Center for Veterinary Biologics
Public Notices |
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Contact the Center for Veterinary Biologics to obtain copies of Notices not listed here.
Year of Publication
2012 2011 2010 2009 2008 2007 2006
2005 2004 2003 2002 2001 2000 1999
CVB Notices--2012 |
ID |
Size (KB) |
Title (All documents in PDF format.) |
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49 |
Issuance of Licenses |
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34 |
Change in Contact Information for the Policy, Evaluation, and Licensing, Operational Support Section |
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36 |
Exemption to Shipping a Sample of Inactivated Lot or Bulk Rabies Antigen to the Center for Veterinary Biologics |
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61 |
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) |
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40 |
Testing Exemptions for Antibody Product Donor Animals |
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37 |
Detection of Mycoplasma Contamination in Vaccines and Biological
Products |
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37 |
Submission of Master Seeds, Master Cell Stocks, and Master Sequences to the Center for Veterinary Biologics for Confirmatory Testing |
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44 |
Issuance of Licenses |
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46 |
Licensing of Vaccines as Preharvest Food Safety Interventions |
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34 |
Issuance of a Conditional License for Corynebacterium Pseudotuberculosis Bacterin |
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CVB Notices--2011 |
ID |
Size (KB) |
Title (All documents in PDF format.) |
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1260 |
Veterinary Biological Products in Licensed Establishments Produced and Destroyed 01/01/2010 through 12/31/2010 |
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37 |
The Management and Disposition of Eggs, Chickens, and Biological Products Following a Chicken Anemia Virus (CAV) Outbreak in a Source Flock |
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26 |
Generation and Implementation of Draft Guidance |
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50 |
Issuance of Licenses |
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27 |
Expiration Date Extension and Discontinued Reagents: Salmonella Standard Reference Bacterins |
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27 |
Replacement of the Center for Veterinary Biologics Escherichia coli, HRP-labeled K88 Monoclonal Antibody |
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26 |
Cancellation of Veterinary Services Memorandum 800.96 and Notice of Example Data Files |
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28 |
Distribution of a new lot of Leptospira grippotyphosa Polyclonal Antibody, IRP 511-04 |
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55 |
Issuance of Licenses |
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26 |
Expiration Date Extension for Erysipelothrix Rhusiopathiae Standard Reference Bacterin, IRP 529(05) |
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22 |
Paper Reduction Initiatives |
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19 |
Replacement Lots of the Center for Veterinary Biologics' Mycobacterium Tuberculosis Sensitinogen, Escherichia coli Anti-K99 Pilus Horseradish Peroxidase (HRP)-Labeled Monoclonal Antibody, and Clostridium tetani Antitoxin 5.0 AU/mL (guinea pig origin) |
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23 |
Product Licensing Plans |
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16 |
Distribution of a New Lot of Leptospira kirschneri Serogroup grippotyphosa Mouse Ascites (also designated as Leptospira grippotyphosa Monoclonal Antibody (LG MAb) IRP 04-505 |
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43 |
Use of Symbols on Labeling for Diagnostic Test Kits |
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22 |
Discontinued Reagents: Standard Reference Preparations and Test Reagents for Virus Biological Products |
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28 |
Issuance of Licenses |
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20 |
Withdrawal of Supplemental Assay Method (SAM) for the Mikrozone
Electrophoretic Separation of Blood Fractions Used in Veterinary Biologics, SAM 509 |
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19 |
Virus Inactivation and Safety Test for Rabies Virus Bulks, Title 9, Code of Federal Regulations (9 CFR), Part 113.209 |
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36 |
Avian Influenza (H5 and H7 Subtypes) Vaccine Bank |
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40 |
Supplemental Assay Methods |
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50 |
Issuance of Licenses |
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36 |
Routine Distribution and Replacement of the Center for Veterinary Biologics' Bacterial Testing Reagents |
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35 |
Issuance of a Conditional License for West Nile Virus Vaccine, Killed
Virus |
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CVB Notices--2010 |
ID |
Size (KB) |
Title (All documents in PDF format.) |
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779 |
