SOLICITATION NOTICE
A -- Targeted Clinical Trials To Reduce the Risk of Antimicrobial Resistance
- Notice Date
- 3/16/2010
- Notice Type
- Presolicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- 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, Maryland, 20892-7612
- ZIP Code
- 20892-7612
- Solicitation Number
- BAA-DMID-NIHAI2010089
- Archive Date
- 8/14/2010
- Point of Contact
- Deborah A Baca, Phone: 301-443-4490, Michael Finn, Phone: 301-496-3699
- E-Mail Address
-
dbaca@mail.nih.gov, finnm@mail.nih.gov
(dbaca@mail.nih.gov, finnm@mail.nih.gov)
- Small Business Set-Aside
- N/A
- 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, to develop strategies that test the safety and effectiveness of different therapeutic approaches/regimens to 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 II, Phase III, and/or Phase IV clinical trials of new strategies to optimize the use of licensed, off-patent antimicrobial agents and reduce the risk of antimicrobial resistance in selected infectious diseases. [Note: Pivotal clinical trials primarily to change product label or package insert (such as new indications) will not be supported. See Exceptions listed below.] Clinical trials must be conducted in locations experiencing the antimicrobial resistance issues identified in the offeror's proposal. Strategies including the use of licensed antimicrobial therapies still on-patent will be considered if the therapies are firmly established in the local standard of care. For the purposes of this BAA, the disease areas that may be supported under this BAA are limited to the following: Pneumonia; Bacteremia; Tuberculosis (pulmonary); and Non-tuberculous mycobacterial (NTM) lung infections in HIV negative persons. 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 pneumococcal pneumonia; 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. Exceptions : Additionally, protocols for TB and mycobacterial diseases may include: L imited sub-studies to evaluate biomarkers for response to treatment; PK studies with PK/PD endpoints only to define the optimal dosing parameters; Studies to create medical evidence for the off-label use of licensed antimicrobial agents in TB or NTM therapy. This solicitation will not support research to evaluate the safety and efficacy of investigational therapeutics or diagnostics. However, currently available diagnostics may be used to help specify optimal treatment plans. It is anticipated that multiple cost reimbursement, completion type contracts consisting of the base and Options for additional phases of performances will be awarded on or about March 31, 2011. The length of the project proposed by the offeror, including all options, should be consistent with the nature and complexity of the proposed research, but should not exceed 5 years. The NIAID estimates that one or more contracts may be issued for a total cost (direct and indirect costs combined) of up to $9 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). All responsible sources may submit a proposal which shall be considered by the Agency. This BAA will be available electronically on/about March 30, 2010, 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.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIAID/BAA-DMID-NIHAI2010089/listing.html)
- Record
- SN02093043-W 20100318/100316234647-e6feaa4da1d25504c4fbbd9eddc8d148 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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