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withdrawn,object_id FDA-2008-D-0659-0034,FDA,FDA-2008-D-0659,"Guidance for Industry Current Good Tissue Practice and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products; Availability",Notice,Notice of Availability,2011-12-30T05:00:00Z,2011,12,2011-12-30T05:00:00Z,,2024-11-11T21:35:46Z,2011-33572,1,0,0900006480f8b716 FDA-2011-N-0002-0153,FDA,FDA-2011-N-0002,Oncologic Drugs Advisory Committee; Notice of Meeting,Notice,Meeting,2011-12-30T05:00:00Z,2011,12,2011-12-30T05:00:00Z,,2011-12-30T14:13:50Z,2011-33552,0,0,0900006480f8b71a FDA-2011-D-0028-0003,FDA,FDA-2011-D-0028,Medical Devices: Ovarian Adnexal Mass Assessment Score Test System; Labeling; Black Box Restrictions,Rule,Final Rule,2011-12-30T05:00:00Z,2011,12,2011-12-30T05:00:00Z,,2011-12-30T14:31:25Z,2011-33588,0,0,0900006480f8b788 FDA-2011-N-0002-0155,FDA,FDA-2011-N-0002,Oncologic Drugs Advisory Committee; Notice of Meeting,Notice,Meeting,2011-12-30T05:00:00Z,2011,12,2011-12-30T05:00:00Z,,2011-12-30T14:38:03Z,2011-33548,0,0,0900006480f8b7c4 FDA-2011-D-0868-0001,FDA,FDA-2011-D-0868,Draft Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices; Availability,Notice,Notice of Availability,2011-12-30T05:00:00Z,2011,12,2011-12-30T05:00:00Z,2012-03-30T03:59:59Z,2020-04-29T00:35:05Z,2011-33550,0,0,0900006480f8b728 FDA-2011-D-0872-0002,FDA,FDA-2011-D-0872,Draft Guidance for Industry on Use of Histology in Biomarker Qualification Studies,Other,Guidance,2011-12-30T05:00:00Z,2011,12,2011-12-30T05:00:00Z,2011-03-30T03:59:59Z,2011-12-30T13:38:31Z,,0,0,0900006480f8b808 FDA-2011-N-0827-0001,FDA,FDA-2011-N-0827,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Labeling Requirements for Blood and Blood Components, Including Source Plasma; Revisions",Notice,General Notice,2011-12-30T05:00:00Z,2011,12,2011-12-30T05:00:00Z,2012-02-29T04:59:59Z,2011-12-30T14:28:59Z,2011-33555,0,0,0900006480f8b750 FDA-2011-D-0868-0002,FDA,FDA-2011-D-0868,Draft Guidance for Industry on Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices,Other,Citizen Petition,2011-12-30T05:00:00Z,2011,12,2011-12-30T05:00:00Z,,2024-11-07T23:55:25Z,,1,0,0900006480f8b82a FDA-2009-N-0247-0300,FDA,FDA-2009-N-0247,Report on Good Guidance Practices Improving Efficiency and Transparency; Availability,Notice,Availability of Document,2011-12-30T05:00:00Z,2011,12,2011-12-30T05:00:00Z,2012-02-29T04:59:59Z,2011-12-30T14:36:05Z,2011-33573,0,0,0900006480f8b7c2 FDA-2011-N-0002-0154,FDA,FDA-2011-N-0002,Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting,Notice,Meeting,2011-12-30T05:00:00Z,2011,12,2011-12-30T05:00:00Z,,2011-12-30T14:26:10Z,2011-33561,0,0,0900006480f8b74c FDA-2008-P-0555-0004,FDA,FDA-2008-P-0555,Determinations that Drugs Were Not Withdrawn from Sale for Reasons of Safety or Effectiveness: HYCODAN,Notice,General Notice,2011-12-30T05:00:00Z,2011,12,2011-12-30T05:00:00Z,,2011-12-30T13:50:53Z,2011-33549,0,0,0900006480f8b709 FDA-2011-D-0872-0001,FDA,FDA-2011-D-0872,Draft Guidance for Industry on Use of Histology in Biomarker Qualification Studies; Availabilty,Notice,Notice