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withdrawn,object_id FDA-2004-N-0061-0056,FDA,FDA-2004-N-0061,See FDA-2004-N-0061-0002,Rule,Final Rule,2011-08-22T04:00:00Z,2011,8,2011-08-22T04:00:00Z,,2011-08-22T17:51:39Z,,0,0,0900006480ee8af2 FDA-2004-N-0061-0031,FDA,FDA-2004-N-0061,Citizen Petition et al Denial Response from FDA CDER to Robert Reinhard,Other,Denial of Petition,2008-10-27T04:00:00Z,2008,10,2008-10-27T04:00:00Z,,2016-02-04T20:24:29Z,,0,0,090000648077f414 FDA-2004-N-0061-0014,FDA,FDA-2004-N-0061,Letter from Robert Reinhard,Other,Electronic Letter,2008-07-13T04:00:00Z,2008,7,2008-07-13T04:00:00Z,,2016-02-04T17:59:13Z,,0,0,0900006480657958 FDA-2004-N-0061-0012,FDA,FDA-2004-N-0061,Acknowlegement Letter from FDA DDM to Robert Reinhard re: Petition for Stay of Action,Other,Acknowledgement Letter/Receipt,2008-06-30T04:00:00Z,2008,6,2008-06-30T04:00:00Z,,2016-02-05T14:15:19Z,,0,0,090000648061cf34 FDA-2004-N-0061-0013,FDA,FDA-2004-N-0061,Letter from Robert Reinhard to FDA DDM,Other,Letter(s),2008-06-30T04:00:00Z,2008,6,2008-06-30T04:00:00Z,,2016-02-04T17:57:07Z,,0,0,090000648061cf4c FDA-2004-N-0061-0009,FDA,FDA-2004-N-0061,Citizen Petition from Robert Reinhard,Other,Citizen Petition,2008-06-30T04:00:00Z,2008,6,2008-06-30T04:00:00Z,,2016-02-04T19:43:39Z,,0,0,090000648061ce38 FDA-2004-N-0061-0004,FDA,FDA-2004-N-0061,Tab A Initial Draft (FRN) Submitted to OMB OIRA for Review re: Human Subject Protection; Foreign Clinical Studies not Conducted under an Investigational New Drug Application,Supporting & Related Material,Background Material,2008-06-30T04:00:00Z,2008,6,,,2016-02-05T15:43:31Z,,0,0,090000648046ec02 FDA-2004-N-0061-0007,FDA,FDA-2004-N-0061,Regulations Policy and Management Staff [Human Subject Protection; Foreign Clinical Studies not Conducted Under an Investigational New Drug Application] OMB/OIRA Review,Supporting & Related Material,Background Material,2008-06-30T04:00:00Z,2008,6,,,2016-02-04T17:00:34Z,,0,0,0900006480607c8d FDA-2004-N-0061-0010,FDA,FDA-2004-N-0061,Acknowledgement Letter from FDA DDM to Robert Reinhard re: Citizen Petition,Other,Acknowledgement Letter/Receipt,2008-06-30T04:00:00Z,2008,6,2008-06-30T04:00:00Z,,2016-02-05T14:13:26Z,,0,0,090000648061cede FDA-2004-N-0061-0011,FDA,FDA-2004-N-0061,Petition for Stay of Action from Robert Reinhard,Other,Petition(s),2008-06-30T04:00:00Z,2008,6,2008-06-30T04:00:00Z,,2016-02-04T19:55:18Z,,0,0,090000648061cf0a FDA-2004-N-0061-0008,FDA,FDA-2004-N-0061,Objection to Rule and Request for a Hearing from Robert Reinhard,Other,Objection(s),2008-06-30T04:00:00Z,2008,6,2008-06-30T04:00:00Z,,2016-02-05T14:11:17Z,,0,0,090000648061ce08 FDA-2004-N-0061-0005,FDA,FDA-2004-N-0061,Tab B Changes of Initial Draft (FRN) Submitted to OIRA for Review and Action re: Human Subject Protection; Foreign Clinical Studies not Conducted under an Investigational New Drug Application,Supporting & Related Material,Background Material,2008-06-30T04:00:00Z,2008,6,,,2016-02-05T15:48:34Z,,0,0,090000648046ec03 FDA-2004-N-0061-0003,FDA,FDA-2004-N-0061,Regulations Policy and Management Staff [Human Subject Protection; Foreign Clinical Studies not Conducted Under an Investigational New Drug Application] OMB/OIRA Review,Supporting & Related Material,Background Material,2008-06-30T04:00:00Z,2008,6,,,2016-02-05T15:36:02Z,,0,0,090000648046ec01 FDA-2004-N-0061-0002,FDA,FDA-2004-N-0061,Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application; Final Rule,Rule,Final Rule,2008-04-28T04:00:00Z,2008,4,2008-04-28T04:00:00Z,,2016-02-04T16:49:48Z,E8-09200,0,0,0900006480537f08 FDA-2004-N-0061-0001,FDA,FDA-2004-N-0061,Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application; Proposed Rule,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2004-06-14T04:00:00Z,2004,6,2004-06-09T04:00:00Z,2004-09-09T03:59:59Z,2016-02-05T22:00:35Z,,0,0,090000648046ebfe