[Federal Register Volume 65, Number 45 (Tuesday, March 7, 2000)]
[Notices]
[Page 11975]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-5429]


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 Notices
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains documents other than rules 
 or proposed rules that are applicable to the public. Notices of hearings 
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 delegations of authority, filing of petitions and applications and agency 
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  Federal Register / Vol. 65, No. 45 / Tuesday, March 7, 2000 / 
Notices  

[[Page 11975]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 00-015-1]


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

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice of public meeting.

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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 (515) 232-5785, fax (515) 232-7120, or e-mail: 
[email protected].
    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 (515) 
294-7632, fax (515) 294-8259, or e-mail: [email protected].
    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__ [email protected]. 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.
[FR Doc. 00-5429 Filed 3-6-00; 8:45 am]
BILLING CODE 3410-34-U