CVB Policy, Evaluation and Licensing - Reviewer Manual

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

1.1  Overview of the Review and Licensing Process (November 23, 2015)

1.2  APHIS Policy on Confidential Business Information (August 19, 2010)

1.3  True Names and Product Codes (January 25, 2013)

1.4  Reviewer Staff Meetings (August 19, 2010)

1.5  Product Licensing Plans and Critical Path Agreements (March 27, 2015)

1.6  Transfer of firms

1.7  Ex parte communication

2.  Office Procedures

2.1  General guide formatting correspondence, routing documents for processing & supervisor approval

2.1.1  Process for checking in daily mail

2.1.2  Using the PEL Mail Log

2.1.3  Fileroom organization

2.1.4  Targeted distribution of correspondence to other CVB personnel

2.2  Final Steps for Licensure (Preparing a licensing package) (May 14, 2014)

2.2.1  List of Standard License Restrictions (April 8, 2016)

2.3  Electronic Archive Instructions

2.4  Quarterly Submission Acknowledgement Summaries(October 25, 2013)

3.  Types of Licenses/Limits of Authority

3.1  Establishment Licenses (April 29, 2014)

3.2  Conditional Licenses (September 22, 2014)

3.3  Exemptions to the Virus-Serum-Toxin Act (May 23, 2014)

3.4  Food and Drug Administration-Export Reform and Enhancement Act (aka DEREA) (September 24, 2015 - 62KB)

3.4.1  Text of FDA-EREA regulation (U.S. Code 382)

3.5  Memorandum of Understanding with Food and Drug Administration (division of authority) (June 27, 2013 - 39 KB)

3.6  Regulation of veterinary vaccines that reduce colonization/shedding of organisms that are mainly human pathogens (2005 agreement with FDA)

3.7  Federal Preemption and Veterinary Biologics

4.  Reviewing Specific Submissions

4.1  Outlines of Production (November 12, 2015 -  167 KB)

4.1.1  Using the Pending Special Outline Worksheet (November 06, 2014 - 268 KB)

              4.1.1.1  Special Outline Worksheet

4.1.2  Section V.C Potency Assay Tests

4.1.3  Outline Changes for Bacterial Products (August 26, 2013 - 25 KB)

4.1.4  Validating Alternate Techniques for Detection of Mycoplasmas (August 3, 2016 - 49 KB)

4.1.5  Dilution of Preservative Studies (August 1, 2014 - 23 KB)

4.2  Labels (March 26, 2015 - 906 KB)

4.2.1  Precedents for International Label Non-compliance (August 16, 2016 - 1.47 MB)

4.3  Study Protocols (December 9, 2015)

4.4  Efficacy Studies (including Interference Studies) (December 31, 2015)

4.4.1  Efficacy/Reference Qualification by Serology

4.4.2  Electronic Freedom of Information (efoia) Summaries (June 7, 2013)

4.4.3  Master Reference Qualification and Requalification

              4.4.3.1  Master Reference Data Worksheet

4.4.4  Efficacy Requirements for Specific Antigens

4.5  Field Safety Studies (September 14, 2015) (see also VS Memo 800.204 )

4.5.1  Animal Safety Testing Exemption (April 2, 2015)

4.6  Potency Test Development & Validation Studies

4.6.1  Potency Test References - introduction to terminology (May 30, 2014)

4.6.2  Using Software to Estimate Relative Potency (July 01, 2016)

4.7  Diagnostic Test Kits (see also VS Memo 800.73 ) (October 2, 2014)

4.7.1  APHIS Directive 6910.1 (process for coordinating licensing and approval for diagnostics used in official control programs)

4.8  Antibody Products (September 23, 2016)

4.9  Adjuvants and Excipients (September 16, 2016)

4.9.1  Adjuvant spreadsheet

4.10  Stability

4.10.1  Proposed rule regarding 9 CFR 114.12 and 114.13

4.10.2  Stability Draft CVB Notice Document 155

4.10.3  Evaluation of Confirmation of Dating Studies

4.11  Patent Term Extensions (September 6, 2013)

4.12  Summary Information Format (SIF) and Risk Analyses

4.12.1  Office Procedure for Routing & Processing SIFs and RAs (July 1, 2016)

4.12.2  Outline for content of risk analyses (July 9, 2015)

4.12.3  SIF/RA Worksheet (December 23, 2013)

4.12.4  Regulatory Process for Biotech Products (July 01, 2016)

4.13  Master Seeds/Cells/Sequences (April 8, 2016)

4.14  Preservatives in biologics (September 1, 2010)

4.15  Sterile diluents (March 8, 2013)

4.16  Autogenous Biologics (May 13, 2014)

4.17  Import Permits (October 7, 2015)

5.  Testing Biological Products

5.1  Requesting tests at the CVB laboratory (September 24, 2015)

5.2  Issuing Special Request for Lab Testing Master Seeds and Master Cells 

5.3  Issuing Special Request for Lab Testing of Prelicensing Serials

5.4  Section V testing at Alternate Locations (April 8, 2016 )

6.  Shipping/Use of Experimental Products

6.1  Shipping Experimental Product under 9CFR 103.3/Experimental Product on Licensed Premises/Experimental Slaughter Permits (December 9, 2014)

         6.1.1  Instructions for processing 103.3 forms

6.2  Shipping Animal Pathogens and Select Agents (also info about movement of serum) (January 25, 2013)

7.  Statistics

7.1  Overview of Statistics (October 31, 2016)

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