of Availability,2011-12-30T05:00:00Z,2011,12,2011-12-30T05:00:00Z,2012-03-30T03:59:59Z,2013-11-23T02:02:25Z,2011-33553,0,0,0900006480f8b6cb FDA-2011-N-0619-0002,FDA,FDA-2011-N-0619,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Medical Devices; Humanitarian Use Devices",Notice,General Notice,2011-12-30T05:00:00Z,2011,12,2011-12-30T05:00:00Z,2012-01-31T04:59:59Z,2011-12-30T13:41:14Z,2011-33551,0,0,0900006480f8b6e5 FDA-1991-P-0165-0002,FDA,FDA-1991-P-0165,"FDA/CDRH Hydergine Memo, dated 12/28/2011 to Division of Dockets Management",Other,Memo,2011-12-29T05:00:00Z,2011,12,2011-12-29T05:00:00Z,,2024-11-12T04:15:45Z,,1,0,0900006480f8ae25 FDA-2011-N-0003-0057,FDA,FDA-2011-N-0003,Freedom of Information Summary ANDA 200-318 Bimectin Pour-On (Ivermectin),Supporting & Related Material,Reference (internal unless indicated),2011-12-29T05:00:00Z,2011,12,,,2011-12-29T14:03:11Z,,0,0,0900006480f8ad17 FDA-2011-N-0003-0056,FDA,FDA-2011-N-0003,Ophthalmic and Topical Dosage Form New Animal Drugs: Ivermectin Topical Solution,Rule,Final Rule,2011-12-29T05:00:00Z,2011,12,2011-12-29T05:00:00Z,,2011-12-29T13:58:17Z,2011-33382,0,0,0900006480f8acdf FDA-2011-N-0345-0003,FDA,FDA-2011-N-0345,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Experimental Study on Consumer Responses to Nutrition Facts Labels, etc.",Notice,General Notice,2011-12-29T05:00:00Z,2011,12,2011-12-29T05:00:00Z,2012-01-31T04:59:59Z,2014-06-14T01:03:15Z,2011-33303,0,0,0900006480f8abb7 FDA-1995-P-0246-0002,FDA,FDA-1995-P-0246,Memorandum from FDA CDER to FDA DDM,Other,Memorandum,2011-12-29T05:00:00Z,2011,12,2011-12-29T05:00:00Z,,2025-09-15T23:09:53Z,,1,0,0900006480f8ae55 FDA-1997-S-0006-1140,FDA,FDA-1997-S-0006,"Indiana Botanic Gardens, Inc., LET1140 Response From FDA/CFSAN - Courtesy Letter",Other,Letter(s),2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,,2011-12-28T19:17:21Z,,0,0,0900006480f85d4d FDA-1997-S-0006-1137,FDA,FDA-1997-S-0006,New Century Company LET1137 Response From FDA/CFSAN - Courtesy Letter,Other,Letter(s),2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,,2011-12-28T18:47:38Z,,0,0,0900006480f85d47 FDA-2011-P-0913-0002,FDA,FDA-2011-P-0913,"Acknowledgement Letter to KVK-Tech, Inc.",Other,Acknowledgement Letter/Receipt,2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,,2011-12-28T23:00:45Z,,0,0,0900006480f847f9 FDA-2011-P-0923-0001,FDA,FDA-2011-P-0923,Public Citizen Health Research Group - Citizen Petition,Other,Citizen Petition,2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,,2012-08-08T18:44:33Z,,0,0,0900006480f88963 FDA-2011-D-0652-0001,FDA,FDA-2011-D-0652,"Draft Guidances for Industry and Staff; Availability: 510(k) Program, Evaluating Substantial Equivalence in Premarket Notifications; Availability",Notice,Notice of Availability,2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,2012-04-27T03:59:59Z,2012-05-25T02:00:27Z,2011-33232,0,0,0900006480f8a26b FDA-1997-S-0006-1141,FDA,FDA-1997-S-0006,Cobalis Corporation LET1141 Response From FDA/CFSAN - Courtesy Letter,Other,Letter(s),2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,,2011-12-28T19:23:16Z,,0,0,0900006480f85d4f