[Federal Register Volume 66, Number 110 (Thursday, June 7, 2001)]
[Notices]
[Pages 30740-30741]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-14365]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Child Health & Human Development (NICHD): 
Opportunity for Cooperative Research and Development Agreement (CRADA)

SUMMARY: The National Institute of Child Health & Human Development is 
seeking at least one Collaborator to participate in a CRADA to develop 
computer software that will assist in the diagnostic and clinical 
management of amenorrhea.

DATES: On or before August 6, 2001, interested parties should send 
informal written notice to the Technology Transfer Branch of the 
National Cancer Institute (NCI TTB), acting on behalf of NICHD, of the 
intent to file a formal proposal. Formal proposals must be submitted to 
the NCI TTB on or before September 5, 2001. Proposals submitted after 
September 5, 2001 will be considered, but only after any and all 
proposals submitted within the ninety-day period.

ADDRESSES: Inquiries and proposals regarding this opportunity should be 
addressed to: Bruce D. Goldstein, NCI Technology Transfer Branch, 
Executive Plaza South, 6120 Executive Blvd., Suite 450, Rockville, 
Maryland, 20852 (Phone 301-496-0477, Fax # 301-402-2117). Scientific 
questions should be addressed to: Dr. Lawrence Nelson, Head, NICHD 
Gynecologic Endocrinology Unit, Developmental Endocrinology Branch, 
Building 10, Room 10N262, Bethesda, MD 20892-1862 (Phone (direct) 301-
402-6608; Phone (office) 301-496-4686; Fax 301-402-0574; email 
[email protected]).

SUPPLEMENTARY INFORMATION: A CRADA is the anticipated joint agreement 
to be entered into by NICHD and a collaborator pursuant to the Federal 
Technology Transfer Act of 1986 (15 U.S.C. 3710a), 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 
NICHD is prohibited from transferring funds to a CRADA collaborator.
    Under a CRADA, the NICHD 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 property rights 
arising under the CRADA, and may qualify as an inventor or co-inventor 
of new technology developed under the CRADA. Any party is eligible to 
participate; however, as between two or more sufficient, overlapping 
research proposals (where the overlap cannot be cured), the NICHD, 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 that products either embodying inventions made 
under the CRADA or produced through the use of such inventions will be 
manufactured substantially in the United States. In all other respects, 
the decision whether to begin negotiating a particular CRADA will turn 
on how well the proposal addresses the selection criteria below and how 
closely the proposed research matches the research interests of the 
NICHD.
    The NICHD's general objectives for all CRADAs are the rapid 
publication of research findings, and the timely commercialization of 
prognostic, diagnostic, or therapeutic products. Specific CRADA 
research goals will be tailored to the particular needs of the NICHD 
laboratory, the expertise of the collaborator and NICHD, and any 
proprietary technology the collaborator and/or NICHD brings to the 
project. Under the present opportunity, the goals of the CRADA are 
anticipated to include, but not be limited to, the development of the 
following technology:
     Development of one or more software packages for analyzing 
patient data in cases of amenorrhea;
     Examination of possible automated processes for conducting 
differential diagnoses of conditions causing amenorrhea; and
     Development of improved tools for diagnosing conditions 
causing amenorrhea, to be used by clinicians in a clinical setting.
    The software to be developed will be able to collect standardized 
data from patients with amenorrhea at the point of care. This system 
will be used to collect research data that will accurately characterize 
the clinical presentation of a broad range of disorders that may 
present with a chief complaint of amenorrhea. As this data is collected 
and analyzed the findings will be used to update the software. This 
iterative process will build an effective instrument that eventually 
can be used by caregivers at the point of patient contact to assist in 
the diagnosis and management of amenorrhea. After the system has been 
fully validated in a research setting this ``working model'' may be 
modified so as to collect basic screening data from women with 
amenorrhea in preparation for a visit to their health care provider. 
Thus, the development of a successful system will depend heavily on 
insight and experience on how to best meet the needs of the health care 
consumer as well as the health care provider.
    A strategy should be developed to collect the patient data, link it 
to the pertinent published medical literature across disciplines, and 
provide a process for guided investigation and clinical decision 
making. Strategies should also be developed to employ the system for 
patient education, disease prevention, and health promotion.
    The term of the CRADA(s) will be up to five (5) years, depending on 
the proposal(s). Applicants are encouraged to recommend in the written 
proposal alternative, additional applications and technologies to be 
developed.

Anticipated Party Contributions

    The role of NICHD may include the following:
    (1) Plan research studies, interpret research results, and jointly 
publish the conclusions with the collaborator;
    (2) Provide collaborator with access to existing NICHD research 
data (both already collected and yet to be collected);
    (3) Provide staff, expertise, & materials for the development and 
testing of promising products; and
    (4) Provide work space and equipment for testing of any prototype 
systems developed.
    The role of the successful collaborator will include the following:
    (1) Provide significant intellectual, scientific, and technical 
expertise in the development and manufacture of relevant products;
    (2) Plan research studies, interpret research results, and jointly 
publish the conclusions with NICHD;

[[Page 30741]]

    (3) As necessary for the project, provide to NICHD any specialized 
or unusual equipment, access to necessary proprietary technology and/or 
data; and
    (4) As necessary for the project, provide 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 qualifications:
    (1) Expertise:
    A. Expertise in the research and development of high quality 
software utilizing artificial intelligence;
    B. Experience in determining and meeting the needs of health care 
consumers; and
    C. Demonstrated ability in the production and verification of 
software products.
    (2) Reliability as a research partner:
    A. Develops and produces products in a timely manner (for example, 
as demonstrated by a history of meeting benchmarks in licenses);
    B. Indications of high levels of satisfaction by industry with the 
collaborator's products; and
    C. Commitment to supporting the advancement of scientific research, 
as evidenced by a willingness to publish research results in a prompt 
manner; and
    D. Willingness to be bound, to the extent applicable, by DHHS and 
PHS policies regarding:
    (i) The rapid, public distribution of pure research tools,
    (ii) The care and handling of animals, and
    (iii) Human subjects 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 any 
evolving communication technologies; and
    C. Sufficient financial and material resources to support, at a 
minimum, the anticipated activities of the CRADA.

    Dated: May 31, 2001.
Kathleen Sybert,
Chief, TTB/NCI/NIH.
[FR Doc. 01-14365 Filed 6-6-01; 8:45 am]
BILLING CODE 4140-01-P