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withdrawn,object_id FDA-2010-N-0118-0005,FDA,FDA-2010-N-0118,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Imported Food under 2002 Public Health Security and Bioterrorism Preparedness and Response Act of 2002",Notice,N-Notice,2010-12-30T05:00:00Z,2010,12,2010-12-30T05:00:00Z,,2010-12-30T14:44:54Z,2010-32946,0,0,0900006480bc26ef FDA-2010-N-0356-0004,FDA,FDA-2010-N-0356,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Designated New Animal Drugs for Minor Use and Minor Species",Notice,N-Notice,2010-12-30T05:00:00Z,2010,12,2010-12-30T05:00:00Z,,2010-12-30T14:39:28Z,2010-32948,0,0,0900006480bc26eb FDA-2010-N-0001-0163,FDA,FDA-2010-N-0001,Meetings: Pulmonary-Allergy Drugs Advisory Committee,Notice,NM-Notice of Meeting,2010-12-29T05:00:00Z,2010,12,2010-12-29T05:00:00Z,,2010-12-29T15:23:00Z,2010-32735,0,0,0900006480bc1b9a FDA-2010-N-0640-0001,FDA,FDA-2010-N-0640,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Data To Support Food and Nutrition Product Communications, as Used by Food and Drug Administration",Notice,N-Notice,2010-12-29T05:00:00Z,2010,12,2010-12-29T05:00:00Z,2011-03-01T04:59:59Z,2010-12-29T15:29:12Z,2010-32739,0,0,0900006480bc1bc0 FDA-2010-N-0198-0003,FDA,FDA-2010-N-0198,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Premarket Notification",Notice,N-Notice,2010-12-28T05:00:00Z,2010,12,2010-12-28T05:00:00Z,,2010-12-28T16:44:38Z,2010-32508,0,0,0900006480bc11ca FDA-2010-P-0326-0003,FDA,FDA-2010-P-0326,"Determination that Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness: TRANDATE (Labetalol Hydrochloride) Tablets, 300 Milligrams and 400 Milligrams",Notice,N-Notice,2010-12-28T05:00:00Z,2010,12,2010-12-28T05:00:00Z,,2010-12-28T16:37:57Z,2010-32507,0,0,0900006480bc11ac FDA-2010-N-0001-0161,FDA,FDA-2010-N-0001,Meetings: Anesthetic and Life Support Drugs Advisory Committee,Notice,NM-Notice of Meeting,2010-12-28T05:00:00Z,2010,12,2010-12-28T05:00:00Z,,2010-12-28T16:11:53Z,2010-32591,0,0,0900006480bc0c47 FDA-2010-N-0001-0162,FDA,FDA-2010-N-0001,Request for Nominations: Voting and Non-Voting Members of Public Advisory Committees or Panels,Notice,N-Notice,2010-12-28T05:00:00Z,2010,12,2010-12-28T05:00:00Z,,2010-12-28T16:28:32Z,2010-32624,0,0,0900006480bc1153 FDA-2010-N-0447-0003,FDA,FDA-2010-N-0447,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Third Party Review Program Under the Food and Drug Administration Modernization Act",Notice,N-Notice,2010-12-28T05:00:00Z,2010,12,2010-12-28T05:00:00Z,,2011-03-14T20:37:01Z,2010-32603,0,0,0900006480bc0c82 FDA-2010-N-0001-0160,FDA,FDA-2010-N-0001,Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting,Notice,NM-Notice of Meeting,2010-12-27T05:00:00Z,2010,12,2010-12-27T05:00:00Z,,2010-12-27T14:48:01Z,2010-32367,0,0,0900006480bc03c3 FDA-2010-N-0001-0159,FDA,FDA-2010-N-0001,Oncologic Drugs Advisory Committee; Cancellation,Notice,N-Notice,2010-12-27T05:00:00Z,2010,12,2010-12-27T05:00:00Z,,2010-12-27T14:44:55Z,2010-32413,0,0,0900006480bc0306 FDA-2010-D-0575-0001,FDA,FDA-2010-D-0575,"Draft Compliance Policy Guide Sec. 510.800 Beverages, Serving Size Labeling; Availability",Notice,NAD-Notice of Availability of Data,2010-12-23T05:00:00Z,2010,12,2010-12-23T05:00:00Z,2011-02-23T04:59:59Z,2010-12-23T14:41:09Z,2010-32249,0,0,0900006480bbe9be FDA-2010-N-0266-0007,FDA,FDA-2010-N-0266,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Study of Clinical Efficacy Information in Professional Labeling, etc.; Correction",Notice,NCR-Notice of