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withdrawn,object_id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-N-1155-0004,FDA,FDA-2013-N-1155,Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling Regulations,Notice,60 Day Proposed Information Collection,2016-12-30T05:00:00Z,2016,12,2016-12-30T05:00:00Z,2017-03-01T04:59:59Z,2017-04-26T12:10:50Z,2016-31733,0,0,0900006482441427
FDA-2015-D-0025-0015,FDA,FDA-2015-D-0025,Medical Device Accessories—Describing Accessories and Classification Pathway for New Accessory Types; Guidance for Industry and Food and Drug Administration Staff; Availability,Notice,Notice of Availability,2016-12-30T05:00:00Z,2016,12,2016-12-30T05:00:00Z,,2016-12-30T14:17:49Z,2016-31669,0,0,0900006482441379
FDA-2013-N-0879-0004,FDA,FDA-2013-N-0879,"Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request: Procedures for Safe and Sanitary Processing and Importing of Fish and Fishery Products",Notice,30 Day Proposed Information Collection,2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,2017-01-31T04:59:59Z,2017-01-31T02:00:17Z,2016-31424,0,0,090000648243d253
FDA-2016-D-4318-0001,FDA,FDA-2016-D-4318,"Compounding and Repackaging of Radiopharmaceuticals by State-
Licensed Nuclear Pharmacies and Federal Facilities; Draft Guidance for
Industry; Availability",Notice,Notice of Availability,2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,,2016-12-29T14:29:37Z,2016-31513,0,0,090000648243d2fb
FDA-2000-D-0103-0009,FDA,FDA-2000-D-0103,Botanical Drug Development; Guidance for Industry; Availability,Notice,Notice of Availability,2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,,2016-12-29T14:39:34Z,2016-31627,0,0,090000648243d468
FDA-2009-D-0524-0032,FDA,FDA-2009-D-0524,Listing of Ingredients in Tobacco Products; Revised Guidance for Industry; Availability,Notice,Notice of Availability,2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,,2016-12-29T15:34:59Z,2016-31587,0,0,090000648243d2a5
FDA-2016-N-0002-0035,FDA,FDA-2016-N-0002,"Abbott Laboratories, et al.; Withdrawal of Approval of Four New Drug
Applications and Two Abbreviated New Drug Applications",Notice,Withdrawal,2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,,2016-12-29T15:02:22Z,2016-31625,0,0,090000648243d2a9
FDA-2016-D-2495-0013,FDA,FDA-2016-D-2495,Submission of Warning Plans for Cigars; Guidance for Industry; Availability,Notice,Notice of Availability,2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,,2016-12-29T14:48:32Z,2016-31586,0,0,090000648243d469
FDA-2014-D-0234-0029,FDA,FDA-2014-D-0234,Clinical Pharmacology Data To Support a Demonstration of Biosimilarity to a Reference Product; Guidance for Industry; Availability,Notice,Notice of Availability,2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,,2016-12-29T14:18:33Z,2016-31511,0,0,090000648243d24e
FDA-2016-D-0269-0112,FDA,FDA-2016-D-0269,"Prescription Requirement Under Section 503A of the Federal Food,
Drug, and Cosmetic Act; Guidance for Industry; Availability",Notice,Notice of Availability,2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,,2016-12-29T14:33:49Z,2016-31607,0,0,090000648243d35a
FDA-2016-D-4317-0001,FDA,FDA-2016-D-4317,Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,,2016-12-29T14:53:06Z,2016-31512,0,0,090000648243d4ab
FDA-2016-N-0001-0129,FDA,FDA-2016-N-0001,"Identification and Characterization of the Infectious Disease Risks of Human Cells, Tissues, and Cellular and Tissue-Based Products; Public Workshop",Notice,Public Meetings,2016-12-29T05:00:00Z,2016,12,2016-12-29T05:00:00Z,,2016-12-29T14:11:28Z,2016-31628,0,0,090000648243d171
FDA-2014-D-1953-0002,FDA,FDA-2014-D-1953,"Providing Regulatory Submissions in Electronic Format—Submission of
