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withdrawn,object_id FDA-1979-N-0409-0020,FDA,FDA-1979-N-0409,Withdrawal of Certain Pre-1986 Proposed Rules; Opportunity for Public Comment - Notice of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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 FDA-1997-N-0057-0009,FDA,FDA-1997-N-0057,See FDA-1997-N-0057-0008,Notice,Correction,2013-12-23T05:00:00Z,2013,12,2013-12-23T05:00:00Z,,2013-12-24T02:03:01Z,,0,0,09000064814d1f30 FDA-2013-N-0001-0114,FDA,FDA-2013-N-0001,"Food and Drug Administration/American Academy of Ophthalmology Workshop on Developing Novel Endpoints for Premium Intraocular Lenses; Public Workshop",Notice,Meeting,2013-12-19T05:00:00Z,2013,12,,,2013-12-19T18:54:11Z,2013-30148,0,0,09000064814cb583 FDA-2013-N-0796-0002,FDA,FDA-2013-N-0796,"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Testing Communications on Medical Devices and Radiation-Emitting Products",Notice,30 Day Proposed Information Collection,2013-12-19T05:00:00Z,2013,12,2013-12-19T05:00:00Z,,2016-10-28T12:27:02Z,2013-30149,0,0,09000064814cb0ec FDA-2013-D-0636-0024,FDA,FDA-2013-D-0636,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Unique Device Identification System",Notice,,2013-12-19T05:00:00Z,2013,12,,,2013-12-19T18:18:35Z,2013-30147,0,0,09000064814cb540 FDA-2013-N-1588-0001,FDA,FDA-2013-N-1588,"Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Products, Exemptions From Substantial Equivalence Requirements",Notice,60 Day Proposed Information Collection,2013-12-19T05:00:00Z,2013,12,2013-12-19T05:00:00Z,2014-02-19T04:59:59Z,2022-07-25T17:27:30Z,2013-30137,0,0,09000064814cb538 FDA-2008-D-0150-0019,FDA,FDA-2008-D-0150,"Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims",Notice,Notice of Approval,2013-12-19T05:00:00Z,2013,12,2013-12-19T05:00:00Z,,2013-12-19T17:20:33Z,2013-30146,0,0,09000064814cb007 FDA-2013-N-1619-0001,FDA,FDA-2013-N-1619,"Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements",Notice,60 Day Proposed Information Collection,2013-12-19T05:00:00Z,2013,12,2013-12-19T05:00:00Z,2014-02-19T04:59:59Z,2024-11-07T23:01:20Z,2013-30185,1,0,09000064814cb57f FDA-2013-N-1204-0006,FDA,FDA-2013-N-1204,Draft Risk Profile on Pathogens and Filth in Spices: Availability; Extension of Comment Period,Notice,Extension of Comment Period,2013-12-18T05:00:00Z,2013,12,2013-12-18T05:00:00Z,2014-03-04T04:59:59Z,2014-03-07T02:03:54Z,2013-30055,0,0,09000064814c936a FDA-2010-N-0308-0045,FDA,FDA-2010-N-0308,See FDA-2010-N-0308-0046,Notice,General Notice,2013-12-18T05:00:00Z,2013,12,2013-12-18T05:00:00Z,2014-03-04T04:59:59Z,2014-03-09T03:44:59Z,2013-30055,0,0,09000064814c8a96 FDA-2010-N-0308-0046,FDA,FDA-2010-N-0308,Pilot Program for Parallel Review of Medical Products; Extension of the Duration of the Program,Notice,General Notice,2013-12-18T05:00:00Z,2013,12,2013-12-18T05:00:00Z,2014-03-04T04:59:59Z,2014-03-06T21:48:24Z,2013-29822,0,0,09000064814c8999 FDA-2013-N-0001-0113,FDA,FDA-2013-N-0001,Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting,Notice,Meeting,2013-12-17T05:00:00Z,2013,12,2013-12-17T05:00:00Z,,2013-12-17T14:24:41Z,2013-29917,0,0,09000064814c48d2 FDA-2013-N-0001-0112,FDA,FDA-2013-N-0001,Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting,Notice,Meeting,2013-12-17T05:00:00Z,2013,12,2013-12-17T05:00:00Z,,2013-12-17T14:21:02Z,2013-29933,0,0,09000064814c4854 FDA-2013-N-0001-0111,FDA,FDA-2013-N-0001,Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting,Notice,General