2014 12 2014-12-11T05:00:00Z 2015-02-10T04:59:59Z 2015-02-10T03:01:55Z 2014-29035 0 0 090000648196d9d1
FDA-2010-D-0073-0001 FDA None FDA-2010-D-0073 Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Consultation Procedures: Foods Derived From New Plant Varieties Notice 60 Day Proposed Information Collection 2014-12-11T05:00:00Z 2014 12 2014-12-11T05:00:00Z 2015-02-10T04:59:59Z 2014-12-12T03:11:47Z 2014-29046 0 0 090000648196daaf
FDA-2014-N-2029-0001 FDA None FDA-2014-N-2029 Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Practices and Procedures; Formal Evidentiary Public Hearing Notice 60 Day Proposed Information Collection 2014-12-10T05:00:00Z 2014 12 2014-12-10T05:00:00Z 2015-02-10T04:59:59Z 2014-12-12T00:08:03Z 2014-28825 0 0 090000648196aa0c
FDA-2014-N-1998-0001 FDA None FDA-2014-N-1998 Patient-Focused Drug Development Public Meeting on Chagas Disease Notice Public Meetings 2014-12-10T05:00:00Z 2014 12 2014-12-10T05:00:00Z 2015-06-30T03:59:59Z 2015-07-10T01:30:44Z 2014-28828 0 0 090000648196ab25
FDA-2014-N-2032-0001 FDA None FDA-2014-N-2032 Request for Nominations for Voting Members on the Food Advisory Committee Notice Request for Nominations 2014-12-10T05:00:00Z 2014 12 2014-12-10T05:00:00Z   2014-12-10T14:36:12Z 2014-28889 0 0 090000648196a9b4
FDA-2011-D-0588-0004 FDA None FDA-2011-D-0588 International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Guidance for Industry on Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data; Availability Notice Notice of Availability 2014-12-10T05:00:00Z 2014 12 2014-12-10T05:00:00Z   2024-11-12T05:32:29Z 2014-28830 1 0 090000648196aa72
FDA-2014-N-0001-0099 FDA None FDA-2014-N-0001 Oncologic Drugs Advisory Committee; Notice of Meeting Notice Public Meetings 2014-12-10T05:00:00Z 2014 12 2014-12-10T05:00:00Z   2014-12-10T14:23:49Z 2014-28847 0 0 090000648196a971
FDA-2014-N-0001-0100 FDA None FDA-2014-N-0001 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Postponement of Meeting Notice Meeting Postponement 2014-12-10T05:00:00Z 2014 12 2014-12-10T05:00:00Z   2014-12-10T14:32:39Z 2014-28881 0 0 090000648196a973
FDA-2013-D-1067-0004 FDA None FDA-2013-D-1067 Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products--Content and Format; Guidance for Industry; Availability Notice Notice of Availability 2014-12-10T05:00:00Z 2014 12 2014-12-10T05:00:00Z   2024-11-12T05:32:29Z 2014-28888 1 0 090000648196aa70
FDA-2014-N-0987-0005 FDA None FDA-2014-N-0987 Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications; Correction Notice Correction 2014-12-09T05:00:00Z 2014 12 2014-12-09T05:00:00Z   2014-12-12T23:31:53Z 2014-28714 0 0 090000648196810f
FDA-2014-D-2083-0001 FDA None FDA-2014-D-2083 Draft Guidance for Industry on Drug Supply Chain Security Act Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers; Availability Notice Notice of Availability 2014-12-09T05:00:00Z 2014 12 2014-12-09T05:00:00Z 2015-02-10T04:59:59Z 2020-04-23T18:06:28Z 2014-28711 0 0 0900006481968115
FDA-2014-D-1492-0003 FDA None FDA-2014-D-1492 Two-Phased Chemistry, Manufacturing, and Controls Technical Sections; Draft Guidance for Industry; Extension of Comment Period Notice Extension of Comment Period 2014-12-09T05:00:00Z 2014 12 2014-12-09T05:00:00Z 2015-02-18T04:59:59Z 2015-03-19T02:12:12Z 2014-28713 0 0 0900006481967c1e
FDA-2013-D-1275-0001 FDA None FDA-2013-D-1275 General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products; Draft Guidance for Industry; Availability Notice Notice of Availability 2014-12-09T05:00:00Z 2014 12 2014-12-09T05:00:00Z 2015-02-10T04:59:59Z 2015-02-25T03:05:16Z 2014-28716 0 0 0900006481967c22
