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Newly Published Information

Veterinary Biologics Information Published in the Last 90 Days

All documents are in PDF format.

CVB Notices
Title ID Size (KB) Publication Date
Change in Distribution Policy for Memoranda and Notices 14-10 21 June 5, 2014
Availability of Porcine Delta Coronavirus Isolate 14-11 25 June 5, 2014
Issuance of a Conditional License for Porcine Epidemic Diarrhea Vaccine 14-12 21 June 16, 2014
Veterinary Services Memorandums (new or revised)
Title ID Size (KB) Publication Date
Standard Reference Preparations, Test Reagents, and Seed Cultures for Laboratory Test Reagents 800.97 27 June 12, 2014
General Licensing Consideration: Study Practices and Documentation 800.200 74 June 12, 2014
Release of Biological Products 800.53 124 June 27, 2014
Dilution of Preservative Screening for Sterility Testing of Veterinary Biologics 800.120 39 June 27, 2014
Rulemaking
Title FR Citation Size (KB) Effective Date
In Vitro Tests for Serial Release APHIS-2013-33 197 May 30, 2014
Proposed Rulemaking
Title Federal Register Vol/Page Publication Date
Viruses, Serums, Toxins, and Analogous Products; Standard Requirements; Addition of Terminology To Define Veterinary Biologics Test Results [Docket No. APHIS-2013-0034] Vol. 79, No. 104 Page 31054 - 31056 Comments Due July 29, 2014
Supplemental Assay Methods (SAMs)
Title ID Size (KB) Document Date
Supplemental Assay Method for Titration of Feline Calicivirus in Cell Culture 306 179 May 20, 2014
Supplemental Assay Method for Titration of Feline Calicivirus in Cell Culture 306 179 May 20, 2014
Supplemental Assay Method for Titration of Feline Rhinotracheitis Virus in Cell Culture 307 155 May 20, 2014
Supplemental Assay Method for Titrating Tissue Culture Adapted Vaccine Strain of Infectious Bursal Disease Virus 408 123 May 20, 2014
Supplemental Assay Method for Potency Testing Clostridium perfringens Type C Beta Antigen 201 139 June 12, 2014
Supplemental Assay Method for Potency Testing Clostridium perfringens Type C Beta Antitoxins 202 134 June 18, 2014
Supplemental Assay Method for Potency Testing Tetanus Antitoxins 206 158 June 12, 2014
Supplemental Assay Method for Potency Testing of Erysipelas Bacterins in Mice 611 185 June 18, 2014
Supplemental Assay Method for Potency Testing Clostridium novyi Type B Alpha Antigen 207 235 June 25, 2014
Testing Protocols (PROs)
Title ID Size (KB) Document Date
Potency Testing of Clostridium chauvoei Bacterins using an ELISA Procedure BBPRO0220 137 Apr 17, 2014
Detection of Hemagglutinating Viruses VIRPRO0096 455 Jun 5, 2014
Detection of Pathogens by the Inoculation Test in Embryonated Chicken Eggs VIRPRO1017 115 Aug 9, 2013
Reagent Data Sheets (DATs)
Title ID Size (KB) Date Posted
Pasteurella multocida Standard Reference Bacterin, IRP PMA 1062 Serial 2 BBDAT0005 12 Apr 16, 2014
Erysipelothrix rhusiopathiae Reference Bacterin; Lot IRP 529 (05) BBDAT1012 15 Apr 24, 2014
Pasteurella multocida, Avian Type 1 Challenge Culture; Lot # IRP P1C Serial 3 BBDAT0002 81 Apr 24, 2014
Salmonella choleraesuis Challenge Culture; Lot # IRP SCC Serial #5 BBDAT0007 12 Apr 24, 2014