Notice,2013-12-17T05:00:00Z,2013,12,2013-12-17T05:00:00Z,,2013-12-17T14:17:28Z,2013-29945,0,0,09000064814c478b FDA-2013-D-0117-0005,FDA,FDA-2013-D-0117,"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Providing Information About Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act",Notice,General Notice,2013-12-16T05:00:00Z,2013,12,2013-12-16T05:00:00Z,2014-01-16T04:59:59Z,2013-12-16T15:33:09Z,2013-29796,0,0,09000064814c1d1f FDA-2011-D-0889-0156,FDA,FDA-2011-D-0889,Guidance for Industry on New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions With Guidance for Industry #209; Availability,Notice,Notice of Availability,2013-12-12T05:00:00Z,2013,12,2013-12-12T05:00:00Z,,2013-12-12T16:37:47Z,2013-29697,0,0,09000064814b9f8c FDA-2013-N-1504-0001,FDA,FDA-2013-N-1504,Independent Assessment of the Process for the Review of Device Submissions; High Priority Recommendations,Notice,General Notice,2013-12-12T05:00:00Z,2013,12,2013-12-12T05:00:00Z,,2013-12-12T15:04:28Z,2013-29612,0,0,09000064814ba585 FDA-2013-D-0928-0003,FDA,FDA-2013-D-0928,Draft Guidance for Industry on Recommendations for Preparation and Submission of Animal Food Additive Petitions; Reopening of the Comment Period,Notice,Notice of Availability,2013-12-10T05:00:00Z,2013,12,2013-12-10T05:00:00Z,2014-01-10T04:59:59Z,2014-01-10T02:01:50Z,2013-29392,0,0,09000064814b5b83 FDA-2013-D-1478-0001,FDA,FDA-2013-D-1478,Agency Information Collection Activities; Proposed Collection; Comment Request; Providing Waiver-Related Materials in Accordance With Draft Guidance for Industry on Providing Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format,Notice,60 Day Proposed Information Collection,2013-12-10T05:00:00Z,2013,12,2013-12-10T05:00:00Z,2014-02-11T04:59:59Z,2013-12-10T14:19:50Z,2013-29393,0,0,09000064814b5a80 FDA-2013-N-1434-0001,FDA,FDA-2013-N-1434,"Draft Guidance for Industry on Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules; Availability",Notice,Notice of Availability,2013-12-10T05:00:00Z,2013,12,2013-12-10T05:00:00Z,2014-03-11T03:59:59Z,2014-04-06T02:24:30Z,2013-29395,0,0,09000064814b5c63 FDA-2013-N-0853-0002,FDA,FDA-2013-N-0853,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical DevicesCurrent Good Manufacturing Practice Quality System Regulation,Notice,30 Day Proposed Information Collection,2013-12-10T05:00:00Z,2013,12,2013-12-10T05:00:00Z,2014-01-10T04:59:59Z,2013-12-10T15:23:32Z,2013-29394,0,0,09000064814b5b4b FDA-2013-N-0823-0002,FDA,FDA-2013-N-0823,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Over-the-Counter Drugs; Labeling Requirements,Notice,30 Day Proposed Information Collection,2013-12-05T05:00:00Z,2013,12,2013-12-05T05:00:00Z,2014-01-07T04:59:59Z,2013-12-08T15:37:58Z,2013-29079,0,0,09000064814a9e18 FDA-2013-D-1464-0001,FDA,FDA-2013-D-1464,Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application; Availability,Notice,Notice of Availability,2013-12-05T05:00:00Z,2013,12,2013-12-05T05:00:00Z,2014-03-06T04:59:59Z,2014-03-06T02:01:21Z,2013-29081,0,0,09000064814a9ea0 FDA-2007-D-0369-0277,FDA,FDA-2007-D-0369,Draft Guidance for Industry; Availability: Bioequivalence Recommendations for Paliperidone Palmitate Extended-Release Injectable Suspension,Notice,Notice of Availability,2013-12-05T05:00:00Z,2013,12,2013-12-05T05:00:00Z,2014-02-04T04:59:59Z,2014-02-13T02:02:08Z,2013-29080,0,0,09000064814a9e1e FDA-2013-D-1444-0001,FDA,FDA-2013-D-1444,"Draft Guidance; Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Withdrawal of