[Federal Register Volume 66, Number 30 (Tuesday, February 13, 2001)]
[Notices]
[Pages 10025-10026]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-3603]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Diabetes and Digestive and Kidney Diseases 
(NIDDK): Opportunity for Cooperative Research and Development 
Agreements (CRADAs) to Develop Monoclonal Antibodies and/or Other 
Reagents and Products for Use in Identifying the Dombrock Blood Group 
Carrier Molecule Aimed at Improving Blood Typing Practices Through 
Molecular Means

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

ACTION: Notice.

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SUMMARY: The National Institute of Diabetes and Digestive and Kidney 
Diseases (NIDDK) of the National Institutes of Health (NIH) is seeking 
Licensee(s) and/or proposals in the form of capability statements from 
potential collaborators for a Cooperative Research and Development 
Agreement (CRADA) to develop monoclonal antibodies and/or other 
reagents and products for use in identifying the Dombrock blood group 
carrier molecule. The U.S. government-owned technology is encompassed 
within U.S. Provisional Patent Application Serial No. 60/235,162, 
entitled ``Identification of The Dombrock Blood Group Glycoprotein as a 
Polymorphic Member of The ADP-Ribosyltransferase Gene Family''.
    Pursuant to the Federal Technology Transfer Act of 1986 (FTTA, 15 
U.S.C. 3710; and Executive Order 12591 of April 10, 1987, as amended by 
the National Technology Transfer and Advancement Act of 1995), the 
National Institute of Diabetes and Digestive and Kidney Diseases 
(NIDDK) 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 to develop monoclonal 
antibodies and/or other reagents for use in identifying the Dombrock 
blood group carrier molecule. The goals of the CRADA include the rapid 
publication of research results and timely commercialization of 
products or methods that may result from the research.
    The potential Collaborator(s) capability statement should provide 
proof of expertise in blood typing practices through molecular means 
along with a brief commercialization plan. The NIH also will consider 
proposals from Collaborators with demonstrated expertise in developing 
kits designed to identify blood group antibodies in recipients of 
transfused blood or blood products.

DATES: Only written CRADA capability statements received by the NIDDK 
on or before March 30, 2001 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 Collaborator's expense to provide additional 
information. The Institute may issue an additional notice of CRADA 
opportunity during the design phase.

FOR FURTHER INFORMATION CONTACT: Capability statements should be 
submitted to Dr. Michael W. Edwards, Office of Technology Development, 
National Institute of Diabetes and Digestive and Kidney Diseases, 
National Institutes of Health, BSA Building, Suite 350 MSC 2690, 9190 
Rockville Pike, Bethesda, MD 20814-3800; Tel: 301/496-7778, Fax: 301/
402-0535; Email: [email protected].

SUPPLEMENTARY INFORMATION: A CRADA is an agreement designed to enable 
certain collaborations between Government laboratories and non-
Government laboratories. It is not a grant, and is not a contract for 
the procurement of goods/services. The NIDDK is prohibited from 
transferring funds to a CRADA collaborator. Under a CRADA, NIDDK 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 
receives an exclusive option to negotiate an exclusive or non-exclusive 
license to Government intellectual property rights arising under the 
CRADA in a pre-determined field of use and may qualify as a co-inventor 
of new technology developed under the CRADA.
    Identification of the 25 known human blood group molecules is of 
fundamental importance for the fields of erythroid cell biology and 
transfusion medicine. The molecular description of the ``Dombrock'' 
blood group system has been determined. A candidate gene was identified 
by in silico analyses of approximately 5000 expressed sequence tags 
(ESTs) from terminally differentiating human erythroid cells. 
Transfection experiments demonstrated specific binding of anti-Dombrock 
and confirmed glycosylphosphatidylinositol membrane attachment.
    Currently, reagents may not be available to readily type all blood 
using serology. The information derived by this invention of the 
Dombrock blood group carrier gene can be used to type the human blood 
supply. The public health need is to improve the blood typing practices 
through molecular means and thereby prevent clinical problems 
associated with improperly cross-matched blood.

Capability Statements

    A Selection Committee will utilize the information provided in the 
``Collaborator Capability Statements'' received in response to this 
announcement to help in its deliberations. It is the intention of the 
NIDDK 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 selection criteria:
    (1) The statement should provide specific details of the method to 
be utilized in the development of the monoclonal antibody to the 
Dombrock molecule.
    (2) The statement should include a detailed plan demonstrating the 
ability to provide sufficient quantities of the agent in a timely 
manner for the duration of the study.
    (3) The statement may include outline outcome measures of interest 
to the Collaborator. The specifics of the proposed outcome measures and 
the proposed support should include but not be limited to the 
following: monoclonal development expertise, specific funding 
commitment to support the advancement of scientific research, personnel 
services, facilities, equipment, or other resources that would 
contribute to the conduct of the commercial development.
    (4) The statement must address willingness to promptly publish 
research results and ability to be bound

[[Page 10026]]

by PHS intellectual property policies (see CRADA: http://ott.od.nih.gov/newpages/crada.pdf).

Licensing Information

    This technology was previously advertised in the December 26, 2000 
issue of the Federal Register as a licensing opportunity [65 FR 81532]. 
Briefly, the gene and its polymorphisms that result in the Dombrock 
blood group antigenicity, for the first time, provide a route for 
reliable blood typing. Products aimed at improving blood typing 
practices through molecular means, thereby preventing mismatched blood 
transfusions, can also be developed with this technology. For the sake 
of completeness, the licensing contact is provided here: John Rambosek; 
301/496-7056, ext. 270; fax: 301/402-0220; e-mail: [email protected].

    Dated: February 5, 2001.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer.
[FR Doc. 01-3603 Filed 2-12-01; 8:45 am]
BILLING CODE 4140-01-M