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

follows:

________________________________________________________________

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

issued as follows:

United States Department of Agriculture

Animal and Plant

Health Inspection

Services

Veterinary Services

Center for Veterinary

Biologics

1920 Dayton Ave

PO Box 844

Ames, IA 50010

(515) 337-6100

CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 18-01

TO: Biologics Licensees, Permittees, and Applicants

Directors, Center for Veterinary Biologics

Veterinary Services Leadership Team

FROM: Byron Rippke

Director

SUBJECT: Issuance of Licenses

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

terminated between October 01, 2017 and December 31, 2017. These do not include those licenses

reissued to update pertinent information.

Est. Name and Address Est. No. Type

TechLab, Inc.

Radford, VA

446 Licensee

True Name Code Est. Name/No.

Autogenous Vaccine, Killed Virus, Autogenous Bacterin 4500.20 Hennessy Research Associates,

LLC/Est No. 597

Autogenous Vaccine, Killed Virus, Autogenous Bacterin 4500.90 Colorado Serum Company/Est No. 188

Avian Influenza Vaccine, H5 Subtype, DNA 1057.D0 Antelope Valley Bios, Inc./Est No. 419

Bordetella Bronchiseptica Bacterin 2100.00 Boehringer Ingelheim Vetmedica,

Inc./Est No. 124

Bovine IgG 3606.03 Alta Genetics USA, Inc./Est No. 448A

Bovine Rotavirus-Coronavirus-Escherichia Coli Antibody, Bovine Origin 3625.R2 ImmuCell Corporation/Est No. 327

Bovine Virus Diarrhea Antigen Test Kit 5A05.50 Zoetis Inc./Est No. 190

Canine Anaplasma Antibody Test Kit 5751.20 SA Scientific, Ltd./Est No. 373

Canine Osteosarcoma Vaccine, Live Listeria Vector 9243.R0 Antelope Valley Bios, Inc./Est No. 419

Canine Parainfluenza Vaccine, Modified Live Virus 1421.20 Boehringer Ingelheim Vetmedica,

Inc./Est No. 124

Canine Parainfluenza Vaccine, Modified Live Virus, Bordetella Bronchiseptica

Bacterin

47A1.20 Boehringer Ingelheim Vetmedica,

Inc./Est No. 124

Equine Rhinopneumonitis Vaccine, Killed Virus 1525.22 Boehringer Ingelheim Vetmedica,

Inc./Est No. 124

Equine Rhinopneumonitis-Influenza Vaccine, Killed Virus 1515.22 Boehringer Ingelheim Vetmedica,

Inc./Est No. 124

Giardia Antigen Test Kit 5G05.20 TechLab, Inc./Est No. 446

Hemorrhagic Enteritis Vaccine, Live Virus 17E1.20 Hygieia Biological Laboratories/Est

No. 407

Marek's Disease-Newcastle Disease Vaccine, Serotypes 2 & 3, Live Virus, Live

Marek's Disease Vector

17H1.R1 Merial, Inc./Est No. 298

Marek's Disease-Newcastle Disease Vaccine, Serotypes 2 & 3, Live Virus, Live

Marek's Disease Vector

17H1.R2 Merial, Inc./Est No. 298

Porcine Circovirus Vaccine, Type 2, Killed Baculovirus Vector 19K5.R2 Boehringer Ingelheim Vetmedica,

Inc./Est No. 124

An Equal Opportunity Provider and Employer
CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 18-01

Page 2

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U.S. Veterinary Biologics Establishment Licenses and Permits (Permittees) were terminated without

prejudice as follows:

________________________________________________________________

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

as follows:

________________________________________________________________

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

True Name Code Est. Name/No.

Swine Influenza Virus Type A Antigen Test Kit 5181.51 Zoetis Inc./Est No. 190

Transmissible Spongiform Encephalopathy Antigen Test Kit, ELISA 5431.20 Bio-Rad Laboratories/Est No. 624

Est. Name and Address Est. No. Type

Alere Scarborough, Inc. 330 Licensee

Vetazyme Corporation 321 Licensee

True Name Code Est. Name/No.

Allergenic Extract, Prescription Product 9531.00 Vetazyme Corporation/Est No. 321

Autogenous Killed Culture B051.00 Newport Laboratories, Inc./Est No. 455

Autogenous Virus, Killed Virus A015.20 Newport Laboratories, Inc./Est No. 455

Autogenous Virus, Killed Virus, Autogenous Killed Culture D500.20 Newport Laboratories, Inc./Est No. 455

Avian Influenza Virus Type A Antigen Test Kit 5180.50 Alere Scarborough, Inc./Est No. 330

Avian Influenza Virus, H5 Subtype, Killed Baculovirus Vector A057.R0 Boehringer Ingelheim Vetmedica,

Inc./Est No. 124

Bovine Rhinotracheitis-Virus Diarrhea-Parainfluenza 3-Respiratory Syncytial

Virus Vaccine, Modified Live Virus

1181.26 Zoetis Inc./Est No. 190

Coccidiosis Vaccine, Live Oocysts 1431.59 Intervet Inc./Est No. 165A

Encephalomyelitis Vaccine, Eastern & Western, Killed Virus 1475.00 Colorado Serum Company/Est No. 188

Encephalomyelitis Vaccine, Eastern & Western, Killed Virus, Tetanus Toxoid 4865.00 Colorado Serum Company/Est No. 188

Encephalomyelitis Virus, Eastern, Killed Virus A475.00 Colorado Serum Company/Est No. 188

Encephalomyelitis Virus, Western, Killed Virus A495.00 Colorado Serum Company/Est No. 188

Mycobacterium Paratuberculosis Antibody Test Kit 5064.01 Thermo Fisher Scientific/Est No. 582A

Mycobacterium Tuberculosis Gamma Interferon Test Kit, For Non-Human

Primates

5A64.20 Thermo Fisher Scientific/Est No. 582A

An Equal Opportunity Provider and Employer