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July 14, 2004

CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 04-13

Subject: The Use of Minimum Age Animals in Licensure Studies

To: Biologics Licensees, Permittees, and Applicants

 Directors, Center for Veterinary Biologics

I. PURPOSE

This notice informs licensees, permittees, and applicants of current Center for Veterinary

Biologics (CVB) policy concerning the use of minimum age animals in the various

studies conducted to support licensure of a product.

II. BACKGROUND

Title 9 Code of Federal Regulations (9CFR) Part 112.2(a)(5) indicates that product

labeling should provide full instructions for the proper use of the product, including

vaccination schedules, warnings, and cautions. This notice clarifies the connection

between vaccination schedules recommended on the labeling, and the use of minimum

age animals in licensure studies. The issue of use of minimum age animals is discussed

in Veterinary Services Memorandums 800.50, 800.202, and 800.204.

III. POLICY

A minimum age for vaccination with the product should be established and indicated on

the labeling to represent the proper use of the product. The minimum age for vaccination

should be supported by data indicating the product is both safe and effective when given

as indicated. The age of animals used in the safety and efficacy studies should be

consistent. If the age is not consistent, the older age will be utilized for labeling

purposes. In some cases, the younger age study may be referred to in the labeling.

For poultry, production animal products, and aquaculture products, minimum age animals

should be used in the safety and efficacy studies.

For companion animal and equine products, minimum age animals should be used in the

efficacy studies and should represent one-third of the animals used for the field safety

study.

For production animal products for breeding animals, minimum age animals should be

used in the efficacy studies, and should represent one-third of the animals used for the

field safety study.

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. 04-13 2

For studies to support onset of immunity and duration of immunity label claims,

minimum age animals should be used.

IV. ACTION

All outlines should indicate minimum ages in Section VI.D. Firms should bring their

Outlines of Production into compliance with this notice before or at the next annual

review of the Outline of Production. All outlines should specify this information by one

year from the date of this notice.

Information in the Outline of Production and on the labeling should be consistent. The

full instructions for the proper use of the product should indicate the youngest age

animals for which the product is both safe and efficacious.

/s/ Richard E. Hill, Jr.

Richard E. Hill, Jr.

Director

Center for Veterinary Biologics