Prospective Grant of Exclusive License: Dengue Virus Vaccine, 14221-14222 [E6-4048]

Download as PDF Federal Register / Vol. 71, No. 54 / Tuesday, March 21, 2006 / Notices Dated: March 14, 2006. Alvin Hall, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 06–2652 Filed 3–20–06; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention sroberts on PROD1PC70 with NOTICES National Center for Environmental Health/Agency for Toxic Substances and Disease Registry The Board of Scientific Counselors, Centers for Disease Control and Prevention (CDC), National Center for Environmental Health/Agency for Toxic Substances and Disease Registry (NCEH/ ATSDR): Meeting. In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), CDC and NCEH/ ATSDR announce the following committee meeting: Name: Board of Scientific Counselors (BSC), NCEH/ATSDR. Times and Dates: 8 a.m. –4:45 p.m., May 4, 2006. 8 a.m.–12:15 p.m., May 5, 2006. Place: 1825 Century Boulevard, Atlanta, Georgia 30345. Status: Open to the public, limited only by the space available. The meeting room accommodates approximately 75 people. Purpose: The Secretary, Department of Health and Human Services (HHS) and by delegation, the Director, CDC, and Administrator, NCEH/ATSDR, are authorized under section 301 (42 U.S.C. 241) and section 311 (42 U.S.C. 243) of the Public Health Service Act, as amended, to: (1) Conduct, encourage, cooperate with, and assist other appropriate public authorities, scientific institutions, and scientists in the conduct of research, investigations, experiments, demonstrations, and studies relating to the causes, diagnosis, treatment, control, and prevention of physical and mental diseases and other impairments; (2) assist states and their political subdivisions in the prevention of infectious diseases and other preventable conditions and in the promotion of health and well being; and (3) train state and local personnel in health work. The BSC, NCEH/ATSDR provides advice and guidance to the Secretary, HHS; the Director, CDC, and Administrator, ATSDR; and the Director, NCEH/ATSDR, regarding program goals, objectives, strategies, and priorities in fulfillment of the agency’s VerDate Aug<31>2005 19:01 Mar 20, 2006 Jkt 208001 mission to protect and promote people’s health. The board provides advice and guidance that will assist NCEH/ATSDR in ensuring scientific quality, timeliness, utility, and dissemination of results. The board also provides guidance to help NCEH/ATSDR work more efficiently and effectively with its various constituents and to fulfill its mission in protecting America’s health. Matters To Be Discussed: Items will include but are not limited to a discussion of Fiscal Years 2006 and 2007 budget implications; an update on the peer review of the Air Pollution and Respiratory Health Branch and the Division of Toxicology and Environmental Medicine; a discussion of the Program Peer Review Subcommittee process; updates on the Community and Tribal Subcommittee, the Health Department Subcommittee and the Delisting Workgroup; a discussion on the implications of the Office of Management and Budget Data Quality Guidelines and proposed bulletin on risk assessments; a discussion on the environmental health aspects of pandemic flu planning, the environmental health implications; discussion on future goals, directions, and new priorities; and an introduction of the Goals’ Managers. Agenda items are tentative and subject to change. FOR FURTHER INFORMATION CONTACT: Sandra Malcom, Committee Management Specialist, NCEH/ATSDR, 1600 Clifton Road, Mail Stop E–28, Atlanta, Georgia 30303; telephone (404) 498–0003, fax (404) 498–0622; E-mail: smalcom@cdc.gov. The deadline for notification of attendance is April 24, 2006. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities for both CDC and NCEH/ATSDR. Dated: March 14, 2006. Alvin Hall, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention (CDC). [FR Doc. 06–2653 Filed 3–20–06; 8:45 am] BILLING CODE 4163–18–P PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 14221 DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Prospective Grant of Exclusive License: Dengue Virus Vaccine Technology Transfer Office, Centers for Disease Control and Prevention (CDC), Department of Health and Human Services. ACTION: Notice. AGENCY: SUMMARY: This is a notice in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i) that the Centers for Disease Control and Prevention (CDC), Technology Transfer Office, Department of Health and Human Services (DHHS), is contemplating the grant of a worldwide, limited field of use, exclusive license to practice the inventions embodied in the patent application referred to below to Inviragen, LLC, having a place of business in Fort Collins, Colorado. The patent rights in these inventions have been assigned to the government of the United States of America. SUPPLEMENTARY INFORMATION: In accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i), CDC is providing public notice of its intention to grant an exclusive license. CDC will accept written comments concerning this notice for 30 days after publication of this notice. Applications for a license filed in response to this notice will be treated as objections to the grant of 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. A signed Confidential Disclosure Agreement (available under Forms @ https://www.cdc.gov/tto) will be required to receive a copy of any pending patent application. The patent application(s) to be licensed are: PCT/US01/05142 entitled ‘‘Chimeric Dengue Viruses as Candidate Vaccines for Humans,’’ filed February 16, 2001. Status: Received notice of allowance. Issue Date: N/A 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. Technology: This technology provides a new pathway for a dengue virus vaccine. ADDRESSES: Requests for a copy of this patent application, inquiries, comments, and other materials relating to the E:\FR\FM\21MRN1.SGM 21MRN1 14222 Federal Register / Vol. 71, No. 54 / Tuesday, March 21, 2006 / Notices contemplated license should be directed to Andrew Watkins, Director, Technology