Newly Published Information

Veterinary Biologics Information Published in the Last 90 Days

CVB Notices
Title ID Publication Date Posted Date
Relative Potency Terminology for References and Related Preparations 17-14 Dec 19, 2017 Dec 20, 2017
Center for Veterinary Biologics Laboratory-supplied Reagents 17-15 Dec 19, 2017 Dec 20, 2017
Issuance of a Conditional License for Canine Osteosarcoma Vaccine, Live Listeria Vector 17-16 Dec 19, 2017 Dec 20, 2017
Veterinary Biological Products in Licensed Establishments Produced and Destroyed 01/01/2017 through 12/31/2017 85 Jan 12, 2018 Jan 12, 2018
Issuance of a Conditional License for Avian Paramyxovirus Vaccine, Type 1, Killed Virus 18-02 Jan 26, 2018 Jan 29, 2018
Issuance of Licenses 18-01 Feb 07, 2018 Feb 08, 2018
Changes in True Names Based on Accepted Nomenclature 18-03 Feb 06, 2018 Feb 08, 2018
Veterinary Services Memoranda (new or revised)
Title ID Publication Date Posted Date
General Licensing Considerations: Backpassage Studies 800.201 Jan 25, 2018 Jan 26, 2018
General Licensing Considerations: Field Safety Studies 800.204 Jan 25, 2018 Jan 26, 2018
Rulemaking
Title FR Citation Effective Date Posted Date
       
Proposed Rulemaking
Title Federal Register Vol/Page Comments Due Date Posted Date
       
Supplemental Assay Methods (SAMs)
Title ID Document Date Posted Date
Potency Testing Products Containing Clostridium chauvoei Antigen 200 Dec 13, 2017 Dec 29, 2017
Potency Testing Clostridium perfringens Type C Beta Antigen 201 Dec 12, 2017 Dec 29, 2017
Potency Testing Clostridium perfringens Type C Beta Antitoxins 202 Dec 12, 2017 Dec 29, 2017
Potency Testing Clostridium perfringens Type D Epsilon Antigen 203 Dec 13, 2017 Dec 29, 2017
Potency Testing Clostridium perfringens Type D Epsilon Antitoxins 204 Dec 13, 2017 Dec 29, 2017
Potency Testing Tetanus Antitoxins 206 Dec 18, 2017 Dec 29, 2017
Potency Testing Clostridium novyi Type B Alpha Antigen 207 Dec 15, 2017 Dec 29, 2017
Potency Testing Products Containing Clostridium haemolyticum Antigen 209 Dec 13, 2017 Dec 29, 2017
Potency Testing Clostridium sordellii Antigen 212 Dec 15, 2017 Dec 29, 2017
Potency Testing of Erysipelas Bacterins in Mice 611 Dec 15, 2017 Dec 29, 2017
Potency Testing of Pasteurella multocida Bacterins of Bovine Origin 634 Dec 18, 2017 Dec 29, 2017
Potency Testing of Pasteurella multocida Bacterins of Porcine Origin 635 Dec 18, 2017 Dec 29, 2017
Testing Protocols (PROs)
Title ID Document Date Posted Date
Detection of Hemagglutinating Viruses VIRPRO0096  Jan 09, 2018  Jan 23, 2018 
Testing Protocol for Enzyme Linked Immunosorbent Assay (ELISA) for Extraneous Avian Leukosis Virus (ALV) *author update only VIRPRO0123 Jan 31, 2018 Feb 20, 2018
Reagent Data Sheets (DATs)
Title Lot # Publication Date Posted Date
Negative Guinea Pig Serum IRP 550 (07) Jan 19, 2018 Jan 26, 2018
Clostridium chauvoei Spore Preparation IRP 631 Jan 17, 2018 Jan 26, 2018
Erysipelothrix rhusiopathiae Reference Bacterin IRP 609 Jan 25, 2018 Feb 09, 2018
Leptospira canicola Challenge Culture IRP 653 Jan 29, 2018 Feb 22, 2018
Leptospira grippotyphosa Challenge Culture IRP 656 Jan 30, 2018 Feb 22, 2018
Leptospira icterohaemorrhagiae Challenge Culture IRP 655 Jan 30, 2018 Feb 22, 2018
Leptospira pomona Challenge Culture IRP 654 Jan 30, 2018 Feb 22, 2018
Other
Title ID Publication Date Posted Date
Examples of a variety of Individual Study Summaries Single Tier Label Claim Guidance Document -- Nov 21, 2017 Nov 27, 2017
User Guide #16 - CVB Data Guide (how to submit data to PEL) 16 Nov 20, 2017 Nov 29, 2017
Inspection and Compliance Manual Facility Document Form Plot Plan/Plot Plan Legend - Preliminary Review (BCA) (Section 9.1.1) ICFRM0018 Nov 16, 2017 Nov 29, 2017
Inspection and Compliance Manual Facility Document Form Blueprint/Blueprint Legend - Preliminary Review (BCA)(Section 9.1.2) ICFRM0019 Nov 16, 2017 Nov 29, 2017
Inspection and Compliance Manual Items to Consider When Processing Preliminary Drawings (Sec. 9.4.5) ICWI0132 Nov 28, 2017 Dec 06, 2017
Inspection and Compliance Manual Items to Consider for No Tests Regarding the Wet Chick Safety Test, 9 CFR 113.207(a) (Sec. 6.2.20) ICWI0133 Nov 28, 2017 Dec 06, 2017
Testing for Senecavirus A in Biological Products -- -- Dec 20, 2017
Listing of Current Supplemental Assay Methods (SAMs) -- Dec 28, 2017 Dec 29, 2017
Current Veterinary Biologics Product Catalogue -- Jan 04, 2018 Jan 12, 2018
STATS Work Instruction - Technical Notes for Estimating Diagnostic Sensitivity and Specificity STATWI0002 Jan 10, 2018 Jan 23, 2018
PEL Reviewer Manual Outlines of Production & Special Outlines Chapter 4.1 Jan 18, 2018 Jan 30, 2018
Center for Veterinary Biologics Reagent Catalog -- Jan 31, 2018 Feb 08, 2018
Organization Chart (Administration Unit) -- Oct 01, 2017 Feb 09, 2018
Organization Chart (Information Management Unit) -- Jan 21, 2018 Feb 09, 2018
Organization Chart (Inspection and Compliance) -- Nov 13, 2017 Feb 09, 2018
Organization Chart (Safety and Security Unit) -- Nov 26, 2017 Feb 09, 2018
Organization Chart (Policy, Evaluation and Licensing) -- Jan 03, 2018 Feb 09, 2018
Inspection and Compliance Manual Facility Documents: Specialist Review and Outgoing Correspondence (Sec. 9.2) ICWI0083 Feb 07, 2018 Feb 09, 2018
PEL Reviewer Manual List of Standard License Restrictions Chapter 2.2.1 Jan 31, 2018 Feb 09, 2018
Printable Version of Single Tier Label Claim Guidance Single Tier Label Claim Guidance Document -- Feb 06, 2018 Feb 09, 2018