Notice of Intent
Ref# 2009-72444
The Centers for Disease Control and Prevention, National Center for Zoonotic Vectorborne and Enteric Diseases, Division of Foodborne Bacterial and Mycotic Diseases, Bacterial Zoonoses Branch, intents to award a sole source, firm fixed price contract, in accordance with FAR Part 13 and FAR Part 6.302(1), using simplified acquisition procedures, to Wellcome Trust- Mahidol University Oxford Tropical Medicine Research Programme, Mahidol University, 420/6 Rajvithi Road., Rajthevee, Bangkok 10400, Thailand for a period of 12 months. The contractor will provide a research plan to identify potential antimicrobial and other agents/regiments for use in post-exposure prophylaxis againsyB. Pesudomallei and meet the program requirements including cost and time constraints. The research plan will provide the following plan
1. Incorporate clinical efficacy information from areas endemic for melioidosis.
2. Incorporate information on routes of B.pseudomallei acquisition and existing data on accidental exposure events and their management
3. Incorporate standards for identifying appropriate animal models for use in studies intending to meet the FDA's animal rule approval methods.
4. Identify antimicrobial agents and combination that should be tested for PEP testing under the animal rule.
5. Prioritize antimicrobial agents and combinations for PEP testing under the animal rule.
6. Describe how previous and future animal studies can most effectively be used to evaluate and demonstrate the efficacy of current POP recommendations
7. Develop a research plan and methods for identifying and testing potential PEP agents and protocols, including testing for pediatric and pregnant populations.
The researcher available at Wellcome Trust- Mahidol university oxford Tropical medicine Research Program is the lead author on the only published preliminary guidance on post exposure prophlyaxis for B pseudomallei, and has extensive publications related to routes of acquisition, evaluation of treatment protocols, and publication of treatment guidelines for melioidosis, and as such is considered the leading worldwide authority on these aspects of melioidosis treatment. There is only researcher identified with research experience in routes of acquisition of B pseudomallei, extensive experience in clinical trails, evaluation of treatment protocols for melioidosis, and engagement in defining preliminary guidance for post-exposure prophylaxis against melioidosis in laboratory worker exposures, all of which are necessary components for fulfilling contract requirements. This project addresses issues that are applicable to all researchers and laboratories working with Burkholderia pseudomallei, and as such it is important that the information that will ultimately result from these studies be highly visible in published medical literature from a well-respected source, which this product is uniquely qualified to perform. No Request for Quotes (RFQ) will be issued based upon this Notice of Intent. Any interested companies are welcome to submit there credentials and ability to provide the services, via e-mail, [email protected] . Include reference number (2009-72444). Send responses by Thursday July 16, 2009.