Veterinary Biological Products in Licensed Establishments Produced and Destroyed 01/01/2009 through 12/31/2009 |
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48 |
Issuance of Licenses |
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20 |
Issuance of Licenses |
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15 |
Extension of Dating for Clostridium Novyi type B antitoxin, IRP 507(04) |
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17 |
Replacement of the Center for Veterinary Biologics Killed Veterinary Rabies References |
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20 |
International Cooperation on Harmonization of Technical Requirements
for the Registration of Veterinary Medicinal Products (VICH): Final Guidelines for Target Animal Safety for Veterinary Live and Inactivated Vaccines |
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16 |
Withdrawal of Supplemental Assay Method 216 |
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23 |
Extension of Dating for Pasteurella Multocida Type A Standard References Bacterin, IRP 573 (08); Pasteurella Multocida Standard Reference Bacterin, IRP PMA 1062 Serial 2; and Clostridium haemolyticum spore preparation IRP 526 (06) |
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25 |
Issuance of Licenses |
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43 |
Issuance of Licenses |
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27 |
Follow-up Sterility Check Testing |
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26 |
Obtaining the Testing Plan for Authorized Master Seed/Master Cell Sample Submissions |
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24 |
Product Code Book Availability |
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CVB Notices--2009 |
ID |
Size (KB) |
Title (All documents in PDF format.) |
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774 |
Veterinary Biological Products in Licensed Establishments Produced and Destroyed 01/01/2008 through 12/31/2008 |
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22 |
Issuance of Licenses |
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22 |
Dilution of Preservative Screening for Broth-Based Sterility Tests |
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21 |
Issuance of a Conditional License for Escherichia Coli Bacterial Extract |
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31 |
Conversion Formulas for S/P Ratio to Titer in Diagnostic Test Kit Inserts |
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22 |
Consistency of Avian Safety Testing Parameters in Outlines of Production for Multi-fraction Avian Products |
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20 |
Issuance of Licenses |
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18 |
Extension of Dating for Pasteurella Multocida Type A Standard Reference Bacterin, IRP PMA 169 Serial 3 |
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20 |
APHIS Form 2015 Available Electronically (APHIS Form 2015 Fillable, 70 KB) |
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28 |
Discontinued Reagents: Sarcocystis neurona and Sarcocystis falcatula, Rabies Serum Neutralization Indicator Virus, Feline Leukemia Positive Control (ELISA Reagent), Equine Rhinopneumonitis (EHV1) Antiserum |
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25 |
Availability of H1N1 Influenza Virus (Material Transfer Agreement, 25 KB) |
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21 |
Center for Veterinary Biologics Move to New Location in Ames, Iowa |
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18 |
Issuance of a Conditional License for Canine Influenza Vaccine, H3N8, Killed Virus |
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24 |
Issuance of Licenses |
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23 |
Withdrawal of Supplemental Assay Methods 101, 102, 105, and 125 |
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16 |
Autogenous Vaccines Containing Porcine Circovirus |
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32 |
Qualification of Leptospira Canicola, Leptospira Grippotyphosa, Leptospira Icterohaemorrhagiae, and Leptospira Pomona Reference Bacterins for Products Intended for Use in Swine and/or Cattle |
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16 |
Accepting Product License Application for Epizootic Hemorrhagic Disease Vaccine |
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17 |
Novel H1N1 Influenza Master Seed Virus Available from Center for Veterinary Biologics (CVB) (Material Transfer Agreement, 70 KB) |
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15 |
Submission of APHIS Forms Used for Export of Veterinary Biologic Products |
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16 |
Withdrawal of Supplemental Assay Methods 601, 605, and 606 |
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17 |
Transition Period for Implementation of a New Lot of Porcine Pasteurella Multocida Standard Reference Bacterin |
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25 |
Issuance of Licenses |
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16 |
Expiration Date Extension and Discontinued Reagents: Salmonella Standard Reference Bacterins |
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16 |
Issuance of a Conditional License for Swine Influenza Vaccine, pH1N1, Killed Virus |
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21 |
Dilution of Preservative Screening for Plate-Based Sterility Tests |
