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Center for Veterinary Biologics
Public Notices

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Contact the Center for Veterinary Biologics to obtain copies of Notices not listed here.

Year of Publication

2012  2011  2010  2009  2008  2007  2006

2005  2004  2003  2002  2001  2000  1999  

 

CVB Notices--2012

ID
Size (KB)
Title     (All documents in PDF format.)
49
Issuance of Licenses
34
Change in Contact Information for the Policy, Evaluation, and Licensing, Operational Support Section
36
Exemption to Shipping a Sample of Inactivated Lot or Bulk Rabies Antigen to the Center for Veterinary Biologics
61
Appropriate Use of Controls for Chicken Anemia Virus Extraneous Agent Testing, Availability of a PCR-based Testing Protocol, and Availability of a New Testing Reagent (Referenced Documents: VIRPRO0118 and VIRNPP0001)
40
Testing Exemptions for Antibody Product Donor Animals
37
Detection of Mycoplasma Contamination in Vaccines and Biological Products
37
Submission of Master Seeds, Master Cell Stocks, and Master Sequences to the Center for Veterinary Biologics for Confirmatory Testing
44
Issuance of Licenses
46
Licensing of Vaccines as Preharvest Food Safety Interventions
34
Issuance of a Conditional License for Corynebacterium Pseudotuberculosis Bacterin

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CVB Notices--2011

ID
Size (KB)
Title     (All documents in PDF format.)
1260
Veterinary Biological Products in Licensed Establishments Produced and Destroyed 01/01/2010 through 12/31/2010
37
The Management and Disposition of Eggs, Chickens, and Biological Products Following a Chicken Anemia Virus (CAV) Outbreak in a Source Flock
26
Generation and Implementation of Draft Guidance
50
Issuance of Licenses
27
Expiration Date Extension and Discontinued Reagents: Salmonella Standard Reference Bacterins
27
Replacement of the Center for Veterinary Biologics Escherichia coli, HRP-labeled K88 Monoclonal Antibody
26
Cancellation of Veterinary Services Memorandum 800.96 and Notice of Example Data Files
28
Distribution of a new lot of Leptospira grippotyphosa Polyclonal Antibody, IRP 511-04
55
Issuance of Licenses
26
Expiration Date Extension for Erysipelothrix Rhusiopathiae Standard Reference Bacterin, IRP 529(05)
22
Paper Reduction Initiatives
19
Replacement Lots of the Center for Veterinary Biologics' Mycobacterium Tuberculosis Sensitinogen, Escherichia coli Anti-K99 Pilus Horseradish Peroxidase (HRP)-Labeled Monoclonal Antibody, and Clostridium tetani Antitoxin 5.0 AU/mL (guinea pig origin)
23
Product Licensing Plans
16
Distribution of a New Lot of Leptospira kirschneri Serogroup grippotyphosa Mouse Ascites (also designated as Leptospira grippotyphosa Monoclonal Antibody (LG MAb) IRP 04-505
43
Use of Symbols on Labeling for Diagnostic Test Kits
22
Discontinued Reagents: Standard Reference Preparations and Test Reagents for Virus Biological Products
28
Issuance of Licenses
20
Withdrawal of Supplemental Assay Method (SAM) for the Mikrozone Electrophoretic Separation of Blood Fractions Used in Veterinary Biologics, SAM 509
19
Virus Inactivation and Safety Test for Rabies Virus Bulks, Title 9, Code of Federal Regulations (9 CFR), Part 113.209
36
Avian Influenza (H5 and H7 Subtypes) Vaccine Bank
40
Supplemental Assay Methods
50
Issuance of Licenses
36
Routine Distribution and Replacement of the Center for Veterinary Biologics' Bacterial Testing Reagents
35
Issuance of a Conditional License for West Nile Virus Vaccine, Killed Virus

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CVB Notices--2010

ID
Size (KB)
Title     (All documents in PDF format.)
779
Veterinary Biological Products in Licensed Establishments Produced and Destroyed 01/01/2009 through 12/31/2009
48
Issuance of Licenses
20
Issuance of Licenses
15
Extension of Dating for Clostridium Novyi type B antitoxin, IRP 507(04)
17
Replacement of the Center for Veterinary Biologics Killed Veterinary Rabies References
20
International Cooperation on Harmonization of Technical Requirements for the Registration of Veterinary Medicinal Products (VICH): Final Guidelines for Target Animal Safety for Veterinary Live and Inactivated Vaccines
16
Withdrawal of Supplemental Assay Method 216
23
Extension of Dating for Pasteurella Multocida Type A Standard References Bacterin, IRP 573 (08); Pasteurella Multocida Standard Reference Bacterin, IRP PMA 1062 Serial 2; and Clostridium haemolyticum spore preparation IRP 526 (06)
25
Issuance of Licenses
43
Issuance of Licenses
27
Follow-up Sterility Check Testing
26
Obtaining the Testing Plan for Authorized Master Seed/Master Cell Sample Submissions
24
Product Code Book Availability