Correction,2010-12-23T05:00:00Z,2010,12,2010-12-23T05:00:00Z,,2010-12-23T15:27:48Z,2010-32278,0,0,0900006480bbea66 FDA-2010-N-0631-0001,FDA,FDA-2010-N-0631,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guidance for Industry on Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products, etc.",Notice,N-Notice,2010-12-23T05:00:00Z,2010,12,2010-12-23T05:00:00Z,2011-02-23T04:59:59Z,2010-12-23T15:30:54Z,2010-32276,0,0,0900006480bbea69 FDA-2009-D-0466-0008,FDA,FDA-2009-D-0466,Compliance Policy Guide; Dairy Products; Availability: Microbial Contaminants and Alkaline Phosphatase Activity,Notice,NAD-Notice of Availability of Data,2010-12-23T05:00:00Z,2010,12,2010-12-23T05:00:00Z,,2024-11-07T22:30:06Z,2010-32232,1,0,0900006480bbe9e4 FDA-2010-N-0074-0003,FDA,FDA-2010-N-0074,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments, etc.",Notice,N-Notice,2010-12-23T05:00:00Z,2010,12,2010-12-23T05:00:00Z,,2010-12-23T14:16:46Z,2010-32277,0,0,0900006480bbe9b2 FDA-2010-N-0368-0007,FDA,FDA-2010-N-0368,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Pet Event Tracking Network -- State, Federal Cooperation to Prevent Spread of Pet Food Related Diseases",Notice,N-Notice,2010-12-23T05:00:00Z,2010,12,2010-12-23T05:00:00Z,2011-01-25T04:59:59Z,2010-12-23T14:34:11Z,2010-32275,0,0,0900006480bbe9b3 FDA-2004-D-0298-0005,FDA,FDA-2004-D-0298,Compliance Policy Guides: Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs,Notice,NEC-Notice of Extension,2010-12-23T05:00:00Z,2010,12,2010-12-23T05:00:00Z,,2024-11-07T22:30:10Z,2010-32274,1,0,0900006480bbea44 FDA-2010-N-0001-0158,FDA,FDA-2010-N-0001,Meetings: Advisory Committees; Tentative Schedule for 2011,Notice,N-Notice,2010-12-21T05:00:00Z,2010,12,2010-12-21T05:00:00Z,,2010-12-21T14:54:16Z,2010-31961,0,0,0900006480bbcc5e FDA-2010-N-0626-0001,FDA,FDA-2010-N-0626,"Abbott Laboratories, Inc.; Withdrawal of Approval of a New Drug Application for MERIDIA",Notice,Withdrawal,2010-12-21T05:00:00Z,2010,12,,,2018-02-26T16:00:33Z,2010-31986,0,0,0900006480bbcc3f FDA-2010-E-0042-0005,FDA,FDA-2010-E-0042,Regulatory Review Periods for Purposes of Patent Extensions; Determinations: LIVALO,Notice,N-Notice,2010-12-20T05:00:00Z,2010,12,2010-12-20T05:00:00Z,2011-02-19T04:59:59Z,2010-12-20T16:01:56Z,2010-31847,0,0,0900006480bba8e1 FDA-2010-N-0420-0004,FDA,FDA-2010-N-0420,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Testing Communications on FDA-Regulated Products Used in Animals",Notice,N-Notice,2010-12-20T05:00:00Z,2010,12,2010-12-20T05:00:00Z,2011-01-20T04:59:59Z,2010-12-20T15:38:33Z,2010-31891,0,0,0900006480bba849 FDA-2010-N-0528-0001,FDA,FDA-2010-N-0528,Unapproved Animal Drugs,Notice,N-Notice,2010-12-20T05:00:00Z,2010,12,2010-12-20T05:00:00Z,2011-02-19T04:59:59Z,2010-12-20T15:22:13Z,2010-31889,0,0,0900006480bba831 FDA-2010-E-0030-0005,FDA,FDA-2010-E-0030,Regulatory Review Periods for Purposes of Patent Extensions; Determinations: FOLOTYN,Notice,N-Notice,2010-12-20T05:00:00Z,2010,12,2010-12-20T05:00:00Z,2011-02-19T04:59:59Z,2010-12-20T15:54:26Z,2010-31846,0,0,0900006480bba892 FDA-2010-N-0001-0157,FDA,FDA-2010-N-0001,Meetings: Defense Advanced Research Projects Agency and Food and Drug Administration Expanding in Vivo Biomarker Detection Devices Workshop,Notice,NM-Notice of Meeting,2010-12-20T05:00:00Z,2010,12,2010-12-20T05:00:00Z,,2010-12-20T15:47:37Z,2010-31811,0,0,0900006480bba880 FDA-2010-N-0627-0001,FDA,FDA-2010-N-0627,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application for Food and Drug Administration Approval