[Federal Register Volume 65, Number 136 (Friday, July 14, 2000)]
[Notices]
[Page 43774]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-17828]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institutes of Health Clinical Center, Diagnostic 
Radiology Department, Division of Special Procedures (NIHCC): 
Opportunity for Cooperative Research and Development Agreement (CRADA) 
in the Field of Percutaneous Soft Tissue Ablation

AGENCY: NIHCC, NIH, PHS, DHHS.

ACTION: Notice of a Cooperative Research and Development Agreement 
(CRADA) opportunity.

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SUMMARY: The Special Procedures division of the Diagnostic Radiology 
Department of the National Institutes of Health Clinical Center (NIHCC) 
are developing a research initiative in the area of percutaneous 
thermal ablation technologies, including radio-frequency, microwave, 
ultrasound, laser, and cryotherapy. Consequently, the NIHCC is seeking 
one or more partners for (a) Cooperative Research and Development 
Agreement(s) (CRADA) to further develop applications and to study 
clinical applications and the engineering basis of minimally-invasive 
percutaneous methods of soft tissue ablation.
    Currently, the NIHCC is conducting studies to develop new clinical 
applications for thermal ablation, including kidney tumors, adrenal 
tumors, and painful soft tissue tumors for palliation. The NIHCC also 
plans to implement studies to combine radiofrequency ablation with 
other treatment modalities and therapies, as well as to develop 
guidance and treatment planning systems for thermal ablations. Please 
see www.cc.nih.gov/drd/rfa for more information regarding the NIHCC 
ablation program.
    Consequently, the NIHCC would like to further its research by 
establishing a collaborative, bench-to-bedside, basis-science 
initiative for investigating the potential applications of thermal 
ablation techniques, while refining existing ablative technologies. The 
collaborative effort will involve clinical refinements in ablation 
technology, development of novel imaging-guided techniques, and 
attempts to solve basis recurrent problems relating to local 
oncological ablative therapies. The collaboration, in part, will 
investigate the potential of combining new technology with existing 
surgical, medical, immunological, genetic, and radiation therapies.
    The anticipated term of the CRADA is four(4) years.
    Successful respondent(s) will be selected based upon their ability 
to collaborate with the NIHCC in the development of soft tissue 
ablation technologies.

Dates: Interested parties should submit a one-paragraph statement of 
interest addressing the collaborator's ability to perform the 
collaboration responsibilities. The statement of interest should be 
submitted to the NIHCC in writing no later than August 14, 2000.

ADDRESSES: Inquiries and statements of interest regarding this 
opportunity should be addressed to Steve Galen, Technology Development 
Coordinator, National Institutes of Health Clinical Center. Phone: 
(301) 594-4509, FAX (301) 402-2143, 6011 Executive Boulevard, Suite 
511, Rockville, MD 20852.

SUPPLEMENTARY INFORMATION: A CRADA is the anticipated joint agreement 
to be entered into by the NIHCC pursuant to the Federal Technology 
Transfer Act of 1986 as amended by the National Technology Transfer and 
Advancement Act of 1995 (Pub. L. 104-113 (Mar. 7, 1996)) and by 
Executive Order 12591 of April 10, 1987.
    Under a CRADA, the NIHCC can offer selected collaborators access to 
facilities, staff, materials, and expertise. The collaborator may 
contribute facilities, staff, materials, expertise and funding to the 
collaboration. THE NIHCC CANNOT CONTRIBUTE FUNDING. The CRADA 
collaborator may elect an option to an exclusive or non-exclusive 
license to Government intellectual property rights arising under the 
CRADA and may qualify as a co-inventor of new technology developed 
under the CRADA.
    The objective of the CRADA is the rapid publication of research 
findings and the timely commercialization of improved diagnostic and 
treatment strategies in the field of soft tissue ablation.
    CRADA proposals will be evaluated under the following criteria:
     Corporate research and development competencies;
     Demonstrated abilities to collaborate productively in 
research programs;
     Expertise in performing clinical trials and regulatory 
affairs;
     The nature of resources to be contributed to the 
collaboration;
     Key staff expertise, qualifications, and relevant 
experience;
     Willingness to assign technical staff to participate in 
on-site collaborative efforts; and
     Ability to commercialize new discoveries effectively.
    It is anticipated that the role of the NIHCC under the CRADA will 
include the following:
     Provide expertise in thermal ablation;
     Provide expertise in ablation engineering;
     Provide input on probe, generator, and treatment algorithm 
design;
     Evaluate technological considerations for patient safety;
     Provide an ongoing evaluation of the technologic advances 
and designs of the probes;
     Develop study designs to scientifically evaluate thermal 
ablation concepts; and
     Provide an existing protocol or create a new protocol for 
the phase 1 clinical study of the resulting device, if appropriate for 
clinical use.
    It is anticipate that the role of the CRADA Collaborator will 
include the following:
     Provide expertise in thermal ablation;
     Provide advice and support in ablation engineering;
     Assist in the production of a probe prototype for clinical 
testing; and
     Provide equipment necessary to study the probe.

    Dated: June 6, 2000.
Kathleen Sybert,
Chief, Technology Development and Commercialization Branch, NCI.
[FR Doc. 00-17828 Filed 7-13-00; 8:45 am]
BILLING CODE 4140-18-M