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Current CVB Notices
Current CVB Notices
Last Modified: April 10, 2024
CVB Notices - 2024 ID Title 24-06 Availability of Highly Pathogenic Avian Influenza (HPAI) virus genomic sequence (H5 clade 2.3.4.4b) 24-01 Request Input on Proposed Enhancement for Export Certification 24-02 Issuance of Licenses 24-03 Veterinary Vaccines and Veterinary Diagnostic Products Targeting Avian Metapneumovirus (all subtypes) 24-04 Posting of Selected Center for Veterinary Biologics Notices and Veterinary Services Memoranda on the Center for Veterinary Biologics Web Site for Comment 24-05 Availability of a Pilot Project to Implement a Focused Review Option for Review of Outlines of Production Submitted through the NCAH Portal Back to Top
CVB Notices - 2023 ID Title 90 Veterinary Biological Products in Licensed Establishments Produced and Destroyed 01/01/2022 through 12/31/2022 23-01 Issuance of Licenses 23-02 Issuance of a Conditional License for American Foulbrood 23-03 Change of True Name for antivenin products 23-04 Availability of Duck Atadenovirus 1 (DAdV-1; aka Egg drop 76, adenovirus 127, duck adenovirus) genetic sequence and isolate 23-05 Notification of U.S. Department of Agriculture’s (USDA) Sources Sought Notice (SSN) for Foreign Animal Disease (FAD) Diagnostic Products 23-06 Antimicrobial Resistance (AMR) Genes in Veterinary Biological Products 23-07 Sale of Unlicensed Autologous Therapeutic Biologics 23-08 Update for Documenting Appropriate Details for Potency Tests 23-09 Issuance of Licenses 23-10 Inclusion of Master Seed, and Master Cell Labels with Submissions to the Center of Veterinary Biologics (CVB) Laboratory 23-11 Killed/Non-viable Veterinary Vaccines and Veterinary Diagnostic Products Targeting Egg Drop Syndrome in Chickens 23-12 Issuance of a Conditional License for Canine Parvovirus Monoclonal Antibody 23-13 Issuance of Licenses 23-14 Issuance of Licenses 23-15 Issuance of a Conditional License for Rabbit Hemorrhagic Disease Virus Back to Top
CVB Notices - 2022 ID Title 89 Veterinary Biological Products in Licensed Establishments Produced and Destroyed 01/01/2021 through 12/31/2021 22-01 Issuance of Licenses 22-02 Availability of Avian Influenza Isolate and Sequence Information 22-03 Extended use of currently approved, non-Single Tier compliant domestic labels 22-04 Discontinued Availability of Erysipelothrix rhusiopathiae Rabbit Polyclonal Antibody (Detection Antibody) 22-05 Issuance of a Conditional License for Mink Coronavirus 22-06 Issuance of Licenses 22-07 Issuance of Licenses 22-08 Review of Labels for Use in Countries that are Members or Observers of the Veterinary International Conference on Harmonization 22-09 Issuance of Licenses Back to Top
CVB Notices - 2021 ID Title 88 Veterinary Biological Products in Licensed Establishments Produced and Destroyed 01/01/2020 through 12/31/2020 21-01 Issuance of Licenses 21-02 Record Audit Inspections 21-03 Issuance of Inspection Certificate 21-04 Issuance of Licenses 21-05 Supply Chain Disruptions Associated with the COVID-19 Pandemic 21-06 Issuance of Licenses 21-07 Updated Process for Video Submission for Virtual Inspections related to Remodeled or New Facilities for Existing Licensed Establishments 21-08 Issuance of Licenses Back to Top