Manufacturing Establishment Information; Draft Guidance for Industry; Availability",Notice,,2016-12-29T00:00:00Z,2016,12,,,2019-05-22T14:57:37Z,,0,1,090000648243d173
FDA-2016-E-1179-0006,FDA,FDA-2016-E-1179,Determinations of Regulatory Review Periods for Purposes of Patent Extensions: IMLYGIC,Notice,Determinations,2016-12-28T05:00:00Z,2016,12,2016-12-28T05:00:00Z,2017-06-27T03:59:59Z,2016-12-28T14:27:41Z,2016-31322,0,0,090000648243a972
FDA-2016-E-1182-0006,FDA,FDA-2016-E-1182,Determinations of Regulatory Review Periods for Purposes of Patent Extensions: IMLYGIC,Notice,Determinations,2016-12-28T05:00:00Z,2016,12,2016-12-28T05:00:00Z,2017-06-27T03:59:59Z,2016-12-28T14:20:56Z,2016-31322,0,0,0900006482439ffb
FDA-2010-N-0067-0003,FDA,FDA-2010-N-0067,"Pharmaceutical Science and Clinical Pharmacology Advisory Committee;
Notice of Meeting; Correction",Notice,Correction,2016-12-28T05:00:00Z,2016,12,2016-12-28T05:00:00Z,,2016-12-28T14:16:07Z,2016-31391,0,0,0900006482439e88
FDA-2016-E-1181-0006,FDA,FDA-2016-E-1181,Determinations of Regulatory Review Periods for Purposes of Patent Extensions: IMLYGIC,Notice,Determinations,2016-12-28T05:00:00Z,2016,12,2016-12-28T05:00:00Z,2017-06-27T03:59:59Z,2016-12-28T14:27:57Z,2016-31322,0,0,090000648243a973
FDA-2015-D-5105-0057,FDA,FDA-2015-D-5105,Postmarket Management of Cybersecurity in Medical Devices; Guidance for Industry and Food and Drug Administration; Availability,Notice,Notice of Availability,2016-12-28T05:00:00Z,2016,12,2016-12-28T05:00:00Z,,2016-12-28T14:24:37Z,2016-31406,0,0,090000648243a197
FDA-2016-N-4187-0001,FDA,FDA-2016-N-4187,Coordinated Registry Network for Devices Used for Acute Ischemic Stroke Intervention; Public Workshop; Request for Comments,Notice,Public Meetings,2016-12-27T05:00:00Z,2016,12,2016-12-27T05:00:00Z,2017-03-03T04:59:59Z,2017-03-03T02:01:15Z,2016-31143,0,0,090000648243741a
FDA-2016-N-0001-0128,FDA,FDA-2016-N-0001,Psychopharmacologic Drugs Advisory Committee; Notice of Meeting,Notice,Meeting,2016-12-27T05:00:00Z,2016,12,2016-12-27T05:00:00Z,,2016-12-27T13:46:42Z,2016-31144,0,0,09000064824373d0
FDA-2016-D-1495-0014,FDA,FDA-2016-D-1495,"Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions; Guidance for Industry and Food and Drug Administration Staff; Availability",Notice,Notice of Availability,2016-12-27T05:00:00Z,2016,12,2016-12-27T05:00:00Z,,2016-12-27T15:04:22Z,2016-31145,0,0,0900006482437595
FDA-2012-N-1021-0033,FDA,FDA-2012-N-1021,"Medical Device User Fee and Modernization Act; Notice to Public of
Web Site Location of Fiscal Year 2017 Proposed Guidance Development",Notice,Announcement,2016-12-23T05:00:00Z,2016,12,2016-12-23T05:00:00Z,2017-02-22T04:59:59Z,2019-10-15T14:26:03Z,2016-31006,0,0,0900006482433eae
FDA-2016-N-4342-0001,FDA,FDA-2016-N-4342,Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Participation in the Food and Drug Administration Regulatory Science Student Internship Program,Notice,60 Day Proposed Information Collection,2016-12-23T05:00:00Z,2016,12,2016-12-23T05:00:00Z,2017-02-22T04:59:59Z,2016-12-23T14:37:29Z,2016-30967,0,0,0900006482433da8
FDA-2016-N-4319-0001,FDA,FDA-2016-N-4319,"Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Unique Device
Identification System",Notice,30 Day Proposed Information Collection,2016-12-23T05:00:00Z,2016,12,2016-12-23T05:00:00Z,2017-01-24T04:59:59Z,2016-12-23T14:30:43Z,2016-30966,0,0,0900006482433811
FDA-2007-D-0369-0399,FDA,FDA-2007-D-0369,"Product-Specific Bioequivalence Recommendations; Draft and Revised
Draft Guidances for Industry; Availability",Notice,Notice of Availability,2016-12-23T05:00:00Z,2016,12,2016-12-23T05:00:00Z,2017-02-22T04:59:59Z,2017-03-08T02:01:43Z,2016-30984,0,0,09000064824338b3
