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Newly Published Information

Veterinary Biologics Information Published in the Last 90 Days

CVB Draft Guidance Documents for Comment
Title ID COMMENTS DUE DATE Posted Date




CVB Notices
Title ID Publication Date Posted Date
Extension of Implementation Period of Single Tier Label Claim 19-14 Oct 24, 2019 Oct 28, 2019
Availability of New Inactivated Veterinary Rabies Reference 19-15 Dec 19, 2019 Dec 20, 2019
Issuance of Licenses 20-01 Jan 08, 2020 Jan 08, 2020
Veterinary Biological Products in Licensed Establishments Produced and Destroyed 01/01/2019 through 12/31/2019 87 Jan 08, 2020 Jan 15, 2020
Veterinary Services Memoranda (new or revised)
Title ID Publication Date Posted Date




Rulemaking
Title FR Citation Effective Date Posted Date
       
Proposed Rulemaking
Title Federal Register Vol/Page Comments Due Date Posted Date
       
Notices of Availability
Title Federal Register Vol/Page Comments Due Date Posted Date




Supplemental Assay Methods (SAMs)
Title ID Document Date Posted Date
Potency Assay of Leptospira interrogans serogroup canicola Bacterins  609 Oct 28, 2019  Nov 06, 2019 
Potency Assay of of Leptospira interrogans serogroup pomona Bacterins 608 Nov 26, 2019 Dec 12, 2019
Potency Assay of of Leptospira interrogans serogroup icterohaemorrhagiae Bacterins 610 Nov 26, 2019 Dec 12, 2019
Testing Protocols (PROs)
Title ID Document Date Posted Date




Reagent Data Sheets (DATs)
Title Lot ID Publication Date Posted Date
Pasteurella multocida Type A Bacterin (Bovine Isolate)
IRP 591
Jan 02, 2020
Jan 08, 2020
Other
Title ID Publication Date Posted Date
Inspection and Compliance Manual - Processes for Evaluating Compliance with Requirements of VS Memo 800.210 and VS Memo 800.57 CVB-WI-5218 Oct 01, 2019 Oct 18, 2019
Inspection and Compliance Manual - Facility Documents; Specialist Review, including Electronic Processing CVB-WI-0115 Oct 03, 2019 Oct 21, 2019
NCAH Portal User Guide - General Guide for E-Submissions to CVB-Policy, Evaluation and Licensing 10 Oct 18, 2019 Oct 21, 2019
Inspection and Compliance Manual - Processing Administrative Inspection Reviews CVB-SOP-0028 Nov 04, 2019 Nov 27, 2019
Inspection and Compliance Manual - Process for Prelicensing Inspection Requests CVB-WI-0093 Nov 04, 2019 Nov 27, 2019
Inspection and Compliance Manual - Items to Consider When Processing Preliminary Drawings CVB-WI-0131 Nov 25, 2019 Nov 27, 2019
Historical Summary of CVB Draft Documents -- Nov 13, 2019 Nov 27, 2019
Single Tier Label Claim - Implementation Timeline -- Nov 19, 2019 Nov 29, 2019
PEL Reviewer Manual - Shipping Experimental Product CVB-WI-0172 Nov 07, 2019 Nov 29, 2019
PEL Reviewer Manual - Patent Term Extensions CVB-WI-0192 Nov 12, 2019 Nov 29, 2019
Inspection and Compliance Manual - Preparation of Administrative Inspection Reviews CVB-WI-0145 Nov 07, 2019 Nov 29, 2019
Inspection and Compliance Manual - Voluntary Stop Distribution and Sale Acknowledgement in Mail Log CVB-WI-5210 Oct 03, 2019 Dec 09, 2019
Organizational Chart - Inspection and Compliance -- Dec 05, 2019 Dec 12, 2019
Organizational Chart - Policy, Evaluation and Licensing -- Nov 24, 2019 Dec 18, 2019
Inspection and Compliance Manual - Hold Management Process for APHIS Form 2008s CVB-WI-0158 Nov 12, 2019 Dec 20, 2019
Inspection and Compliance Manual - Biologics Compliance Assistant (BCA) Finalization of Correspondence CVB-WI-0101 Nov 12, 2019 Dec 20, 2019
Organizational Chart - Administration -- Dec 08, 2019 Dec 26, 2019
Organizational Chart - Management -- Nov 24, 2019 Dec 26, 2019
Organizational Chart - Assistant Director -- Nov 24, 2019 Dec 26, 2019
Current Veterinary Biologics Product Catalog -- Jan 08, 2020 Jan 08, 2020

 

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