Broad Agency Announcement (BAA) for the Advanced Development of Medical Countermeasures for Pandemic Influenza

This amendment extends the Deadline for Submission to November 30, 2017.

Amendment two (2) is to 1.) remove the mailing address and add instructions on how to obtain the applicable mailing address under Stage 2: Full Proposal Submission and 2.) add cost proposal page limitation under Volume II-Cost Proposal.

BAA-16-100-SOL-00002

Synopsis:

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 Pandemic Influenza in support of the preparedness mission and priorities of the HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) articulated in the 2014 PHEMCE Implementation Plan. The Implementation Plan is located on the ASPR website: http://www.phe.gov/Preparedness/mcm/phemce/Documents/2014-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.

Development Area of Interest:
The purpose of this BAA is to solicit proposals that focus on one or more of the following area of interest as listed below:

Development Area of Interest
• Personal Protective Equipment (Mask and Respirators) for Influenza Infection for All- Hazards
• Full-Featured Continuous Ventilators for Influenza and All-Hazards
• Influenza Test Systems and Diagnostic Tools
• Influenza Therapeutics
• Influenza Vaccines

BARDA anticipates that research and development activities awarded from this Broad Agency Announcement (BAA) will serve to advance the knowledge and scientific understanding of candidates' to protect the civilian population of the United States against pandemic influenza and serve to advance candidate medical countermeasures towards licensure or approval by the Food and Drug Administration (FDA).

The Government intends to promote full & open competition for this requirement in the form of a BAA. This synopsis is not a BAA; BAA solicitation no. BAA-16-100-SOL-00002 is anticipated to be posted on or about October 13, 2015. The Government expects to make 1 or more awards, subject to the availability of funds. The open period of the BAA will be specified in the BAA. This advertisement does not commit the Government to award a contract.

Contact Information:
Technical Point of Contact - Chuong Huynh, Chuong.Huynh@hhs.gov
Comments to this announcement, referencing synopsis of BAA- 16-100-SOL-00002 may be submitted to email address Flu-BAA@hhs.gov.

Contracting Office Address:
Department of Health & Human Services (DHHS)
Office of the Assistant Secretary for Preparedness & Response (ASPR)
Acquisition Management Contracts & Grants (AMCG)
330 Independence Ave., S.W., Room G-644
Washington, D.C. 20201

Pre-proposal Conference:
A Multi-BAA Pre-Proposal Conference will be held in Washington, DC on October 14-16, 2015. 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-2015