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Veterinary Biologics Information Published in the Last 90 Days

All documents are in PDF format.

CVB Notices
Title ID Size (KB) Publication Date Posted Date
Change in Distribution Policy for Memoranda and Notices 14-10 21 Jun 5, 2014  
Availability of Porcine Delta Coronavirus Isolate 14-11 25 Jun 5, 2014  
Issuance of a Conditional License for Porcine Epidemic Diarrhea Vaccine 14-12 21 Jun 16, 2014  
Issuance of Licenses 14-13 50 Jul 28, 2014  
Veterinary Services Memorandums (new or revised)
Title ID Size (KB) Publication Date Posted Date
Standard Reference Preparations, Test Reagents, and Seed Cultures for Laboratory Test Reagents 800.97 27 Jun 12, 2014  
General Licensing Consideration: Study Practices and Documentation 800.200 74 Jun 12, 2014  
Release of Biological Products 800.53 124 Jun 27, 2014  
Dilution of Preservative Screening for Sterility Testing of Veterinary Biologics 800.120 39 Jun 27, 2014  
Rulemaking
Title FR Citation Size (KB) Effective Date Posted Date
In Vitro Tests for Serial Release APHIS-2013-33 197 May 30, 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
Supplemental Assay Method for Potency Testing Clostridium perfringens Type C Beta Antigen 201 139 Jun 12, 2014  
Supplemental Assay Method for Potency Testing Clostridium perfringens Type C Beta Antitoxins 202 134 Jun 18, 2014  
Supplemental Assay Method for Potency Testing Tetanus Antitoxins 206 158 Jun 12, 2014  
Supplemental Assay Method for Potency Testing of Erysipelas Bacterins in Mice 611 185 Jun 18, 2014  
Supplemental Assay Method for Potency Testing Clostridium novyi Type B Alpha Antigen 207 235 Jun 25, 2014  
Testing Protocols (PROs)
Title ID Size (KB) Document Date Posted Date
Potency Testing of Clostridium chauvoei Bacterins using an ELISA Procedure BBPRO0220 137 Apr 17, 2014  
Detection of Pathogens by the Inoculation Test in Embryonated Chicken Eggs VIRPRO1017 115 Aug 9, 2013  
Detection of Hemagglutinating Viruses VIRPRO0096 447 Jul 17, 2014 Aug 29, 2014
Reagent Data Sheets (DATs)
Title ID Size (KB) Publication Date Posted Date
Clostridium chauvoei Spore Preparation, Lot # IRP 509 (4) BBDAT0079 97 May 21, 2014 May 27, 2014
Clostridium perfringens type C (beta) toxin, Lot # IRP 513 (04) BBDAT0080 17 May 21, 2014 May 27, 2014
Erysipelothrix rhursiopathiae Challenge Culture, Lot # IRP ERC Serial #4 BBDAT0084 14 May 21, 2014 May 27, 2014
Leptospira grippotyphosa Reference Bacterin, IRP 523 (05) BBDAT0088 15 May 21, 2014 May 27, 2014
Leptospira icterohaemorrhagiae Reference Bacterin, Lot # IRP 542 (06) BBDAT0089 16 May 21, 2014 May 27, 2014
Leptospira pomona Master Reference Bacterin, Lot #IRP 524 (05) BBDAT0092 15 May 21, 2014 May 27, 2014
Leptospira canicola Master Reference Bacterin, Lot #82518 BBDAT0093 16 May 21, 2014 May 27, 2014
Leptospira pomona Monoclonal Antibody (LP MAb), Lot # IRP 04-476 BBDAT0094 13 May 21, 2014 May 27, 2014
Leptospira icterohaemorrrhagiae Polyclonal Antibody (LI PAb), Lot #IRP 04-481 BBDAT0096 81 May 21, 2014 May 27, 2014
Leptospira pomona Polyclonal Antibody (LP PAb), Lot # IRP 04-482 BBDAT0097 81 May 21, 2014 May 27, 2014
Leptospira canicola Polyclonal Antibody (LC PAb); Lot # IRP 4 BBDAT0099 80 Apr 18, 2014 Jul 3, 2014
Leptospira canicola Monoclonal Antibody (LC MAb); Lot # IRP 04-500 BBDAT0100 13 Apr 18, 2014 Jul 3, 2014
Leptospira pomona Monoclonal Antibody (LP MAb); Lot # IRP 04-504 BBDAT0101 12 Jun 5, 2014 Jul 3, 2014
Leptospira grippotyphosa Monoclonal Antibody (LG MAb) Lot # IRP 04-505 BBDAT0102 13 Apr 18, 2014 Jul 3, 2014
Leptospira icterohaemorrhagiae Monoclonal Antibody (LI MAb); Lot # IRP 04-506 BBDAT0103 13 Apr 18, 2014 Jul 3, 2014
Escherichia coli Anti-K99 Pilus Monoclonal Antibody (K99 MAb); Lot # IRP 557 907 BBDAT0104 13 Apr 18, 2014 Jul 3, 2014
Clostridium perfringens Type A (alpha) Antitoxin; Lot # IRP 538 (06) BBDAT0105 15 Apr 18, 2014 Jul 3, 2014
