An Equal Opportunity Provider and Employer

CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 17-08

TO: Veterinary Services Leadership Team

Directors, Center for Veterinary Biologics

Biologics Licensees, Permittees, and Applicants

FROM: Byron E. Rippke

Director

SUBJECT: Retention of Policy Documents Posted to Center for Veterinary Biologics 

Website

I. PURPOSE

The purpose of this Notice is to inform interested parties of standardized retention 

periods for policy documents posted to the Center for Veterinary Biologics (CVB) 

Website.

II. BACKGROUND

The CVB posts Veterinary Services Memoranda (VSM) and CVB Notices relevant to 

the biologics program on its Website at https://www.aphis.usda.gov/aphis/

ourfocus/animalhealth/veterinary-biologics/biologics-regulations-andguidance/ct_regs_guidance. Document retention periods have been standardized to 

keep Web content current and manageable.

III. ACTION

A. Veterinary Services Memoranda

VSMs are used to publish CVB regulatory policy and do not have a standard 

retirement date. VSMs are posted on the Website until they are specifically 

superseded by another VSM or formally retired without a replacement. 

1. If superseded, the obsolete memo will be removed 60 days after the 

replacement memo is published. Superseded memos are listed in the 

“Cancellation” section of the replacement VSM. Additional rescinded 

memos also may be listed there if their content is incorporated into the 

newly published memo.

2. When a VSM is retired without a direct replacement or incorporation into 

another document, a CVB Notice will be published to announce the 

retirement prior to 60 days removing it from the Website. 

Animal and Plant

Health Inspection

Service

Veterinary Services

Center for Veterinary 

Biologics

1920 Dayton Avenue

PO Box 844

Ames, IA 50010

(515) 337-6100
CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 17-08

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 An Equal Opportunity Provider and Employer

B. CVB Notices

1. Routine Notices

CVB Notices are used to publish administrative announcements regarding the 

veterinary biologics program. Many of the announcements are routine and do not 

have long-term relevance. The following retention periods have been established 

for routine Notices:

Description

Retention 

Period 

(Years) after 

Publication

Quarterly announcement of new license issuances 1

Yearly announcement of doses produced/destroyed 1

Announcement of new conditional license 1

Announcement of new version of biologics forms 1

Announcement of change in contact info 1

Announcement of retired VSM 1

Announcement of new or retired Supplemental Assay Method 

(SAM) 3

Announcement of new/retired reagent or change in reagent 

dating 3

Announcement of acceptance of applications for new class of 

biologic

Upon licensure 

of first 

applicable 

product

Solicitations for new biological products (e.g., vaccine bank) 1

Taxonomic name changes 1

2. Non-Routine Notices

CVB Notices also may be used as an expedited means to publish new regulatory 

policies or procedures, but these are typically followed by a more permanent 

document, like a VSM. 

This type of Notice may be retired when the follow-up document, containing 

information covered in the Notice, is published. Procedural notices also may be 

retired when the information contained in them is no longer applicable.

IV. IMPLEMENTATION/APPLICABILITY

Documents listed in the Appendix of this Notice will be removed from the Website 60 days 

after the date of this Notice. Individuals wishing to keep archival copies of these documents 

should download them from the Website within that 60-day grace period. From then on, 
CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 17-08

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 An Equal Opportunity Provider and Employer

documents will be removed from the Website, according to the retention schedule in this 

Notice, without further notification.
CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 17-08

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 An Equal Opportunity Provider and Employer

Appendix. Documents Currently Eligible to be Removed from CVB Website

Routine CVB Notices

ID Title

00-05 Issuance of a Conditional License for Lawsonia Intracellularis Vaccine, 

Avirulent Live Culture

00-12 Issuance of a Conditional License for Mycoplasma Bovis Bacterin

00-13 Issuance of a Conditional License for Avian Influenza Vaccine, Killed 

Virus, H5 Subtype

00-15 Issuance of New Supplemental Assay Method

00-16 Issuance of New Supplemental Assay Method

00-17 Issuance of a Conditional License for Sarcocystis Neurona Vaccine, 

Killed Protozoa

02-08 Diagnostic Test Kits for Scrapie and Chronic Wasting Disease

04-08 Diagnostic Test Kits for Bovine Spongiform Encephalopathy

06-21 Replacement of the CVB Killed Veterinary Rabies Reference

10-04 Replacement of the CVB Killed Veterinary Rabies Reference

78 Veterinary Biological Products in Licensed Establishments Produced and 

Destroyed 01/01/2010 through 12/31/2010

11-03 Issuance of Licenses

11-04 Expiration Date Extension and Discontinued Reagents: Salmonella 

Standard Reference Bacterins

11-05 Replacement of the Center for Veterinary Biologics Escherichia coli, 

HRP-labeled K88 Monoclonal Antibody

11-06 Cancellation of Veterinary Services Memorandum 800.96 and Notice of 

Example Data Files

11-07 Distribution of a New Lot of Leptospira grippotyphosa Polyclonal 

Antibody, IRP 511-04

11-08 Issuance of Licenses

11-11 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)

11-13 Distribution of a new lot of Leptospira kirschneri Serogroup 

grippotyphosa Mouse Ascites (also designated as Leptospira 

grippotyphosa Monoclonal Antibody (LG MAb) IRP 04-505

11-15 Discontinued Reagents: Standard Reference Preparations and Test 

Reagents for Virus Biological Products

11-16 Issuance of Licenses

11-17 Withdrawal of Supplemental Assay Method (SAM) for the Mikrozone 

Electrophoretic Separation of Blood Fractions Used in Veterinary 

Biologics, SAM 509

11-19 Avian Influenza (H5 and H7 Subtypes) Vaccine Bank

11-20 Supplemental Assay Methods
CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 17-08

