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

• Overview of the Review and Licensing Process (364.68 KB) CVB-SOP-0056 (May 26, 2017)
• APHIS Policy on Confidential Business Information (32.27 KB) (August 19, 2010)
• True Names, Product Codes and Establishment Codes (132.14 KB) CVB-SOP-0057 (March 26, 2018)
• Reviewer Staff Meetings (383.65 KB) CVB-SOP-0058 (January 11, 2021)
• Preparing Product Licensing Plans (3.16 MB) CVB-SOP-0059 (January 6, 2021)
• 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
• Final Steps for Licensure (3.17 MB) (Preparing a licensing package) CVB-SOP-0063 (May 21, 2021)
• List of Standard License Restrictions (139.09 KB) CVB-WI-0175 (September 19, 2024)
• Quarterly Submission Acknowledgement Summaries (228.86 KB) CVB-SOP-0064 (September 13, 2023)

3.  Types of Licenses/Limits of Authority

• Establishment Licenses (2.02 MB) CVB-SOP-0065 (February 23, 2023)
• Conditional Licenses (2.16 MB) CVB-SOP-0066 (May 17, 2019)
• Exemptions to the Virus-Serum-Toxin Act (193.54 KB) CVB-WI-0176 (May 23, 2014)
• Food and Drug Administration-Export Reform and Enhancement Act (aka DEREA) (2.04 MB) CVB-WI-0177 (June 3, 2019)
• Text of FDA-EREA regulation (U.S. Code 382)
• Memorandum of Understanding with Food and Drug Administration (division of authority)
• Regulation of veterinary vaccines that reduce colonization/shedding of organisms that are mainly human pathogens (15.37 KB) (2005 agreement with FDA) CVB Notice 05-07
• Federal Preemption and Veterinary Biologics

4.  Reviewing Specific Submissions

• Outlines of Production & Special Outlines (1.58 MB) CVB-SOP-0067 (August 14, 2023)
• Section V.C Potency Assay Tests
• Considerations to Requests for Changes to Outlines of Production for Bacterial Products (2.19 MB) CVB-WI-0180 (May 21, 2021)
• Validating Alternate Techniques for the Detection of Mycoplasmas (1.49 MB) CVB-WI-0181 (August 20, 2019)
• Dilution of Preservative Studies (328.66 KB) CVB-WI-0182 (August 20, 2019)
• Labels (278.31 KB) CVB-SOP-0068 (July 5, 2018)
• Precedents for International Label Non-compliance (8.2 MB) CVB-WI-0183 (December 12, 2023)
• Study Protocols (521.69 KB) CVB-SOP-0069 (December 9, 2015)
• Efficacy Studies (1.91 MB) CVB-SOP-0070 (including Interference Studies) (June 30, 2017)
• Efficacy/Reference Qualification by Serology
• Master Reference Qualification and Requalification
• Companion Overview for 800.211 Guidance for Master Reference Qualification, Requalification, Dating and Monitoring (211.58 KB) CVB-REF-5109
• Efficacy Requirements for Specific Antigens
• Field Safety Studies (292.48 KB) CVB-SOP-0073 (September 14, 2015) (see also VS Memo 800.204)
• Target Animal Safety Testing Exemption (263.68 KB) CVB-SOP-0074 (September 18, 2018)
• Potency Test Development & Validation Studies
• Potency Test References - introduction to terminology (391.04 KB) CVB-WI-0187 (May 30, 2014)
• Hold-over Information from Veterinary Services Memorandum No. 800.90 (170.53 KB) (posted on September 13, 2019)
• Proposals for Estimating Relative Potency (1.15 MB) CVB-WI-0188 (February 25, 2023)
• Diagnostic Test Kits (671.09 KB) CVB-SOP-0076 (see also VS Memo 800.73) (March 31, 2017)
• APHIS Directive 6910.1 (process for coordinating licensing and approval for diagnostics used in official control programs)
• Antibody Products (44.96 KB) CVB-SOP-0077 (September 23, 2016)
• Adjuvants and Excipients (1.17 MB) CVB-SOP-0078 (February 26, 2020)
• Adjuvant spreadsheet
• Stability
• Evaluation of Confirmation of Dating Studies
• Patent Term Extensions (1.23 MB) CVB-WI-0192 (November 12, 2019)
• Office Procedure for Routing & Processing SIFs and RAs (1.39 MB) CVB-WI-0193 (May 21, 2021)
• Outline for Content of Risk Assessment (56.78 KB) CVB-WI-0194 (July 9, 2015)
• SIF/RA Worksheet (587.92 KB) CVB-WI-0195 (May 21, 2021)
• Regulatory Process for Biotech Products (17.18 KB) CVB-WI-0196 (July 01, 2016)
• Master Seeds/Cells/Sequences (773.22 KB) CVB-SOP-0080 (April 8, 2016)
• Preservatives in biologics (175.54 KB) CVB-SOP-0081 (September 1, 2010)
• Sterile diluents (143.82 KB) CVB-SOP-0082 (March 8, 2013)
• Autogenous Biologics (204.05 KB) CVB-SOP-0083 (May 13, 2014)
• Import Permits for Distribution and Sale (2.93 MB) CVB-SOP-0084 (July 21, 2020)

5.  Testing Biological Products

• Testing of Biological Products (844.14 KB) CVB-SOP-0085 (June 23, 2017)
• Issuing Special Request for Lab Testing Master Seeds and Master Cells 
• Issuing Special Request for Lab Testing of Prelicensing Serials
• Section V testing at Alternate Locations (772.23 KB) CVB-WI-0171 (April 8, 2016)
• Antimicrobial Resistance Policy (810.89 KB) CVB-SOP-5114 (January 11, 2021)

6.  Shipping/Use of Experimental Products

• Shipping Experimental Product (1.58 MB) CVB-WI-0172 (August 23, 2022)
• Instructions for processing 103.3 forms
• Shipping Animal Pathogens and Select Agents (1.49 MB) CVB-WI-0292 (also info about movement of serum) (May 06, 2019)
• Import Permits for Research and Evaluation or Transit Shipment Only (3.32 MB) CVB-SOP-5109 (July 20, 2020)

7.  Statistics

• Overview of Statistics (104.09 KB) CVB-WI-0293 (October 31, 2016)

8.  Guidance for New Firms

• Guidance for Reviewers on Portal Access for New Firms (184.85 KB) CVB-WI-5233 (October 28, 2020)
• New Firm Informational Packet for Antivenin Products (270.31 KB) CVB-WI-5234 (October 28, 2020)
• New Firm Informational Packet for Cancer Products and Immunomodulatory Products that Require Client Owned Animals Efficacy and Safety Studies (309.28 KB) CVB-WI-5235 (October 2, 2020)
• New Firm Informational Packet for Diagnostic Test Kits (289.75 KB) CVB-WI-5236 (October 28, 2020)
• New Firm Informational Packet for Live and Inactivated Vaccines Including Recombinants (280.34 KB) CVB-WI-5237 (October 28, 2020)