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Newly Published Information

Veterinary Biologics Information Published in the Last 90 Days

CVB Draft Guidance Documents for Comment
Title ID COMMENTS DUE DATE Posted Date
There are no documents for comment at this time


CVB Notices
Title ID Publication Date Posted Date
Issuance of Licenses
22-06 April 27, 2022 August 12, 2022
Issuance of Licenses
22-07 July 5, 2022 August 12, 2022
Review of Labels for Use in Countries that are Members or Observers of the Veterinary International Conference on Harmonization
22-08 August 19, 2022 August 26, 2022
Veterinary Services Memoranda (new or revised)
Title ID Publication Date Posted Date
Reissuance of Product Licenses for Products Under Conditional Licenses
800.75 July 14, 2022 July 19, 2022
Rulemaking
Title FR Citation Effective Date Posted Date
       
Proposed Rulemaking
Title Federal Register Vol/Page Comments Due Date Posted Date

 

Notices of Availability
Title Federal Register Vol/Page Comments Due Date Posted Date




Supplemental Assay Methods (SAMs)
Title ID Document Date Posted Date
Potency Testing of Tetanus Toxoid by ELISA 217 June 17, 2022 August 2, 2022
Determination of Phenol in Veterinary Biologics (pullorum antigen, Mycoplasma synoviae antigen, and Mycoplasma gallisepticum antigen) 500 June 16, 2022 August 2, 2022
Determination of Residual Moisture in Veterinary Biologics Products 502 June 17, 2022 August 2, 2022
Manual Determination of Protein Content of Veterinary Biologics (Biuret) 504 June 17, 2022 August 2, 2022
Determination of Protein and Phenol in PPD (Purified Protein Derivative Produced from Cultures of Mycobacterium bovis Strain AN-5) Bovis Tuberculin 513 June 17, 2022 August 2, 2022
Determination of Hydrogen Ion Concentration, Total Nitrogen, TCA Nitrogen, Phenol and Clarity in Intradermic (Filtrate Produced from Cultures of Pn, C, and Dt Strains of Mycobacterium tuberculosis) Tuberculin 514 June 17, 2022 August 2, 2022
Potency Testing of Fowl Cholera (Pasteurella multocida) Bacterins, Type 3 603 June 17, 2022 August 2, 2022
Evaluation of Koch's Old Tuberculin 604 June 17, 2022 August 2, 2022
Potency Testing of Fowl Cholera (Pasteurella multocida) Bacterins, Type 1 607 June 17, 2022 August 2, 2022
In vitro Potency Testing of Erysipelothrix rhusiopathiae Bacterins 613 June 17, 2022 August 2, 2022
Potency Testing of Fowl Cholera (Pasteurella multocida) Bacterins, Type 4 630 June 17, 2022 August 2, 2022
Potency Testing of Salmonella typhimurium Bacterins 631 June 17, 2022 August 2, 2022
Potency Testing of Salmonella choler aesuis Bacterins 632 June 17, 2022 August 2, 2022
Potency Testing of Salmonella dublin Bacterins 633 June 17, 2022 August 2, 2022
Evaluation of Tuberculin Purified Protein Derivative (PPD) 636 June 17, 2022 August 2, 2022
Testing Protocols (PROs)
Title ID Document Date Posted Date
Modified Potency Testing Protocol for Purified Protein Derivative (PPD) Tuberculins CVB-PRO-0001 May 25, 2022 June 25, 2022
Production of Chicken Anemia Virus (CAV) DNA Positive Control CVB-PP-0063 May 27, 2022 June 25, 2022
Polymerase Chain Reaction Assay for Detection and Identity of Extraneous Chicken Anemia Virus (CAV) DNA CVB-PRO-0027 July 12, 2022 August 5, 2022
Reagent Data Sheets (DATs)
Title Lot ID Publication Date Posted Date