to Market New Drug",Notice,N-Notice,2010-12-17T05:00:00Z,2010,12,2010-12-17T05:00:00Z,2011-02-16T04:59:59Z,2010-12-17T14:36:03Z,2010-31693,0,0,0900006480bb91f0 FDA-2010-N-0235-0001,FDA,FDA-2010-N-0235,Debarment Orders: Ehigiator O. Akhigbe,Notice,NFR-Notice of Final Rule,2010-12-17T05:00:00Z,2010,12,2010-12-17T05:00:00Z,,2010-12-17T14:31:06Z,2010-31776,0,0,0900006480bb919d FDA-2010-D-0605-0001,FDA,FDA-2010-D-0605,"Small Entity Compliance Guides; Availability, etc.: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements",Notice,NAD-Notice of Availability of Data,2010-12-16T05:00:00Z,2010,12,2010-12-16T05:00:00Z,,2024-11-12T05:00:25Z,2010-31613,1,0,0900006480bb8272 FDA-2001-E-0027-0020,FDA,FDA-2001-E-0027,Determinations of Regulatory Review Periods for Purposes of Patent Extensions: ANGIOMAX,Notice,N-Notice,2010-12-16T05:00:00Z,2010,12,2010-12-16T05:00:00Z,,2024-11-12T05:00:23Z,2010-31583,1,0,0900006480bb825a FDA-2010-D-0616-0001,FDA,FDA-2010-D-0616,Draft Guidance for Industry; Availability: Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination,Notice,NAD-Notice of Availability of Data,2010-12-15T05:00:00Z,2010,12,2010-12-15T05:00:00Z,2011-02-15T04:59:59Z,2010-12-15T22:26:14Z,2010-31426,0,0,0900006480bb7048 FDA-2010-N-0184-0007,FDA,FDA-2010-N-0184,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Experimental Study of Patient Information Prototypes",Notice,NAD-Notice of Availability of Data,2010-12-15T05:00:00Z,2010,12,2010-12-15T05:00:00Z,2011-01-15T04:59:59Z,2010-12-15T21:58:54Z,2010-31388,0,0,0900006480bb7010 FDA-2010-N-0623-0001,FDA,FDA-2010-N-0623,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Voluntary Cosmetic Registration Program",Notice,N-Notice,2010-12-15T05:00:00Z,2010,12,2010-12-15T05:00:00Z,2011-02-15T04:59:59Z,2010-12-15T22:04:45Z,2010-31386,0,0,0900006480bb7013 FDA-2009-D-0008-0009,FDA,FDA-2009-D-0008,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guidance for Industry on Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of Federal Food, Drug, and Cosmetic Act",Notice,N-Notice,2010-12-15T05:00:00Z,2010,12,,,2010-12-15T22:16:59Z,2010-31380,0,0,0900006480bb70ec FDA-2010-N-0380-0002,FDA,FDA-2010-N-0380,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Generic Food and Drug Administration Rapid Response Surveys",Notice,N-Notice,2010-12-15T05:00:00Z,2010,12,2010-12-15T05:00:00Z,2011-01-15T04:59:59Z,2010-12-15T21:54:50Z,2010-31381,0,0,0900006480bb6f22 FDA-2009-N-0360-0003,FDA,FDA-2009-N-0360,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Public Health Notification Readership Survey",Notice,N-Notice,2010-12-15T05:00:00Z,2010,12,,,2010-12-15T22:09:18Z,2010-31387,0,0,0900006480bb7067 FDA-2010-N-0418-0003,FDA,FDA-2010-N-0418,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Institutional Review Boards",Notice,N-Notice,2010-12-15T05:00:00Z,2010,12,,,2010-12-15T22:13:12Z,2010-31389,0,0,0900006480bb70a6 FDA-2010-E-0038-0005,FDA,FDA-2010-E-0038,Determinations of Regulatory Review Periods for Purposes of Patent Extensions: SAMSCA,Notice,N-Notice,2010-12-14T05:00:00Z,2010,12,2010-12-14T05:00:00Z,,2010-12-14T20:35:51Z,2010-31298,0,0,0900006480bb6397 FDA-2009-E-0014-0006,FDA,FDA-2009-E-0014,Determinations of Regulatory Review Periods for Purposes of Patent Extensions: FREESTYLE NAVIGATOR,Notice,N-Notice,2010-12-14T05:00:00Z,2010,12,2010-12-14T05:00:00Z,,2010-12-14T20:43:14Z,2010-31240,0,0,0900006480bb5eeb FDA-2010-E-0024-0005,FDA,FDA-2010-E-0024,Determinations of Regulatory Review Periods for Purposes of Patent