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withdrawn,object_id FDA-2013-V-1596-0001,FDA,FDA-2013-V-1596,Duality- Application for Variance,Other,Application for Variance (VAR),2013-12-31T05:00:00Z,2013,12,2013-12-31T05:00:00Z,,2013-12-31T18:19:11Z,,0,0,09000064814b23ab FDA-1979-N-0409-0001,FDA,FDA-1979-N-0409,Blood and Blood Components; Error and Accident Reports - Notice of Proposed Rule,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2013-12-31T05:00:00Z,2013,12,2013-12-31T05:00:00Z,1980-11-07T04:59:59Z,2014-05-08T14:18:07Z,,0,0,090000648055636a FDA-1979-N-0409-0003,FDA,FDA-1979-N-0409,Regulatory Analysis Assessment for Proposed Rule Making for Blood and Blood Components Concerning Error and Accident Reports - Regulatory Analysis,Supporting & Related Material,Regulatory Analysis,2013-12-31T05:00:00Z,2013,12,,,2013-12-31T15:35:10Z,,0,0,09000064814e3e84 FDA-2011-N-0922-0017,FDA,FDA-2011-N-0922,Request for Extension from American Feed Industry Association,Other,Request for Extension,2013-12-31T05:00:00Z,2013,12,2013-12-31T05:00:00Z,,2013-12-31T19:44:06Z,,0,0,0900006481492bbf FDA-1979-N-0409-0002,FDA,FDA-1979-N-0409,Regulatory Analysis Assessment for Proposed Rule Making for Blood and Blood Components Concerning Error and Accident Reports - Regulatory Analysis,Supporting & Related Material,Regulatory Analysis,2013-12-31T05:00:00Z,2013,12,,,2013-12-31T15:28:51Z,,0,0,0900006480556369 FDA-2013-V-1595-0001,FDA,FDA-2013-V-1595,Create Nightclub - Application for Variance,Other,Application for Variance (VAR),2013-12-31T05:00:00Z,2013,12,2013-12-31T05:00:00Z,,2013-12-31T18:24:52Z,,0,0,09000064814b34bd FDA-1979-N-0028-0035,FDA,FDA-1979-N-0028,Supplement from Colorcon,Supporting & Related Material,Supplement,2013-12-31T05:00:00Z,2013,12,,,2014-05-14T14:37:03Z,,0,0,0900006480553999 FDA-1979-N-0028-0036,FDA,FDA-1979-N-0028,Letter from SunChemical Corporation to FDA Dated March 20 1997,Other,Letter(s),2013-12-31T05:00:00Z,2013,12,1998-04-15T04:00:00Z,,2015-04-01T19:48:32Z,,0,0,090000648055399b FDA-1979-N-0409-0020,FDA,FDA-1979-N-0409,Withdrawal of Certain Pre-1986 Proposed Rules; Opportunity for Public Comment - Notice of Intent,Notice,Notice of Intent,2013-12-31T05:00:00Z,2013,12,2013-12-31T05:00:00Z,1991-10-29T04:59:59Z,2014-05-09T14:38:20Z,,0,0,090000648055637d FDA-2013-V-1596-0002,FDA,FDA-2013-V-1596,Acknowledgement Letter to Duality,Other,Acknowledgement Letter/Receipt,2013-12-31T05:00:00Z,2013,12,2013-12-31T05:00:00Z,,2013-12-31T18:19:19Z,,0,0,09000064814b34bb FDA-2013-V-1595-0002,FDA,FDA-2013-V-1595,Acknowledgement Letter to Create Nightclub,Other,Acknowledgement Letter/Receipt,2013-12-31T05:00:00Z,2013,12,2013-12-31T05:00:00Z,,2013-12-31T18:25:02Z,,0,0,09000064814b34bf FDA-1979-N-0409-0021,FDA,FDA-1979-N-0409,Withdrawal of Certain Pre-1986 Proposed Rules; Final Action - Notice of Withdrawal,Notice,Withdrawal,2013-12-31T05:00:00Z,2013,12,2013-12-31T05:00:00Z,,2014-05-09T14:38:40Z,,0,0,090000648055637e FDA-2013-N-1317-0092,FDA,FDA-2013-N-1317,"Tentative Determination Regarding Partially Hydrogenated Oils; Request for Comments and for Scientific