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withdrawn,object_id FDA-2011-N-0467-0008,FDA,FDA-2011-N-0467,"Non-Face-to-Face Sale and Distribution of Tobacco Products and Advertising, Promotion, and Marketing of Tobacco Products; Extension of Comment Period",Proposed Rule,Notice of Extension,2011-12-06T05:00:00Z,2011,12,2011-12-06T05:00:00Z,2012-01-20T04:59:59Z,2012-02-02T20:27:07Z,2011-31225,0,0,0900006480f7c538 FDA-1997-P-0417-0009,FDA,FDA-1997-P-0417,New Drugs for Human Use; Clarification of Requirements for Patent Holder,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2011-11-21T05:00:00Z,2011,11,1998-03-08T05:00:00Z,1998-06-05T03:59:59Z,2025-01-31T21:08:23Z,98 5800,0,0,09000064805d4291 FDA-2011-N-0493-0001,FDA,FDA-2011-N-0493,Restrictions on the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2011-11-17T05:00:00Z,2011,11,2011-11-17T05:00:00Z,2012-02-01T04:59:59Z,2011-11-17T18:26:10Z,2011-29702,0,0,0900006480f6e64c FDA-2011-N-0729-0001,FDA,FDA-2011-N-0729,Microbiology Devices: Classification of In Vitro Diagnostic Device for Yersinia Species Detection,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2011-11-07T05:00:00Z,2011,11,2011-11-07T05:00:00Z,2012-02-07T04:59:59Z,2011-11-07T16:35:32Z,2011-28724,0,0,0900006480f6709f FDA-2011-N-0583-0001,FDA,FDA-2011-N-0583,Orphan Drug Regulations,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2011-10-19T04:00:00Z,2011,10,2011-10-19T04:00:00Z,2012-01-18T04:59:59Z,2011-10-19T20:37:45Z,2011-27037,0,0,0900006480f55c83 FDA-2011-N-0650-0001,FDA,FDA-2011-N-0650,Cardiovascular Devices: Reclassification of External Pacemaker Pulse Generator Devices,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2011-10-17T04:00:00Z,2011,10,2011-10-17T04:00:00Z,2012-01-18T04:59:59Z,2011-10-17T13:19:24Z,2011-26625,0,0,0900006480f54001 FDA-1978-N-0018-0706,FDA,FDA-1978-N-0018,Sunscreen Drug Products for Over-the-Counter Human Use: Request for Data and Information Regarding Dosage Forms; Extension of Comment Period,Proposed Rule,Notice of Extension,2011-09-14T04:00:00Z,2011,9,2011-09-14T04:00:00Z,2011-10-18T03:59:59Z,2012-03-24T19:28:47Z,2011-23479,0,0,0900006480f19657 FDA-2011-N-0467-0001,FDA,FDA-2011-N-0467,"Non-Face-to-Face Sale and Distribution of Tobacco Products and Advertising, Promotion, and Marketing of Tobacco Products",Proposed Rule,Advance Notice of Proposed Rulemaking (ANPRM),2011-09-09T04:00:00Z,2011,9,2011-09-09T04:00:00Z,2011-12-09T04:59:59Z,2011-09-09T14:09:10Z,2011-23096,0,0,0900006480f14d3c FDA-2011-S-0009-0002,FDA,FDA-2011-S-0009,"Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators; Extension of Comment Period",Proposed Rule,Extension of Comment Period,2011-09-01T04:00:00Z,2011,9,2011-09-01T04:00:00Z,,2011-09-01T14:11:29Z,2011-22341,0,0,0900006480f0df90 FDA-2011-N-0505-0002,FDA,FDA-2011-N-0505,Effective Date of Requirement for Premarket Approval for Cardiovascular Permanent Pacemaker Electrode; Correction,Proposed