FDA-2004-N-0451-0040,FDA,FDA-2004-N-0451,"Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 046",Notice,Announcement,2016-12-23T05:00:00Z,2016,12,2016-12-23T05:00:00Z,,2016-12-23T14:47:43Z,2016-31008,0,0,0900006482433ef3
FDA-2016-N-2474-0002,FDA,FDA-2016-N-2474,"Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Reporting
Associated With Designated New Animal Drugs for Minor Use and Minor
Species",Notice,30 Day Proposed Information Collection,2016-12-22T05:00:00Z,2016,12,2016-12-22T05:00:00Z,2017-01-24T04:59:59Z,2016-12-22T14:46:45Z,2016-30770,0,0,090000648243058b
FDA-2014-D-2275-0001,FDA,FDA-2014-D-2275,"Lead in Cosmetic Lip Products and Externally Applied Cosmetics:
Recommended Maximum Level; Draft Guidance for Industry; Availability",Notice,Notice of Availability,2016-12-22T05:00:00Z,2016,12,2016-12-22T05:00:00Z,,2016-12-22T14:49:34Z,2016-30781,0,0,0900006482430288
FDA-2010-N-0597-0005,FDA,FDA-2010-N-0597,"Agency Information Collection Activities; Proposed Collection; Comment Request; Index of Legally Marketed Unapproved New Animal Drugs 
for Minor Species",Notice,60 Day Proposed Information Collection,2016-12-21T05:00:00Z,2016,12,2016-12-21T05:00:00Z,2017-02-22T04:59:59Z,2017-02-08T14:02:51Z,2016-30676,0,0,090000648242d101
FDA-2016-N-4320-0001,FDA,FDA-2016-N-4320,"Sun Pharmaceutical Industries, Inc.; Withdrawal of Approval of 28
Abbreviated New Drug Applications",Notice,Withdrawal,2016-12-20T05:00:00Z,2016,12,2016-12-20T05:00:00Z,,2016-12-20T14:56:31Z,2016-30623,0,0,09000064824290f9
FDA-2016-D-0620-0003,FDA,FDA-2016-D-0620,"Question-Based Review for the Chemistry, Manufacturing, and Controls Technical Section of Animal Drug Applications; Guidance for Industry; Availability",Notice,Notice of Availability,2016-12-20T05:00:00Z,2016,12,2016-12-20T05:00:00Z,,2016-12-20T14:52:21Z,2016-30613,0,0,09000064824290f3
FDA-2016-E-0626-0006,FDA,FDA-2016-E-0626,Determinations of Regulatory Review Periods for Purposes of Patent Extensions: COSENTYX,Notice,Determinations,2016-12-20T05:00:00Z,2016,12,2016-12-20T05:00:00Z,2017-06-20T03:59:59Z,2016-12-20T14:49:29Z,2016-30528,0,0,09000064824290f2
FDA-2016-N-0969-0003,FDA,FDA-2016-N-0969,"Authorization of Emergency Use of an In Vitro Diagnostic Device for
Detection of Zika Virus; Availability",Notice,Announcement,2016-12-20T05:00:00Z,2016,12,2016-12-20T05:00:00Z,,2016-12-20T14:59:56Z,2016-30532,0,0,090000648242960c
FDA-2012-N-0873-0007,FDA,FDA-2012-N-0873,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Announcement of Office of Management and Budget Approvals",Notice,Notice of Approval,2016-12-19T05:00:00Z,2016,12,2016-12-19T05:00:00Z,,2016-12-19T15:45:14Z,2016-30351,0,0,09000064824264ce
FDA-2016-N-1593-0002,FDA,FDA-2016-N-1593,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Announcement of Office of Management and Budget Approvals",Notice,Notice of Approval,2016-12-19T05:00:00Z,2016,12,2016-12-19T05:00:00Z,,2016-12-19T15:47:32Z,2016-30351,0,0,09000064824264d5
FDA-2015-N-2406-0009,FDA,FDA-2015-N-2406,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Announcement of Office of Management and Budget Approvals",Notice,Notice of Approval,2016-12-19T05:00:00Z,2016,12,2016-12-19T05:00:00Z,,2016-12-19T15:48:15Z,2016-30351,0,0,09000064824264d6
FDA-2013-N-0450-0006,FDA,FDA-2013-N-0450,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Announcement of Office of Management and Budget Approvals",Notice,Notice of Approval,2016-12-19T05:00:00Z,2016,12,2016-12-19T05:00:00Z,,2016-12-19T15:48:56Z,2016-30351,0,0,09000064824264f0
FDA-2011-N-0830-0030,FDA,FDA-2011-N-0830,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Announcement of Office of Management and Budget Approvals",Notice,Notice of Approval,2016-12-19T05:00:00Z,2016,12,2016-12-19T05:00:00Z,,2016-12-19T15:32:16Z,2016-30351,0,0,0900006482423485