FDA-2014-D-1814-0001 FDA None FDA-2014-D-1814 Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services To Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability Notice Notice of Availability 2014-12-09T05:00:00Z 2014 12 2014-12-09T05:00:00Z 2015-02-10T04:59:59Z 2015-01-04T02:57:01Z 2014-28809 0 0 09000064819681fe
FDA-2014-N-0001-0098 FDA None FDA-2014-N-0001 Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting Notice Meeting 2014-12-09T05:00:00Z 2014 12 2014-12-09T05:00:00Z   2014-12-09T14:48:56Z 2014-28702 0 0 0900006481967c76
FDA-2014-N-2031-0001 FDA None FDA-2014-N-2031 Request for Nominations on the Food Advisory Committee Notice Request for Nominations 2014-12-08T05:00:00Z 2014 12 2014-12-08T05:00:00Z 2015-01-08T04:59:59Z 2014-12-08T16:28:40Z 2014-28652 0 0 0900006481964124
FDA-2014-N-0987-0004 FDA None FDA-2014-N-0987 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications Notice 30 Day Proposed Information Collection 2014-12-08T05:00:00Z 2014 12 2014-12-08T05:00:00Z 2014-12-09T04:59:59Z 2014-12-12T23:38:02Z 2014-28635 0 0 0900006481963f5e
FDA-2014-N-1697-0001 FDA None FDA-2014-N-1697 Privacy Act of 1974; Report of a New System of Records; Food and Drug Administration Commissioning of State and Local Officials Notice Privacy Act System of Records 2014-12-08T05:00:00Z 2014 12 2014-12-08T05:00:00Z 2015-01-23T04:59:59Z 2014-12-08T16:20:47Z 2014-28634 0 0 090000648196402c
FDA-2014-D-1891-0001 FDA None FDA-2014-D-1891 How To Obtain a Letter From the Food and Drug Administration Stating That Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable Risk Evaluation and Mitigation Strategies for Reference Listed Drugs; Draft Guidance for Industry; Availability Notice Notice of Availability 2014-12-05T05:00:00Z 2014 12 2014-12-05T05:00:00Z 2015-02-04T04:59:59Z 2020-04-23T19:23:52Z 2014-28540 0 0 090000648195e613
FDA-2014-N-1795-0001 FDA None FDA-2014-N-1795 Mallinckrodt Inc. et al.; Withdrawal of Approval of 23 New Drug Applications and 68 Abbreviated New Drug Applications Notice Withdrawal 2014-12-05T05:00:00Z 2014 12 2014-12-05T05:00:00Z   2014-12-05T15:11:49Z 2014-28541 0 0 090000648195e55c
FDA-2014-D-1551-0001 FDA None FDA-2014-D-1551 Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products—Content and Format; Draft Guidance for Industry; Availability Notice Notice of Availability 2014-12-04T05:00:00Z 2014 12 2014-12-04T05:00:00Z 2015-02-03T04:59:59Z 2015-02-03T03:15:00Z 2014-28242 0 0 090000648195a5df
FDA-2013-D-0295-0010 FDA None FDA-2013-D-0295 Guidance for Industry on Scale-Up Post-Approval Changes: Manufacturing Equipment Addendum; Availability Notice Notice of Availability 2014-12-02T05:00:00Z 2014 12 2014-12-02T05:00:00Z   2014-12-02T16:29:51Z 2014-28256 0 0 0900006481953f5c
FDA-2010-D-0194-0024 FDA None FDA-2010-D-0194 Infusion Pumps Total Product Life Cycle; Guidance for Industry and Food and Drug Administration Staff; Availability Notice Notice of Availability 2014-12-02T05:00:00Z 2014 12 2014-12-02T05:00:00Z   2014-12-02T17:21:26Z 2014-28267 0 0 0900006481953fe6
FDA-2013-D-0168-0009 FDA None FDA-2013-D-0168 Recommendations for Labeling Medical Products To Inform Users That the Product or Product Container Is Not Made With Natural Rubber Latex; Guidance for Industry and Food and Drug Administration Staff; Availability. Notice Notice of Availability 2014-12-02T05:00:00Z 2014 12 2014-12-02T05:00:00Z   2014-12-02T16:23:58Z 2014-28265 0 0 0900006481953f62
FDA-2014-N-1936-0001 FDA None FDA-2014-N-1936 Establishment of a Public Docket; Electronic Cigarettes and the Public Health Workshop Notice Request for Comments 2014-12-02T05:00:00Z 2014 12 2014-12-02T05:00:00Z 2015-04-16T03:59:59Z 2015-07-15T12:41:06Z 2014-28261 0 0 0900006481953f90