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 An Equal Opportunity Provider and Employer

ID Title

11-21 Issuance of Licenses

11-20 Supplemental Assay Methods

11-22 Routine Distribution and Replacement of the Center for Veterinary

Biologics’ Bacterial Testing Reagents

11-23 Issuance of a Conditional License for West Nile Virus Vaccine, Killed 

Virus

79 Veterinary Biological Products in Licensed Establishments Produced and 

Destroyed 01/01/2011 through 12/31/2011

12-01 Issuance of Licenses

12-02 Change in Contact Information for the Policy, Evaluation, and Licensing, 

Operational Support Section

12-08 Issuance of Licenses

12-10 Issuance of a Conditional License for Corynebacterium 

Pseudotuberculosis Bacterin

12-13 Issuance of a Conditional License for Foot and Mouth Disease Virus 

Vaccine, Live Adenovirus Vector

12-16 Issuance of Licenses

12-19 Issuance of a Conditional License for Polyprenyl Immunostimulant

12-20 Issuance of Licenses

12-22 Issuance of a Conditional License for Equine Rhinitis A Vaccine

12-23 Issuance of a Conditional License for Canine Lymphoma Monoclonal 

Antibody

12-24 Issuance of a Conditional License for Streptococcus Uberis Bacterin

80 Veterinary Biological Products in Licensed Establishments Produced and 

Destroyed 01/01/2012 through 12/31/2012

13-01 Issuance of Licenses

13-04 Discontinued Bacterial Challenge Cultures

13-07 Issuance of Licenses

13-08 Extension of Dating for Erysipelothrix Rhusiopathiae Bacterin, IRP 

529(05)

13-09 Issuance of Licenses

13-12 Issuance of a Conditional License for Rift Valley Fever Vaccine, 

Modified Live Virus

13-14 Issuance of Licenses

13-15 Issuance of a Conditional License for Bronchitis Vaccine, Georgia Type, 

Live Virus

13-16 Availability of New and Revised Biologics Forms

81 Veterinary Biological Products in Licensed Establishments Produced and 

Destroyed 01/01/2013 through 12/31/2013

14-01 Issuance of Licenses

14-02 Availability of Porcine Epidemic Diarrhea Virus (PEDV)

14-03 Issuance of a Conditional License for Canine Lymphoma Monoclonal 

Antibody
CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 17-08

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 An Equal Opportunity Provider and Employer

ID Title

14-04 Availability of Revised APHIS Form 2007

14-05 Availability of Swine Influenza Virus (SIV) Isolates

14-07 Issuance of a Conditional License for Feline Interleukin-2 

Immunomodulator, Live Canarypox Vector

14-08 Extension of Dating for Erysipelothrix Rhusiopathiae Bacterin, IRP 529 

(05)

14-09 Issuance of Licenses

14-11 Availability of Porcine Delta Coronavirus Isolate

14-12 Issuance of a Conditional License for Porcine Epidemic Diarrhea 

Vaccine

14-13 Issuance of Licenses

14-14 Issuance of Licenses

82 Veterinary Biological Products in Licensed Establishments Produced and 

Destroyed 01/01/2014 through 12/31/2014

15-01 Issuance of Licenses

15-05 Issuance of Licenses

15-09 Issuance of Licenses

15-10 Issuance of a Conditional License for Canine Atopic Dermatitis 

Immunotherapeutic

15-11 Issuance of a Conditional License for Canine Lymphoma Vaccine, DNA

15-12 Issuance of Licenses

83 Veterinary Biological Products in Licensed Establishments Produced and 

Destroyed 01/01/2015 through 12/31/2015

16-01 Issuance of Licenses

16-04 Issuance of a production platform-based license for Prescription Product, 

RNA Particle

16-06 Issuance of Licenses

16-08 Name Change for Biologicals Containing Arcanobacterium pyogenes

16-10 Issuance of Licenses

16-11 Final solicitation for Eurasian (EA) highly pathogenic Avian Influenza 

(HPAI) Virus H5 vaccine

Other CVB Notices 

ID Title Reason for Retirement

00-04 Collaborative Studies on Moisture and 

Formaldehyde

Collaboration opportunity ended

00-10 Courtesy Notification of Serial Release 

Actions

New procedure incorporated into 

VSM 800.53

02-02 Change in Finished Label Submission 

Requirement

Incorporated into 9CFR 112 and 

VSM 800.54

05-05 Confidence Interval Estimation in 

Serological Interference Studies

Incorporated into VSM 800.203
CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 17-08

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 An Equal Opportunity Provider and Employer

ID Title Reason for Retirement

06-13 Transfer of Food Safety and Inspection 

Service (FSIS) Support of Adjuvant 

Reviews from FSIS to the Animal and 

Plant Health Inspection Service (APHIS)

Current procedure described in 

VSM 800.51

07-17 Labeling of Equine Influenza and Swine 

Influenza Vaccines

Incorporated into VSM 800.54

13-03 Change in Issuance of Permits for 

General Sale and Distribution

All affected permits have been 

converted.

13-11 Changes to the Final Disposition 

Notification for Release of Biological 

Products

Current procedure described now 

in VSM 800.53

13-13 Electronic Submissions for Policy, 

Evaluation, and Licensing

Superseded by procedures 

described in NCAH Portal User 

Guide for CVB

15-02 Recognized ISO 15223-1 Symbols on 

Labeling for Diagnostic Test Kits

Incorporated into VSM 800.54

16-09 Submission of Foreign Language Labels Incorporated into VSM 800.54

VSMs being retired due to incorporation in VSM 800.54

ID Title

800.76 Trade Names and Logos on Licensed Veterinary Biological Products 

800.80 Distributor Labels