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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CVB Draft Guidance Documents for Comment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 no 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




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
Detection of Hemagglutinating Viruses
CVB-PRO-0021
March 9, 2021
March 11, 2021
Reagent Data Sheets (DATs)
Title Lot ID Publication Date Posted Date
Clostridium tetani Toxin
IRP 648
March 1, 2021
March 11, 2021
Escherichia coli Anti-K99 Pilus Horseradish Peroxidase (HRP)-Labeled Monoclonal Antibody (K99-HRP Conjugate)
IRP 680
January 7, 2021
January 22, 2021
Escherichia coli Anti-K99 Pilus Horseradish Peroxidase (HRP)-Labeled Monoclonal Antibody (K99-HRP Conjugate)
IRP 595
March 10, 2021
March 29, 2021
Other
Title ID Publication Date Posted Date
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
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
Polymerase Chain Reaction (PCR) Seminar Series -- January 2021 March 9, 2021
Submission Compliance Guide - Submitting Complete and Accurate License Applications, Outlines, and Labels *For Paper Submissions Only* CVB-SOP-5106 March 8, 2021 March 11, 2021
Adverse Event Reporting (AER) Guidance - Instructional Guidance for PV Express II for Licensed Establishments -- March 12, 2021 March 17, 2021
Inspection and Compliance Manual Chapter - Pre-Inspection Activities CVB-SOP-0034 April 1, 2020 March 19, 2021
Inspection and Compliance Manual Chapter - BCA Process for Finalization of Inspection Reports CVB-WI-0121 April 1, 2020 March 19, 2021
Inspection and Compliance Manual Chapter - Routing of Inspection Reports – for Specialist CVB-WI-0136 April 1, 2020 March 19, 2021
Inspection and Compliance Manual Chapter - BCA Initial Review CVB-WI-0164 April 1, 2020 March 19, 2021
Organizational Chart - Policy, Evaluation and Licensing -- March 14, 2021 March 29, 2021
NCAH Portal User Guide - Application for United States Veterinary Biological Product Permit - RESEARCH AND EVALUATION #27 March 22, 2021 March 29, 2021
NCAH Portal User Guide - Application for United States Veterinary Biological Product Permit - TRANSIT SHIPMENT ONLY #28 March 22, 2021 March 29, 2021
NCAH Portal User Guide - Application for United States Veterinary Biological Product Permit - SALES AND DISTRIBUTION #29 March 22, 2021 March 29, 2021

 

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