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withdrawn,object_id FDA-1996-N-0274-0016,FDA,FDA-1996-N-0274,Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation,Rule,Final Rule,2017-01-13T05:00:00Z,2017,1,2017-01-13T05:00:00Z,2002-05-28T03:59:59Z,2017-04-12T16:39:39Z,2000-13210,0,0,090000648050450d FDA-1996-N-0274-0017,FDA,FDA-1996-N-0274,"Reference 1: Eastern Research Group: ""Cost Impact on the Pharmaceutical Industry of Final Sterility Requirements for Inhalation Solution Products"" Final Report July 23, 1998",Supporting & Related Material,Background Material,2017-01-13T05:00:00Z,2017,1,,,2017-01-13T15:39:25Z,,0,0,090000648050450c FDA-1996-N-0274-0019,FDA,FDA-1996-N-0274,"Letter from FDA CDER to Pascal Company, Inc",Other,Letter(s),2017-01-13T05:00:00Z,2017,1,2017-01-13T05:00:00Z,,2017-01-13T15:47:21Z,,0,0,0900006480504510 FDA-1996-N-0274-0021,FDA,FDA-1996-N-0274,Tab A - Draft Regulatory Action as submitted to OMB OIRA for review re: Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation; Final Rule,Supporting & Related Material,Background Material,2017-01-13T05:00:00Z,2017,1,,,2017-01-13T16:18:42Z,,0,0,0900006480504516 FDA-1996-N-0274-0018,FDA,FDA-1996-N-0274,"Letter from Pascal Company, Inc to FDA CDER",Other,Letter(s),2017-01-13T05:00:00Z,2017,1,2017-01-13T05:00:00Z,,2017-01-13T15:43:54Z,,0,0,090000648050450f FDA-1996-N-0274-0022,FDA,FDA-1996-N-0274,Tab B - Substantive Changes between Draft submitted to OIRA for Review and Action Subsequently Announced re: Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation; Final Rule,Supporting & Related Material,Background Material,2017-01-13T05:00:00Z,2017,1,,,2017-01-13T16:22:27Z,,0,0,0900006480504512 FDA-1996-N-0274-0020,FDA,FDA-1996-N-0274,OMB Review Notice to Dockets re: Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation; Final Rule,Supporting & Related Material,Background Material,2017-01-13T05:00:00Z,2017,1,,,2017-01-13T16:15:14Z,,0,0,0900006480504515 FDA-1996-N-0274-0012,FDA,FDA-1996-N-0274,Agency Information Collection Activities; Announcement of OMB Approval (Sterility Requirements for Inhalation Solution Products),Notice,Notice of Approval,2016-10-06T04:00:00Z,2016,10,1997-12-30T05:00:00Z,2000-12-01T04:59:59Z,2017-04-12T16:37:47Z,,0,0,0900006480504504 FDA-1996-N-0274-0001,FDA,FDA-1996-N-0274,Sterility Requirements for Inhalation Solution Products,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2016-09-21T04:00:00Z,2016,9,1997-09-23T04:00:00Z,1997-12-23T04:59:59Z,2017-04-12T16:36:07Z,1997–25130,0,0,09000064805044ca