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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CVB Draft Guidance Documents for Comment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
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
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
Reagent Data Sheets (DATs)
Title Lot ID Publication Date Posted Date
Leptospira icterohaemorrhagiae Monoclonal Antibody (LI MAb)
IRP 04-506 April 15, 2022
April 23, 2022
Escherichia coli, Anti F41 Pilus Polyclonal Antibody (F41 PAb)
IRP F41 PAb, NVSL Lot 1 April 15, 2022
April 23, 2022
Chicken Anemia Virus DNA Positive Control
15-07 April 21, 2022
April 23, 2022
Erysipelothrix rhusiopathiae Challenge Culture
IRP 592 April 21, 2022
April 23, 2022
Escherichia coli Anti-987P Pilus Monoclonal Antibody (987P MAb)
IRP 475 May 6, 2022
May 17, 2022
Leptospira pomona Master Reference Bacterin
IRP 524 (05) May 6, 2022
May 17, 2022
Clostridium chauvoei Flagella-specific (7D11/YD7) Monoclonal Antibody (MAb)
IRP 608 May 5, 2022
May 17, 2022
Secondary Reference Serum-Bovine IgG; Stock for Bovine IgG Species Standard
IRP 10848 May 6, 2022
May 17, 2022
Clostridium chauvoei Flagella-specific Rabbit Polyclonal Antibody (detection antibody)
IRP 440 May 5, 2022
May 17, 2022
Leptospira pomona Challenge Cuture
IRP 654 May 6, 2022
May 17, 2022
Avian Lymphoid Leukosis Virus Type B Positive Control (PC)
11-14 May 17, 2022
May 20, 2022
Other
Title ID Publication Date Posted Date
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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