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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CVB Draft Guidance Documents for Comment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
Name Change for Biologicals Containing Mycobacterium avium subspecies paratuberculosis, formerly Mycobacterium paratuberculosis 628 Apr 22, 2019
Apr 08, 2019
CVB Notices
Title ID Publication Date Posted Date
Issuance of Licenses 19-01 Feb 01, 2019 Feb 01, 2019
Veterinary Biological Products in Licensed Establishments Produced and Destroyed 01/01/2018 through 12/31/2018 86 Jan 31, 2019 Feb 01, 2019
Issuance of Licenses 19-02 Apr 01, 2019 Apr 10, 2019
New Extraneous Agent Testing Requirement for Equine-Origin Antibody, Antitoxin, Serum, and Plasma Products Regulated by APHIS 19-03 Apr 05, 2019 Apr 10, 2019
Veterinary Services Memoranda (new or revised)
Title ID Publication Date Posted Date
Guidelines Regarding the Revision to Animal and Plant Health Inspection Service (APHIS) Implementing Procedures for the National Environmental Policy Act (NEPA) 800.215 Jan 31, 2019 Feb 01, 2019
In Vitro Serial Release Potency Test for Completed Product Containing Clostridium chauvoei 800.104 Dec 13, 2018 Mar 06, 2019
General Licensing Considerations: Preparing Outlines of Production for Vaccines, Bacterins, Antigens, and Toxoids and Diagnostic Test Kits 800.206 Nov 13, 2018 Mar 06, 2019
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
       
Testing Protocols (PROs)
Title ID Document Date Posted Date
       
Reagent Data Sheets (DATs)
Title Lot ID Publication Date Posted Date
Pasteurella multocida Type A Standard Reference Bacterin IRP 573 (08) Dec 21, 2018 Feb 19, 2019
Clostridium tetani Antitoxin 5.0 AU/mL (guinea pig origin) IRP 466 Apr 03, 2019 Apr 17, 2019
Erysipelothrix rhusiopathiae Challenge Culture IRP 592 Apr 03, 2019 Apr 17, 2019
Clostridium perfringens type C (beta) toxin IRP 624 Apr 09, 2019 Apr 17, 2019
Clostridium novyi Type B (alpha) Antitoxin IRP 507 (04) Apr 09, 2019 Apr 17, 2019
Other
Title ID Publication Date Posted Date
NCAH Portal User Guide #2 - Description of Portal Roles and Privileges -- Feb 27, 2019 Mar 01, 2019
NCAH Portal User Guide B - Outline Templates B Mar 18, 2019 Mar 18, 2019
Organizational Chart - Safety and Security Unit -- Mar 03, 2019 Mar 18, 2019
Organizational Chart - Information ManagementUnit -- Feb 17, 2019 Mar 18, 2019
Inspection and Compliance Manual Facility Documents; Specialist Review, including Electronic Processing (Section 9.2.2) CVB-WI-0115 Dec 19, 2018 Mar 18, 2019
Inspection and Compliance Manual Tracking Customer Service using LSRTIS Phone Log (Section 19.2.8) CVB-WI-0141 Feb 19, 2019 Mar 18, 2019
Current Veterinary Biologics Product Catalogue -- Apr 01, 2019 Apr 10, 2019
Inspection and Compliance Manual Submitting Letter to the U.S. Department of State Office of Authentications CVB-WI-0094 Mar 07, 2019 Apr 10, 2019
Organizational Chart - CVB Management -- Mar 02, 2019 Apr 12, 2019
Organizational Chart - Administration Unit -- Jan 28, 2019 Apr 12, 2019
Organizational Chart - Policy, Evaluation and Licensing -- Mar 17, 2019 Apr 12, 2019
Organizational Chart - Inspection and Compliance -- Oct 27, 2018 Apr 12, 2019

 

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