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CVB UPDATE 2017
BY R O N R I P P K ED I R E C TO R , C E N T E R F O R V E T E R I N A RY B I O LO G I C SU . S . D E PA R T ME N T O F A G R I C U LT U R EA N I M A L A N D P L A N T H E A LT H I N S P E C T I O N S E RV I C EV E T E R I N A RY S E RV I C E SO C TO B E R 2 0 1 7
CVB Budget ComparisonFY 2016 FY 2017
Vet Biologics Enacted - $16.4
VS Vet Biologics Approp - $14.2M
CVB Allocation - $20.0M ◦ Vet Biologics Line - $12.4M◦ Commodity Lines - $3.7M◦ IT & Other Misc Lines - $2.8M◦ Supplemental (H1N1/HPAI) - $0
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 2016 Staffing
Total Program Staffing – 107◦ PEL – 67
◦ IC – 23
◦ Admin/Other – 17
Total Program Vacancies - 21
NCAH Shared Staffing – 259
NCAH Vacancies - 55
FY 2017 Staffing
Total Program Staffing – 107◦ PEL – 66
◦ IC – 24
◦ Admin/Other – 17
Total Program Vacancies - 22
NCAH Shared Staffing – 259
NCAH Vacancies - 59
Gains since Oct 2016 Losses since Oct 2016
Katy McKee-Richmond Secretary
Deborah Nelson SHEP
Jodeane Nootz IT Specialist
Jennifer Johnson VMO
Michel Carr Microbiologist
John Wile IT Specialist
Anita Hansen Program Assistant
Carol Belzer Microbiologist
Diana Gass Program Support Assistant
Donna Jones Occ. Health Nurse
CVB Staffing Gains/Losses FY2017
Aaron Monroy BioSafety Manager
Matt Erdman VMO
David Morris Librarian
Bruce Thomsen VMO
Rudolf Rampersad IT Specialist
Patti Woo Program Support Assistant
Megan Sisson VMO
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 Affected
Single Label Claim
Vaccines, bacterins, toxoids, immunomodulators
NOT diagnostics, antibody products, allergenic extracts
Labeling and Packaging
All domestically marketed biologics
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 and Virus C, and respiratory and enteric disease due to Virus B. See
productdata.aphis.usda.gov for efficacy and safety data.
Simplified labeling format
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
• Older product allowances
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.
CVB SUBMISSION TYPES
• JUNE 6, 2016 1. 2007s (Qualification of Veterinary Biologics Personnel)
2. 2008s (Veterinary Biologics Production and Test Report)
3. 2020s (Shipment and Receipt of Biologics Samples)
• SEPTEMBER 15, 20161. 2048s (E-submission to Inspection and Compliance)
2. 2049s (E-submission to Policy, Evaluation and Licensing)
• MARCH 16, 2017
1. 2049s (E-submission to Policy, Evaluation and Licensing)
• Expanded to include Outlines of Production and Special Outlines
NCAH Portal Timeline:
85%
15%
APHIS FORM 2008s
Portal Not Portal
11,856 2,138
73%
27%
Samples
Portal Not Portal
3,423
94%
6%
APHIS FORM 2007s
Portal Not Portal
64
Total Submissions Submitted via the NCAH Portal in FY17 by Type
9,231 942
Total Submissions Submitted via the NCAH Portal in FY17 by Type
62%
38%
Inspection & Compliance Correspondence
Portal Not Portal
937
51%49%
Policy, Evaluation & Licensing Correspondence
Portal Not Portal
3,2141,532 3,354
42
57 58
64
6771
7174
7474
7575
75
56
41
40
34
31
27 2724 24 24 23
23
23
0
10
20
30
40
50
60
70
80
Sep-16 Oct-16 Nov-16 Dec-16 Jan-17 Feb-17 Mar-17 Apr-17 May-17 Jun-17 Jul-17 Aug-17 Sep-17
NCAH Portal Usage by Firms
Number of Firms Using Portal Number of Firms Not Using Portal
Other items
Extraneous agents in serum/trypsin◦ SVA paper at AASV
◦ Risk assessment by CEAH
◦ Next steps
NEPA Implementing Rule Revision◦ Proposed rule published
◦ Not as many comments as expected
◦ CVB’s have been responded to
◦ Date not set to publish
◦ Important implications
International Quality Stds.
◦ Looking at CFR vs. GMP
◦ International recognition
Pharmacovigilance Final Rule◦ Proposed rule published Fall of 2015
◦ All comments addressed
◦ Signed off through Dept.
Platform technologies◦ First published in Spring 2015
◦ New Memo soon
Questions?????
Dr. Byron RippkeDirector, Center for Veterinary BiologicsU.S. Department of AgricultureAnimal and Plant Health Inspection ServiceVeterinary ServicesEmail: [email protected]
