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Veterinary Biologics Information Published in the Last 90 Days

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CVB Notices
Title ID Size (KB) Publication Date Posted Date
Issuance of Licenses 14-13 50 Jul 28, 2014  
Issuance of Licenses 14-14 43 Oct 07, 2014 Oct 16, 2014
Processing Special Outlines Describing Proposed Serial Release Assays 14-16 24 Oct 10, 2014 Oct 16, 2014
Veterinary Services Memorandums (new or revised)
Title ID Size (KB) Publication Date Posted Date
General Licensing Considerations: Efficacy Studies for Prophylactic and Therapeutic Biologics 800.202 132 Oct 27, 2014 Oct 30, 2014
Rulemaking
Title FR Citation Size (KB) Effective Date Posted Date
Viruses, Serums,Toxins, and Analogous Products; Standard Requirements; Addition of Terminology To Define Veterinary Biologics Test Results APHIS-2013-34 200 October 20, 2014 Sep 26, 2014
Proposed Rulemaking
Title Federal Register Vol/Page Size (KB) Comments Due Date Posted Date
         
Supplemental Assay Methods (SAMs)
Title ID Size (KB) Document Date Posted Date
         
Testing Protocols (PROs)
Title ID Size (KB) Document Date Posted Date
Detection of Hemagglutinating Viruses VIRPRO0096 447 Jul 17, 2014 Aug 29, 2014
Testing Protocol for Enzyme Linked Immunsorbent Assay (ELISA) for Extraneous Avian Leukosis Virus (ALV) VIRPRO0123 119 Sep 25, 2014 Oct 23, 2014
Reagent Data Sheets (DATs)
Title ID Size (KB) Publication Date Posted Date
Salmonella pullorum Stained K Polyvalent Antigen; Lot 13-304 VIRDAT4055 13 Jul 15, 2014 Jul 25, 2014
Escherichia coli Anti-K99 Pilus Horseradish Peroxidase (HRP)-Labeled Monoclonal Antibody (K99-HRP Conjugate); Lot # IRP 595 BBDAT0129 83 Apr 18, 2014 Aug 13, 2014
Erysipelothrix rhusiopathiae Challenge Culture; Lot # IRP 592 BBDAT0130 13 Apr 18, 2014 Aug 13, 2014
Clostridium perfringens Type C (beta) Antitoxin; Lot # IRP 585-A BBDAT0131 94 Apr 18, 2014 Aug 13, 2014
Escherichia coli Anti-K88 Pilus Horseradish Peroxidate (HRP)-Labeled Monoclonal Antibody (K88-HRP Conjugate); Lot # IRP 597 BBDAT0132 108 Apr 18, 2014 Aug 13, 2014
Escherichia coli harboring the pMyco plasmid (E. coli/pMyco); Lot # 091510B BBDAT0135 86 Apr 18, 2014 Aug 13, 2014
Acholeplasma laidlawii Lot # 17Apr12-AL BBDAT0138 14 Apr 18, 2014 Aug 13, 2014
Mycoplasma fermentans Lot # 17Apr12-MF BBDAT0139 14 Apr 18, 2014 Aug 13, 2014
Mycoplasma hyorhinis Lot # 16Apr12 BBDAT0140 14 Apr 18, 2014 Aug 13, 2014
Mycoplasma orale Lot # 18Apr12 BBDAT0141 14 Apr 18, 2014 Aug 13, 2014
Mycoplasma synoviae Lot # 17Apr12-MS BBDAT0142 14 Apr 18, 2014 Aug 13, 2014
Clostridium septicum Antitoxin Lot # IRP 600 BBDAT0144 128 Apr 18, 2014 Aug 13, 2014
Salmonella typhimurium Challenge Culture; Lot # IRP STC Serial #6 BBDAT0057 27 Aug 5, 2014 Aug 13, 2014
Pasteurella multocida (bovine) Challenge Culture; Lot # IRP 471 BBDAT0058 13 Aug 5, 2014 Aug 13, 2014
Pasteurella multocida, Avian Type 4 Challenge Culture; Lot # IRP 551-07 BBDAT0126 13 Aug 7, 2014 Aug 13, 2014
Salmonella typhimurium Challenge Culture; Lot # IRP 596 BBDAT0134 13 Aug 12, 2014 Aug 13, 2014
Avian Lymphoid Leukosis Virus Type A Positive Control (PC); Lot # 12-02 VIRDAT1220 15 Oct 01, 2014 Oct 03, 2014
Avian Lymphoid Leukosis Virus Type B Positive Control (PC); Lot # 11-14 VIRDAT1221 15 Oct 01, 2014 Oct 03, 2014
Other
Title ID Size (KB) Publication Date Posted Date
PEL Policy Manual - Dilution of Preservative Studies (Section 4.1.5) -- -- Aug 1, 2014 Aug 1, 2014
PEL Policy Manual - Using Software to Estimate Relative Potency (Section 4.6.2) -- -- Aug 18, 2014 Aug 22, 2014
PEL Policy Manual - Conditional Licenses (Section 3.2) -- -- Sep 22, 2014 Sep 29, 2014
PEL Policy Manual - Diagnostic Test Kits (Section 4.7) -- -- Oct 02, 2014 Oct 03, 2014
IC Manual - Inspection Techniques & Report Citing of 9 CFR 148(d) & 102.5(c)(1) (Section 3.3.6) -- -- Sep 04, 2014 Oct 03, 2014
Current Veterinary Biologics Product Catalogue -- 221 Oct 06, 2014 Oct 07, 2014
IC Manual - Serial Spec Sheets (formerly known as Mocks) (Section 6.2.18) -- -- Aug 27, 2014 Oct 10, 2014
Center for Veterinary Biologics Reagent Catalog -- 121 Oct 16, 2014 Oct 16, 2014


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