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Targeted Clinical trials to Reduce the Risk of Antimicrobial Resistance

Solicitation Number: BAA-NIAID-DMID-NIHAI2008025
Agency: Department of Health and Human Services
Office: National Institutes of Health
Location: National Institute of Allergy and Infectious Diseases
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BAA-NIAID-DMID-NIHAI2008025
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Solicitation
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Added: Apr 28, 2008 1:42 pm

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The NIAID, Division of Microbiology and Infectious Diseases has a requirement to support research identifying ways to effectively treat bacterial infections with antimicrobials that minimize the development of drug resistance. This BAA targets infectious diseases where improved treatment strategies could reduce the risk of antimicrobial resistance and preserve the effectiveness of existing antimicrobials. A central goal of this solicitation is to target disease areas experiencing the greatest antimicrobial selective pressure, and within these areas, develop strategies that test the safety and effectiveness of different therapeutic approaches/regimens that reduce the probability of the emergence of drug resistance by minimizing unnecessary drug exposure. Contracts to be awarded under this BAA will support the design and conduct of Phase III and/or Phase IV clinical trials of new strategies for the use of licensed, off-patent antimicrobial therapies to reduce the risk of antimicrobial resistance in selected infectious diseases. For the purposes of this BAA, the disease areas of interest are the following:(1) Acute otitis media; (2) Pneumonia; (3) Urinary tract infections; and (4) Bacteremia. Both community- and hospital-associated infections in these disease areas are eligible. For the purposes of this BAA, the experimental variables of interest are the following: (1) Need for antimicrobial therapy (single or combination therapy); (2) Length of antimicrobial therapy; and (3) Frequency/dosage of antimicrobial therapy. Eligible strategies may include, but are not limited to: (1) Shorter treatment duration for pneumonia and other infections, e.g., otitis media, urinary tract infections and bacteremia; (2) Different dosage or frequency, supported by PK/PD data, where optimal treatment has not been well defined, e.g., the use of penicillin in penicillin-resistant pneumonia; or (3) Withholding of antimicrobials (altogether) for certain diseases, e.g., otitis media and identifying eligible populations for this type of strategy. It is anticipated that multiple cost reimbursement, completion type contracts will be awarded for a seven-year period of performance beginning on or about June 1, 2009. The NIAID estimates that the total cost (direct and indirect costs combined) available for all contract awards is $9.1 million per year. However, it is anticipated that the total cost for the award(s) may vary depending upon the scope of the project and the technical objectives of the award(s). The length of time for which funding is requested should be consistent with the nature and complexity of the proposed research. In no event shall the period of performance proposed by an offeror exceed seven years. All responsible sources may submit a proposal which shall be considered by the Agency. This BAA will be available electronically on/about May 12, 2008, and may be accessed through FedBizOpps http://www.fedbizopps.gov/. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.

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Solicitation 1

Type:
Solicitation
Posted Date:
May 12, 2008
Description: BAA-NIAID-DMID-NIHAI2008025
:
Office of Acquisitions
6700 B Rockledge Room 3214 MSC7612
Bethesda, Maryland 20892-7612
:
Frank Vidergar,
Contract Specialist
Phone: 301-402-1490
Fax: 301-480-4675
:
Teresa A Baughman,
Contracting Officer
Phone: 301-451-3690
Fax: 301-402-0972