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Veterinary Biologics Information Published in the Last 90 Days

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CVB Notices
Title ID Size (KB) Publication Date Posted Date
Issuance of Licenses 14-14 43 Oct 07, 2014 Oct 16, 2014
Processing Special Outlines Describing Proposed Serial Release Assays 14-16 24 Oct 10, 2014 Oct 16, 2014
Veterinary Services Memorandums (new or revised)
Title ID Size (KB) Publication Date Posted Date
General Licensing Considerations: Efficacy Studies for Prophylactic and Therapeutic Biologics 800.202 67 Oct 27, 2014 Oct 30, 2014
Rulemaking
Title FR Citation Size (KB) Effective Date Posted Date
Viruses, Serums,Toxins, and Analogous Products; Standard Requirements; Addition of Terminology To Define Veterinary Biologics Test Results APHIS-2013-34 200 October 20, 2014 Sep 26, 2014
Proposed Rulemaking
Title Federal Register Vol/Page Size (KB) Comments Due Date Posted Date
         
Supplemental Assay Methods (SAMs)
Title ID Size (KB) Document Date Posted Date
Supplemental Assay Method for Isolation of Parainfluenza-3 Virus from Nasal Excretions 104 146 Oct 10, 2014 Dec 02, 2014
Supplemental Assay Method for the In vitro Potency Assay of Bovine Respiratory Viruses in Killed Vaccines 120 170 Oct 16, 2014 Dec 02, 2014
Supplemental Assay Method for the Titration of Bovine Rhinotracheitis Neutralizing Antibody (Constant Virus-Varying Serum Method) 109 295 Oct 16, 2014 Dec 10, 2014
Supplemental Assay Method for Conducting the Hemagglutination Inhibition Assay for Equine Influenza Antibody 124 227 Oct 23, 2014 Dec 10, 2014
Fluorescent Antibody Staining Procedure for Detection of Extraneous Agents in Master Seeds 314 150 Nov 13, 2014 Dec 10, 2014
Supplemental Assay Method for Titration of Bovine Virus Diarrhea Neutralizing Antibody (Constant Serum-Varying Virus Method) 115 183 Oct 16, 2014 Dec 12, 2014
Supplemental Assay Method for Titration of Pseudorabies Virus Neutralizing Antibody (Constant Virus-Varying Serum Method) 117 255 Oct 16, 2014 Dec 12, 2014
Supplemental Assay Method for Titration of Pseudorabies Virus in Vaccine 118 131 Oct 16, 2014 Dec 12, 2014
Supplemental Assay Method for Titration of Eastern, Western, and Venezuelan Equine Encephalomyelitis Virus Neutralizing Antibodies 110 164 Oct 16, 2014 Dec 16, 2014
Supplemental Assay Method for Titration of Bovine Viral Diarrhea Virus Neutralizing Antibody (Constant Virus – Varying Serum Method) 112 256 Oct 16, 2014 Dec 16, 2014
Supplemental Assay Method for the Detection of Extraneous Hemadsorbing Agents in Master Seed Virus 313 272 Nov 13, 2014 Dec 16, 2014
Supplemental Assay Method for Titration of Canine Adenovirus in Canine Kidney Cell Culture 317 201 Nov 13, 2014 Dec 16, 2014
Supplemental Assay Method for Titration of Porcine Transmissible Gastroenteritis Virus 114 191 Oct 16, 2014 Dec 18, 2014
Supplemental Assay Method for the Phenotypic Examination of Pseudorabies Virus for Thymidine Kinase Activity by a Plaque Selection Method 116 158 Oct 16, 2014 Dec 18, 2014
Supplemental Assay Method for the Titration of Porcine Rotavirus Antibody (Constant Virus- Varying Serum Method) 122 216 Oct 21, 2014 Dec 18, 2014
Supplemental Assay Method for Titration of Bovine Rotavirus Antibody (Constant Virus-Varying Serum Method) 126 186 Oct 23, 2014 Dec 18, 2014
Testing Protocols (PROs)
Title ID Size (KB) Document Date Posted Date
Testing Protocol for Enzyme Linked Immunsorbent Assay (ELISA) for Extraneous Avian Leukosis Virus (ALV) VIRPRO0123 119 Sep 25, 2014 Oct 23, 2014
