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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
Recognized ISO 15223-1 Symbols on Labeling for Diagnostic Test Kits 15-02 80 Mar 06, 2015 Mar 09, 2015
Adjustment for Clostridium perfringens Type C and Type D Reagents 15-03 30 Mar 27, 2015 Mar 31, 2015
Veterinary Biological Products in Licensed Establishments Produced and Destroyed 01/01/2014 through 12/31/2014 82 73 Mar 19, 2015 Mar 31, 2015
Nomenclature and Level of Identification Required for Leptospira Master Seed Bacteria and Challenge Cultures 15-04 45 Apr 02, 2015 Apr 06, 2015
Issuance of Licenses 15-05 34 Apr 10, 2015 Apr 10, 2015
Veterinary Services Memorandums (new or revised)
Title ID Size (KB) Publication Date Posted Date
Guidelines for Validation of In Vitro Potency Assays 800.112 88 Apr 10, 2015 Apr 22, 2015
Export Certificates and Certificates of Licensing and Inspection for Animal Biological Products 800.52 216 Mar 19, 2015 Apr 24, 2015
Licensing Guidelines for Production Platform-Based, Non-Replicating, Nonviable Products 800.213 49 Apr 29, 2015 Apr 29, 2015
Rulemaking
Title FR Citation Size (KB) Effective Date Posted Date
         
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 Detecting Lymphoid Leukosis Biocontamination by the COFAL Test 405 413 Nov 28, 2014 Feb 03, 2015
Supplemental Assay Method for Examination of Trypsin Solutions for Porcine Parvovirus Contamination 803 159 Nov 28, 2014 Feb 03, 2015
Supplemental Assay Method for Bacterial Plate Count of Erysipelothrix rhusiopathiae Vaccines 612 126 Feb 05, 2015 Feb 20, 2015
Supplemental Assay Method for Titration of Pseudorabies Virus Neutralizing Antibody (Constant Virus - Varying Serum Method) 119 172 Jan 09, 2015 Feb 20, 2015
Supplemental Assay Method for Quantitating the GP70 Antigen of Feline Leukemia Virus in Veterinary Vaccines 321 165 Jan 09, 2015 Feb 20, 2015
Supplemental Assay Method for Determination of the Specific Viral Antigen Content in Inactivated Canine Coronavirus Vaccines 322 213 Jan 09, 2015 Feb 20, 2015
Supplemental Assay Method for Testing Growth-Promoting Qualities of Brain Heart Infusion Agar using Bacillus subtilis Spores and Issatchenkia orientalis as Indicator Organisms 902 159 Feb 25, 2015 Mar 16, 2015
Supplemental Assay Method for the Detection of Serum Neutralizing Antibodies to Rabies Virus using the Rapid Fluorescent Focus Inhibition Test (RFFIT) 315 181 Nov 13, 2014 Mar 25, 2015
Supplemental Assay Method for Testing Growth Promoting Qualities of Fluid Thioglycollate Medium and Soybean-Casein Digest Medium using Bacillus subtilis Spores and Issatchenkia orientalis as the Indicator Organisms 900 249 Mar 19, 2015 Apr 06, 2015
Supplemental Assay Method for Testing Growth-Promoting Qualities of Fluid Thioglycollate Medium with Beef Extract Using Clostridium chauvoei Spores as the Indicator Organism 901 178 Mar 19, 2015 Apr 10, 2015
Testing Protocols (PROs)
Title ID Size (KB) Document Date Posted Date
Polymerase Chain Reaction Assay for Detection and Identity of Extraneous Reticuloendotheliosis Virus (REV) VIRPRO0119 248 Jan 09, 2015 Feb 20, 2015
Neutralization and Passage of Master Seed in Cell Cultures VIRPRO1013 453 Jan 09, 2015 Mar 06, 2015
Potency Testing of Clostridium chauvoei Bacterins using an ELISA Procedure BBPRO0220 137 Mar 19, 2015 Apr 06, 2015
Reagent Data Sheets (DATs)
Title ID Size (KB) Publication Date Posted Date
Clostridium perfringens Type D (epsilon) Antitoxin; Lot #IRP 249 BBDAT0024 14 Feb 3, 2015 Feb 13, 2015
Clostridium perfringens Type D (epsilon) Toxin; Lot #IRP 450 BBDAT0050 16 Feb 3, 2015 Feb 13, 2015
