An Equal Opportunity Provider and Employer

CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 23-10

TO: Biologics Licensees, Permittees, and Applicants

Directors, Center for Veterinary Biologics

Veterinary Services Leadership Team

FROM: David M. White

Acting Director

SUBJECT: Inclusion of Master Seed, and Master Cell Labels with Submissions to 

the Center of Veterinary Biologics (CVB) Laboratory

I. PURPOSE

The purpose of this Notice is to inform licensees, permittees, and applicants of a 

change in CVB laboratory protocol for documentation of receipt and confirmation of 

required identification of Master Seed and Master Cell sample submissions. 

Implementation of the change in protocol will be facilitated by requesting that firms 

include additional detached copies of sample container labels with Master Seed and 

Master Cell submissions.

II. BACKGROUND

In accordance with Title 9, Code of Federal Regulations (9CFR sections 113.3 and

113.52), Master Seed and Master Cell Stock (MS/MCS) samples are required to be 

submitted to CVB prior to licensure of a veterinary biologic, to support approval of 

certain changes to the Outline of Production, or as otherwise requested. These 

samples must be labeled with a unique number or other identifier matching that of

the MS/MCS stored at the establishment and the description found in the Outline of 

Production (additional guidance on sample identification may be found in Veterinary 

Services Memorandum 800.59). Identification on sample containers must also 

exactly match the item as it is listed on APHIS Form 2070, which is submitted prior 

to authorization of shipment, as well as APHIS Form 2020, which either 

accompanies the shipment or is submitted through the NCAH Portal. Upon receipt 

of the material, CVB personnel are required to verify that the sample container 

matches that of the submitted forms. Any discrepancies are resolved prior to testing 

of the sample. To confirm this process and further prevent the potential for 

misidentification, CVB is seeking to more permanently capture the verified correct 

identity of the submitted material upon receipt.

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. 23-10

Page 2

 An Equal Opportunity Provider and Employer

III. ACTION (or POLICY)

CVB is requesting that firms submit at least two additional detached copies of container 

labels for any MS/MCS material submitted to the CVB Laboratory. These may be

adhesive labels printed using the exact template of the labels on the sample vial or other 

container. If exact copies are unavailable, a reproduction of the label is acceptable,

provided that the content is identical to that found on the sample container. Upon receipt 

by laboratory personnel, the sample container, additional label copies, submitted forms, 

and identifying information entered into CVB’s electronic database will be compared to 

confirm correct identification of the samples received. The additional label copy will be 

attached to the signed APHIS Form 2020 and digitally retained.

IV. IMPLEMENTATION/ APPLICABILITY

This change will be effective 30 days from the date of this notice.