FDA-2013-N-0093-0010,FDA,FDA-2013-N-0093,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Announcement of Office of Management and Budget Approvals",Notice,Notice of Approval,2016-12-19T05:00:00Z,2016,12,2016-12-19T05:00:00Z,,2016-12-19T15:47:08Z,2016-30351,0,0,09000064824264d4
FDA-2015-E-3157-0005,FDA,FDA-2015-E-3157,"Determination of Regulatory Review Period for Purposes of Patent
Extension; TRULICITY",Notice,Determinations,2016-12-19T05:00:00Z,2016,12,2016-12-19T05:00:00Z,2017-06-20T03:59:59Z,2016-12-19T15:35:53Z,2016-30399,0,0,0900006482423949
FDA-2013-N-0242-0009,FDA,FDA-2013-N-0242,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Announcement of Office of Management and Budget Approvals",Notice,Notice of Approval,2016-12-19T05:00:00Z,2016,12,2016-12-19T05:00:00Z,,2016-12-19T15:46:13Z,2016-30351,0,0,09000064824264d1
FDA-2008-D-0031-0005,FDA,FDA-2008-D-0031,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Announcement of Office of Management and Budget Approvals",Notice,Notice of Approval,2016-12-19T05:00:00Z,2016,12,2016-12-19T05:00:00Z,,2016-12-19T15:45:42Z,2016-30351,0,0,09000064824264d0
FDA-2013-N-0125-0024,FDA,FDA-2013-N-0125,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Announcement of Office of Management and Budget Approvals",Notice,Notice of Approval,2016-12-19T05:00:00Z,2016,12,2016-12-19T05:00:00Z,,2016-12-19T15:46:41Z,2016-30351,0,0,09000064824264d3
FDA-2015-D-4361-0005,FDA,FDA-2015-D-4361,Gifts to the Food and Drug Administration: Evaluation and Acceptance; Guidance for the Public and Food and Drug Administration; Availability,Notice,Notice of Availability,2016-12-16T05:00:00Z,2016,12,2016-12-16T05:00:00Z,,2016-12-16T15:05:07Z,2016-30312,0,0,0900006482414334
FDA-2014-D-1352-0005,FDA,FDA-2014-D-1352,International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Bioequivalence: Blood Level Bioequivalence Study; Guidance for Industry; Availability,Notice,Notice of Availability,2016-12-16T05:00:00Z,2016,12,2016-12-16T05:00:00Z,,2016-12-16T15:12:36Z,2016-30309,0,0,0900006482414488
FDA-2016-N-3995-0001,FDA,FDA-2016-N-3995,"Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended To Treat, Diagnose, or Cure",Notice,60 Day Proposed Information Collection,2016-12-16T05:00:00Z,2016,12,2016-12-16T05:00:00Z,2017-02-15T04:59:59Z,2016-12-16T15:15:37Z,2016-30243,0,0,0900006482414962
FDA-2015-D-0390-0025,FDA,FDA-2015-D-0390,"Use of Electronic Informed Consent—Questions and Answers; Guidance for Institutional Review Boards, Investigators, and Sponsors; Availability",Notice,Notice of Availability,2016-12-15T05:00:00Z,2016,12,2016-12-15T05:00:00Z,,2016-12-15T15:09:26Z,2016-30146,0,0,090000648240b6b5
FDA-2013-N-0795-0005,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,30 Day Proposed Information Collection,2016-12-15T05:00:00Z,2016,12,2016-12-15T05:00:00Z,2017-01-18T04:59:59Z,2016-12-15T14:59:29Z,2016-30113,0,0,090000648240b585
FDA-2016-N-4119-0001,FDA,FDA-2016-N-4119,"Food Safety Modernization Act Third-Party Certification Program User Fee
Rate for Fiscal Year 2017",Notice,Announcement,2016-12-14T05:00:00Z,2016,12,2016-12-14T05:00:00Z,,2016-12-14T14:50:58Z,2016-30034,0,0,090000648240749a
FDA-2016-N-4198-0001,FDA,FDA-2016-N-4198,"Public Meeting on Patient-Focused Drug Development for Sarcopenia;
Request for Comments",Notice,Request for Comments,2016-12-14T05:00:00Z,2016,12,2016-12-14T05:00:00Z,2017-06-07T03:59:59Z,2017-06-07T01:02:42Z,2016-29998,0,0,0900006482407424
FDA-2012-N-0477-0008,FDA,FDA-2012-N-0477,"Agency Information Collection Activities; Announcement of Office of
Management and Budget Approvals",Notice,Notice of Approval,2016-12-14T05:00:00Z,2016,12,2016-12-14T05:00:00Z,,2016-12-14T16:05:49Z,2016-30035,0,0,0900006482408288