CVB Notices - 2020 ID Title 87 Veterinary Biological Products in Licensed Establishments Produced and Destroyed 01/01/2019 through 12/31/2019 20-01 Issuance of Licenses 20-02 NCAH Portal Functionality: Electronic Labeling Submission Revision 20-03 Issuance of Licenses 20-04 Issuance of Licenses 20-05 Name Change for Biologicals containing Glaesserella parasuis , formerly Haemophilus parasuis , and Clostridioides difficile , formerly Clostridium difficile 20-06 Virtual Inspections for Remodeled or New Facilities for Existing Licensed Establishments 20-07 Issuance of a Conditional License for Epizootic Bovine Abortion Agent Vaccine, Live Culture 20-08 Update to Equine Parvovirus Extraneous Agent Testing Requirement for Equine-Origin Antibody, Antitoxin, Antivenin, Serum, and Plasma Biological Products Regulated by APHIS 20-09 Issuance of Licenses 20-10 Certification of Veterinary Vaccines and Immunotherapeutics as Containing Genetically Modified Organisms 20-12 Veterinary Vaccines Targeting SARS-CoV-2 Virus in Mink 20-13 Use of Nonproprietary Names from the United States Adopted Names (USAN) Council as True Names for Veterinary Biologic Immunotherapeutics Back to Top
CVB Notices - 2019 ID Title 86 Veterinary Biological Products in Licensed Establishments Produced and Destroyed 01/01/2018 through 12/31/2018 19-01 Issuance of Licenses 19-02 Issuance of Licenses 19-03 New Extraneous Agent Testing Requirement for Equine-Origin Antibody, Antitoxin, Serum, and Plasma Products Regulated by APHIS 19-04 Name Change for Biologicals Containing Mycobacterium avium subspecies paratuberculosis , formerly Mycobacterium paratuberculosis 19-05 Name Change for In Vitro Diagnostics (Test Kits) Intended to Detect Canine or Feline Heartworm Antigen 19-06 Issuance of Licenses 19-07 Discontinued Availability of Pasteurella multocida 169 (Porcine) Bacterin 19-09 Availability of Newcastle Disease Isolate and Sequence Information 19-10 Expanded NCAH Portal Functionality: APHIS Form 2005 Applications for Sale and Distribution 19-11 Expanded NCAH Portal Functionality: APHIS Form 2005 Applications for Research and Evaluation, and Transit Shipment Permits 19-12 Issuance of a Conditional License for Avian Reovirus Vaccine, Killed Virus 19-13 Issuance of Licenses 19-14 Extension of Implementation Period of Single Tier Label Claim 19-15 Availability of New Inactivated Veterinary Rabies Reference Back to Top
CVB Notices - 2018 ID Title 85 Veterinary Biological Products in Licensed Establishments Produced and Destroyed 01/01/2017 through 12/31/2017 18-01 Issuance of Licenses 18-02 Issuance of a Conditional License for Avian Paramyxovirus Vaccine, Type 1, Killed Virus 18-03 Changes in True Names Based on Accepted Nomenclature 18-04 Expanded NCAH Portal Functionality: Submission of Export Documents 18-05 Detection of Senecavirus A in Veterinary Biological Products 18-06 Issuance of Licenses 18-07 Digital Signatures on Microsoft Word Documents 18-08 Expanded NCAH Portal Functionality: Submission of Facility Documents 18-09 Implementation Period for the Submission of Adverse Event Reports 18-10 Issuance of Licenses 18-11 Policy for Long-Term Recognition of CVB Digital Signatures in Microsoft Word documents 18-12 Issuance of Licenses 18-13 Labeling of Vaccines Containing Porcine Circovirus Type 2 Back to Top
CVB Notices - 2017 ID Title 84 Veterinary Biological Products in Licensed Establishments Produced and Destroyed 01/01/2016 through 12/31/2016 17-01 Issuance of Licenses 17-02 Issuance of a Conditional License for Moraxella Bovoculi Bacterin 17-03 Expanded NCAH Portal Functionality: Electronic Outlines of Production and Special Outlines 17-04 Availability of Avian Influenza Isolate and Sequence Information 17-05 Issuance of Licenses 17-06 Option to Remove Back-titration Hamsters from In Vivo Potency Tests for Leptospira Serogroups Pomona and Grippotyphosa 17-07 Transfer of Availability