Newly Published Information

Newly Published Information

Veterinary Biologics Information Published in the Last 90 Days

CVB Notices
Title ID Publication Date Posted Date
Revised Scope of Eligibility for Studies Requiring Single-Tier Summaries 17-13 Nov 03, 2017 Nov 03, 2017
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
Veterinary Services Memoranda (new or revised)
Title ID Publication Date Posted Date
Electronic Recordkeeping and Compliance with 9 CFR Part 116 800.122 Nov 03, 2017 Nov 08, 2017
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
       
Reagent Data Sheets (DATs)
Title Lot # Publication Date Posted Date
Clostridium tetani Toxin IRP 648 Nov 07, 2016 Nov 30, 2017
Other
Title ID Publication Date Posted Date
NCAH Portal User Guide #19 - Versioning Electronic Outlines 19 Oct 17, 2017 Oct 17, 2017
Org. Chart (CVB Management) -- Oct 01, 2017 Oct 31, 2017
Org. Chart (Assistant Director) -- Oct 01, 2017 Oct 31, 2017
Org. Chart (Administration Unit) -- Oct 01, 2017 Oct 31, 2017
NCAH Portal User Guide B - Outline Templates B Oct 25, 2017 Oct 31, 2017
NCAH Portal User Guide #12 - Working with Digital Signatures 12 Oct 25, 2017 Oct 31, 2017
Inspection and Compliance Manual Facility Documents: Specialist Review and Outgoing Correspondence (Section 9.2) ICWI0083 Oct 11, 2017 Oct 31, 2017
Inspection and Compliance Manual Facility Document Correspondence (Section 9.2.1) ICTEM0045 Oct 12, 2017 Oct 31, 2017
Inspection and Compliance Manual Processing Facility Documents (Sec. 9) ICSOP0018 Oct 06, 2017 Oct 31, 2017
Inspection and Compliance Manual Preliminary Review of Facility Documents (BCA) (Sec. 9.1) ICWI0081 Oct 12, 2017 Oct 31, 2017
Individual Study Summary (ISS) Procedure Data RequirementsSingle Tier Label Claim Guidance Document -- Oct 31, 2017 Nov 03, 2017
Scope of Studies Requiring Single-Tier SummariesSingle Tier Label Claim Guidance Document -- Oct 31, 2017 Nov 03, 2017
Inspection and Compliance Manual Finalization of Facility Document Submission (Sec. 9.3) ICWI0084 Oct 31, 2017 Nov 13, 2017
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
STATS Work Instruction - Technical Notes for Estimating Diagnostic Sensitivity and Specificity STATWI0002 Dec 06, 2017 Dec 11, 2017
Center for Veterinary Biologics Reagent Catalog -- Dec 18, 2017 Dec 20, 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

 

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