FDA-2016-D-4120-0001,FDA,FDA-2016-D-4120,"Fruit Juice and Vegetable Juice as Color Additives in Food; Draft
Guidance for Industry; Availability",Notice,Notice of Availability,2016-12-14T05:00:00Z,2016,12,2016-12-14T05:00:00Z,2017-02-14T04:59:59Z,2017-02-14T02:00:19Z,2016-29968,0,0,0900006482407498
FDA-2013-N-0662-0006,FDA,FDA-2013-N-0662,"Agency Information Collection Activities; Announcement of Office of
Management and Budget Approvals",Notice,Notice of Approval,2016-12-14T05:00:00Z,2016,12,2016-12-14T05:00:00Z,,2016-12-14T16:05:07Z,2016-30035,0,0,0900006482408286
FDA-2013-N-0519-0006,FDA,FDA-2013-N-0519,"Agency Information Collection Activities; Announcement of Office of
Management and Budget Approvals",Notice,Notice of Approval,2016-12-14T05:00:00Z,2016,12,2016-12-14T05:00:00Z,,2016-12-14T14:45:15Z,2016-30035,0,0,0900006482407453
FDA-2009-N-0511-0006,FDA,FDA-2009-N-0511,"Agency Information Collection Activities; Announcement of Office of
Management and Budget Approvals",Notice,Notice of Approval,2016-12-14T05:00:00Z,2016,12,2016-12-14T05:00:00Z,,2016-12-14T16:02:32Z,2016-30035,0,0,090000648240823d
FDA-2013-N-0134-0005,FDA,FDA-2013-N-0134,"Agency Information Collection Activities; Announcement of Office of
Management and Budget Approvals",Notice,Notice of Approval,2016-12-14T05:00:00Z,2016,12,2016-12-14T05:00:00Z,,2016-12-14T16:02:06Z,2016-30035,0,0,090000648240823b
FDA-2013-N-0450-0005,FDA,FDA-2013-N-0450,"Agency Information Collection Activities; Announcement of Office of
Management and Budget Approvals",Notice,Notice of Approval,2016-12-14T05:00:00Z,2016,12,2016-12-14T05:00:00Z,,2016-12-14T16:05:28Z,2016-30035,0,0,0900006482408287
FDA-2013-N-0375-0005,FDA,FDA-2013-N-0375,"Agency Information Collection Activities; Announcement of Office of
Management and Budget Approvals",Notice,Notice of Approval,2016-12-14T05:00:00Z,2016,12,2016-12-14T05:00:00Z,,2016-12-14T16:01:21Z,2016-30035,0,0,0900006482408237
FDA-2013-N-0370-0005,FDA,FDA-2013-N-0370,"Agency Information Collection Activities; Announcement of Office of
Management and Budget Approvals",Notice,Notice of Approval,2016-12-14T05:00:00Z,2016,12,2016-12-14T05:00:00Z,,2016-12-14T16:01:43Z,2016-30035,0,0,0900006482408238
FDA-2011-N-0902-0009,FDA,FDA-2011-N-0902,"Agency Information Collection Activities; Announcement of Office of
Management and Budget Approvals",Notice,Notice of Approval,2016-12-14T05:00:00Z,2016,12,2016-12-14T05:00:00Z,,2016-12-14T16:04:45Z,2016-30035,0,0,0900006482408240
FDA-1997-N-0020-0194,FDA,FDA-1997-N-0020,"Agency Information Collection Activities; Announcement of Office of
Management and Budget Approvals",Notice,Notice of Approval,2016-12-14T05:00:00Z,2016,12,2016-12-14T05:00:00Z,,2016-12-14T16:04:21Z,2016-30035,0,0,090000648240823f
FDA-2015-D-4803-0030,FDA,FDA-2015-D-4803,"Public Notification of Emerging Postmarket Medical Device Signals
(‘‘Emerging Signals’’); Guidance for Industry and Food and Drug
Administration Staff; Availability",Notice,Notice of Availability,2016-12-14T05:00:00Z,2016,12,2016-12-14T05:00:00Z,,2016-12-14T14:56:12Z,2016-29989,0,0,0900006482407d7e
FDA-2016-N-2836-0008,FDA,FDA-2016-N-2836,"Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Donor Risk
Assessment Questionnaire for the Food and Drug Administration/National Heart, Lung, and Blood Institute-Sponsored Transfusion-Transmissible Infections Monitoring System—Risk Factor Elicitation",Notice,30 Day Proposed Information Collection,2016-12-13T05:00:00Z,2016,12,2016-12-13T05:00:00Z,2017-01-13T04:59:59Z,2019-12-27T18:27:32Z,2016-29814,0,0,09000064823fed94
FDA-2009-D-0508-0014,FDA,FDA-2009-D-0508,"Registration and Product Listing for Owners and Operators of Domestic
