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March 26, 2007 

CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 07-04 

Subject: Submission of Outsourced Studies 

To: Biologics Licensees, Permittees, and Applicants 

 Veterinary Services Management Team 

 Directors, Center for Veterinary Biologics 

 Area Veterinarians in Charge, VS 

 State Veterinarians 

 

I. PURPOSE 

The purpose of this notice is to provide interested parties with guidance regarding the 

submission of materials to the Center for Veterinary Biologics (CVB) when outside 

service providers are involved. 

II. BACKGROUND 

Fee-for-service testing is a growing business utilized by the biologics industry. Although 

serial release testing must be performed by licensees on licensed premises, other studies 

and non-codified testing (especially that requiring specialized facilities and/or equipment) 

may be outsourced to competent service providers, provided that the licensee (or license 

applicant) maintains adequate oversight and the service provider agrees to inspection by 

the CVB at any time. 

When both the licensee/applicant and the outside service provider are in contact with the 

CVB, there can be confusion regarding the routing and filing of submissions. The CVB 

may have document files associated with both the licensee/applicant and the service 

provider. Service providers may perform testing for more than one licensee/applicant. 

The following guidance is provided to clarify the delineation of responsibilities of the 

licensee/applicant and the service provider. 

III. GUIDANCE 

All correspondence (including study protocols and reports) regarding outsourced work 

should be submitted to the CVB by the licensee or license applicant, not the service 

provider. This does not preclude provider participation in the preparation of the 

submission, but it ensures that the licensee/applicant is aware of, and assumes legal 

responsibility for, all submissions that will be used to support product licensure. 

United States 

Department of 

Agriculture

Animal and Plant 

Health Inspection 

Service 

Veterinary Services 

Center for Veterinary 

Biologics 

510 S. 17th Street, 

Suite 104 

Ames, IA 50010 

(515) 232-5785 

FAX (515) 232-7120 
Center for Veterinary Biologics Notice No. 07-04 2 

Service providers requiring authorization to ship experimental product from their 

facilities should submit their own requests in accordance with Title 9, Code of Federal 

Regulations (9CFR), Section 103.3. If, however, the product being shipped is the 

property of another company, the identity of that company (including its CVB 

establishment code, if applicable) should be included in the request. The true name of the 

product (and product code, if applicable) also should be included. This will facilitate 

cross-referencing of these submissions to the applicable product files if the shipped 

product is, or eventually will be, in the licensing process. 

Regulations require the submission of a summary report for any study authorized under 

9CFR 103.3. These summaries should be provided by the entity shipping the product. 

Thus, when service providers request the authorization to ship, they should provide a 

brief summary when the work is completed, even if a more complete report is submitted 

by the licensee/applicant for the product. If the service provider is aware that a more 

complete report will be submitted by the licensee/applicant, this should be noted in the 

summary provided by the service provider. 

/s/Richard E. Hill, Jr. 

Richard E. Hill, Jr. 

Director 

Center for Veterinary Biologics