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CVB Notices--2009

ID
Size (KB)
Title     (All documents in PDF format.)
774
Veterinary Biological Products in Licensed Establishments Produced and Destroyed 01/01/2008 through 12/31/2008
22
Issuance of Licenses
22
Dilution of Preservative Screening for Broth-Based Sterility Tests
21
Issuance of a Conditional License for Escherichia Coli Bacterial Extract
31
Conversion Formulas for S/P Ratio to Titer in Diagnostic Test Kit Inserts
22
Consistency of Avian Safety Testing Parameters in Outlines of Production for Multi-fraction Avian Products
20
Issuance of Licenses
18
Extension of Dating for Pasteurella Multocida Type A Standard Reference Bacterin, IRP PMA 169 Serial 3
20
APHIS Form 2015 Available Electronically (APHIS Form 2015 Fillable, 70 KB)
28
Discontinued Reagents: Sarcocystis neurona and Sarcocystis falcatula, Rabies Serum Neutralization Indicator Virus, Feline Leukemia Positive Control (ELISA Reagent), Equine Rhinopneumonitis (EHV1) Antiserum
25
Availability of H1N1 Influenza Virus (Material Transfer Agreement, 25 KB)
21
Center for Veterinary Biologics Move to New Location in Ames, Iowa
18
Issuance of a Conditional License for Canine Influenza Vaccine, H3N8, Killed Virus
24
Issuance of Licenses
23
Withdrawal of Supplemental Assay Methods 101, 102, 105, and 125
16
Autogenous Vaccines Containing Porcine Circovirus
32
Qualification of Leptospira Canicola, Leptospira Grippotyphosa, Leptospira Icterohaemorrhagiae, and Leptospira Pomona Reference Bacterins for Products Intended for Use in Swine and/or Cattle
16
Accepting Product License Application for Epizootic Hemorrhagic Disease Vaccine
17
Novel H1N1 Influenza Master Seed Virus Available from Center for Veterinary Biologics (CVB) (Material Transfer Agreement, 70 KB)
15
Submission of APHIS Forms Used for Export of Veterinary Biologic Products
16
Withdrawal of Supplemental Assay Methods 601, 605, and 606
17
Transition Period for Implementation of a New Lot of Porcine Pasteurella Multocida Standard Reference Bacterin
25
Issuance of Licenses
16
Expiration Date Extension and Discontinued Reagents: Salmonella Standard Reference Bacterins
16
Issuance of a Conditional License for Swine Influenza Vaccine, pH1N1, Killed Virus
21
Dilution of Preservative Screening for Plate-Based Sterility Tests

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CVB Notices--2008

ID
Size (KB)
Title     (All documents in PDF format.)
919
Veterinary Biological Products in Licensed Establishments Produced and Destroyed 01/01/2007 through 12/31/2007
22
Issuance of Licenses
12
Availability of Clostridium perfringens Type A Standard Antitoxin and Toxin
18
Dating Extension for Salmonella choleraesuis Standard Reference Bacterin
12
Reinstatement and Dating Extension for Erysipelothrix Rhusiopathiae Standard Reference Bacterin, Serial 5
21
Application for United States Biological Product Permits
26
Issuance of Licenses
17
Discontinued Reagent: Transmissible Gastroenteritis Challenge Virus
18
Availability of Bovine Viral Diarrhea Challenge Virus
18
Discontinued Reagent: Eastern Equine Encephalomyelitis Challenge Virus
18
Extension of Dating for Pasteurella Multocida Standard Reference Bacterins
19
Reinstatement of Erysipelothrix Rhusiopathiae Standard Reference Bacterin, IRP 529(05)
25
Issuance of Licenses
31
International Cooperation on Harmonization of Technical Requirements for the Registration of Veterinary Medicinal Products (VICH): Final Guidelines for Backpassage Studies
23
Discontinued Reagent: GB Texas Newcastle Disease Challenge Virus

