CURRENT CVB Notices
Last Modified: Jul 15, 2019
| 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 |
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| 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 |
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| 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
Draft of the FDS and instructions for use |
| 17-12 |
Issuance of Licenses |
| 17-13 |
Revised Scope of Eligibility for Studies Requiring Single-Tier Summaries |
| 17-14 |
Relative Potency Terminology for References and Related Preparations |
| 17-15 |
Center for Veterinary Biologics Laboratory-supplied Reagents |
| 17-16 |
Issuance of a Conditional License for Canine Osteosarcoma Vaccine, Live Listeria Vector |
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| 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 |
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| 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 |
| 15-14 |
System Change at Customs and Border Protection for Importing Commodities into the United States, including Permitted Veterinary Biologics |
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| 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 |
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| 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 |
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| 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 |
| 12-17 |
not issued |
| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
| 06-23 |
Production Changes for Rabies Vaccines |
| 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) |
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| 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 |
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| 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 |
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| 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 |
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| CVB Notices - 2002 |
| ID |
Title |
| 02-01 |
Critical Study Dates for Licensing and Reference Qualification Studies |
| 02-04 |
Autogenous Vaccine Use in Turkeys |
| 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 |
| 02-24 |
Guidance Document for Veterinary Biologics Derived from Bioengineered Plants |
| 02-25 |
Conditional Licenses for Products Containing Clostridium perfringens Type A |
| 02-29 |
Availability of Monoclonal Antibodies from the Center for Veterinary Biologics |
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| 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 |
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| CVB Notices - 1999 |
| ID |
Title |
| 99-17 |
International Cooperation on Harmonization of Technical Requirements for the Registration of Veterinary Medicinal Products (VICH): Request for Comments Regarding Proposed Guidelines for Technical Requirements |
| 99-19 |
Autogenous Virus Vaccines for Infectious Salmon Anemia Virus |
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Additional Information
United States Department of Agriculture