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CVB Notices--2008 |
ID |
Size (KB) |
Title (All documents in PDF format.) |
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919 |
Veterinary Biological Products in Licensed Establishments Produced and Destroyed 01/01/2007 through 12/31/2007 |
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22 |
Issuance of Licenses |
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12 |
Availability of Clostridium perfringens Type A Standard Antitoxin and Toxin |
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18 |
Dating Extension for Salmonella choleraesuis Standard Reference Bacterin |
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12 |
Reinstatement and Dating Extension for Erysipelothrix Rhusiopathiae Standard Reference Bacterin, Serial 5 |
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21 |
Application for United States Biological Product Permits |
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26 |
Issuance of Licenses |
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17 |
Discontinued Reagent: Transmissible Gastroenteritis Challenge Virus |
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18 |
Availability of Bovine Viral Diarrhea Challenge Virus |
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18 |
Discontinued Reagent: Eastern Equine Encephalomyelitis Challenge Virus |
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18 |
Extension of Dating for Pasteurella Multocida Standard Reference Bacterins |
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19 |
Reinstatement of Erysipelothrix Rhusiopathiae Standard Reference Bacterin, IRP 529(05)
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25 |
Issuance of Licenses
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31 |
International Cooperation on Harmonization of Technical Requirements for the Registration of Veterinary Medicinal Products (VICH): Final Guidelines for Backpassage Studies |
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23 |
Discontinued Reagent: GB Texas Newcastle Disease Challenge Virus
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Dating Extension for Salmonella typhimurium and Salmonella dublin Standard Reference Bacterins
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23 |
Discontinued Reagent: Feline Rhinotracheitis Challenge Virus |
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48 |
Issuance of Licenses |
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32 |
Changes to the Administrative Inspection Review Program (Administrative Inspection Review Form, 694 KB) |
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29 |
Electronic Maintenance of Paper Records |
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27 |
Extension of Dating of Pasteurella Multocida and Salmonella Choleraesuis Standard Reference Bacterins |
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CVB Notices--2007 |
ID |
Size (KB) |
Title (All documents in PDF format.) |
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1304 |
Veterinary Biological Products in Licensed Establishments Produced and Destroyed 01/01/06 through 12/31/06 |
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25 |
Issuance of Licenses |
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37 |
Qualification of Leptospira grippotyphosa and Leptospira icterohaemorrhagiae Reference Bacterins for Products Intended for Use in Dogs |
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18 |
Issuance of a Conditional License for Canine Melanoma Vaccine, DNA |
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21 |
Submission of Outsourced Studies |
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18 |
Issuance of Licenses |
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23 |
Preparation and Testing of Experimental Biological Products that are Derived from Biotechnology |
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22 |
Post-Challenge Observation Periods for Efficacy Studies |
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17 |
Discontinued Reagent: Avian Leukosis Virus Antiserum |
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18 |
Discontinued Reagent: Canine Coronavirus Coating Antibody |
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32 |
Issuance of Licenses |
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13 |
Revised URL for Center for Veterinary Biologics Website |
|
25 |
Qualification of Leptospira pomona and Leptospira canicola Reference Bacterins for Products Intended for Use in Dogs |
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18 |
Availability of Feline Panleukopenia Virus Challenge Seed Material |
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18 |
Availability of a New Erysipelothrix Rhusiopathiae Standard Reference
Bacterin |
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31 |
Software Patch for Estimating Prevented Fraction Confidence Intervals |
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23 |
Issuance of Licenses |
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16 |
Labeling of Equine Influenza and Swine Influenza Vaccines |
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CVB Notices--2006 |
ID |
Size (KB) |
Title (All documents in PDF format.) |
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20 |
Issuance of Licenses |
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22 |
