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DEVELOPMENT OF TECHNOLOGIES TO FACILITATE THE USE OF, AND RESPONSE TO, BIODEFENSE VACCINES

Solicitation Number: BAA-NIAID-DMID-NIHAI2009055
Agency: Department of Health and Human Services
Office: National Institutes of Health
Location: National Institute of Allergy and Infectious Diseases
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BAA-NIAID-DMID-NIHAI2009055
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Award
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Added: Aug 04, 2009 12:10 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 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.
Description
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.


It is anticipated that multiple cost reimbursement, completion type contracts will be awarded for a 5-year period of performance beginning on or about August 30, 2010.


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. In no event shall the period of performance proposed by an offeror exceed five years.


All responsible sources may submit a proposal which shall be considered by the Agency. This BAA will be available electronically on/about August 18, 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.


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Solicitation 1

Type:
Solicitation
Posted Date:
August 18, 2009
Description: BAA-NIAID-DMID-NIHAI2009055

Amendment 1

Type:
Mod/Amendment
Posted Date:
September 11, 2009
Description: Amendment Number One (1)
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Office of Acquisitions
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Timni Mahase,
Contract Specialist
Phone: 301-451-2569
Fax: 301-402-0972
:
Michael Finn,
Contract Specialist
Phone: 301-496-3699
Fax: 301-402-0972