[Federal Register Volume 66, Number 85 (Wednesday, May 2, 2001)]
[Notices]
[Pages 21989-21990]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-10933]


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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 an application 
specific artificial neural network based intelligent computing system 
for on-line and off-line quality control of a process, particularly a 
medical process, and especially test result production in clinical 
laboratory automated analyzers. 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 than 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. Sec. 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.
    The CRADA will employ a generalized computational system and method 
developed earlier at the National Institutes of Health. This technology 
was developed for the purpose of detecting errors in processes 
including, but not limited to, data collection in laboratory automated 
analyzers. The technology is capable of early on-line detection of 
various types of errors such as bias, precision, and random errors. It 
may also be developed as an off-line computational component. 
Theoretical studies have demonstrated significant advantages of this 
technology over current state-of-the art quality control practice in 
laboratory instrument quality control monitoring. The primary goal of 
the CRADA is to use the developed system and method to build practical 
and useful software and/or hardware components for application in real-
world production or assembly process environments such as commercially 
available laboratory automated analyzers and other appropriate medical 
or non-medical applications.
    The described methods and system are the subject of a U.S. patent 
application filed November 26, 1998 by the Public Health Service on 
behalf of the Federal Government. Commercialization of new CRADA 
technology may require obtaining an appropriate PHS license.
    The collaborator in this endeavor is expected to commit technical 
personnel 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,

[[Page 21990]]

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. 01-10933 Filed 5-1-01; 8:45 am]
BILLING CODE 4140-01-P