00-5429. Plant-Derived Biologics for Human and Veterinary Applications; Public Meeting

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Notice of public meeting.

SUMMARY:

This is to notify producers and users of human and veterinary vaccines, therapeutics, and diagnostics, as well as other interested persons, that a public meeting will be held to provide a forum for discussion on the regulatory and policy issues related to the manufacture, distribution, and use of biological products derived from plants. The meeting is being organized by the Food and Drug Administration and the Animal and Plant Health Inspection Service and is sponsored by the Institute for International Cooperation in Animal Biologics.

DATES:

The meeting will be held on Thursday, April 6, 2000, from 1 p.m. to 5 p.m.

ADDRESSES:

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

FOR FURTHER INFORMATION CONTACT:

For information about the meeting, contact Dr. Bruce Carter, Center for Veterinary Biologics, Licensing and Policy Development, VS, APHIS, 510 South 17th Street, Suite 104, Ames, IA 50010; phone [phone], fax [phone], or e-mail: [e-mail].

For registration information, contact Ms. Dawne Buhrow, Institute for International Cooperation in Animal Biologics, 2160 College of Veterinary Medicine, Iowa State University, Ames, IA 50011; phone [phone], fax [phone], or e-mail: [e-mail].

In addition, information regarding the meeting and registration is available on the Internet at http://www.vetmed.iastate.edu/​iicab/​transpl.htm.

SUPPLEMENTARY INFORMATION:

Under its regulations in title 9 of the Code of Federal Regulations (CFR), issued under the Virus-Serum-Toxin Act (21 U.S.C. 151 et seq.), the Animal and Plant Health Inspection Service (APHIS) regulates, among other things, the production of veterinary biological products. Although none have been licensed to date, APHIS' Center for Veterinary Biologics anticipates receiving applications for licenses authorizing the production of veterinary biological products derived from plants. In addition, under its regulations in title 7 of the CFR (7 CFR part 340), issued under the Federal Plant Pest Act (7 U.S.C. 150aa et seq.) and the Plant Quarantine Act (7 U.S.C. 151 et seq.), APHIS also regulates, among other things, the field testing of transgenic plants that may be plant pests. Since 1991, APHIS' Plant Protection and Quarantine program has issued 25 permits for the field testing of transgenic plants containing genes whose products are intended for use in the development of human and veterinary biologics. Finally, under its regulations in title 21 of the CFR issued under the Public Health Service Act (42 U.S.C. 300aa et seq.), the Food and Drug Administration (FDA) regulates, among other things, the production of biological products intended for use in humans. The FDA's Center for Biologics Evaluation and Research has received applications for plant-derived products intended for use in humans.

In order to provide a forum for the discussion of regulatory and policy issues related to the manufacture, distribution, and use of biological products derived from plants, 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 6, 2000, and will provide an opportunity for the exchange of information between APHIS and FDA representatives, producers and users of biological products derived from plants, and other interested persons on issues of common concern. The public meeting will begin at 1 p.m. and is scheduled to end at 5 p.m. Information regarding the meeting and registration instructions may be obtained from the persons listed under FOR FURTHER INFORMATION CONTACT.

Persons interested in making an oral presentation at the meeting should submit a brief written statement of the general views they wish to present, the name and address of each person who will participate in the presentation, and an estimate of the approximate length of time needed to make the presentation. This information should be e-mailed by March 20, 2000, to: APHIS_FDA_Plants_ [e-mail]. The number of oral presentations and the time allocated for each may be limited, depending upon the number of requests. Oral presentations will be recorded in the proceedings of the meeting. Persons interested in submitting written comments for inclusion in the proceedings may do so by e-mailing them, by March 20, 2000, to: APHIS_FDA_Plants_written @iastate.edu. Written comments and the requested information regarding oral presentations may also be mailed or faxed to Dr. Bruce Carter; his address and fax number are provided under FOR FURTHER INFORMATION CONTACT.

Done in Washington, DC, this 1st day of March 2000.

Bobby R. Acord,

Acting Administrator, Animal and Plant Health Inspection Service.