Extensions: VIBATIV,Notice,N-Notice,2010-12-14T05:00:00Z,2010,12,2010-12-14T05:00:00Z,,2010-12-14T19:45:10Z,2010-31250,0,0,0900006480bb6337 FDA-2010-E-0022-0005,FDA,FDA-2010-E-0022,Determinations of Regulatory Review Periods for Purposes of Patent Extensions: VIBATIV,Notice,N-Notice,2010-12-14T05:00:00Z,2010,12,2010-12-14T05:00:00Z,,2010-12-14T19:17:04Z,2010-31250,0,0,0900006480bb5ecf FDA-2010-N-0618-0001,FDA,FDA-2010-N-0618,"Statements of Organization, Functions and Delegations of Authority",Notice,N-Notice,2010-12-14T05:00:00Z,2010,12,,,2010-12-15T22:21:20Z,2010-31383,0,0,0900006480bb70c2 FDA-2010-E-0037-0005,FDA,FDA-2010-E-0037,Determinations of Regulatory Review Periods for Purposes of Patent Extensions: SAMSCA,Notice,N-Notice,2010-12-14T05:00:00Z,2010,12,2010-12-14T05:00:00Z,,2010-12-14T16:49:55Z,2010-31298,0,0,0900006480bb5ebd FDA-2010-N-0622-0001,FDA,FDA-2010-N-0622,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Color Additive Certification Requests and Recordkeeping",Notice,60 Day Proposed Information Collection,2010-12-13T05:00:00Z,2010,12,2010-12-13T05:00:00Z,2011-02-12T04:59:59Z,2017-03-17T14:13:33Z,2010-31195,0,0,0900006480bb4ff1 FDA-1976-N-0111-0001,FDA,FDA-1976-N-0111,"Food and Drug Administration, Department of Health, Education, and Welfare; Recodification Editorial and Technical Amendments",Notice,N-Notice,2010-12-13T05:00:00Z,2010,12,2010-12-13T05:00:00Z,,2010-12-13T23:14:26Z,,0,0,090000648051dacf FDA-2010-N-0389-0017,FDA,FDA-2010-N-0389,Meetings: Medical Device User Fee Program; Request for Notification of Patientand Consumer Advocacy Group Intentions to Participate,Notice,N-Notice,2010-12-13T05:00:00Z,2010,12,2010-12-13T05:00:00Z,,2010-12-13T15:25:18Z,2010-31160,0,0,0900006480bb4fc1 FDA-2010-E-0040-0006,FDA,FDA-2010-E-0040,Deteermination of Regulatory Review Period for Purposes of Patent Extension; MULTAQ,Notice,N-Notice,2010-12-10T05:00:00Z,2010,12,2010-12-10T05:00:00Z,,2010-12-10T16:25:59Z,,0,0,0900006480bb3d90 FDA-2010-N-0001-0156,FDA,FDA-2010-N-0001,Tobacco Products Scientific Advisory Committee; Notice of Meeting,Notice,GDL-Guidance,2010-12-10T05:00:00Z,2010,12,2010-12-10T05:00:00Z,,2010-12-10T16:30:50Z,2010-31066,0,0,0900006480bb392a FDA-2005-D-0072-0005,FDA,FDA-2005-D-0072,"Guidance for Public, FDA Advisory Committee Members, and FDA Staff; Availability: The Open Public Hearing at FDA Advisory Committee Meetings;Availability",Notice,NAD-Notice of Availability of Data,2010-12-10T05:00:00Z,2010,12,2010-12-10T05:00:00Z,,2024-11-07T22:28:26Z,2010-31022,1,0,0900006480bb387e FDA-2009-E-0510-0012,FDA,FDA-2009-E-0510,Determination of Regulatory Review Period for Purposes of Patent Extension: COARTEM,Notice,N-Notice,2010-12-10T05:00:00Z,2010,12,2010-12-10T05:00:00Z,,2024-11-07T22:28:12Z,2010-31074,1,0,0900006480bb3967 FDA-2010-E-0039-0006,FDA,FDA-2010-E-0039,Determination of Regulatory Review Period for Purposes of Patent Extension: MULTAQ,Notice,N-Notice,2010-12-10T05:00:00Z,2010,12,2010-12-10T05:00:00Z,,2010-12-10T16:20:27Z,2010-31064,0,0,0900006480bb389f FDA-2010-E-0021-0005,FDA,FDA-2010-E-0021,Determinations of Regulatory Review Periods for Purposes of Patent Extension; SABRIL,Notice,N-Notice,2010-12-09T05:00:00Z,2010,12,2010-12-09T05:00:00Z,,2024-11-07T22:27:57Z,2010-30995,1,0,0900006480bb2d85 FDA-2010-E-0044-0005,FDA,FDA-2010-E-0044,Determinations of Regulatory Review Periods for Purposes of Patent Extension; BEPREVE,Notice,N-Notice,2010-12-09T05:00:00Z,2010,12,2010-12-09T05:00:00Z,,2024-11-07T22:28:14Z,2010-30991,1,0,0900006480bb2846 