Notice Number: NOT-DK-05-008

Key Dates
Release Date: March 2, 2005

The purpose of this Notice is to announce the availability of Request for Proposal NIH-NIDDK-05-04 Preclinical Study of Efficacy in Animal Models of Diabetic Complications. NIDDK is seeking an organization or an institution to perform preclinical studies of potential new therapeutics for the prevention or treatment of diabetic complications. A clinical evaluation is not required at this time. The contractor will work closely with NIDDK project staff and external scientific consultants in designing protocols appropriate for the individual requirements of these compounds. The contractor shall prepare draft protocols with the final design to be approved by the Project Officer. The contractor shall conduct studies of potential therapeutics for the treatment and prevention of diabetic complications as approved by the Project Officer. The contractor shall prepare final study reports in consultation with the Project Officer for submission as Investigational New Drug Applications (IND) to the Food and Drug Administration (FDA) for support of efficacy and/or mechanism of action of the potential new therapeutics.

A contract has not previously been awarded for this work.

The Type 1 Diabetes – Rapid Access to Intervention Development (T1D-RAID) program is designed to assist translation from the research bench to the clinic of novel therapeutic interventions for Type 1 diabetes and its complications. These potential interventions can be either synthetic, natural product or biologic.

T1D-RAID is not a grant mechanism. Approved request to T1D-RAID gain access to the drug development contract resources of the National Cancer Institute’s Development Therapeutics Program (NCI DTP). The output of the use of these resources is provided to the originating investigator and may include GMP synthesized material, formulation research, pharmacological methods of IND-directed toxicology for support of an investigator-held IND application and clinical trials. T1D-RAID does not support clinical trials; it supports the work needed to get ready to do clinical trials.

Inquiries

For questions or further information, contact:

Mr. Dana Harris
Contract Specialist
Acquisition Management Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Two Democracy Plaza, Room 781
6707 Democracy Blvd
Bethesda, MD 20892-5456
Phone: 301-594-9987
Fax: 301-480-4226
E-mail: dh307s@nih.gov

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