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withdrawn,object_id FDA-1998-N-1290-0007,FDA,FDA-1998-N-1290,OMB Review on 10/5/99 - [New Drug and Biological Drug Products; Evidence Needed to Demonstrate Efficacy of New Drugs for Use Against Lethal or Permanently Disabling Toxic Substances When Efficacy Studies in Humans Ethically Cannot Be Conducted] - Reference,Supporting & Related Material,REF-Reference (internal unless indicated),2009-04-23T04:00:00Z,2009,4,,,2009-04-24T00:57:34Z,,0,0,09000064805a6f41 FDA-1998-N-1290-0006,FDA,FDA-1998-N-1290,OMB Review on 5/31/02 - [New Drug and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible] - Reference,Supporting & Related Material,REF-Reference (internal unless indicated),2009-04-23T04:00:00Z,2009,4,,,2009-04-24T00:57:33Z,,0,0,09000064805a6f3f FDA-1998-N-1290-0002,FDA,FDA-1998-N-1290,New Drug and Biological Drug Products; Evidence Needed to Demonstrate Efficacy of New Drugs for Use Against Lethal or Permanently Disabling Toxic Substances When Efficacy Studies in Humans Ethically Cannot Be Conducted,Proposed Rule,NPR-Notice of Proposed Rule-Making,2009-04-23T04:00:00Z,2009,4,2009-04-23T04:00:00Z,1999-12-21T04:59:59Z,2009-04-24T00:57:14Z,99–25377,0,0,09000064805a6f34 FDA-1998-N-1290-0005,FDA,FDA-1998-N-1290,OMB Information Collection - [New Drug and Biological Drug Products; Evidence Needed to Demonstrate Efficacy of New Drugs for Use Against Lethal or Permanently Disabling Toxic Substances When Efficacy Studies in Humans Ethically Cannot Be Conducted; Proposed Rule] - Supporting Statement,Supporting & Related Material,SS-Supporting Statement,2009-04-23T04:00:00Z,2009,4,,,2009-04-24T00:57:32Z,,0,0,09000064805a6f3b FDA-1998-N-1290-0004,FDA,FDA-1998-N-1290,Reference List - [Evidence Needed To Demonstrate Efficacy of New Drugs for Use Against Lethal or Permanently Disabling Toxic Substances When Efficacy Studies in Humans Ethically Cannot Be Conducted] - Background,Supporting & Related Material,BKG-Background Material,2009-04-23T04:00:00Z,2009,4,,,2009-04-24T00:57:18Z,,0,0,09000064805a6f37 FDA-1998-N-1290-0003,FDA,FDA-1998-N-1290,Agency Information Collection Activities; Announcement of OMB Approval; New Drug and Biological Drug Products; Evidence Needed to Demonstrate Efficacy of New Drugs for Use Against Lethal or Permanently Disabling Toxic Substances When Efficacy Studies in Humans Ethically Cannot Be Conducted,Notice,NAL-Notice of Approval,2009-04-23T04:00:00Z,2009,4,2009-04-23T04:00:00Z,,2009-04-24T00:57:15Z,00–991,0,0,09000064805a6f3c FDA-1998-N-1290-0001,FDA,FDA-1998-N-1290,New Drug and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible,Rule,NFR-Notice of Final Rule,2002-06-04T04:00:00Z,2002,6,,,2009-04-23T22:59:35Z,,0,0,09000064805a6f2d