FDA-2010-E-0047-0003,FDA,FDA-2010-E-0047,Determination of Regulatory Review Period for Purposes of Patent Extension; ILARIS,Notice,N-Notice,2010-12-09T05:00:00Z,2010,12,2010-12-09T05:00:00Z,,2024-11-07T22:27:57Z,2010-30992,1,0,0900006480bb2d66 FDA-2010-P-0177-0004,FDA,FDA-2010-P-0177,Determination That AUGMENTIN ‘125’ (Amoxicillin; Clavulanate Potassium) Chewable Tablet and Six Other AUGMENTIN (Amoxicillin; Clavulanate Potassium) Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness,Notice,N-Notice,2010-12-08T05:00:00Z,2010,12,2010-12-08T05:00:00Z,,2010-12-08T16:13:47Z,2010-30622,0,0,0900006480bb20d9 FDA-2010-N-0602-0001,FDA,FDA-2010-N-0602,Biologies Price Competition and Innovation Act of 2009;Meetings: User Fee Program for Biosimilar and Interchangeable Biological Product Applications; Request for Notification of Stakeholer Intention to Participate,Notice,N-Notice,2010-12-08T05:00:00Z,2010,12,2010-12-08T05:00:00Z,2011-01-11T04:59:59Z,2010-12-08T16:09:30Z,2010-30713,0,0,0900006480bb1e4f FDA-2010-N-0088-0003,FDA,FDA-2010-N-0088,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Electronic Products; General Requirements",Notice,NAL-Notice of Approval,2010-12-07T05:00:00Z,2010,12,2010-12-07T05:00:00Z,,2010-12-08T14:17:25Z,2010-30555,0,0,0900006480bb0cf7 FDA-2010-N-0568-0006,FDA,FDA-2010-N-0568,Required Warnings for Cigarette Packages and Advertisements; Research Report,Notice,N-Notice,2010-12-07T05:00:00Z,2010,12,2010-12-07T05:00:00Z,2011-01-12T04:59:59Z,2011-06-11T16:29:00Z,2010-30685,0,0,0900006480bb0be7 FDA-2010-P-0172-0005,FDA,FDA-2010-P-0172,Determinations that Drug Products Not Withdrawn from Sale for Reasons of Safety or Effectiveness: AUGMENTIN 125 (Amoxicillin; Clavulanate Potassium) Chewable Tablet and Six Other AUGMENTIN (Amoxicillin; Clavulanate Potassium),Notice,N-Notice,2010-12-07T05:00:00Z,2010,12,2010-12-07T05:00:00Z,,2010-12-07T17:42:31Z,2010-30622,0,0,0900006480bb0c74 FDA-2010-N-0551-0001,FDA,FDA-2010-N-0551,"Compliance Policy Guides; Withdrawals: Laser(s) as Medical Devices for Facelift, Wrinkle Removal, Acupuncture, Auricular Stimulation, etc.",Notice,NWL-Notice of Withdrawl,2010-12-07T05:00:00Z,2010,12,2010-12-07T05:00:00Z,,2010-12-07T16:06:30Z,2010-30679,0,0,0900006480bb0c03 FDA-2010-N-0316-0002,FDA,FDA-2010-N-0316,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Adverse Event Pilot Program for Medical Products",Notice,N-Notice,2010-12-07T05:00:00Z,2010,12,2010-12-07T05:00:00Z,2011-01-07T04:59:59Z,2010-12-07T16:43:53Z,2010-30583,0,0,0900006480bb0c2a FDA-2010-N-0550-0001,FDA,FDA-2010-N-0550,Withdrawals Of Guidance: Compliance Policy Guide Sec. 390.500 Definition of High-Voltage Vacuum Switch,Notice,NWL-Notice of Withdrawl,2010-12-07T05:00:00Z,2010,12,2010-12-07T05:00:00Z,,2010-12-08T13:59:45Z,2010-30677,0,0,0900006480bb0caf FDA-2010-N-0001-0154,FDA,FDA-2010-N-0001,Meetings: Third Annual Sentinel Initiative; Public Workshop,Notice,NM-Notice of Meeting,2010-12-07T05:00:00Z,2010,12,2010-12-07T05:00:00Z,,2010-12-08T14:06:32Z,2010-30562,0,0,0900006480bb0c93 FDA-2010-P-0275-0003,FDA,FDA-2010-P-0275,"Determinations that Product Withdrawal From Sale Was Not for Reasons of Safety or Effectiveness: GLEEVEC (Imatinib Mesylate) Capsules, 50 Milligrams and 100 Milligrams",Notice,N-Notice,2010-12-07T05:00:00Z,2010,12,2010-12-07T05:00:00Z,,2010-12-07T15:24:43Z,2010-30570,0,0,0900006480bb0be6 FDA-2004-N-0056-0012,FDA,FDA-2004-N-0056,Annual Guidance Agenda - Notice,Notice,N-Notice,2010-12-07T05:00:00Z,2010,12,2010-12-07T05:00:00Z,,2011-01-19T13:30:11Z,2010-30623,0,0,0900006480bb0c04 FDA-2010-N-0606-0001,FDA,FDA-2010-N-0606,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Additional Listing Information for Medical Device Registration and Listing",Notice,N-Notice,2010-12-07T05:00:00Z,2010,12,2010-12-07T05:00:00Z,2011-02-08T04:59:59Z,2010-12-08T14:31:55Z,2010-30582,0,0,0900006480bb0c5c FDA-2010-N-0083-0004,FDA,FDA-2010-N-0083,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed",Notice,NAL-Notice of Approval,2010-12-07T05:00:00Z,2010,12,2010-12-07T05:00:00Z,,2010-12-08T14:20:57Z,2010-30556,0,0,0900006480bb0c4c FDA-2010-N-0001-0152,FDA,FDA-2010-N-0001,Meetings: Oncologic Drugs Advisory Committee,Notice,NM-Notice of Meeting,2010-12-06T05:00:00Z,2010,12,2010-12-06T05:00:00Z,,2010-12-06T16:46:45Z,2010-30502,0,0,0900006480bafeac FDA-2000-N-0163-0023,FDA,FDA-2000-N-0163,"Reclassifications of Category IIIA Biological Products, Bacterial Vaccines and Related Biological Products, etc.: Delmont Laboratories, Inc.; Denial of Request for Hearing and Revocation of License",Notice,NFR-Notice of Final Rule,2010-12-06T05:00:00Z,2010,12,2010-12-06T05:00:00Z,,2010-12-06T17:22:07Z,2010-30441,0,0,0900006480bafeaf FDA-2009-E-0584-0005,FDA,FDA-2009-E-0584,Determination of Regulatory Review Period for Purposes of Patent Extension: Besivance,Notice,N-Notice,2010-12-06T05:00:00Z,2010,12,2010-12-06T05:00:00Z,,2010-12-08T16:21:28Z,2010-30510,0,0,0900006480baff29 FDA-2010-N-0595-0001,FDA,FDA-2010-N-0595,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Exports; Notification and Recordkeeping Requirements",Notice,N-Notice,2010-12-06T05:00:00Z,2010,12,2010-12-06T05:00:00Z,2011-02-05T04:59:59Z,2010-12-06T16:36:03Z,2010-30433,0,0,0900006480bafe8a FDA-2010-E-0036-0004,FDA,FDA-2010-E-0036,Determination of Regulatory Review Period for Purposes of Patent Extension; STELARA,Notice,N-Notice,2010-12-06T05:00:00Z,2010,12,2010-12-06T05:00:00Z,,2010-12-06T20:53:16Z,2010-30512,0,0,0900006480bafc54 FDA-2010-E-0032-0004,FDA,FDA-2010-E-0032,Determination of Regulatory Review Period for Purposes of Patent Extension: Stelara,Notice,N-Notice,2010-12-06T05:00:00Z,2010,12,2010-12-06T05:00:00Z,,2010-12-06T17:40:07Z,2010-30512,0,0,0900006480baff07 FDA-2010-N-0001-0153,FDA,FDA-2010-N-0001,Meetings: Peripheral and Central Nervous System Drugs Advisory Committee,Notice,NM-Notice of Meeting,2010-12-06T05:00:00Z,2010,12,2010-12-06T05:00:00Z,,2010-12-06T17:28:55Z,2010-30501,0,0,0900006480bafed0 FDA-2009-D-0137-0025,FDA,FDA-2009-D-0137,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guidance for Industry; Use of Serological Tests to Reduce Risk of Transmission of Trypanosoma cruzi Infection, etc.",Notice,30 Day Proposed Information Collection,2010-12-06T05:00:00Z,2010,12,2010-12-06T05:00:00Z,2011-01-06T04:59:59Z,2016-10-28T18:34:06Z,2010-30404,0,0,0900006480bafe83 FDA-2009-D-0137-0026,FDA,FDA-2009-D-0137,"Guidance for Industry: Use of Serological Tests to Reduce Riskof Transmission of Trypanosoma cruzi Infection, etc.",Notice,Notice of Availability,2010-12-06T05:00:00Z,2010,12,2010-12-06T05:00:00Z,,2016-10-28T18:39:30Z,2010-30405,0,0,0900006480baff0b FDA-2009-D-0533-0008,FDA,FDA-2009-D-0533,"Guidance for Industry: Recommendations for Blood Establishments; Availability: Training of Back-UpPersonnel, Assessment of Blood Donor Suitability, and Reporting Certain Changes to an Approved Application",Notice,NAD-Notice of Availability of Data,2010-12-03T05:00:00Z,2010,12,2010-12-03T05:00:00Z,,2010-12-03T19:53:33Z,2010-30388,0,0,0900006480bad6f5 