Rule,Correction,2011-08-30T04:00:00Z,2011,8,2011-08-30T04:00:00Z,,2012-03-24T19:28:48Z,2011-22107,0,0,0900006480f09106 FDA-2000-P-0102-0055,FDA,FDA-2000-P-0102,Food Labeling; Health Claim; Phytosterols and Risk of Coronary Heart Disease; Reopening of the Comment Period,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2011-08-11T04:00:00Z,2011,8,2011-08-11T04:00:00Z,2011-10-26T03:59:59Z,2011-08-11T14:38:52Z,2011-20406,0,0,0900006480eddf11 FDA-2006-P-0033-0055,FDA,FDA-2006-P-0033,Food Labeling; Health Claim; Phytosterols and Risk of Coronary Heart Disease; Reopening of the Comment Period,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2011-08-11T04:00:00Z,2011,8,2011-08-11T04:00:00Z,2011-10-26T03:59:59Z,2011-08-11T14:47:58Z,2011-20406,0,0,0900006480eddb34 FDA-2000-P-0133-0050,FDA,FDA-2000-P-0133,Food Labeling; Health Claim; Phytosterols and Risk of Coronary Heart Disease; Reopening of the Comment Period,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2011-08-11T04:00:00Z,2011,8,2011-08-11T04:00:00Z,2011-10-26T03:59:59Z,2011-08-11T14:44:41Z,2011-20406,0,0,0900006480eddb33 FDA-2011-N-0505-0001,FDA,FDA-2011-N-0505,Requirement for Premarket Approval for Cardiovascular Permanent Pacemaker Electrode,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2011-08-08T04:00:00Z,2011,8,2011-08-08T04:00:00Z,2011-11-08T04:59:59Z,2011-08-08T13:56:21Z,2011-19959,0,0,0900006480ed9ebf FDA-2011-N-0504-0001,FDA,FDA-2011-N-0504,Requirement for Premarket Approval for Cranial Electrotherapy Stimulator,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2011-08-08T04:00:00Z,2011,8,2011-08-08T04:00:00Z,2011-11-08T04:59:59Z,2011-08-24T16:36:04Z,2011-19957,0,0,0900006480ed9ea7 FDA-2011-N-0526-0001,FDA,FDA-2011-N-0526,Effective Date of Requirement for Premarket Approval for a Pacemaker Programmer,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2011-08-04T04:00:00Z,2011,8,2011-08-04T04:00:00Z,2011-11-03T03:59:59Z,2011-08-04T15:12:53Z,2011-19733,0,0,0900006480ed6ee5 FDA-2005-N-0404-0135,FDA,FDA-2005-N-0404,Food Labeling: Gluten-Free Labeling of Foods; Reopening of Comment Period,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2011-08-03T04:00:00Z,2011,8,2011-08-03T04:00:00Z,2011-10-04T03:59:59Z,2011-09-21T21:41:05Z,2011-19620,0,0,0900006480ed4ad8 FDA-2011-N-0522-0001,FDA,FDA-2011-N-0522,Effective Date of Requirement for Premarket Approval for an Implantable Pacemaker Pulse Generator,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2011-07-27T04:00:00Z,2011,7,2011-07-27T04:00:00Z,2011-10-26T03:59:59Z,2011-07-27T16:47:13Z,2011-18957,0,0,0900006480ecd3f2 FDA-2011-S-0009-0001,FDA,FDA-2011-S-0009,"Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators",Proposed Rule,Advance Notice of Proposed Rulemaking (ANPRM),2011-07-26T04:00:00Z,2011,7,2011-07-26T04:00:00Z,2011-09-27T03:59:59Z,2012-07-30T15:07:20Z,2011-18792,0,0,0900006480ecb7f2 FDA-2011-N-0446-0001,FDA,FDA-2011-N-0446,Removal of Certain Requirements