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Animal and Plant Health Inspection Service
U.S. Department of Agriculture

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CVB Draft Guidance Documents for Comment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
Guidelines for Autogenous Biologics 638
January 19, 2021
extended to February 2, 2021
December 23, 2020
CVB Notices
Title ID Publication Date Posted Date
Veterinary Vaccines Targeting SARS-CoV-2 Virus in Mink 20-12 November 12, 2020 November 13, 2020
Use of Nonproprietary Names from the United States Adopted Names (USAN) Council as True Names for Veterinary Biologic Immunotherapeutics 20-13 November 9, 2020 November 13, 2020
Issuance of Licenses 21-01 January 5, 2021 January 8, 2021
Record Audit Inspections 21-02 January 5, 2021 January 8, 2021
Veterinary Services Memoranda (new or revised)
Title ID Publication Date Posted Date
Guidelines for Potency Specifications of Biological Products Administered to Animals
800.124
October 2, 2020
December 1, 2020
Inspection of U.S. Veterinary Biologics Licensed and Permitted Establishments
800.91
December 8, 2020
December 22, 2020
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
Clostridium haemolyticum spore preparation
IRP 526 (06)
October 28, 2020 
 November 6, 2020
Erysipelothrix rhusiopathiae Reference Bacterin
IRP 609
October 27, 2020
 November 6, 2020
Clostridium tetani Toxin
IRP 664
August 21, 2020
 November 30, 2020
Other
Title ID Publication Date Posted Date
General Guide for Submission of Veterinary Biologics Production and Test Report 5 October 8, 2020 October 21, 2020
Submitting Routine Biologics Samples 6 October 21, 2020 October 21, 2020
Submitting Special Request Biologics Samples 7 October 21, 2020 October 21, 2020
General Guide for E-Submissions to CVB-Policy, Evaluation and Licensing 10 October 14, 2020 October 21, 2020
Center for Veterinary Biologics Reagents Catalog -- October 20, 2020 October 22, 2020
Organizational Chart - Inspection and Compliance -- November 1, 2020 November 13, 2020
Summary Information Format for the Importation of Veterinary Biological Products into the United States -- November 2020 November 21, 2020
Policy, Evaluation and Licensing (PEL) Reviewer Manual Chapter - Guidance for Reviewers on Portal Access for New Firms CVB-WI-5233 October 28, 2020 December 5, 2020
Policy, Evaluation and Licensing (PEL) Reviewer Manual Chapter - New Firm Informational Packet for Antivenin Products CVB-WI-5234 October 28, 2020 December 5, 2020
Policy, Evaluation and Licensing (PEL) Reviewer Manual Chapter - New Firm Informational Packet for Cancer Products and Immunomodulatory Products that Require Client Owned Animals Efficacy and Safety Studies CVB-WI-5235 October 2, 2020 December 5, 2020
Policy, Evaluation and Licensing (PEL) Reviewer Manual Chapter - New Firm Informational Packet for Diagnostic Test Kits CVB-WI-5236 October 28, 2020 December 5, 2020
Policy, Evaluation and Licensing (PEL) Reviewer Manual Chapter - New Firm Informational Packet for Live and Inactivated Vaccines Including Recombinants CVB-WI-5237 October 28, 2020 December 5, 2020
Organizational Chart - Administration Unit -- December 6, 2020 December 29, 2020
NCAH Portal User Guide - Description of Portal Roles and Privileges #4 December 29, 2020 January 8, 2020
Policy, Evaluation and Licensing (PEL) Reviewer Manual Chapter - Preparing Product Licensing Plans CVB-SOP-0059 January 6, 2021 January 8, 2021
Revisions to Outlines of Production for Single Tier Label Claims -- December 2020 January 8, 2021
Organizational Chart - Safety and Security Unit -- January 2, 2021 January 15, 2021
Organizational Chart - Policy, Evaluation and Licensing -- January 1, 2021 January 15, 2021
Organizational Chart - Management -- January 1, 2021 January 15, 2021
Policy, Evaluation and Licensing (PEL) Reviewer Manual Chapter - Reviewer Staff Meetings CVB-SOP-0058 January 11, 2021 January 15, 2021

 

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