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withdrawn,object_id FDA-2014-D-2254-0001,FDA,FDA-2014-D-2254,The Drug Supply Chain Security Act Implementation Product Tracing Requirements Compliance Policy Guidance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,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,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,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,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FDA-2014-D-2065-0001,FDA,FDA-2014-D-2065,Radiation Biodosimetry Devices Draft Guidance for Industry and Food and Drug Administration Staff Availability,Notice,Notice of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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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