Accessibility Information

Users of assistive technologies such as screen readers should use the following link to activate Accessibility Mode before continuing: Learn more and Activate accessibility mode.

TARGETED CLINICAL TRIALS TO REDUCE THE RISK OF ANTIMICROBIAL RESISTANCE

Solicitation Number: BAA-NIAID-DMID-NIHAI2009058
Agency: Department of Health and Human Services
Office: National Institutes of Health
Location: National Institute of Allergy and Infectious Diseases
  • Print

Note:

There have been modifications to this notice. To view the most recent modification/amendment, click here
:
BAA-NIAID-DMID-NIHAI2009058
:
Award
:
Added: Jun 16, 2009 4:14 pm
Introduction



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.



Description



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

• 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. This BAA 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.

Please consult the list of document viewers if you cannot open a file.

Solicitation 1

Type:
Solicitation
Posted Date:
June 30, 2009
Description: Targeted Clinical Trials to Reduce the Risk of Antimicrobial Resistance

Amendment 1

Type:
Mod/Amendment
Posted Date:
August 17, 2009
Description: BAA-NIAID-DMID-NIHAI2009058 Amendment 1

Amendment 2

Type:
Mod/Amendment
Posted Date:
October 8, 2009
Description: BAA-NIAID-DMID-NIHAI2009058 - Amendment #2
“Targeted Clinical Trials to Reduce the Risk of Antimicrobial Resistance”
:
Office of Acquisitions
6700 B Rockledge Room 3214 MSC7612
Bethesda, Maryland 20892-7612
:
Bijan Mansoury,
Contract Specialist
Phone: 301-594-4573
Fax: 301-402-0972
:
Nichele Robinson,
Contract Specialist
Phone: (301) 402-2234
Fax: (301) 402-0972