[Federal Register Volume 65, Number 179 (Thursday, September 14, 2000)]
[Notices]
[Pages 55637-55638]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-23672]



[[Page 55637]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Cancer Institute: Development of a Method for High Speed 
Parallel Nucleic Acid Sequencing

    An opportunity for a Cooperative Research and Development Agreement 
(CRADA) is available for collaboration with the NCI Intramural Division 
of Basic Sciences to develop a new high speed method for DNA sequencing 
called Two Dye Sequencing (TDS). This new sequencing method employs the 
use of a fluoresced DNA polymerase to catalyze polymerization of 
likewise fluoresced oligonucleotides, with the entire construct working 
in the chamber of a microscope point of view which can detect 
individual molecules. Collaborator expertise in genetic engineering is 
essential to this project.

AGENCY: National Cancer Institute, National Institutes of Health, PHS, 
DHHS.

ACTION: Notice of opportunity for cooperative research and development 
agreement.

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SUMMARY: Pursuant to the Federal Technology Transfer Act of 1986 (FTTA, 
15 U.S.C. 3710; Executive Order 12591 of April 10, 1987 as amended by 
the National Technology Transfer and Advancement Act of 1995), the 
National Cancer Institute (NCI) of the National Institutes of Health 
(NIH) of the Public Health Service (PHS) of the Department of Health 
and Human Services (DHHS) seeks a Cooperative Research and Development 
Agreement (CRADA) with a pharmaceutical or biotechnology company. CRADA 
proposals should include development of a prototype. The CRADA would 
have an expected duration of one(1) to five(5) years. The goals of the 
CRADA will include the rapid publication of research results and timely 
commercialization of products, diagnostics and treatments that result 
from the research. The CRADA Collaborator will have an option to 
negotiate the terms of an exclusive or nonexclusive commercialization 
license to subject inventions arising under the CRADA.

ADDRESSES: Proposals and questions about this CRADA opportunity may be 
addressed to Mr. Kevin Brand, Technology Development & 
Commercialization Branch, National Cancer Institute--Frederick Cancer 
Research and Development Center, Fairview Center, 1003 West Seventh 
Street, Room 502, Frederick, MD 21701, Telephone: (301) 846-5222; 
Facsimile: (301) 846-6820.

EFFECTIVE DATE: Organizations must submit a proposal summary of one 
page or less, to NCI on or before November 13, 2000. Guidelines for 
preparing full CRADA proposals will be communicated shortly thereafter 
to all respondents with whom initial discussions will have established 
sufficient mutual interest.

SUPPLEMENTARY INFORMATION:

Technology Available

    The National Cancer Institute (NCI) of the National Institutes of 
Health (NIH) has initiated the development of a new high speed DNA 
sequencing method designated as Two Dye Sequencing (TDS), and has a 
pending patent application embodying this technology. This method 
employs engineered DNA polymerases which are labeled with a fluorophore 
such as Green Fluorescent Protein (GFP) and are combined with an 
annealed oligonucleotide primer in a chamber of a microscope field of 
view capable of detecting individual molecules. Four nucleotide 
triphosphates, each labeled on the base with a different fluorescent 
dye are introduced to the reaction. Light of a specific wavelength is 
used to excite the fluorophore on the polymerase, which in turn excites 
the neighboring fluorophore on the nucleotide by Fluorescence Resonance 
Energy Transfer (FRET). As nucleotides are added to the primer, their 
spectral emissions provide sequence information of the DNA molecule. 
The NCI, in accordance with the regulations governing the transfer of 
agents which the Government has taken an active role in developing (37 
CFR 404.8), is seeking a pharmaceutical or biotechnology company which 
can assist in the development of a working construct that embodies this 
technology for commercialization. Those potential collaborators 
interested in reviewing NCI's pending patent application on this 
technology should contact J.P. Kim at the National Institutes of 
Health, Office of Technology Transfer, 6011 Executive Boulevard, Suite 
325, Rockville, Maryland 20852, Telephone (301) 496-7056; Facsimile 
(301) 496-0220.
    The role of the National Cancer Institute in this CRADA may 
include, but not be limited to:
    1. Providing intellectual, scientific, and technical expertise and 
experience related to the development of this new method for sequencing 
DNA via the TDS technology.
    2. Providing collaborator access to confidential information 
relating to the pending patent application which embodies this 
technological improvement in DNA sequencing.
    3. Planning research studies and interpreting research results.
    4. Publishing research results.
    The role of the CRADA Collaborator may include, but not be limited 
to:
    1. Providing significant intellectual, scientific, and technical 
expertise or experience to the development of a prototype that employs 
this two-dye sequencing method. Although expertise in genetic 
engineering is essential, expertise in chemical synthesis, microscopy, 
laser optics, single molecule detection, imaging processing and 
computer algorithms or a willingness to enter these fields will be 
favored.
    2. Providing technical and financial support to facilitate these 
scientific goals, as well as personnel and laboratory space.
    3. Assuming responsibility for the commercialization, marketing and 
distribution of this sequencing method.
    4. Planning research studies and interpreting research results.
    5. Publishing research results.
    Selection criteria for choosing the CRADA Collaborator may include, 
but not be limited to:
    1. The ability to collaborate with NCI on the research and 
development of this technology. The ability to collaborate with NCI can 
be demonstrated through experience and expertise in this or related 
areas of technology indicating the ability to contribute intellectually 
to ongoing research and development.
    2. The demonstration of adequate resources to perform the research 
and development of this technology (e.g. facilities, personnel and 
expertise) and accomplish objectives according to an appropriate 
timetable to be outlined in the CRADA Collaborator's proposal.
    3. The willingness to commit best effort and demonstrated resources 
to the research and development of this technology, as outlined in the 
CRADA Collaborator's proposal.
    4. The demonstration of expertise in the commercial development and 
production of products related to this area of technology.
    5. The level of financial support the CRADA Collaborator will 
provide for CRADA-related Government activities.
    6. The willingness to cooperate with the National Cancer Institute 
in the timely publication of research results.
    7. The agreement to be bound by the appropriate DHHS regulations 
relating to human subjects, and all PHS policies relating to the use 
and care of laboratory animals.
    8. The willingness to accept the legal provisions and language of 
the CRADA

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with only minor modification, if any. These provisions govern the 
distribution of patent rights to CRADA inventions. Generally, the 
rights of ownership are retained by the organization that is the 
employer of the inventor, with (1) the grant of a license for research 
and other Government purposes to the Government when the CRADA 
Collaborator's employee is the sole inventor, or (2) the grant of an 
option to elect an exclusive or nonexclusive license to the CRADA 
Collaborator when the Government employee is the sole inventor.

    Dated: September 3, 2000.
Kathleen Sybert,
Branch Chief, Technology Development & Commercialization Branch, 
National Cancer Institute, National Institutes of Health.
[FR Doc. 00-23672 Filed 9-13-00; 8:45 am]
BILLING CODE 4140-01-P