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withdrawn,object_id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-2000-N-0163-0023,FDA,FDA-2000-N-0163,"Reclassifications of Category IIIA Biological Products, Bacterial Vaccines and Related Biological Products, etc.: Delmont Laboratories, Inc.; Denial of Request for Hearing and Revocation of License",Notice,NFR-Notice of Final Rule,2010-12-06T05:00:00Z,2010,12,2010-12-06T05:00:00Z,,2010-12-06T17:22:07Z,2010-30441,0,0,0900006480bafeaf
FDA-2000-N-0163-0022,FDA,FDA-2000-N-0163,"Tab G - ""Bacterial Vaccines and Bacterial Antigens with No U.S. Standard of Potency, dated October 27, 1978"" - [Covington & Burling [Delmont Laboratories, Inc.] - Supplement Appearance Request] re: FDA-2000-N-0163-0018",Supporting & Related Material,SUP-Supplement (Supporting and Related Material),2009-09-22T04:00:00Z,2009,9,,,2009-09-22T19:06:00Z,,0,0,09000064804d1a2f
FDA-2000-N-0163-0010,FDA,FDA-2000-N-0163,"Tab 2 - ""License Revocation Letter to BioPort Corporation,"" dated November 20, 2000 - [Biological Products; Bacterial Vaccines and Related Biological Products; Revocation of Biologics Licenses - Notice] - Background re: FDA-2000-N-0163-0002",Supporting & Related Material,BKG-Background Material,2009-09-17T04:00:00Z,2009,9,,,2009-09-17T14:48:08Z,,0,0,09000064804d1a1b
FDA-2000-N-0163-0021,FDA,FDA-2000-N-0163,"Tab C - ""Delmont Comments of January 8, 1978 (Docket No. 77N-0091), w/attachments"" - [Covington & Burling [Delmont Laboratories, Inc.] - Supplement Appearance Request] re: FDA-2000-N-0163-0018",Supporting & Related Material,SUP-Supplement (Supporting and Related Material),2009-09-17T04:00:00Z,2009,9,,,2009-09-17T21:03:48Z,,0,0,09000064804d1a39
FDA-2000-N-0163-0015,FDA,FDA-2000-N-0163,"Tab B - ""FDA/CBER Response to Delmont Laboratories, Inc., dated October 12, 1993"" - [Delmont Laboratories, Inc. - Comment] re: FDA-2000-N-0163-0013",Supporting & Related Material,C-Comment (Supporting and Related Material),2009-09-17T04:00:00Z,2009,9,,,2009-09-17T18:56:41Z,,0,0,09000064804d1a0a
FDA-2000-N-0163-0014,FDA,FDA-2000-N-0163,"Tab A - ""Bacterial Vaccines and Bacterial Antigens with No U.S. Standard of Potency: Revocation of Licenses and Reclassification"" - [Delmont Laboratories, Inc. - Comment] re: FDA-2000-N-0163-0013",Supporting & Related Material,C-Comment (Supporting and Related Material),2009-09-17T04:00:00Z,2009,9,,,2009-09-17T18:51:09Z,,0,0,09000064804d1a0f
FDA-2000-N-0163-0016,FDA,FDA-2000-N-0163,"Tab D - ""Minutes and Attendance List from Meeting between Delmont Laboratories, Inc., and FDA/CBER"" - [Delmont Laboratories, Inc. - Comment] re: FDA-2000-N-0163-0013",Supporting & Related Material,C-Comment (Supporting and Related Material),2009-09-17T04:00:00Z,2009,9,,,2009-09-17T19:49:06Z,,0,0,09000064804d1a14
FDA-2000-N-0163-0019,FDA,FDA-2000-N-0163,"Tab A - ""Table of Attachments"" - [Covington & Burling [Delmont Laboratories, Inc.] - Supplement Appearance Request ] re: FDA-2000-N-0163-0018",Supporting & Related Material,SUP-Supplement (Supporting and Related Material),2009-09-17T04:00:00Z,2009,9,,,2009-09-17T20:55:10Z,,0,0,09000064804d1a3f
FDA-2000-N-0163-0017,FDA,FDA-2000-N-0163,"Delmont Laboratories, Inc. - Appearance Request",Other,APE-Appearance Request,2009-09-17T04:00:00Z,2009,9,2009-09-17T04:00:00Z,,2013-07-27T21:05:57Z,,0,0,09000064804d1a24
FDA-2000-N-0163-0011,FDA,FDA-2000-N-0163,"Tab 1 - ""License Revocation Letter to Hollister-Stier Laboratories, LLC, dated August 3, 2000"" - [Biological Products; Bacterial Vaccines and Related Biological Products; Revocation of Biologics Licenses - Notice] - Background re: FDA-2000-N-0163-0002",Supporting & Related Material,BKG-Background Material,2009-09-17T04:00:00Z,2009,9,,,2009-09-17T14:48:56Z,,0,0,09000064804d1a1c
FDA-2000-N-0163-0020,FDA,FDA-2000-N-0163,"Tab B - ""Delmont Laboratories, Inc.; Opportunity for Hearing on a Proposal to Revoke U.S. License No. 229"" - [Covington & Burling [Delmont Laboratories, Inc.] - Supplement Appearance Request] re: FDA-2000-N-0163-0018",Supporting & Related Material,SUP-Supplement (Supporting and Related Material),2009-09-17T04:00:00Z,2009,9,,,2009-09-17T20:57:04Z,,0,0,09000064804d1a3d
