Safeguarding American Agriculture

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March 14, 2012 

VETERINARY SERVICES MEMORANDUM NO. 800.64 

TO: VS Leadership Team (VSLT) 

Directors, Center for Veterinary Biologics 

 Biologics Licensees, Permittees, and Applicants 

 

FROM: John R. Clifford /s/ John R. Clifford 

Deputy Administrator 

SUBJECT: Preparation of Experimental Products at Licensed Establishments 

I. PURPOSE 

Under title 9, Code of Federal Regulations (9 CFR), section 103.1, the Animal and Plant 

Health Inspection Service may authorize the preparation of experimental products on the 

premises of a licensed establishment if such preparation will not result in contamination 

of the licensed products. This memorandum provides directions to licensees regarding the 

introduction of any unapproved organisms or fractions into licensed production facilities. 

II. CANCELLATION 

This memorandum cancels Veterinary Services (VS) Memorandum 800.64, dated 

October 1, 1999. 

III. GENERAL 

A. Production is considered any step in the preparation of a product, as defined in 

9 CFR 101.2 under prepare or preparation. Production includes processing, 

testing, packaging, labeling, and storing the biological product. 

B. In general, licensees must request permission to introduce all organisms into their 

licensed production facilities, regardless of the use of the organisms. Licensees 

must receive permission before introducing the organisms into the facilities. 

C. A licensee must request permission if the Center for Veterinary BiologicsInspection and Compliance (CVB-IC) determines that the licensed firm’s research 

facility is not separate and apart from the production facility. 

D. A licensee is not required to request permission if CVB-IC determines that the 

licensed firm’s research facility is separate and apart from the production facility. 

However, we suggest that the licensee notify CVB-Policy, Evaluation, and 

Licensing (CVB-PEL) when isolates or experimental product is transferred to 

United States 

Department of 

Agriculture

Animal and Plant 

Health Inspection 

Service 

Veterinary Services 

Washington, DC 

20250 
VETERINARY SERVICES MEMORANDUM NO. 800.64 

Page 2 

these research facilities. In some cases, especially for select agents or high profile 

seeds or killed antigens, it may be prudent to inform CVB. 

If the licensee elects to notify CVB of these transfers, the licensee can notify CVB 

of its intention via a letter that describes what is being transferred, the amount, 

locations, the recipient, the preparation, shipping conditions, and purpose of the 

shipment. 

In addition, maintaining an inventory could make it easier to show compliance 

with National Center for Import and Export (NCIE) permits. Although CVB 

approval is not required for these permits, the recipient must comply with NCIE 

requirements regarding the receipt of animal pathogens. 

IV. PROCEDURES 

A. Request permission 

1. Submit requests for permission to prepare an experimental veterinary 

biological product in production facilities of a licensed firm to: 

Center for Veterinary Biologics 

Policy, Evaluation, and Licensing 

1920 Dayton Avenue 

Box 844 

Ames, IA 50010 

2. Include the supporting information specified in 9 CFR 103.1: 

a. Methods used to ensure the introduction of the organism or fraction will 

not result in contamination of a licensed product. 

b. The nature of the experimental product to be prepared from the organism 

or fraction. 

c. The location (building and room) to be used to prepare the experimental 

product. 
VETERINARY SERVICES MEMORANDUM NO. 800.64 

Page 3 

B. Limit production 

The CVB-PEL will limit the quantity of experimental product prepared to the 

amount the licensee needs for the experiment. 

C. Revise facility documents 

1. After the CVB-PEL authorizes the introduction of an organism or fraction, 

CVB-IC will require the licensee to: 

a. Submit the revised blueprint legends identifying the organism or fraction 

and the location where the experimental product will be prepared. 

b. Describe, if required, any additional precautions needed to prevent cross 

contamination of licensed products, prepared in accordance with VS 

Memorandum 800.78. 

c. Submit a copy of the letter received from the CVB-PEL authorizing the 

production of the experimental product in licensed production facilities or 

introduction of the organism or fraction into licensed production 

facilities. 

2. Send this information to: 

Center for Veterinary Biologics 

Inspection and Compliance 

1920 Dayton Avenue 

Box 844 

Ames, IA 50010