FDA-2014-N-0639-0002 FDA None FDA-2014-N-0639 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Notification of the Intent To Use an Accredited Person Under the Accredited Persons Inspection Program Notice 30 Day Proposed Information Collection 2014-12-01T05:00:00Z 2014 12 2014-12-01T05:00:00Z 2014-12-02T04:59:59Z 2014-12-13T20:55:06Z 2014-28184 0 0 0900006481950b67
FDA-2014-N-1952-0001 FDA None FDA-2014-N-1952 Seventh Annual Sentinel Initiative; Public Workshop; Amendment of Notice Notice Meeting 2014-12-01T05:00:00Z 2014 12 2014-12-01T05:00:00Z 2015-03-11T03:59:59Z 2014-12-01T15:00:48Z 2014-28196 0 0 0900006481950b62
FDA-2014-N-1030-0002 FDA None FDA-2014-N-1030 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Allergen Labeling and Reporting Notice 30 Day Proposed Information Collection 2014-12-01T05:00:00Z 2014 12 2014-12-01T05:00:00Z 2014-12-02T04:59:59Z 2014-12-13T20:56:46Z 2014-28185 0 0 0900006481950a43
FDA-2011-N-0619-0004 FDA None FDA-2011-N-0619 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Humanitarian Use Devices Notice 30 Day Proposed Information Collection 2014-12-01T05:00:00Z 2014 12 2014-12-01T05:00:00Z 2014-12-02T04:59:59Z 2014-12-13T20:55:54Z 2014-28183 0 0 0900006481950a3d
FDA-2013-N-1152-0003 FDA None FDA-2013-N-1152 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Petition To Request an Exemption From 100 Percent Identity Testing of Dietary Ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements Notice 30 Day Proposed Information Collection 2014-11-28T05:00:00Z 2014 11 2014-11-28T05:00:00Z 2014-11-29T04:59:59Z 2014-12-13T20:54:28Z 2014-28087 0 0 090000648194b565
FDA-2014-N-0987-0003 FDA None FDA-2014-N-0987 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for the Collection of Quantitative Data on Tobacco Products and Communications Notice 30 Day Proposed Information Collection 2014-11-28T05:00:00Z 2014 11 2014-11-28T05:00:00Z 2014-11-29T04:59:59Z 2014-12-12T23:37:08Z 2014-28106 0 0 090000648194b257
FDA-2014-N-1904-0001 FDA None FDA-2014-N-1904 Agency Information Collection Activities; Proposed Collection; Comment Request; Comparing Food Safety Knowledge, Attitude, and Behavior Among English-Dominant Hispanics, Spanish-Dominant Hispanics, and Other Consumers Notice 60 Day Proposed Information Collection 2014-11-28T05:00:00Z 2014 11 2014-11-28T05:00:00Z 2015-01-28T04:59:59Z 2014-11-28T14:28:03Z 2014-28088 0 0 090000648194b1da
FDA-2014-D-1862-0001 FDA None FDA-2014-D-1862 Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions; Draft Guidance for Industry; Availability Notice Notice of Availability 2014-11-28T05:00:00Z 2014 11 2014-11-28T05:00:00Z 2015-01-28T04:59:59Z 2015-01-28T03:22:04Z 2014-28086 0 0 090000648194b65d
FDA-2014-D-1981-0001 FDA None FDA-2014-D-1981 The Drug Supply Chain Security Act Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How To Exchange Product Tracing Information; Availability Notice Notice of Availability 2014-11-28T05:00:00Z 2014 11 2014-11-28T05:00:00Z   2022-07-06T14:58:35Z 2014-28085 0 0 090000648194a808
FDA-2014-D-1804-0001 FDA None FDA-2014-D-1804 Immediately in Effect Guidance Document: Product Labeling for Laparoscopic Power Morcellators; Guidance for Industry and Food and Drug Administration Staff; Availability Notice Notice of Availability 2014-11-25T05:00:00Z 2014 11 2014-11-25T05:00:00Z 2015-01-27T04:59:59Z 2015-01-25T02:57:39Z 2014-27857 0 0 0900006481944332
FDA-2011-D-0360-0003 FDA None FDA-2011-D-0360 Framework for Regulatory Oversight of Laboratory Developed Tests; Public Workshop; Request for Comments Notice Request for Comments 2014-11-24T05:00:00Z 2014 11 2014-11-24T05:00:00Z 2015-02-03T04:59:59Z 2015-02-21T03:01:26Z 2014-27713 0 0 090000648194152d
