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| CVB Draft Guidance Documents for Comment | |||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 |
| Basic Licensing Requirements and Guidelines for Diagnostic Products | 12774 | May 9, 2022 extended to May 23, 2022 |
April 13, 2022 |
| CVB Notices | |||
| Title | ID | Publication Date | Posted Date |
| Extended use of currently approved, non-Single Tier compliant domestic labels | 22-03 | February 28, 2022 | March 1, 2022 |
| Veterinary Biological Products in Licensed Establishments Produced and Destroyed 01/01/2021 through 12/31/2021 | 89 | January 2022 | March 29, 2022 |
| Discontinued Availability of Erysipelothrix rhusiopathiae Rabbit Polyclonal Antibody (Detection Antibody) | 22-04 | April 12, 2022 | April 13, 2022 |
| Issuance of a Conditional License for Mink Coronavirus | 22-05 | April 27, 2022 | May 4, 2022 |
| Veterinary Services Memoranda (new or revised) | |||
| Title | ID | Publication Date | Posted Date |
| Exemption to Sterility Test Requirement for Allergenic Extract Prescription Product | 800.106 | February 16, 2022 | February 18, 2022 |
| Guidelines for Conducting Product Stability Studies | 800.127 | March 29, 2022 | March 30, 2022 |
| 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 |
| Potency Assay of Leptospira interrogans serogroup canicola Bacterins | 609 | April 19, 2022 | May 16, 2022 |
| Potency Assay Leptospira kirschneri serogroup grippotyphosa Bacterins | 617 | April 26, 2022 | May 16, 2022 |
| Determination of Formaldehyde in Veterinary Biologics (Ferric Chloride Test) | 512 | April 5, 2022 | May 16, 2022 |
| Testing Protocols (PROs) | |||
| Title | ID | Document Date | Posted Date |
| Potency Test for Clostridium septicum Alpha Antitoxin Using a Cell Assay | CVB-PRO-0009 | April 21, 2022 | April 23, 2022 |
| Using Software to Estimate Relative Potency | CVB-SOP-0102 | May 8, 2019 | April 23, 2022 |
| Detection of Pathogens by the Inoculation Test in Embryonated Chicken Eggs | CVB-PRO-0041 | May 6, 2022 | May 17, 2022 |
| Other | |||
| Title | ID | Publication Date | Posted Date |
| Organizational Chart - CVB Management | -- | February 13, 2022 | February 18, 2022 |
| Current Veterinary Biologics Product Catalog | -- | March 9, 2022 | March 10, 2022 |
| Instructional Guidance for PV Express II for Public Submissions | -- | March 2022 | April 1, 2022 |
| Organizational Chart - Assistant Director | -- | April 10, 2022 | April 23, 2022 |
| Center for Veterinary Biologics Reagent Catalog | -- | April 26, 2022 | May 7, 2022 |
| Organizational Chart - Policy, Evaluation and Licensing | -- | April 24, 2022 | May 7, 2022 |
| Organizational Chart - Inspection and Compliance | -- | April 24, 2022 | May 7, 2022 |
| Inspection & Compliance Manual Chapter - CVB Inspection and Compliance Policy Concerning Compliance to Title 9 CFR 113.53 - Ingredients of Animal Origin Testing | CVB-WI-0083 | August 11, 2021 | May 16, 2022 |
| Inspection & Compliance Manual Chapter - Ready for Signature Action in LSRTIS (Specialist and BCA duties) | CVB-WI-0088 | August 12, 2021 | May 16, 2022 |
| Inspection & Compliance Manual Chapter - General Guidelines for Violations Attachment Report Format | CVB-WI-0095 | August 20, 2021 | May 16, 2022 |
| Inspection & Compliance Manual Chapter - Reviewing, Coding and Assessing Adverse Event Reports from the Public in PV-Works | CVB-WI-0124 | August 10, 2021 | May 16, 2022 |
| Inspection & Compliance Manual Chapter - APHIS Dispositions and Associated Information on Form 2008s | CVB-WI-0129 | August 19, 2021 | May 16, 2022 |
| Inspection & Compliance Manual Chapter - Items to Consider for No Tests Regarding the Wet Chick Safety Test, 9 CFR 113.207(a) | CVB-WI-0133 | August 19, 2021 | May 16, 2022 |
| Inspection & Compliance Manual Chapter - Processes for Evaluating Compliance with Requirements of VS Memo 800.210 and VS Memo 800.57 | CVB-WI-5218 | August 16, 2021 | May 16, 2022 |
| Inspection & Compliance Manual Chapter - Routing of Inspection Reports – for Specialist | CVB-WI-0136 | August 11, 2021 | May 16, 2022 |
| Inspection & Compliance Manual Chapter - Processing Incoming Administrative Inspection Review (AIR) Documents by CVB | CVB-WI-0144 | March 8, 2022 | May 16, 2022 |
| Inspection & Compliance Manual Chapter - BCA Ready for Approval | CVB-WI-0165 | March 8, 2022 | May 16, 2022 |
| Inspection & Compliance Manual Chapter - Preparation of Administrative Inspection Reviews | CVB-WI-0145 | March 8, 2022 | May 16, 2022 |
| Inspection & Compliance Manual Chapter - Mail Log Work Flow for Correspondence for Inspection and Compliance: Section Leader Review | CVB-WI-0105 | March 8, 2022 | May 16, 2022 |
| Inspection & Compliance Manual Chapter - Program Coordinator Duties | CVB-WI-0090 | March 29, 2022 | May 16, 2022 |
| Inspection & Compliance Manual Chapter - QA Process for Serial Release | CVB-WI-0162 | March 29, 2022 | May 16, 2022 |
| Inspection & Compliance Manual Chapter - BCA Entry and Review of Incoming Correspondence | CVB-WI-0100 | March 29, 2022 | May 16, 2022 |
| Inspection & Compliance Manual Chapter - Items to Consider when Approving a Third-Party Cold Storage for Autogenous Biologics - VS Memo 800.69 | CVB-WI-5291 | March 8, 2022 | May 17, 2022 |
| Organizational Chart - Safety and Security Unit | -- | May 8, 2022 | May 17, 2022 |
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