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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CVB Draft Guidance Documents for Comment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
Inspection of U.S. Veterinary Biologics Licensed and Permitted Establishments Draft 662
September 21, 2020
August 28, 2020
CVB Notices
Title ID Publication Date Posted Date
Issuance of Licenses
20-04 July 07, 2020
July 21, 2020
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
Veterinary Services Memoranda (new or revised)
Title ID Publication Date Posted Date
Avian Influenza Vaccines
800.85
July 13, 2020
July 21, 2020
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
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
NCAH Portal User Guide #18 - Creating and Revising Electronic Outlines 18 June 18, 2020 June 18, 2020
NCAH Portal User Template B - Outline Templates B June 18, 2020 June 18, 2020
Organizational Chart - Assistant Director -- June 21, 2020 June 26, 2020
NCAH Portal User Guide #15 - Formatting Documents for Policy, Evaluation and Licensing (PEL) Submissions 15 June 18, 2020 June 26, 2020
Policy, Evaluation and Licensing (PEL) Reviewer Manual Chapter 4, Precidents for International Label Non-compliance
CVB-WI-0183
July 9, 2020 July 16, 2020
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

 

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