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[Federal Register Volume 66, Number 45 (Wednesday, March 7, 2001)]
[Notices]
[Page 13696]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-5591]

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Notices
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains documents other than rules 
or proposed rules that are applicable to the public. Notices of hearings 
and investigations, committee meetings, agency decisions and rulings, 
delegations of authority, filing of petitions and applications and agency 
statements of organization and functions are examples of documents 
appearing in this section.

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Federal Register / Vol. 66, No. 45 / Wednesday, March 7, 2001 / 
Notices

[[Page 13696]]

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 01-011-1]

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.

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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 (515) 232-5785, fax (515) 232-7120, or e-mail 
[email protected]. 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 (515) 294-7632, fax (515) 294-8259, 
or e-mail [email protected]. 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.
[FR Doc. 01-5591 Filed 3-6-01; 8:45 am]
BILLING CODE 3410-34-U
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