FDA-2000-N-0163-0018,FDA,FDA-2000-N-0163,"Covington & Burling [Delmont Laboratories, Inc.] - Supplement Appearance Request",Other,SUP-Supplement,2009-09-17T04:00:00Z,2009,9,2009-09-17T04:00:00Z,,2013-08-11T04:10:38Z,,0,0,09000064804d1a40
FDA-2000-N-0163-0012,FDA,FDA-2000-N-0163,"""Index of Supporting Documents"" - [Biological Products; Bacterial Vaccines and Related Biological Products; Revocation of Biologics Licenses - Notice] - Background re: FDA-2000-N-0163-0002",Supporting & Related Material,BKG-Background Material,2009-09-17T04:00:00Z,2009,9,,,2009-09-17T14:49:58Z,,0,0,09000064804d1a1e
FDA-2000-N-0163-0009,FDA,FDA-2000-N-0163,"Tab 3 - ""Letter from Hollister-Stier Laboratories, LLC Surrendering License,"" dated June 19, 2000 - [Biological Products; Bacterial Vaccines and Related Biological Products; Revocation of Biologics Licenses - Notice] - Background re: FDA-2000-N-0163-0002",Supporting & Related Material,BKG-Background Material,2009-09-15T04:00:00Z,2009,9,,,2009-09-15T19:53:44Z,,0,0,09000064804d1a19
FDA-2000-N-0163-0005,FDA,FDA-2000-N-0163,"""Reports for Submission to Docket 00N-1219"" - [Biological Products; Bacterial Vaccines and Related Biological Products; Implementation of Efficacy Review - Notice] - Background re: FDA-2000-N-0163-0001",Supporting & Related Material,BKG-Background Material,2009-09-15T04:00:00Z,2009,9,,,2009-09-15T19:37:43Z,,0,0,09000064804d19e3
FDA-2000-N-0163-0008,FDA,FDA-2000-N-0163,"Tab 4 - ""Letter from BioPort Corporation Surrendering License,"" dated August 9, 2000"" - [Biological Products; Bacterial Vaccines and Related Biological Products; Revocation of Biologics Licenses - Notice] - Background re: FDA-2000-N-0163-0002",Supporting & Related Material,BKG-Background Material,2009-09-15T04:00:00Z,2009,9,,,2009-09-15T19:51:01Z,,0,0,09000064804d1a17
FDA-2000-N-0163-0006,FDA,FDA-2000-N-0163,"Tab 1 - ""Panel on Review of Allergenic Extracts Category IIIA Reclassification, Final Report, December 1983"" - [Biological Products; Bacterial Vaccines and Related Biological Products; Implementation of Efficacy Review - Notice] - Background re: FDA-2000-N-0163-0001",Supporting & Related Material,BKG-Background Material,2009-09-15T04:00:00Z,2009,9,,,2009-09-15T19:40:18Z,,0,0,09000064804d1a04
FDA-2000-N-0163-0007,FDA,FDA-2000-N-0163,"Tab 2 - ""Final Report: Addendum to Previous Panel Reports for the Reclassification of Category IIIA Biologics"" - [Biological Products; Bacterial Vaccines and Related Biological Products; Implementation of Efficacy Review - Notice] - Background re: FDA-2000-N-0163-0001",Supporting & Related Material,BKG-Background Material,2009-09-15T04:00:00Z,2009,9,,,2009-09-15T19:41:53Z,,0,0,09000064804d1a06
FDA-2000-N-0163-0004,FDA,FDA-2000-N-0163,"Separation of Functions: Delmont Laboratories, Inc.; Opportunity for a Hearing on a Proposal to Revoke U.S. License No. 229 - Memorandum",Other,M-Memorandum,2004-06-08T04:00:00Z,2004,6,,,2009-09-11T16:30:09Z,,0,0,09000064804d1a44
FDA-2000-N-0163-0003,FDA,FDA-2000-N-0163,"Delmont Laboratories, Inc.; Opportunity for Hearing on a Proposal to Revoke U.S. License No. 229 - Notice of Opportunity of Hearing",Notice,NPH-Notice of Opportunity of Hearing,2003-02-27T05:00:00Z,2003,2,2003-02-27T05:00:00Z,2003-04-29T03:59:59Z,2009-09-11T16:25:50Z,,0,0,09000064804d1a22
FDA-2000-N-0163-0002,FDA,FDA-2000-N-0163,Biological Products; Bacterial Vaccines and Related Biological Products; Revocation of Biologics Licenses - Notice,Notice,N-Notice,2001-05-29T04:00:00Z,2001,5,,,2009-09-09T18:32:17Z,,0,0,09000064804d1a21
FDA-2000-N-0163-0001,FDA,FDA-2000-N-0163,Biological Products; Bacterial Vaccines and Related Biological Products; Implementation of Efficacy Review; Proposed Order - Notice,Notice,N-Notice,2000-05-16T04:00:00Z,2000,5,2000-05-16T04:00:00Z,2000-08-14T03:59:59Z,2009-09-09T14:56:32Z,,0,0,09000064804d19cb