Guidances",Notice,Notice of Availability,2013-12-04T05:00:00Z,2013,12,2013-12-04T05:00:00Z,2014-02-04T04:59:59Z,2014-02-05T02:03:21Z,2013-28963,0,0,09000064814a6225 FDA-2013-N-0579-0002,FDA,FDA-2013-N-0579,"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing; Forms FDA 3486 and 3486A",Notice,30 Day Proposed Information Collection,2013-12-04T05:00:00Z,2013,12,2013-12-04T05:00:00Z,2014-01-04T04:59:59Z,2013-12-30T02:01:45Z,2013-28990,0,0,09000064814a61ed FDA-2013-N-0795-0002,FDA,FDA-2013-N-0795,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Third-Party Review Under the Food and Drug Administration Modernization Act,Notice,60 Day Proposed Information Collection,2013-12-04T05:00:00Z,2013,12,2013-12-04T05:00:00Z,2014-01-04T04:59:59Z,2013-12-04T17:27:21Z,2013-29010,0,0,09000064814a6173 FDA-2013-N-1429-0001,FDA,FDA-2013-N-1429,"Draft Guidance for Industry on Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Availability",Notice,Notice of Availability,2013-12-04T05:00:00Z,2013,12,2013-12-04T05:00:00Z,2014-02-04T04:59:59Z,2020-04-23T20:10:32Z,2013-28962,0,0,09000064814a62d0 FDA-2012-D-1083-0007,FDA,FDA-2012-D-1083,Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked Questions; Availability,Notice,Notice of Availability,2013-12-04T05:00:00Z,2013,12,2013-12-04T05:00:00Z,,2015-03-24T19:07:23Z,2013-28961,0,0,09000064814a62d1 FDA-2013-N-1428-0001,FDA,FDA-2013-N-1428,"Draft Guidance for Industry on Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Availability",Notice,Notice of Availability,2013-12-04T05:00:00Z,2013,12,2013-12-04T05:00:00Z,2014-02-04T04:59:59Z,2019-07-17T12:21:27Z,2013-28960,0,0,09000064814a6172 FDA-2013-N-0797-0003,FDA,FDA-2013-N-0797,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Human Tissue Intended for Transplantation,Notice,30 Day Proposed Information Collection,2013-12-04T05:00:00Z,2013,12,2013-12-04T05:00:00Z,2014-01-04T04:59:59Z,2014-01-05T02:56:10Z,2013-28989,0,0,09000064814a6316 FDA-2013-N-0719-0002,FDA,FDA-2013-N-0719,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Planning for the Effects of High Absenteeism To Ensure Availability of Medically Necessary Drug Products,Notice,30 Day Proposed Information Collection,2013-12-02T05:00:00Z,2013,12,2013-12-02T05:00:00Z,2014-01-03T04:59:59Z,2013-12-03T01:11:39Z,2013-28735,0,0,09000064814a2106 FDA-2013-N-0748-0002,FDA,FDA-2013-N-0748,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Focus Groups About Drug Products as Used by the Food and Drug Administration,Notice,30 Day Proposed Information Collection,2013-12-02T05:00:00Z,2013,12,2013-12-02T05:00:00Z,2014-01-03T04:59:59Z,2013-12-03T01:04:57Z,2013-28736,0,0,09000064814a1fbf FDA-2013-N-0716-0002,FDA,FDA-2013-N-0716,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Designated New Animal Drugs for Minor Use and Minor Species,Notice,General Notice,2013-11-29T05:00:00Z,2013,11,2013-11-29T05:00:00Z,2013-12-31T04:59:59Z,2013-11-29T17:13:49Z,2013-28598,0,0,090000648149f1ca FDA-2013-N-1439-0001,FDA,FDA-2013-N-1439,Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Program for Medical Products,Notice,General Notice,2013-11-29T05:00:00Z,2013,11,2013-11-29T05:00:00Z,2014-01-29T04:59:59Z,2013-11-29T17:16:39Z,2013-28600,0,0,090000648149f214 FDA-2013-N-1422-0001,FDA,FDA-2013-N-1422,Agency Information Collection Activities; Proposed Collection; Comment Request; Eye Tracking Study of Direct-to-Consumer Prescription Drug Advertisement Viewing,Notice,General