Transfer Office, Centers for Disease Control and Prevention (CDC), 4770 Buford Highway, Mailstop K–79, Atlanta, GA 30341, telephone: (770) 488–8610; facsimile: (770) 488–8615. Dated: March 14, 2006. James D. Seligman, Chief Information Officer, Centers for Disease Control and Prevention. [FR Doc. E6–4048 Filed 3–20–06; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: sroberts on PROD1PC70 with NOTICES SUMMARY: The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. ADDRESSES: Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852–3804; telephone: (301) 496–7057; fax: (301) 402–0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications. Rapid Methods for Human Artificial Chromosome (HAC) Formation Vladimir Larionov (NCI), Hiroshi Masumoto (NCI), Megumi Nakano (NCI), Vladimir Noskov (NCI), Natalay Kouprina (NCI), J. Carl Barrett (NCI), et al. U.S. Provisional Application No. 60/ 669,589 filed April 8, 2005 (HHS Reference No. E–128–2005/0–US–01) Licensing Contact: Susan Carson, D. Phil.; 301/435–5020; carsonsu@mail.nih.gov. Human artificial chromosomes (HACs) provide a unique opportunity to develop a new generation of vectors for therapeutic use as gene expression and VerDate Aug<31>2005 19:01 Mar 20, 2006 Jkt 208001 delivery systems. The advantages of a high-capacity, non-integrating chromosome-based vector capable of autonomous replication and long-term gene expression are evident for potential use in gene therapy and this area is one of active research. In particular, the generation of a functional centromere (a complex structure needed for segregation at cell division) has been recognized as key in the production of synthetic chromosomes. However, a typical human centromere extends over many millions of base pairs containing mainly alphoid satellite DNA (171 bp repeating units) organized into higher order repeats (HORs), which have been difficult to fully characterize or modify readily. There remains a need to elucidate the structural requirements of alphoid DNA arrays for efficient de novo assembly of centromere structure in order to construct HAC vectors able to carry intact mammalian genes capable of fully regulated gene expression and which can be stably maintained in the host nucleus for use in gene therapy. The group of Dr. Larionov at the NCI and colleagues have recently developed a novel strategy to rapidly construct large synthetic alphoid DNA arrays with a predetermined structure by in vivo recombination in yeast (Nucleic Acids Res., Sep 2005; 33: e130). The invention is a two step method involving (1) rolling-circle amplification (RCA) of a short alphoid DNA multimer (e.g. a dimer) and (2) subsequent assembly of the amplified fragments by in vivo homologous recombination during transformation with a TransformationAssociated Recombination targeting vector (TAR–NV) into yeast cells. This method or Recombinational Amplification of Repeats (RAR) has been used to construct sets of different synthetic alphoid DNA arrays varying in size from 30 to 120 kb which were shown to be competent in HAC formation. Thus, these long arrays are engineered centromere-like regions that permit construction of mammalian artificial chromosomes with a predefined centromeric region structure. As any nucleotide can be easily changed into an alphoid dimer before its amplification, this new system is optimal for identifying the critical regions of the alphoid repeat for de novo centromere seeding. The Mammalian Artificial Chromosome Portfolio [HHS Ref. No. E–128–2005/0–US–01 and HHS Ref. No. E–253–2000/0–US–03], including methods of generating engineered centromeric sequences, mammalian artificial chromosomes and methods of their use is available for licensing and PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 will be of direct use to those interested in vectors providing long-term regulated expression of genes used in therapy for human disease. Related technologies available for licensing also include: the TAR cloning Portfolio [HHS Ref. No. E–121–1996/0US–06 (USPN 6,391,642 and global IP coverage); HHS Ref. No. E–158–2001/0– US–02, U.S. Publication No. US2004/ 0248289 filed October 4, 2002]. In addition to licensing, the technology is available for further development through collaborative research opportunities with the inventors. Transformation-Associated Recombination (TAR) Cloning Vladimir Larionov (NCI), Natalay Kouprina (NCI), Michael A. Resnick (NIEHS), et al. U.S. Patent No. 6,391,642 issued May 21, 2002 (HHS Reference No. E–121– 1996/0–US–06) and global IP coverage Licensing Contact: Susan Carson, D. Phil., 301/435–5020; carsonsu@mail.nih.gov. Transformation-Associated Recombination (TAR) cloning in yeast is a unique method for selective isolation of large chromosomal fragments or entire genes from complex genomes without the time-consuming step of library construction (PNAS (1996) 93, 491–496). The technique involves homologous recombination during yeast spheroplast transformation between genomic DNA and a TAR vector that has short (approximately 60bp) 5’ and 3’ gene targeting sequences (hooks). Further, because up to 15% sequence divergence does not prevent recombination in yeast, TAR cloning is highly efficient for isolation of gene homologs and synthenic regions. Using this technology, chromosomal regions up to 250kb can be rescued in yeast as circular YACs within 3–5 working days (NAR (2003) 31, e29; Current Protocols in Human Genetics (1999) 5.17.1). NIH researchers Drs. Larionov, Kouprina and Resnick have championed the use of this technology and TAR cloning has been used to efficiently isolate haplotypes, gene families (Genome Research (2005) 15, 1477) as well as genomic regions which are not present in existing BAC libraries. Known mutations and new modifications, including point mutations, deletions and insertions, can easily be introduced into DNA fragments hundreds of kilobases in size without introducing any unwanted alterations. The modified DNAs can then be tested functionally in mammalian cells and transgenic mice. TAR has also been used for structural E:\FR\FM\21MRN1.SGM 21MRN1

