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Policy, Evaluation and Licensing - Reviewer's 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 2, 2012 - 150 KB)

1.2  APHIS Policy on Confidential Business Information (August 19, 2010 - 33 KB)

1.3  True Names and Product Codes (January 25, 2013- 511 KB)

1.4  Reviewer Staff Meetings (August 19, 2010 - 16 KB)

1.5  Product Licensing Plans (March 20, 2012- 177 KB)

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 - 42 KB)

2.2.1  List of standard license restrictions (October 12,, 2012 - 186 KB)

2.3  Electronic Archive Instructions

2.4  Quarterly Submission Acknowledgement Summaries(October 25, 2013 - 28 KB)

3.  Types of Licenses/Limits of Authority

3.1  Establishment Licenses (April 29, 2014 - 51 KB)

3.2  Conditional Licenses (June 20, 2013 - 349 KB)

3.3  Exemptions to the Virus-Serum-Toxin Act (May 23, 2014 - 194 KB)

3.4  Food and Drug Administration-Export Reform and Enhancement Act (aka DEREA) (February 6, 2013 - 81 KB)

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 (June 15, 2012- 287KB)

4.1.1  Tagging "pending" Special Outlines (with Pending SO worksheet) (February 19, 2014 - 95 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 Techniquest for Detection of Mycoplasmas (March 22, 2013 - 47 KB)

4.2  Labels (July 12, 2013 - 641 KB)

4.3  Study Protocols (January 30, 2014 - 1.74 MB)

4.4  Efficacy Studies (includes Lack of Interference) (May 27, 2014 - 858 KB)

4.4.1  Efficacy/Reference Qualification by Serology

4.4.2  Electronic Freedom of Information (efoia) Summaries (June 7, 2013 - 288 KB)

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 (March 22, 2013 - 450 KB) (see also VS Memo   800.204 )

4.5.1  Animal Safety Testing Exemption (January 2, 2014 - 242 KB)

4.6  Potency Test Development & Validation Studies

4.6.1  Potency Test References -- introduction to terminology (May 30, 2014 - 391 KB)

4.6.2  Using Software to Estimate Relative Potency (April 10, 2014 - 26KB)

4.7  Diagnostic Test Kits (see also VS Memo   800.73 ) (May 30, 2014 - 851 KB)

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 29, 2011- 108 KB)

4.9  Adjuvants and Excipients (November 15, 2013 - 388 KB)

4.9.1  Adjuvant spreadsheet

4.10  Stability

4.10.1  Proposed rule regarding 9 CFR 114.12 and 114.13 (153 KB)

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 - 29 KB)

4.12  Summary Information Format (SIF) and Risk Analyses

4.12.1  Office Procedure for Routing & Processing SIFs and RAs (December 27, 2013 - 231 KB)

4.12.2  Outline for content of risk analyses

4.12.3  SIF/RA Worksheet (December 23, 2013 - 12 KB)

4.12.4  Regulatory Flowchart for Biotech Products (June 27, 2013 - 134 KB)

4.13  Master Seeds/Cells/Sequences (February 21, 2014 - 667 KB)

4.14  Preservatives in biologics (September 1, 2010 - 22 KB)

4.15  Sterile diluents (March 8, 2013- 170 KB)

4.16  Autogenous Biologics (May 13, 2014 - 204 KB)

5.  Testing Biological Products

5.1  Requesting tests at the CVB laboratory (September 25, 2013- 71 KB)

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

5.3  Issuing Special Request for Lab Testing of Prelicensing Serials

6.  Shipping/Use of Experimental Products

6.1  Shipping Experimental Product under 9CFR 103.3/Experimental Product on Licensed Premises/Experimental Slaughter Permits (August 2, 2013 - 810 KB)

         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- 347 KB)

7.  Statistics

7.1  Overview of Statistics (August 21, 2013 - 644 KB)



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