FDA-1999-F-0056-0003,FDA,FDA-1999-F-0056,National Fisheries Institute; Filing of Food Additive Petition (FAP 9M4682),Notice,NFL-Notice of Filing,2010-12-03T05:00:00Z,2010,12,2010-12-03T05:00:00Z,,2010-12-03T17:37:36Z,,0,0,09000064804a61c6 FDA-2010-D-0566-0001,FDA,FDA-2010-D-0566,Draft Guidance for Industry on Residual Solvents in Animal Drug Products; Questions and Answers;Availability,Notice,NAD-Notice of Availability of Data,2010-12-03T05:00:00Z,2010,12,2010-12-03T05:00:00Z,2011-02-02T04:59:59Z,2010-12-03T17:35:27Z,2010-30387,0,0,0900006480bad670 FDA-2010-N-0597-0001,FDA,FDA-2010-N-0597,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Index of Legally Marketed Unapproved New Animal Drugs for Minor Species",Notice,60 Day Proposed Information Collection,2010-12-03T05:00:00Z,2010,12,2010-12-03T05:00:00Z,2011-02-02T04:59:59Z,2016-12-08T14:14:19Z,2010-30335,0,0,0900006480bad543 FDA-2010-N-0266-0005,FDA,FDA-2010-N-0266,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Study of ClinicalEfficacy Information in Professional Labeling and Direct-to-Consumer Print Advertisements for Prescription Drugs",Notice,N-Notice,2010-12-03T05:00:00Z,2010,12,2010-12-03T05:00:00Z,2011-01-04T04:59:59Z,2010-12-03T17:25:33Z,2010-30385,0,0,0900006480bad6f4 FDA-2010-N-0001-0151,FDA,FDA-2010-N-0001,Meetings: Gastrointestinal Drugs Advisory Committee,Notice,NM-Notice of Meeting,2010-12-02T05:00:00Z,2010,12,2010-12-02T05:00:00Z,,2010-12-02T18:04:06Z,2010-30274,0,0,0900006480babfeb FDA-2010-N-0603-0001,FDA,FDA-2010-N-0603,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Animal Drug User Fees and Fee Waivers and Reductions",Notice,N-Notice,2010-12-02T05:00:00Z,2010,12,2010-12-02T05:00:00Z,2011-02-01T04:59:59Z,2010-12-02T17:58:10Z,2010-30264,0,0,0900006480bac029 FDA-2010-N-0182-0003,FDA,FDA-2010-N-0182,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Procedures for Safe and Sanitary Processing and Importing of Fish and Fishery Products",Notice,NAL-Notice of Approval,2010-12-02T05:00:00Z,2010,12,2010-12-02T05:00:00Z,,2010-12-02T17:53:36Z,2010-30277,0,0,0900006480babf74 FDA-2010-N-0001-0149,FDA,FDA-2010-N-0001,Food Advisory Committee; Notice of Meeting,Notice,NM-Notice of Meeting,2010-12-01T05:00:00Z,2010,12,,,2011-08-16T19:06:57Z,2010-30187,0,0,0900006480baaef2 FDA-2010-N-0001-0150,FDA,FDA-2010-N-0001,Workshops: Food Labeling,Notice,NM-Notice of Meeting,2010-12-01T05:00:00Z,2010,12,2010-12-01T05:00:00Z,,2010-12-01T20:48:06Z,2010-30191,0,0,0900006480baaf41 FDA-2010-N-0576-0001,FDA,FDA-2010-N-0576,Requests for Supplemental Applications: Supplemental Funding under Food and Drug Administration'sConvener of Active Medical Product Surveillance Discussions,Notice,NI-Notice of Intent,2010-11-30T05:00:00Z,2010,11,2010-11-30T05:00:00Z,,2010-11-30T17:35:37Z,2010-30054,0,0,0900006480ba953e FDA-2010-M-0519-0002,FDA,FDA-2010-M-0519,Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval,Notice,NAL-Notice of Approval,2010-11-30T05:00:00Z,2010,11,2010-11-30T05:00:00Z,,2010-11-30T17:29:06Z,,0,0,0900006480ba9673 FDA-1996-M-0183-0001,FDA,FDA-1996-M-0183,Home Access Health Corp.; Premarket Approval of the Home Access HIV-1 Test System,Notice,NAL-Notice of Approval,2010-11-30T05:00:00Z,2010,11,2010-11-30T05:00:00Z,,2010-11-30T18:48:05Z,,0,0,0900006480500b9a FDA-2010-N-0594-0001,FDA,FDA-2010-N-0594,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Focus Groups as Usedby Food and Drug Administration (All Food and Drug Administration Regulated