Current CVB Notices

Last Modified: June 18, 2024

Year of Publication
2024 | 2023 | 2022 | 2021 | 2020 | 2019 | 2018 | 2017 | 2016 | 2015 | 2014
2013 | 2012 | 2011 | 2010 | 2009 | 2008 | 2007 | 2006 | 2005 | 2004 | 2003
2002 | 2001 | 1999
CVB Notices - 2024
IDTitle
91Veterinary Biological Products in Licensed Establishments Produced and Destroyed 01/01/2023 through 12/31/2023
24-10Veterinary Vaccines and Veterinary Diagnostic Products Targeting Avian Metapneumovirus (all subtypes)
24-09Notification of U.S. Department of Agriculture’s (USDA) Request for Information for Highly Pathogenic Avian Influenza (HPAI) Vaccines for Use in Cattle
24-08National Animal Health Laboratory Network (NAHLN) Requirements for Veterinary Biologics Manufacturers to Meet for Diagnostic Products Detecting Transboundary and Foreign Animal Diseases to be Used in the NAHLN
24-07Issuance of Licenses
24-06Availability of Highly Pathogenic Avian Influenza (HPAI) virus genomic sequence (H5 clade 2.3.4.4b)
24-01Request Input on Proposed Enhancement for Export Certification
24-02Issuance of Licenses
24-04Posting of Selected Center for Veterinary Biologics Notices and Veterinary Services Memoranda on the Center for Veterinary Biologics Web Site for Comment
24-05Availability of a Pilot Project to Implement a Focused Review Option for Review of Outlines of Production Submitted through the NCAH Portal
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CVB Notices - 2023
IDTitle
90Veterinary Biological Products in Licensed Establishments Produced and Destroyed 01/01/2022 through 12/31/2022
23-01Issuance of Licenses
23-02Issuance of a Conditional License for American Foulbrood
23-03Change of True Name for antivenin products
23-04Availability of Duck Atadenovirus 1 (DAdV-1; aka Egg drop 76, adenovirus 127, duck adenovirus) genetic sequence and isolate
23-05Notification of U.S. Department of Agriculture’s (USDA) Sources Sought Notice (SSN) for Foreign Animal Disease (FAD) Diagnostic Products
23-06Antimicrobial Resistance (AMR) Genes in Veterinary Biological Products
23-07Sale of Unlicensed Autologous Therapeutic Biologics
23-08Update for Documenting Appropriate Details for Potency Tests
23-09Issuance of Licenses
23-10Inclusion of Master Seed, and Master Cell Labels with Submissions to the Center of Veterinary Biologics (CVB) Laboratory
23-11Killed/Non-viable Veterinary Vaccines and Veterinary Diagnostic Products Targeting Egg Drop Syndrome in Chickens
23-12Issuance of a Conditional License for Canine Parvovirus Monoclonal Antibody
23-13Issuance of Licenses
23-14Issuance of Licenses
23-15Issuance of a Conditional License for Rabbit Hemorrhagic Disease Virus
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CVB Notices - 2022
IDTitle
89Veterinary Biological Products in Licensed Establishments Produced and Destroyed 01/01/2021 through 12/31/2021
22-01Issuance of Licenses
22-02Availability of Avian Influenza Isolate and Sequence Information
22-03Extended use of currently approved, non-Single Tier compliant domestic labels
22-04Discontinued Availability of Erysipelothrix rhusiopathiae Rabbit Polyclonal Antibody (Detection Antibody)
22-05Issuance of a Conditional License for Mink Coronavirus
22-06Issuance of Licenses
22-07Issuance of Licenses
22-08Review of Labels for Use in Countries that are Members or Observers of the Veterinary International Conference on Harmonization
22-09Issuance of Licenses
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CVB Notices - 2021
IDTitle
88Veterinary Biological Products in Licensed Establishments Produced and Destroyed 01/01/2020 through 12/31/2020
21-01Issuance of Licenses
21-02Record Audit Inspections
21-03Issuance of Inspection Certificate
21-04Issuance of Licenses
21-05Supply Chain Disruptions Associated with the COVID-19 Pandemic
21-06Issuance of Licenses
21-07Updated Process for Video Submission for Virtual Inspections related to Remodeled or New Facilities for Existing Licensed Establishments
21-08Issuance of Licenses
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CVB Notices - 2020
IDTitle
87Veterinary Biological Products in Licensed Establishments Produced and Destroyed 01/01/2019 through 12/31/2019
20-01Issuance of Licenses
20-02NCAH Portal Functionality: Electronic Labeling Submission Revision
20-03Issuance of Licenses
20-04Issuance of Licenses
 