Tobacco Product Establishment; Guidance for Industry; Availability",Notice,Notice of Availability,2016-12-13T05:00:00Z,2016,12,2016-12-13T05:00:00Z,,2016-12-13T14:22:26Z,2016-29776,0,0,09000064823fe52b
FDA-2016-E-0625-0005,FDA,FDA-2016-E-0625,Determinations of Regulatory Review Periods for Purposes of Patent Extensions: NUCALA,Notice,Determinations,2016-12-13T05:00:00Z,2016,12,2016-12-13T05:00:00Z,2017-06-13T03:59:59Z,2016-12-13T14:24:15Z,2016-29838,0,0,09000064823fe725
FDA-2013-N-0764-0009,FDA,FDA-2013-N-0764,"Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Animal Feed
Regulatory Program Standards",Notice,30 Day Proposed Information Collection,2016-12-13T05:00:00Z,2016,12,2016-12-13T05:00:00Z,2017-01-13T04:59:59Z,2016-12-13T14:27:29Z,2016-29839,0,0,09000064823fed90
FDA-2016-P-1363-0005,FDA,FDA-2016-P-1363,"Determination That SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER 
(Sodium Chloride), Injectable, 234 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness",Notice,Determinations,2016-12-12T05:00:00Z,2016,12,2016-12-12T05:00:00Z,,2016-12-12T14:18:25Z,2016-29674,0,0,09000064823f9857
FDA-2000-D-0128-0003,FDA,FDA-2000-D-0128,Medical Devices: Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test Systems; Guidance for Industry and FDA; Availability,Notice,Notice of Availability,2016-12-12T05:00:00Z,2016,12,2016-12-12T05:00:00Z,,2016-12-13T02:01:35Z,,0,0,09000064823fc479
FDA-2016-D-3466-0001,FDA,FDA-2016-D-3466,"Immediately in Effect Guidance Document: Conditions for Sale for Air-Conduction Hearing Aids; Guidance for Industry and Food and Drug 
Administration Staff; Availability",Notice,Notice of Availability,2016-12-12T05:00:00Z,2016,12,2016-12-12T05:00:00Z,,2016-12-12T13:46:11Z,2016-29724,0,0,09000064823f97ff
FDA-2016-D-1814-0001,FDA,FDA-2016-D-1814,Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2016-12-09T05:00:00Z,2016,12,2016-12-09T05:00:00Z,2017-02-08T04:59:59Z,2017-02-08T02:04:29Z,2016-29587,0,0,09000064823f44a8
FDA-2014-D-0609-0022,FDA,FDA-2014-D-0609,Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification; Guidance for Industry; Availability,Notice,Notice of Availability,2016-12-09T05:00:00Z,2016,12,2016-12-09T05:00:00Z,,2025-04-01T16:32:50Z,2016-29588,0,0,09000064823f4a40
FDA-2016-N-4096-0001,FDA,FDA-2016-N-4096,Final Assessment of the Program for Enhanced Review Transparency and Communication; Public Meeting and Establishment of Docket,Notice,Announcement,2016-12-09T05:00:00Z,2016,12,2016-12-09T05:00:00Z,2017-04-04T03:59:59Z,2017-04-04T13:00:45Z,2016-29589,0,0,09000064823f4bfc
FDA-2011-N-0146-0239,FDA,FDA-2011-N-0146,Third-Party Certification Body Accreditation for Food Safety Audits:  Model Accreditation Standards; Guidance for Industry and Food and Drug Administration Staff; Availability,Notice,Notice of Availability,2016-12-07T05:00:00Z,2016,12,2016-12-07T05:00:00Z,,2016-12-07T16:14:15Z,2016-29278,0,0,09000064823e6ef0
FDA-2016-E-0630-0005,FDA,FDA-2016-E-0630,"Determination of Regulatory Review Period for Purposes of Patent
Extension; GARDASIL 9",Notice,Determinations,2016-12-07T05:00:00Z,2016,12,2016-12-07T05:00:00Z,2017-02-07T04:59:59Z,2016-12-07T14:56:23Z,2016-29303,0,0,09000064823e7947
FDA-2016-N-3274-0001,FDA,FDA-2016-N-3274,"Posting Adverse Event Report Data Associated With Conventional Foods,
Dietary Supplements, and Cosmetics on the Internet; Availability",Notice,Notice of Availability,2016-12-07T05:00:00Z,2016,12,2016-12-07T05:00:00Z,,2016-12-07T14:52:14Z,2016-29277,0,0,09000064823e6fa0
FDA-2016-E-1102-0003,FDA,FDA-2016-E-1102,"Determination of Regulatory Review Period for Purposes of Patent
Extension; GARDASIL 9",Notice,Determinations,2016-12-07T05:00:00Z,2016,12,2016-12-07T05:00:00Z,2017-02-07T04:59:59Z,2016-12-07T14:55:45Z,2016-29303,0,0,09000064823e7105