Data and Information; Extension of Comment Period",Notice,Extension of Comment Period,2013-12-31T05:00:00Z,2013,12,2013-12-31T05:00:00Z,2014-03-09T04:59:59Z,2015-06-20T01:30:52Z,2013-31294,0,0,09000064814e42b9 FDA-2013-N-1634-0001,FDA,FDA-2013-N-1634,"Request for Notification From Industry Organizations Interested in Participating in Selection Process for a Nonvoting Industry Representative on the Food Advisory Committee and Request for Nominations for a Nonvoting Industry Representative on the Food Advisory Committee",Notice,General Notice,2013-12-31T05:00:00Z,2013,12,2013-12-31T05:00:00Z,,2014-01-02T14:51:51Z,2013-31321,0,0,09000064814e428c FDA-2013-N-0001-0120,FDA,FDA-2013-N-0001,"Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting",Notice,Meeting,2013-12-31T05:00:00Z,2013,12,2013-12-31T05:00:00Z,,2014-01-02T15:01:22Z,2013-31320,0,0,09000064814e431a FDA-2013-V-1607-0001,FDA,FDA-2013-V-1607,DJ Leo Entertainment - Application for Variance,Other,Application for Variance (VAR),2013-12-30T05:00:00Z,2013,12,2013-12-30T05:00:00Z,,2013-12-30T15:50:09Z,,0,0,09000064814baabb FDA-2013-V-1608-0002,FDA,FDA-2013-V-1608,Acknowledgement Letter to Nu-Salt,Other,Acknowledgement Letter/Receipt,2013-12-30T05:00:00Z,2013,12,2013-12-30T05:00:00Z,,2013-12-30T15:10:14Z,,0,0,09000064814ba667 FDA-1980-N-0149-0002,FDA,FDA-1980-N-0149,Withdrawal of Certain Pre-1986 Proposed Rules; Opportunity for Public Comment - Notice of Intent,Notice,Notice of Intent,2013-12-30T05:00:00Z,2013,12,2013-12-30T05:00:00Z,1991-10-29T04:59:59Z,2014-05-08T12:59:27Z,,0,0,09000064805bcf63 FDA-1979-N-0309-0003,FDA,FDA-1979-N-0309,Withdrawal of Certain Pre-1986 Proposed Rules; Final Action - Notice of Withdrawal,Notice,Withdrawal,2013-12-30T05:00:00Z,2013,12,2013-12-30T05:00:00Z,,2014-05-12T14:04:10Z,,0,0,09000064805551a5 FDA-1980-N-0149-0003,FDA,FDA-1980-N-0149,Withdrawal of Certain Pre-1986 Proposed Rules; Final Action - Notice of Withdrawal,Notice,Withdrawal,2013-12-30T05:00:00Z,2013,12,2013-12-30T05:00:00Z,,2014-05-08T13:00:01Z,,0,0,09000064805bcf64 FDA-2013-P-1611-0002,FDA,FDA-2013-P-1611,Acknowledgement Letter to Clarissa Clarke,Other,Acknowledgement Letter/Receipt,2013-12-30T05:00:00Z,2013,12,2013-12-30T05:00:00Z,,2024-07-25T12:19:07Z,,0,0,09000064814ba8c7 FDA-2013-N-1676-0001,FDA,FDA-2013-N-1676,"International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Tapentadol; Tramadol; Ketamine; gamma-Butyrolactone; 22 Additional Substances; Request for Comments",Notice,Request for Comments,2013-12-30T05:00:00Z,2013,12,2013-12-30T05:00:00Z,2014-01-30T04:59:59Z,2024-11-07T23:00:25Z,2013-31212,1,0,09000064814e192b FDA-2013-V-1599-0001,FDA,FDA-2013-V-1599,The Living Room - Application for Variance,Other,Application for Variance (VAR),2013-12-30T05:00:00Z,2013,12,2013-12-30T05:00:00Z,,2013-12-30T14:58:50Z,,0,0,09000064814b6fb0 FDA-2013-V-1599-0002,FDA,FDA-2013-V-1599,Acknowledgement Letter to The Living Room,Other,Acknowledgement Letter/Receipt,2013-12-30T05:00:00Z,2013,12,2013-12-30T05:00:00Z,,2013-12-30T14:58:51Z,,0,0,09000064814b6ff2 FDA-2013-N-0002-0045,FDA,FDA-2013-N-0002,New Animal