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| CVB Draft Guidance Documents for Comment | |||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