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###### Department of Health and Human Services

###### National Institutes of Health

# AGENCY:

National Institutes of Health, PHS, DHHS.

# ACTION:

Notice. 

# SUMMARY:

                        The National Cancer Institute (NCI) and the Center for Information Technology (CIT) seek a Cooperative Research and Development Agreement (CRADA) Collaborator to provide programming and systems integration support to NCI for the further development and commercialization of the TELESYNERGYTM                         Medical Consultation WorkStation.                    

                        Over the past six years, the Center for Information Technology at the National Institutes of Health has developed TELESYNERGYTM, a multimedia medical imaging and personal interaction infrastructure within an electronic imaging environment, to facilitate professional collaboration and education concerning cancer research protocols and clinical cancer care. TELESYNERGYTM                         has been designed to provide for the simultaneous high-resolution display of images from numerous medical modalities, in both real-time and store-and-forward modes, as well as for the simultaneous interaction of medical experts and other research professionals. One example of implementation of TELESYNERGYTM                         is underway within the Radiation Oncology Branch (ROB) in the National Cancer Institute. ROB's initial applications are in the areas of research participation in radiotherapy planning and treatment, and the related subsequent clinical and research interactions and collaborations as a result.                    

                        Potential areas of application for the TELESYNERGYTM                         platform include oncology, general medicine, family practice, and specialties such as OB/                              ( print page 20470)                            GYN, cardiology, nuclear medicine, radiology, otolaryngology, ophthalmology, dermatology, urology, cytogenetics and pathology. Further development of this system will ultimately bring expanded participation in NCI clinical research and eventual improvement in clinical care to urban and rural health care systems both nationally and internationally.                    

# DATES:

Interested parties should notify the Technology Development and Commercialization Branch of the NCI in writing of their interest in filing a formal proposal no later than thirty (30) days from the date of this announcement. Potential CRADA Collaborators will then have an additional thirty (30) days to submit a formal proposal. CRADA proposals submitted thereafter may be considered if a suitable CRADA Collaborator has not been selected.

# ADDRESSES:

Inquiries and proposals regarding this opportunity should be addressed to Stephanie Amoroso, Ph.D., Technology Development Specialist (Tel. #301-496-0477, FAX #301-402-2117), Technology Development and Commercialization Branch, National Cancer Institute, 6120 Executive Blvd., Suite 450, Rockville, MD 20852.

# SUPPLEMENTARY INFORMATION:

                    A Cooperative Research and Development Agreement (CRADA) is the anticipated joint agreement to be entered into with NCI and the CIT pursuant to the Federal Technology Transfer Act of 1986 and Executive Order 12591 of April 10, 1987 as amended by the National Technology Transfer Advancement Act of 1995. The NCI and CIT are looking for a collaborator to further develop and integrate systems for the TELESYNERGYTM                     program. The proposed term of the CRADA can be up to five (5) years.                

                    The TELESYNERGYTM                     system functions by transporting audio and video data streams continuously through a 155 Mbits/sec ATM and/or ISDN line link connecting the NCI and national and international sites. Microphones and speakers allow bi-directional voice communication, and video capability is provided with S-Video cameras and monitors. As stated above, if ATM capability is not available or is too expensive at a remote site, a 1.5 Mbits/sec ISDN PRI telephone circuit can utilized for connectivity, with only very minimal degradation in audio and video quality.                

                    Two high-resolution monochrome image display systems each function as an Electronic View Box (EVB) for the display of 14 x 17 inch format digitized “electronic films.” Utilizing the EVBs, discussion, diagnosis, or organ and lesion contouring can be performed via a shared-cursor technique in consultation mode, which allows the oncologists to collaborate in identifying features. These identified regions-of-interest are transmitted simultaneously and in real-time as is audio during the TELESYNERGYTM                     consultation session.                

A remote-controlled microscope capability allows biopsy specimens to be discussed and manipulated by a number if sites concurrently. In addition, a patient exam camera allows high-resolution viewing of patient exams, including identification of dermatological lesions, skin coloration, and other physical characteristics during a patient examination.