of Cell Lines from the Center for Veterinary Biologics 17-08 Retention of Policy Documents Posted to Center for Veterinary Biologics Website 17-09 Issuance of Licenses 17-10 Discontinued Availability of Diagnostic Test Kit Serial Release Panels Obtained from the Center for Veterinary Biologics (CVB) 17-11 Facility Documents Processing Changes – Pilot Project 17-12 Issuance of Licenses 17-13 Revised Scope of Eligibility for Studies Requiring Single-Tier Summaries 17-15 Center for Veterinary Biologics Laboratory-supplied Reagents 17-16 Issuance of a Conditional License for Canine Osteosarcoma Vaccine, Live Listeria Vector Back to Top
CVB Notices - 2016 ID Title 16-02 Availability of Avian Influenza Isolate and Sequence Information 16-03 Veterinary Biologics Containing Senecavirus A 16-05 Initiation of the National Centers for Animal Health (NCAH) Portal for the Center for Veterinary Biologics 16-07 In-depth Inspection Report Format 16-12 Name Change for Biologicals Containing Haemophilus paragallinarum, Babesia equi, and Ehrlichia risticii 16-13 Cancellation of Veterinary Services Memorandum 800.90 and 800.92 16-14 Expansion of the National Centers for Animal Health (NCAH) Portal for the Center for Veterinary Biologics 16-15 Implementation of Single Label Claim and Labeling/Packaging Rules 16-16 Issuance of Licenses Back to Top
CVB Notices - 2015 ID Title 15-03 Adjustment for Clostridium perfringens Type C and Type D Reagents 15-04 Nomenclature and Level of Identification Required for Leptospira Master Seed Bacteria and Challenge Cultures 15-06 Availability of Canine Influenza Virus Subtype H3N2 15-07 Availability of Avian Influenza Isolates 15-08 Changes to the Administrative Inspection Review Program 15-13 Option to Remove Back-titration Hamsters from In Vivo Potency Tests for Leptospira Serogroups Canicola and Icterohaemorrhagiae Back to Top
CVB Notices - 2014 ID Title 14-06 Safety Data to Support Using Multiple Strains of Potentially Immunosuppressive Viruses in the Same Modified Live Product 14-10 Change in Distribution Policy for Memoranda and Notices 14-16 Processing Special Outlines Describing Proposed Serial Release Assays Back to Top
CVB Notices - 2013 ID Title 13-02 Quarterly Acknowledgement Summaries for Selected Submissions 13-05 Use of Polymerase Chain Reaction (PCR) Assays to Measure Potency of Inactivated Protein-Based Biologicals 13-06 Reporting Inactivation Test Results on APHIS Forms 2008 for Inactivated Veterinary Biological Products with the Restriction "For Further Manufacture (FFM)" 13-10 Changes to the Rabies Virus NIH Potency Test Validity Requirements 13-17 Summary of Changes for Related Study Protocols 13-18 Discontinuing the Use of RelPot Software Back to Top
CVB Notices - 2012 ID Title 12-03 Exemption to Shipping a Sample of Inactivated Lot or Bulk Rabies Antigen to the Center for Veterinary Biologics 12-04 Appropriate Use of Controls for Chicken Anemia Virus Extraneous Agent Testing, Availability of a PCR-based Testing Protocol, and Availability of a New Testing Reagent (Referenced Documents: VIRPRO0118 and VIRNPP0001 ) 12-05 Testing Exemptions for Antibody Product Donor Animals 12-06 Detection of Mycoplasma Contamination in Vaccines and Biological Products 12-07 Submission of Master Seeds, Master Cell Stocks, and Master Sequences to the Center for Veterinary Biologics for Confirmatory Testing 12-09 Licensing of Vaccines as Preharvest Food Safety Interventions 12-11 Virulent Systemic Feline Calicivirus Label Claims 12-12 Use of Humane Endpoints and Methods in Animal Testing of Biological Products 12-21 Conducting Dilution of Preservative Studies for Live Bacterial Vaccines 12-25 New Policy on Biological Product Samples Submitted to the Center for Veterinary Biologics and Concurrent Testing Selection Period Back to Top