Clostridium perfringens Type A (alpha) toxin; Lot # IRP 560-07 BBDAT0106 133 Apr 18, 2014 Jul 3, 2014
Clostridium novyi Type B Toxin; Lot # IRP 581 BBDAT0111 86 Apr 18, 2014 Jul 3, 2014
Escherichia coli Anti-K88 Pilus Monoclonal Antibody (K88 MAb); Lot # IRP 499-05 BBDAT0112 107 Apr 18, 2014 Jul 3, 2014
Negative Guinea Pig Serum; Lot # IRP 550 (07) BBDAT0113 83 Apr 18, 2014 Jul 3, 2014
Escherichia coli Anti-987P Pilus Polyclonal Antibody (987P PAb); Lot # IRP 534-06 BBDAT0114 13 Apr 18, 2014 Jul 3, 2014
Pasteurella multocida Type A Standard Reference Bacterin; Lot # IRP 573 (08) BBDAT0115 13 Apr 18, 2014 Jul 3, 2014
Clostridium haemolyticum spore preparation; Lot # IRP 526 (06) BBDAT0116 84 Apr 18, 2014 Jul 3, 2014
Chicken Anemia Virus DNA Positive Control; Lot #11-10 VIRDAT0069 13 Apr 15, 2014 Jul 3, 2014
Fowl Laryngotracheitis Challenge Virus; Lot #07-3 VIRDAT1214 39 Apr 15, 2014 Jul 3, 2014
Avian Lymphoid Leukosis Virus Type A Positive Control (PC); Lot # 12-02 VIRDAT1220 16 Apr 15, 2014 Jul 3, 2014
Avian Lymphoid Leukosis Virus Type B Positive Control (PC); Lot # 11-14 VIRDAT1221 17 Apr 15, 2014 Jul 3, 2014
Rabies challenge, fox salivary gland origin; Lot #92-5 VIRDAT1083 86 Apr 8, 2014 Jul 3, 2014
Veterinary Rabies Reference Vaccine, killed virus; Lot # 08-14 VIRDAT1212 128 Apr 8, 2014 Jul 3, 2014
Rabies challenge, fox salivary gland origin; Lot # 92-5A VIRDAT1219 13 Apr 8, 2014 Jul 3, 2014
Ersipelothrix rhusiopathiae Anti-65 kD Protein Monoclonal Antibody (ERHU MAb); Lot IRP 569-08 BBDAT0118 13 Apr 18, 2014 Jul 16, 2014
Leptospira grippotyphosa Polyclonal Antibody (LG PAb); Lot IRP 511-04 BBDAT0119 81 Apr 18, 2014 Jul 16, 2014
Escherichia coli Anti-K88 Pilus Horseradish Peroxidase (HRP)-Labeled Monoclonal Antibody (K88-HRP Conjugate); Lot IRP 589 BBDAT0123 108 Apr 18, 2014 Jul 16, 2014
Clostridium tetani Toxin; Lot IRP 588 BBDAT0124 97 Apr 18, 2014 Jul 16, 2014
Mycobacterium Tuberculosis Sensitinogen; Lot MTS-3 1001 BBDAT0127 54 Apr 18, 2014 Jul 16, 2014
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
Other
Title ID Size (KB) Publication Date Posted Date
Inspection and Compliance (IC) Manual - IC Pre-Inspection Packet Checklist (Section 3.2.6) -- --   May 28, 2014
Inspection and Compliance (IC) Manual - Product Sampling (Section 7) -- --   May 28, 2014
Inspection and Compliance (IC) Manual - APHIS Mandated Stop Distribution and Sale Procedures (Section 14.3) -- --   May 28, 2014
PEL Policy Manual - Exemptions to the Virus-Serum-Toxin Act (Section 3.3) -- --   May 30, 2014
PEL Policy Manual - Diagnostic Test Kits (Section 4.7) -- --   Jun 3, 2014
Inspection and Compliance (IC) Manual - Legal Hold Release Document (Section 19.6) -- --   Jun 4, 2014
PEL Policy Manual - Potency Test References - introduction to terminology (Section 4.6.1) -- --   Jun 6, 2014
Data for Statistics Template - General.zip -- 360   Jun 10, 2014
PEL Policy Manual - Efficacy Studies (Section 4.4) -- --   May 27, 2014
Inspection and Compliance (IC) Manual - Creating Certificates of Licensing and Inspection in LSRTIS Phase III (Section 18.3) -- --   May 19, 2014
CVB Organizational Charts - Assistant Director, Administration Unit and Inspection and Compliance (IC) Organizational Charts -- --   Jun 26, 2014
PEL Policy Manual - Using Software to Estimate Relative Potency (Section 4.6.2) -- --   Jun 26, 2014
Submittal Template for MS Word for PC for Electronic Submissions to PEL -- 43   Jul 10, 2014
Current Veterinary Biologics Product Catalogue -- 177   Jul 11, 2014
Current SAMs -- 118   Jul 15, 2014
PEL Policy Manual - Dilution of Preservative Studies (Section 4.1.5) -- -- Aug 1, 2014 Aug 1, 2014
Center for Veterinary Biologics Reagent Catalog -- 122 Aug 15, 2014 Aug 18, 2014
PEL Policy Manual - Using Software to Estimate Relative Potency (Section 4.6.2) -- -- Aug 18, 2014 Aug 22, 2014


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