29

Dating Extension for Salmonella typhimurium and Salmonella dublin Standard Reference Bacterins
23
Discontinued Reagent: Feline Rhinotracheitis Challenge Virus
48
Issuance of Licenses
32
Changes to the Administrative Inspection Review Program (Administrative Inspection Review Form, 694 KB)
29
Electronic Maintenance of Paper Records
27
Extension of Dating of Pasteurella Multocida and Salmonella Choleraesuis Standard Reference Bacterins

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CVB Notices--2007

ID
Size (KB)
Title     (All documents in PDF format.)
1304
Veterinary Biological Products in Licensed Establishments Produced and Destroyed 01/01/06 through 12/31/06
25
Issuance of Licenses
37
Qualification of Leptospira grippotyphosa and Leptospira icterohaemorrhagiae Reference Bacterins for Products Intended for Use in Dogs
18
Issuance of a Conditional License for Canine Melanoma Vaccine, DNA
21
Submission of Outsourced Studies
18
Issuance of Licenses
23
Preparation and Testing of Experimental Biological Products that are Derived from Biotechnology
22
Post-Challenge Observation Periods for Efficacy Studies
17
Discontinued Reagent: Avian Leukosis Virus Antiserum
18
Discontinued Reagent: Canine Coronavirus Coating Antibody
32
Issuance of Licenses
13
Revised URL for Center for Veterinary Biologics Website
25
Qualification of Leptospira pomona and Leptospira canicola Reference Bacterins for Products Intended for Use in Dogs
18
Availability of Feline Panleukopenia Virus Challenge Seed Material
18
Availability of a New Erysipelothrix Rhusiopathiae Standard Reference
Bacterin
31
Software Patch for Estimating Prevented Fraction Confidence Intervals
23
Issuance of Licenses
16
Labeling of Equine Influenza and Swine Influenza Vaccines

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CVB Notices--2006

ID
Size (KB)
Title     (All documents in PDF format.)
20
Issuance of Licenses
22
Issuance of a Conditional License for Avian Influenza Virus Type A Antigen Test Kit
23
Potential Contamination of Porcine Kidney Cells
20
Withdrawal of Supplemental Assay Methods 310 and 311
20
Issuance of Conditional Licenses for Avian Influenza Vaccine, Killed Virus – Subtypes H5N2, H5N9, H7N2, H7N3
25
Type (Species) Designation of Vaccines Containing Bovine Viral Diarrhea Virus(es)
20
Center for Veterinary Biologics Public Meeting
23
Avian Influenza (H5 Subtypes) Vaccine Bank
20
Mailing Lists for Center for Veterinary Biologics Notices and Veterinary Services Memorandums
26
Issuance of Licenses
27
Replacement of Potency Assay Reference Samples for Immunodiagnostic Test Kits
21
Authorization to Use Remaining Inventories of Replaced Labels
20
Transfer of Food Safety and Inspection Service (FSIS) Support of Adjuvant Reviews from FSIS to the Animal and Plant Health Inspection Service (APHIS)
20
Dating Extension for Pasteurella multocida Standard Reference Bacterins
30
Request for Adjuvant and Excipient Data    
(MS Excel Template, 13.5KB)
23
True Name Change for Canine Vaccines with Bacterins Containing Leptospira
27
Issuance of Licenses
21
Avian Influenza (H7 Subtypes) Vaccine Bank
25
Issuance of a Conditional License for Mycobacterium Paratuberculosis DNA Test Kit, Polymerase Chain Reaction
22
Dating Extension and Dilution Adjustment for Selected Standard References
22
Replacement of the Center for Veterinary Biologics Killed Veterinary Rabies Reference
19
Issusances of Licenses
18
Production Changes for Rabies Vaccines
19
Exemptions to allow live poultry vaccines administered via wing web to be tested for detection of extraneous viable bacteria and fungi via Title 9, Code of Federal Regulations, Part 113.27 (e)
18
Issuance of a Conditional License for Lymphocyte T-Cell Immunodulator