Notice,2013-11-29T05:00:00Z,2013,11,2013-11-29T05:00:00Z,2014-01-29T04:59:59Z,2014-09-04T17:41:07Z,2013-28599,0,0,090000648149f075 FDA-2012-D-0880-0009,FDA,FDA-2012-D-0880,Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers (Revision 1); Reopening of the Comment Period,Notice,General Notice,2013-11-27T05:00:00Z,2013,11,2013-11-27T05:00:00Z,2013-12-12T04:59:59Z,2016-11-18T14:46:02Z,2013-28392,0,0,090000648149c2b6 FDA-2013-N-1424-0001,FDA,FDA-2013-N-1424,Transport Format for the Submission of Regulatory Study Data; Notice of Pilot Project,Notice,General Notice,2013-11-27T05:00:00Z,2013,11,2013-11-27T05:00:00Z,2014-01-28T04:59:59Z,2024-11-12T05:23:15Z,2013-28391,1,0,090000648149c255 FDA-2013-N-0001-0110,FDA,FDA-2013-N-0001,Risk Communications Advisory Committee; Notice of Meeting,Notice,Meeting,2013-11-27T05:00:00Z,2013,11,2013-11-27T05:00:00Z,,2013-11-27T15:57:46Z,2013-28435,0,0,090000648149c214 FDA-2013-N-1423-0001,FDA,FDA-2013-N-1423,Agency Information Collection Activities; Proposed Collection; Comment Request; Importer's Entry Notice,Notice,General Notice,2013-11-27T05:00:00Z,2013,11,2013-11-27T05:00:00Z,2014-01-28T04:59:59Z,2024-11-12T05:23:18Z,2013-28438,1,0,090000648149c36a FDA-2007-D-0369-0275,FDA,FDA-2007-D-0369,Draft Guidance for Industry on Bioequivalence Recommendations for Fluticasone Propionate; Salmeterol Xinafoate; Reopening of the Comment Period,Notice,Notice of Availability,2013-11-27T05:00:00Z,2013,11,2013-11-27T05:00:00Z,2013-12-12T04:59:59Z,2013-12-08T18:23:54Z,2013-28394,0,0,090000648149c332 FDA-2013-N-0002-0040,FDA,FDA-2013-N-0002,Withdrawal of Approval of New Animal Drug Applications; Arsanilic Acid,Notice,General Notice,2013-11-26T05:00:00Z,2013,11,2013-11-26T05:00:00Z,,2013-11-26T14:17:06Z,2013-28255,0,0,0900006481498795 FDA-2011-D-0305-0058,FDA,FDA-2011-D-0305,Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Guidance for Industry and Food and Drug Administration Staff; Availability,Notice,Notice of Availability,2013-11-25T05:00:00Z,2013,11,2013-11-25T05:00:00Z,,2013-11-26T13:37:08Z,2013-28084,0,0,0900006481495921 FDA-2012-D-1038-0017,FDA,FDA-2012-D-1038,Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products; Availability,Notice,Notice of Availability,2013-11-25T05:00:00Z,2013,11,2013-11-25T05:00:00Z,,2013-11-26T13:43:05Z,2013-28173,0,0,0900006481495aaa FDA-2013-N-0002-0038,FDA,FDA-2013-N-0002,Withdrawal of Approval of New Animal Drug Applications; Carbarsone; Roxarsone,Notice,General Notice,2013-11-22T05:00:00Z,2013,11,2013-11-22T05:00:00Z,,2013-11-22T14:37:17Z,2013-27916,0,0,09000064814910b5 FDA-2013-D-0269-0003,FDA,FDA-2013-D-0269,Guidance for Industry: Purchasing Reef Fish Species Associated with the Hazard of Ciguatera Fish Poisoning; Availability,Notice,Notice of Availability,2013-11-22T05:00:00Z,2013,11,2013-11-22T05:00:00Z,,2013-11-22T15:33:10Z,2013-27913,0,0,090000648149122c FDA-2013-P-0573-0003,FDA,FDA-2013-P-0573,"Determination That BANZEL (Rufinamide) Tablet, 100 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness",Notice,General Notice,2013-11-21T05:00:00Z,2013,11,2013-11-21T05:00:00Z,,2013-11-21T14:54:32Z,2013-27874,0,0,090000648148e297 FDA-2013-N-1432-0001,FDA,FDA-2013-N-1432,Agency Information Collection Activities; Proposed Collection; Comment Request; Guide to Minimize Microbial Food Safety Hazards of Fresh-Cut Fruits and Vegetables,Notice,General Notice,2013-11-20T05:00:00Z,2013,11,2013-11-20T05:00:00Z,2014-01-22T04:59:59Z,2014-01-22T02:01:42Z,2013-27782,0,0,090000648148bb1a