BAA ANNOUNCEMENT: Targeted Clinical Trials to Reduce the Risk of Antimicrobial Resistance -BAA-NIAID-DMID-NIHAI2009058

Notice Number: NOT-AI-09-049

Key Dates
Release Date: July 9, 2009
Receipt Date: September 30, 2009

Issued by
National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov)

Description

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 an interest in identifying innovative approaches 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 that may be supported under this BAA are limited to the following:  acute otitis media; pneumonia; and bacteremia.

Both community-associated and hospital-associated infections in these disease areas are eligible.
Eligible strategies may include, but are not limited to:  different dosage or frequency, supported by PK/PD data, where optimal treatment is well defined, e.g., the use of penicillin in penicillin-resistant  pneumonia; or withholding of antimicrobials (altogether) for certain diseases and identifying eligible populations for this type of strategy; or shorter treatment duration for the disease areas listed above.
It is anticipated that multiple cost reimbursement, completion type contracts will be awarded for a 5-year period of performance beginning on or about June 30, 2010.   

The NIAID estimates that the total cost (direct and indirect costs combined) for a single award is approximately $20 million.  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 five (5) years.
All responsible sources may submit a proposal which shall be considered by the Agency.  BAA NIAID-DMID-NIHAI2009058 will be available electronically on/about June 30, 2009 and may be accessed through FedBizOpps http://www.fbo.gov/.  This notice does not commit the Government to award a contract.  No collect calls will be accepted.  No facsimile transmissions will be accepted. Responses to this BAA will be due on/before September 30, 2009.

Contracting Office Address

Department of Health and Human Services
National Institutes of Health
National Institute of Allergy and Infectious Diseases
Division of Extramural Activities
Office of Acquisitions
6700-B Rockledge Drive
Room 3214, MSC 7612
Bethesda, MD  20892-7612

Inquiries

Bijan Mansoury
Contract Specialist
Office of Acquisitions, Division of Extramural Activities, NIAID, NIH, DHHS
6700-B Rockledge Drive, Room 3214, MSC 7612
Bethesda, MD  20892-7612 (Express mail:  Use Zip Code 20817-7612)
Phone 301-594-4573
Fax 301-402-0972
Email mansouryb@niaid.nih.gov

Nichele C. Robinson
Contract Specialist, Team Lead
Office of Acquisitions, Division of Extramural Activities, NIAID, NIH, DHHS
6700-B Rockledge Drive, Room 3214, MSC 7612
Bethesda, MD  20892-7612 (Express mail:  Use Zip Code 20817-7612)
Phone 301-402-2234
Fax 301-402-0972
Email robinsonnc@niaid.nih.gov


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
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and Human Services (HHS)
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