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March 4, 2005

CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 05-07

Subject: Biologics for Reduction of Colonization and/or Shedding in Animals

To: Biologics Licensees, Permittees, and Applicants

 Veterinary Services Management Team

 Directors, Centers for Veterinary Biologics

The purpose of this notice is to inform interested parties of a change in United States

Department of Agriculture, Animal and Plant Health Inspection Service (APHIS) policy

regarding licensing requirements for veterinary biological products with a claim of

reduced colonization and/or shedding of organisms that may not cause significant clinical

disease in animals, but have the potential to adversely impact the management or care of

the animal by causing the animal to be a disease carrier.

I. BACKGROUND

Title 9 of the Code of Federal Regulations, Part 101.2 states, “The term biological

products, also referred to as biologics, biologicals, or products, shall mean all viruses,

serums, toxins (excluding substances that are selectively toxic to microorganisms, e.g.,

antibiotics), or analogous products at any stage of production, shipment, distribution, or

sale, which are intended for use in the treatment of animals and which act primarily

through the direct stimulation, supplementation, enhancement, or modulation of the

immune system or immune response.” Part 101.2(a)(3) also states, “The term treatment

shall mean the prevention, diagnosis, management, or cure of diseases of animals.” To

this end, and for the purposes of this notice, managing diseases of animals can include

managing a carrier state of a disease.

Historically, products whose primary purpose is to reduce or eliminate a carrier state

have not been interpreted to fall under the jurisdiction of the Virus-Serum-Toxin Act,

even when those products otherwise met the definition of a biologic. APHIS now

proposes to interpret its authority to treat or manage an animal disease to include the

carrier state for some pathogens.

II. GUIDELINES

In response to requests from industry, the APHIS and the United States Department of

Health and Human Services, Food and Drug Administration (FDA) have agreed that the

jurisdiction for animal vaccines targeted at the reduction or elimination of a carrier state

of organisms that can infect other animals (even if that infection is only rarely associated

with significant clinical disease in animals), will lie with APHIS as long as certain

criteria are met.

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. 05-07 2

Those criteria include:

1. Products must be indicated for administration to animals only, and must act primarily

through the direct stimulation, supplementation, enhancement, or modulation of the

immune system or immune response.

2. Label claims and advertising must contain only factual statements supported by data

(e.g., as an aid in the reduction of colonization and/or shedding). No food safety or

human health claims, either implicit or explicit, would be allowed by APHIS. Products

with such claims would fall under the authority of the FDA and require their approval.

3. The products will be required to show significant, substantively meaningful, and

clinically relevant efficacy as defined by APHIS. For claims of reduction of colonization

and/or shedding, products must demonstrate the ability to cause a substantial decrease in

number of animals colonized and/or numbers of organisms shed by vaccinated animals.

/s/ Richard E. Hill, Jr.

Richard E. Hill, Jr.

Director

Center for Veterinary Biologics