FDA-2013-N-0001-0108,FDA,FDA-2013-N-0001,Changing Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Obesity and Metabolic Diseases: How to Estimate and Reward True Patient-Centric Value in Innovation; Public Workshop,Notice,Meeting,2013-11-20T05:00:00Z,2013,11,2013-11-20T05:00:00Z,,2013-11-20T15:29:32Z,2013-27771,0,0,090000648148bb54 FDA-1999-D-4079-0004,FDA,FDA-1999-D-4079,"Draft Guidance for Industry on Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling; Availability",Notice,Notice of Availability,2013-11-20T05:00:00Z,2013,11,2013-11-20T05:00:00Z,2014-01-25T04:59:59Z,2014-01-17T02:02:42Z,2013-27770,0,0,090000648148bad1 FDA-2013-D-1358-0001,FDA,FDA-2013-D-1358,Draft Guidance for Industry: Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation; Availability,Notice,Notice of Availability,2013-11-20T05:00:00Z,2013,11,2013-11-20T05:00:00Z,2014-02-19T04:59:59Z,2015-07-13T17:54:08Z,2013-27774,0,0,090000648148bc0a FDA-2013-D-0576-0003,FDA,FDA-2013-D-0576,Draft Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Extension of Comment Period,Notice,Notice of Availability,2013-11-20T05:00:00Z,2013,11,2013-11-20T05:00:00Z,2014-05-10T03:59:59Z,2014-05-13T14:34:04Z,2013-27769,0,0,090000648148ba3d FDA-2013-N-0879-0002,FDA,FDA-2013-N-0879,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products,Notice,30 Day Proposed Information Collection,2013-11-20T05:00:00Z,2013,11,2013-11-20T05:00:00Z,2013-12-21T04:59:59Z,2016-12-08T13:41:55Z,2013-27775,0,0,090000648148ba3c FDA-2013-N-1427-0001,FDA,FDA-2013-N-1427,Agency Information Collection Activities; Proposed Collection; Comment Request; Hazard Analysis and Critical Control Point Procedures for the Safe and Sanitary Processing and Importing of Juice,Notice,60 Day Proposed Information Collection,2013-11-20T05:00:00Z,2013,11,2013-11-20T05:00:00Z,2014-01-22T04:59:59Z,2016-08-09T18:09:39Z,2013-27811,0,0,090000648148bb55 FDA-2013-N-0878-0002,FDA,FDA-2013-N-0878,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notification for a New Dietary Ingredient,Notice,General Notice,2013-11-18T05:00:00Z,2013,11,2013-11-18T05:00:00Z,2013-12-19T04:59:59Z,2015-02-11T23:13:29Z,2013-27536,0,0,0900006481486d8c FDA-2013-N-1119-0002,FDA,FDA-2013-N-1119,"Agency Information Collection Activities; Proposed Collection; Comment Request; Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers; Extension of Comment Period",Notice,Extension of Comment Period,2013-11-18T05:00:00Z,2013,11,2013-11-18T05:00:00Z,,2024-11-12T05:23:33Z,2013-27537,1,0,0900006481486d8d FDA-2013-N-1394-0001,FDA,FDA-2013-N-1394,Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Special Protocol Assessment,Notice,General Notice,2013-11-18T05:00:00Z,2013,11,2013-11-18T05:00:00Z,2014-01-18T04:59:59Z,2014-01-14T19:56:34Z,2013-27503,0,0,0900006481486bba FDA-2013-D-0715-0001,FDA,FDA-2013-D-0715,Draft Guidance for Industry on Acrylamide in Foods; Availability,Notice,Notice of Availability,2013-11-15T05:00:00Z,2013,11,2013-11-15T05:00:00Z,2014-01-15T04:59:59Z,2014-01-15T02:03:26Z,2013-27362,0,0,0900006481481e8f FDA-2013-N-1038-0003,FDA,FDA-2013-N-1038,Over-the-Counter Ophthalmic Drug Products--Emergency Use Eyewash Products; Rescheduling of Public Hearing,Notice,Public Meetings,2013-11-15T05:00:00Z,2013,11,2013-11-15T05:00:00Z,2014-06-07T03:59:59Z,2014-06-07T01:06:55Z,2013-27359,0,0,0900006481481db2 FDA-2013-N-1306-0001,FDA,FDA-2013-N-1306,International Medical Device Regulators Forum; Medical Device Single Audit Program International Coalition Pilot