FDA-1997-S-0006-1136,FDA,FDA-1997-S-0006,Country Life LET1136 Response From FDA/CFSAN - Courtesy Letter,Other,Letter(s),2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,,2011-12-28T17:27:48Z,,0,0,0900006480f85d45 FDA-1997-S-0006-1143,FDA,FDA-1997-S-0006,"New Chapter, Inc., LET1143 Response From FDA/CFSAN - Courtesy Letter",Other,Letter(s),2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,,2011-12-28T19:50:27Z,,0,0,0900006480f85d53 FDA-2011-N-0912-0001,FDA,FDA-2011-N-0912,Communications and Activities: Off-Label Uses of Marketed Products and Use of Products Not Yet Legally Marketed,Notice,General Notice,2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,2012-03-28T03:59:59Z,2012-05-04T12:01:27Z,2011-33188,0,0,0900006480f8a26a FDA-2011-D-0652-0002,FDA,FDA-2011-D-0652,Draft Guidance for Industry and Food and Drug Administration Staff The 510(k) Program Evaluating Substantial Equivalence in Premarket Notifications [510(k)],Other,Guidance,2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,2012-04-27T03:59:59Z,2014-09-27T01:07:24Z,,0,0,0900006480f8a513 FDA-2011-D-0893-0002,FDA,FDA-2011-D-0893,Draft Guidances for Industry and Staff Center for Devices and Radiological Health Appeals Processes,Other,Guidance,2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,2012-04-27T03:59:59Z,2011-12-28T16:23:06Z,,0,0,0900006480f8a53c FDA-2011-P-0923-0002,FDA,FDA-2011-P-0923,Acknowledgement Letter to Public Citizen Health Research Group,Other,Acknowledgement Letter/Receipt,2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,,2011-12-28T22:30:59Z,,0,0,0900006480f88965 FDA-2010-D-0313-0018,FDA,FDA-2010-D-0313,"Guidance for Industry; Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation",Other,Guidance,2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,,2024-11-07T01:40:00Z,,1,0,0900006480f89bae FDA-2011-P-0913-0001,FDA,FDA-2011-P-0913,"KVK-Tech, Inc. - Citizen Petition",Other,Citizen Petition,2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,,2013-01-31T14:54:18Z,,0,0,0900006480f847f5 FDA-1997-S-0006-1139,FDA,FDA-1997-S-0006,"Nuvilex, Inc., LET1139 Response From FDA/CFSAN - Courtesy Letter",Other,Letter(s),2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,,2011-12-28T19:10:07Z,,0,0,0900006480f85d4b FDA-1997-S-0006-1142,FDA,FDA-1997-S-0006,"NatureGift (USA), Inc., LET1142 Response From FDA/CFSAN - Courtesy Letter",Other,Letter(s),2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,,2011-12-28T19:40:19Z,,0,0,0900006480f85d51 FDA-1997-S-0006-1132,FDA,FDA-1997-S-0006,"Nutrition21, LET1132 Response From FDA/CFSAN - Courtesy Letter",Other,Letter(s),2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,,2011-12-28T16:34:57Z,,0,0,0900006480f85d3d FDA-1997-S-0006-1138,FDA,FDA-1997-S-0006,Better Health Beverage (Foley & Lardner LLP.) LET1138 Response From FDA/CFSAN - Courtesy Letter,Other,Letter(s),2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,,2011-12-28T18:57:22Z,,0,0,0900006480f85d49 FDA-2011-P-0734-0003,FDA,FDA-2011-P-0734,FDA/CDER Response to Richard