Notice Number: NOT-AI-09-052
Release Date: September 16, 2009
Receipt Date: November 18, 2009
National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov)
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 advance the development of new medical countermeasures against the biological agents that are most likely to be used in a terror attack on civilian populations.
The primary objective of this solicitation is to support the advanced development of a candidate product, which consists of a vaccine component and a delivery technology, for use in post-event settings following the intentional release of a biothreat agent or naturally occurring outbreaks of infectious diseases. In this type of setting, simplicity of operation and efficiency of delivery of the vaccine to and the effectiveness in large numbers of patients, are primary goals.
Candidate products that reduce the time to establish immunity, increase vaccine stability and/or reduce logistical requirements are important secondary objectives and would further enhance the capabilities of a candidate product that is easily delivered.
Delivery technologies that propose delivery routes other than the traditional intramuscular or subcutaneous routes will be considered. Anticipated benefits should include decreased manpower and time required to prepare and administer the vaccine, maximum compliance, and production of a protective immune response with 1-2 doses of vaccine.
Organizations responding to this BAA must have documented expertise in product development, including regulatory submissions, to advance the development and evaluation of candidate products, against select biological threats identified as NIAID Category A and B Priority Pathogens (http://www3.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/research/CatA.htm) or Top Priority Biological Threats in the HHS, PHEMCE Implementation Plan (http://www.hhs.gov/aspr/barda/phemce/enterprise/strategy/index.html).
Eligible candidate products include those for agents identified as NIAID Category A and B Priority Pathogens.
Additional technologies, when applicable, that reduce the time to establish immunity, increase vaccine stability and/or reduce logistical requirements, will be supported as components of the candidate product. Novel delivery platforms, formulations and adjuvants, other than aluminum, may be components of the candidate product to be developed. Cross-cutting platform delivery technologies applicable to more than one vaccine are also of interest.
The NIAID estimates that one or more contracts may be issued for a total cost (direct and indirect costs combined) of up to $17.6 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.
It is anticipated that multiple cost reimbursement, completion type contracts will be awarded for a period of five years, beginning approximately August 30, 2010. BAA NIH-NIAID-NIHAI2009055 will be available electronically on or about August 18, 2009, and may be accessed at http://www.fbo.gov/. Only electronic copies of the BAA will be available. All information required for the submission of an offer will be contained in the BAA. Responses to this BAA will be due on or before November 18, 2009.
Any responsible offeror may submit a proposal that will be considered by the Government, however, this notice does not commit the Government to the award of a contract. No collect calls will be accepted. No facsimile submissions will be accepted.
Contacting 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
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)
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
Office of Extramural
National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
Department of Health
and Human Services (HHS)
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