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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| CVB Draft Guidance Documents for Comment | |||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 |
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| 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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