Leptospira canicola Challenge Culture BBDAT0008 13 Apr 24, 2014
Leptospira grippotyphosa Challenge Culture BBDAT0010 13 Apr 24, 2014
Leptospira icterohaemorrhagiae Challenge Culture BBDAT0013 13 Apr 24, 2014
Leptospira Pomona Challenge Culture BBDAT0015 13 Apr 24, 2014
Pasteurella multocida, Avian Isolate, Type 3 Challenge Culture; Lot # IRP 04-503 BBDAT0016 27 Apr 24, 2014
Clostridium septicum Antitoxin; Lot # IRP 228 BBDAT0021 59 Apr 24, 2014
Clostridium perfringens Type D (epsilon) Antitoxin; Lot # IRP 249 BBDAT0024 14 Apr 24, 2014
Clostridium sordellii Challenge Culture; Lot # IRP 313 BBDAT0030 14 May 09, 2014
Equine Negative Serum; Lot # IRP 319 BBDAT0032 81 May 09, 2014
Clostridium botulinum Type C Toxin; Lot # IRP 421 BBDAT0034 16 May 09, 2014
Clostridium botulinum Type C Antitoxin; Lot # IRP 428 BBDAT0037 82 May 09, 2014
Clostridium botulinum Type B Toxin; Lot # IRP 430 BBDAT0039 31 May 09, 2014
Clostridium botulinum type b antitoxin; Lot # IRP 435 BBDAT0042 87 May 09, 2014
Clostridium chauvoei Flagella-specific Rabbit Polyclonal Antibody (detection antibody); Lot # IRP 440 BBDAT0045 12 May 09, 2014
Clostridium chauvoei Flagella-specific Monoclonal Antibody (MAb); Lot # IRP 441 BBDAT0046 12 May 09, 2014
Clostridium tetani Antitoxin, 500 AU/mL; Lot # IRP 445 BBDAT0048 13 May 09, 2014
Clostridium perfringens type D (epsilon) toxin; Lot # IRP 450 BBDAT0050 16 May 09, 2014
Clostridium septicum (alpha) Toxin; Lot # IRP 455 BBDAT0052 86 May 09, 2014
Clostridium tetani HRP-labeled Monoclonal Antibody (Tetanus conjugate); Lot # IRP 458 BBDAT0053 62 May 09, 2014
Salmonella dublin challenge culture; Lot # IRP SDC Serial #5 BBDAT0054 14 May 09, 2014
Clostridium tetani Antitoxin 5.0 AU/mL (guinea pig origin); Lot # IRP 466 BBDAT0056 13 May 09, 2014
Escherichia coli Anti-987P Pilus Monoclonal Antibody (987P MAb); Lot # IRP 475 BBDAT0062 13 May 09, 2014
Clostridium novyi Type B (alpha) Antitoxin; Lot # IRP 507 (04) BBDAT0065 15 May 09, 2014
Pasteurella multocida, 169 (Swine) Challenge Culture; Lot # IRP 490 BBDAT0067 84 May 09, 2014
Clostridium sordellii toxin; Lot # IRP 497 BBDAT0071 86 May 09, 2014
Clostridium botulinum Type C Toxin; Lot # IRP 583 BBDAT0137 177 May 09, 2014
Clostridium chauvoei Spore Preparation, Lot # IRP 509 (4) BBDAT0079 97 May 21, 2014
Clostridium perfringens type C (beta) toxin, Lot # IRP 513 (04) BBDAT0080 17 May 21, 2014
Erysipelothrix rhursiopathiae Challenge Culture, Lot # IRP ERC Serial #4 BBDAT0084 14 May 21, 2014
Leptospira grippotyphosa Reference Bacterin, IRP 523 (05) BBDAT0088 15 May 21, 2014
Leptospira icterohaemorrhagiae Reference Bacterin, Lot # IRP 542 (06) BBDAT0089 16 May 21, 2014
Leptospira pomona Master Reference Bacterin, Lot #IRP 524 (05) BBDAT0092 15 May 21, 2014
Leptospira canicola Master Reference Bacterin, Lot #82518 BBDAT0093 16 May 21, 2014
Leptospira pomona Monoclonal Antibody (LP MAb), Lot # IRP 04-476 BBDAT0094 13 May 21, 2014
Leptospira icterohaemorrrhagiae Polyclonal Antibody (LI PAb), Lot #IRP 04-481 BBDAT0096 81 May 21, 2014
Leptospira pomona Polyclonal Antibody (LP PAb), Lot # IRP 04-482 BBDAT0097 81 May 21, 2014
