Notice Number: NOT-AI-07-046

Key Dates
Release Date: September 18, 2007
Receipt Date:  January 22, 2008

Issued by
National Institutes of Allergy and Infectious Diseases (NIAID), (http://www.niaid.nih.gov)

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.  This project will be funded in whole or in part with Federal funds from the Biomedical Advanced Research and Development Authority (BARDA), DHHS, in conjunction with the NIAID, NIH.  The NIAID, Division of Microbiology and Infectious Diseases (DMID) has a requirement for vaccine candidate(s) for NIAID Category A or B Priority Pathogens (Part A) or a candidate third generation anthrax vaccine (Part B). The purpose of this solicitation is to fund organizations with demonstrated vaccine product development experience to produce a vaccine candidate either for a NIAID Category A or B Priority Pathogen (PART A) or a candidate third generation anthrax vaccine (PART B).  Candidate vaccines eligible for support must have demonstrated safety and proof of concept efficacy in an animal model. Offerors must propose a well-defined and feasible Product Development Plan for advancing the vaccine candidate to achieve the following objectives as specified in the Research and Technical Objectives. 

Part A (Base):  Development and update of the Product Development Plan for a NIAID Category A or B Priority Pathogen vaccine candidate, including regulatory, clinical, non-clinical, and manufacturing activities to be undertaken; manufacturing and formulation process development; manufacturing of pilot lot cGMP material; real time and accelerated vaccine stability studies; conduct of non-clinical studies, including all Investigational New Drug (IND)-enabling toxicology studies and multivalent immunogenicity interference studies; development, qualification and, where necessary, validation of all assays necessary to support product development; rapid immune response with no more than two (2) vaccinations; long-term stability of three (3) years or longer at temperatures of at least 35oC; development of stabilization technology that is broadly applicable to a variety of vaccines; and a safety profile that meets all existing U.S. Food and Drug Administration (FDA) requirements. 

Part A Option:  May be exercised at the discretion of the Government to provide support for the submission of an Investigational New Drug (IND) Application to the FDA and for the design, conduct, completion and analysis of a Phase 1 clinical trial for contracts awarded to carry out product development activities under Part A for NIAID Category A or B Priority Pathogen vaccine candidates. 

Part B (Base):  Development and update of the Product Development Plan for a third generation anthrax vaccine candidate, including regulatory, clinical, non-clinical, and manufacturing activities to be undertaken; manufacturing and formulation process development; manufacturing of pilot lot cGMP material; real time and accelerated vaccine stability studies; conduct of non-clinical studies, including all Investigational New Drug (IND)-enabling toxicology studies and multivalent immunogenicity interference studies; development, qualification and, where necessary, validation of all assays necessary to support product development; rapid immune response with no more than two (2) vaccinations; long-term stability of three (3) years or longer at temperatures of at least 35oC; development of stabilization technology that is broadly applicable to a variety of vaccines; a safety profile that meets all existing U.S. Food and Drug Administration (FDA) requirements; development, submission, and sponsorship of an IND, including compliance with all regulatory requirements; design, conduct, completion, and analysis of a Phase 1 dose-escalating clinical trial of the multivalent vaccine candidate in healthy subjects ages 18 to 40; and the provision of clinical and non-clinical samples from all studies to NIAID and, for clinical trials, obtaining future use consent from volunteers for their samples. 

Part B Option 1 may be exercised at the discretion of the Government to provide for performance of activities associated with scale-up, cGMP manufacturing and release of 200,000 doses of the recombinant protective antigen (rPA)-based third generation anthrax vaccine candidate. 

Part B Option 2 may be exercised at the discretion of the Government to provide for the design, conduct, completion, and analysis of a Phase 2 clinical trial to evaluate further the safety and immunogenicity of the recombinant protective antigen (rPA)-based third generation anthrax vaccine candidate. 

It is anticipated that multiple cost-reimbursement, completion type contracts will be awarded for a three-year BASE period of performance beginning on or about September 30, 2008, with the Options to be exercised at the discretion of the Government.  The Part A Option, if exercised, will extend the Part A contract(s) for an additional one year, for a maximum period of performance of four years. The Options for Part B, if exercised, will extend Part B contract(s) for two years each, for a maximum period of performance of seven years.  This requirement is being solicited as two Parts and offerors may propose under both Part A and Part B.  In responding to Part A, offerors may propose multiple NIAID Category A or B Priority Pathogen vaccine candidate but are required to submit a separate proposal for each vaccine candidate.  A separate proposal must be submitted for Part B. This Broad Agency Announcement, BAA NIH-BARDA-NIAID-DMID-AI2007007, will be available electronically on or about September 21, 2007and may be accessed at http://www.fedbizopps.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 January 18, 2008. 

It is estimated that the provision of total FTEs per year will be approximately as follows:  Part A Base = 13.85 FTEs for a 3-year period; Part A Option 1 = 3.5 FTEs for a 1-year period; Part B Base = 13.85 FTEs for a 3-year period; Part B Option 1 = 3.7 FTEs for a 2-year period; and Part B Option 2 = 9.45 FTEs a 2-year period. 

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.

Inquiries

Inquiries regarding this notice may be directed to:

Jordan Pulaski
Contracting Officer
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)
Phone 301-451-2569
Fax 301-401-0972
Email jpulaski@niaid.nih.gov

Terry Baughman
Contracting Officer
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)
Phone 301-451-3690
Fax 301-402-0972
Email baughmat@niaid.nih.gov

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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