J. Miller - Petition Denial,Other,Denial of Petition,2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,,2011-12-28T23:15:07Z,,0,0,0900006480f8a924 FDA-2011-N-0002-0152,FDA,FDA-2011-N-0002,"Meetings: Cellular, Tissue, and Gene Therapies Advisory Committee",Notice,Meeting,2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,,2011-12-28T20:10:31Z,2011-33220,0,0,0900006480f8a239 FDA-2007-N-0265-0007,FDA,FDA-2007-N-0265,Temperature-Indicating Devices: Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers; Correction,Rule,Correction,2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,,2011-12-28T20:10:32Z,2011-33183,0,0,0900006480f8a284 FDA-2011-D-0893-0001,FDA,FDA-2011-D-0893,Draft Guidances for Industry and Staff; Availability: Center for Devices and Radiological Health Appeals Processes,Notice,Notice of Availability,2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,2012-04-27T03:59:59Z,2014-01-13T17:39:02Z,2011-33230,0,0,0900006480f8a2c3 FDA-1997-S-0006-1134,FDA,FDA-1997-S-0006,Source Naturals LET1134 Response From FDA/CFSAN - Courtesy Letter,Other,Letter(s),2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,,2011-12-28T17:14:06Z,,0,0,0900006480f85d41 FDA-1997-S-0006-1133,FDA,FDA-1997-S-0006,New Century Company LET1133 Response From FDA/CFSAN - Courtesy Letter,Other,Letter(s),2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,,2011-12-28T17:07:01Z,,0,0,0900006480f85d3f FDA-2010-D-0313-0017,FDA,FDA-2010-D-0313,"Guidance for Industry: Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation; Availability",Notice,Notice of Availability,2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,,2024-11-07T01:39:58Z,2011-33292,1,0,0900006480f8a23c FDA-1997-S-0006-1135,FDA,FDA-1997-S-0006,Planetary Ayurvedics LET1135 Response From FDA/CFSAN - Courtesy Letter,Other,Letter(s),2011-12-28T05:00:00Z,2011,12,2011-12-28T05:00:00Z,,2011-12-28T17:20:39Z,,0,0,0900006480f85d43 FDA-2011-P-0852-0001,FDA,FDA-2011-P-0852,Dr. S. Albert Edwards - Citizen Petition,Other,Citizen Petition,2011-12-27T05:00:00Z,2011,12,2011-12-27T05:00:00Z,,2016-05-17T10:48:51Z,,0,0,0900006480f74b19 FDA-2011-N-0002-0151,FDA,FDA-2011-N-0002,Requests for Nominations: Voting Members on Public Advisory Panels or Committees,Notice,General Notice,2011-12-27T05:00:00Z,2011,12,2011-12-27T05:00:00Z,,2011-12-27T16:38:57Z,2011-33060,0,0,0900006480f898b3 FDA-2011-N-0915-0001,FDA,FDA-2011-N-0915,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products, etc.",Notice,General Notice,2011-12-27T05:00:00Z,2011,12,2011-12-27T05:00:00Z,2012-02-28T04:59:59Z,2011-12-27T16:45:58Z,2011-33140,0,0,0900006480f89156 FDA-2011-D-0787-0003,FDA,FDA-2011-D-0787,"Draft Guidance for Industry and Staff; Availability: Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human Studies",Notice,Notice of Extension,2011-12-27T05:00:00Z,2011,12,2011-12-27T05:00:00Z,2012-03-10T04:59:59Z,2011-12-27T16:55:21Z,2011-33142,0,0,0900006480f89d41 FDA-2011-D-0790-0004,FDA,FDA-2011-D-0790,"Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Staff; Availability: Decisions for Investigational Device