CVB UPDATE 2017 - USAHA · CVB SUBMISSION TYPES •JUNE 6, 2016 1. 2007s (Qualification of...

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: byron.e.rippke@aphis.usda.gov