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withdrawn,object_id FDA-2016-N-0832-0046,FDA,FDA-2016-N-0832,Letter granting CVM's request for an extension,Other,Letter(s),2016-11-29T05:00:00Z,2016,11,2016-11-29T05:00:00Z,,2016-11-29T15:18:48Z,,0,0,09000064823c6e21 FDA-2016-N-0832-0045,FDA,FDA-2016-N-0832,Letter to Petitioner,Other,Letter(s),2016-10-05T04:00:00Z,2016,10,2016-10-05T04:00:00Z,,2016-10-05T16:54:57Z,,0,0,090000648229bd86 FDA-2016-N-0832-0040,FDA,FDA-2016-N-0832,"Exhibit 2 Expert Opinion of David H. Bechtel, Ph.D., D.A.B.T. re: Request for Hearing from Phibro Animal Health Corporation Redacted CV",Supporting & Related Material,Background Material,2016-07-15T04:00:00Z,2016,7,,,2016-07-15T15:59:53Z,,0,0,09000064820b5e32 FDA-2016-N-0832-0043,FDA,FDA-2016-N-0832,"Exhibit 7 Expert Opinion of Stephen Scypinski, Ph.D. re: Request for Hearing from Phibro Animal Health Corporation Redacted CV",Supporting & Related Material,Background Material,2016-07-15T04:00:00Z,2016,7,,,2016-07-15T16:00:57Z,,0,0,09000064820b5e35 FDA-2016-N-0832-0042,FDA,FDA-2016-N-0832,"Exhibit 4 Expert Opinion of John G. Dorsey, Ph.D. re: Request for Hearing from Phibro Animal Health Corporation Redacted CV",Supporting & Related Material,Background Material,2016-07-15T04:00:00Z,2016,7,,,2016-07-15T16:00:01Z,,0,0,09000064820b5e34 FDA-2016-N-0832-0041,FDA,FDA-2016-N-0832,"Exhibit 3 Expert Opinion of Neil. Kelleher, Ph.D. re: Request for Hearing from Phibro Animal Health Corporation Redacted CV",Supporting & Related Material,Background Material,2016-07-15T04:00:00Z,2016,7,,,2016-07-15T15:59:56Z,,0,0,09000064820b5e33 FDA-2016-N-0832-0044,FDA,FDA-2016-N-0832,"Exhibit 8 Expert Opinion of Robert D. Gibbons, Ph.D. re: Request for Hearing from Phibro Animal Health Corporation Redacted CV",Supporting & Related Material,Background Material,2016-07-15T04:00:00Z,2016,7,,,2016-07-15T16:01:58Z,,0,0,09000064820b5e36 FDA-2016-N-0832-0038,FDA,FDA-2016-N-0832,"Exhibit 20 Corey Grass, C. F. Grass Consulting, Impact & Cost if Mecadox Was Not Available (June 2016) re: Request for Hearing from Phibro Animal Health Corporation",Supporting & Related Material,Background Material,2016-07-12T04:00:00Z,2016,7,,,2016-07-13T16:58:17Z,,0,0,09000064820a3173 FDA-2016-N-0832-0031,FDA,FDA-2016-N-0832,Exhibit 6 FDA Location Directory (July 1990) re: Request for Hearing from Phibro Animal Health Corporation,Supporting & Related Material,Background Material,2016-07-12T04:00:00Z,2016,7,,,2016-07-13T16:57:07Z,,0,0,09000064820a3165 FDA-2016-N-0832-0036,FDA,FDA-2016-N-0832,"Exhibit 14 M. Karlsson, et al Decreased Susceptibility to Tiamulin in German Isolates of Brachyspira hyodysenteriae (Paper 43), Proc. 17th Int. Pig Vet. Soc. Cong., Ames, Iowa (2002) re: Request for Hearing from Phibro Animal Health Corporation",Supporting & Related Material,Background Material,2016-07-12T04:00:00Z,2016,7,,,2016-07-13T16:57:57Z,,0,0,09000064820a316d FDA-2016-N-0832-0030,FDA,FDA-2016-N-0832,"Exhibit 5 Proceedings of the EuroResidue Conference, Noorwijkerhout re: Request for Hearing from Phibro Animal Health Corporation",Supporting & Related Material,Background Material,2016-07-12T04:00:00Z,2016,7,,,2016-07-13T16:56:58Z,,0,0,09000064820a3111 FDA-2016-N-0832-0032,FDA,FDA-2016-N-0832,Exhibit 9 Declaration of Paul Duquette re: Request for Hearing from Phibro Animal Health Corporation,Supporting & Related Material,Background Material,2016-07-12T04:00:00Z,2016,7,,,2016-07-13T16:57:18Z,,0,0,09000064820a3168 FDA-2016-N-0832-0033,FDA,FDA-2016-N-0832,Exhibit 10 Declaration of Kevin Bynum re: Request for Hearing from Phibro Animal Health Corporation,Supporting & Related Material,Background Material,2016-07-12T04:00:00Z,2016,7,,,2016-07-13T16:57:26Z,,0,0,09000064820a3169 FDA-2016-N-0832-0035,FDA,FDA-2016-N-0832,"Exhibit 12 R. Korty, et al A Cost Effective Alternative to Finishing Depopulation for Swine Dysentery, Am. Ass. Swine Vet. re: Request for Hearing from Phibro Animal Health Corporation",Supporting & Related Material,Background Material,2016-07-12T04:00:00Z,2016,7,,,2016-07-13T16:57:48Z,,0,0,09000064820a316b FDA-2016-N-0832-0037,FDA,FDA-2016-N-0832,"Exhibit 15 A.C.J. Gresham, et al Treatment of Swine Dysentery Problems of Antibiotic Resistance and Concurrent Salmonellosis, 143 Vet. Rec. 619 (1998) re: Request for Hearing from Phibro Animal Health Corporation",Supporting & Related Material,Background Material,2016-07-12T04:00:00Z,2016,7,,,2016-07-13T16:58:07Z,,0,0,09000064820a316e FDA-2016-N-0832-0034,FDA,FDA-2016-N-0832,"Exhibit 11 John C.S. Harding, Emergence of""Brachyspira hampsonii"" in Western Canada: A Collaborative Success, Am. Ass. Swine Vet. 12-21 (2016) re: Request for Hearing from Phibro Animal Health Corporation",Supporting & Related Material,Background Material,2016-07-12T04:00:00Z,2016,7,,,2016-07-13T16:57:39Z,,0,0,09000064820a316a FDA-2016-N-0832-0039,FDA,FDA-2016-N-0832,Exhibit 21 Timeline April 2015 to April 2016: Summary of communications between Phibro Animal Health Corporation (PAH) and CVM re: Request for Hearing from Phibro Animal Health Corporation,Supporting & Related Material,Background Material,2016-07-12T04:00:00Z,2016,7,,,2016-07-13T16:58:26Z,,0,0,09000064820a3174 FDA-2016-N-0832-0029,FDA,FDA-2016-N-0832,Request for Hearing from Phibro Animal Health Corporation,Other,Request for Hearing,2016-07-12T04:00:00Z,2016,7,2016-04-12T04:00:00Z,2016-07-12T03:59:59Z,2016-07-13T16:04:37Z,,0,0,09000064820a1fdb FDA-2016-N-0832-0027,FDA,FDA-2016-N-0832,Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Opportunity for Hearing; Correction,Notice,Meeting,2016-04-21T04:00:00Z,2016,4,2016-04-21T04:00:00Z,,2016-04-21T15:22:46Z,2016-09265,0,0,0900006481f7cd6a FDA-2016-N-0832-0026,FDA,FDA-2016-N-0832,Request for Hearing from Phibro Animal Health Corporation,Other,Request for Hearing,2016-04-19T04:00:00Z,2016,4,2016-04-19T04:00:00Z,,2016-04-19T14:38:49Z,,0,0,0900006481f6c57f FDA-2016-N-0832-0025,FDA,FDA-2016-N-0832,Reference List re Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Opportunity for Hearing,Supporting & Related Material,Background Material,2016-04-15T04:00:00Z,2016,4,,,2016-04-15T14:18:36Z,,0,0,0900006481f6c898 FDA-2016-N-0832-0024,FDA,FDA-2016-N-0832,FDA Memorandum regarding the Separation of Functions for Carbadox,Other,Memorandum,2016-04-13T04:00:00Z,2016,4,2016-04-13T04:00:00Z,,2016-04-13T15:08:39Z,,0,0,0900006481f65aca FDA-2016-N-0832-0013,FDA,FDA-2016-N-0832,"Reference 12 FDA Memorandum dtd. July 29, 1975 re Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Opportunity for Hearing",Supporting & Related Material,Background