Safeguarding American Agriculture 

Federal Relay Service 

APHIS is an agency of USDA’s Marketing and Regulatory Programs (Voice/TTY/ASCII/Spanish)

An Equal Opportunity Provider and Employer 1-800-877-8339 

April 4, 2012 

CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 12-07 

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: Submission of Master Seeds, Master Cell Stocks, and Master Sequences to 

 the Center for Veterinary Biologics for Confirmatory Testing

I. PURPOSE 

This Notice describes procedures that are being implemented to streamline Master Seed, 

Master Cell Stock, and Master Sequence sample submission. 

II. BACKGROUND 

Confirmatory testing of Master Seeds, Master Cell Stocks, and Master Sequences (MS) is 

conducted at the Center for Veterinary Biologics (CVB) as part of the 

licensing/permitting process for veterinary biologic products. After review of the firm’s 

MS report, the firm’s Reviewer will issue a test authorization number, authorizing the 

firm to submit samples for confirmatory testing at the CVB. For biotechnology-derived 

MSs, a Summary Information Format (SIF) must be submitted by the firm for review and 

an Institutional Biosafety Committee (IBC) number assigned prior to issuance of the test 

authorization number. 

III. POLICY 

The following procedures are being implemented to facilitate the coordination of the test 

authorization, sample submission, and initiation of testing: 

1. The firm’s MS report and SIF (if applicable) must be complete and contain 

sufficient detail for procedures used in non-codified tests. The MS should be 

identified using the complete lot number (or other unique identifier), exactly as it 

appears on the label on the MS vials. 

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. 12-07 

Page 2 

2. A CVB laboratory coordinator will be assigned to each test authorization. This 

person, along with the firm’s reviewer, should serve as the primary contact for 

issues concerning sample submission. The CVB Laboratory Coordinator will 

provide the firm with a complete list of reagents needed for the testing. 

3. In order to facilitate communication, the firm may wish to provide the CVB with 

the name and e-mail address, or phone number, of a laboratory contact person at 

the firm. 

4. Samples should be sent within 30 days of the issuance of a test authorization. 

Samples submitted within 30 days will be given priority based on the date 

received at the CVB. 

5. To facilitate the CVB’s scheduling of confirmatory testing, firms should notify 

the Laboratory Coordinator with an anticipated ship date of samples upon receipt 

of the test authorization number. 

6. Samples and reagents must be submitted with an APHIS Form 2020, with the 

following information included in the Remarks section: 

a. Test authorization number; 

b. IBC number, if applicable; and 

c. Submit to the attention of the CVB Laboratory Coordinator 

7. The firm should provide the shipment tracking number to the CVB Laboratory 

Coordinator and the Reviewer at the time of shipment. 

8. If the CVB laboratory encounters problems with confirmatory testing, the CVB 

will contact the firm to confirm the assay methodology and possible alignment 

needs. If/when these findings confirm that further trouble shooting is required by 

the firm, the test authorization may be canceled and reissued at a later date. 

IV. IMPLEMENTATION/ APPLICABILITY 

These procedures will be implemented immediately.