Related to Prescription Drug Marketing Act: Opportunity for Public Comment,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2011-07-14T04:00:00Z,2011,7,2011-07-14T04:00:00Z,2011-09-13T03:59:59Z,2011-07-14T13:29:56Z,2011-17696,0,0,0900006480ec1bf6 FDA-2011-F-0171-0113,FDA,FDA-2011-F-0171,Food Labeling: Calorie Labeling of Articles of Food in Vending Machines; Correction,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2011-06-27T04:00:00Z,2011,6,2011-06-27T04:00:00Z,,2015-02-20T20:10:55Z,2011-15983,0,0,0900006480eb4100 FDA-2011-N-0080-0001,FDA,FDA-2011-N-0080,Sterility Test Requirements for Biological Products,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2011-06-21T04:00:00Z,2011,6,2011-06-21T04:00:00Z,2011-09-20T03:59:59Z,2011-06-21T13:35:14Z,2011-15346,0,0,0900006480e6a0e9 FDA-1990-N-0025-0004,FDA,FDA-1990-N-0025,"Food Labeling, Declaration of Ingredients (See FDA-1990-N-0025-0002)",Proposed Rule,Notice of Proposed Rulemaking (NPRM),2011-06-17T04:00:00Z,2011,6,2011-06-17T04:00:00Z,,2024-11-07T22:30:55Z,,1,0,0900006480e51f8b FDA-1978-N-0018-0697,FDA,FDA-1978-N-0018,Sunscreen Drug Products for Over-the-Counter Human Use; Request for Data and Information Regarding Dosage Forms,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2011-06-17T04:00:00Z,2011,6,2011-06-17T04:00:00Z,2011-09-16T03:59:59Z,2011-08-12T15:28:51Z,2011-14768,0,0,0900006480e51fc3 FDA-1978-N-0018-0699,FDA,FDA-1978-N-0018,Revised Effectiveness Determination; Sunscreen Drug Products for Over-the-Counter Human Use,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2011-06-17T04:00:00Z,2011,6,2011-06-17T04:00:00Z,2011-09-16T03:59:59Z,2012-02-08T21:51:20Z,2011-14769,0,0,0900006480e52098 FDA-1998-N-1016-0001,FDA,FDA-1998-N-1016,"Notice of Proposed Rule-Making re General Requirements for Blood, Blood Components, and Blood Derivatives; Notification of Deferred Donors",Proposed Rule,NPR-Notice of Proposed Rule-Making,2011-06-03T04:00:00Z,2011,6,2011-06-03T04:00:00Z,1999-11-18T04:59:59Z,2015-12-07T15:01:57Z,,0,0,09000064805a29f6 FDA-2011-F-0172-0235,FDA,FDA-2011-F-0172,Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments,Proposed Rule,NEC-Notice of Extension,2011-05-24T04:00:00Z,2011,5,2011-05-24T04:00:00Z,2011-07-06T03:59:59Z,2011-07-13T20:31:42Z,2011-12736,0,0,0900006480e30f32 FDA-2011-F-0172-0234,FDA,FDA-2011-F-0172,Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Correction,Proposed Rule,NCR-Notice of Correction,2011-05-24T04:00:00Z,2011,5,2011-05-24T04:00:00Z,,2011-06-11T16:30:33Z,2011-12735,0,0,0900006480e30f4a FDA-1993-N-0065-0012,FDA,FDA-1993-N-0065,Proposal to Establish Procedures for the Safe Processing & Importing of Fish & Fishery Products,Proposed Rule,NCR-Notice of Correction,2011-05-18T04:00:00Z,2011,5,2011-05-18T04:00:00Z,1994-04-29T03:59:59Z,2011-05-18T19:05:29Z,,0,0,09000064804fcb70 FDA-2011-N-0103-0001,FDA,FDA-2011-N-0103,Microbiology Devices: Classification of In Vitro Diagnostic