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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 15-01 26 Jan 15, 2015 Jan 16, 2015
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
Veterinary Services Memorandums (new or revised)
Title ID Size (KB) Publication Date Posted Date
General Guidance for Test Kits Intended for the Diagnosis of Animal Diseases 800.73 98 Jan 06, 2015 Jan 13, 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 Titration of Neutralizing Antibody (Constant Virus-Varying Serum Method) 106 182 Oct 16, 2014 Jan 12, 2015
Supplemental Assay Method for the Detection of Extraneous Bovine Viral Diarrhea Virus in Modified-Live Vaccines 108 189 Oct 16, 2014 Jan 12, 2015
Supplemental Assay Method for Titration of Canine Distemper Virus in Primary Cell Culture 302 213 Oct 29, 2014 Jan 12, 2015
Supplemental Assay Method for the Titration of Distemper Virus in Embryonated Chicken Eggs 303 207 Oct 30, 2014 Jan 13, 2015
Supplemental Assay Method for Titration of Infectious Canine Hepatitis Virus in Primary Canine Kidney Cell Culture 304 206 Oct 30, 2014 Jan 13, 2015
Supplemental Assay Method for the Titration of Feline Panleukopenia Virus in Cell Culture 305 209 Oct 30, 2014 Jan 13, 2015
Supplemental Assay Method for the Titration of Feline Rhinotracheitis Virus in Cell Culture 307 155 Oct 30, 2014 Jan 13, 2015
Supplemental Assay Method for Titration of Chlamydophila felis (formerly Feline Chlamydia psittaci) in Embryonated Chicken Eggs 320 145 Nov 20, 2014 Jan 13, 2015
Supplemental Assay Method for Titration of Parainfluenza 3 Neutralizing Antibody (Constant Virus – Varying Serum Method) 113 276 Oct 16, 2014 Jan 16, 2015
Supplemental Assay Method for the Titration of Feline Calicivirus in Cell Culture 306 179 Oct 30, 2014 Jan 16, 2015
Supplemental Assay Method for Titration of Canine Parainfluenza Virus in Vero Cell Culture 309 215 Oct 30, 2014 Jan 16, 2015
Supplemental Assay Method for the Detection of Extraneous Cytopathogenic Agents in Master Seed Virus 312 124 Oct 30, 2014 Jan 16, 2015
Supplemental Assay Method for Titration of Chlamydophila felis (formerly Feline Chlamydia psittaci) in Cell Culture 319 307 Nov 13, 2014 Jan 16, 2015
Supplemental Assay Method for Identification of Vaccine Strains of Newcastle Disease Virus 802 144 Nov 28, 2014 Jan 20, 2015
Supplemental Assay Method for Titrating the Fractions of Combination Avian Encephalomyelitis/Pox Vaccine 409 123 Nov 28, 2014 Jan 20, 2015
Supplemental Assay Method for Titration of Canine Distemper Virus in Vero Cell Culture 323 205 Nov 20, 2014 Jan 20, 2015
Supplemental Assay Method for Titration of Monovalent, Cell Associated Marek’s Disease Vaccines of Serotypes 1,2, or 3 406 223 Nov 20, 2014 Jan 30, 2015
Supplemental Assay Method for Titration of Marek’s Serotype 3 (Herpesvirus of Turkeys Strain FC-126), Lyophilized 407 201 Nov 20, 2014 Jan 30, 2015
Supplemental Assay Method for Titrating Tissue Culture Adapted Vaccine Strains of Infectious Bursal Disease Virus 408 124 Nov 28, 2014 Jan 30, 2015
Supplemental Assay Method for the Titration of Newcastle Disease Vaccine, Infectious Bronchitis Vaccine, and Combination Newcastle Disease-Infectious Bronchitis Vaccine in Chicken Embryos 411 132 Nov 28, 2014 Jan 30, 2015
Supplemental Assay Method for Examination of Porcine Cells for Porcine Parvovirus Contamination 801 160 Nov 28, 2014 Jan 30, 2015
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
Bacterial Plate Count of Erysipelothrix rhusiopathiae Vaccines 612 126 Feb 05, 2015 Feb 20, 2015
Titration of Pseudorabies Virus Neutralizing Antibody (Constant Virus - Varying Serum Method) 119 172 Jan 09, 2015 Feb 20, 2015
Quantitating the GP70 Antigen of Feline Leukemia Virus in Veterinary Vaccines 321 165 Jan 09, 2015 Feb 20, 2015
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
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
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
Other
Title ID Size (KB) Publication Date Posted Date
Current Veterinary Biologics Product Catalogue -- 221 Jan 07, 2015 Jan 07, 2015
PEL Policy Manual - Antibody Products (Section 4.8) -- -- Dec 09, 2014 Jan 30, 2015
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
Current SAMs -- 117 Mar 24, 2015 Mar 25, 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


Additional Information