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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CVB Draft Guidance Documents for Comment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
Availability of New Inactivated Veterinary Rabies Reference
Draft 636
Sep 30, 2019
Sep 09, 2019
CVB Notices
Title ID Publication Date Posted Date
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
Availability of Newcastle Disease Isolate and Sequence Information 19-09 Sep 05, 2019 Sep 09, 2019
Expanded NCAH Portal Functionality: APHIS Form 2005 Applications for Sale and Distribution 19-10 Sep 09, 2019 Sep 09, 2019
Expanded NCAH Portal Functionality: APHIS Form 2005 Applications for Research and Evaluation, and Transit Shipment Permits 19-11 Sep 09, 2019 Sep 09, 2019
Veterinary Services Memoranda (new or revised)
Title ID Publication Date Posted Date




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
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
Veterinary Rabies Reference Vaccine, killed virus Lot 08-14 Aug 15, 2019 Aug 28, 2019
Other
Title ID Publication Date Posted Date
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
Organizational Chart - Administration -- Jul 07, 2019 Aug 28, 2019
Organizational Chart - Inspection and Compliance -- Jul 07, 2019 Aug 28, 2019
Organizational Chart - Information Management Unit -- Jul 07, 2019 Aug 28, 2019
Organizational Chart - Safety and Security Unit -- Jul 07, 2019 Aug 28, 2019
NCAH Portal User Guide - Application for United States Veterinary Biological Product Permit - RESEARCH AND EVALUATION *functionality will be available in NCAH Portal on 9/26/2019 27 Sep 11, 2019 Sep 12, 2019
NCAH Portal User Guide - Application for United States Veterinary Biological Product Permit - TRANSIT SHIPMENT ONLY *functionality will be available in NCAH Portal on 9/26/2019 28 Sep 11, 2019 Sep 12, 2019
NCAH Portal User Guide - Application for United States Veterinary Biological Product Permit - SALES AND DISTRIBUTION *functionality will be available in NCAH Portal on 9/26/2019 29 Sep 11, 2019 Sep 12, 2019
Inspection and Compliance Manual - Scheduling and Approval of Inspections in LSRTIS CVB-WI-0119 Jul 12, 2019 Sep 12, 2019
Hold-over Information from Veterinary Services Memorandum No. 800.90 -- Sep 13, 2019 Sep 13, 2019
NCAH Portal User Guide - General Guide for Submission of Veterinary Biologics Production and Test Report 5 Sep 13, 2019 Sep 13, 2019
NCAH Portal User Guide - General Guide for E-Submissions to CVB-Policy, Evaluation and Licensing 10 Sep 13, 2019 Sep 13, 2019
Inspection and Compliance Manual - Workload Indicator Calculations for Compliance CVB-WI-0149 Aug 20, 2019 Sep 16, 2019
PEL Reviewer Manual - Validating Alternate Techniques for the Detection of Mycoplasmas CVB-WI-0181 Aug 20, 2019 Sep 16, 2019
PEL Reviewer Manual - Dilution of Preservative Studies CVB-WI-0182 Aug 20, 2019 Sep 16, 2019
PEL Reviewer Manual - Quarterly Submission Acknowledgement Summaries CVB-SOP-0064 Aug 30, 2019 Sep 16, 2019

 

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