01-5591. Public Meeting; Veterinary Biologics

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Notice of public meeting on biologics for cancer diagnosis, prevention, and immunotherapy.

SUMMARY:

We are issuing this notice to inform interested individuals, including producers and users of human and veterinary biological products, that we will be holding a public meeting to discuss regulatory and policy issues related to the manufacture, distribution, and use of biological products for the diagnosis, prevention, and treatment of cancer in humans and animals. The meeting is being organized by the Food and Drug Administration, Center for Biologics Evaluation and Research, and the Animal and Plant Health Inspection Service, Veterinary Services, Center for Veterinary Biologics. The Institute for International Cooperation in Animal Biologics is sponsoring the meeting.

DATES:

The public meeting will be held on Thursday and Friday, April 12 and 13, 2001, from 8 a.m. to approximately 5 p.m.

ADDRESSES:

The public meeting will be held in the Scheman Building at the Iowa State Center, Iowa State University, Ames, IA.

FOR FURTHER INFORMATION CONTACT:

For further information about the meeting, contact Dr. Dave M. Dusek, Center for Veterinary Biologics, Veterinary Services, APHIS, 510 South 17th Street, Suite 104, Ames, IA 50010-8197; phone [phone], fax [phone], or e-mail [e-mail]. For registration information, contact Ms. Dawne Buhrow at the Institute for International Cooperation in Animal Biologics, room 2160, College of Veterinary Medicine, Iowa State University, Ames, IA 50011; phone [phone], fax [phone], or e-mail [e-mail]. Information is also available online at http://www.vetmed.iastate.edu/​iicab/​cancerbiologics.htm.

SUPPLEMENTARY INFORMATION:

The Animal and Plant Health Inspection Service (APHIS) specifies licensing requirements for veterinary biological products for the treatment of animals in title 9 of the Code of Federal Regulations, parts 101 to118. Veterinary biological products include, but are not limited to, viruses, serums, toxins (except antibiotics), immunostimulants, cytokines, diagnostic components, and analogous products that are intended for use in the treatment of animals and that act primarily through the direct stimulation, supplementation, enhancement, or modulation of the immune system or immune response. To date, most cancer biologics licensed by APHIS have been conventional in design. However, APHIS anticipates receiving applications for licenses to produce veterinary biological products intended for use in the diagnosis, prevention, or treatment of cancer that are based on advances in biotechnology. The Food and Drug Administration (FDA) regulates the production of biologics for use in humans under its regulations in title 21 of the Code of Federal Regulations. Within the FDA, the Center for Biologics Evaluation and Research has received applications for licensure of biologics for the diagnosis, prevention, or treatment of cancer.

To provide a forum for the discussion of regulatory and policy issues related to the manufacture, distribution, and use of biological products intended for use in the diagnosis, prevention, or treatment of cancer, APHIS and FDA are organizing a public meeting. This public meeting, which is sponsored by the Institute for International Cooperation in Animal Biologics, is scheduled for April 12-13, 2001, will provide an opportunity for the exchange of information and discussion of issues of common concern among APHIS and FDA representatives; producers and users of biological products intended for use in the diagnosis, prevention, or treatment of cancer; and other interested persons. The public meeting will begin at 8 a.m. and is scheduled to end at 5 p.m. each day.

Information regarding the meeting and registration instructions may be obtained from the persons listed under FOR FURTHER INFORMATION CONTACT.

Done in Washington, DC, this 1st day of March 2001.

Bobby R. Acord,

Acting Administrator, Animal and Plant Health Inspection Service.