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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CVB Draft Guidance Documents for Comment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
Serial Release of Licensed Biological Products Draft 629 Aug 12, 2019 Jul 22, 2019
CVB Notices
Title ID Publication Date Posted Date
Name Change for In Vitro Diagnostics (Test Kits) Intended to Detect Canine or Feline Heartworm Antigen 19-05 Jun 17, 2019 Jun 17, 2019
Issuance of Licenses 19-06 Jul 09, 2019 Jul 15, 2019
Discontinued Availability of Pasteurella multocida 169 (Porcine) Bacterin 19-07 Jul 19, 2019 Jul 22, 2019
Veterinary Services Memoranda (new or revised)
Title ID Publication Date Posted Date
Potency and Safety Testing by Unlicensed Facilities 800.115 Apr 11, 2019 May 10, 2019
Preparation and Submission of Facilities Documents 800.78 Jun 10, 2019 Jun 12, 2019
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
       
Testing Protocols (PROs)
Title ID Document Date Posted Date
Testing Protocol for Enzyme Linked Immunosorbent Assay (ELISA) for Extraneous Avian Leukosis Virus (ALV) CVB-PRO-0030
May 17, 2019 Jun 04, 2019
Master Seed Testing in the Virology Section CVB-SOP-0149
Jul 30, 2019 Aug 08, 2019
Hematoxylin and Eosin Staining Procedure for Detection of Cytopathic Extraneous Agents in Master Seeds CVB-PRO-0038
Jul 11, 2019 Aug 08, 2019
Fluorescent Antibody Staining Procedure for Detection of Viral Antigens CVB-PRO-0040
Jul 11, 2019 Aug 08, 2019
Reagent Data Sheets (DATs)
Title Lot ID Publication Date Posted Date
Clostridium sordellii antitoxin IRP 501 (04) Jun 24, 2019 Jul 19, 2019
Clostridium perfringens Type C (beta) Antitoxin IRP 637 Jun 24, 2019 Jul 19, 2019
Clostridium septicum (alpha) Toxin IRP 628 Jun 24, 2019 Jul 19, 2019
Clostridium septicum Antitoxin IRP 600 Jun 24, 2019 Jul 19, 2019
Clostridium sordellii Toxin IRP 604 Jun 24, 2019 Jul 19, 2019
Clostridium perfringens type A recombinant-alpha antitoxin IRP 564 (08) Jun 24, 2019 Jul 19, 2019
Clostridium perfringens type A (alpha) Toxin IRP 560-07 Jul 11, 2019 Jul 19, 2019
Pasteurella multocida (bovine) Challenge Culture IRP 610 Jul 30, 2019 Aug 08, 2019
Other
Title ID Publication Date Posted Date
Organizational Chart - Assistant Director's Office -- Feb 03, 2019 May 20, 2019
PEL Reviewer Manual - Using Software to Estimate Relative Potency CVB-WI-0188 May 08, 2019 May 24, 2019
PEL Reviewer Manual - Shipment of Animal Pathogens and Select Agents CVB-WI-0292 May 06, 2019 May 24, 2019
CVB Data Guide (for NCAH Portal users and Paper Submitters) NCAH Portal Guide #16 May 20, 2019 Jun 07, 2019
Portal Eligibility Requirements for New Establishments -- May 07, 2019 Jun 07, 2019
PEL Reviewer Manual - Food and Drug Administration-Export Reform and Enhancement Act (aka DEREA) CVB-WI-0177 Jun 03, 2019 Jun 19, 2019
PEL Reviewer Manual - Final Steps for Licensure (Preparing a Licensing Package) CVB-SOP-0063 Jun 12, 2019 Jun 19, 2019
PEL Reviewer Manual - Establishment Licenses CVB-SOP-0065 May 17, 2019 Jun 19, 2019
PEL Reviewer Manual - Conditional Licenses CVB-SOP-0066 May 17, 2019 Jun 19, 2019
Current Veterinary Biologics Product Catalog -- Jul 01, 2019 Jul 08, 2019
Inspection and Compliance Manual - Redaction Process for Documents Posted to the CVB Procedure Manuals on the CVB Website CVB-WI-0078 Jul 01, 2019 Jul 18, 2019

 

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