[Federal Register Volume 77, Number 222 (Friday, November 16, 2012)]
[Notices]
[Page 68783]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-27896]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Prospective Grant of Co-Exclusive License: Veterinary Vaccines 
for Rift Valley Fever Virus

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This is a notice in accordance with 35 U.S.C. 209(e) and 37 
CFR 404.7(a)(1)(i) that the Technology Transfer Office, Centers for 
Disease Control and Prevention (CDC), Department of Health and Human 
Services (HHS), is thinking about giving a co-exclusive license in 
Africa, in the field of use of veterinary vaccines, to practice the 
inventions listed in the patent applications referred to below to 
Deltamune Ltd., having a place of business in Centurion, South Africa. 
The patent rights in these inventions have been assigned to the 
government of the United States of America. The patent applications(s) 
to be licensed are:

    US Provisional Application 61/016,065, filed 12/21/2007, 
entitled ``Development of Rift Valley Fever Virus Utilizing Reverse 
Genetics,'' US Provisional Application 61/042,987, filed 4/7/2008, 
entitled ``Recombinant Rift Valley Fever (RVF) Viruses and Method of 
Use,'' PCT Application PCT/US2008/087023, filed 12/16/2008, entitled 
``Recombinant Rift Valley Fever (RVF) Viruses and Method of Use,'' 
US National Stage Application 12/809,561, filed 6/18/2010, entitled 
``Recombinant Rift Valley Fever (RVF) Viruses and Methods of Use,'' 
and all related continuing and foreign patents/patent applications 
for the technology family. CDC Technology ID No. I-008-08.

    Status: Pending.
    Priority Date(s):

61/042,987: 4/7/2008
61/016,065: 12/21/2007

    The planned co-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.
    Technology: The technology allows for the generation of precisely 
defined attenuated vaccine constructs that contain complete deletions 
of critical virulence factors of Rift Valley Fever (RVF) virus. These 
attenuated vaccines constructs still have the ability to induce robust 
protective immunity following the administration of a single vaccine 
dose in a rat model of lethal disease. The vaccines can protect 
immunized animals against virulent virus challenge. The vaccine 
candidates also allow for the differentiation of naturally infected and 
vaccinated animals--a feature that is critical in agricultural 
settings. This approach will allow for the rapid generation of 
effective, safe RVF vaccine candidates to control and prevent the 
spread of wild-type RVF virus in a variety of settings, including 
preventing the infection of humans or animals during endemic, epidemic 
or epizootic situations in affected countries, or for prophylactic use 
among humans in high risk occupational settings, or following 
intentional release of RVF virus during bioterrorism.

DATES: Only written comments and/or applications for a license which 
are received by CDC on or before December 17, 2012 will be considered.

ADDRESSES: Requests for a copy of these patent applications, inquiries, 
comments, and other materials relating to the planned license should be 
directed to Donald Prather, J.D., Ph.D., Technology Licensing and 
Marketing Specialist, Technology Transfer Office, Centers for Disease 
Control and Prevention (CDC), 4770 Buford Highway, Mailstop K-79, 
Atlanta, GA 30341, Telephone: (770) 488-8612; Facsimile: (770) 488-
8615; Email: [email protected].

SUPPLEMENTARY INFORMATION: Applications for a license filed in response 
to this notice will be treated as objections to giving the planned 
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: November 8, 2012.
J. Ronald Campbell,
Director, Division of Executive Secretariat, Centers for Disease 
Control and Prevention.
[FR Doc. 2012-27896 Filed 11-15-12; 8:45 am]
BILLING CODE 4163-18-P