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A -- Development of Therapeutic Agents for Select Biodefense Pathogens

Notice Date
Notice Type
Solicitation Notice
541710 — Research and Development in the Physical, Engineering, and Life Sciences (NAICS 2002)
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, MD, 20892-7612, UNITED STATES
ZIP Code
Solicitation Number
Response Due
Point of Contact
Suzanne Dawkins, Contract Specialist, Phone 301-451-3698, Fax 301-480-4675, - Robert Singman, Contracting Officer, Phone 301-451-2607, Fax 301-480-4675
E-Mail Address
sd33r@nih.gov, RSingman@niaid.nih.gov
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 diseases. The NIAID Division of Microbiology and Infectious Diseases (DMID) has a requirement for the development of therapeutic agents for select biodefense pathogens. Description: Through this solicitation, the NIAID, is seeking to support projects to advance the development of promising candidate therapeutics with demonstrated in vivo activity against one or more of the following NIAID biodefense priority pathogens: Bacillus anthracis, Variola major, Filoviruses: Marburg and Ebola, Influenza, Gram negative biodefense bacteria. Note: NIAID seeks to support the development of broad spectrum antimicrobials with activity against more than one NIAID Category A, B, or C priority biodefense Gram negative pathogen, (e.g. Francisella tularensis, Yersinia pestis, Burkholderia pseudomallei, B. mallei, Rickettsia prowazeki, Coxiella burnetti, Escherichia coli, Campylobacter jejuni). Antimicrobial resistant pathogens were recently added to the NIAID Category C priority biodefense pathogens list and are defined as pathogens, excluding sexually-transmitted organisms (see http://www3.niaid.nih.gov/biodefense/anti_stis.htm for list of excluded organisms), resistant to antimicrobial agents. Broad spectrum Gram negative candidate therapeutic agents proposed for advancement under this program should have demonstrated in vivo activity against at least one Gram negative Category A, B, or C pathogen; AND in vitro activity against at least three different genera of Gram negative Category A, B, or C pathogens. The candidate therapeutic should be at a stage of development that is, at a minimum, within five (5) years of completion of a Phase 1 clinical trial. Support will be provided for non-clinical studies, medicinal chemistry, manufacturing, Phase 1 and Phase 2 clinical trials, and other Investigational New Drug (IND)-, New Drug Application (NDA)-, or Biologic License Application (BLA)-enabling studies. The NIAID is particularly interested in candidate therapeutics with broad spectrum activity and that are within the regulatory purview of the Center for Drug Evaluation and Review (CDER) of the U.S. Food and Drug Administration (FDA). Contracts awarded under this solicitation will not support: The design and conduct of Phase 3 clinical trials, the development of vaccines (vaccine is defined as an intervention that directly elicits a pathogen specific immune response), and the development of polyclonal antibody blood-derived products. It is anticipated that one or more cost reimbursement, completion type contracts will be awarded for a five-year period of performance beginning on or about July 31, 2008. It is estimated that the provision of FTEs will be approximately 5 ? 8. Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about July 11, 2007, and may be accessed through the NIAID Office of Acquisitions (OA) Home Page at http://www.niaid.nih.gov/contract and on 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. See Government-Wide Numbered Note 26. NOTE: THIS NOTICE MAY HAVE POSTED ON FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (26-JUN-2007). IT ACTUALLY APPEARED OR REAPPEARED ON THE FEDBIZOPPS SYSTEM ON 24-JAN-2008, BUT REAPPEARED IN THE FTP FEED FOR THIS POSTING DATE. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
Web Link
Link to FedBizOpps document.
Place of Performance
Address: 6700B Rockledge Drive Room 3105, MSC 7612 Bethesda, MD
Zip Code: 20892-7612
SN01492311-F 20080126/080124230243 (fbodaily.com)
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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