FDA-2013-D-0117-0006,FDA,FDA-2013-D-0117,Agency Information Collection Activities; Proposed Collection; Comment Request; Providing Information About Pediatric Uses of Medical Devices,Notice,60 Day Proposed Information Collection,2016-12-05T05:00:00Z,2016,12,2016-12-05T05:00:00Z,2017-02-04T04:59:59Z,2016-12-05T16:11:40Z,2016-29105,0,0,09000064823ded6b
FDA-1999-D-1875-0024,FDA,FDA-1999-D-1875,"Compliance Policy Guide Sec. 615.115 on Extralabel Use of Medicated Feeds
for Minor Species; Availability",Notice,Notice of Availability,2016-12-05T05:00:00Z,2016,12,2016-12-05T05:00:00Z,,2016-12-05T16:29:04Z,2016-29133,0,0,09000064823def04
FDA-2013-N-1089-0004,FDA,FDA-2013-N-1089,Agency Information Collection Activities; Proposed Collection; Comment Request; Recommended Glossary and Educational Outreach To Support Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use,Notice,60 Day Proposed Information Collection,2016-12-05T05:00:00Z,2016,12,2016-12-05T05:00:00Z,2017-02-04T04:59:59Z,2016-12-05T16:32:01Z,2016-29104,0,0,09000064823def94
FDA-2016-N-2544-0002,FDA,FDA-2016-N-2544,"Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Medical Device:
Current Good Manufacturing Practice Quality System Regulations",Notice,30 Day Proposed Information Collection,2016-12-05T05:00:00Z,2016,12,2016-12-05T05:00:00Z,2017-01-05T04:59:59Z,2016-12-05T16:16:22Z,2016-29028,0,0,09000064823dedfc
FDA-2016-E-0617-0005,FDA,FDA-2016-E-0617,Determinations of Regulatory Review Periods for Purposes of Patent Extension: BEXSERO,Notice,Determinations,2016-12-05T05:00:00Z,2016,12,2016-12-05T05:00:00Z,2017-06-06T03:59:59Z,2016-12-05T16:32:55Z,2016-29025,0,0,09000064823e018b
FDA-2016-N-2896-0004,FDA,FDA-2016-N-2896,Public Meeting on Pre-Market Evaluation of Abuse-Deterrent Properties of Opioid Drug Products; Extension of Comment Period,Notice,Extension of Comment Period,2016-12-05T05:00:00Z,2016,12,2016-12-05T05:00:00Z,2017-01-04T04:59:59Z,2017-01-04T02:00:17Z,2016-29097,0,0,09000064823ded68
FDA-2016-E-0619-0005,FDA,FDA-2016-E-0619,Determinations of Regulatory Review Periods for Purposes of Patent Extension: BEXSERO,Notice,Determinations,2016-12-05T05:00:00Z,2016,12,2016-12-05T05:00:00Z,2017-06-06T03:59:59Z,2016-12-05T16:22:30Z,2016-29025,0,0,09000064823deeab
FDA-2009-D-0095-0015,FDA,FDA-2009-D-0095,"Clinical Pharmacology Section of Labeling for Human Prescription Drug
and Biological Products—Content and Format; Guidance for Industry;
Availability",Notice,Notice of Availability,2016-12-05T05:00:00Z,2016,12,2016-12-05T05:00:00Z,,2016-12-05T16:25:46Z,2016-29125,0,0,09000064823deeb0
FDA-2009-D-0600-0019,FDA,FDA-2009-D-0600,"Health Document Submission Requirements for Tobacco Products;
Guidance for Industry; Availability",Notice,Notice of Availability,2016-12-05T05:00:00Z,2016,12,2016-12-05T05:00:00Z,,2016-12-05T15:39:55Z,2016-29117,0,0,09000064823ded63
FDA-2015-E-3159-0004,FDA,FDA-2015-E-3159,Determination of Regulatory Review Period for Purposes of Patent Extension; TRUMENBA,Notice,Determinations,2016-12-02T05:00:00Z,2016,12,2016-12-02T05:00:00Z,2017-06-01T03:59:59Z,2016-12-02T17:20:09Z,2016-28916,0,0,09000064823db1ad
FDA-2016-E-0616-0005,FDA,FDA-2016-E-0616,Determination of Regulatory Review Period for Purposes of Patent Extension; OPDIVO,Notice,Determinations,2016-12-02T05:00:00Z,2016,12,2016-12-02T05:00:00Z,2017-06-01T03:59:59Z,2016-12-02T17:04:55Z,2016-28917,0,0,09000064823da02e
FDA-2015-E-5107-0004,FDA,FDA-2015-E-5107,Determination of Regulatory Review Period for Purposes of Patent Extension; TRESIBA,Notice,Determinations,2016-12-02T05:00:00Z,2016,12,2016-12-02T05:00:00Z,2017-06-01T03:59:59Z,2016-12-02T16:58:01Z,2016-28939,0,0,09000064823d9ecd
