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Veterinary Services Memorandums

Number Size (KB) Title (PDF format)
800.50 69 Basic License Requirements and Guidelines for Submission of Materials in Support of Licensure (February 9, 2011)
800.51 31 Additives in Animal Biological Products (October 18, 2007)
800.52 16 Export Certificates for Animal Biological Products
(April 2, 2001)
800.53 124 Release of Biological Products (June 27, 2014)
800.54 15 Guidelines for the Preparation and review of Labeling Materials (August 31, 1988)
800.55 5 Concurrent and Confirmatory Tests of Market Serials (February 17, 1986)
800.56 23 Disposal of Unsatisfactory and Undesirable Materials (March 12, 2008)
800.57 46 Market Suspensions (March 29, 2012)
800.58 22 Sublicensing of Veterinary Biological Products
(October 18, 2007)
800.59 75 Veterinary Biological Product Samples (September 4, 2013)
800.60 20 Biological Products Returned to Licensed Establishments (March 11, 2008)
800.61 21 Split Manufacturing of Veterinary Biological Products (October 21, 1999)
800.62 18 Relabeling, Rebottling, and Reprocessing Veterinary Biological Products (December 22, 1999)
800.63 13 Personnel at Licensed Establishments (October 1, 1999)
800.64 23 Preparation of Experimental Products at Licensed Establishments (March 14, 2012)
800.65 18 Eggs and Chickens for Production of Veterinary Biological Products (September 20, 2002)
800.66 15 Freedom of Information Act Requests Involving Veterinary Biological Products (October 21, 1999)
800.67 41 Shipment of Experimental Veterinary Biological Products (November 16, 2011)
800.68 10 New Biotechnology for Preparation of Animal Biological Products (December 4, 1984)
800.69 45 Guidelines for Autogenous Biologics (August 7, 2009)
800.70 15 Rabies Vaccine Immunogenicity Test Protocols
(April 27, 2000)
800.73 36 General Requirements for Immunodiagnostic Test Kits for the Detection of Antibody or Antigen (June 20, 2002)
800.74 15 Preparation and Distribution of Sterile Diluents
(November 4, 1999)
800.75 14 Reissuance of Product Licenses for Products Under Conditional Licenses (October 27, 1999)
800.76 14 Trade Names and Logos on Licensed Veterinary Biological Products (October 27, 1999)
800.77 12 Unsatisfactory Product Stability (July 14, 1986)
800.78 238 Preparation and Submission of Facilities Documents
(November 11, 2010)
800.79 46 Submission of Host Animal Serum Samples for In Vitro Potency Tests (March 20, 2013)
800.80 14 Distributor Labels (July 23, 1999)
800.81 22 Chicken Bursa Origin Bursal Disease Vaccines
(March 30, 2001)
800.83 24 Export of Serials Before Completion of Serial Release Testing (November 14, 2011)
800.84 -- Canceled. Superseded by VSM 800.50
800.85 39 Avian Influenza Vaccines (May 18, 2006)
800.86 10 Exemption from Mycoplasma Testing in Accordance with Title 9, Code of Federal Regulations, Part 113.200 (c) (3) (November 4, 1999)
800.87 185 Guidelines for Licensing Establishments with Separated Premises (May 13, 2005)
800.88 11 Testing for Reticuloendotheliosis Virus Contamination (August 23, 1999)
800.89 21 Chicken Anemia Virus (December 22, 1999)
800.90 55 Guidelines for Veterinary Biological Relative Potency Assays and Reference Preparations Based on ELISA Antigen Quantification (August 5, 1998)
800.91 46 Categories of Inspection for Licensed Veterinary Biologics Establishments (May 13, 1999)
800.92 27 Potency Reference Preparation Summaries (October 18, 2007) (fillable version Appendix 1: Potency Reference Submission Worksheet (38KB)
800.93 -- Canceled. Superseded by CVB Notice 11-20.
