Notice Number: NOT-AI-05-041
Release Date: May 6, 2005
Receipt Date(s): June 8, 2005
Peer Review Date(s): August, 2005
Earliest Anticipated Start Date: September 30, 2005
Expiration Date: June 9, 2005
National Institute of Allergy and Infectious Diseases (NIAID), (http://www.niaid.nih.gov/)
This notice is a combined synopsis/solicitation for other than commercial items. This announcement constitutes the only solicitation; offers are being requested and a written solicitation will not be issued. This procurement is being conducted under the Simplified Acquisition Procedures (SAP) set forth in FAR Part 13. This notice is being issued as a Request for Proposal (RFP) support the discovery and demonstration of proof-of-concept of prodrugs or alternative (oral, inhalation, or transdermal) formulations of DTPA that deliver plasma levels sufficient to decorporate systemic transuranyl compounds for use by the general public in case of radiation emergencies.
The potential for radiation exposures to occur from terrorist acts, radiation accidents or nuclear detonation mandates that the health care system develop and implement preparedness plans that include the stockpiling of radioprotective drugs and therapeutics. Radiation exposure can occur from external irradiation, external contamination with radioactive materials, and internal contamination by inhalation, ingestion or absorption through skin or wounds. The removal of internal radioactive contaminants can be accomplished by administering chelating agents that can preferentially complex with radionuclides in the body and increase their rate of clearance, thereby decreasing radiation exposure.
Pentetate (diethylenetriaminepentaacetate) calcium trisodium (Ca-DTPA) and pentetate (diethylenetriaminepentaacetate) zinc trisodium (Zn-DTPA) have been shown to be effective in treating internal contamination with radionuclides such as plutonium, americium, or curium. DTPA increases the rates of elimination of these substances from the body through the exchange of calcium or zinc ions with the transuranium element. The transuranium-DTPA complex is stable and is excreted in urine. The calcium salt is 10X more effective than the zinc salt of DTPA in the first 24 hours following internal contamination, but after 24 hours, the salts are similarly effective.
DTPA has been available for distribution from the Radiation Emergency Assistance Center/Training Site under an IND and formulations of Ca-DTPA and Zn-DTPA suitable for intravenous administration, or inhalation via nebulizer, were approved by the FDA in August 2004. Other formulations (for example oral, inhalation or transdermal) would be more easily administered than the injectable formulations, making DTPA easier to use in a mass casualty situation; however, because of its hydrophilicity, DTPA is poorly absorbed when administered by these routes. The NIAID is interested in facilitating the discovery and demonstration of proof-of-concept of prodrugs, alternative formulations, or alternative delivery methods of DTPA that provide for plasma levels sufficient to decorporate systemic transuranic compounds for use by the general public in the case of a radiation emergency. In addition, the NIAID is interested in facilitating the development of prodrugs, alternative formulations, or alternative delivery methods that provide for lung clearance of transuranic compounds and that can be used in a mass casualty situation. The ultimate goal of the DTPA development effort is to identify effective candidates that could be evaluated for inclusion in the Strategic National Stockpile.
The NIAID anticipates awarding up to three (3) contracts based on technical merit, available funds, scientific priority, and programmatic balance. The NIAID estimates that the average total cost (direct and indirect cost combined) for these contracts will be greater than $1 million per contract; however, it is anticipated that the total cost for each award may vary depending upon the scope of the project and the technical objectives of the award. The length of time for which funding is requested should be consistent with the nature and complexity of the proposed research. The period of performance is expected to be a total of twenty-one (21) months. The anticipated base contract period (Phase 1) will be fourteen (14) months with Option 1 (Phase 2), if exercised, being seven (7) months.
For questions or further information, contact:
National Institute of Allergy and Infectious Diseases
6700-B Rockledge Drive
Bethesda, MD 20892-7620
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
Office of Extramural
National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
Department of Health
and Human Services (HHS)
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