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Animal Health
Veterinary Services Memorandums |
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| 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 |
35 |
Release of Biological Products (November 7, 2006) |
| 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 | 39 |
Veterinary Biological Product Samples (November 3, 2010) |
| 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 | 20 |
Standard Reference Preparations, Test Reagents, and Seed Cultures for Laboratory Test Reagents (November 14, 2011) |
| 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 | 12 |
Exemption from Leptospira Bacterin Testing Under 9 CFR 113.101(c), 113.102(c), 113.103(c), and 113.104(c) (May 23, 2002) |
| 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) |
| 800.200 | 30 |
General Licensing Considerations: Study Practices and Documentation (June 14, 2002) |
| 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 | 68 |
General Licensing Considerations: Preparing Outlines of Production for Vaccines, Bacterins, Antigens, and Toxoids (April 13, 2012) |
| 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) |
| 800.300 | 30 |
Stability Testing of New Biotechnological/Biological Veterinary Medicinal Products (July 26, 2001) |
| 800.301 | 61 |
Good Clinical Practices (July 26, 2001)
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Last Modified:
June 24, 2013