Animal and Plant
Health Inspection
Services

Veterinary Services

Center for Veterinary
Biologics

1920 Dayton Ave
PO Box 844
‘Ames, IA 50010

(515) 337-6100

USDA

United States Department of Agriculture

CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 18-12

TO: Biologics Licensees, Permittees, and Applicants
Directors, Center for Veterinary Biologics
Veterinary Services Leadership Team

FROM: Byron Rippke =
Director ( °

SUBJECT: Issuance of Licensés

The purpose of this notice is to bring to the attention of interested parties licenses issued and

terminated between July 01, 2018 and September 30, 2018. These do not include those licenses

reissued to update pertinent information.

New U.S. Veterinary Biological Establishment Licenses and Permits (new permittees) were issued as

follows:

Est. Name and Address Est. No. Type
HIPRA USA, LLC 449A Permittee
Lincoln, NE

New U.S. Veterinary Biologics Product Licenses and Biological Product Permits (new codes) were

issued as follows:

Chimera

True Name Code Est. Name/No.

Bursal Disease-Marek's Disease Vaccine, Serotypes | & 3, Live Marek's Disease ]1281.R3 | Merial, Inc./Est No. 298

Vector, Live Herpesvirus Chimera

Encephalomyelitis Vaccine, Eastern & Western & Venezuelan, Killed Virus, [4865.40 Boehringer Ingelheim Vetmedica,

Tetanus Toxoid Inc/Est No. 124

Encephalomyelitis Vaccine, Eastern & Western, Killed Virus, Tetanus Toxoid [4865.A1__| Boehringer Ingelheim Vetmedica,
Inc/Est No. 124

Encephalomyelitis-Influenza-West Nile Virus Vaccine, Eastern & Western, 46WS.A1 | Boehringer Ingelheim Vetmedica,

Killed Virus, Tetanus Toxoid Inc./Est No. 124

Encephalomyelitis-Rabies-West Nile Virus Vaccine, Eastern & Western & 48R5.20 | Zoetis Inc./Est No. 190

Venezuelan, Killed Virus, Tetanus Toxoid

Encephalomyelitis-Rabies-West Nile Virus Vaccine, Eastern & Western, Killed |48R5.21 Zoetis Inc./Est No. 190

Virus, Tetanus Toxoid

Encephalomyelitis-Rhinopneumonitis-Influenza Vaccine, Eastern & Western & [4847.40 | Boehringer Ingelheim Vetmedica,

Venezuelan, Killed Virus, Tetanus Toxoid Inc/Est No. 124

Encephalomyelitis-Rhinopneumonitis-Influenza Vaccine, Eastern & Western, |4845.A1__ | Boehringer Ingelheim Vetmedica,

Killed Virus, Tetanus Toxoid Inc/Est No. 124

Encephalomyelitis-Rhinopneumonitis-Influenza-West Nile Virus Vaccine, 49W5.A0 | Boehringer Ingelheim Vetmedica,

Eastern & Western & Venezuelan, Killed Virus, Tetanus Toxoid Inc./Est No. 124

Encephalomyelitis-Rhinopneumonitis-Influenza-West Nile Virus Vaccine, 4855.A0 _| Boehringer Ingelheim Vetmedica,

Eastern & Western, Killed Virus, Tetanus Toxoid Inc/Est No. 124

Encephalomyelitis-West Nile Virus Vaccine, Eastern & Western & Venezuelan, [48W5.A2 | Bochringer Ingelheim Vetmedica,

Killed Virus, Tetanus Toxoid Inc./Est No. 124

Encephalomyelitis-West Nile Virus Vaccine, Eastern & Western, Killed Virus, ]48W5.A3 | Bochringer Ingelheim Vetmedica,

Tetanus Toxoid Inc./Est No. 124

Marek's Disease Vaccine, Serotypes | & 3, Live Virus, Live Herpesvirus 16GLRO | Merial, Inc./Est No. 298



Page 2

True Name Code Est. Name/No.
Moraxella Bovoculi Bacterin 2A77.01 Addison Biological Laboratory, Inc./Est
lo.
Porcine Circovirus Vaccine, Type 2, Killed Baculovirus Vector 19KS.R4 Boehringer Ingelheim Vetmedica,
Inc./Est No, 124
Staphylococcus Aureus Bacterin 2852.00 HIPRA USA, LLC/Est No. 449A.
West Nile Virus Vaccine, Killed Virus 1995.21 Boehringer Ingelheim Vetmedica,

Inc /Est No. 124

There were no U.S. Veterinary Biologics Establishment Licenses or Permits (Permittees) terminated

this quarter.

U.S. Veterinary Biological Product Licenses and Permits (codes) were terminated without prejudice

as follows:

True Name Code Est. Name/No.

