CVB Update USAHA 2016 · CVB Budget Comparison FY 2015 Vet Biologics Enacted ‐$16.4 VS Vet...
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CVB UPDATE FOR USAHA BYRON RIPPKE, DVM DIRECTOR, CENTER FOR VETERINARY BIOLOGICS U.S. DEPARTMENT OF AGRICULTURE ANIMAL AND PLANT HEALTH INSPECTION SERVICE VETERINARY SERVICES OCTOBER 2016
Transcript of CVB Update USAHA 2016 · CVB Budget Comparison FY 2015 Vet Biologics Enacted ‐$16.4 VS Vet...
CVB UPDATE FOR USAHA
BYRON R I P P K E , DVMD I R ECTOR , C ENTER FOR V E T ER INARY B IO LOG I C SU . S . D E PARTMENT OF AGR I CU LTUREAN IMAL AND P LANT HEA LTH I N S P EC T ION S ERV I C EVETER INARY S ERV I C ESOCTOBER 2 0 16
Staffing & Budget
CVB Budget Comparison
FY 2015
Vet Biologics Enacted ‐ $16.4
VS Vet Biologics Approp ‐ $13.3M
CVB Allocation ‐ $18.8M◦ Vet Biologics Line ‐ $12M◦ Commodity Lines ‐ $3.6M◦ IT & Other Misc Lines ‐ $2.4M◦ Supplemental (H1N1/HPAI) ‐ $871K
FY 2016
Vet Biologics Enacted ‐ $16.4
VS Vet Biologics Approp ‐ $14.1M
CVB Allocation ‐ $19.3M◦ Vet Biologics Line ‐ $12.4M◦ Commodity Lines ‐ $3.5M◦ IT & Other Misc Lines ‐ $2.4M◦ Supplemental (H1N1/HPAI) ‐ $1M
CVB Budget Comparison
FY 15 ≈ FY 16 ≈ FY 17 ≈ FY 18
CVB Staffing ComparisonFY 2015 STAFFING
Total Program Staffing – 106◦ PEL – 66 ◦ IC – 23◦ Admin/Other – 17
Total Program Vacancies ‐ 21
NCAH Shared Staffing – 257
NCAH Vacancies ‐ 44
FY 2016 STAFFING
Total Program Staffing – 107◦ PEL – 67◦ IC – 23◦ Admin/Other – 17
Total Program Vacancies ‐ 22
NCAH Shared Staffing – 259
NCAH Vacancies ‐ 55
Single‐tier label rule
New labeling regulations• APHIS rule 2011‐0049: simplifies effectiveness claims on labeling and requires publication of efficacy/safety data at productdata.aphis.usda.gov
• APHIS rule 2008‐0008: provides numerous changes to label content, disclosures
Co‐implementation beginning October 31, 2016• Newly licensed products will comply immediately• Previously licensed products phased in over 4‐year period
Scope of Products AffectedSingle Label Claim• Vaccines, bacterins, toxoids, immunomodulators• NOT diagnostics, antibody products, allergenic extracts
Labeling and Packaging• All domestically marketed biologics
Simplified labeling format
This product is indicated for the prevention of disease against
Virus A, as an aid in the control of respiratory disease due to Virus B, an aid in the prevention of
infection with Virus C, and an aid in the prevention of enteric disease due to Virus B.
Previously: Now:
This product is effective against Virus A, Virus C, and
respiratory and enteric disease due to Virus B. See productdata.aphis.usda.gov for efficacy and safety data.
productdata.aphis.usda.gov(note: no “www”)
Search engine to find desired products by:• Trade Name• True Name• Manufacturer• Distributor• USDA Product Code
• Animal species for use
Product Compilation Summary
• Posted to productdata.aphis.usda.gov
• Contains each efficacy and safety study used to support licensure of a single product
• Studies may be added if product approved for additional claims after initial licensure
Cover page
Individual Study Summaries on subsequent pages
Additional labeling changes
• Revaccination statements—must be based on data, no default to yearly
• Reproductive safety—must state whether product has been evaluated in pregnant animals
• Additions:• Veterinary Biologics Product Code• Consumer contact telephone • All preservatives, not just antibiotics
NCAH PortalWeb‐based submissions
Features of NCAH Portal
• Access based on level 2 USDA e‐authorization credentials
• Entirely paperless• Customer entry based on familiar APHIS forms• Can upload a variety of supporting documents• Interacts directly with CVB’s database and internal routing system (LSRTIS)
Example Portal Entry
Example Portal Entry, Cont’d
Efficiencies of NCAH Portal
• Time and cost savings printing/mailing submissions and regulatory responses
• Maintains a complete list of pending submissions for each establishment, with current review status
• Simultaneous access to the same information for every authorized user at an establishment
• Facilitates team assembly of submissions—each can upload their contribution to a draft submission.
Other items
NIES Risk Assessment◦ Set back a year due to HPAI◦ Initial draft commented on◦ Still being worked on, but not finished
NEPA Implementing Rule Revision◦ Proposed rule published◦ Not as many comments as expected
◦ CVB’s have been responded to◦ Not sure when final may be published
◦ Important implications
Pharmacovigilance Final Rule◦ Proposed rule published Fall of 2015
◦ All comments addressed◦ Signed off though Dept.
Questions?????
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Byron Rippke, DVMDirector, Center for Veterinary BiologicsU.S. Department of AgricultureAnimal and Plant Health Inspection ServiceVeterinary Services(515) 337‐[email protected]