20-05Name Change for Biologicals containing Glaesserella parasuis, formerly Haemophilus parasuis, and Clostridioides difficile, formerly Clostridium difficile
 
20-06Virtual Inspections for Remodeled or New Facilities for Existing Licensed Establishments
 
20-07Issuance of a Conditional License for Epizootic Bovine Abortion Agent Vaccine, Live Culture
 
20-08Update to Equine Parvovirus Extraneous Agent Testing Requirement for Equine-Origin Antibody, Antitoxin, Antivenin, Serum, and Plasma Biological Products Regulated by APHIS
 
20-09Issuance of Licenses
 
20-10Certification of Veterinary Vaccines and Immunotherapeutics as Containing Genetically Modified Organisms
 
20-12Veterinary Vaccines Targeting SARS-CoV-2 Virus in Mink
 
20-13Use of Nonproprietary Names from the United States Adopted Names (USAN) Council as True Names for Veterinary Biologic Immunotherapeutics
 
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CVB Notices - 2019
IDTitle
86Veterinary Biological Products in Licensed Establishments Produced and Destroyed 01/01/2018 through 12/31/2018
19-01Issuance of Licenses
19-02Issuance of Licenses
19-03New Extraneous Agent Testing Requirement for Equine-Origin Antibody, Antitoxin, Serum, and Plasma Products Regulated by APHIS
19-04Name Change for Biologicals Containing Mycobacterium avium subspecies paratuberculosis, formerly Mycobacterium paratuberculosis
19-05Name Change for In Vitro Diagnostics (Test Kits) Intended to Detect Canine or Feline Heartworm Antigen
19-06Issuance of Licenses
19-07Discontinued Availability of Pasteurella multocida 169 (Porcine) Bacterin
19-09Availability of Newcastle Disease Isolate and Sequence Information
19-10Expanded NCAH Portal Functionality: APHIS Form 2005 Applications for Sale and Distribution
19-11Expanded NCAH Portal Functionality: APHIS Form 2005 Applications for Research and Evaluation, and Transit Shipment Permits
19-12Issuance of a Conditional License for Avian Reovirus Vaccine, Killed Virus
19-13Issuance of Licenses
19-14Extension of Implementation Period of Single Tier Label Claim
19-15Availability of New Inactivated Veterinary Rabies Reference
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CVB Notices - 2018
IDTitle
85Veterinary Biological Products in Licensed Establishments Produced and Destroyed 01/01/2017 through 12/31/2017
18-01Issuance of Licenses
18-02Issuance of a Conditional License for Avian Paramyxovirus Vaccine, Type 1, Killed Virus
18-03Changes in True Names Based on Accepted Nomenclature
18-04Expanded NCAH Portal Functionality: Submission of Export Documents
18-05Detection of Senecavirus A in Veterinary Biological Products
18-06Issuance of Licenses
18-07Digital Signatures on Microsoft Word Documents
18-08Expanded NCAH Portal Functionality: Submission of Facility Documents
18-09Implementation Period for the Submission of Adverse Event Reports
18-10Issuance of Licenses
18-11Policy for Long-Term Recognition of CVB Digital Signatures in Microsoft Word documents
18-12Issuance of Licenses
18-13Labeling of Vaccines Containing Porcine Circovirus Type 2
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CVB Notices - 2017
IDTitle
84Veterinary Biological Products in Licensed Establishments Produced and Destroyed 01/01/2016 through 12/31/2016
17-01Issuance of Licenses
17-02Issuance of a Conditional License for Moraxella Bovoculi Bacterin
17-03Expanded NCAH Portal Functionality: Electronic Outlines of Production and Special Outlines
17-04Availability of Avian Influenza Isolate and Sequence Information
17-05Issuance of Licenses
17-06Option to Remove Back-titration Hamsters from In Vivo Potency Tests for Leptospira Serogroups Pomona and Grippotyphosa
17-07Transfer of Availability of Cell Lines from the Center for Veterinary Biologics
17-08Retention of Policy Documents Posted to Center for Veterinary Biologics Website
17-09Issuance of Licenses
17-10Discontinued Availability of Diagnostic Test Kit Serial Release Panels Obtained from the Center for Veterinary Biologics (CVB)
17-11Facility Documents Processing Changes – Pilot Project
 
