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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CVB Draft Guidance Documents for Comment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
Efficacy and Safety Studies for Cancer Immunotherapeutics
597
March 23, 2020
extended to April 6, 2020
January 31, 2020
Preparation and Submission of Adverse Event Reports for Biological Products by Licensees and Permittees
637
April 9, 2020 January 31, 2020
CVB Notices
Title ID Publication Date Posted Date
Availability of New Inactivated Veterinary Rabies Reference 19-15 Dec 19, 2019 Dec 20, 2019
Issuance of Licenses 20-01 Jan 08, 2020 Jan 08, 2020
Veterinary Biological Products in Licensed Establishments Produced and Destroyed 01/01/2019 through 12/31/2019 87 Jan 08, 2020 Jan 15, 2020
Veterinary Services Memoranda (new or revised)
Title ID Publication Date Posted Date




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
Pasteurella multocida Type A Bacterin (Bovine Isolate)
IRP 591
Jan 02, 2020
Jan 08, 2020
Clostridium chauvoei Spore Preparation
IRP 631
Jan 28, 2020
Jan 30, 2020
Clostridium sordellii Toxin
IRP 675
Jan 16, 2020
Feb 06, 2020
Veterinary Rabies Reference Vaccine, killed virus
17-06
Feb 05, 2020
Feb 06, 2020
Other
Title ID Publication Date Posted Date
Inspection and Compliance Manual - Hold Management Process for APHIS Form 2008s CVB-WI-0158 Nov 12, 2019 Dec 20, 2019
Inspection and Compliance Manual - Biologics Compliance Assistant (BCA) Finalization of Correspondence CVB-WI-0101 Nov 12, 2019 Dec 20, 2019
Organizational Chart - Management -- Nov 24, 2019 Dec 26, 2019
Organizational Chart - Assistant Director -- Nov 24, 2019 Dec 26, 2019
Current Veterinary Biologics Product Catalog -- Jan 08, 2020 Jan 08, 2020
Technical Notes Regarding Establishing Control Chart Parameters CVB-WI-5224 Jan 22, 2020 Jan 28, 2020
Inspection and Compliance Manual - Log APHIS Form 2008 CVB-WI-0163 Jan 02, 2020 Jan 28, 2020
Inspection and Compliance Manual - Program Coordinator Duties CVB-WI-0090 Jan 02, 2020 Jan 28, 2020
NCAH Portal User Guide #1 - Logging In and IT Security Awareness Training 1 Jan 17, 2020 Jan 28, 2020
NCAH Portal User Guide #5 - General Guide for Submission of Veterinary Biologics Production and Test Report 5 Jan 17, 2020 Jan 28, 2020
NCAH Portal User Guide #9 - General Guide for E-Submission of General Correspondence to CVB-Inspection and Compliance 9 Jan 17, 2020 Jan 28, 2020
NCAH Portal User Guide #22 - General Guide for E-Submission of General Correspondence to CVB-Inspection and Compliance 22 Dec 27, 2019 Jan 28, 2020
NCAH Portal Access Guide - Eligibility Requirements for New Establishments - Dec 27, 2019 Jan 28, 2020
NCAH Portal Access Guide - Requirements for Licensed Establishments - Dec 27, 2019 Jan 28, 2020
Organizational Chart - Administration -- Jan 19, 2020 Jan 28, 2020
Organizational Chart - Policy, Evaluation and Licensing -- Jan 19, 2020 Jan 28, 2020
Organizational Chart - Safety and Security Unit -- Jan 21, 2020 Jan 28, 2020
Center for Veterinary Biologics Reagent Catalog -- Jan 30, 2020 Jan 31, 2020
Historical Summary of CVB Draft Documents -- Feb 4, 2020 Feb 4, 2020
Inspection and Compliance Manual - Inspection Product Check-off Sheet CVB-WI-0083 Jan 13, 2020 Feb 05, 2020
Inspection and Compliance Manual - Product Sampling CVB-SOP-0040 Jan 13, 2020 Feb 05, 2020
Inspection and Compliance Manual - Assessing Compliance with the Requirement of State Veterinarian Approval CVB-WI-5209 Jan 02, 2020 Feb 05, 2020
Inspection and Compliance Manual - Receipt of Submissions from CVB-PEL CVB-WI-5215 Aug 30, 2019 Feb 05, 2020
Inspection and Compliance Manual - Rebottling/Reprocessing - Process CVB-WI-0106 Feb 11, 2020 Feb 25, 2020
Inspection and Compliance Manual - Workload Indicator Calculations for Imported Product CVB-WI-0156 Feb 11, 2020 Feb 25, 2020
Inspection and Compliance Manual - Process for Prelicensing Inspection Requests CVB-WI-0093 Feb 11, 2020 Feb 25, 2020
Inspection and Compliance Manual - Work Flow for Initiating a Regulatory Action or Regulatory Correspondence Using the Mail Log System and Portal CVB-WI-0155 Feb 19, 2020 Mar 06, 2020
Inspection and Compliance Manual - Special Test Requests Initiated by Inspection and Compliance Staff CVB-WI-0116 Feb 19, 2020 Mar 06, 2020
NCAH Portal User Guide #3 - Submission History (CVB) and Account Details 3 Mar 11, 2020 Mar 12, 2020

 

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