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CVB Policy, Evaluation and Licensing - Reviewer Manual

This policy manual represents the Center for Veterinary Biologics (CVB) current thinking on these topics. It does not create or confer any rights for, or on any person, and does not operate to bind CVB or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the CVB staff responsible for implementing these policies.

1.  General

  • Transfer of firms
  • Ex parte communication

2.  Office Procedures

  • General guide formatting correspondence, routing documents for processing & supervisor approval
  • Process for checking in daily mail
  • Fileroom organization
  • Targeted distribution of correspondence to other CVB personnel

3.  Types of Licenses/Limits of Authority

  • Federal Preemption and Veterinary Biologics

4.  Reviewing Specific Submissions

  • Section V.C Potency Assay Tests
  • Labels CVB-SOP-0068 (July 5, 2018)
  • Efficacy Studies CVB-SOP-0070 (including Interference Studies) (June 30, 2017)
  • Efficacy/Reference Qualification by Serology
  • Master Reference Qualification and Requalification
  • Efficacy Requirements for Specific Antigens
  • Potency Test Development & Validation Studies
  • APHIS Directive 6910.1 (process for coordinating licensing and approval for diagnostics used in official control programs)
  • Adjuvant spreadsheet
  • Stability
  • Evaluation of Confirmation of Dating Studies

5.  Testing Biological Products

  • Issuing Special Request for Lab Testing Master Seeds and Master Cells 
  • Issuing Special Request for Lab Testing of Prelicensing Serials

6.  Shipping/Use of Experimental Products

  • Instructions for processing 103.3 forms

7.  Statistics

8.  Guidance for New Firms

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