Leptospira canicola Polyclonal Antibody (LC PAb); Lot # IRP 4 BBDAT0099 80 Apr 18, 2014
Leptospira canicola Monoclonal Antibody (LC MAb); Lot # IRP 04-500 BBDAT0100 13 Apr 18, 2014
Leptospira pomona Monoclonal Antibody (LP MAb); Lot # IRP 04-504 BBDAT0101 12 Jun 5, 2014
Leptospira grippotyphosa Monoclonal Antibody (LG MAb) Lot # IRP 04-505 BBDAT0102 13 Apr 18, 2014
Leptospira icterohaemorrhagiae Monoclonal Antibody (LI MAb); Lot # IRP 04-506 BBDAT0103 13 Apr 18, 2014
Escherichia coli Anti-K99 Pilus Monoclonal Antibody (K99 MAb); Lot # IRP 557 907 BBDAT0104 13 Apr 18, 2014
Clostridium perfringens Type A (alpha) Antitoxin; Lot # IRP 538 (06) BBDAT0105 15 Apr 18, 2014
Clostridium perfringens Type A (alpha) toxin; Lot # IRP 560-07 BBDAT0106 133 Apr 18, 2014
Clostridium novyi Type B Toxin; Lot # IRP 581 BBDAT0111 86 Apr 18, 2014
Escherichia coli Anti-K88 Pilus Monoclonal Antibody (K88 MAb); Lot # IRP 499-05 BBDAT0112 107 Apr 18, 2014
Negative Guinea Pig Serum; Lot # IRP 550 (07) BBDAT0113 83 Apr 18, 2014
Escherichia coli Anti-987P Pilus Polyclonal Antibody (987P PAb); Lot # IRP 534-06 BBDAT0114 13 Apr 18, 2014
Pasteurella multocida Type A Standard Reference Bacterin; Lot # IRP 573 (08) BBDAT0115 13 Apr 18, 2014
Clostridium haemolyticum spore preparation; Lot # IRP 526 (06) BBDAT0116 84 Apr 18, 2014
Chicken Anemia Virus DNA Positive Control; Lot #11-10 VIRDAT0069 13 Apr 15, 2014
Fowl Laryngotracheitis Challenge Virus; Lot #07-3 VIRDAT1214 39 Apr 15, 2014
Avian Lymphoid Leukosis Virus Type A Positive Control (PC); Lot # 12-02 VIRDAT1220 16 Apr 15, 2014
Avian Lymphoid Leukosis Virus Type B Positive Control (PC); Lot # 11-14 VIRDAT1221 17 Apr 15, 2014
Rabies challenge, fox salivary gland origin; Lot #92-5 VIRDAT1083 86 Apr 8, 2014
Veterinary Rabies Reference Vaccine, killed virus; Lot # 08-14 VIRDAT1212 128 Apr 8, 2014
Rabies challenge, fox salivary gland origin; Lot # 92-5A VIRDAT1219 13 Apr 8, 2014
Ersipelothrix rhusiopathiae Anti-65 kD Protein Monoclonal Antibody (ERHU MAb); Lot IRP 569-08 BBDAT0118 13 Apr 18, 2014
Leptospira grippotyphosa Polyclonal Antibody (LG PAb); Lot IRP 511-04 BBDAT0119 81 Apr 18, 2014
Escherichia coli Anti-K88 Pilus Horseradish Peroxidase (HRP)-Labeled Monoclonal Antibody (K88-HRP Conjugate); Lot IRP 589 BBDAT0123 108 Apr 18, 2014
Clostridium tetani Toxin; Lot IRP 588 BBDAT0124 97 Apr 18, 2014
Mycobacterium Tuberculosis Sensitinogen; Lot MTS-3 1001 BBDAT0127 54 Apr 18, 2014
Other
Title ID Size (KB) Publication Date
PEL Policy Manual - Establishment Licenses (Section 3.1) -- -- May 9, 2014
CVB Organizational Chart - PEL Organizational Chart -- -- May 9, 2014
VS 800 series Memoranda and CVB Notices - Historical Summary of Proposed Documents -- 56 May 12, 2014
PEL Policy Manual - Autogenous Biologics (Section 4.16) -- -- May 13, 2014
PEL Policy Manual - Final Steps for Licensure (Section 2.2) -- -- May 14, 2014
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
Center for Veterinary Biologics Reagent Catalog -- 122 Jun 27, 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


Additional Information