FDA-2013-N-1429-0011 FDA None FDA-2013-N-1429 Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act; Final Guidance for Industry; Availability Notice Notice of Availability 2014-11-24T05:00:00Z 2014 11 2014-11-24T05:00:00Z   2020-04-23T20:13:48Z 2014-27693 0 0 090000648194152e
FDA-2013-N-1428-0010 FDA None FDA-2013-N-1428 Electronic Product Reporting for Human Drug Compounding Outsourcing Facilities; Draft Guidance Notice Notice of Availability 2014-11-24T05:00:00Z 2014 11 2014-11-24T05:00:00Z 2015-01-24T04:59:59Z 2019-07-17T12:23:03Z 2014-27691 0 0 09000064819413b6
FDA-2014-N-1818-0001 FDA None FDA-2014-N-1818 New Clinical Trials Demographic Data; Availability for Comment Notice Notice of Availability 2014-11-24T05:00:00Z 2014 11 2014-11-24T05:00:00Z 2015-01-24T04:59:59Z 2015-01-25T02:56:52Z 2014-27732 0 0 0900006481941403
FDA-2014-D-0329-0004 FDA None FDA-2014-D-0329 Fees for Human Drug Compounding Outsourcing Facilities Under the FD&C Act; Guidance for Industry; Availability Notice Notice of Availability 2014-11-24T05:00:00Z 2014 11 2014-11-24T05:00:00Z   2017-04-05T13:49:47Z 2014-27692 0 0 0900006481941448
FDA-2011-D-0357-0003 FDA None FDA-2011-D-0357 Framework for Regulatory Oversight of Laboratory Developed Tests; Public Workshop; Request for Comments Notice Request for Comments 2014-11-24T05:00:00Z 2014 11 2014-11-24T05:00:00Z 2015-02-03T04:59:59Z 2015-02-03T03:13:23Z 2014-27713 0 0 09000064819425ac
FDA-2013-N-0502-0050 FDA None FDA-2013-N-0502 Report on the Standardization of Risk Evaluation and Mitigation Strategies; Correction Notice Correction 2014-11-21T05:00:00Z 2014 11 2014-11-21T05:00:00Z   2014-11-21T19:01:09Z 2014-27522 0 0 090000648193d6aa
FDA-2014-N-0001-0097 FDA None FDA-2014-N-0001 Developing and Using Precision Therapies in the ‘‘Omics’’ Era: Generating and Interpreting Evidence for Rare Subsets; Public Workshop Notice Meeting 2014-11-21T05:00:00Z 2014 11 2014-11-21T05:00:00Z   2014-11-21T18:34:55Z 2014-27523 0 0 090000648193d51a
FDA-2014-N-0001-0096 FDA None FDA-2014-N-0001 Anti-Infective Drugs Advisory Committee; Notice of Meeting Notice Meeting 2014-11-21T05:00:00Z 2014 11 2014-11-21T05:00:00Z   2014-11-21T17:41:22Z 2014-27573 0 0 090000648193d6f0
FDA-1999-D-3528-0006 FDA Human Blood & Blood Components Intended for Transfusion FDA-1999-D-3528 Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture; Guidance for Industry; Availability Notice Notice of Availability 2014-11-21T05:00:00Z 2014 11 2014-11-21T05:00:00Z   2014-11-21T18:56:20Z 2014-27521 0 0 090000648193d6f2
FDA-2011-N-0535-0003 FDA None FDA-2011-N-0535 Agency Information Collection Activities; Proposed Collection; Comment Request; Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body Notice 60 Day Proposed Information Collection 2014-11-21T05:00:00Z 2014 11 2014-11-21T05:00:00Z 2015-01-21T04:59:59Z 2014-11-21T18:49:39Z 2014-27517 0 0 090000648193d5b3
FDA-2011-N-0510-0003 FDA None FDA-2011-N-0510 Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Prohibited From Use in Animal Food or Feed Notice 60 Day Proposed Information Collection 2014-11-21T05:00:00Z 2014 11 2014-11-21T05:00:00Z 2015-01-21T04:59:59Z 2014-11-25T03:01:11Z 2014-27518 0 0 090000648193d51f
FDA-2014-N-0373-0002 FDA None FDA-2014-N-0373 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Risk and Benefit Perception Scale Development Notice 30 Day Proposed Information Collection 2014-11-20T05:00:00Z 2014 11 2014-11-20T05:00:00Z 2014-11-21T04:59:59Z 2014-12-13T20:54:10Z 2014-27431 0 0 0900006481939878