Exemption Clinical Investigations",Notice,Notice of Extension,2011-12-27T05:00:00Z,2011,12,2011-12-27T05:00:00Z,2012-03-10T04:59:59Z,2011-12-27T17:03:18Z,2011-33141,0,0,0900006480f89877 FDA-2011-P-0852-0002,FDA,FDA-2011-P-0852,Acknowledgement Letter to Dr. S. Albert Edwards,Other,Acknowledgement Letter/Receipt,2011-12-27T05:00:00Z,2011,12,2011-12-27T05:00:00Z,,2011-12-27T19:31:22Z,,0,0,0900006480f74b64 FDA-2011-N-0002-0150,FDA,FDA-2011-N-0002,Requests for Nominations: Food Advisory Committee Voting Members,Notice,General Notice,2011-12-27T05:00:00Z,2011,12,2011-12-27T05:00:00Z,,2011-12-27T16:32:38Z,2011-33108,0,0,0900006480f89874 FDA-2011-N-0002-0149,FDA,FDA-2011-N-0002,Endocrinologic and Metabolic Drugs Advisory Committee Meeting,Notice,Meeting,2011-12-27T05:00:00Z,2011,12,2011-12-27T05:00:00Z,,2011-12-27T16:27:31Z,2011-33059,0,0,0900006480f89822 FDA-1978-N-0021-0042,FDA,FDA-1978-N-0021,FDA/CDER Maalox Total Relief Memo Meeting minutes and Quarterly Reports 12 9 11,Other,Report,2011-12-27T05:00:00Z,2011,12,2011-12-27T05:00:00Z,,2011-12-27T13:50:45Z,,0,0,0900006480f899cc FDA-2011-M-0866-0001,FDA,FDA-2011-M-0866,Premarket Approval of Dako Denmark A/S HER2 CISH pharmDx™ Kit,Other,Approval,2011-12-23T05:00:00Z,2011,12,2011-12-23T05:00:00Z,,2011-12-23T19:22:55Z,,0,0,0900006480f80833 FDA-2011-V-0895-0002,FDA,FDA-2011-V-0895,Acknowledgement Letter to Laser Sky Designs,Other,Acknowledgement Letter/Receipt,2011-12-23T05:00:00Z,2011,12,2011-12-23T05:00:00Z,,2011-12-23T19:10:11Z,,0,0,0900006480f805cf FDA-2011-A-0346-0003,FDA,FDA-2011-A-0346,"Acknowledgement Letter to Radiation Safety Committee, University of California, Irvine Medical Center",Other,Acknowledgement Letter/Receipt,2011-12-23T05:00:00Z,2011,12,2011-12-23T05:00:00Z,,2014-01-20T20:06:38Z,,0,0,0900006480c6cd64 FDA-2010-P-0222-0003,FDA,FDA-2010-P-0222,"Alaunus Pharmaceutical, LLC - Withdrawal",Other,Withdrawal,2011-12-23T05:00:00Z,2011,12,2011-12-23T05:00:00Z,,2011-12-23T18:47:04Z,,0,0,0900006480f81d09 FDA-2010-P-0460-0003,FDA,FDA-2010-P-0460,"Alaunus Pharmaceutical, LLC - Amendment",Other,Amendment,2011-12-23T05:00:00Z,2011,12,2011-12-23T05:00:00Z,,2011-12-23T17:54:48Z,,0,0,0900006480f82074 FDA-2011-A-0346-0002,FDA,FDA-2011-A-0346,"Radiation Safety Committee, University of California, Irvine Medical Center - Advisory Opinion",Other,Advisory Opinion Petition,2011-12-23T05:00:00Z,2011,12,2011-12-23T05:00:00Z,,2014-01-20T20:20:54Z,,0,0,0900006480c6cd63 FDA-2011-V-0894-0002,FDA,FDA-2011-V-0894,Acknowledgement Letter to Hypnotix Entertainment,Other,Acknowledgement Letter/Receipt,2011-12-23T05:00:00Z,2011,12,2011-12-23T05:00:00Z,,2011-12-23T18:59:17Z,,0,0,0900006480f805c8 FDA-2011-V-0894-0001,FDA,FDA-2011-V-0894,Hypnotix Entertainment - Application for Variance,Other,Application for Variance (VAR),2011-12-23T05:00:00Z,2011,12,2011-12-23T05:00:00Z,,2011-12-23T18:59:17Z,,0,0,0900006480f80586 FDA-2011-V-0895-0001,FDA,FDA-2011-V-0895,Laser Sky Designs - Application for Variance,Other,Application for Variance (VAR),2011-12-23T05:00:00Z,2011,12,2011-12-23T05:00:00Z,,2011-12-23T19:10:10Z,,0,0,0900006480f805cc