MODIFICATION
A -- A-Development of Therapeutic Agents for Selected Biodefense Bacterial Diseases
- Notice Date
- 4/3/2006
- Notice Type
- Modification
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions 6700 B Rockledge Room 3214 MSC7612, Bethesda, MD, 20892-7612
- ZIP Code
- 20892-7612
- Solicitation Number
- BAA--NIH-NIAID-DMID-07-37
- Response Due
- 8/3/2006
- Archive Date
- 10/1/2006
- Description
- Research supported and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Health (NIH), strives to understand, treat and ultimately prevent the myriad infectious, immunologic, and allergic diseases that threaten millions of human lives. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research to control and prevent diseases caused by virtually all infectious agents. This includes basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics, which are funded through a variety of research grants and contracts. In this context, the NIAID's mission includes the development of new medical countermeasures against the biological agents that are most likely to be used in a terror attack on civilian populations. These biological agents have been prioritized as Category A, B, and C. Through this solicitation the NIAID is seeking to advance the development of therapeutics against selected NIAID Category A, B, and C bacterial pathogens via a focused, staged approach. Specifically the goal of this solicitation is to develop new, safe, and effective therapeutics for: * Bacillus anthracis * Yersinia pestis * Francisella tularensis * Burkholderia pseudomallei * Burkholderia mallei * Rickettsia prowazekii Pathogens, excluding sexually-transmitted organisms (see http://www3.niaid.nih.gov/biodefense/anti_stis.htm for list of excluded organisms), resistant to antimicrobial agents were recently added to the NIAID Biodefense Category C priority pathogens list. This solicitation will also support the development of candidate therapeutics with broad spectrum activity against NIAID Category C antimicrobial resistant bacterial pathogen(s) and at least one of the selected Category A or B bacterial pathogens (B. anthracis, Y. pestis, F. tularensis, B. pseudomallei, B. mallei and R. prowazekii). The candidate therapeutic should be at a stage of development that is minimally within five (5) years of completion of a Phase 1 clinical trial. This solicitation will support non-clinical studies, medicinal chemistry, manufacturing, Phase 1 and Phase 2 clinical trials, and other Investigational New Drug (IND)-, New Drug Application (NDA)-, or Biologic License Application (BLA)-enabling studies. The NIAID is particularly interested in candidate therapeutics that have broad spectrum activity and are within the regulatory purview of the Center for Drug Evaluation and Review (CDER) of the U.S. Food and Drug Administration (FDA). It is anticipated that multiple cost-reimbursement, completion type contracts will be awarded for a period of up to five (5) years beginning on or about June 12, 2007. BAA NIH-NIAID-DMID-07-37 will be available electronically on or about March 31, 2006 and may be accessed through the NIAID Office of Acquisitions (AO) Home Page by using the following electronic address and instructions: NIAID/OA Home Page (via the WWW): Use http://www.niaid.nih.gov/contract to access the NIAID/AO Home Page. Once at the NIAID/AO Home Page, click on the "RFPs" link and then click on "BAA NIH-NIAID-DMID-07-37, entitled, 'Development of Therapeutic Agents for Selected Biodefense Bacterial Diseases'." Proposals will be due on or about September 12, 2006. Any responsible Offeror may submit a proposal for consideration by the Government. This advertisement does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted. See Government-wide numbered note 26.
- Place of Performance
- Address: To Be Determined
- Zip Code: TBD
- Country: TBD
- Zip Code: TBD
- Record
- SN01019842-W 20060405/060403220138 (fbodaily.com)
- Source
-
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