[Federal Register Volume 68, Number 156 (Wednesday, August 13, 2003)]
[Notices]
[Pages 48393-48394]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-20561]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Heart, Lung, and Blood Institute: Licensing Opportunity 
and Cooperative Research and Development Agreement (CRADA) Opportunity 
to Develop Therapeutic Uses for the Newly Identified Cardiac Precursor 
Cells Named ``SPOC'' Cells

AGENCY: National Heart, Lung, and Blood Institute.

ACTION: Notice.

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SUMMARY: The National Heart Lung and Blood Institute is seeking 
licensees and/or CRADA partners to further develop, evaluate, and 
commercialize therapeutic uses for the newly identified cardiac 
precursor cells named ``spoc'' cells. The U.S government-owned 
technology is encompassed within PCT Patent Application No. PCT/US02/
33860, entitled, ``Stem Cells that Transform to Beating 
Cardiomyocytes''.
    The NHLBI seeks potential Collaborator(s) wishing to provide 
expertise in (1) genomics/proteomics and analysis; (2) animal models of 
heart disease; (3) high throughput drug screening.
    Prospective collaborators need only be interested in pursuing a 
focused aspect of the potential applications.

DATES: Only written CRADA capability statements received by the NHLBI 
on or before September 29, 2003, will be considered during the initial 
design phase. Confidential information must be clearly labeled. 
Potential collaborators may be invited to meet with the Selection 
Committee at the collaborators' expense to provide

[[Page 48394]]

additional information. The Institute may issue an additional notice of 
CRADA opportunity during the design phase if circumstances change or if 
the design alters substantially.
    Inventions described in the patent application(s) are available for 
either exclusive or non-exclusive licensing in accordance with 35 
U.S.C. 207 and 37 CFR part 404. Respondees interested in licensing the 
invention(s) should submit an ``Application for License to Public 
Health Service Inventions.''

FOR FURTHER INFORMATION AND QUESTIONS: Questions about licensing 
opportunities should be addressed to Fatima Sayyid, M.H.P.M., 
Technology Licensing Specialist, Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, Maryland 20852-3804, Tel: 301-435-4521; Fax: 301-402-0220; 
E-mail: [email protected]. Information about Patent Applications and 
pertinent information not yet publicly described can be obtained under 
the terms of a Confidential Disclosure Agreement.
    Capability statements and questions about this CRADA opportunity 
should be submitted to Dr. Vincent Kolesnitchenko, Office of Technology 
Transfer and Development, National Heart, Lung, and Blood Institute, 
National Institutes of Health, 6705 Rockledge Drive, Suite 6018, MSC 
7992, Bethesda, MD 20892-7992; Tel: 301-594-4115; Fax: 301-594-3080; E-
mail: [email protected].

SUPPLEMENTARY INFORMATION: A CRADA is an agreement designed to enable 
certain collaborations between the Government laboratories and non-
Government laboratories. It is not a grant, and is not a contract for 
the procurement of goods/services. The NHLBI is prohibited from 
transferring funds to a CRADA collaborator. Under a CRADA, NHLBI can 
contribute facilities, staff, materials, and expertise to the effort. 
The collaborator typically contributes facilities, staff, materials, 
expertise, and funding to the collaboration. The CRADA collaborator may 
elect an option to negotiate an exclusive or non-exclusive license to 
Government intellectual property rights arising under the CRADA in a 
predetermined field of use and may qualify as a co-inventor of new 
technology developed under the CRADA.
    Respondees interested in licensing the technology will be required 
to submit an Application for License to Public Health Service 
Inventions. Inventions described in the patent application(s) are 
available for either exclusive or non-exclusive licensing in accordance 
with 35 U.S.C. 207 and 37 CFR part 404. Information about patent 
application(s) and pertinent information not yet publicly described can 
be obtained under the terms of a Confidential Disclosure Agreement.
    Technology Description: Spoc cells are a previously unknown 
subpopulation of stem cells in adult murine skeletal muscle that can be 
transformed into beating cardiomyocytes in primary tissue culture. 
These cells are not satellite cells, myofibroblasts or myoblasts or 
hematopoietic stem cells. A portion of these marked freshly isolated 
spoc cells, injected into the tail vein of a mouse with an acute 
myocardial infarct populates the infarct in 2 weeks time; by 3 months 
they differentiate into cardiac myocytes in the region of the infarct. 
Spoc cells can be used to isolate orthologue human cells that may be 
useful in treating chronic and acute heart failure. These cells may 
also be used to produce cell lines from transgenic animals with 
targeted genes that are important to cardiac function. Such cell lines 
will be useful in high throughput pharmaceutical screening projects.
    Capability Statements: A Selection Committee will use the 
information provided in the ``Collaborator Capability Statements'' 
received in response to this announcement to help its deliberations. It 
is the intention of the NHLBI that all qualified Collaborators have the 
opportunity to provide information to the Selection Committee through 
their capability statements. The Capability Statement should not exceed 
10 pages and should address the following criteria:
    (1) The ability to collaborate with NHLBI on further research and 
development of this technology. This ability can be demonstrated 
through experience and expertise in this or related areas of technology 
indicating the ability to contribute intellectually to on-going 
research and development.
    (2) Expertise and experience in the following area: genomics/
proteomics and analysis; animal models of heart disease; high 
throughput drug screening. Prospective collaborators need only be 
interested in pursuing a focused aspect of the potential applications.
    (3) The demonstration of adequate resources to perform the 
research, development and commercialization 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.
    (4) The willingness to cooperate with the NHLBI in the timely 
publication of research results and to accept the legal provisions and 
language of the CRADA with only minor modifications, if any.

    Dated: July 24, 2003.
Lili Portilla,
Director, Office of Technology Transfer and Development, National 
Heart, Lung, and Blood Institute.
    Dated: August 4, 2003.
Steven M. Ferguson,
Acting Director, Division of Technology Development and Transfer, 
Office of Technology Transfer, National Institutes of Health.
[FR Doc. 03-20561 Filed 8-12-03; 8:45 am]
BILLING CODE 4140-01-P