FDA-2015-E-3158-0004,FDA,FDA-2015-E-3158,Determination of Regulatory Review Period for Purposes of Patent Extension; TRUMENBA,Notice,Determinations,2016-12-02T05:00:00Z,2016,12,2016-12-02T05:00:00Z,2017-06-01T03:59:59Z,2016-12-02T17:14:07Z,2016-28916,0,0,09000064823da076
FDA-2016-D-3969-0001,FDA,FDA-2016-D-3969,Physiologically Based Pharmacokinetic Analyses--Format and Content; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2016-12-02T05:00:00Z,2016,12,2016-12-02T05:00:00Z,2017-02-01T04:59:59Z,2017-02-01T02:02:41Z,2016-28971,0,0,09000064823da07b
FDA-2016-D-2635-0125,FDA,FDA-2016-D-2635,"The Judicious Use of Medically Important Antimicrobial Drugs in Food-
Producing Animals; Establishing Appropriate Durations of Therapeutic
Administration; Extension of Comment
Period",Notice,Extension of Comment Period,2016-11-29T05:00:00Z,2016,11,2016-11-29T05:00:00Z,2017-03-14T03:59:59Z,2017-03-22T01:02:45Z,2016-28660,0,0,09000064823c5eee
FDA-2016-F-3880-0001,FDA,FDA-2016-F-3880,"Novus International, Inc.; Filing of Food Additive Petition (Animal Use);
Correction",Notice,Correction,2016-11-29T05:00:00Z,2016,11,2016-11-29T05:00:00Z,,2016-11-29T14:42:23Z,2016-28656,0,0,09000064823c5ea5
FDA-2014-D-2153-0012,FDA,FDA-2014-D-2153,Mitigating the Risk of Cross-Contamination From Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes;  Guidance for Industry and Food and Drug Administration Staff;  Availability,Notice,Notice of Availability,2016-11-29T05:00:00Z,2016,11,2016-11-29T05:00:00Z,,2016-11-29T15:27:12Z,2016-28604,0,0,09000064823c5eed
FDA-2016-N-0735-0026,FDA,FDA-2016-N-0735,"Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Superimposed
Text in Direct-to-Consumer Promotion of Prescription Drugs",Notice,30 Day Proposed Information Collection,2016-11-29T05:00:00Z,2016,11,2016-11-29T05:00:00Z,2016-12-30T04:59:59Z,2016-12-02T02:01:55Z,2016-28733,0,0,09000064823c5eef
FDA-2013-D-0575-0033,FDA,FDA-2013-D-0575,Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry on Expedited Programs for Serious Conditions—Drugs and Biologics,Notice,60 Day Proposed Information Collection,2016-11-29T05:00:00Z,2016,11,2016-11-29T05:00:00Z,2017-01-31T04:59:59Z,2016-11-29T15:05:48Z,2016-28732,0,0,09000064823c5ea9
FDA-2015-E-4669-0004,FDA,FDA-2015-E-4669,Determination of Regulatory Review Period for Purposes of Patent  Extension; IXINITY,Notice,Determinations,2016-11-29T05:00:00Z,2016,11,2016-11-29T05:00:00Z,2017-05-31T03:59:59Z,2016-11-29T16:20:41Z,2016-28653,0,0,09000064823c693a
FDA-2011-N-0830-0029,FDA,FDA-2011-N-0830,"Agency Information Collection Activities; Announcement of Office of
Management and Budget Approval; Abbreviated New Drug Applications
and 505(b)(2) Applications",Notice,Notice of Approval,2016-11-29T05:00:00Z,2016,11,2016-11-29T05:00:00Z,,2016-11-29T16:14:37Z,2016-28655,0,0,09000064823c607f
FDA-2015-E-4659-0004,FDA,FDA-2015-E-4659,Determination of Regulatory Review Period for Purposes of Patent  Extension; IXINITY,Notice,Determinations,2016-11-29T05:00:00Z,2016,11,2016-11-29T05:00:00Z,2017-05-31T03:59:59Z,2016-11-29T14:56:12Z,2016-28653,0,0,09000064823c5ea6
FDA-2010-N-0067-0002,FDA,FDA-2010-N-0067,"Pharmaceutical Science and Clinical Pharmacology Advisory Committee;
Establishment of a Public Docket; Request for Comments; Notice of
Meeting",Notice,Request for Comments,2016-11-29T05:00:00Z,2016,11,2016-11-29T05:00:00Z,2017-04-15T03:59:59Z,2017-04-15T01:02:05Z,2016-28605,0,0,09000064823c6040
FDA-2013-D-0349-0010,FDA,FDA-2013-D-0349,"Providing Postmarketing Periodic Safety Reports in the International
Council for Harmonisation E2C(R2) Format (Periodic Benefit-Risk
Evaluation Report); Guidance for Industry; Availability",Notice,Notice of Availability,2016-11-29T05:00:00Z,2016,11,2016-11-29T05:00:00Z,,2016-11-29T15:53:39Z,2016-28606,0,0,09000064823c5f73