CVB Notices - 2011 ID Title 11-01 The Management and Disposition of Eggs, Chickens, and Biological Products Following a Chicken Anemia Virus (CAV) Outbreak in a Source Flock 11-02 Generation and Implementation of Draft Guidance 11-12 Product Licensing Plans 11-14 superseded by CVB Notice 15-02 11-18 Virus Inactivation and Safety Test for Rabies Virus Bulks, Title 9, Code of Federal Regulations (9 CFR), Part 113.209 Back to Top
CVB Notices - 2009 ID Title 09-02 Dilution of Preservative Screening for Broth-Based Sterility Tests 09-04 Conversion Formulas for S/P Ratio to Titer in Diagnostic Test Kit Inserts 09-05 Consistency of Avian Safety Testing Parameters in Outlines of Production for Multi-fraction Avian Products 09-15 Autogenous Vaccines Containing Porcine Circovirus 09-25 Dilution of Preservative Screening for Plate-Based Sterility Tests Back to Top
CVB Notices - 2007 ID Title 07-04 Submission of Outsourced Studies 07-06 Preparation and Testing of Experimental Biological Products that are Derived from Biotechnology 07-07 Post-Challenge Observation Periods for Efficacy Studies Back to Top
CVB Notices - 2006 ID Title 06-03 Potential Contamination of Porcine Kidney Cells 06-06 Type (Species) Designation of Vaccines Containing Bovine Viral Diarrhea Virus(es) 06-11 Replacement of Potency Assay Reference Samples for Immunodiagnostic Test Kits 06-24 Exemptions to allow live poultry vaccines administered via wing web to be tested for detection of extraneous viable bacteria and fungi via Title 9, Code of Federal Regulations, Part 113.27 (e) Back to Top
CVB Notices - 2005 ID Title 05-06 Requirements for Addition of Leptospira bratislava in Canine Bacterins 05-07 Biologics for Reduction of Colonization and/or Shedding in Animals 05-16 Posting of Selected Center for Veterinary Biologics Notices and Veterinary Services Memoranda on the Center for Veterinary Biologics Web Site for Comment 05-23 Chimera as an Additional Naming Convention for Live Recombinant Products Back to Top
CVB Notices - 2004 ID Title 04-13 Use of Minimum Age Animals in Licensure Studies 04-16 Efficacy Requirements and Label Claims for Bovine Rotavirus Vaccine 04-17 Exemption to 3-year Master Seed Immunogenicity Retesting Back to Top
CVB Notices - 2003 ID Title 03-08 Purpose of the Equine Infectious Anemia Weak Positive Serum Sample Outlined in Veterinary Services Memorandum No. 555-16 03-13 Detection of Avian Lymphoid Leukosis Virus in Veterinary Biological Products 03-14 Customer Feedback on Reagents Back to Top
CVB Notices - 2002 ID Title 02-01 Critical Study Dates for Licensing and Reference Qualification Studies 02-15 Permit Requirements for Pathogenic Organisms, Including Challenge Materials 02-21 Domestic Manufacture of Biologicals Used in the Prevention or Treatment of Foreign Animal Diseases 02-25 Conditional Licenses for Products Containing Clostridium perfringens Type A 02-29 Availability of Monoclonal Antibodies from the Center for Veterinary Biologics Back to Top
CVB Notices - 2001 ID Title 01-07 Identification of Testing Methods for Detection of Extraneous Agents in Fetal Bovine Serum 01-11 International Cooperation on Harmonization of Technical Requirements for the Registration of Veterinary Medicinal Products (VICH): Final Guidelines for Good Clinical Practice 01-16 Autogenous Products for Avian Influenza Back to Top
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