Material,2016-04-12T04:00:00Z,2016,4,,,2016-04-15T13:44:51Z,,0,0,0900006481f56773 FDA-2016-N-0832-0019,FDA,FDA-2016-N-0832,"Reference 18 Report, 28th Codex Session, Rome, 2005 re Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Opportunity for Hearing",Supporting & Related Material,Background Material,2016-04-12T04:00:00Z,2016,4,,,2016-04-15T13:48:05Z,,0,0,0900006481f5677e FDA-2016-N-0832-0023,FDA,FDA-2016-N-0832,"Reference 22 FDA Memorandum dtd. July 29, 2012 re Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Opportunity for Hearing",Supporting & Related Material,Background Material,2016-04-12T04:00:00Z,2016,4,,,2016-04-15T13:50:07Z,,0,0,0900006481f56782 FDA-2016-N-0832-0017,FDA,FDA-2016-N-0832,"Reference 16 FOI Summary for sNADA 041-061, approved Oct. 5, 1998 re Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Opportunity for Hearing",Supporting & Related Material,Background Material,2016-04-12T04:00:00Z,2016,4,,,2016-04-15T13:46:54Z,,0,0,0900006481f56777 FDA-2016-N-0832-0004,FDA,FDA-2016-N-0832,"Reference 3 FDA Memorandum dtd. Mar. 17, 2014 re Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Opportunity for Hearing",Supporting & Related Material,Background Material,2016-04-12T04:00:00Z,2016,4,,,2016-04-15T13:40:35Z,,0,0,0900006481f56d1d FDA-2016-N-0832-0006,FDA,FDA-2016-N-0832,"Reference 5 Baars, A.J., et al., 1990 re Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Opportunity for Hearing",Supporting & Related Material,Background Material,2016-04-12T04:00:00Z,2016,4,,,2016-04-15T13:41:29Z,,0,0,0900006481f56d1f FDA-2016-N-0832-0008,FDA,FDA-2016-N-0832,"Reference 7 CVM GFI #3, July 25, 2006 re Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Opportunity for Hearing",Supporting & Related Material,Background Material,2016-04-12T04:00:00Z,2016,4,,,2016-04-15T13:42:23Z,,0,0,0900006481f5676e FDA-2016-N-0832-0009,FDA,FDA-2016-N-0832,"Reference 8 FDA Memorandum dtd. Sept. 22, 1972 re Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Opportunity for Hearing",Supporting & Related Material,Background Material,2016-04-12T04:00:00Z,2016,4,,,2016-04-15T13:42:50Z,,0,0,0900006481f5676f FDA-2016-N-0832-0014,FDA,FDA-2016-N-0832,"Reference 13 Citizen Petition, FDA Docket No. 86P-0212, May 9, 1986 re Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Opportunity for Hearing",Supporting & Related Material,Background Material,2016-04-12T04:00:00Z,2016,4,,,2016-04-15T13:45:23Z,,0,0,0900006481f56774 FDA-2016-N-0832-0010,FDA,FDA-2016-N-0832,"Reference 9 FDA Memorandum dtd. Aug. 27, 1970 re Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Opportunity for Hearing",Supporting & Related Material,Background Material,2016-04-12T04:00:00Z,2016,4,,,2016-04-15T13:43:25Z,,0,0,0900006481f56770 FDA-2016-N-0832-0012,FDA,FDA-2016-N-0832,"Reference 11 FDA Memorandum dtd. July 7, 1972 re Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Opportunity for Hearing",Supporting & Related Material,Background Material,2016-04-12T04:00:00Z,2016,4,,,2016-04-15T13:44:24Z,,0,0,0900006481f56772 FDA-2016-N-0832-0002,FDA,FDA-2016-N-0832,"Reference 1 FOI Summary for sNADA 041-061, approved Jan. 30, 1998 re Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Opportunity for Hearing",Supporting & Related Material,Background Material,2016-04-12T04:00:00Z,2016,4,,,2016-04-15T13:39:41Z,,0,0,0900006481f56d1b