Bordetella Bronchiseptica-Erysipelothrix Rhusiopathiae-Haemophilus Parasuis- | 7045.00 Boehringer Ingelheim Vetmedica,

Pasteurella Multocida Bacterin-Toxoid Inc/Est No. 124

Bordetella Bronchiseptica-Erysipelothrix Rhusiopathiae-Pasteurella Multocida | 7054.00 Boehringer Ingelheim Vetmedica,

Bagterin-Toxoid Inc /Est No, 134

Bovine Rhinotracheitis Vaccine, Killed Virus, Haemophilus Somnus- 45H5.20 Texas Vet Lab, Inc./Est No. 290

Mannheimia Haemolytica-Pasteurella Multocida Bacterin-Toxoid

Bovine Rhinotracheitis Vaccine, Killed Virus, Haemophilus Somnus- ASH5.21 Texas Vet Lab, Inc./Est No. 290

Mannheimia Haemolytica-Pasteurella Multocida Bacterin-Toxoid

Bovine Rhinotracheitis-Virus Diarrhea Vaccine, Modified Live Virus 1151.20 Boehringer Ingelheim Vetmedica,
Inc./Est No. 124

Bovine Rhinotracheitis-Virus Diarthea-Parainfluenza 3-Respiratory Syncytial {1181.20 Boehringer Ingelheim Vetmedica,

Virus Vaccine, Modified Live Virus Inc/Est No. 124

Bovine Spongiform Encephalopathy Antigen Test Kit, ELISA $430.22 Bio-Rad Laboratories/Est No. 624

Bovine Virus Diarrhea Vaccine, Killed Virus, Haemophilus Somnus- 4C95,20 | Texas Vet Lab, Inc./Est No. 290

Mannheimia Haemolytica-Pasteurella Multocida Bacterin-Toxoid

‘Campylobacter Fetus-Jejuni Bacterin 2860.00 Hygieia Biological Laboratories/Est
No. 407

Canine Coronavirus-Parvovirus Vaccine, Modified Live & Killed Virus 14R7.22___[Elanco US Inc./Est No. 196

Canine Distemper-Adenovirus Type 2-Coronavirus-Parainfluenza-Parvovirus | 1599.20 Elanco US Inc./Est No. 196

Vaccine, Modified Live & Killed Virus

Canine Distemper-Adenovirus Type 2-Coronavirus-Parainfluenza-Parvovirus | 469.28 Elanco US Inc./Est No. 196

Vaccine, Modified Live & Killed Virus, Leptospira Canicola-Grippotyphosa-

Icterohaemorrhagiae-Pomona Bacterial Extract

Canine Distemper-Adenovirus Type 2-Parainfluenza-Parvovirus Vaccine, 4637.28 Elanco US Inc./Est No. 196

Modified Live Virus, Leptospira Canicola-Grippotyphosa-Icterohaemorthagiac~

Pomona Bacterial Extract

Canine Distemper-Adenovirus Type 2-Parainfluenza-Parvovirus Vaccine, 4639.28 Elanco US Inc./Est No. 196

Modified Live Virus, Leptospira Canicola-Icterohaemorrhagiae Bacterial Extract

Canine Distemper-Adenovirus Type 2-Parvovirus Vaccine, Modified Live Virus [1331.20 Elanco US Inc./Est No. 196

Chronic Wasting Disease Antigen Test Kit, ELISA 5420.22 Bio-Rad Laboratories/Est No. 624

Clostridium Perfringens Type C Toxoid H101,00 [Colorado Serum Company/Est No. 188

Encephalomyelitis-Influenza-West Nile Virus Vaccine, Eastern & Western, 46W5.21 | Boehringer Ingelheim Vetmedica,

Killed Virus, Tetanus Toxoid Inc./Est No. 124

Encephalomyelitis-Rhinopneumonitis-Influenza Vaccine, Eastern & Western & |4847,20 Boehringer Ingelheim Vetmedica,

Venezuelan, Killed Virus, Tetanus Toxoid Inc,/Est No, 124

Feline Calicivirus Vaccine, Killed Virus 15C5.21 Elanco US Ine./Est No. 196

Feline Immunodeficiency-Leukemia Virus Vaccine, Killed Virus 15DS.RO__ | Elanco US Inc/Est No. 196

Feline Leukemia-Rhinotracheitis-Calici-Panleukopenia Vaccine, Killed Virus |15B5.20 __ | Elanco US Inc/Est No. 196

Feline Rhinotracheitis-Calicivirus Vaccine, Modified Live Virus 16C1.22 __|Elanco US IneJ/Est No. 196

Haemophilus Somnus-Mannheimia Haemolytica-Pasteurella Multocida Bacterin- | 7895.00 ‘Texas Vet Lab, Inc./Est No. 290

Toxoid

Leptospira Canicola-lcterohaemorrhagiae Bacterial Extract 2671.05 Elanco US Inc./Est No. 196

Mannheimia Haemolytica Bacterin-Toxoid 7905.00 Texas Vet Lab, Inc/Est No. 290

Parvovirus Vaccine, Modified Live Virus 18M1.24 _|Elanco US Inc/Est No. 196

Porcine Epidemic Diarthea Vaccine, RNA 19US.D0__[Intervet Inc./Est No. 165A,



Page 3

True Name Code Est. Name/No.
Porcine Reproductive & Respiratory Syndrome Vaccine, Respiratory Form, 1981.21 Boehringer Ingelheim Vetmedica,
Modified Live Virus Inc /Est No. 124
Salmonella Choleraesuis Vaccine, Avirulent Live Culture 19A1.01 | Boehringer Ingelheim Vetmedica,

Inc /Est No. 124
Salmonella Enteritidis Antibody Test Kit 5SE5.00 | IDEXX Laboratories, Inc./Est No. 313
Scrapie Antigen Test Kit, ELISA 5410.21 Bio-Rad Laboratories/Est No. 624

There were no Product Licenses or Permits (codes) issued due to an acquisition this quarter.