Drugs for Use in Animal Feeds; Bambermycins; Correction,Rule,Correction,2013-12-30T05:00:00Z,2013,12,2013-12-30T05:00:00Z,,2013-12-30T15:28:01Z,2013-31184,0,0,09000064814e1974 FDA-1979-N-0307-0001,FDA,FDA-1979-N-0307,Allergenic Products; Proposed Testing and Labeling Requirements; Proposed Rule,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2013-12-30T05:00:00Z,2013,12,2013-12-30T05:00:00Z,1980-07-02T03:59:59Z,2014-06-18T16:36:34Z,,0,0,090000648055517f FDA-1979-N-0028-0014,FDA,FDA-1979-N-0028,"Comment from Colorcon, Inc. re FDA-1979-N-0028-0040",Supporting & Related Material,Background Material,2013-12-30T05:00:00Z,2013,12,,,2015-02-13T18:50:40Z,,0,0,0900006480553968 FDA-1979-N-0084-0002,FDA,FDA-1979-N-0084,Withdrawal of Certain Pre-1986 Proposed Rules; Opportunity for Public Comment - Notice of Intent,Notice,Notice of Intent,2013-12-30T05:00:00Z,2013,12,2013-12-30T05:00:00Z,1991-10-29T04:59:59Z,2014-05-12T18:35:27Z,,0,0,0900006480553e83 FDA-1979-N-0309-0001,FDA,FDA-1979-N-0309,Additional Standards for Human Blood Products; Antihemophillic Factor (Human) - Notice of Proposed Rule,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2013-12-30T05:00:00Z,2013,12,2013-12-30T05:00:00Z,,2014-05-13T14:33:51Z,,0,0,090000648055519b FDA-1979-N-0084-0001,FDA,FDA-1979-N-0084,Food Labeling; Net Weight Labeling Requirements - Notice of Proposed Rule,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2013-12-30T05:00:00Z,2013,12,2013-12-30T05:00:00Z,1980-11-07T04:59:59Z,2014-05-12T18:31:25Z,,0,0,0900006480553e82 FDA-2012-N-1239-0004,FDA,FDA-2012-N-1239,"Dental Devices; Reclassification of Temporary Mandibular Condyle Prosthesis",Rule,Final Rule,2013-12-30T05:00:00Z,2013,12,2013-12-30T05:00:00Z,,2013-12-30T15:21:52Z,2013-31217,0,0,09000064814e1b8c FDA-2013-V-1607-0002,FDA,FDA-2013-V-1607,Acknowledgement Letter to DJ Leo Entertainment,Other,Acknowledgement Letter/Receipt,2013-12-30T05:00:00Z,2013,12,2013-12-30T05:00:00Z,,2013-12-30T15:50:09Z,,0,0,09000064814baabd FDA-2013-V-1608-0001,FDA,FDA-2013-V-1608,Nu-Salt - Application for Variance,Other,Application for Variance (VAR),2013-12-30T05:00:00Z,2013,12,2013-12-30T05:00:00Z,,2013-12-30T15:10:13Z,,0,0,09000064814ba665 FDA-2013-N-0581-0002,FDA,FDA-2013-N-0581,"Cardiovascular Devices; Reclassification of Intra-Aortic Balloon and Control Systems for Acute Coronary Syndrome, Cardiac and Non- Cardiac Surgery, or Complications of Heart Failure; Effective Date of Requirement for Premarket Approval for Intra-Aortic Balloon and Control Systems for Septic Shock or Pulsatile Flow Generation",Rule,Final Rule,2013-12-30T05:00:00Z,2013,12,2013-12-30T05:00:00Z,,2013-12-30T14:52:49Z,2013-31218,0,0,09000064814e1976 FDA-2013-P-1609-0001,FDA,FDA-2013-P-1609,"Lachman Consultant Services, Inc. - Citizen Petition",Other,Citizen Petition,2013-12-30T05:00:00Z,2013,12,2013-12-30T05:00:00Z,,2024-11-07T22:59:08Z,,1,0,09000064814ba5ba FDA-2013-N-1155-0002,FDA,FDA-2013-N-1155,"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Labeling Regulations",Notice,General Notice,2013-12-30T05:00:00Z,2013,12,2013-12-30T05:00:00Z,2014-01-30T04:59:59Z,2014-01-25T02:04:00Z,2013-31215,0,0,09000064814e19fd