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

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7,453 rows where agency_id = "FDA" and posted_year = 2013 sorted by posted_date descending

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  • 2013 · 7,453 ✖

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  • FDA · 7,453 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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 Blood & Blood Components Error & Accident Reports - CLOSED 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 Blood & Blood Components Error & Accident Reports - CLOSED 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 Blood & Blood Components Error & Accident Reports - CLOSED 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 Lakes of Color Additives 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 Lakes of Color Additives 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 Blood & Blood Components Error & Accident Reports - CLOSED 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 Blood & Blood Components Error & Accident Reports - CLOSED 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 Platelet Concentrate & Cryoprecipitated Anthihemophilic - CLOSED 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 Antihemophilic Factor (Human) - CLOSED 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 Platelet Concentrate & Cryoprecipitated Anthihemophilic - CLOSED 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 Allergenic Extract Labeling - CLOSED 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 Lakes of Color Additives 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 Food Labeling; Net Weight Labeling Requirements-CLOSED 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 Antihemophilic Factor (Human) - CLOSED 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 Food Labeling; Net Weight Labeling Requirements-CLOSED 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 Allergenic Extract Labeling - CLOSED 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 Antihemophilic Factor (Human) - CLOSED 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 Antihemophilic Factor (Human) - CLOSED 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 Antihemophilic Factor (Human) - CLOSED 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 Allergenic Extract Labeling - CLOSED 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 Platelet Concentrate & Cryoprecipitated Anthihemophilic - CLOSED 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 Allergenic Extract Labeling - CLOSED 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 Platelet Concentrate & Cryoprecipitated Anthihemophilic - CLOSED 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 Food Labeling; Net Weight Labeling Requirements-CLOSED 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 Food Labeling; Net Weight Labeling Requirements-CLOSED 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 Antihemophilic Factor (Human) - CLOSED 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 New Animal Drugs for use in Animal Feeds 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 New Animal Drugs for use in Animal Feeds 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 New Animal Drugs for use in Animal Feeds 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 New Animal Drugs for use in Animal Feeds 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 New Animal Drugs for use in Animal Feeds 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

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