Detecting Extraneous Avian Leukosis Virus in Biologic Products by p27 ELISA VIRPRO0415 238 Oct 02, 2014 Nov 12, 2014
Hematoxylin and Eosin Staining Procedure for Detection of Cytopathic Extraneous Agents in Master Seeds VIRPRO1012 224 Oct 02, 2014 Nov 12, 2014
Potency Testing Clostridium septicum Antigen BBPRO1301 107 Jun 24, 2011 Nov 21, 2014
Fluorescent Antibody Staining Procedure for Detection of Viral Antigens VIRPRO1014 202 Oct 10, 2014 Nov 21, 2014
Polymerase Chain Reaction Assay for Detection and Identity of Extraneous Chicken Anemia Virus (CAV) VIRPRO0118 216 Sep 25, 2014 Nov 21, 2014
Detection of Pathogens by the Inoculation Test in Embryonated Chicken Eggs VIRPRO1017 129 Oct 02, 2014 Dec 01, 2014
Master Seed Testing in the Virology Section VIRSOP2007 122 Oct 10, 2014 Dec 10, 2014
Reagent Data Sheets (DATs)
Title ID Size (KB) Publication Date Posted Date
Avian Lymphoid Leukosis Virus Type A Positive Control (PC); Lot # 12-02 VIRDAT1220 15 Oct 01, 2014 Oct 03, 2014
Avian Lymphoid Leukosis Virus Type B Positive Control (PC); Lot # 11-14 VIRDAT1221 15 Oct 01, 2014 Oct 03, 2014
Clostridium novyi Type B (alpha) Antitoxin; Lot #IRP 507 (04) BBDAT0065 14 Oct 29, 2014 Nov 10, 2014
Other
Title ID Size (KB) Publication Date Posted Date
PEL Policy Manual - Conditional Licenses (Section 3.2) -- -- Sep 22, 2014 Sep 29, 2014
PEL Policy Manual - Diagnostic Test Kits (Section 4.7) -- -- Oct 02, 2014 Oct 03, 2014
IC Manual - Inspection Techniques & Report Citing of 9 CFR 148(d) & 102.5(c)(1) (Section 3.3.6) -- -- Sep 04, 2014 Oct 03, 2014
Current Veterinary Biologics Product Catalogue -- 221 Oct 06, 2014 Oct 07, 2014
Center for Veterinary Biologics Reagent Catalog -- 121 Oct 16, 2014 Oct 16, 2014
PEL Policy Manual - Using Software to Estimate Relative Potency (Section 4.6.2) -- -- Nov 05, 2014 Nov 06, 2014
PEL Policy Manual - Using the Pending Special Outline Worksheet (Section 4.1.1) -- -- Nov 06, 2014 Nov 10, 2014
IC Manual - Requesting Special Inspections (Section 3.2.1) -- -- Oct 10, 2014 Dec 01, 2014
IC Manual - Serial Spec Sheets (formerly known as Mocks) (Section 6.2.18) -- -- Oct 10, 2014 Dec 01, 2014
IC Manual - Scheduling and Approval of Inspections in LSRTIS (Section 3.2.7) -- -- Oct 10, 2014 Dec 01, 2014
IC Manual - Receiving and Updating Establishment Personnel Data (Section 6.5.1) -- -- Nov 06, 2014 Dec 03, 2014
IC Manual - Special Test Requests Initiated by Inspection and Compliance Staff (Section 6.4.1) -- -- May 05, 2014 Dec 03, 2014
IC Manual - CVB Inspection and Compliance Policy Concerning Response to Firms and the Queue Process (Section 14.5) -- -- Oct 10, 2014 Dec 03, 2014
VS 800 series Memoranda and CVB Notices - Historical Summary of Proposed Documents -- 85 Dec 05, 2014 Dec 05, 2014
PEL Policy Manual - Shipping Experimental Product under 9CFR 103.3/Experimental Product on Licensed Premises/Experimental Slaughter Permits (Section 6.1) -- -- Dec 09, 2014 Dec 10, 2014
Current SAMs -- 114 Dec 17, 2014 Dec 18, 2014
IC Manual - CVB Inspection and Compliance Policy Concerning Purity Test Expectations for a Serial in Multiple Container Sizes (Section 3.3.9) -- -- Jun 05, 2014 Dec 18, 2014
IC Manual - CVB – IC Policy and Procedures When the Licensee/Permittee has been Granted an Animal Safety Testing Exemption Under VS Memo 800.116 (Section 14.4) -- -- Jun 26, 2014 Dec 18, 2014
IC Manual - BCA Initial Review (Section 6.8) -- -- Dec 03, 2014 Dec 18, 2014


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