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CVB Notices--2005

ID
Size (KB)
Title     (All documents in PDF format.)
13
Mouse Safety Testing
15
Issuance of Licenses
41
Implementation of the Administrative Inspection Review Program
14
Issuance of a Conditional License for Clostridium Perfringens Type A Toxoid
13
Confidence Interval Estimation in Serological Interference Studies
28
Requirements for Addition of Leptospira bratislava in Canine Bacterins
16
Biologics for Reduction of Colonization and/or Shedding in Animals
20
GB Texas Newcastle Disease Challenge Virus; Change in Select Agent Status
26
Issuance of Licenses
19
Issuance of a Conditional License for Streptococcus Equi Antibody
25
Conditional License for Product Containing Clostridium perfringens Type A
24
New Directors for Center for Veterinary Biologics
18
Avian Influenza (H5 and H7 Subtypes) Vaccine Bank
21
Issuance of Licenses
19
Issuance of a Conditional License for Porphyromonas Denticanis-Gulae-Salivosa Bacterin
27
Posting of Selected Center for Veterinary Biologics Notices and Veterinary Services Memoranda on the Center for Veterinary Biologics Web Site for Comment
27
Dating Extension and Dilution Adjustment for Standard Reference Bacterin IRP ERB-5
18
Canine Influenza Virus Vaccine and Related Diagnostic Test Kits
05-19
--
[Not Issued]
28
Issuance of Licenses
20
Issuance of a Conditional License for Porcine Circovirus Vaccine, Type 2, Killed Baculovirus Vector
20
Avian Influenza (H5 and H7 Subtypes) Vaccine Bank
24
Chimera as an Additional Naming Convention for Live Recombinant Products
31
Immediate Notifications to the Center for Veterinary Biologics per 9 CFR Part 116

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CVB Notices--2004

ID
Size (KB)
Title     (All documents in PDF format.)
22
Exporting of Veterinary Biologics Products Containing Ruminant-Derived Materials
23
Diagnostic Test Kits for Bovine Spongiform Encephalopathy
19
Issuance of Licenses
19
Resumption of Signing of Certificates of Licensing and Inspection and Official Export Certificates for Animal Biological Products
20
Replacement of the Center for Veterinary Biologics’ IgG Species Standard for Qualification of IgG Reference Product for Failure of Passive Transfer Products
21
Issuance of a Conditional License for Canine Gonadotropin Releasing Factor Immunotherapeutic
24
Request for Master Seed and Master Cell Stock Lists
24
Diagnostic Test Kits for Bovine Spongiform Encephalopathy
8
Use of Humane Endpoints in Animal Testing of Biological Products
18
Issuance of Licenses
13
Name Change for Biologicals Containing Actinomyces pyog
9
Avian Influenza (H5 and H7 Subtypes) Vaccine Bank
15
Use of Minimum Age Animals in Licensure Studies
24
Issuance of Licenses
17
Name Change for Biologicals Containing Avian Influenza Virus
13
Efficacy Requirements and Label Claims for Bovine Rotavirus Vaccine
17
Exemption to 3-year Master Seed Immunogenicity Retesting
35
Issuance of Licenses
14
Issuance of a Conditional License for Salmonella Newport Bacterial Extract
13
Issuance of New Supplemental Assay Method
13
Issuance of a Conditional License for West Nile Virus Antibody, Equine Origin
14
Issuance of a Conditional License for Crotalus Atrox Toxoid
16
Posting of Selected Center for Veterinary Biologics Draft Notices and Veterinary Services Draft Memoranda on the Center for Veterinary Biologics Web site for a Comment Period

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CVB Notices--2003

ID
Size (KB)
Title     (All documents in PDF format.)
19
Issuance of Licenses
20
Amended Change in Implementation Date for the New Center for Veterinary Biologics' Killed Veterinary Rabies Reference
22
Temporary Change in Services Provided by the Center for Veterinary Biologics
20
Current Center for Veterinary Biologics Bluetongue Virus Reference Serum Panel
21
Organizational Realignment within the Center for Veterinary Biologics
23
Implementation of the New Center for Veterinary Biologics' Killed Veterinary Rabies Reference
10
Issuance of Licenses
20
Purpose of the Equine Infectious Anemia Weak Positive Serum Sample Outlined in Veterinary Services Memorandum No. 555-16
15
Issuance of Licenses
20
Issuance of New Supplemental Assay Method
122
Issuance of a Conditional License for Mycobacterium Bovis Gamma Interferon Test Kit for Cervids
110
Issuance of a Conditional License for West Nile Virus Antibody, Equine Origin
129
Detection of Avian Lymphoid Leukosis Virus in Veterinary Biological Products
20
Customer Feedback on Reagents
23
Availability of Specific Pathogen Free Eggs
20
Issuance of Licenses
20
Change in Product Label Numbering System

