Animal Health
Center for Veterinary Biologics
Click on this link for Archived Notices .
2013 2012 2011 2010 2009 2008 2007
2006 2005 2004 2003 2002 2001 1999
CVB Notices-- 2013
ID
Size (KB)
Title (All documents in PDF format.)
66
Veterinary Biological Products in Licensed Establishments Produced and Destroyed 01/01/2012 through 12/31/2012
88
Issuance of Licenses
58
Quarterly Acknowledgement Summaries for Selected Submissions
43
Change in Issuance of Permits for General Sale and Distribution
50
Discontinued Bacterial Challenge Cultures
48
Use of Polymerase Chain Reaction (PCR) Assays to Measure Potency of Inactivated Protein-Based Biologicals
45
Reporting Inactivation Test Results on APHIS Forms 2008 for Inactivated Veterinary Biological Products with the Restriction "For Further Manufacture (FFM)"
61
Issuance of Licenses
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CVB Notices-- 2012
ID
Size (KB)
Title (All documents in PDF format.)
71
Veterinary Biological Products in Licensed Establishments Produced and Destroyed 01/01/2011 through 12/31/2011
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
35
Virulent Systemic Feline Calicivirus Label Claims
42
Use of Humane Endpoints and Methods in Animal Testing of Biological
Products
41
Issuance of a Conditional License for Foot and Mouth Disease Virus Vaccine, Live Adenovirus Vector
43
Revised Procedure for Depletion of Existing Inventories of Superseded Labels
397
Soliciting Input on Potential Form to Facilitate Requests to Ship Experimental Biological Product
73
Issuance of Licenses
12-17
--
not issued
135
Potential Forms to Facilitate Requests to Submit Samples of Master Seeds, Master Cells, and Product Serials for Confirmatory Testing
31
Issuance of a Conditional License for Polyprenyl Immunostimulant
49
Issuance of Licenses
46
Conducting Dilution of Preservative Studies for Live Bacterial Vaccines
48
Issuance of a Conditional License for Equine Rhinitis A Vaccine
47
Issuance of a Conditional License for Canine Lymphoma Monoclonal Antibody
53
Issuance of a Conditional License for Streptococcus Uberis Bacterin
60
New Policy on Biological Product Samples Submitted to the Center for Veterinary Biologics and Concurrent Testing Selection Period
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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.)
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
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)
27
Follow-up Sterility Check Testing
26
Obtaining the Testing Plan for Authorized Master Seed/Master Cell Sample Submissions
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CVB Notices-- 2009
ID
Size (KB)
Title (All documents in PDF format.)
22
Dilution of Preservative Screening for Broth-Based Sterility Tests
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
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
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.)
29
Electronic Maintenance of Paper Records
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CVB Notices-- 2007
ID
Size (KB)
Title (All documents in PDF format.)
37
Qualification of Leptospira grippotyphosa and Leptospira icterohaemorrhagiae Reference Bacterins for Products Intended for Use in Dogs
21
Submission of Outsourced Studies
23
Preparation and Testing of Experimental Biological Products that are Derived from Biotechnology
22
Post-Challenge Observation Periods for Efficacy Studies
25
Qualification of Leptospira pomona and Leptospira canicola Reference Bacterins for Products Intended for Use in Dogs
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.)
23
Potential Contamination of Porcine Kidney Cells
25
Type (Species) Designation of Vaccines Containing Bovine Viral Diarrhea
Virus(es)
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)
22
Replacement of the Center for Veterinary Biologics Killed Veterinary Rabies Reference
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)
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CVB Notices-- 2005
ID
Size (KB)
Title (All documents in PDF format.)
13
Mouse Safety Testing
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
27
Posting of Selected Center for Veterinary Biologics Notices and Veterinary Services Memoranda on the Center for Veterinary Biologics Web Site for Comment
24
Chimera as an Additional Naming Convention for Live Recombinant Products
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CVB Notices-- 2004
ID
Size (KB)
Title (All documents in PDF format.)
24
Diagnostic Test Kits for Bovine Spongiform Encephalopathy
8
Use of Humane Endpoints in Animal Testing of Biological Products
15
Use of Minimum Age Animals in Licensure Studies
13
Efficacy Requirements and Label Claims for Bovine Rotavirus Vaccine
17
Exemption to 3-year Master Seed Immunogenicity Retesting
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CVB Notices-- 2003
ID
Size (KB)
Title (All documents in PDF format.)
20
Purpose of the Equine Infectious Anemia Weak Positive Serum Sample Outlined in Veterinary Services Memorandum No. 555-16
129
Detection of Avian Lymphoid Leukosis Virus in Veterinary Biological Products
20
Customer Feedback on Reagents
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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
16
Autogenous Vaccine Use in Turkeys
125
Diagnostic Test Kits for Scrapie and Chronic Wasting Disease
109
Issuance of Additional RelPot Software and Supplemental Assay Method
23
Permit Requirements for Pathogenic Organisms, Including Challenge Materials
25
Domestic Manufacture of Biologicals Used in the Prevention or Treatment of Foreign Animal Diseases
214
Guidance Document for Veterinary Biologics Derived from Bioengineered Plants
122
Conditional Licenses for Products Containing Clostridium perfringens Type A
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.)
6
Identification of Component Products in Combination Package Biologics
12
Identification of Testing Methods for Detection of Extraneous Agents in Fetal Bovine Serum
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-- 1999
ID
Size (KB)
Title (All documents in PDF format.)
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
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Last Modified:
April 17, 2013