FDA-1977-N-0014-1438,FDA,FDA-1977-N-0014,Withdrawal of Notices of Opportunity for a Hearing: Penicillin and Tetracycline Used in Animal Feed,Notice,Withdrawal,2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,,2019-04-09T18:17:07Z,2011-32775,0,0,0900006480f87dc5 FDA-2011-N-0508-0002,FDA,FDA-2011-N-0508,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Blood Establishment Registration and Product Listing",Notice,General Notice,2011-12-22T05:00:00Z,2011,12,,,2011-12-22T17:02:14Z,2011-32777,0,0,0900006480f87cba FDA-2011-A-0346-0001,FDA,FDA-2011-A-0346,"FDA/CDER Response to Radiation Safety Committee, University of California, Irvine Medical Center - Letter",Other,Letter(s),2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,,2011-12-23T18:35:16Z,,0,0,0900006480f854fd FDA-2001-P-0123-0186,FDA,FDA-2001-P-0123,FDA-CDER/ to Center for Reproductive Rights - Petition Denial,Other,Denial of Petition,2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,,2011-12-22T18:07:45Z,,0,0,0900006480f8816b FDA-2007-N-0475-0035,FDA,FDA-2007-N-0475,"FDA/OC to Parties, from the Office of the Commissioner, December 15, 2011 - Letter",Other,Letter(s),2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,,2011-12-22T18:45:27Z,,0,0,0900006480f88195 FDA-2011-P-0552-0003,FDA,FDA-2011-P-0552,Robert Wagner to FDA's Division of Dockets Management - Letter,Other,Letter(s),2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,,2011-12-22T21:26:14Z,,0,0,0900006480f8158b FDA-2011-V-0896-0002,FDA,FDA-2011-V-0896,"Acknowledgement Letter to Patete Taylor Films, Inc. dba Boulevard Films",Other,Acknowledgement Letter/Receipt,2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,,2011-12-22T17:21:12Z,,0,0,0900006480f805fe FDA-1977-N-0019-0067,FDA,FDA-1977-N-0019,Withdrawal of Notices of Opportunity for a Hearing; Penicillin and Tetracycline Used in Animal Feed,Notice,Withdrawal,2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,,2019-04-25T18:21:26Z,2011-32775,0,0,0900006480f87c5a FDA-2011-V-0892-0001,FDA,FDA-2011-V-0892,The Boys DJ - Application for Variance,Other,Application for Variance (VAR),2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,,2011-12-22T16:45:22Z,,0,0,0900006480f80581 FDA-2011-M-0865-0001,FDA,FDA-2011-M-0865,Premarket Approval of PROMUS® Element™ Plus Everolimus-Eluting Platinum Coronary Stent System (Monorail™ and Over-The-Wire),Other,Approval,2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,,2011-12-22T20:58:20Z,,0,0,0900006480f807f8 FDA-2011-V-0897-0002,FDA,FDA-2011-V-0897,Acknowledgement Letter to NLFX Professional,Other,Acknowledgement Letter/Receipt,2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,,2011-12-22T17:27:57Z,,0,0,0900006480f80657 FDA-2011-V-0891-0002,FDA,FDA-2011-V-0891,Acknowledgement Letter to Lore2mix,Other,Acknowledgement Letter/Receipt,2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,,2011-12-22T15:26:26Z,,0,0,0900006480f8057f FDA-1977-N-0022-0146,FDA,FDA-1977-N-0022,Withdrawal of Notices of Opportunity for a Hearing: Penicillin and Tetracycline Used in Animal