FDA-2013-N-0001-0119,FDA,FDA-2013-N-0001,"Strategies To Address Hemolytic Complications of Immune Globulin Infusions; Public Workshop",Notice,Public Meetings,2013-12-30T05:00:00Z,2013,12,2013-12-30T05:00:00Z,,2013-12-30T14:17:54Z,2013-31213,0,0,09000064814e18f0 FDA-2013-P-1623-0001,FDA,FDA-2013-P-1623,"Sigmapharm Laboratories, LLC - Citizen Petition",Other,Citizen Petition,2013-12-30T05:00:00Z,2013,12,2013-12-30T05:00:00Z,,2019-07-08T13:35:40Z,,0,0,09000064814bd194 FDA-2013-N-0487-0004,FDA,FDA-2013-N-0487,"Cardiovascular Devices; Reclassification of External Counter- Pulsating Devices for Treatment of Chronic Stable Angina; Effective Date of Requirement for Premarket Approval for External Counter- Pulsating Devices for Other Specified Intended Uses",Rule,Final Rule,2013-12-30T05:00:00Z,2013,12,2013-12-30T05:00:00Z,,2013-12-30T14:58:02Z,2013-31216,0,0,09000064814e1adf FDA-1979-N-0307-0003,FDA,FDA-1979-N-0307,Withdrawal of Certain Pre-1986 Proposed Rules; Final Action - Withdrawal of Proposed Rule,Notice,Withdrawal,2013-12-30T05:00:00Z,2013,12,2013-12-30T05:00:00Z,,2013-12-30T18:42:25Z,,0,0,0900006480555185 FDA-1979-N-0309-0011,FDA,FDA-1979-N-0309,Background Material Items 4 and 5; Appendices I through V,Supporting & Related Material,Background Material,2013-12-30T05:00:00Z,2013,12,,,2014-05-12T15:05:06Z,,0,0,0900006480555199 FDA-1979-N-0309-0012,FDA,FDA-1979-N-0309,Background Material items 1 and 2,Supporting & Related Material,Environmental Impact Analysis Report,2013-12-30T05:00:00Z,2013,12,,,2014-05-12T15:18:55Z,,0,0,0900006480555198 FDA-1979-N-0309-0010,FDA,FDA-1979-N-0309,Background Material Items 2 and 3,Supporting & Related Material,Regulatory Analysis,2013-12-30T05:00:00Z,2013,12,,,2014-05-12T14:42:31Z,,0,0,090000648055519a FDA-1979-N-0307-0004,FDA,FDA-1979-N-0307,Regulatory Analysis Assessment for Proposed Rule Making Concerning Allergenic Products - Regulatory Assessment,Supporting & Related Material,Regulatory Analysis,2013-12-30T05:00:00Z,2013,12,,,2014-05-14T13:06:09Z,,0,0,090000648055517d FDA-2013-P-1623-0002,FDA,FDA-2013-P-1623,Acknowledgement Letter to Sigmapharm Laboratories LLC,Other,Acknowledgement Letter/Receipt,2013-12-30T05:00:00Z,2013,12,2013-12-30T05:00:00Z,,2013-12-30T16:12:16Z,,0,0,09000064814bd198 FDA-1980-N-0149-0009,FDA,FDA-1980-N-0149,Proposed Rule - Quality Control Testing of Platelet Concentrate (Human) and Cryoprecipitated Antihemophilic Factor (Human) - Regulatory Analysis Assessment,Supporting & Related Material,Regulatory Analysis,2013-12-30T05:00:00Z,2013,12,,,2013-12-30T18:35:48Z,,0,0,09000064805bcf5c FDA-2013-N-1425-0003,FDA,FDA-2013-N-1425,List of References From PRIA Reference 65,Other,List (LST),2013-12-30T05:00:00Z,2013,12,2013-12-30T05:00:00Z,,2013-12-30T14:09:49Z,,0,0,09000064814e179f FDA-1979-N-0307-0002,FDA,FDA-1979-N-0307,Withdrawal of Certain Pre-1986 Proposed Rules; Opportunity for Public Comment - Notice of Intent,Notice,Notice of Intent,2013-12-30T05:00:00Z,2013,12,2013-12-30T05:00:00Z,1991-10-29T04:59:59Z,2013-12-30T18:42:24Z,,0,0,0900006480555184 