[Federal Register Volume 65, Number 56 (Wednesday, March 22, 2000)]
[Notices]
[Pages 15345-15347]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-7050]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Cancer Institute; Targeted Screening for Inhibitors of 
Human Herpesvirus 8 DNA Polymerase Activity

    Opportunities for Cooperative Research and Development Agreements 
(CRADAs) are available for collaborations with the Screening 
Technologies Branch (STB), Developmental Therapeutics Program (DTP), 
National Cancer Institute (NCI) to discover and develop inhibitors of 
human herpesvirus 8 (HHV8) DNA polymerase. Collaborative projects will 
focus upon the inhibition of HHV8 as it relates to the disease 
processes of cancers which occur in patients with AIDS. This has been 
identified as an area of high national and international priority.

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

ACTION: Notice of opportunities for Cooperative Research and 
Development Agreements (CRADAs).

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SUMMARY: Pursuant to the Federal Technology Transfer Act of 1986 (FTTA, 
15 U.S.C. 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 one or more Cooperative Research and 
Development Agreements (CRADAs) with pharmaceutical or chemical 
companies to discover and develop new potential antiviral (HHV8) drug 
leads. 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, methods of treatment 
or prevention that may result from the research. The CRADA Collaborator 
will have an option to negotiate the terms of an exclusive or non-
exclusive commercialization license to subject inventions arising under 
the CRADA

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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 inquires should be submitted to Dr. Robert Shoemaker, 
Chief, Screening Technologies Branch, National Cancer Institute-
Frederick Cancer Research & Development Center, Bldg. 431A, P.O. Box B, 
Frederick MD, 21702-1201 [phone: (301)-846-5432; Fax: (301)-846-6844; 
e-mail [email protected] .

EFFECTIVE DATE: Inquiries regarding CRADA proposals and scientific 
matters may be forwarded at any time. Confidential, preliminary CRADA 
proposals, preferably two pages or less, must be submitted to the NCI 
within 30 days from date of this publication. Guidelines for preparing 
final CRADA proposals will be communicated shortly thereafter to all 
respondents with whom initial confidential discussions will have 
established sufficient mutual interest.

SUPPLEMENTARY INFORMATION:

Technology Available

    The Screening Technologies Branch (STB) of the Developmental 
Therapeutics Program is an NCI extramural research activity dedicated 
to the discovery of new potential lead molecules for antitumor, 
antiviral, or antimicrobial drug development. General background and 
contact information for the DTP are available on the Internet at http://www.dtp.nci.nih.gov. The STB comprises an interdisciplinary research 
team, and appropriate resources, expertise and experience, to carry out 
all essential aspects of lead-discovery, including high-throughput 
screening (HTS), cell-based bioassays, chemical isolation, purification 
and structural determinations.
    STB's principal lead-discovery strategy employs high-throughput 
screening (HTS) to identify bioactive molecules. The sought-for 
bioactivity is defined by the specific type(s) of assay and/or 
target(s) employed in the primary screen(s) used for bioassay support 
of the process. In the current solicitation, CRADA partners are sought 
for discovery efforts targeted to the DNA polymerase and processivity 
factor of human herpesvirus 8. This target was cloned and characterized 
in the laboratory of Dr. Robert Ricciardi and is proprietary to the 
University of Pennsylvania. STB is implementing HTS against this target 
in collaboration with Dr. Ricciardi. Therefore, it is anticipated that 
the University of Pennsylvania will either be a third party to this 
CRADA collaboration or the potential CRADA collaborator would obtain 
rights to the target under a separate agreement with the University of 
Pennsylvania.

Technology Sought

    STB now seeks potential collaborators with novel or distinctive 
pure compound collections suitable for high-throughput screening and 
medicinal and synthetic chemical expertise and resources for follow-up 
and optimization of antiviral drug leads. Primary consideration will be 
given to collaborators with large well-characterized chemical libraries 
available as individual compounds in multiwell plates. Availability of 
bulk compound for ``hit'' confirmation and characterization and ability 
to rapidly perform synthetic work to optimize lead compounds will also 
be major factors in consideration of potential CRADA partners.

Collaborators Sought

    Accordingly, DHHS now seeks collaborative arrangements for the 
joint STB and collaborator discovery research and development of novel, 
clinically useful, antiviral (HHV8) drugs of high public health 
priority. For collaborations with the commercial sector, a Cooperative 
Research and Development Agreement (CRADA) will be established to 
provide for 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.
    As a minimum, the successful Collaborator should either possess 
broad experience in most, if not all, of the following areas; or 
possess highly specialized, unique expertise in one or more of the 
following areas, as particularly pertinent to drug lead-discovery and 
development: (a) creation of chemical libraries for use in high-
throughput drug screening; (b) ability to carry out or direct chemical 
synthetic studies supporting lead-optimization, drug candidate 
selection and development.
    NCI will provide no funding to the Collaborator in as much as 
financial contributions by the U.S. Government to non-Federal parties 
under a CRADA are not authorized under the Federal Technology Transfer 
Act [15 U.S.C. 3710(a)(d)(1)].

NCI and Collaborator Responsibilities

    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 screening and test data 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. Providing chemical libraries for use in high-throughput 
screening and synthetic compounds necessary for follow-up and 
optimization of leads identified by screening.
    3. Planning research studies and interpreting research results.
    4. Publishing research results.
    Selection criteria for choosing the CRADA Collaborator may include, 
but not be limited to:
    1. The ability to collaborate with NCI on research and development 
of this technology involving lead discovery/optimization and biological 
evaluation. This ability can be demonstrated through experience, 
expertise, and the ability to contribute intellectually in this or 
related areas of drug discovery research and development.
    2. The demonstration of adequate resources to perform the research, 
development and commercialization of this lead discovery/optimization 
and biological evaluation technology (e.g. facilities, personnel and 
expertise) and accomplish objectives according to an appropriate 
timetable to be outlined in the CRADA Collaborator's proposal.
    3. The willingness to commit best effort and demonstrated resources 
to the research, development and commercialization of this technology 
as defined above.
    4. The willingness to cooperate with the National Cancer Institute 
in the timely publication of research results.
    5. 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.
    6. The willingness to accept the legal provisions and language of 
the CRADA with only minor modifications, if any. These provisions 
govern the equitable distribution of patent rights to CRADA inventions. 
Generally, the rights of

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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 non-exclusive license to the CRADA Collaborator when 
the Government employee is the sole inventor.

    Dated: March 7, 2000.
Kathleen Sybert,
Chief, Technology Development & Commercialization Branch, National 
Cancer Institute, National Institutes of Health.
[FR Doc. 00-7050 Filed 3-21-00; 8:45 am]
BILLING CODE 4140-01-P