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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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45 rows where docket_id = "FDA-2016-N-0832" and posted_year = 2016 sorted by posted_date descending

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document_type 3

  • Supporting & Related Material 38
  • Other 5
  • Notice 2

posted_year 1

  • 2016 · 45 ✖

agency_id 1

  • FDA 45
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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

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CREATE TABLE documents (
    id TEXT PRIMARY KEY,
    agency_id TEXT,
    docket_id TEXT REFERENCES dockets(id),
    title TEXT,
    document_type TEXT,
    subtype TEXT,
    posted_date TEXT,
    posted_year INTEGER,
    posted_month INTEGER,
    comment_start_date TEXT,
    comment_end_date TEXT,
    last_modified TEXT,
    fr_doc_num TEXT,
    open_for_comment INTEGER,
    withdrawn INTEGER,
    object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;
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