National Institutes of Health, Public Health Service, DHHS.
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 Start Printed Page 17720final 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.
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.Start Further Info
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@example.com.End Further Info End Preamble Start Supplemental 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.
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).Start Signature
Dated: March 23, 2001.
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