[Federal Register Volume 66, Number 64 (Tuesday, April 3, 2001)]
[Notices]
[Pages 17719-17720]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-8085]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Diabetes and Digestive and Kidney Diseases 
(NIDDK): Opportunity for Cooperative Research and Development 
Agreements (CRADAs) To Identify Novel Candidate Genes for Obesity and 
Insulin Resistance Using Global Gene Expression Profiling

AGENCY: National Institutes of Health, Public Health Service, DHHS.

ACTION: Notice.

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

SUMMARY: The National Institute of Diabetes and Digestive and Kidney 
Diseases (NIDDK) of the National Institutes of Health (NIH) announces 
the opportunity for Cooperative Research and Development Agreements 
(CRADAs) to identify novel candidate genes for obesity and insulin 
resistance using global gene expression profiling. The NIH seeks 
potential Collaborator(s) wishing to provide expertise in (1) 
identification of genes that may contribute to the development of 
obesity; (2) identification of genes that may contribute to the 
development of insulin resistance; (3) characterization of potentially 
novel sub-pathways of insulin signaling mechanisms; and (4) 
identification of genes regulated by free-fatty acid.
    The NIDDK seeks capability statements from parties interested in 
entering into a potential CRADA to identify novel candidate genes for 
obesity and insulin resistance using global gene expression profiling. 
Collaborator applicants developing capability statements may also 
include proposals to provide funding for possible commercial uses of 
interest to the Collaborator. The availability of private sector 
support may increase the feasibility of particular aspects of the

[[Page 17720]]

final design, but the primary criterion for selecting potential 
Collaborator(s) is the scientific merit of proposals for developing a 
plan to identify novel candidate genes for obesity and insulin 
resistance using global gene expression profiling.
    The control of clinical trials shall reside entirely with the 
Institute and the scientific participants of the trial. In the event 
that any adverse effects are encountered which, for legal or ethical 
reasons, may require communication with the FDA, the relevant 
collaborating institutions will be notified. Neither the conduct of the 
trial nor the results should be represented as an NIDDK endorsement of 
the drug under study.

DATES: Only written CRADA capability statements received by the NIDDK 
on or before May 1, 2001 will be considered during the initial design 
phase, confidential information must be clearly labeled. Potential 
Collaborators may be invited to meet with the Selection Committee at 
the Collaborator's expense to provide additional information. The 
Institute may issue an additional notice of CRADA opportunity during 
the design phase if circumstances change or if the design alters 
substantially.

FOR FURTHER INFORMATION CONTACT: Capability statements should be 
submitted to Dr. Michael W. Edwards, Office of Technology Development, 
National Institute of Diabetes and Digestive and Kidney Diseases, 
National Institutes of Health, BSA Building, Suite 350 MSC 2690, 9190 
Rockville Pike, Bethesda, MD 20814-3800; Tel: 301/496-7778, Fax: 301/
402-0535; Email: [email protected].

SUPPLEMENTARY INFORMATION: Substantial evidence indicates that 
susceptibility to type 2 diabetes is largely genetically determined, 
especially in certain ethnic groups in which the prevalence of diabetes 
may be 10 times that of the general U.S. population. NIDDK has 
performed genomic linkage scans in subject populations and are planning 
to positionally clone diabetes susceptibility genes. In general, 
diabetes is not inherited as a simple Mendelian trait. Multiple genes 
with small to moderate effects are likely to contribute to the 
development of the diabetes. In most populations, obesity and insulin 
resistance precede and predict the development of type 2 diabetes. 
These traits are themselves highly heritable, suggesting that they have 
a substantial genetic basis. Genes influencing these metabolic 
precursors of type 2 diabetes may be fewer in number and, therefore, 
easier to identify than those contributing to the overall syndrome. An 
extensive study in the subject population has indicated several 
chromosomal regions that provide evidence for linkage not only to 
diabetes but also to pre-diabetic phenotypes. We plan to perform gene 
expression profiling experiments to identify susceptibility genes for 
obesity and insulin resistance that may serve as possible targets of 
intervention.

Capability Statements

    A Selection Committee will utilize the information provided in the 
``Collaborator Capability Statements'' received in response to this 
announcement to help in its deliberations. It is the intention of the 
NIDDK that all qualified Collaborators have the opportunity to provide 
information to the Selection Committee through their capability 
statements. The Capability Statement should not exceed 10 pages and 
should address the following selection criteria:
    (1) The statement should provide specific details of the method to 
be utilized in the development of novel candidate genes for obesity and 
insulin resistance using global gene expression profiling.
    (2) The statement should include a detailed plan demonstrating the 
ability to provide sufficient capacity using global gene expression 
profiling.
    (3) The statement may include outline outcome measures of interest 
to the Collaborator. The specifics of the proposed outcome measures and 
the proposed support should include but not be limited to the 
following: global gene expression profiling expertise, specific funding 
commitment to support the advancement of scientific research, 
personnel, services, facilities, equipment, or other resources that 
would contribute to the conduct of the commercial development.
    (4) The statement must address willingness to promptly publish 
research results and ability to be bound by PHS intellectual property 
policies (see CRADA: http://ott.od.nih.gov/NewPages/crada.pdf).

    Dated: March 23, 2001.
Jack Spiegel,
Director, Division of Technology Development and Transfer Office of 
Technology Transfer.
[FR Doc. 01-8085 Filed 4-2-01; 8:45 am]
BILLING CODE 4140-01-M