BARDA Broad Agency Announcement for the Advanced Research and Development of Chemical, Biological, Radiological, and Nuclear Medical Countermeasures

This announcement is for the award of a cost plus fixed fee contract to Nanotherapeutics, Inc. for the development of a Nanotherapeutics oral solid dose form DTPA product.   

This cost reimbursement contract is awarded to the University of Arkansas for Medical Sciences for the development of SOM230 as a countermeasure against acute radiation syndrome (ARS).

This announcement is for the award of a cost reimbursement research and development contract to Dartmouth College for the advanced development of in vivo electron paramagnetic resonance (EPR) tooth dosimetry for rapid point-of-care diagnostic assessment of absorbed doses of ionizing radiation under the procedures of the subject Broad Agency Announcement (BAA).

This action is for the awards of a cost plus fixed fee contract for the research and development of HemaMaxTM (rhuIL-12) towards a BLA submission for the mitigation of the Hematopoietic Syndrome of Acute Radiation Syndrome (HSARS) under the FDA Animal Rule.

This action is for the award of a Cost Plus Fixed Fee (CPFF) type contract to  Vaxin, Incorporated for the research and development of a Non-Invasive Rapid Response Anthrax Vaccine utilizing the procedures under BARDA-BAA-09-34.

This contract is awarded to Countervail Corporation utilizing the procedures in BAA-BARDA-09-34 for advanced development of a drug to treat injury from exposure to deadly chemical agents.

This contract is awarded to Apogee Biotechnology Corporation utilizing the procedures in BAA-BARDA-09-34 for the evaluation of drug compound ABC294640 as a medical countermeasure for the mitigation of GI Acute Radiation Syndrome.

This contract is awarded to Avaxia Biologics, Inc. utilizing the procedures in BAA-BARDA-09-34 for the development of AVX-470 as a medical countermeasure for GI Acute Radiation Syndrome.

This contract is awarded to US Biotest, Inc. utilizing the procedures in BAA-BARDA-09-34 for the advanced development of DSC127, a non-hypertensive topical formulation AngiotensinII agonist to promote epithelial healing and hematopoesis.

This contract is awarded to Aeolus Pharmaceuticals utilizing the procedures in BAA-BARDA-09-34 for the development of AEOL 10150 as a MCM against ARS/DEARE pulmonary effects.

This action is for the award of a Cost Plus Fixed Fee (CPFF) type contract to KAKETSUKEN, the Chemo-Sero-Therapeutic Research Institute of Japan for the development of an Alternative Live Attenuated Vaccinia Vaccine (LC16m8) for the Prevention of Smallpox.

This contract is awarded to Emergent Product Development Gaithersburg, Incorporated utilizing the procedures in BAA-BARDA-09-34 for the advanced development of a Recombinant Protective Antigen (rPA) Anthrax Vaccine Revision 1.

This contract is awarded to Achaogen, Incorporated utilizing the procedures in BAA-BARDA-09-34 for the development of a novel, Broad Spectrum "Neoglycoside" Antibiotic for the treatment of Resistent Threat Agents.

Through this BAA, BARDA encourages the advanced research and development of medical countermeasures such as vaccines, therapeutics, and diagnostics, as well as innovative approaches to meet the threat of CBRN agents in support of the preparedness mission and priorities of the HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE), as articulated in the PHEMCE Implementation Plan for CBRN Threats. The Implementation Plan is located on the ASPR website (http://www.hhs.gov/aspr/barda/phemce/index.html).



The Pandemic and All Hazard Preparedness Act (PAHPA) directs BARDA to promote (i) innovations in technologies that may assist countermeasure and product advanced research and development, (ii) research on and development of research tools and other devices and technologies, and (iii) research to promote strategic initiatives. Through this BAA, BARDA seeks to apply these technological advancements to medical countermeasures for biodefense CBRN threats. The PAHPA is located on the ASPR website (http://www.hhs.gov/aspr/opsp/pahpa/index.html).



Offerors should note that this is an announcement to declare BARDAs broad role in competitive funding of meritorious and quality research across a spectrum of medical countermeasures. The purpose of this Broad Agency Announcement (BAA) is to solicit proposals that focus on one or more of the following areas of interest as listed here and will be further described in Part I of the full BAA.



Research Areas of Interest:

1. Vaccines

2. Antitoxins andTherapeutics

3. Antimicrobial Drugs

4. Radiological and Nuclear Threat Countermeasures

5. Chemical Threat Countermeasures

6. Clinical Diagnostic Tools



BARDA anticipates that contracts, grants, cooperative agreements, or other transaction authority for research and development activities awarded from this BAA will serve to facilitate the development, testing, manufacture, and utilization of medical countermeasures and/or supportive reagents and assays for regulatory acceptance in the U.S. The results of those awards will inform future acquisition decisions.



Pre-Proposal Conferences:



Two pre-proposal conferences will be held at the following address:



330 Independence Ave. S.W.

Mary E. Switzer Building, 3rd floor Conference Room 3005

Washington, DC 20201



Pre-proposal 1. March 10, 2009 from 1-3 pm for research area 1: vaccines, research area 2: antitoxins and therapeutics.



Pre-proposal 2. March 24, 2009 from 1-3 pm for research area 3: antimicrobial drugs; research area 4: radiological/nuclear threat medical countermeasures; research area 5: chemical threat medical countermeasures and research area 6: clinical diagnostics tool.



Offerors are requested to submit questions they would like addressed at the pre-proposal conferences to CBRN-BAA@hhs.gov by March 4, 2009 for pre-proposal conference 1 and March 16, 2009 for pre-proposal conference 2.



Point of Contact:



Comments to this announcement, referencing synopsis BAA-BARDA-09-34 may be submitted to Glynis Fisher, Contracting Officer at 202-260-1880 or in writing to glynis.fisher@hhs.gov.