[Federal Register Volume 66, Number 176 (Tuesday, September 11, 2001)]
[Notices]
[Page 47236]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-22792]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Veterinary Vaccine 
Against Escherichia Coli O157 Infection Composed of Detoxified LPS 
Conjugated to Proteins

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

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SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 
CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), 
Department of Health and Human Services, is contemplating the grant of 
an exclusive license to practice the invention embodied in: United 
States Patent Application 09/744,289 and its foreign equivalents 
entitled ``Vaccine Against Escherichia Coli O157 Infection Composed of 
Detoxified LPS Conjugated to Proteins'' filed January 22, 2001, with 
priority back to PCT/US98/14976, filed July 20, 1998 to Fort Dodge 
Animal Health, a Division of American Home Products, having a place of 
business in Overland Park, Kansas. The patent rights in this invention 
have been assigned to the United States of America.

DATES: Only written comments and/or application for a license which are 
received by the NIH Office of Technology Transfer on or before November 
13, 2001 will be considered.

ADDRESSES: Requests for a copy of the patent application, inquiries, 
comments and other materials relating to the contemplated license 
should be directed to: Peter Soukas, Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, MD 20852-3804; Email: [email protected]; Telephone: (301) 496-
7056, ext. 268; Facsimile: (301) 402-0220.

SUPPLEMENTARY INFORMATION: This invention comprises the O-specific 
polysaccharide of Shiga toxin-producing bacteria, particularly E. coli 
O157, conjugated to a carrier protein such as Pseudomonas aeruginosa 
recombinant exoprotein A or hepatitis B surface or core antigen. This 
vaccine is suitable for use in humans and animals. Cattle are carriers 
of E. coli O157, and are the primary reservoir of E. coli O157 by 
shedding the bacteria into the environment. Fifty percent (50%) of 
cattle are estimated to be carriers of E. coli O157. Use of this 
vaccine in cattle could eliminate E. coli O157 and prevent 
contamination of meat in slaughterhouses.
    The prospective exclusive license will be royalty bearing and will 
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. 
The prospective exclusive license may be granted unless, within 60 days 
from the date of this published Notice, NIH receives written evidence 
and argument that establishes that the grant of the license would not 
be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7.
    The field of use may be limited to E. coli conjugate vaccines for 
veterinary use.
    Properly filed competing applications for a license filed in 
response to this notice will be treated as objections to the 
contemplated license. Comments and objections submitted in response to 
this notice will not be made available for public inspection, and, to 
the extent permitted by law, will not be released under the Freedom of 
Information Act, 5 U.S.C. 552.

    Dated: September 4, 2001.
Jack Spiegel, Ph.D.,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer.
[FR Doc. 01-22792 Filed 9-10-01; 8:45 am]
BILLING CODE 4140-01-P