[Federal Register Volume 65, Number 74 (Monday, April 17, 2000)]
[Notices]
[Pages 20469-20471]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-9429]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Cancer Institute (NCI) and the NIH Center for 
Information Technology (CIT): Opportunity for a Cooperative Research 
and Development Agreement (CRADA) for the Development of Software 
Enhancement for Expanding the Medical Uses of the 
TELESYNERGY<SUP>TM</SUP> Medical Consultation Workstation

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 TELESYNERGY<SUP>TM</SUP> Medical Consultation 
WorkStation.
    Over the past six years, the Center for Information Technology at 
the National Institutes of Health has developed 
TELESYNERGY<SUP>TM</SUP>, 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. TELESYNERGY<SUP>TM</SUP> 
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 TELESYNERGY<SUP>TM</SUP> 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 TELESYNERGY<SUP>TM</SUP> 
platform include oncology, general medicine, family practice, and 
specialties such as OB/

[[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 TELESYNERGY<SUP>TM</SUP> program. The proposed term of the 
CRADA can be up to five (5) years.
    The TELESYNERGY<SUP>TM</SUP> 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 TELESYNERGY<SUP>TM</SUP> 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 <SUP>TM</SUP> also included a mechanism to allow remote 
consultations and education between geographically distributed medical 
specialists of all types Pairing the TELESYNERGY <SUP>TM</SUP> system 
with the NCI's Net-Trials <SUP>TM</SUP> 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 <SUP>TMTM</SUP> 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 <SUP>TM</SUP> Medical 
Consultation WorkStation. The CRADA, with the intellectual assistance 
of NCI and CIT, would provide systems development and integration of 
TELESYNERGY <SUP>TM</SUP> 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 <SUP>TM</SUP> 
Medical Consultation WorkStation.
    2. To provide programming support for the broad commercialization/
dissemination and enhancement into other medical disciplines of the 
TELESYNERGY <SUP>TM</SUP> system.
    3. To develop a distribution and service plan for the TELESYNERGY 
<SUP>TM</SUP> 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 <SUP>TM</SUP>.
    3. Publishing research results.
    4. Development additional potential clinical applications for the 
TELESYNERGY <SUP>TM</SUP> 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

[[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