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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
         
Testing Protocols (PROs)
Title ID Size (KB) Document Date Posted Date
Detection of Hemagglutinating Viruses VIRPRO0096 447 Jul 17, 2014 Aug 29, 2014
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
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
IC Manual - Serial Spec Sheets (formerly known as Mocks) (Section 6.2.18) -- -- Aug 27, 2014 Oct 10, 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
PEL Policy Manual - Outline of Production (Section 4.1) -- -- Nov 06, 2014 Nov 10, 2014


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