CURRENT CVB Notices

CURRENT CVB Notices

Year of Publication
2017   2016   2015   2014   2013   2012   2011   2010   2009   2008   2007   2006   2005 2004   2003   2002   2001   1999

 

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
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 - 2010
ID Title
10-10 Follow-up Sterility Check Testing
10-11 Obtaining the Testing Plan for Authorized Master Seed/Master Cell Sample Submissions
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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 - 2008
ID Title
08-19 Electronic Maintenance of Paper Records
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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
01-16 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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