Device for Bacillus Species Detection,Proposed Rule,NPR-Notice of Proposed Rule-Making,2011-05-18T04:00:00Z,2011,5,2011-05-18T04:00:00Z,2011-08-17T03:59:59Z,2011-05-18T13:52:27Z,2011-12088,0,0,0900006480d4154e FDA-2011-N-0121-0001,FDA,FDA-2011-N-0121,Further Amendments to General Regulations of Food and Drug Administration to Incorporate Tobacco Products,Proposed Rule,NPR-Notice of Proposed Rule-Making,2011-04-14T04:00:00Z,2011,4,2011-04-14T04:00:00Z,2011-06-14T03:59:59Z,2011-06-11T16:30:42Z,2011-09044,0,0,0900006480c2c60e FDA-2011-N-0079-0001,FDA,FDA-2011-N-0079,Disqualification of a Clinical Investigator,Proposed Rule,NPR-Notice of Proposed Rule-Making,2011-04-13T04:00:00Z,2011,4,2011-04-13T04:00:00Z,2011-07-13T03:59:59Z,2011-06-11T16:30:42Z,2011-08786,0,0,0900006480c25e36 FDA-2011-F-0171-0001,FDA,FDA-2011-F-0171,Food Labeling: Calorie Labeling of Articles of Food in Vending Machines,Proposed Rule,NPR-Notice of Proposed Rule-Making,2011-04-06T04:00:00Z,2011,4,2011-04-06T04:00:00Z,2011-07-06T03:59:59Z,2011-06-11T16:30:00Z,2011-08037,0,0,0900006480c1cfbc FDA-2011-F-0172-0001,FDA,FDA-2011-F-0172,Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments,Proposed Rule,NPR-Notice of Proposed Rule-Making,2011-04-06T04:00:00Z,2011,4,2011-04-06T04:00:00Z,2011-06-07T03:59:59Z,2015-02-20T20:05:04Z,2011-07940,0,0,0900006480c1cf20 FDA-1976-N-0519-0031,FDA,FDA-1976-N-0519,"Notice of Proposed Rule-Making re Cold, Cough, Allergy, Bronchodilator, And Antiasthmatic Drug Products For Over-The-Counter Human Use, Reopening Of Record For Receipt Of Comments Regarding The Marketing Status Of Combination Drug Products Containing Promethazine Hydrochloride; Correction",Proposed Rule,Notice of Proposed Rulemaking (NPRM),2011-03-23T04:00:00Z,2011,3,2011-03-23T04:00:00Z,,2016-03-02T16:28:24Z,,0,0,090000648053bcee FDA-1976-N-0519-0032,FDA,FDA-1976-N-0519,"Notice of Extension re Cold, Cough, Allergy, Bronchodilator, And Antiasthmatic Drug Products For Over-The-Counter Human Use; Reopening Of Record For Receipt Of Comments Regarding The Marketing Status Of Combination Drug Products Containing Promethazine Hydrochloride; Extension Of Comment Period",Proposed Rule,Extension of Comment Period,2011-03-23T04:00:00Z,2011,3,2011-03-23T04:00:00Z,1990-05-30T03:59:59Z,2016-03-02T18:53:21Z,,0,0,090000648053bcf1 FDA-2011-N-0029-0001,FDA,FDA-2011-N-0029,Medical Devices Ovarian Adnexal Mass Assessment Score Test System; Labeling; Black Box Restrictions,Proposed Rule,NPR-Notice of Proposed Rule-Making,2011-03-23T04:00:00Z,2011,3,2011-03-23T04:00:00Z,2011-05-24T03:59:59Z,2011-03-23T19:07:04Z,2011-06621,0,0,0900006480c0eca4 FDA-1976-N-0519-0037,FDA,FDA-1976-N-0519,"Notice of Proposed Rule-Making re Cold, Cough, Allergy, Bronchodilator, And Antiasthmatic Drug Products For Over-The-Counter Human Use, Reopening Of Record For Receipt Of Comments Regarding The Marketing Status Of Combination Drug Products Containing Promethazine