800.94 35 Food and Drug Administration's Export Reform and Enhancement Act of 1996 (May 10, 2011)
800.95 19 GB Texas Newcastle Disease Challenge Virus
(June 25, 2008)
800.96 27 Guidelines for Submitting Electronic Data Files for Statistical Analysis (December 17, 2008) - canceled by CVB Notice No. 11-06 (March 17, 2011)
800.97 27 Standard Reference Preparations, Test Reagents, and Seed Cultures for Laboratory Test Reagents (June 12, 2014)
800.98 31 Advertising and Promotional Materials (July 25, 2008)
800.99 18 Guidelines for Using In Vitro Relative Potency Tests to Determine the Antigen Content of Inactivated Bovine Rhinotracheitis Vaccine (April 26, 2001)
800.100 10 Exemption from Using Heat or Ionizing Radiation to Treat Equine Plasma Used in Manufacturing Plasma Products for Oral or Parenteral Administration to Horses Under 9 CFR 113.450(e)(1) and Exemption from the Mouse Safety Test Under 9 CFR 113.450 (i) (July 29, 2002)
800.101 69 U.S. Veterinary Biological Product Permits for Distribution and Sale (June 6, 2013)
800.102 74 Exemption from Leptospira Bacterin Testing Under 9 CFR 113.101-104 and the Associated References and Studies
(December 12, 2013)
800.103 10 Reissuance of Product Licenses for Autogenous Products and Guidance Concerning Restrictions on the Production and Use of Veterinary Biologics (May 28, 2002)
800.104 16 In Vitro Serial Release Potency Test for Completed Product Containing Clostridium chauvoei (May 29, 2003)
800.106 9 Exemption to Sterility Test Requirement for Allergenic Extract Prescription Product (December 9, 2002)
800.107 8 Policy for Changing Cells and Cell Substrates of Licensed Vaccines (November 25, 2002)
800.108 6 Inventory and Disposition Records (January 15, 2003)
800.109 20 Master Seed and Master Cell Stock Testing Report Submission (May 26, 2004)
800.110 218 Exemption from Label Warning Concerning the Use of Bovine Rhinotracheitis Vaccine, Modified Live Virus in Pregnant Cows or in Calves Nursing Pregnant Cows Under 9 Code of Federal Regulations 112.7(e) (October 18, 2004)
800.111 27 Viral Strain Changes in Equine Influenza and Swine Influenza Vaccines (Killed Virus) (September 19, 2007)
800.112 95 Guidelines for Validation of In Vitro Potency Assays (August 29, 2011)
800.113 29 Production, Testing and Storage of Master Seed and Master Cell Stocks at Alternate Locations (September 17, 2008)
800.114 117 Alternative Test Procedure for Tuberculin, PPD Bovis, Intradermic (April 13, 2012)
800.115 65 Potency Testing by Unlicensed Facilities (June 21, 2013)
800.116 153 Animal Safety Testing Exemption (July 31, 2013)
800.117 90 Guidance for Inactivation Studies (August 12, 2013)
800.118 64 Live Master References (December 12, 2013)
800.119 52 Exemptions to title 9, Code of Federal Regulations (9 CFR), Part 113.28, Detection of Mycoplasma Contamination (March 19, 2014)
800.120 39 Dilution of Preservative Screening for Sterility Testing of Veterinary Biologics (June 27, 2014)
800.200 74 General Licensing Considerations: Study Practices and Documentation (June 12, 2014)
800.201 124 General Licensing Considerations: Backpassage Studies (June 25, 2008)
800.202 27 General Licensing Considerations: Efficacy Studies
(June 14, 2002)
800.203 28 General Licensing Considerations:  Compatibility of Components (January 16, 2007)
800.204 40 General Licensing Considerations: Field Safety Studies (March 16, 2007)
800.205 19 General Licensing Considerations: Biotechnology-derived Veterinary Biologics Categories I, II, and III (May 28, 2003)
800.206 114 General Licensing Considerations: Preparing Outlines of Production for Vaccines, Bacterins, Antigens, and Toxoids (March 26, 2014)
800.207 109 General Licensing Considerations: Target Animal Safety (TAS) Studies Prior to Product Licensure - VICH Guideline 44 (July 6, 2010)
800.208 37 Special Labels for Product for Export (October 21, 2010)
800.209 36 Bovine Corona Virus and Rotavirus Master Reference Qualification by Colostral Antibody Titers (December 8, 2010)
800.210 34 Minor Temperature Deviations of Biological Products (December 22, 2010)
800.211 35 Guidelines for Master Reference Qualification and Requalification (June 28, 2011)
800.212 69 Licensing Considerations: Vaccine Claims for Protection of the Fetus Against Bovine Virus Diarrhea Virus (November 14, 2011)
800.213 74 Guidelines for Obtaining a Conditional Veterinary Biologics License for Production Platform Derived, Recombinant, Non-replicating, Nonviable Constructs (August 12, 2013)
800.300 30 Stability Testing of New Biotechnological/Biological Veterinary Medicinal Products (July 26, 2001)
800.301 61 Good Clinical Practices (July 26, 2001)
(See CVB Notice 01-11 for additional guidance regarding application of this VS Memo.)


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