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

Development of a sample-to-result influenza diagnostic product (unitized, automated influenza array assay).

The Contract award is for the advanced development of a novel antiviral drug for the treatment of influenza in severely ill or high risk patients.

Contract No. HHSO100201500010C was awarded on May 22, 2015 to GlaxoSmithKline LLC in the amount of $79,998,267 for the base period and either a $120,000,000 or $112,000,344 option period to support the development of cell-based influenza virus vaccines against influenza subtypes with pandemic potential.

*** UPDATE to BAA:  Amendment No. 0002 is issued.

***UPDATE to BAA: References to ORCA and CCR are changed to System for Award Management, www.sam.gov. The Report of Government-owned, Contractor-held Property is available at http://oamp.od.nih.gov/DGS/FORMS/Govt-Owned-Prop.pdf.

A Broad Agency Announcement (BAA) will be issued that sets forth advanced development areas of interest for the Influenza Division of the Office of the Biomedical Advanced Research and Development Authority (BARDA), a component of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services.

BARDA is the lead Federal agency for the advanced development of medical countermeasures (MCM) to protect the United States against public health emergency threats, including chemical, biological, radiological and nuclear agents, emerging infectious diseases, and pandemic influenza.

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) direct BARDA to promote (i) innovations in technologies that may assist MCM advanced research and development, (ii) research and development of tools, devices, and technologies, and (iii) research to promote strategic initiatives, such as rapid diagnostics, broad spectrum antimicrobials, and vaccine manufacturing technologies.

BARDA's Influenza Division seeks the advanced research and development of MCMs to protect the civilian population of the United States against pandemic influenza, and anticipates that research and development activities awarded under the BAA will serve to advance the knowledge and scientific understanding of candidate MCMs toward licensure or approval by the Food and Drug Administration.

The priorities of the BARDA Influenza Division are closely aligned with the National Strategy for Pandemic Influenza (November 2005), the National Pandemic Influenza Implementation Plan (May 2005), The Public Health Emergency Medical Countermeasures Enterprise Review (August 2010), the President's Council of Advisors on Science and Technology report on influenza vaccine manufacturing (August 2010), and the BARDA Strategic Plan 2011-2016 (October 2011).

Influenza Areas of Interest

The BAA will seek white papers that focus on one or more of the following areas of interest, which will be further described in Part I of the BAA.

1. Personal Protective Equipment (Masks and Respirators) for Influenza Infection & All-
    Hazards
2. Full-Featured Continuous Ventilators for Influenza Infection and All-Hazards
3. Clinical Influenza Test Systems and Diagnostic Tools
4. Influenza Therapeutics
5. Influenza Vaccines
6. Influenza Vaccine Manufacturing Improvement

The BAA will be issued under sections 6.102(d)(2) and 35.016 of the Federal Acquisition Regulation, and submissions selected for award will result from full and open competition in compliance with The Competition in Contracting Act of 1984, Pub. L. No. 98-369, as amended.

This synopsis is not a BAA; the BAA is anticipated to be posted on or about July 31, 2013. The BAA's open period will be identified in the BAA itself. The BAA will be open to all responsible sources regardless of business size. Multiple awards may be made under the BAA.

Contact Information:

Comments on this synopsis should reference BAA-13-100-SOL-00019 and be submitted to FLU-BAA@hhs.gov.

A Broad Agency Announcement (BAA) will be issued that sets forth advanced development areas of interest for the Influenza Division of the Office of the Biomedical Advanced Research and Development Authority (BARDA), a component of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services.

BARDA is the lead Federal agency for the advanced development of medical countermeasures (MCM) to protect the United States against public health emergency threats, including chemical, biological, radiological and nuclear agents, emerging infectious diseases, and pandemic influenza.

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) direct BARDA to promote (i) innovations in technologies that may assist MCM advanced research and development, (ii) research and development of tools, devices, and technologies, and (iii) research to promote strategic initiatives, such as rapid diagnostics, broad spectrum antimicrobials, and vaccine manufacturing technologies.

BARDA's Influenza Division seeks the advanced research and development of MCMs to protect the civilian population of the United States against pandemic influenza, and anticipates that research and development activities awarded under the BAA will serve to advance the knowledge and scientific understanding of candidate MCMs toward licensure or approval by the Food and Drug Administration.

The priorities of the BARDA Influenza Division are closely aligned with the National Strategy for Pandemic Influenza (November 2005), the National Pandemic Influenza Implementation Plan (May 2005), The Public Health Emergency Medical Countermeasures Enterprise Review (August 2010), the President's Council of Advisors on Science and Technology report on influenza vaccine manufacturing (August 2010), and the BARDA Strategic Plan 2011-2016 (October 2011).

Influenza Areas of Interest

The BAA will seek white papers that focus on one or more of the following areas of interest, which will be further described in Part I of the BAA.

1. Personal Protective Equipment (Masks and Respirators) for Influenza Infection & All-
    Hazards
2. Full-Featured Continuous Ventilators for Influenza Infection and All-Hazards
3. Clinical Influenza Test Systems and Diagnostic Tools
4. Influenza Therapeutics
5. Influenza Vaccines
6. Influenza Vaccine Manufacturing Improvement

The BAA will be issued under sections 6.102(d)(2) and 35.016 of the Federal Acquisition Regulation, and submissions selected for award will result from full and open competition in compliance with The Competition in Contracting Act of 1984, Pub. L. No. 98-369, as amended.

This synopsis is not a BAA; the BAA is anticipated to be posted on or about July 31, 2013. The BAA's open period will be identified in the BAA itself. The BAA will be open to all responsible sources regardless of business size. Multiple awards may be made under the BAA.

Contact Information:

Comments on this synopsis should reference BAA-13-100-SOL-00019 and be submitted to FLU-BAA@hhs.gov.