Hydrochloride",Proposed Rule,Notice of Proposed Rulemaking (NPRM),2011-03-23T04:00:00Z,2011,3,2011-03-23T04:00:00Z,1990-01-21T04:59:59Z,2016-03-02T16:15:25Z,,0,0,090000648053bcea FDA-1976-N-0519-0013,FDA,FDA-1976-N-0519,"Notice of Proposed Rulemaking re Cold, Cough, Allergy, Bronchodilator, And Antiasthmatic Drug Products For Over-The Counter Human Use; Tentative Final Monograph For Combination Drug Products",Proposed Rule,Notice of Proposed Rulemaking (NPRM),2011-03-18T04:00:00Z,2011,3,2011-03-18T04:00:00Z,1988-12-13T04:59:59Z,2018-12-20T02:02:21Z,,0,0,090000648053bc8f FDA-1981-N-0012-0044,FDA,FDA-1981-N-0012,Weight Control Drug Products for Over-the-Counter Human Use: Benzocaine; Status Change,Proposed Rule,NPR-Notice of Proposed Rule-Making,2011-03-09T05:00:00Z,2011,3,2011-03-09T05:00:00Z,2011-06-08T03:59:59Z,2011-06-11T16:25:42Z,2011-05145,0,0,0900006480c03fb5 FDA-2006-P-0033-0027,FDA,FDA-2006-P-0033,"Health Claim, Phytosterols and Risk of Coronary Heart Disease",Proposed Rule,NEC-Notice of Extension,2011-02-18T05:00:00Z,2011,2,2011-02-18T05:00:00Z,2011-04-20T03:59:59Z,2011-02-28T21:08:27Z,2011-3678,0,0,0900006480bf2522 FDA-2000-P-0102-0028,FDA,FDA-2000-P-0102,Health Claim; Phytosterols and Risk of Coronary Heart Disease,Proposed Rule,NEC-Notice of Extension,2011-02-18T05:00:00Z,2011,2,2011-02-18T05:00:00Z,2011-04-20T03:59:59Z,2011-02-18T23:12:37Z,2011-3678,0,0,0900006480bf2393 FDA-2000-P-0133-0025,FDA,FDA-2000-P-0133,Health Claim; Phytosterols and Risk of Coronary Heart Disease,Proposed Rule,NEC-Notice of Extension,2011-02-18T05:00:00Z,2011,2,2011-02-18T05:00:00Z,2011-04-20T03:59:59Z,2011-02-28T20:59:23Z,2011-3678,0,0,0900006480bf251c FDA-1978-N-0021-0037,FDA,FDA-1978-N-0021,Notice of Proposed Rulemaking re Professional Labeling for Laxative Drug Products for Over-the-Counter Human Use: Amendment to Tentative Final Monograph,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2011-02-11T05:00:00Z,2011,2,2011-02-11T05:00:00Z,2011-03-15T03:59:59Z,2016-08-22T20:55:33Z,2011-3091,0,0,0900006480becd42 FDA-1978-N-1268-0001,FDA,FDA-1978-N-1268,Notice of Proposed Rulemaking- Medical Devices Proposed Procedures for Development of Standards,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2011-02-10T05:00:00Z,2011,2,2011-02-10T05:00:00Z,1978-09-26T03:59:59Z,2019-05-03T01:01:01Z,70-20370,0,0,09000064805999d5 FDA-1975-N-0017-0055,FDA,FDA-1975-N-0017,"Proposal To Establish Monographs For OTC Nighttime Sleep-Aid, Daytime Sedative, And Stimulant Products (Part 1)",Proposed Rule,Notice of Proposed Rulemaking (NPRM),2011-02-07T05:00:00Z,2011,2,2011-02-07T05:00:00Z,1976-03-09T04:59:59Z,2018-01-24T21:03:21Z,75-32774,0,0,09000064805c22a6 FDA-2010-N-0646-0001,FDA,FDA-2010-N-0646,Tobacco Products: Exemptions From Substantial Equivalence Requirements,Proposed Rule,NPR-Notice of Proposed Rule-Making,2011-01-06T05:00:00Z,2011,1,2011-01-06T05:00:00Z,2011-03-23T03:59:59Z,2011-06-11T16:29:58Z,2011-34,0,0,0900006480bc5f9b