PEL UPDATE PEL UPDATE

USAHA 2010

PEL 2010 Priority Activiti

PEL 2010 Priority Activiti

• CVB Operational Priorities

– Mycoplasma PCR test development– Extraneous Agent Microarray development Extraneous Agent Microarray development– LSRTIS data population and implementation– BID Section testing backlog– Firm merger activities

• Application Review • Management & Culture Review activities Management

& Culture Review activities

• Program Documentation & Quality Assuran• pH1N1
2010 Program Documen

2010 Program Documen

• CVB Notices Published – 10• VS Memorandums Published 

–

2

• D t P t d t th CVB W b 

Documen

ts 

Pos

t

e

d

to the CVB

W

e

b

Comment – 11

• Federal Register Publications – 1 No
FY 2010

Establishments and Permitte

Issued

1 Establishment Licenses8 Permittee 8 Permittee

Terminated

10 E t bli h t Li 10 Establishment License

4 Permittee

Total

77 Licensees22 Permittees 22 Permittees
FY 2010

P d ro ucts

Issued

57 Product Licenses

These include: 1 Unique Products

Terminated

106 Product Licenses 106 Product Licenses

Total

1,942 Active Product Licenses
Licensed Establishments v

Products

by Year Products 

FY2010 Value as of 09/30/10
Product License Activity

by Year

2500300015002000 TotalActive Li

Products Licen

500

1000 Year

Products Term

During Year

0

FY2010 Licensed and Terminated Values from 10/01/2009 to 09/30/2010
Active Biotech Product Licen

155 159 154 160 14

180

108 113

132

14

120140160

80 84 77 84

6080

Number 100

0

2040

2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 20

Year

FY2010 Value as of 09/30/10
Biotech Products by Catego

b Yy 

Year

140

Number

100120

6080 Cat

Cat

2

0

4060 Cat

Cat

0

0

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010

FY2010 Values as of 09/30/10

Note: Figures for 2001‐2006 do not include Diagnostics.
Biotech Products – FY2010

All Categories (as of 09/30/10)

C I ategory I C II ategory III-A-1 Non-replicating recombinant antigen(s)-vaccine

12 II Live Gene 

Deleted

I-A-2 Non-replicating recombinant antigen(s)-kits

14 Category III

I-B-1 Monoclonal 1 Monoclonal antibody antibody- 1 III-A Live Vectored therapeutic/prophylactic use

1 III

A Live Vectored 

I-B-2 Monoclonal antibody-used in diagnostic tests

67 III-B-1 Transgenic 

plant-based vaccine

diagnostic tests plant based vaccineI-C-1 Synthetic peptidetherapeutic/prophylactic use

2

I-C-2 S th ti 2

Synth

etic peptid / e

/

7

oligonucleotide-in diagnostic

7

I-D-1 Nucleic Acid-Mediated (not S th ti ) i

2

Synth

eti

c)-vaccine

I-D-2 Nucleic Acid-Mediated (not Synthetic)-diagnostic

2
Number of Diagnostic Product Lice

Number of Diagnostic Product Lice

250 Current Lice

Number

200

Lice

IssuedTerminated

150

50

100

0

95 96 97 98 99 00 01 02 03 04 05 06 07 08 09 10

FY2010 Values from 10/01/09 – 09/30/10

Year
For Further Manufacture Produc

Licensed

by Year

350

Number

250300 Total Lic150200250

50

100

0

95 96 97 98 99 00 01 02 03 04 05 06 07 08 09 10

Licensed and Terminated Values from 10/01/09 through 09/30/10
Active Unique Products

by Year

705 705 701 720 706

688

678

661

660680700

634

624

614

60

600620640660560580600540

00 01 02 03 04 05 06 07 08 09 1

N

u be m

r

o

f Products

FY2010 Value as of 09/30/10
P it erm s – FY 2010 FY 2010

No of Research and Evaluation Permits No. of Research and Evaluation Permits No. of Transit Shipment Permits 
Veterinary Biologics Permit

FY 1995 through FY 2010

400300350150200250

0

50

100

95 96 97 98 99 00 01 02 03 04 05 06 07 08 

Research and Evaluation Transit ShipmentOnly

FY2010 Value from 10/01/2009 to 09/30/2010
Doses Produced and Destro

1990 through 2009 (by calendar year)

Number of Doses ‐ Billion

7080904050607010203040

0

1990

1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

2001

2002

2003

2004

2005

2006

2007

Produced Destroyed
Total Submissions - Compare

Category

700080009000400050006000 Mics.

Data Corre

1000200030004000

OutlinLabel

0

1000

00 01 02 03 04 05 06 07 08 09 10

FY2010 Values from 10/01/09 ‐ 09/30/10
Aquaculture Products Licens

4550

Number

35402025301015

05

95 96 97 98 99 00 01 02 03 04 05 06 07 08 09 10

Year

FY2010 Value as of 09/30/10 (increase in 2010 due to new report)
Permittees ‐ FY 2010

 Canada

 12 Vaccine/Bacterins

 Europe

1 V 

 Asia

 5 Diagnostics  12 Vaccine/Bacterins

 2 Antibodies

 1 Vacc

 13 Diag 1 Imm

 5 Diagnostics

 Mexico

 3 Diagnostics

 Australia/New Zealand

 18 Vaccine/Bacterins

 Central/South America

 1 Immunomodulator

18 Vaccine/Bacterins

 7 Diagnostics

 1 Immunomodulator

As of 09/30/2010
Center for Veterinary Biolo

FY 2009 Li i S FY 2009 Licens

ing 

Summa

FY06 FY07 FY08 FY0

Submissions Processed

6646 6656 5663 563

Product Licenses & Permits

78 63 59 8

Total Active Total Active 2348 2063 2013 196

Licenses & Permits

2348 2063 2013 196

Biotechnology Biotechnology 26 19 12 1

Products Licensed

26 19 12 1

Unique Products Li d

11 2 1 

License

d

R&E Permits 292 265 359 38
Confirmatory and 

Investigatory Testing Investigatory Testing

• T ti N b f Fi l Y 2010 Testing 

Num

bers 

for Fiscal Year 2010

– Serials Eligible Serials Eligible 18 721 ,– Serials (%) Tested 728 (4– Serials (%) Unsatisfactory 8 (

– Master Cells Tested 10

– Master Seeds Tested 25– Recombinant/ GM MS 7
Reagents 2010 Reagents 2010

• Reagents shipped (vials): Reagents shipped (vials): 3,93

– Domestic 3,90– Foreign 3

• Kit panels/slides 79• Supplied internal (vials) Supplied internal (vials) 25 08

,

• Reagents developed 1• Reagents replenished Reagents replenished 2