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 Posted Date
Issuance of a production platform-based license for Prescription Product, RNA Particle 16-04 119 Mar 15, 2016 Mar 15, 2016
Initiation of the National Centers for Animal Health (NCAH) Portal for the Center for Veterinary Biologics 16-05 1.12MB Apr 22, 2016 Apr 25, 2016
Issuance of Licenses 16-06 302 Apr 22, 2016 Apr 25, 2016
In-depth Inspection Report Format 16-07 127 May 16, 2016 May 17, 2016
Veterinary Services Memoranda (new or revised)
Title ID Size (KB) Publication Date Posted Date
Eggs and Chickens for Production of Veterinary Biological Products 800.65 152 May 03, 2016 May 06, 2016
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 the Determination of Phenol in Veterinary Biologics (Pullorum antigen, Mycoplasma synoviae antigen, and Mycoplasma gallisepticum antigen) 500 281 Feb 05, 2016 Mar 16, 2016
Supplemental Assay Method for the Determination of Residual Moisture in Veterinary Biologics Products 502 256 Feb 05, 2016 Mar 16, 2016
Supplemental Assay Method for the Manual Determination of Protein Content of Veterinary Biologics (Biuret) 504 182 Feb 08, 2016 Mar 16, 2016
Supplemental Assay Method for the Determination of Formaldehyde in Veterinary Biologics (Ferric Chloride Test) 512 117 Feb 08, 2016 Mar 16, 2016
Supplemental Assay Method for the Determination of Protein and Phenol in PPD Bovis Tuberculin (Purified Protein Derivative Produced from Cultures of Mycobacterium bovis (Strain AN-5)) 513 390 Feb 08, 2016 Mar 16, 2016
Supplemental Assay Method for the Determination of Hydrogen Ion Concentration, Total Nitrogen, Phenol and Clarity in Intradermic Tuberculin (Filtrate Produced From Cultures of Pn, C, and Dt Strains of Mycobacterium tuberculosis) 514 433 Feb 08, 2016 Mar 17, 2016
Supplemental Assay Method for the Potency Assay of Leptospira interrogans serogroup pomona Bacterins 608 86 Mar 09, 2016 Mar 17, 2016
Supplemental Assay Method for the Potency Assay of Leptospira interrogans serogroup canicola Bacterins 609 312 Mar 09, 2016 Mar 17, 2016
Supplemental Assay Method for the Potency Assay of Leptospira interrogans serogroup icterohaemorrhagiae Bacterins 610 237 Mar 09, 2016 Mar 17, 2016
Supplemental Assay Method for the Potency Assay Leptospira kirschneri serogroup grippotyphosa Bacterins 617 176 Mar 09, 2016 Mar 17, 2016
Testing Protocols (PROs)
Title ID Size (KB) Document Date Posted Date
         
Reagent Data Sheets (DATs)
Title ID Size (KB) Publication Date Posted Date
Clostridium perfringens type D (epsilon) toxin BBDAT0050 36 Apr 15, 2016 Apr 26, 2016
Erysipelothrix rhusiopathiae Reference Bacterin BBDAT1012 15 May 02, 2016 May 05, 2016
Clostridium chauvoei Flagella-specific Rabbit Polyclonal Antibody (detection antibody) BBDAT0045 127 May 12, 2016 May 25, 2016
Clostridium chauvoei Flagella-specific (7D11/YD7) Monoclonal Antibody (MAb) BBDAT1033 126 May 12, 2016 May 25, 2016
Other
Title ID Size (KB) Publication Date Posted Date
Inspection and Compliance Policy Manual - BCA Ready for Approval (Section 6.9) -- -- Nov 05, 2015 Mar 03, 2016
Common Statistics Data Formatting Issues -- 1.48MB Mar 02, 2016 Mar 08, 2016
Current SAMs -- 118 Mar 17, 2016 Mar 17, 2016
PEL Policy Manual - List of Standard License Restrictions (Section 2.2.1) -- -- Apr 08, 2016 Apr 20, 2016
PEL Policy Manual - Master Seeds/Cells/Sequences (Section 2.2.1) -- -- Apr 08, 2016 Apr 20, 2016
APHIS 2049 - Veterinary Biologics Regulatory E-Submission Form Policy, Evaluation, and Licensing -- -- -- May 25, 2016
PEL Policy Manual - Section V testing at Alternate Locations (Section 5.4) -- -- Apr 08, 2016 May 11, 2016
CVB Organizational Charts -- -- -- May 20, 2016

 

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