[Federal Register Volume 66, Number 85 (Wednesday, May 2, 2001)]
[Notices]
[Pages 21990-21991]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-10934]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES (DHHS)

National Institutes of Health (NIH)


National Institutes of Health Clinical Center (NIHCC) Opportunity 
for Cooperative Research and Development Agreement (CRADA)

SUMMARY: The National Institutes of Health Clinical Center (NIHCC) is 
seeking to enter at least one Cooperative Research and Development 
Agreement (CRADA). The goal is to develop and implement application 
specific computer-learned medical-outcome indexes as partially 
described in the April 2001 issue of the periodical entitled ``Advance 
for Administrators of the Laboratory.'' The development of this 
technology is part of the ongoing activities of the NIHCC. The term of 
any CRADA will be up to five (5) years.

DATES: Interested parties should notify this office in writing of their 
intent to file a formal proposal no later June 1, 2001. Formal 
proposals should be submitted to this office no later than July 2, 
2001. Proposals received after this date will still be considered, but 
only after all proposals received before this date have been 
considered.

ADDRESSES: Questions concerning this announcement, and all research 
proposals, should be submitted to Bruce D. Goldstein, Esq., Technology 
Transfer Branch, National Cancer Institute, National Institutes of 
Health, Suite 450, 6120 Executive Blvd., Rockville, MD 20852, Phone: 
301-496-0477, Fax: 301-402-2117. Scientific questions should be 
addressed to James M. DeLeo, 6100 Executive Blvd., Suite 5C01, 
Rockville, MD 20852; Phone (direct): 301-496-3848; Fax: 301-496-3848; 
e-mail: [email protected]. Inquiries directed to obtaining patent 
license(s) related to participation in the CRADA opportunity should be 
addressed to Dale Berkley, PhD., J.D., Senior Technology Licensing 
Specialist, Office of Technology Transfer, National Institutes of 
Health, 6011 Executive Blvd., Suite 325, Rockville, MD 20852-3804, 
Phone: 301-496-7735, Fax: 301-402-0220, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: A CRADA is the anticipated joint agreement 
to be entered into by NIHCC and a collaborator pursuant to the Federal 
Technology Transfer Act of 1986 (15 U.S.C. 3710 a), as amended. 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 
NIHCC IS PROHIBITED FROM TRANSFERRING FUNDS TO A CRADA COLLABORATOR. 
Under a CRADA, the NIHCC can offer the selected collaborator access to 
facilities, staff, materials, and expertise. The collaborator may 
contribute facilities, staff, materials, expertise, and funding to the 
collaboration. A CRADA collaborator may elect an option to an exclusive 
or non-exclusive license to Government intellectual patent rights 
arising under the CRADA, and may qualify as an inventor or co-inventor 
of new technology developed under the CRADA. As between two or more 
sufficient, overlapping research proposals (where the overlap cannot be 
cured), the NIHCC, as specified in 15 U.S.C. 3710a(c)(4), will give 
special consideration to small businesses, and will give preference to 
business units located in the U.S. that agree to manufacture CRADA 
products in the U.S.
    As used here, the expression ``computer-learned medical outcome 
indexes'' refers to probability or degree of membership values 
indicating (``indexing'') particular medical outcomes such as 
diagnostic categories, preferred treatments, times to events, and other 
medical classifications and outcomes. These indexes and their 
confidence intervals are computed using laboratory and other patient 
data with neural networks and other machine-learning computer programs 
which, once trained, may run as background tasks in laboratory 
instrument computers, hospital information systems, and various 
personnel computers including desk, lap, and palm top computers. These 
programs could also be inscribed in hardware. It is expected that 
medical index computer programs will provide valuable patient 
information at virtually no extra cost, and that they will be in 
everyday use in future clinical settings to aid health care providers 
in making important cost-effective patient management decisions.
    The described methods are the subject of an Employee Invention 
Report filed with the NIH Office of Technology Transfer. Also the 
initial report and characterization of the invention is partially 
described in an article entitled ``Computer-Learned Medical Outcome 
Indexes, by Jim DeLeo,'' in the April 2001 issue of Advance for 
Administrators of the Laboratory. Commercialization of new CRADA 
technology may require obtaining an appropriate PHS license to practice 
this described prior art.
    The collaborator in this endeavor is expected to commit technical 
personnel

[[Page 21991]]

commensurate with the level of research activities defined by the CRADA 
Research Plan. It is anticipated that PHS facilities and/or those of 
the collaborator will be utilized, as appropriate, for the research 
activities as defined by the Research Plan. NIHCC anticipates, in 
addition, that the Collaborator, as appropriate, will provide funding 
for the project.

Party Contributions

    The NIHCC anticipates that its role may include, but not be limited 
to, the following:
    (1) Plan research studies, interpret research results, and, as 
appropriate, jointly publish the conclusions with the collaborator;
    (2) Provide collaborator with access to existing NIHCC research 
data, both already collected and yet to be collected (except for 
medical or other personal data regarding identifiable patients);
    (3) Provide staff, expertise, and materials for the development and 
testing of promising application products;
    (4) Provide work space and equipment for testing of any prototype 
products developed.
    The NIHCC anticipates that the role of the successful collaborator 
will include at least the following:
    (1) Provide significant intellectual, scientific, and technical 
expertise in the development of relevant products;
    (2) Plan research studies, interpret research results, and, as 
appropriate, jointly publish the conclusions; and
    (3) Provide NIHCC a supply of necessary materials, access to 
necessary proprietary technology and/or data, and as necessary for the 
project, staff and funding in support of the research goals.
    Other contributions may be necessary for particular proposals.

Selection Criteria

    Proposals submitted for consideration should address, as best as 
possible and to the extent relevant to the proposal, each of the 
following:
    (1) Expertise:
    A. Expertise in the research and development of diagnostic, 
prognostic, and/or therapeutic products pertinent to the technology; 
and
    B. Ability to secure national marketing and distribution of its 
products (international distribution a plus).
    (2) Reliability as a research partner, specifically:
    A. Willingness to commit best effort and to provide adequate and 
sustained resources and/or funding, as appropriate, to support the 
CRADA studies;
    B. Development of this technology, as outlined in the CRADA 
Collaborator's proposal;
    C. Ability to develop and produce products in a timely manner, as 
applicable (for example, as demonstrated by a history of meeting 
benchmarks in licenses);
    D. Commitment to supporting the advancement of scientific research, 
as evidenced by a willingness to jointly publish research results in a 
prompt manner; and
    E. Willingness to be bound by DHHS and PHS policies regarding:
    (i) the public distribution of research tools,
    (ii) the care and handling of animals, and
    (iii) protection of humans who are subjects of research.
    (3) Physical Resources:
    A. An established headquarters, with office space and basic office 
equipment;
    B. Access to the organization during business hours by telephone, 
facsimile, courier, U.S. Post, e-mail, the World-Wide-Web, and, as 
appropriate, other evolving information technologies; and
    C. Sufficient financial and material resources to support, at a 
minimum, the anticipated activities of the CRADA to meet the needs of 
NIHCC under the proposal.
    The collaborator is encouraged to propose, in the written research 
statement, related applications and technologies other than those 
specifically described herein.

    Dated: April 23, 2001.
Kathleen Sybert,
Chief, TTB/NCI/NIH.
[FR Doc. 01-10934 Filed 5-1-01; 8:45 am]
BILLING CODE 4140-01-P