Amendment 3.docx

AMENDMENT TO BARDA BROAD AGENCY ANNOUNCEMENT

ADVANCED DEVELOPMENT OF CHEMICAL, BIOLOGICAL, RADIOLOGICAL, AND NUCLEAR MEDICAL COUNTERMEASURES Broad Agency Announcement Number: BARDA-CBRN-BAA-12-100-SOL-00011

330 Independence Ave., SW, Room G640 Washington, D.C. 20201 Point of Contact: Primary Point of Contact:

Thomas P. Hastings-Tickerhoff, Contracting Officer thomas.hastings-tickerhoff@hhs.gov Phone: 202-720-2823 Secondary Point of Contact:

Matthew A. McCord, Contract Specialist matthew.mccord@hhs.gov Phone: 202-260-0689

SUMMARY OF CHANGES

A. PURPOSE: The purpose of this Amendment 3 to BARDA-CBRN-BAA-12-100-SOL-00011 is to delete Area of Interest #1: Vaccines on Page 10 under PART 1 Research Areas of Interest and replace it with the following information contained below:

B. Except as provided herein, all other terms and conditions of BARDA-CBRN-BAA-12-100-SOL-00011 remain unchanged.

Area of Interest #1: Vaccines

1.1 Advanced development projects for next generation anthrax vaccines that provide significant advantages over the currently licensed Anthrax Vaccine Absorbed (AVA, or BioThrax®) that is in the Strategic National Stockpile under a pre-EUA for post exposure prophylaxis (PEP), including one or more of the following (e.g.):

· Fewer doses to protection (current AVA regimen is 3 doses over a 28-day period)

· Faster protective immune response

· Improved storage conditions (e.g. no cold chain)

The proposed vaccine candidate must have demonstrated at least non-inferiority (superiority is preferred) to AVA in a non-clinical or clinical study with a minimum of 12 months stability (as measured by acceptable stability indicating assays) prior to White Paper submission. If the offeror is submitting a proposal for an adjuvanted anthrax vaccine, the active pharmaceutical ingredient must have 12 months of stability at the time of White Paper submission.

1.2 Projects to expand availability of licensed anthrax and smallpox vaccines for at-risk populations, e.g. pediatric populations.

1.3 Submissions for smallpox vaccines that do not address at-risk populations will not be considered during the open period of this BAA, unless specifically announced through Special Instructions.

Technical Point of Contact: Dr. Eric Espeland; eric.espeland@hhs.gov