Feed,Notice,Withdrawal,2011-12-22T05:00:00Z,2011,12,,,2011-12-22T16:45:03Z,2011-32775,0,0,0900006480f87ea8 FDA-2011-N-0511-0002,FDA,FDA-2011-N-0511,"Agency Information Collection Activities; Proposals, Submissions, andApprovals: Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components, etc.",Notice,General Notice,2011-12-22T05:00:00Z,2011,12,,,2011-12-22T14:02:15Z,2011-32778,0,0,0900006480f87c31 FDA-2011-N-0908-0001,FDA,FDA-2011-N-0908,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Establishment and Operation of Clinical Trial Data Monitoring Committees",Notice,General Notice,2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,2012-02-22T04:59:59Z,2011-12-22T17:04:41Z,2011-32776,0,0,0900006480f87d15 FDA-2011-V-0897-0001,FDA,FDA-2011-V-0897,NLFX Professional - Application for Variance,Other,Application for Variance (VAR),2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,,2011-12-22T17:27:57Z,,0,0,0900006480f80602 FDA-2011-N-0513-0010,FDA,FDA-2011-N-0513,"FDA/OC and ISTA Pharmaceuticals to G. Mathew Warren, FDA Senior Regulatory Counsel, December 16, 2011 - Letter",Other,Letter(s),2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,,2011-12-22T17:27:13Z,,0,0,0900006480f88124 FDA-1977-N-0224-0138,FDA,FDA-1977-N-0224,Withdrawal of Notices of Opportunity for a Hearing: Penicillin and Tetracycline Used in Animal Feed,Notice,Withdrawal,2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,,2019-04-29T15:42:47Z,2011-32775,0,0,0900006480f87ed5 FDA-2011-V-0892-0002,FDA,FDA-2011-V-0892,Acknowledgement Letter to The Boys DJ,Other,Acknowledgement Letter/Receipt,2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,,2011-12-22T16:45:22Z,,0,0,0900006480f80584 FDA-2011-V-0891-0001,FDA,FDA-2011-V-0891,Lore2mix - Application for Variance,Other,Application for Variance (VAR),2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,,2011-12-22T15:26:26Z,,0,0,0900006480f8057d FDA-2011-N-0411-0003,FDA,FDA-2011-N-0411,"Withdrawal of Approval of 70 New Drug Applications and 97 Abbreviated New Drug Applications: Bristol-Myers Squibb Co., et al.; Correction",Notice,Correction,2011-12-22T05:00:00Z,2011,12,,,2011-12-22T17:07:37Z,2011-32822,0,0,0900006480f87d1a FDA-2010-P-0520-0007,FDA,FDA-2010-P-0520,"FDA/CDER/ to Extremity Innovations, Inc. - Petition Denial",Other,Denial of Petition,2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,,2011-12-22T22:31:18Z,,0,0,0900006480f882c3 FDA-2011-P-0552-0004,FDA,FDA-2011-P-0552,FDA/CDRH Response to Robert Wagner - Petition Denial,Other,Denial of Petition,2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,,2011-12-22T21:35:22Z,,0,0,0900006480f878b0 FDA-2011-P-0645-0003,FDA,FDA-2011-P-0645,FDA/CDER to Center for Inquiry and Committee for Skeptical Inquiry - Petition Denial,Other,Denial of Petition,2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,,2011-12-22T17:22:27Z,,0,0,0900006480f88146 FDA-2011-P-0484-0003,FDA,FDA-2011-P-0484,"Turtle Island Restoration (TIRN), and The Center for Biological Diversity (CBD) - Supplement",Other,Supplement (SUP),2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,,2013-07-28T00:10:37Z,,0,0,0900006480f81d0b FDA-2011-P-0644-0003,FDA,FDA-2011-P-0644,FDA-CDER/ to Center for Inquiry and Committee for Skeptical Inquiry - Petition Denial,Other,Denial of Petition,2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,,2011-12-22T17:08:29Z,,0,0,0900006480f8812b FDA-2011-V-0896-0001,FDA,FDA-2011-V-0896,"Patete Taylor Films, Inc. dba Boulevard Films - Application for Variance",Other,Application for Variance (VAR),2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,,2011-12-22T17:21:12Z,,0,0,0900006480f805fc FDA-2011-N-0902-0001,FDA,FDA-2011-N-0902,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Prescription Drug Product Labeling; Medication Guide Requirements",Notice,60 Day Proposed Information Collection,2011-12-21T05:00:00Z,2011,12,2011-12-21T05:00:00Z,2012-02-22T04:59:59Z,2011-12-21T21:40:13Z,2011-32548,0,0,0900006480f87038 FDA-2011-V-0877-0002,FDA,FDA-2011-V-0877,Acknowledgement Letter to SLO DJ,Other,Acknowledgement Letter/Receipt,2011-12-21T05:00:00Z,2011,12,2011-12-21T05:00:00Z,,2011-12-21T16:24:34Z,,0,0,0900006480f7c980 FDA-2011-N-0656-0002,FDA,FDA-2011-N-0656,Animal Drug User Fee Act; Reopening of Comment Period,Notice,Notice of Extension,2011-12-21T05:00:00Z,2011,12,2011-12-21T05:00:00Z,2013-01-16T04:59:59Z,2013-01-16T03:07:49Z,2011-32567,0,0,0900006480f87129 FDA-2011-V-0877-0001,FDA,FDA-2011-V-0877,SLO DJ - Application for Variance,Other,Application for Variance (VAR),2011-12-21T05:00:00Z,2011,12,2011-12-21T05:00:00Z,,2011-12-21T16:24:34Z,,0,0,0900006480f7c961 FDA-2011-N-0003-0054,FDA,FDA-2011-N-0003,New Animal Drugs for Use in Animal Feeds: Monensin,Rule,Final Rule,2011-12-21T05:00:00Z,2011,12,2011-12-21T05:00:00Z,,2011-12-21T22:06:14Z,2011-32427,0,0,0900006480f87099 FDA-2011-P-0804-0003,FDA,FDA-2011-P-0804,"Bruno Independent Living Aids, Inc. - Letter",Other,Letter(s),2011-12-21T05:00:00Z,2011,12,2011-11-09T05:00:00Z,,2013-08-11T04:49:15Z,,0,0,0900006480f7f21f FDA-2011-N-0003-0055,FDA,FDA-2011-N-0003,New Animal Drugs: Change of Sponsor; Zinc Gluconate,Rule,Final Rule,2011-12-21T05:00:00Z,2011,12,2011-12-21T05:00:00Z,,2011-12-21T22:32:43Z,2011-32591,0,0,0900006480f87170 FDA-2011-V-0876-0002,FDA,FDA-2011-V-0876,Acknowledgement Letter to Painted Bride Art Center,Other,Acknowledgement Letter/Receipt,2011-12-21T05:00:00Z,2011,12,2011-12-21T05:00:00Z,,2011-12-21T16:19:26Z,,0,0,0900006480f7c94d FDA-2011-N-0842-0001,FDA,FDA-2011-N-0842,Gluten in Drug Products,Notice,General Notice,2011-12-21T05:00:00Z,2011,12,2011-12-21T05:00:00Z,2012-03-21T03:59:59Z,2011-12-21T21:31:22Z,2011-32551,0,0,0900006480f87037 FDA-2011-N-0655-0003,FDA,FDA-2011-N-0655,Animal Generic Drug User Fee Act; Reopening of Comment Period,Notice,Notice of Extension,2011-12-21T05:00:00Z,2011,12,2011-12-21T05:00:00Z,2013-01-16T04:59:59Z,2012-12-11T03:01:51Z,2011-32565,0,0,0900006480f8703b FDA-2011-V-0876-0001,FDA,FDA-2011-V-0876,Painted Bride Art Center - Application for Variance,Other,Application for Variance (VAR),2011-12-21T05:00:00Z,2011,12,2011-12-21T05:00:00Z,,2011-12-21T16:19:25Z,,0,0,0900006480f7c91f