Issuance of a Conditional License for Avian Influenza Virus Type A Antigen Test Kit |
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23 |
Potential Contamination of Porcine Kidney Cells |
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20 |
Withdrawal of Supplemental Assay Methods 310 and 311 |
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20 |
Issuance of Conditional Licenses for Avian Influenza Vaccine, Killed
Virus – Subtypes H5N2, H5N9, H7N2, H7N3 |
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25 |
Type (Species) Designation of Vaccines Containing Bovine Viral Diarrhea
Virus(es) |
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20 |
Center for Veterinary Biologics Public Meeting |
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23 |
Avian Influenza (H5 Subtypes) Vaccine Bank |
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20 |
Mailing Lists for Center for Veterinary Biologics Notices and Veterinary
Services Memorandums |
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26 |
Issuance of Licenses |
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27 |
Replacement of Potency Assay Reference Samples for Immunodiagnostic Test Kits |
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21 |
Authorization to Use Remaining Inventories of Replaced Labels |
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20 |
Transfer of Food Safety and Inspection Service (FSIS) Support of
Adjuvant Reviews from FSIS to the Animal and Plant Health Inspection
Service (APHIS) |
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20 |
Dating Extension for Pasteurella multocida Standard Reference Bacterins |
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30 |
Request for Adjuvant and Excipient Data
(MS Excel Template, 13.5KB) |
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23 |
True Name Change for Canine Vaccines with Bacterins Containing Leptospira |
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27 |
Issuance of Licenses |
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21 |
Avian Influenza (H7 Subtypes) Vaccine Bank |
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25 |
Issuance of a Conditional License for Mycobacterium Paratuberculosis DNA Test Kit, Polymerase Chain Reaction |
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22 |
Dating Extension and Dilution Adjustment for Selected Standard References |
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22 |
Replacement of the Center for Veterinary Biologics Killed Veterinary Rabies Reference |
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19 |
Issusances of Licenses |
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18 |
Production Changes for Rabies Vaccines |
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19 |
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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18 |
Issuance of a Conditional License for Lymphocyte T-Cell Immunodulator |
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CVB Notices--2005 |
ID |
Size (KB) |
Title (All documents in PDF format.) |
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13 |
Mouse Safety Testing |
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15 |
Issuance of Licenses |
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41 |
Implementation of the Administrative Inspection Review Program |
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14 |
Issuance of a Conditional License for Clostridium Perfringens Type A Toxoid |
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13 |
Confidence Interval Estimation in Serological Interference Studies |
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28 |
Requirements for Addition of Leptospira bratislava in Canine Bacterins |
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16 |
Biologics for Reduction of Colonization and/or Shedding in Animals |
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20 |
GB Texas Newcastle Disease Challenge Virus; Change in Select Agent Status |
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26 |
Issuance of Licenses |
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19 |
Issuance of a Conditional License for Streptococcus Equi Antibody |
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25 |
Conditional License for Product Containing Clostridium perfringens Type A |
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24 |
New Directors for Center for Veterinary Biologics |
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18 |
Avian Influenza (H5 and H7 Subtypes) Vaccine Bank |
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21 |
Issuance of Licenses |
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19 |
Issuance of a Conditional License for Porphyromonas Denticanis-Gulae-Salivosa Bacterin |
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27 |
Posting of Selected Center for Veterinary Biologics Notices and Veterinary Services Memoranda on the Center for Veterinary Biologics Web Site for Comment |
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27 |
Dating Extension and Dilution Adjustment for Standard Reference Bacterin IRP ERB-5 |
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18 |
Canine Influenza Virus Vaccine and Related Diagnostic Test Kits |
05-19 |
-- |
[Not Issued] |
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28 |
Issuance of Licenses |
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20 |
