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FBO DAILY ISSUE OF MARCH 27, 2011 FBO #3410
MODIFICATION

A -- DEVELOPMENT OF TECHNOLOGIES THAT ACCELERATE THE IMMUNE RESPONSE TO BIODEFENSE VACCINES

Notice Date
3/25/2011
 
Notice Type
Modification/Amendment
 
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-NIAID-DMID-NIHAI2010103
 
Archive Date
7/8/2011
 
Point of Contact
Chase A. Lucas, Phone: 301-402-0641, Michael Finn, Phone: 301-496-3699
 
E-Mail Address
lucasca@niaid.nih.gov, finnm@mail.nih.gov
(lucasca@niaid.nih.gov, finnm@mail.nih.gov)
 
Small Business Set-Aside
N/A
 
Description
DEVELOPMENT OF TECHNOLOGIES THAT ACCELERATE THE IMMUNE RESPONSE TO BIODEFENSE VACCINES BROAD AGENCY ANNOUNCEMENT NUMBER NIAID-DMID-NIHAI2010103 Presolicitation Notice Information 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 candidate products which consist of a vaccine component and a technology that accelerates the immune response for use in post-event settings following the intentional release of NIAID Category A and B Priority Pathogens excluding B. anthracis or in response to naturally occurring outbreaks of infectious diseases caused by NIAID Category A and B Priority Pathogens excluding B. anthracis. In these settings, simplicity and efficiency of delivery of vaccine to, and the effectiveness in large numbers of patients are key considerations. Candidate products that increase vaccine stability and/or reduce logistical requirements are important secondary objectives and would further enhance the capabilities of a candidate product that accelerates the immune response. Anticipated benefits may include: decreased manpower and time required to prepare and administer the vaccine, maximum compliance of the vaccine recipients, and production of a protective immune response with 1-2 doses of vaccine. Although vaccine components at different stages of development may be proposed, ideally, the vaccine component of a proposed candidate product should demonstrate completion of current Good Manufacturing Practices (cGMP) manufacturing; have undergone a Phase 1 clinical trial; and have produced safety and immunogenicity results that support further clinical development. Organizations responding to this Broad Agency Announcment should have documented expertise in product development, including regulatory submissions, to advance the development and evaluation of candidate products, against biological threats identified as NIAID Category A and B Priority Pathogens ( http://www.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/research/pages/cata.aspx ) or Top Priority Biological Threats in the HHS, 2007 PHEMCE Implementation Plan ( https://www.medicalcountermeasures.gov/BARDA/PHEMCE/enterprise/strategy/strategy.aspx ). Eligible candidate products include those for agents identified as NIAID Category A and B Priority Pathogens excluding B. anthracis. Additional technologies, when applicable, that increase vaccine stability and/or reduce logistical requirements, will be supported as components of the candidate product. Novel delivery platforms 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. Candidate products include: 1. Vaccine Component - The vaccine component of a proposed candidate product should demonstrate completion of current Good Manufacturing Practices (cGMP) manufacturing, undergone a Phase 1 clinical trial, and produced safety and immunogenicity results that support further clinical development. 2. Technology Component a.The technology components used in the proposed candidate product may consist of a new adjuvant, an immune modulator, a formulation technology or a delivery platform designed to enhance the immune response onset for category A excluding B. anthracis and Category B priority pathogen vaccine candidates. Simply changing a vaccine formulation, for example taking a liquid to a stable lyophilized vaccine formulation, would not be sufficient to meet the objectives. b. Technology components should address reduced time to establish immunity with proof of concept efficacy data in animal models that demonstrate efficacy with the proposed vaccine- component and the feasibility of attaining a safety profile that meets all existing U.S. Food and Drug Administration (FDA) requirements. It is anticipated that multiple cost reimbursement, completion type contracts will be awarded for a 5 year period of performance beginning on or about April 1, 2012. The NIAID estimates that one or more contracts may be issued for a total cost (direct and indirect costs combined) of up $44.5 million for a five-year period of performance. Importantly, contract activities will be divided into manageable time frames with initial funding of only the Base Period. Funding of subsequent timeframes will be funded by Options. Each Option will be fully funded when exercised and will be dependent on successful completion of critical predecessor activities, including USG acceptance of associated deliverables when applicable. The critical predecessor activities should constitute Go/No Go criteria for successor activities. The contract budget will be aligned with the Base Period, Options and associated tasks identified in the Product Development Plan and associated Gantt Chart. Moreover, 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 Broad Agency Announcemnent will be available electronically on/about March 29, 2011, 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-NIAID-DMID-NIHAI2010103/listing.html)
 
Record
SN02409318-W 20110327/110325234334-4f4c31754059be2f32fd8ea1af0b9df5 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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