FDA-1980-N-0149-0001,FDA,FDA-1980-N-0149,Withdrawal of Certain Pre-1986 Proposed Rules - Notice of Proposed Rulemaking,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2013-12-30T05:00:00Z,2013,12,2013-12-30T05:00:00Z,,2014-05-08T12:45:51Z,,0,0,09000064805bcf5d FDA-2013-P-1609-0002,FDA,FDA-2013-P-1609,"Acknowledgement Letter to Lachman Consultant Services, Inc.",Other,Citizen Petition,2013-12-30T05:00:00Z,2013,12,2013-12-30T05:00:00Z,,2013-12-30T16:00:10Z,,0,0,09000064814ba662 FDA-1979-N-0084-0004,FDA,FDA-1979-N-0084,Memorandum from FDA CFSAN to DDM,Other,Memorandum,2013-12-30T05:00:00Z,2013,12,,,2014-05-12T18:38:57Z,,0,0,0900006480553e85 FDA-1979-N-0084-0003,FDA,FDA-1979-N-0084,Food Labeling; Net Weight Labeling Requirements - Withdrawal of Certain Pre-1986 Proposed Rules; Final Action - Notice of Withdrawal,Notice,Withdrawal,2013-12-30T05:00:00Z,2013,12,2013-12-30T05:00:00Z,,2014-05-12T18:35:45Z,,0,0,0900006480553e84 FDA-1979-N-0309-0002,FDA,FDA-1979-N-0309,Withdrawal of Certain Pre-1986 Proposed Rules; Opportunity for Public Comment - Notice of Intent,Notice,Notice of Intent,2013-12-30T05:00:00Z,2013,12,2013-12-30T05:00:00Z,1991-10-29T04:59:59Z,2014-05-12T14:03:52Z,,0,0,09000064805551a4 FDA-2013-P-1611-0001,FDA,FDA-2013-P-1611,Citizen Petition from Clarissa Clarke,Other,Citizen Petition,2013-12-30T05:00:00Z,2013,12,2013-12-30T05:00:00Z,,2024-07-25T12:18:51Z,,0,0,09000064814ba6d2 FDA-1977-N-0005-0367,FDA,FDA-1977-N-0005,"FDA/Office of Legislative Affairs to Hess & Clark, Inc. - Answer",Other,Answer,2013-12-27T05:00:00Z,2013,12,2013-12-27T05:00:00Z,,2013-12-27T15:16:38Z,,0,0,09000064805d7d65 FDA-2013-N-0002-0049,FDA,FDA-2013-N-0002,Approvals of New Animal Drug Applications Withdrawals Roxarsone,Rule,Final Rule,2013-12-27T05:00:00Z,2013,12,2013-12-27T05:00:00Z,,2014-01-25T23:25:40Z,2013-30837,0,0,09000064814de405 FDA-2013-N-0002-0044,FDA,FDA-2013-N-0002,Withdrawal of Approval of New Animal Drug Applications; Roxarsone,Rule,Final Rule,2013-12-27T05:00:00Z,2013,12,2013-12-27T05:00:00Z,,2013-12-27T15:39:48Z,2013-30838,0,0,09000064814de527 FDA-2011-P-0438-0006,FDA,FDA-2011-P-0438,FDA/CDRH Response to Public Citizen Health Research Group - Partial Petition Approval and Denial,Other,Partial Petition Approval and Denial,2013-12-27T05:00:00Z,2013,12,2013-12-27T05:00:00Z,,2013-12-27T12:55:24Z,,0,0,09000064814ddf89 FDA-2013-N-0500-0006,FDA,FDA-2013-N-0500,Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products; Correction and Extension of Comment Period,Proposed Rule,Extension of Comment Period,2013-12-27T05:00:00Z,2013,12,2013-12-27T05:00:00Z,2014-03-14T03:59:59Z,2014-04-10T01:02:03Z,2013-30881,0,0,09000064814debad FDA-1977-N-0005-0357,FDA,FDA-1977-N-0005,Definitions and General Considerations; Revised Procedures re Medicated Feed Applications - Notice of Extension of Comment Period,Notice,Notice of Extension,2013-12-27T05:00:00Z,2013,12,2013-12-27T05:00:00Z,1981-07-09T03:59:59Z,2013-12-27T14:11:12Z,,0,0,09000064805d7b84 FDA-2013-N-1147-0002,FDA,FDA-2013-N-1147,"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition",Notice,General