Issuance of a Conditional License for Porcine Circovirus Vaccine, Type 2, Killed Baculovirus Vector |
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20 |
Avian Influenza (H5 and H7 Subtypes) Vaccine Bank |
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24 |
Chimera as an Additional Naming Convention for Live Recombinant Products |
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31 |
Immediate Notifications to the Center for Veterinary Biologics per 9 CFR Part 116 |
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CVB Notices--2004 |
ID |
Size (KB) |
Title (All documents in PDF format.) |
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22 |
Exporting of Veterinary Biologics Products Containing Ruminant-Derived Materials |
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23 |
Diagnostic Test Kits for Bovine Spongiform Encephalopathy |
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19 |
Issuance of Licenses |
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19 |
Resumption of Signing of Certificates of Licensing and Inspection and Official Export Certificates for Animal Biological Products |
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20 |
Replacement of the Center for Veterinary Biologics’ IgG Species Standard for Qualification of IgG Reference Product for Failure of Passive Transfer Products |
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21 |
Issuance of a Conditional License for Canine Gonadotropin Releasing Factor Immunotherapeutic |
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24 |
Request for Master Seed and Master Cell Stock Lists |
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24 |
Diagnostic Test Kits for Bovine Spongiform Encephalopathy |
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8 |
Use of Humane Endpoints in Animal Testing of Biological Products |
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18 |
Issuance of Licenses |
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13 |
Name Change for Biologicals Containing Actinomyces pyog |
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9 |
Avian Influenza (H5 and H7 Subtypes) Vaccine Bank |
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15 |
Use of Minimum Age Animals in Licensure Studies |
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24 |
Issuance of Licenses |
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17 |
Name Change for Biologicals Containing Avian Influenza Virus |
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13 |
Efficacy Requirements and Label Claims for Bovine Rotavirus Vaccine |
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17 |
Exemption to 3-year Master Seed Immunogenicity Retesting |
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35 |
Issuance of Licenses |
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14 |
Issuance of a Conditional License for Salmonella Newport Bacterial Extract |
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13 |
Issuance of New Supplemental Assay Method |
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13 |
Issuance of a Conditional License for West Nile Virus Antibody, Equine Origin |
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14 |
Issuance of a Conditional License for Crotalus Atrox Toxoid |
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16 |
Posting of Selected Center for Veterinary Biologics Draft Notices and Veterinary Services Draft Memoranda on the Center for Veterinary Biologics Web site for a Comment Period |
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CVB Notices--2003 |
ID |
Size (KB) |
Title (All documents in PDF format.) |
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19 |
Issuance of Licenses |
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20 |
Amended Change in Implementation Date for the New Center for Veterinary Biologics' Killed Veterinary Rabies Reference |
|
22 |
Temporary Change in Services Provided by the Center for Veterinary Biologics |
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20 |
Current Center for Veterinary Biologics Bluetongue Virus Reference Serum Panel |
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21 |
Organizational Realignment within the Center for Veterinary Biologics |
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23 |
Implementation of the New Center for Veterinary Biologics' Killed Veterinary Rabies Reference |
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10 |
Issuance of Licenses |
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20 |
Purpose of the Equine Infectious Anemia Weak Positive Serum Sample Outlined in Veterinary Services Memorandum No. 555-16 |
|
15 |
Issuance of Licenses |
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20 |
Issuance of New Supplemental Assay Method |
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122 |
Issuance of a Conditional License for Mycobacterium Bovis Gamma Interferon Test Kit for Cervids |
|
110 |
Issuance of a Conditional License for West Nile Virus Antibody, Equine Origin |
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129 |
Detection of Avian Lymphoid Leukosis Virus in Veterinary Biological Products |
|
20 |
Customer Feedback on Reagents |
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23 |
Availability of Specific Pathogen Free Eggs |
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20 |
Issuance of Licenses |
