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Animal and Plant Health Inspection Service
U.S. Department of Agriculture

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CVB Draft Guidance Documents for Comment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
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
CVB Notices
Title ID Publication Date Posted Date
Name Change for Biologicals containing Glaesserella parasuis, formerly Haemophilus parasuis, and Clostridioides difficile, formerly Clostridium difficile 20-05 August 4, 2020 August 5, 2020
Virtual Inspections for Remodeled or New Facilities for Existing Licensed Establishments 20-06 August 27, 2020 August 28, 2020
Issuance of a Conditional License for Epizootic Bovine Abortion Agent Vaccine, Live Culture 20-07 August 27, 2020 August 28, 2020
Update to Equine Parvovirus Extraneous Agent Testing Requirement for Equine-Origin Antibody, Antitoxin, Antivenin, Serum, and Plasma Biological Products Regulated by APHIS 20-08 September 17, 2020 September 17, 2020
Issuance of Licenses 20-09 October 7, 2020 October 9, 2020
Certification of Veterinary Vaccines and Immunotherapeutics as Containing Genetically Modified Organisms 20-10 October 7, 2020 October 9, 2020
Documenting Appropriate Details for Potency Tests 20-11 October 8, 2020 October 9, 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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