December 12, 2012

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. 12-25

TO: Biologics Licensees, Permittees, and Applicants 

Directors, Center for Veterinary Biologics 

Veterinary Services Leadership Team

FROM: Richard E. Hill, Jr. /s/ Byron E. Rippke, for 

Director 

Center for Veterinary Biologics

SUBJECT: New Policy on Biological Product Samples Submitted to the Center for

Veterinary Biologics and the Concurrent Testing Selection Period

I. PURPOSE

This Notice informs licensees, permittees, and applicants of the current Center for 

Veterinary Biologics (CVB) policy concerning the submission of biological product 

samples prior to releasing a serial for marketing. The CVB has decided to reduce the 

number of samples submitted to a minimum of two containers or a sufficient quantity of 

one dose containers to conduct the potency test requiring multiple containers, e.g. rabies,

for all product codes. In addition, the concurrent testing selection period will be reduced

to seven calendar days. There will be no change to diagnostic test kit sample submission 

or the selection period. 

II. BACKGROUND

Title 9, Code of Federal Regulations (9 CFR), Part 113.3 requires each licensee or 

permittee to submit representative samples of each serial or subserial of a biological 

product manufactured or imported into the U.S. prior to serial release. The current 

sample policy is found in Veterinary Services Memorandum 800.59. The annual cost of 

processing, storage, and disposal of biologic test samples has steadily increased. In 

response, the CVB has reviewed alternatives to current testing and sample submission 

processes. Decreasing the number of biologic samples will provide a benefit to the 

National Centers for Animal Health (NCAH) through reduced processing, maintenance, 

and disposal costs, will reduce the environmental impact of the NCAH by reducing the 

volume of hazardous and non-recyclable waste disposal, and will allow the licensee or 

permittee to market samples which would have previously been maintained at the CVB.

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
CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 12-25 

Page 2

III. POLICY

1. The CVB will require prelicense products, Master Seeds and Master Cell sample 

submissions to remain the same as required in 9 CFR 113.3(c).

2. The licensee or permittee will continue to select all prerelease serial samples as 

required in 9 CFR 113.3(b).

a. The licensee or permittee will submit a minimum of two containers or a 

sufficient quantity of one dose containers to conduct the potency test requiring 

multiple containers, e.g. rabies, at the CVB.

b. When a serial of product is imported in more than one shipment, 

representative samples from each shipment must be selected by the permittee 

but only samples from the first shipment must be submitted to CVB as 

prerelease serial samples.

c. The licensee or permittee will hold selected samples not initially submitted at 

the storage temperature recommended on the label while awaiting a request by 

the CVB to submit additional samples.

d. If additional sample submission is not requested by the CVB, the additional 

samples may be returned to the inventory after the serial is released for 

marketing by the CVB.

e. If additional sample submission is requested on a routine basis, the CVB will 

notify the firm to submit the recommended quantity.

3. To offset the time to submit additional samples, the concurrent testing selection 

period will be reduced to 7 calendar days after samples are received by the CVB.

a. If additional samples are requested for testing, the licensee or permittee will 

be notified. 

4. The licensee or permittee will continue to select APHIS reserve samples as 

required in 9 CFR 113.3(e).

The reduced sample submission and selection window are a privilege for the licensee or 

permittee. At any time, the CVB may notify licensees and permittees to submit the full 

complement of samples as required in 9 CFR 113.3(b). Included in this notification, the 

CVB will identify the basis for revoking the limited sample submission privilege. 

Inspection or investigation findings and regulatory/compliance concerns are examples of 

events which may trigger such a notification. 

IV. IMPLEMENTATION/ APPLICABILITY

This change is effective January 1, 2013.