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

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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CVB Draft Guidance Documents for Comment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
There are documents for comment at this time


CVB Notices
Title ID Publication Date Posted Date
Issuance of Licenses 21-01 January 5, 2021 January 8, 2021
Record Audit Inspections 21-02 January 5, 2021 January 8, 2021
Veterinary Biological Products in Licensed Establishments Produced and Destroyed 01/01/2020 through 12/31/2020 88 January 22, 2021 January 25, 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
Standard Bacterial Plate Count
CVB-SOP-0104
January 27, 2021
February 8, 2021
Reagent Data Sheets (DATs)
Title Lot ID Publication Date Posted Date
Clostridium tetani Toxin
IRP 664
August 21, 2020
 November 30, 2020
Escherichia coli Anti-K99 Pilus Horseradish Peroxidase (HRP)-Labeled Monoclonal Antibody (K99-HRP Conjugate)
IRP 680
January 7, 2021
January 22, 2021
Other
Title ID Publication Date Posted Date
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
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 - 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
Organizational Chart - Policy, Evaluation and Licensing -- January 19, 2021 January 25, 2021
VS 800 series Memoranda and CVB Notices - Historical Summary of Proposed Documents -- February 2, 2021 February 3, 2021
Center for Veterinary Biologics Reagents Catalog -- February 3, 2021 February 5, 2021
NCAH Portal User Guide - Submission History (CVB) and Account Details #3 February 8, 2021 February 8, 2021
NCAH Portal User Guide - General Guide for E-Submissions to CVB-Policy, Evaluation and Licensing #10 February 8, 2021 February 8, 2021
Organizational Chart - Administration Unit -- February 15, 2021 February 25, 2021

 

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