BAA SpecialInstructions_20100628 BSA Amendment 3.pdf

Part VI: Special Instructions

NEW REQUIREMENT FOR BROAD SPECTRUM ANTIMICROBIALS

AMENDMENT TO BARDA BROAD AGENCY ANNOUNCEMENT (BAA)

ADVANCED DEVELOPMENT OF CHEMICAL, BIOLOGICAL,

RADIOLOGICAL, AND NUCLEAR MEDICAL COUNTERMEASURES

BAA Number: BARDA-CBRN-BAA-10-100-SOL-00012

Amendment Number: Three (3)

Amendment Posting Date: July 9, 2010

Issued By: Biomedical Advanced Research and Development

Authority (BARDA) 330 Independence Ave., SW, Room G640 Washington, D.C. 20201

Point of Contact: Primary: Ethan J. Mueller, Contracting Officer, Ethan.Mueller@hhs.gov

Alternate: Jeannett Jackman, Contract Specialist, jeannett.jackman@hhs.gov

SUMMARY OF CHANGES

A. PURPOSE: The following are special instructions for offerors submitting White Papers and Quad Charts for Area of Interest #3: Broad Spectrum Antimicrobials. The purpose of these special instructions is to expand the scope of studies to be supported to include efforts which support the development of non-biological threat agent indications.

(1) White Papers and Quad Charts will be accepted for funding consideration under this BAA and must be submitted electronically only and titled Broad Spectrum Antimicrobials to the following e-mail address: CBRN-BAA@hhs.gov. The date for receipt of Quad Charts and White Papers under these special instructions is open for the duration of BARDA-CBRN-BAA-10-100-SOL-00012.

(2) The page limit is increased as follows for Part IV: Proposal Preparation and Submission, Section 2: Stage 1 Quad Chart and White Paper Preparation, Initial submission is limited to a one-page Quad Chart; a one-page integrated product development timeline/ task overview; a cover page; a White Paper not to exceed ten (10) pages and an addendum (not to exceed three (3) pages).

mailto:Ethan.Mueller@hhs.gov mailto:jeannett.jackman@hhs.gov mailto:CBRN-BAA@hhs.gov

(3) Questions from industry regarding the special instructions may be emailed and titled Broad Spectrum Antimicrobials to CBRN-BAA@hhs.gov.

(4) Except as provided herein, all other terms and conditions of the BAA remain unchanged.

Special Instructions – Broad Spectrum Antimicrobials

The purpose of these special instructions is to expand the scope of advanced research and development under Area #3 Antimicrobial Drugs to include studies which support indications for clinically relevant and emerging infectious diseases.

In accordance with the Pandemic and All-Hazards Preparedness Act of 2006 (PAHPA), BARDA has the responsibility to ensure that the United States has a sufficient supply of vaccines and drugs to respond to public health emergencies caused by pandemic influenza, emerging infectious diseases, and chemical, biological, and radiological and nuclear threats. Recognizing the dual utility of antimicrobials for the treatment and prevention of diseases caused by bacterial threat agents and clinically relevant emerging and drug resistant bacterial pathogens, BARDA is expanding the scope of its BAA in order to maximize the return on research investment.

BARDA is expanding the scope of the BAA Research Area #3 to include the following:

Pre-clinical and clinical studies to support non-biological threat agent indications.

Additional work (e.g. manufacturing methodology development, assay development and validation) to support non-biological threat agent indications.

While support of non-biological threat agent studies will be permitted, the pursuit of indications for biological threat agents is mandatory to be considered for award.

All White Paper and Quad Chart submissions must be UNCLASSIFIED.

All Offerors will receive a letter and/or e-mail acknowledging receipt of their White Paper and Quad Chart submission. Offerors will receive either a Rejection Letter or a Letter inviting the submission of a Full Proposal based on the evaluation of the White Paper and Quad Chart.

Debriefings for White Papers and Quad Charts will not be provided.

Evaluation Criteria: Please refer to the BAA and all Amendments.

mailto:CBRN-BAA@hhs.gov