Clostridium perfringens Type C (beta) Antitoxin; Lot # IRP 585-A BBDAT0131 94 Feb 3, 2015 Feb 13, 2015
Clostridium haemolyticum spore preparation BBDAT0116 84 Feb 11, 2015 Feb 20, 2015
Pasteurella multocida (bovine) Challenge Culture BBDAT0145 12 Jan 04, 2012 May 01, 2015
Clostridium chauvoei Flagella-specific (7D11/Yd7) Monoclonal Antibody (MAb) BBDAT1033 12 Jun 16, 2014 May 01, 2015
Erysipelothrix rhusiopathiae Rabbit Polyclonal Antibody (detection antibody) BBDAT0047 20 Apr 09, 2010 May 01, 2015
Escherichia coli, Anti F41 Pilus Polyclonal Antibody (F41 PAb) BBDAT0087 20 Apr 09, 2010 May 01, 2015
Other
Title ID Size (KB) Publication Date Posted Date
IC Manual - Processing CVB Reference and Reagent Test Reports (Section 6.10.2) -- -- Jan 14, 2015 Feb 9, 2015
IC Manual - Delegation of Authority for Center for Veterinary Biologics-Inspection and Compliance (Section 2.3) -- -- Apr 25, 2014 Feb 13, 2015
IC Manual - Tests Requested to Assist Investigations – Processes and Responsibilities (Section 4.4) -- -- May 30, 2014 Feb 13, 2015
IC Manual - Serials Ready for Conditional Action (Section 6.2.1) -- -- Apr 25, 2013 Feb 13, 2015
IC Manual - Specialist Review Action within LSRTIS (Section 6.2.19) -- -- Dec 17, 2014 Feb 17, 2015
IC Manual - Ready for Signature Action in LSRTIS (Specialist and BCA duties) (Section 6.2.20) -- -- Dec 17, 2014 Feb 17, 2015
IC Manual - Inspection Report – Closing Action Items in LSRTIS (Section 3.5.5) -- -- Dec 17, 2014 Feb 17, 2015
IC Manual - Program Coordinator Duties (Section 15.11) -- -- Feb 06, 2015 Feb 17, 2015
IC Manual - CVB Inspection and Compliance Procedure for Generating Case Summaries from PV Works System (Section 5.1.4) -- -- Nov 06, 2014 Feb 17, 2015
IC Manual - Review of Work Instructions for Inspection and Compliance (Section 19.13) -- -- Dec 24, 2014 Feb 17, 2015
IC Manual - Tracking Customer Service Using LRTIS Phone Log (Section 19.2.12) -- -- Feb 05, 2015 Feb 17, 2015
Using Software to Estimate Relative Potency CVBSOP0102 342 Feb 09, 2015 Feb 20, 2015
PEL Policy Manual - Study Protocols (Section 4.3) -- -- Feb 11, 2015 Mar 06, 2015
Electronic Submission Guidance -- 79 Mar 10, 2015 Mar 12, 2015
PEL Policy Manual - Master Seeds/Cells/Sequences (Section 4.13) -- -- Feb 27, 2015 Mar 16, 2015
PEL Policy Manual - Using Software to Estimate Relative Potency (Section 4.6.2) -- -- Mar 19, 2015 Mar 31, 2015
PEL Policy Manual - Labels (Section 4.2) -- -- Mar 26, 2015 Mar 31, 2015
PEL Policy Manual - Product Licensing Plans (Section 1.5) -- -- Mar 27, 2015 Apr 1, 2015
Current Veterinary Biologics Product Catalogue -- 240 Apr 09, 2015 Apr 10, 2015
Current SAMs -- 117 Apr 09, 2015 Apr 10, 2015
Currently Licensed Biologics for Aquatic Animals -- 87 Apr 08, 2015 Apr 10, 2015
VS 800 series Memoranda and CVB Notices - Historical Summary of Proposed Documents -- 62 Apr 09, 2015 Apr 10, 2015
PEL Policy Manual - Animal Safety Testing Exemption (Section 4.5.1) -- -- Apr 02, 2015 Apr 13, 2015
Center for Veterinary Biologics Reagents Catalog -- 121 Apr 21, 2015 Apr 22, 2015
CVB-Inspection and Compliance (IC) Organization Chart -- 179 Jan 01, 2015 Apr 24, 2015
CVB-Policy, Evaluation and Licensing (PEL) Organization Chart -- 197 Jan 11, 2015 May 01, 2015
CVB Management Organization Chart -- 191 Jan 11, 2015 May 01, 2015
CVB Administration Organization Chart -- 106 Feb 08, 2015 May 01, 2015
2015 Potency Policy Workshop – CVB Presentations -- -- Apr 28-29, 2015 May 1, 2015
PEL Policy Manual - Master Seeds/Cells/Sequences (Section 4.13) -- -- Apr 24, 2015 May 01, 2015


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