Biomedical Advanced Research and Development Authority (BARDA) Broad Agency Announcement (BAA)

Synopsis:

The Biomedical Advanced Research and Development Authority (BARDA) encourages the advanced research, development, and acquisition of medical countermeasures such as vaccines, therapeutics, and diagnostics, as well as innovative approaches to meet the threat of Chemical, Biological, Radiological and Nuclear (CBRN) agents, emerging infectious diseases, and pandemic influenza. These efforts are in support of the preparedness mission and priorities of the HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) articulated in the 2016 PHEMCE Implementation Plan for CBRN Threats. The Implementation Plan is located on the ASPR website: https://www.phe.gov/Preparedness/mcm/phemce/Documents/2016-phemce-sip.pdf

The Pandemic and All Hazard Preparedness Act Pub. L. No. 109-417, 42 U.S.C. § 241 et seq. (PAHPA: http://www.gpo.gov/fdsys/pkg/PLAW-109publ417/pdf/PLAW-109publ417.pdf) and The Pandemic and All Hazard Preparedness Reauthorization Act Pub. L. No. 113-5, (PAHPRA: http://www.gpo.gov/fdsys/pkg/PLAW-113publ5/pdf/PLAW-113publ5.pdf) authorizes BARDA to (i) conduct ongoing searches for, and support calls for, potential qualified countermeasures and qualified pandemic or epidemic products; (ii) direct and coordinate the countermeasure and product advanced research and development activities of the Department of Health and Human Services; (iii) establish strategic initiatives to accelerate countermeasure and product advanced research and development (which may include advanced research and development for purposes of fulfilling requirements under the Federal Food, Drug, and Cosmetic Act or section 351 of this Act) and innovation in such areas as the Secretary may identify as priority unmet need areas; and (iv) award contracts, grants, cooperative agreements, and enter into other transactions, for countermeasure and product advanced research and development.

Areas of Interest:

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 further described in Part I.

Research and Development Areas of Interest:

1. CBRN Vaccines
2. Antitoxins and Therapeutic Proteins
3. Antibacterials
4. Radiological/Nuclear Threat Medical Countermeasures
5. Chemical Threat Medical Countermeasures
6. Burn Medical Countermeasures
7. CBRN Diagnostics
8. Influenza and Emerging Diseases (IED) Therapeutics
9. Influenza and Emerging Diseases (IED) Vaccines
10. Respiratory Protective Devices
11. Ventilators
12. Influenza and Emerging Diseases (IED) Diagnostics
13. MCM Production Platform Systems
14. Modeling and Forecasting
15. Visual Analytics

BARDA solicits proposals for the advanced research and development of medical countermeasures for chemical, biological, radiological, nuclear agents, pandemic influenza, and emerging infectious diseases that threaten the U.S. civilian population. BARDA anticipates that research and development activities awarded under this BAA will serve to advance candidate medical countermeasures towards licensure or approval by the U.S. Food and Drug Administration (FDA). This BAA will also serve to advance the knowledge and scientific understanding of candidates' platform technologies, modeling and forecasting, and visual analytics.
The Government intends to have a full & open competition for this requirement in the form of a BAA. This synopsis is not a BAA; a BAA itself is anticipated to be posted on or about November 3, 2017. The Government expects to make one or more awards, subject to the availability of funds. The open period of the BAA will be specified in the BAA itself.

Pre-proposal Conference:

A BAA Pre-Proposal Conference is scheduled during the BARDA Industry Day from November 7-8, 2017 in Washington, D.C. Advance registration is required. For additional information, and to register, please visit:
https://www.medicalcountermeasures.gov/federal-initiatives/public-meetings-and-conferences/barda-industry-day-2017.aspx

Contact Information:

Comments to this announcement, referencing synopsis BAA-18-100-SOL-00003, may be submitted to the following email address: BARDA-BAA@hhs.gov

Contracting Office Address:

Department of Health and Human Services (HHS), Office of the Secretary (OS), Assistant Secretary for Preparedness and Response (ASPR), Acquisition Management, Contracts and Grants (AMCG), 330 Independence Avenue, SW, RM G644, Washington, DC, 20201