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CVB Notices--2002

ID
Size (KB)
Title     (All documents in PDF format.)
12
Critical Study Dates for Licensing and Reference Qualification Studies
12
Change in Finished Label Submission Requirement
26
Issuance of Licenses
16
Autogenous Vaccine Use in Turkeys
15
Issuance of a Conditional License for Treponema Bacterin
13
Draft Standard Requirement for Equine Influenza Vaccine, Killed Virus
151
Issuance of Licenses
125
Diagnostic Test Kits for Scrapie and Chronic Wasting Disease
109
Issuance of Additional RelPot Software and Supplemental Assay Method
103
Issuance of a Conditional License for Avian Influenza Vaccine, Killed Virus, H7 Subtype
151
Reagents and Testing of Master Seed Viruses
115
Availability of References and Reagents from the Center for Veterinary Biologics
147
Issuance of Licenses
23
Permit Requirements for Pathogenic Organisms, Including Challenge Materials
18
Issuance of a Conditional License for Mycobacterium Tuberculosis Gamma Interferon Test Kit for Non-Human Primates
139
Replacement of the Center for Veterinary Biologics' Killed Veterinary Rabies Reference
21
Issuance of a Conditional License for Avian Pneumovirus Vaccine Modified Live Virus
56
Vaccine Claims for Protection of the Fetus Against Bovine Virus Diarrhea Virus
21
CVB Liaison Authorization Process
25
Domestic Manufacture of Biologicals Used in the Prevention or Treatment of Foreign Animal Diseases
101
Issuance of a Conditional License for Bacterial Immunomodulator, Killed Bacteria
104
Issuance of Licenses
214
Guidance Document for Veterinary Biologics Derived from Bioengineered Plants
122
Conditional Licenses for Products Containing Clostridium perfringens Type A
99
Change in Implementation Date for the New Center for Veterinary Biologics' Killed Veterinary Rabies Reference
21
Availability of Distemper Virus Aerosol Challenge
21
Name Change for Biologicals Containing Pasteurella haemolytica
22
Availability of Monoclonal Antibodies from the Center for Veterinary Biologics

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CVB Notices--2001

ID
Size (KB)
Title     (All documents in PDF format.)
16
Issuance of New or Revised Supplemental Assay Methods
7
Applications for Licensure of West Nile Virus Vaccine
6
Identification of Component Products in Combination Package Biologics
14
Issuance of Revised RelPot Software and Supplemental Assay
12
Identification of Testing Methods for Detection of Extraneous Agents in Fetal Bovine Serum
18
Stability Testing of New Biotechnological/Biological Veterinary Medicinal Products
20
International Cooperation on Harmonization of Technical Requirements for the Registration of Veterinary Medicinal Products (VICH): Final Guidelines for Good Clinical Practice
13
Temporary Release Procedures for Veterinary Biologics
13
Approved Sources of Animal Origin Ingredients
12
Identification of Electronic Storage Media Submitted to the Center for Veterinary Biologics
9
Autogenous Products for Avian Influenza

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CVB Notices--2000

ID
Size (KB)
Title     (All documents in PDF format.)
7
Collaborative Studies on Moisture and Formaldehyde
6
Issuance of a Conditional License for Lawsonia Intracellularis Vaccine, Avirulent Live Culture
21
Standard Reference Bacterin, ERB-5
7
Courtesy Notification of Serial Release Actions
6
Issuance of a Conditional License for Mycoplasma Bovis Bacterin
6
Issuance of a Conditional License for Avian Influenza Vaccine, Killed Virus, H5 Subtype
12
Issuance of New Supplemental Assay Method
12
Issuance of New Supplemental Assay Method
13
Issuance of a Conditional License for Sarcocystis Neurona Vaccine, Killed Protozoa

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CVB Notices--1999

ID
Size (KB)
Title     (All documents in PDF format.)
7
New Directors for CVB and Change of Address for Submissions to Licensing and Policy Development
10
Completion of Part I of the Outline of Production for Vaccines, Bacterins, Antigens, and Toxoids
5
Supplementary Aids for Applicants
7
Determination of Expiration Dates for Biological Products 
9
International Cooperation on Harmonization of Technical Requirements for the Registration of Veterinary Medicinal Products (VICH): Request for Comments Regarding Proposed Guidelines for Technical Requirements
9
Autogenous Virus Vaccines for Infectious Salmon Anemia Virus
6
Alternative Safety Testing for Serial Release of Oral Antibody Products
16
Solicitation of Representative Samples for International Collaborative Study
6
Center for Veterinary Biologics Y2K Telecommunications Contingency Plan

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Last Modified: May 10, 2012


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