Animal and Plant Health Inspection Service
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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| CVB Draft Guidance Documents for Comment | |||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 |
| Review of labels for use in countries that are members or observers of the Veterinary International Conference on Harmonization (VICH) | Draft 640 |
October 19, 2020 extended to November 19, 2020 |
August 28, 2020 |
| Veterinary Services Memoranda (new or revised) | |||
| Title | ID | Publication Date | Posted Date |
| Serial Release of Licensed Biological Products |
800.53 |
July 15, 2020 |
July 24, 2020 |
| Preparation and Submission of Adverse Event Reports for Biological Products by Licensees and Permittees |
800.125 |
August 17, 2020 |
September 2, 2020 |
| Efficacy and Safety Studies for Cancer Immunotherapeutics |
800.126 |
September 2, 2020 |
September 23, 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 |
| Reverse Transcription (RT) PCR Assay Using Qiagen OneStep to Detect Bovine Viral Diarrhea Virus (BVDV), Porcine and Reproductive Respiratory Virus (PRRSV) or Extraneous Reticuloendotheliosis Virus (REV) |
CVB-PRO-0033 |
July 21, 2020 |
July 31, 2020 |
| Reagent Data Sheets (DATs) | |||
| Title | Lot ID | Publication Date | Posted Date |
| Pasteurella multocida Type A Standard Reference Bacterin |
ID IRP 573 (08) |
September 10, 2020 |
September 11, 2020 |
| Other | |||
| Title | ID | Publication Date | Posted Date |
| Current Veterinary Biologics Product Catalog | -- | July 1, 2020 | July 24, 2020 |
| Operations Manual | CVB-MAN-5100 | July 22, 2020 | July 28, 2020 |
| Organizational Chart - Inspection and Compliance | -- | August 16, 2020 | August 28, 2020 |
| Inspection and Compliance Manual Chapter - APHIS Dispositions and Associated Information on Form 2008s | CVB-WI-0129 | July 20, 2020 | August 28, 2020 |
| Inspection and Compliance Manual Chapter - Investigation and Processing of Alleged Violations fo the Virus-Serum-Toxin Act | CVB-SOP-0037 | July 21, 2020 | September 2, 2020 |
| Organizational Chart - Policy, Evaluation and Licensing | -- | September 13, 2020 | September 16, 2020 |
| Organizational Chart - Administration | -- | September 13, 2020 | September 16, 2020 |
| Inspection and Compliance Manual Chapter - IC Pre-Inspection Packet Checklist - LSRTIS Information and Preparation | CVB-WI-0076 | September 10, 2020 | September 21, 2020 |
| Policy, Evaluation and Licensing (PEL) Reviewer Manual Chapter - Import Permits for Distribution and Sale | CVB-SOP-0084 | July 10, 2020 | September 21, 2020 |
| Organizational Chart - Assistant Director | -- | September 27, 2020 | October 2, 2020 |
| Guidance to Industry Preparing Supporting Summaries for Single Tier (Single Label Claim) Effectiveness Statements | -- | September 1, 2020 | October 2, 2020 |
| VS 800 series Memoranda and CVB Notices - Historical Summary of Proposed Documents | -- | October 8, 2020 | October 9, 2020 |
| Current Product Code Book | -- | October 8, 2020 | October 19, 2020 |
| 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 |
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