Biologics Regulations and Guidance

Regulations and Regulatory Guidance

• Virus-Serum-Toxin Act of 1913, as Amended 1985 (16.44 KB)
• Code of Federal Regulations (9 CFR)
• Veterinary Services Memoranda
• Center for Veterinary Biologics Public Notices
• Single Tier Label Claim Industry Guidance
• Risk Analysis/Summary Information Formats

Testing

• Supplemental Assay Methods
• Protocols and Standard Operating Procedures (SOPs)
• Reagent Data Sheets
• Center for Veterinary Biologics Reagent Catalog (560.14 KB)

Other Guidance and Instructional Materials

• NCAH Portal Guidance for CVB Submitters
• Submission Compliance Guide: Submitting Complete and Accurate License Applications, Outlines, and Labels  (1.58 MB)
  *For Paper Submissions Only* (March 8, 2021)
• Root Cause Analysis Podcast - Transcript (2.26 MB)
• Polymerase Chain Reaction (PCR) Seminar Series
• Principles and Practices of Good Manufacturing as Required by the Virus-Serum-Toxin Act
• CVB Data Guide (how to submit data to PEL) (1.64 MB)

CVB Procedure Manuals

• Inspection and Compliance Manual
• Policy, Evaluation, and Licensing (Reviewer) Manual
• Operations Manual (19.54 MB)
• Decision Tracker Guidance

Rulemaking and Policy Development

• Rulemaking Activities
• Draft Guidance Documents for Comment

Other

• CVB Statement of Scope (523.37 KB)
• Statistical Methods (STATWIs)
• Vaccine Use Following Brucellosis and Pseudorabies Eradication (64.56 KB) (August 2006)
• Memorandum of Understanding Between APHIS and FDA
• Jurisdiction Determination Process Charter for the USDA CVB/FDA CVM Jurisdiction Committee (406.05 KB)