17-12Issuance of Licenses
17-13Revised Scope of Eligibility for Studies Requiring Single-Tier Summaries
17-15Center for Veterinary Biologics Laboratory-supplied Reagents
17-16Issuance of a Conditional License for Canine Osteosarcoma Vaccine, Live Listeria Vector
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CVB Notices - 2016
IDTitle
16-02Availability of Avian Influenza Isolate and Sequence Information
16-03Veterinary Biologics Containing Senecavirus A
16-05Initiation of the National Centers for Animal Health (NCAH) Portal for the Center for Veterinary Biologics
16-07In-depth Inspection Report Format
16-12Name Change for Biologicals Containing Haemophilus paragallinarum, Babesia equi, and Ehrlichia risticii
16-13Cancellation of Veterinary Services Memorandum 800.90 and 800.92
16-14Expansion of the National Centers for Animal Health (NCAH) Portal for the Center for Veterinary Biologics
16-15Implementation of Single Label Claim and Labeling/Packaging Rules
16-16Issuance of Licenses
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CVB Notices - 2015
IDTitle
15-03Adjustment for Clostridium perfringens Type C and Type D Reagents
15-04Nomenclature and Level of Identification Required for Leptospira Master Seed Bacteria and Challenge Cultures
15-06Availability of Canine Influenza Virus Subtype H3N2
15-07Availability of Avian Influenza Isolates
15-08Changes to the Administrative Inspection Review Program
15-13Option to Remove Back-titration Hamsters from In Vivo Potency Tests for Leptospira Serogroups Canicola and Icterohaemorrhagiae
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CVB Notices - 2014
IDTitle
14-06Safety Data to Support Using Multiple Strains of Potentially Immunosuppressive Viruses in the Same Modified Live Product
14-10Change in Distribution Policy for Memoranda and Notices
14-16Processing Special Outlines Describing Proposed Serial Release Assays
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CVB Notices - 2013
IDTitle
13-02Quarterly Acknowledgement Summaries for Selected Submissions
13-05Use of Polymerase Chain Reaction (PCR) Assays to Measure Potency of Inactivated Protein-Based Biologicals
13-06Reporting Inactivation Test Results on APHIS Forms 2008 for Inactivated Veterinary Biological Products with the Restriction "For Further Manufacture (FFM)"
13-10Changes to the Rabies Virus NIH Potency Test Validity Requirements
13-17Summary of Changes for Related Study Protocols
13-18Discontinuing the Use of RelPot Software
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CVB Notices - 2012
IDTitle
12-03Exemption to Shipping a Sample of Inactivated Lot or Bulk Rabies Antigen to the Center for Veterinary Biologics
12-04Appropriate 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)
12-05Testing Exemptions for Antibody Product Donor Animals
12-06Detection of Mycoplasma Contamination in Vaccines and Biological Products
12-07Submission of Master Seeds, Master Cell Stocks, and Master Sequences to the Center for Veterinary Biologics for Confirmatory Testing
12-09Licensing of Vaccines as Preharvest Food Safety Interventions
12-11Virulent Systemic Feline Calicivirus Label Claims
12-12Use of Humane Endpoints and Methods in Animal Testing of Biological Products
12-21Conducting Dilution of Preservative Studies for Live Bacterial Vaccines
12-25New Policy on Biological Product Samples Submitted to the Center for Veterinary Biologics and Concurrent Testing Selection Period
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CVB Notices - 2011
IDTitle
11-01The Management and Disposition of Eggs, Chickens, and Biological Products Following a Chicken Anemia Virus (CAV) Outbreak in a Source Flock
11-02Generation and Implementation of Draft Guidance
11-12Product Licensing Plans