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20 |
Change in Product Label Numbering System |
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CVB Notices--2002 |
ID |
Size (KB) |
Title (All documents in PDF format.) |
|
12 |
Critical Study Dates for Licensing and Reference Qualification Studies |
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12 |
Change in Finished Label Submission Requirement |
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26 |
Issuance of Licenses |
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16 |
Autogenous Vaccine Use in Turkeys |
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15 |
Issuance of a Conditional License for Treponema Bacterin |
|
13 |
Draft Standard Requirement for Equine Influenza Vaccine, Killed Virus |
|
151 |
Issuance of Licenses |
|
125 |
Diagnostic Test Kits for Scrapie and Chronic Wasting Disease |
|
109 |
Issuance of Additional RelPot Software and Supplemental Assay Method |
|
103 |
Issuance of a Conditional License for Avian Influenza Vaccine, Killed Virus, H7 Subtype |
|
151 |
Reagents and Testing of Master Seed Viruses |
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115 |
Availability of References and Reagents from the Center for Veterinary Biologics |
|
147 |
Issuance of Licenses |
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23 |
Permit Requirements for Pathogenic Organisms, Including Challenge Materials |
|
18 |
Issuance of a Conditional License for Mycobacterium Tuberculosis Gamma Interferon Test Kit for Non-Human Primates |
|
139 |
Replacement of the Center for Veterinary Biologics' Killed Veterinary Rabies Reference |
|
21 |
Issuance of a Conditional License for Avian Pneumovirus Vaccine Modified Live Virus |
|
56 |
Vaccine Claims for Protection of the Fetus Against Bovine Virus Diarrhea Virus |
|
21 |
CVB Liaison Authorization Process |
|
25 |
Domestic Manufacture of Biologicals Used in the Prevention or Treatment of Foreign Animal Diseases |
|
101 |
Issuance of a Conditional License for Bacterial Immunomodulator, Killed Bacteria |
|
104 |
Issuance of Licenses |
|
214 |
Guidance Document for Veterinary Biologics Derived from Bioengineered Plants |
|
122 |
Conditional Licenses for Products Containing Clostridium perfringens Type A |
|
99 |
Change in Implementation Date for the New Center for Veterinary Biologics' Killed Veterinary Rabies Reference |
|
21 |
Availability of Distemper Virus Aerosol Challenge |
|
21 |
Name Change for Biologicals Containing Pasteurella haemolytica |
|
22 |
Availability of Monoclonal Antibodies from the Center for Veterinary Biologics |
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CVB Notices--2001 |
ID |
Size (KB) |
Title (All documents in PDF format.) |
|
16 |
Issuance of New or Revised Supplemental Assay Methods |
|
7 |
Applications for Licensure of West Nile Virus Vaccine |
|
6 |
Identification of Component Products in Combination Package Biologics |
|
14 |
Issuance of Revised RelPot Software and Supplemental Assay |
|
12 |
Identification of Testing Methods for Detection of Extraneous Agents in Fetal Bovine Serum |
|
18 |
Stability Testing of New Biotechnological/Biological Veterinary Medicinal Products |
|
20 |
International Cooperation on Harmonization of Technical Requirements for the Registration of Veterinary Medicinal Products (VICH): Final Guidelines for Good Clinical Practice |
|
13 |
Temporary Release Procedures for Veterinary Biologics |
|
13 |
Approved Sources of Animal Origin Ingredients |
|
12 |
Identification of Electronic Storage Media Submitted to the Center for Veterinary Biologics |
|
9 |
Autogenous Products for Avian Influenza |
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CVB Notices--2000 |
ID |
Size (KB) |
Title (All documents in PDF format.) |
|
7 |
Collaborative Studies on Moisture and Formaldehyde |
|
6 |
Issuance of a Conditional License for Lawsonia Intracellularis Vaccine, Avirulent Live Culture |
|
21 |
Standard Reference Bacterin, ERB-5 |
|
7 |
Courtesy Notification of Serial Release Actions |
|
6 |
Issuance of a Conditional License for Mycoplasma Bovis Bacterin |
|
6 |
Issuance of a Conditional License for Avian Influenza Vaccine, Killed Virus, H5 Subtype |
|
12 |
Issuance of New Supplemental Assay Method |
|
12 |
Issuance of New Supplemental Assay Method |
|
13 |
Issuance of a Conditional License for Sarcocystis Neurona Vaccine, Killed Protozoa |
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CVB Notices--1999 |
ID |
Size (KB) |
Title (All documents in PDF format.) |
|
7 |
New Directors for CVB and Change of Address for Submissions to Licensing and Policy Development |
|
10 |
Completion of Part I of the Outline of Production for Vaccines, Bacterins, Antigens, and Toxoids |
|
5 |
Supplementary Aids for Applicants |
|
7 |
Determination of Expiration Dates for Biological Products |
|
9 |
International Cooperation on Harmonization of Technical Requirements for the Registration of Veterinary Medicinal Products (VICH): Request for Comments Regarding Proposed Guidelines for Technical Requirements |
|
9 |
Autogenous Virus Vaccines for Infectious Salmon Anemia Virus |
|
6 |
Alternative Safety Testing for Serial Release of Oral Antibody Products |
|
16 |
Solicitation of Representative Samples for International Collaborative Study |
|
6 |
Center for Veterinary Biologics Y2K Telecommunications Contingency Plan |
--Back to Top--
Last Modified:
May 10, 2012
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