FDA-2016-N-0832-0022,FDA,FDA-2016-N-0832,"Reference 21 CVM GFI #208 - VICH GL49, Sept. 15, 2011 re Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Opportunity for Hearing",Supporting & Related Material,Background Material,2016-04-12T04:00:00Z,2016,4,,,2016-04-15T13:49:39Z,,0,0,0900006481f56781 FDA-2016-N-0832-0015,FDA,FDA-2016-N-0832,"Reference 14 Response to Citizen Petition, FDA Docket No. 86P-0212, May 30, 1995 re Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Opportunity for Hearing",Supporting & Related Material,Background Material,2016-04-12T04:00:00Z,2016,4,,,2016-04-15T13:45:52Z,,0,0,0900006481f56775 FDA-2016-N-0832-0018,FDA,FDA-2016-N-0832,"Reference 17 FOI Summary for oNADA 141-211, approved July 21, 2004 re Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Opportunity for Hearing",Supporting & Related Material,Background Material,2016-04-12T04:00:00Z,2016,4,,,2016-04-15T13:47:23Z,,0,0,0900006481f5677d FDA-2016-N-0832-0007,FDA,FDA-2016-N-0832,"Reference 6 Baars, A.J., et al., 1991 Residues of Carbadox Metabolites in Edible Pork Products re Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Opportunity for Hearing",Supporting & Related Material,Background Material,2016-04-12T04:00:00Z,2016,4,,,2016-04-15T13:41:56Z,,0,0,0900006481f56d20 FDA-2016-N-0832-0011,FDA,FDA-2016-N-0832,Reference 10 1990 JECFA report carbadox re Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Opportunity for Hearing,Supporting & Related Material,Background Material,2016-04-12T04:00:00Z,2016,4,,,2016-04-15T13:43:56Z,,0,0,0900006481f56771 FDA-2016-N-0832-0001,FDA,FDA-2016-N-0832,Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Opportunity for Hearing,Notice,Notice of Opportunity of Hearing,2016-04-12T04:00:00Z,2016,4,2016-04-12T04:00:00Z,2016-07-12T03:59:59Z,2020-08-14T15:22:11Z,2016-08327,0,0,0900006481f61268 FDA-2016-N-0832-0016,FDA,FDA-2016-N-0832,"Reference 15 FDA Memorandum dtd. Sept. 7, 1994 re Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Opportunity for Hearing",Supporting & Related Material,Background Material,2016-04-12T04:00:00Z,2016,4,,,2016-04-15T13:46:25Z,,0,0,0900006481f56776 FDA-2016-N-0832-0021,FDA,FDA-2016-N-0832,"Reference 20 Macintosh, A.I., et al., 1985 re Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Opportunity for Hearing",Supporting & Related Material,Background Material,2016-04-12T04:00:00Z,2016,4,,,2016-04-15T13:49:11Z,,0,0,0900006481f56780 FDA-2016-N-0832-0005,FDA,FDA-2016-N-0832,"Reference 4 Boison, J.O., et al., 2009 re Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Opportunity for Hearing",Supporting & Related Material,Background Material,2016-04-12T04:00:00Z,2016,4,,,2016-04-15T13:41:01Z,,0,0,0900006481f56d1e FDA-2016-N-0832-0020,FDA,FDA-2016-N-0832,"Reference 19 CVM GFI #205 VICH GL46, Sept. 15, 2011 re Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Opportunity for Hearing",Supporting & Related Material,Background Material,2016-04-12T04:00:00Z,2016,4,,,2016-04-15T13:48:34Z,,0,0,0900006481f5677f FDA-2016-N-0832-0003,FDA,FDA-2016-N-0832,Reference 2 2003 JECFA report on carbadox re Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Opportunity for Hearing,Supporting & Related Material,Background Material,2016-04-12T04:00:00Z,2016,4,,,2016-04-15T13:40:07Z,,0,0,0900006481f56d1c