Notice,2013-12-27T05:00:00Z,2013,12,2013-12-27T05:00:00Z,2014-01-28T04:59:59Z,2013-12-27T15:48:56Z,2013-30998,0,0,09000064814de952 FDA-2011-N-0179-0019,FDA,FDA-2011-N-0179,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002,Notice,General Notice,2013-12-27T05:00:00Z,2013,12,2013-12-27T05:00:00Z,2014-01-28T04:59:59Z,2014-04-04T17:00:53Z,2013-30996,0,0,09000064814deaed FDA-2013-N-1558-0001,FDA,FDA-2013-N-1558,Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products,Notice,60 Day Proposed Information Collection,2013-12-27T05:00:00Z,2013,12,2013-12-27T05:00:00Z,2014-02-26T04:59:59Z,2015-02-14T00:29:34Z,2013-30880,0,0,09000064814debdd FDA-1977-N-0005-0385,FDA,FDA-1977-N-0005,FDA/Office of Legislative Affairs to Cooper Evans - Answer,Other,Answer,2013-12-27T05:00:00Z,2013,12,2013-12-27T05:00:00Z,,2013-12-27T16:52:54Z,,0,0,09000064805d7d66 FDA-1977-N-0005-0366,FDA,FDA-1977-N-0005,"Department of Health & Human Services, Public Health Service, Region 5 - Letter",Other,Letter(s),2013-12-27T05:00:00Z,2013,12,2013-12-27T05:00:00Z,,2013-12-27T15:11:24Z,,0,0,09000064805d7b8f FDA-2013-N-1620-0001,FDA,FDA-2013-N-1620,"Agency Information Collection Activities; Proposed Collection; Comment Request; Information From United States Firms and Processors That Export to the European Community",Notice,General Notice,2013-12-26T05:00:00Z,2013,12,2013-12-26T05:00:00Z,2014-02-25T04:59:59Z,2024-11-07T23:00:22Z,2013-30804,1,0,09000064814dcb64 FDA-2013-M-1605-0001,FDA,FDA-2013-M-1605,"Premarket Approval of W.L. Gore and Associates, Inc. P130006",Other,Approval,2013-12-26T05:00:00Z,2013,12,2013-12-26T05:00:00Z,,2013-12-26T15:12:16Z,,0,0,09000064814dab0f FDA-2013-E-1694-0002,FDA,FDA-2013-E-1694,"TriVascular, Inc. - Patent Term Application",Other,Application,2013-12-26T05:00:00Z,2013,12,2013-12-26T05:00:00Z,,2013-12-26T17:49:36Z,,0,0,09000064814dd643 FDA-2013-E-1694-0001,FDA,FDA-2013-E-1694,U.S. Patant and Trademark Office - Letter,Other,Letter(s),2013-12-26T05:00:00Z,2013,12,2013-12-26T05:00:00Z,,2013-12-26T17:49:28Z,,0,0,09000064814dd644 FDA-2013-E-1691-0001,FDA,FDA-2013-E-1691,U.S.. Patatent and Trademark Office - Letter,Other,Letter(s),2013-12-26T05:00:00Z,2013,12,2013-12-26T05:00:00Z,,2013-12-26T14:10:36Z,,0,0,09000064814dc7e9 FDA-2013-D-1566-0002,FDA,FDA-2013-D-1566,Draft Guidance for Industry on Naming of Drug Products Containing Salt Drug Substances,Other,Guidance,2013-12-26T05:00:00Z,2013,12,2013-12-26T05:00:00Z,,2024-11-07T23:00:18Z,,1,0,09000064814dcd46 FDA-2013-N-0001-0118,FDA,FDA-2013-N-0001,Allergenic Products Advisory Committee; Notice of Meeting,Notice,Meeting,2013-12-26T05:00:00Z,2013,12,2013-12-26T05:00:00Z,,2013-12-26T14:51:40Z,2013-30799,0,0,09000064814dc88e FDA-2013-E-1692-0001,FDA,FDA-2013-E-1692,U.S. Patent and Trademark Office - Letter,Other,Letter(s),2013-12-26T05:00:00Z,2013,12,2013-12-26T05:00:00Z,,2013-12-26T14:45:07Z,,0,0,09000064814dc7ee FDA-2013-E-0296-0003,FDA,FDA-2013-E-0296,U.S. Patent and Trademark Office - Letter,Other,Letter(s),2013-12-26T05:00:00Z,2013,12,2013-12-26T05:00:00Z,,2013-12-26T15:48:59Z,,0,0,09000064814dcd48 