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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
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
Availability of Canine Influenza Virus Subtype H3N2 15-06 48 May 12, 2015 May 12, 2015
Availability of Avian Influenza Isolates 15-07 34 Jun 10, 2015 Jun 12, 2015
Changes to the Administrative Inspection Review Program 15-08 28 Jun 10, 2015 Jun 12, 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
Viruses, Serums, Toxins, and Analogous Products; Exemptions From Preparation Pursuant to an Unsuspended and Unrevoked License APHIS–2011–0048 229 Jul 10, 2015 May 12, 2015
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 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
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
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
Secondary Reference Serum-Bovine IgG; Stock for Bovine IgG Species Standard BIDDAT0001 82 Apr 23, 2015 May 20, 2015
Clostridium perfringens type D (epsilon) toxin BBDAT0050 16 Jun 03, 2015 Jun 05, 2015
Other
Title ID Size (KB) Publication Date Posted Date
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
PEL Policy Manual - Food and Drug Administration-Export Reform and Enhancement Act (aka DEREA) (Section 3.4) -- -- May 06, 2015 May 08, 2015
IC Manual - IC Pre-Inspection Packet Checklist (Section 3.2.5) -- -- Mar 17, 2015 May 11, 2015
IC Manual - Administrative Inspection Review – Submittal Template (Section 3.6.1) -- -- Mar 26, 2015 May 11, 2015
IC Manual - Reference and Reagent Review and Release (Section 6.10.1) -- -- Mar 17, 2015 May 11, 2015
IC Manual - Processing APHIS Form 2008s if Unsatisfactory Testing by the CVB and the Possible Challenge of the Test Results by the Manufacturer (Section 6.2.21) -- -- Feb 20, 2015 May 20, 2015
IC Manual - Auditing a Serial or Attaching a Reference Slip within LSRTIS (Section 10.2) -- -- Feb 20, 2015 May 20, 2015
IC Manual - Export Information (Section 18.5) -- -- Feb 20, 2015 May 20, 2015
IC Manual - Items to Consider when Requesting Prelicensing Inspections (Section 3.2.1.1) -- -- Apr 10, 2015 May 20, 2015
IC Manual - Work Flow for Initiating a Regulatory Action or Regulatory Letter Using LSRTIS 2014 and the Mail Log System (Section 4.11) -- -- Mar 09, 2015 May 20, 2015
IC Manual - Work Flow for Initiating a Regulatory Action or Regulatory Letter Generated from LSRTIS 2014 – Inspection Report – Using the Mail Log System (Section 4.12) -- -- Mar 09, 2015 May 20, 2015
IC Manual - Serials Ready for Conditional Action (Section 6.2.1) -- -- Apr 17, 2015 May 20, 2015
IC Manual - Nonconforming Veterinary Biological Investigation (VBI) Files – Maintenance of Work Reports (Section 4.3) -- -- May 01, 2015 May 20, 2015
IC Manual - Veterinary Biologics Investigations (VBI) Log (Section 4.6) -- -- May 01, 2015 May 20, 2015
IC Manual - Conditional Serial Release (Section 6.2.4) -- -- Apr 17, 2015 May 20, 2015
IC Manual - Veterinary Biologics Investigation Summary Sheet (Section 4.7) -- -- Jun 10, 2011 May 27, 2015
IC Manual - Inspection, Processes Observed Worksheet (Section 3.3.3.2) -- -- Apr 17, 2015 May 27, 2015
IC Manual - Inspection, Requested Documents Worksheet (Section 3.3.3.3) -- -- Apr 17, 2015 May 27, 2015
IC Manual - Inspection Tools – Requested Documents and Observations (Section 3.3.3.1) -- -- Apr 17, 2015 May 27, 2015
IC Manual - Submitting Letter to the U.S. Department of State Office of Authentications (Section 18.6) -- -- Apr 28, 2015 May 27, 2015
IC Manual - General Guidelines for Violations Attachment Report Format (Section 3.5.6) -- -- Apr 28, 2015 May 27, 2015


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