FDA-2012-D-1120-0011 FDA None FDA-2012-D-1120 Vaginal Microbicides: Development for the Prevention of Human Immunodeficiency Virus Infection; Guidance for Industry; Availability Notice Notice of Availability 2014-11-19T05:00:00Z 2014 11 2014-11-19T05:00:00Z   2014-11-19T17:02:36Z 2014-27287 0 0 0900006481937e09
FDA-2014-N-1855-0001 FDA None FDA-2014-N-1855 Agency Information Collection Activities; Proposed Collection; Comment Request: Experimental Studies on Consumer Perceptions of Modified Risk Tobacco Products Notice 60 Day Proposed Information Collection 2014-11-19T05:00:00Z 2014 11 2014-11-19T05:00:00Z 2015-01-21T04:59:59Z 2015-01-25T02:53:35Z 2014-27283 0 0 0900006481937d8e
FDA-2014-N-1741-0001 FDA None FDA-2014-N-1741 Proposed Criteria for "First Generic" Submissions for Purposes of Abbreviated New Drug Application Review Prioritization Under the Generic Drug User Fee Amendments Notice Request for Comments 2014-11-19T05:00:00Z 2014 11 2014-11-19T05:00:00Z 2014-12-20T04:59:59Z 2014-12-20T03:00:43Z 2014-27385 0 0 0900006481937e0a
FDA-2014-N-1840-0001 FDA None FDA-2014-N-1840 Electronic Study Data Submission;nData Standards; Validation Rules for Study Data Tabulation ModelnFormatted Studies; Availability Notice Availability of Document 2014-11-19T05:00:00Z 2014 11 2014-11-19T05:00:00Z   2014-11-19T15:25:19Z 2014-27384 0 0 0900006481937e7c
FDA-2014-D-1461-0001 FDA None FDA-2014-D-1461 Rare Pediatric Disease Priority Review Vouchers, Draft Guidance for Industry; Availability Notice Notice of Availability 2014-11-17T05:00:00Z 2014 11 2014-11-17T05:00:00Z 2014-12-25T04:59:59Z 2014-12-24T19:51:24Z 2014-27022 0 0 0900006481932cf7
FDA-2013-N-1285-0002 FDA None FDA-2013-N-1285 Smith Miller and Patch, Inc. et al.; Withdrawal of Approval of 14 New Drug Applications Notice Withdrawal 2014-11-17T05:00:00Z 2014 11 2014-11-17T05:00:00Z   2014-11-17T16:05:27Z 2014-27039 0 0 090000648193331f
FDA-2010-N-0161-0003 FDA None FDA-2010-N-0161 Agency Information Collection Activities; Proposed Collection; Comment Request; Export of Food and Drug Administration Regulated Products: Export Certificates Notice 60 Day Proposed Information Collection 2014-11-14T05:00:00Z 2014 11 2014-11-14T05:00:00Z 2015-01-14T04:59:59Z 2015-01-26T23:08:14Z 2014-26999 0 0 090000648192e746
FDA-2013-N-0878-0004 FDA None FDA-2013-N-0878 Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification for a New Dietary Ingredient Notice 60 Day Proposed Information Collection 2014-11-14T05:00:00Z 2014 11 2014-11-14T05:00:00Z 2015-01-14T04:59:59Z 2015-02-11T23:19:04Z 2014-26998 0 0 090000648192e5a4
FDA-2011-N-0279-0004 FDA None FDA-2011-N-0279 Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Marketing Act of 1987; Administrative Procedures, Policies, and Requirements Notice 60 Day Proposed Information Collection 2014-11-14T05:00:00Z 2014 11 2014-11-14T05:00:00Z 2015-01-14T04:59:59Z 2014-11-17T15:55:51Z 2014-26917 0 0 090000648192e78c
FDA-2014-N-1819-0001 FDA None FDA-2014-N-1819 Agency Information Collection Activities; Proposed Collection; Comment Request; Spousal Influence on Consumer Understanding of and Response to Direct-To-Consumer Prescription Drug Advertisements Notice 60 Day Proposed Information Collection 2014-11-14T05:00:00Z 2014 11 2014-11-14T05:00:00Z 2015-01-14T04:59:59Z 2015-02-07T03:01:28Z 2014-26918 0 0 090000648192e604
FDA-1981-D-0242-0001 FDA ANDROGENS CLASS LABELING GUIDELINE FDA-1981-D-0242 Notice of Availability from FDA Notice Notice of Availability 2014-11-14T05:00:00Z 2014 11 2014-11-14T05:00:00Z   2014-11-14T21:39:29Z   0 0 09000064805b0ae9

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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);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;