Products)",Notice,N-Notice,2010-11-30T05:00:00Z,2010,11,2010-11-30T05:00:00Z,2011-02-01T04:59:59Z,2010-11-30T16:28:27Z,2010-30037,0,0,0900006480ba9035 FDA-2010-N-0588-0001,FDA,FDA-2010-N-0588,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Exceptions or Alternatives to Labeling Requirements for Products Held by Strategic National Stockpile",Notice,N-Notice,2010-11-30T05:00:00Z,2010,11,2010-11-30T05:00:00Z,2011-02-01T04:59:59Z,2020-10-06T19:47:38Z,2010-30036,0,0,0900006480ba953f FDA-2010-N-0583-0001,FDA,FDA-2010-N-0583,"Agency Information Collection Activities: Proposed Collection; Comment Request; Radioactive Drug Research Committees",Notice,60 Day Proposed Information Collection,2010-11-30T05:00:00Z,2010,11,2010-11-30T05:00:00Z,2011-02-01T04:59:59Z,2015-03-09T12:22:51Z,2010-30038,0,0,0900006480ba90d1 FDA-2010-D-0589-0001,FDA,FDA-2010-D-0589,Draft Guidance for Industry on Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment; Availability,Notice,NAD-Notice of Availability of Data,2010-11-29T05:00:00Z,2010,11,2010-11-29T05:00:00Z,2011-03-01T04:59:59Z,2011-03-10T20:37:20Z,2010-29799,0,0,0900006480ba7c22 FDA-2010-N-0600-0001,FDA,FDA-2010-N-0600,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Animal Drug User Fee Cover Sheet",Notice,60 Day Proposed Information Collection,2010-11-29T05:00:00Z,2010,11,2010-11-29T05:00:00Z,2011-01-29T04:59:59Z,2017-06-08T13:21:26Z,2010-29820,0,0,0900006480ba7c1d FDA-2007-D-0150-0008,FDA,FDA-2007-D-0150,Guidance for Industry on Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval,Notice,Notice of Availability,2010-11-29T05:00:00Z,2010,11,2010-11-29T05:00:00Z,,2020-05-06T02:18:14Z,2010-29796,0,0,0900006480ba7bbf FDA-2010-D-0590-0001,FDA,FDA-2010-D-0590,"Guidance for Industry and Food and Drug Administration Staff; Availability, etc.: Blood Lancet Labeling",Notice,NAD-Notice of Availability of Data,2010-11-29T05:00:00Z,2010,11,2010-11-29T05:00:00Z,,2010-11-30T15:02:35Z,2010-29795,0,0,0900006480ba7c33 FDA-2010-M-0361-0002,FDA,FDA-2010-M-0361,Medical Devices; Availabilty of Safety and Effectiveness Summaries for Premarket Approval Applications,Notice,NAL-Notice of Approval,2010-11-29T05:00:00Z,2010,11,2010-11-29T05:00:00Z,,2010-11-29T15:04:46Z,2010-29731,0,0,0900006480ba7e6f FDA-2010-D-0565-0001,FDA,FDA-2010-D-0565,"Draft Guidance for Industry and Food and Drug Administration Staff; Availability, etc.: Establishing Performance Characteristics of In Vitro Diagnostic Devices for Detection of Clostridium difficile",Notice,NAD-Notice of Availability of Data,2010-11-29T05:00:00Z,2010,11,2010-11-29T05:00:00Z,2011-03-01T04:59:59Z,2010-11-29T20:19:53Z,2010-29794,0,0,0900006480ba8169 FDA-2010-D-0584-0001,FDA,FDA-2010-D-0584,Guidance for Industry on Abbreviated New Drug Applications; Availability: Impurities in Drug Products,Notice,Notice of Availability,2010-11-29T05:00:00Z,2010,11,2010-11-29T05:00:00Z,,2020-05-05T20:23:44Z,2010-29896,0,0,0900006480ba7cc3 FDA-2010-N-0547-0001,FDA,FDA-2010-N-0547,Clinical Development Programs for Sedation Products; Request for Assistance,Notice,N-Notice,2010-11-29T05:00:00Z,2010,11,2010-11-29T05:00:00Z,2011-01-29T04:59:59Z,2024-11-07T22:28:43Z,2010-29927,1,0,0900006480ba8187 FDA-2010-N-0601-0001,FDA,FDA-2010-N-0601,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Current Good Manufacturing Practice Regulations for Medicated Feeds",Notice,60 Day Proposed Information Collection,2010-11-29T05:00:00Z,2010,11,2010-11-29T05:00:00Z,2011-01-29T04:59:59Z,2024-11-07T22:28:33Z,2010-29928,1,0,0900006480ba7ce7