Agencies

[Federal Register Volume 71, Number 54 (Tuesday, March 21, 2006)]
[Notices]
[Pages 14221-14222]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-4048]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Prospective Grant of Exclusive License: Dengue Virus Vaccine

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

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 Centers for Disease Control and Prevention 
(CDC), Technology Transfer Office, Department of Health and Human 
Services (DHHS), is contemplating the grant of a worldwide, limited 
field of use, exclusive license to practice the inventions embodied in 
the patent application referred to below to Inviragen, LLC, having a 
place of business in Fort Collins, Colorado. The patent rights in these 
inventions have been assigned to the government of the United States of 
America.

SUPPLEMENTARY INFORMATION: In accordance with 35 U.S.C. 209(e) and 37 
CFR 404.7(a)(1)(i), CDC is providing public notice of its intention to 
grant an exclusive license. CDC will accept written comments concerning 
this notice for 30 days after publication of this notice. Applications 
for a license filed in response to this notice will be treated as 
objections to the grant of 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. A signed Confidential Disclosure Agreement (available under Forms 
@ https://www.cdc.gov/tto) will be required to receive a copy of any 
pending patent application.
    The patent application(s) to be licensed are:
    PCT/US01/05142 entitled ``Chimeric Dengue Viruses as Candidate 
Vaccines for Humans,'' filed February 16, 2001.
    Status: Received notice of allowance.
    Issue Date: N/A
    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.
    Technology:
    This technology provides a new pathway for a dengue virus vaccine.

ADDRESSES: Requests for a copy of this patent application, inquiries, 
comments, and other materials relating to the

[[Page 14222]]

contemplated license should be directed to Andrew Watkins, Director, 
Technology Transfer Office, Centers for Disease Control and Prevention 
(CDC), 4770 Buford Highway, Mailstop K-79, Atlanta, GA 30341, 
telephone: (770) 488-8610; facsimile: (770) 488-8615.

    Dated: March 14, 2006.
James D. Seligman,
Chief Information Officer, Centers for Disease Control and Prevention.
 [FR Doc. E6-4048 Filed 3-20-06; 8:45 am]
BILLING CODE 4163-18-P

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