SOURCES SOUGHT
A -- Clinical Trial for Community-Acquired Methicillin-Resistant Staphylococcus aureus
- Notice Date
- 2/23/2006
- Notice Type
- Sources Sought
- 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 Institutes of Allergy and Infectious Diseases, Contract Management Program 6700 B Rockledge Room 3214 MSC7612, Bethesda, MD, 20892-7612
- ZIP Code
- 20892-7612
- Solicitation Number
- SS-NIH-NIAID-DMID-07-12
- Response Due
- 3/13/2006
- Archive Date
- 3/13/2006
- Description
- THIS NOTICE IS FOR INFORMATION AND PLANNING PURPOSES ONLY. THIS IS NOT A REQUEST FOR PROPOSALS AND DOES NOT COMMIT THE GOVERNMENT TO AWARD A CONTRACT NOW OR IN THE FUTURE. NO SOLICITATION IS AVAILABLE AT THIS TIME. BASED ON CAPABILITY STATEMENTS RECEIVED FROM THIS SOURCES SOUGHT THIS ACQUISITION MAY BE SOLICITED AS AN 8(a) SET-ASIDE; 100% SMALL BUSINESS SET-ASIDE OR AS FULL AND OPEN. ALL SIZE ORGANIZATIONS ARE ENCOURAGED TO RESPOND. THE NAICS CODE IS 541710 WITH A SIZE STANDARD OF 500 EMPLOYEES. The Division of Microbiology and Infectious Diseases (DMID) of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) supports research to understand, and ultimately prevent and/or treat, infectious and immune-mediated diseases that continue to threaten millions of lives each year. The Government is currently considering a competition for this effort which could result in one (1) award for a period of five (5) years. The objective of a contract if awarded would be to advance the field of clinical management for uncomplicated skin and soft tissue infection caused by community-acquired methicillin-resistant Staphylococcus aureus (CA-MRSA) by determining the optimal outpatient treatment strategy. In order to accomplish this objective a Contractor must be able to provide the scientific, technical, and managerial infrastructure, facilities, and other resources required to design and conduct a multi-site Phase II/III clinical trial. In addition, the Contractor must have the ability to determine the efficacy of off-patent oral antimicrobials and /or wound care for the treatment of outpatients with uncomplicated community-acquired skin and soft tissue infection in areas in the U.S, where the prevalence of CA-MRSA is high. An uncomplicated skin and soft tissue infection is defined as the presence of wound infection, abscesses, folliculitis, cellulitis or erysipelas. Community-acquired methicillin-resistant Staphylococcus aureus infections are defined as the isolation of methicillin-resistant Staphylococcus aureus from the relevant disease process from subjects who have not been hospitalized within the previous fourteen (14) days. In order to preserve the efficacy of vancomycin and linezolid, evaluation of these two antimicrobials would not be supported under this effort. In addition, clinical trials of invasive diseases (e.g., bacteremia, endocarditis, osteomylitis or pneumonia) or clinical trials with hospitalized patients would not be supported under this contract. Clinical trials under this effort would require a minimum of two (2) and a maximum of five (5) clinical trial sites. Each clinical trial site, included would also be required to have access to one hundred and twenty (120) subjects with skin and soft tissue infection every three (3) months to ensure enrollment of a minimum of forty (40) subjects every three (3) months. Information submitted in your capability statement shall be pertinent and specific in the technical area under consideration in each of the following qualifications: (1) facilities and expertise necessary for conducting multi-site Phase II/III clinical trials; (2) managerial infrastructure available for conducting multi-site Phase II/III clinical trials; (3) minimum of 2 Clinical sites; and (4) access to required number of subjects. Small business and 8(a) contractors are reminded that in order to qualify as a set-aside, 51% of the direct labor must be performed by the prime contractor. It is estimated that a total effort of approximately 9.5 FTEs per year will be needed to accomplish this project. Interested organizations are encouraged to respond and are required to submit two (2) copies of their capability statement addressing the areas cited above. Please reference the solicitation number on all related correspondence and identify the NAICS and size status of your organization. See Government-Wide Numbered Note 22. NO COLLECT CALLS WILL BE ACCEPTED. FACSIMILE AND E-MAIL TRANSMISSIONS WILL BE ACCEPTED.
- Record
- SN00993214-W 20060225/060223211944 (fbodaily.com)
- Source
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