                    TELESYNERGY TM                     also included a mechanism to allow remote consultations and education between geographically distributed medical specialists of all types Pairing the TELESYNERGY TM                     system with the NCI's Net-Trials TM                     Clinical Trials Information System will allow Phase I and Phase II research trials to be conducted “beyond the NIH campus.” Patient protocol data may then be directly entered into the NCI's Net-trials TMTM                     research database from the offsite location.                

                    NCI and the CIT are seeking a CRADA partner to collaborate with them in the further development, commercialization, education, installation and maintenance of the TELESYNERGY TM                     Medical Consultation WorkStation. The CRADA, with the intellectual assistance of NCI and CIT, would provide systems development and integration of TELESYNERGY TM                     for the applications mentioned above.                

## References

1. Kempner KM, Chow D, Choyke P, Cox JR Jr., Elson JE, Johnson CA, Okunieff P, Ostrow H, Pfeifer JC, and Martino RL: The development of an ATM-based Radiology Consultation WorkStation for radiotherapy treatment planning. Medical Imaging 1997 Conference Proceedings, Volume 3031, Paper 49, published by the Society of Photo-Optical Instrumentation Engineers, Inc., Bellingham, WA, 1997.

2. Govern FS, Coleman CN: Ethical Challenges in the Era of Healthcare Reform: A View from Academic Oncology. J. Oncol Management, Sept./Oct., 4:20-26, 1995.

3. Linggood R, Govern FS, Coleman CN, and et al: Report from the Field: A Blueprint for Linking Academic Oncology and the Community: The Harvard Joint Center for Radiation Therapy Outreach Program. J. Health Politics, Policy and Law, Vol. 23, No. 6, Dec. 1998.

Under the present proposal, the overall goal of the  CRADA collaboration will involve the following:

                    1. To expand and enhance upon the current technology and its usage as developed by CIT and the NCI regarding the TELESYNERGY TM                     Medical Consultation WorkStation.                

                    2. To provide programming support for the broad commercialization/dissemination and enhancement into other medical disciplines of the TELESYNERGY TM                     system.                

                    3. To develop a distribution and service plan for the TELESYNERGY TM                     system.                

## Party Contributions

The role of the NCI/CIT in the CRADA may include, but not be limited to:

1. Providing intellectual, scientific, and technical expertise and experience to the research project.

                    2. Providing the CRADA Collaborator with information and data relating to the current methods implemented for the applications of TELESYNERGY TM.                

3. Publishing research results.

                    4. Development additional potential clinical applications for the TELESYNERGY TM                     system.                

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 research project.

2. Providing programming support for writing novel software, and technical support for writing system manuals.

3. Providing technical and/or financial support to facilitate scientific goals and for further design of applications of the technology outlined in the agreement.

4. Publishing research results.

Selection criteria for choosing the CRADA Collaborator may include, but not limited to:

1. A demonstrated record of success in the development and dissemination of medical software.

2. A demonstrated background and expertise in ATM-ISDN based technology.

3. The ability to collaborate with NCI/CIT on further research and development of this technology. This ability will be demonstrated through experience and expertise in this or related areas of technology indicating the ability to contribute intellectually to ongoing research and development.

                    4. The demonstration of adequate resources to perform the research and development of this technology (                    *e.g.*                     facilities, personnel and expertise) and to accomplish objectives according to an appropriate timetable to be outlined in the CRADA Collaborator's proposal.                

                    5. The willingness to commit best effort and demonstrated resources to the research and development of this                           ( print page 20471)                        technology, as outlined in the CRADA Collaborator's proposal.                

6. The demonstration of expertise in the commercial development and production of products related to this area of technology.

7. The level of financial support the CRADA Collaborator will provide for CRADA-related Government activities.

8. The willingness to cooperate with the National Cancer Institute in the timely publication of research results.

9. The agreement to be bound by the appropriate DHHS regulations relating to human subjects and to all PHS policies relating to the use and care of laboratory animals.

10. The willingness to accept the legal provisions and language of the CRADA with appropriate modifications pertaining to the software-based technology sought to be developed. These provisions govern the distribution of future 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: April 6, 2000.

Kathleen Sybert,

Chief, Technology Development and Commercialization Branch, National Cancer Institute, National Institutes of Health.

[FR Doc. 00-9429  Filed 4-14-00; 8:45 am]

BILLING CODE 4140-01-M