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withdrawn,object_id FDA-2008-N-0334-0017,FDA,FDA-2008-N-0334,"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements",Notice,30 Day Proposed Information Collection,2018-02-09T05:00:00Z,2018,2,2018-02-09T05:00:00Z,2018-03-13T03:59:59Z,2018-02-12T17:10:31Z,2018-02589,0,0,0900006482f06070 FDA-2008-N-0334-0016,FDA,FDA-2008-N-0334,Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements,Notice,60 Day Proposed Information Collection,2017-10-30T04:00:00Z,2017,10,2017-10-30T04:00:00Z,2017-12-30T04:59:59Z,2017-10-30T15:50:49Z,2017-23518,0,0,0900006482c21dfe FDA-2008-N-0334-0015,FDA,FDA-2008-N-0334,"Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Delay of Compliance Date; Safety Reporting Portal of Electronic Submission of Postmarketing Safety Reports for Human Drugs and Nonvaccine Biological Products",Rule,Final Rule,2015-05-27T04:00:00Z,2015,5,2015-05-27T04:00:00Z,,2015-05-27T14:01:38Z,2015-12753,0,0,0900006481b04f02 FDA-2008-N-0334-0014,FDA,FDA-2008-N-0334,"Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Corrections",Rule,Correction,2014-09-08T04:00:00Z,2014,9,2014-09-08T04:00:00Z,,2015-03-08T17:22:10Z,2014-21267,0,0,090000648186336a FDA-2008-N-0334-0013,FDA,FDA-2008-N-0334,"Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Correction",Rule,Correction,2014-09-08T04:00:00Z,2014,9,2014-09-08T04:00:00Z,,2015-03-08T17:22:21Z,2014-21266,0,0,09000064818633f4 FDA-2008-N-0334-0012,FDA,FDA-2008-N-0334,"Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Correction",Notice,Correction,2014-08-14T04:00:00Z,2014,8,2014-08-14T04:00:00Z,,2014-08-14T20:10:01Z,2014-19255,0,0,0900006481822218 FDA-2008-N-0334-0010,FDA,FDA-2008-N-0334,Guidance for Industry Providing Submissions in Electronic Format - Postmarketing Safety Reports-Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements,Other,Guidance,2014-06-10T04:00:00Z,2014,6,2014-06-10T04:00:00Z,,2024-11-11T20:50:51Z,,1,0,09000064817358ac FDA-2008-N-0334-0011,FDA,FDA-2008-N-0334,Reference 1 Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Final Rule - Administrative Practices and Procedures; Drugs; Labeling; Medical Devices; Reporting and Recordkeeping Requirements; Confidential Business Information; Over-the-counter Drugs; Biologics,Supporting & Related Material,Background Material,2014-06-10T04:00:00Z,2014,6,,,2014-06-10T15:58:32Z,,0,0,09000064817358ae FDA-2008-N-0334-0009,FDA,FDA-2008-N-0334,"Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements",Rule,Final Rule,2014-06-10T04:00:00Z,2014,6,2014-06-10T04:00:00Z,,2014-06-10T15:52:19Z,2014-13480,0,0,0900006481734bb1 FDA-2008-N-0334-0001,FDA,FDA-2008-N-0334,Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements,Proposed Rule,NPR-Notice of Proposed Rule-Making,2009-08-21T04:00:00Z,2009,8,2009-08-21T04:00:00Z,2009-11-20T04:59:59Z,2011-06-11T16:27:45Z,E9-19682,0,0,0900006480a0f0ed