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Center for Veterinary Biologics |
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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)
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) (July 6, 2012 - 144 KB)
2.2.1 List of standard license restrictions (October 12, 2012 - 186 KB)
3. Types of Licenses/Limits of Authority
3.1 Establishment Licenses (May 8, 2013- 1.9 MB)
3.2 Conditional Licenses (June 21, 2013 - 291 KB)
3.3 Exemptions to the Virus-Serum-Toxin Act (September 13, 2010 - 22 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 (April 17, 2013- 2 MB)
4.1.1 Tagging "pending" Special Outlines (with Pending SO worksheet) (September 1, 2010 - 10 KB)
4.1.2 Section V.C Potency Assay Tests
4.1.3 Outline Changes for Bacterial Products (September 1, 2010 - 25 KB)
4.1.4 Validating Alternate Techniquest for Detection of Mycoplasmas (March 22, 2013 - 47 KB)
4.2 Labels (March 6, 2013 - 826 KB)
4.3 Study Protocols (October 21, 2010 - 58 KB)
4.4 Efficacy Studies (includes Lack of Interference) (March 15, 2013 - 2.23 MB)
4.4.1 Efficacy/Reference Qualification by Serology
4.4.2 Electronic Freedom of Information (efoia) Summaries (with template summary) (June 12, 2013 - 353 KB)
4.5 Field Safety Studies (March 22, 2013- 448 KB) (see also VS Memo 800.204 )
4.6 Potency Test Development & Validation Studies
4.6.1 Potency Test References -- introduction to terminology (October 21, 2010 - 66 KB)
4.7 Diagnostic Test Kits (see also VS Memo 800.73 ) (October 21, 2010 - 48 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 (November 2, 2010 - 32 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 1, 2010 - 29 KB)
4.12 Summary Information Format (SIF) and Risk Analyses
4.12.1 Office Procedure for Routing & Processing SIFs and RAs (September 7, 2010 - 24 KB)
4.12.2 Outline for content of risk analyses
4.12.3 SIF/RA Worksheet (October 25, 2010 - 12 KB)
4.13 Master Seeds/Cells/Sequences (February 6, 2013 - 1,045 KB)
4.14 Preservatives in biologics (September 1, 2010 - 22 KB)
4.15 Sterile diluents (March 8, 2013- 170 KB)
4.16 Autogenous Biologics (February 7, 2013 - 81 KB)
5. Testing Biological Products
5.1 Requesting tests at the CVB laboratory (March 13, 2013- 583 KB)
5.2 Issuance of Special Request (SR) for Lab Testing of Master Seeds & Master Cells (August 15, 2012 - 95 KB)
6. Shipping/Use of Experimental Products
6.1 Shipping Experimental Product under 9CFR 103.3/Experimental Product on Licensed Premises/Experimental Slaughter Permits (April 4, 2013- 2.35 MB)
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 (October 22, 2010 - 48 KB)
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