11-14superseded by CVB Notice 15-02
11-18Virus Inactivation and Safety Test for Rabies Virus Bulks, Title 9, Code of Federal Regulations (9 CFR), Part 113.209
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CVB Notices - 2010
IDTitle
10-10Follow-up Sterility Check Testing
10-11Obtaining the Testing Plan for Authorized Master Seed/Master Cell Sample Submissions
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CVB Notices - 2009
IDTitle
09-02Dilution of Preservative Screening for Broth-Based Sterility Tests
09-04Conversion Formulas for S/P Ratio to Titer in Diagnostic Test Kit Inserts
09-05Consistency of Avian Safety Testing Parameters in Outlines of Production for Multi-fraction Avian Products
09-15Autogenous Vaccines Containing Porcine Circovirus
09-25Dilution of Preservative Screening for Plate-Based Sterility Tests
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CVB Notices - 2008
IDTitle
08-19Electronic Maintenance of Paper Records
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CVB Notices - 2007
IDTitle
07-04Submission of Outsourced Studies
07-06Preparation and Testing of Experimental Biological Products that are Derived from Biotechnology
07-07Post-Challenge Observation Periods for Efficacy Studies
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CVB Notices - 2006
IDTitle
06-03Potential Contamination of Porcine Kidney Cells
06-06Type (Species) Designation of Vaccines Containing Bovine Viral Diarrhea Virus(es)
06-11Replacement of Potency Assay Reference Samples for Immunodiagnostic Test Kits
06-24Exemptions 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)
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CVB Notices - 2005
IDTitle
05-06Requirements for Addition of Leptospira bratislava in Canine Bacterins
05-07Biologics for Reduction of Colonization and/or Shedding in Animals
05-16Posting of Selected Center for Veterinary Biologics Notices and Veterinary Services Memoranda on the Center for Veterinary Biologics Web Site for Comment
05-23Chimera as an Additional Naming Convention for Live Recombinant Products
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CVB Notices - 2004
IDTitle
04-13Use of Minimum Age Animals in Licensure Studies
04-16Efficacy Requirements and Label Claims for Bovine Rotavirus Vaccine
04-17Exemption to 3-year Master Seed Immunogenicity Retesting
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CVB Notices - 2003
IDTitle
03-08Purpose of the Equine Infectious Anemia Weak Positive Serum Sample Outlined in Veterinary Services Memorandum No. 555-16
03-13Detection of Avian Lymphoid Leukosis Virus in Veterinary Biological Products
03-14Customer Feedback on Reagents
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CVB Notices - 2002
IDTitle
02-01Critical Study Dates for Licensing and Reference Qualification Studies
02-15Permit Requirements for Pathogenic Organisms, Including Challenge Materials
02-21Domestic Manufacture of Biologicals Used in the Prevention or Treatment of Foreign Animal Diseases
02-25Conditional Licenses for Products Containing Clostridium perfringens Type A
02-29Availability of Monoclonal Antibodies from the Center for Veterinary Biologics
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CVB Notices - 2001
IDTitle
01-07Identification of Testing Methods for Detection of Extraneous Agents in Fetal Bovine Serum
01-11International Cooperation on Harmonization of Technical Requirements for the Registration of Veterinary Medicinal Products (VICH): Final Guidelines for Good Clinical Practice
01-16Autogenous Products for Avian Influenza
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CVB Notices - 1999
IDTitle
99-19Autogenous Virus Vaccines for Infectious Salmon Anemia Virus

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