Program; Availability,Notice,Announcement,2013-11-15T05:00:00Z,2013,11,2013-11-15T05:00:00Z,,2024-11-12T05:24:37Z,2013-27358,1,0,0900006481481dfb FDA-1994-D-0007-0003,FDA,FDA-1994-D-0007,Guidance for Industry; Availability: Studies to Evaluate the Utility of Anti-Salmonella Chemical Food Additives in Feeds,Notice,Request for Comments,2013-11-14T05:00:00Z,2013,11,2013-11-14T05:00:00Z,2014-01-14T04:59:59Z,2014-01-18T02:04:25Z,2013-27194,0,0,090000648147d87c FDA-2013-N-1393-0001,FDA,FDA-2013-N-1393,"Agency Information Collection Activities; Proposed Collection; Comment Request; Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions",Notice,60 Day Proposed Information Collection,2013-11-14T05:00:00Z,2013,11,2013-11-14T05:00:00Z,2014-01-14T04:59:59Z,2016-10-24T13:43:28Z,2013-27226,0,0,090000648147d67b FDA-2000-N-0110-0008,FDA,FDA-2000-N-0110,Debarment Orders: Bruce I. Diamond; Denial of Hearing,Notice,General Notice,2013-11-14T05:00:00Z,2013,11,2013-11-14T05:00:00Z,,2013-11-14T15:45:07Z,2013-27186,0,0,090000648147d79f FDA-2013-D-1279-0001,FDA,FDA-2013-D-1279,"Medical Device Development Tools; Draft Guidance for Industry, Tool Developers, and Food and Drug Administration Staff; Availability",Notice,Notice of Availability,2013-11-14T05:00:00Z,2013,11,2013-11-14T05:00:00Z,,2013-11-14T16:39:29Z,2013-27233,0,0,090000648147d82e FDA-2013-D-0880-0006,FDA,FDA-2013-D-0880,Draft Guidance for Industry on Frequently Asked Questions About Medical Foods; Second Edition; Reopening of the Comment Period,Notice,General Notice,2013-11-14T05:00:00Z,2013,11,2013-11-14T05:00:00Z,2013-12-17T04:59:59Z,2016-03-18T18:15:07Z,2013-27213,0,0,090000648147d709 FDA-2013-N-1152-0001,FDA,FDA-2013-N-1152,"Agency Information Collection Activities; Proposed Collection; 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,General Notice,2013-11-14T05:00:00Z,2013,11,2013-11-14T05:00:00Z,2014-01-14T04:59:59Z,2014-01-14T16:41:07Z,2013-27222,0,0,090000648147d67d FDA-2013-N-0001-0106,FDA,FDA-2013-N-0001,Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting,Notice,Meeting,2013-11-12T05:00:00Z,2013,11,2013-11-12T05:00:00Z,,2013-11-12T19:54:30Z,2013-26891,0,0,090000648147745b FDA-2013-N-0001-0105,FDA,FDA-2013-N-0001,Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting,Notice,Meeting,2013-11-12T05:00:00Z,2013,11,2013-11-12T05:00:00Z,,2013-11-12T19:51:02Z,2013-26868,0,0,0900006481477329 FDA-2013-N-1361-0001,FDA,FDA-2013-N-1361,Determination That ADDERALL (Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate) Tablet and 13 Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness,Notice,General Notice,2013-11-12T05:00:00Z,2013,11,2013-11-12T05:00:00Z,,2013-11-12T19:58:09Z,2013-26856,0,0,09000064814774f2 FDA-2013-N-0764-0005,FDA,FDA-2013-N-0764,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Animal Feed Regulatory Program Standards,Notice,30 Day Proposed Information Collection,2013-11-08T05:00:00Z,2013,11,2013-11-08T05:00:00Z,2013-12-10T04:59:59Z,2016-04-04T11:10:30Z,2013-26778,0,0,090000648147379d FDA-2013-N-0001-0107,FDA,FDA-2013-N-0001,Sixth Annual Sentinel Initiative; Public Workshop,Notice,Meeting,2013-11-08T05:00:00Z,2013,11,2013-11-08T05:00:00Z,,2013-11-12T20:11:03Z,2013-26855,0,0,09000064814737a3 FDA-2013-N-1317-0001,FDA,FDA-2013-N-1317,Tentative Determination Regarding Partially Hydrogenated Oils; Request for Comments and for Scientific Data and Information,Notice,Request for Comments,2013-11-08T05:00:00Z,2013,11,2013-11-08T05:00:00Z,2014-01-08T04:59:59Z,2014-12-14T02:23:47Z,2013-26854,0,0,090000648147367f