Clostridium perfringens Type D (epsilon) Antitoxin
IRP 249 May 23, 2022
June 25, 2022
Standard Reference Mycobacterium Tuberculosis Tuberculin (Old Tuberculin
IRP 115B May 24, 2021
June 25, 2022
Clostridium tetani Antitoxin, 1.3 AU/mL
IRP 528 February 4, 2022
June 25, 2022
Clostridium perfringens Type A (alpha) toxin
IRP 612 October 10, 2018
June 25, 2022
Salmonella pullorum Stained K Polyvalent Plate Antigen
16-301 April 22, 2022
June 25, 2022
Leptospira canicola Challenge Culture
IRP 653 May 27, 2022
June 25, 2022
Pasteurella multocida Type A Bacterin (Bovine Isolate)
IRP 591 May 31, 2022
June 25, 2022
Clostridium septicum (alpha) toxin
IRP 688 April 28, 2022
June 25, 2022
Clostridium sordellii Toxin
IRP 675 January 16, 2020
June 25, 2022
Leptospira grippotyphosa Reference Bacterin
IRP 523 (05) July 11, 2022
August 5, 2022
Leptospira icterohaemorrhagiae Polyclonal Antibody (LI PAb)
IRP 04-481 July 11, 2022
August 5, 2022
Leptospira pomona Monoclonal Antibody (LP MAb)
IRP 04-504 July 11, 2022
August 5, 2022
Secondary Reference Serum-Equine IgG; Stock for Equine IgG Species Standard
10849 July 12, 2022
August 5, 2022
Leptospira icterohaemorrhagiae Challenge Culture
IRP 655 July 12, 2022
August 5, 2022
Clostridium chauvoei Flagella-specific Rabbit Polyclonal Antibody (detection antibody)
IRP 440 July 12, 2022
August 5, 2022
Escherichia coli Anti-F41 Pilus Monoclonal Antibody (F41 MAb)
IRP 04-508 July 12, 2022
August 5, 2022
Leptospira grippotyphosa Challenge Culture
IRP 656 July 12, 2022
August 5, 2022
Leptospira icterohaemorrhagiae Reference Bacterin
IRP 542 (06) July 12, 2022
August 5, 2022
Leptospira pomona Polyclonal Antibody (LP PAb)
IRP 04-482 July 12, 2022
August 5, 2022
Leptospira canicola Monoclonal Antibody (LC MAb)
IRP 04-500 July 12, 2022
August 5, 2022
Leptospira grippotyphosa Monoclonal Antibody (LG MAb)
IRP 04-505 July 12, 2022
August 5, 2022
Escherichia coli Anti-987P Pilus Polyclonal Antibody (987P PAb)
IRP 534-06 July 12, 2022
August 5, 2022
Leptospira canicola Polyclonal Antibody (LC PAb)
IRP 491 July 12, 2022
August 5, 2022
Clostridium perfringens type D (epsilon) toxin
IRP 632 July 12, 2022
August 5, 2022
Other
Title ID Publication Date Posted Date
Inspection & Compliance Manual Chapter - Pre-Inspection Activities CVB-SOP-0034 March 8, 2022 June 18, 2022
Inspection & Compliance Manual Chapter - Inspection and Compliance Correspondence (LSRTIS, Mail Log Procedures) CVB-SOP-0049 May 10, 2022 June 18, 2022
Inspection & Compliance Manual Chapter - Receiving and Updating Establishment Personnel Data CVB-WI-0086 May 12, 2022 June 18, 2022
Inspection & Compliance Manual Chapter - Workload Indicator Calculations for Compliance CVB-WI-0149 May 16, 2022 June 18, 2022
Organizational Chart - Policy, Evaluation and Licensing -- June 5, 2022 June 25, 2022
Organizational Chart - Inspection and Compliance -- May 22, 2022 June 25, 2022
Center for Veterinary Biologics Reagent Catalog -- June 1, 2022 June 25, 2022
Organizational Chart - Safety and Security Unit -- June 19, 2022 August 2, 2022
Organizational Chart - Assistant Director -- July 1, 2022 August 2, 2022
Inspection & Compliance Manual Chapter - Processing CVB Reference and Reagent Test Reports CVB-WI-0167 June 6, 2022 August 5, 2022

 

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