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withdrawn,object_id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,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,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,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,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,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,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