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February 15, 2012 

 

 

CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 12-03 

TO: Biologics Licensees, Permittees, and Applicants 

 Directors, Center for Veterinary Biologics 

 Veterinary Services Leadership Team 

 

FROM: Richard E. Hill, Jr. /s/ Richard E. Hill, Jr. 

 Director 

 Center for Veterinary Biologics 

SUBJECT: Exemption to Shipping a Sample of Inactivated Lot or Bulk Rabies 

Antigen to the Center for Veterinary Biologics

I. PURPOSE 

The purpose of this Notice is to clarify how to request an exemption from shipping a 

sample of inactivated lot or bulk rabies antigen to the Center for Veterinary Biologics 

(CVB). 

II. BACKGROUND 

The CVB Notice published on October 12, 1994, regarding safety testing of Rabies 

Vaccine, Killed Virus, provided clarification regarding the procedures for conducting and 

reporting the safety testing defined in Title 9, Code of Federal Regulations (9 CFR) , Part 

113.209(d)(2). The Notice indicated that each serial must have samples submitted of 

each inactivated lot or bulk used to produce a serial. The Notice also indicated that if the 

finished vaccine is lethal to mice by the intracerebral route, the firm must collect 4 

samples of 2 to 5 mL of the inactivated lot or bulk before the addition of the adjuvant or 

any other chemical, component, or fraction. The firm must conduct the safety testing 

described in 9 CFR 113.209(d)(2)(i) with one sample, submit an additional sample to the 

CVB with serial samples, and retain the remaining 2 samples. The Notice indicated each 

serial must have samples submitted of each inactivated lot or bulk used to produce a 

serial. Additional clarifications in reference to testing expectations were published in 

CVB Notice 11-18 dated July 20, 2011. 

Since the bulk samples submitted to the CVB are rarely tested, CVB will consider 

exemption requests to shipping bulk samples to the CVB. 

United States 

Department of 

Agriculture 

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. 12-03 

Page 2 

III. ACTION 

Firms may request an exemption from shipping the inactivated lot or bulk sample to the 

CVB with serial samples. Firms should continue to collect at least 3 inactivated lot or 

bulk samples. Safety testing described in 9 CFR 113.209(d)(2)(i) should be conducted on 

one sample. Two of these bulk samples should continue to be maintained on site and 

these samples must be provided to the CVB upon request, in accordance with 9 CFR 

113.3(c). 

Firms should address requests for an exemption to shipping inactivated lot or bulk sample 

to their Reviewer in writing. Within one year of the exemption approval, Section VI.B. 

of the applicable Outlines of Production should be updated to describe the exemption and 

the date of CVB approval. 

IV. IMPLEMENTATION/ APPLICABILITY 

This change will be effective 30 days from the date of this Notice. This policy applies to 

all products containing killed Rabies Virus.