FDA-2013-N-1618-0001,FDA,FDA-2013-N-1618,"Draft Prescription Drug User Fee Act V Information Technology Plan; Availability for Comment",Notice,General Notice,2013-12-26T05:00:00Z,2013,12,2013-12-26T05:00:00Z,2014-02-25T04:59:59Z,2024-11-07T23:00:00Z,2013-30818,1,0,09000064814dc9f4 FDA-1977-N-0005-0329,FDA,FDA-1977-N-0005,FDA/Office of Legislative Affairs to the Honorable Paul Findley - Comment,Other,Answer,2013-12-26T05:00:00Z,2013,12,2013-12-26T05:00:00Z,,2013-12-26T18:05:15Z,,0,0,09000064805d7d64 FDA-2013-E-1691-0002,FDA,FDA-2013-E-1691,"Morrison & Foerster LLP (on behalf of Genenetech, Inc) - Patent Term Application",Other,Application,2013-12-26T05:00:00Z,2013,12,2013-12-26T05:00:00Z,,2013-12-26T14:27:36Z,,0,0,09000064814db700 FDA-2013-E-1690-0002,FDA,FDA-2013-E-1690,"CEPHALON, Inc. - Patent Term Application",Other,Application,2013-12-26T05:00:00Z,2013,12,2013-12-26T05:00:00Z,,2013-12-26T13:38:09Z,,0,0,09000064814db6fc FDA-2013-E-1692-0002,FDA,FDA-2013-E-1692,"Morrison & Foerster LLP (on behalf of Genenetech, Inc) - Patent Term Application",Other,Application,2013-12-26T05:00:00Z,2013,12,2013-12-26T05:00:00Z,,2013-12-26T14:45:22Z,,0,0,09000064814dc7ed FDA-2013-N-1615-0002,FDA,FDA-2013-N-1615,16452 GDUFA IT Plan,Supporting & Related Material,Background Material,2013-12-26T05:00:00Z,2013,12,,,2013-12-26T16:58:52Z,,0,0,09000064814dd570 FDA-2013-D-1566-0001,FDA,FDA-2013-D-1566,Draft Guidance for Industry on Naming of Drug Products Containing Salt Drug Substances; Availability,Notice,Notice of Availability,2013-12-26T05:00:00Z,2013,12,2013-12-26T05:00:00Z,2014-03-27T03:59:59Z,2014-03-27T01:02:38Z,2013-30800,0,0,09000064814dcb61 FDA-2013-E-1690-0001,FDA,FDA-2013-E-1690,U.S. Patent and Trademark Office - Letter,Other,Letter(s),2013-12-26T05:00:00Z,2013,12,2013-12-26T05:00:00Z,,2013-12-26T13:38:00Z,,0,0,09000064814db6fd FDA-2013-N-1618-0002,FDA,FDA-2013-N-1618,16451 PDUFA IT Plan,Supporting & Related Material,Background Material,2013-12-26T05:00:00Z,2013,12,,,2013-12-26T17:04:34Z,,0,0,09000064814dd571 FDA-2013-N-1615-0001,FDA,FDA-2013-N-1615,"Draft Generic Drug User Fee Act Information Technology Plan; Availability for Comment",Notice,General Notice,2013-12-26T05:00:00Z,2013,12,2013-12-26T05:00:00Z,2014-02-25T04:59:59Z,2014-02-25T02:03:09Z,2013-31008,0,0,09000064814dcba6 FDA-2013-N-0001-0117,FDA,FDA-2013-N-0001,"Science Advisory Board to the National Center for Toxicological Research; Notice of Meeting",Notice,Meeting,2013-12-24T05:00:00Z,2013,12,2013-12-24T05:00:00Z,,2013-12-24T14:55:25Z,2013-30578,0,0,09000064814d558a FDA-2009-E-0087-0013,FDA,FDA-2009-E-0087,U.S. Patent and Trademark Office to Zoetis - Letter,Other,Letter(s),2013-12-24T05:00:00Z,2013,12,2013-12-24T05:00:00Z,,2013-12-24T13:04:38Z,,0,0,09000064814d407b FDA-2013-V-1559-0002,FDA,FDA-2013-V-1559,"Acknowledgement Letter to Coast Digital Solutions, Inc.",Other,Acknowledgement Letter/Receipt,2013-12-24T05:00:00Z,2013,12,2013-12-24T05:00:00Z,,2013-12-24T18:13:20Z,,0,0,09000064814a5fa4 FDA-2013-N-1563-0001,FDA,FDA-2013-N-1563,"Appendix 4 to Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm; Availability",Proposed