[Federal Register Volume 64, Number 63 (Friday, April 2, 1999)]
[Notices]
[Pages 15979-15980]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-8097]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Cancer Institute; Grants and Cooperative Agreements 
Availability

AGENCY: National Cancer Institute, National Institutes of Health, PHS, 
DHHS.

ACTION: Notice for CRADA Opportunities.

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

SUMMARY: New HIV treatments and diagnostic methods: Opportunities for 
Cooperative Research and Development Agreements (CRADAs) for the joint 
evaluation and development of inhibitors for multidrug resistant HIV 
and of methods to measure the biological and biochemical fitness of HIV 
protease mutants, and to assay new protease inhibitors using these 
methods.
    Pursuant to the Federal Technology Transfer Act of 1986 (FTTA, 15 
U.S.C. Sec. 3710; and Executive Order 12591 of April 10, 1987, as 
amended by the National Technology Transfer and Advancement Act of 
1995), the National Cancer Institute (NCI) of the National Institutes 
of Health (NIH) of the Public Health Service (PHS) of the Department of 
Health and Human Services (DHHS) seeks Cooperative Research and 
Development Agreements (CRADAs) with pharmaceutical or biotechnology 
companies to evaluate and develop new treatments and diagnostic methods 
for the multidrug resistant HIV-infected population. Any CRADA for the 
biomedical use of this technology will be considered. The CRADA would 
have an expected duration of one (1) to five (5) years. The goals of 
the CRADA include the rapid publication of research results and timely 
commercialization of products, diagnostics and treatments that result 
from the research. The CRADA Collaborator will have an option to elect 
a non-exclusive or exclusive commercialization license to subject 
inventions arising under the CRADA and which are subject of the CRADA 
Research Plan.

ADDRESSES: Proposals and questions about this CRADA opportunity may be 
addressed to Dr. Bjarne Gabrielsen, Technology Development & 
Commercialization Branch, National Cancer Institute--Frederick Cancer 
Research & Development Center, Fairview Center, Room 502, Frederick, MD 
21701 (phone: 301-846-5465, fax: 301-846-6820).
    Scientific inquiries--Dr. John Erickson, Director, Structural 
Biochemistry Program, National Cancer Institute--Frederick Cancer 
Research & Development Center, P.O. Box B, Building 560, Room 12-68, 
Frederick MD, 21702-1201 (phone: 301-846-1979; FAX: 301-846-6066).

EFFECTIVE DATE: Inquiries regarding CRADA proposals and scientific 
matters may be forwarded at any time. Confidential CRADA proposals, 
preferably two pages or less, must be submitted to the NCI on or before 
May

[[Page 15980]]

3, 1999. Guidelines for preparing full CRADA proposals will be 
communicated shortly thereafter to all respondents who have been 
selected.

SUPPLEMENTARY INFORMATION:

Technology Available

    DHHS scientists in the Structural Biochemistry Program, NCI-
Frederick Cancer Research and Development Center (SBP) have developed 
certain structural and biochemically-based technologies that are 
believed to be of value in the diagnosis and treatment of drug 
resistant HIV. Using these technologies, SBP scientists have developed 
strategies for designing inhibitors to multidrug resistant HIV, and for 
predicting resistance-potentials of HIV protease inhibitors. Recent 
evidence indicates that multidrug resistant HIV strains are appearing 
in the drug-naive population at an increasing rate. Thus, the SBP 
research is believed to be at a stage that is ripe for the development 
of new treatments and diagnostic methods for the multidrug resistant 
HIV-infected population. SBP is interested in a multi-disciplinary but 
highly focussed approach to the biochemical and virologic evaluation of 
protease inhibitors against clinically-derived drug resistant mutant 
viruses, as well as in the structure-based design and chemical 
synthesis of new protease inhibitors for testing.
    The successful Collaborator should possess experience in the 
following areas at a minimum: Experience with pre-clinical and clinical 
drug development for antiretroviral compounds; ability to generate 
site-directed mutant viruses for measurement of phenotypic resistance 
with specific expertise in HIV; application of automation and robotics 
technologies to cell culture-based antiviral assays and to enzyme-based 
biochemical assays with specific expertise in HIV; application of 
automation and robotics technologies to cell culture-based assays 
designed to measure phenotypic resistance; application of database and 
bioinformatics technologies for the manipulation, storage and analysis 
of high throughput assay data, including the development of software as 
required; and, the use of high throughput assay methods to evaluate 
protease inhibitors against multidrug resistant HIV mutants.
    DHHS now seeks collaborative arrangements for the joint evaluation 
and development of methods to biochemical and virologic evaluate 
protease inhibitors against clinically-derived drug resistant mutant 
viruses, as well as in the structure-based design and chemical 
synthesis of new protease inhibitors for further analysis. For 
collaborations with the commercial sector, a Cooperative Research and 
Development Agreement (CRADA) will be established to provide equitable 
distribution of intellectual property rights developed under the CRADA. 
CRADA aims will include rapid publication of research results as well 
as full and timely exploitation of any commercial opportunities.
    The role of the National Cancer Institute in this CRADA will 
include, but not be limited to:
    1. Providing intellectual, scientific, and technical expertise and 
experience to the research project.
    2. Providing the Collaborator with HIV drug resistant gene 
sequences and protease inhibitors for evaluation.
    3. Planning research studies and interpreting research results.
    4. Publishing research results.
    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. Planning research studies and interpreting research results.
    3. Providing technical expertise and/or financial support (e.g. 
facilities, personnel and expertise) for CRADA-related Government 
activities.
    4. Accomplishing 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, development and commercialization of this technology.
    6. The demonstration of expertise in the commercial development, 
production, marketing and sales of products related to this area of 
technology.
    7. The willingness to cooperate with the National Cancer Institute 
in the timely publication of research results.
    8. The agreement to be bound by the appropriate DHHS regulations 
relating to human subjects, and all PHS policies relating to the use 
and care of laboratory animals.
    9. The willingness to accept the legal provisions and language of 
the CRADA with only minor modifications, if any. These provisions 
govern patent rights to CRADA inventions.

    Dated: March 25, 1999.
Kathleen Sybert,
Director, Technology Development & Commercialization Branch, National 
Cancer Institute, National Institutes of Health.
[FR Doc. 99-8097 Filed 4-1-99; 8:45 am]
BILLING CODE 4140-01-P