Rule,Request for Comment,2013-12-24T05:00:00Z,2013,12,2013-12-24T05:00:00Z,2014-04-01T03:59:59Z,2014-01-01T02:04:13Z,2013-30375,0,0,09000064814d536f FDA-2013-V-1559-0001,FDA,FDA-2013-V-1559,"Coast Digital Solutions, Inc. - Application for Variance",Other,Application for Variance (VAR),2013-12-24T05:00:00Z,2013,12,2013-12-24T05:00:00Z,,2013-12-24T18:13:19Z,,0,0,09000064814a5f9f FDA-2013-E-0682-0004,FDA,FDA-2013-E-0682,U.S. Patent and Trademark Office to Venable LLP - Letter,Other,Letter(s),2013-12-24T05:00:00Z,2013,12,2013-12-24T05:00:00Z,,2013-12-24T13:23:43Z,,0,0,09000064814d407d FDA-2013-N-1496-0001,FDA,FDA-2013-N-1496,"Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Rapid Response Surveys (Generic Clearance)",Notice,General Notice,2013-12-24T05:00:00Z,2013,12,2013-12-24T05:00:00Z,2014-02-25T04:59:59Z,2013-12-24T15:06:13Z,2013-30630,0,0,09000064814d55d8 FDA-2013-V-1560-0002,FDA,FDA-2013-V-1560,Acknowledgement Letter to Davaine Lighting,Other,Acknowledgement Letter/Receipt,2013-12-24T05:00:00Z,2013,12,2013-12-24T05:00:00Z,,2013-12-24T18:19:41Z,,0,0,09000064814a5c89 FDA-2013-V-1560-0001,FDA,FDA-2013-V-1560,Davaine Lighting - Application for Variance,Other,Application for Variance (VAR),2013-12-24T05:00:00Z,2013,12,2013-12-24T05:00:00Z,,2013-12-24T18:19:25Z,,0,0,09000064814a5c85 FDA-2013-P-0380-0003,FDA,FDA-2013-P-0380,FDA/CDER Interim Response to the University of Florida College of Medicine - Jacksonville and the UNC School of Medicine - Letter,Other,Letter(s),2013-12-24T05:00:00Z,2013,12,2013-12-24T05:00:00Z,,2015-07-07T22:14:36Z,,0,0,09000064814414e8 FDA-2011-P-0086-0006,FDA,FDA-2011-P-0086,"Janssen Research & Development, LLC. - Supplement",Other,Supplement (SUP),2013-12-24T05:00:00Z,2013,12,2013-12-24T05:00:00Z,,2013-12-24T20:07:39Z,,0,0,09000064814ba9d1 FDA-2012-N-0284-0009,FDA,FDA-2012-N-0284,FDA CDER Memorandum December 17 2013 re for use of Sodium Nitroprusside to Reduce Blood Pressure in Pediatric Patients,Other,Memorandum,2013-12-24T05:00:00Z,2013,12,2013-12-24T05:00:00Z,,2013-12-24T13:59:09Z,,0,0,09000064814d51b8 FDA-2013-N-1425-0001,FDA,FDA-2013-N-1425,"Focused Mitigation Strategies To Protect Food Against Intentional Adulteration; Public Meeting on Proposed Rule",Proposed Rule,Public Meeting,2013-12-24T05:00:00Z,2013,12,2013-12-24T05:00:00Z,,2013-12-24T15:38:06Z,2013-30372,0,0,09000064814d54bf FDA-2013-N-0001-0115,FDA,FDA-2013-N-0001,"Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting",Notice,Meeting,2013-12-24T05:00:00Z,2013,12,2013-12-24T05:00:00Z,,2013-12-24T14:49:23Z,2013-30579,0,0,09000064814d52cb FDA-2013-N-1425-0002,FDA,FDA-2013-N-1425,Focused Mitigation Strategies to Protect Food Against Intentional Adulteration,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2013-12-24T05:00:00Z,2013,12,2013-12-24T05:00:00Z,2014-04-01T03:59:59Z,2014-04-04T01:02:32Z,2013-30373,0,0,09000064814d53fc FDA-2013-N-0001-0116,FDA,FDA-2013-N-0001,"Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting",Notice,Meeting,2013-12-24T05:00:00Z,2013,12,2013-12-24T05:00:00Z,,2013-12-24T14:52:21Z,2013-30580,0,0,09000064814d531a