BARDA Broad Agency Announcement for Advanced Research and Development of Medical Countermeasures for Pandemic Influenza

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 2009 H1N1 influenza pandemic exemplified the unpredictability and rapidity with which a novel influenza strain can impact the world's population. Despite widespread infections, the 2009 H1N1 virus was only mildly pathogenic, with relatively low rates of morbidity and mortality. With historic efforts by government and industry partners, vaccines were developed and produced in record time, available to the public six months after the initial outbreak. However, it is almost inevitable that future pandemics will feature morbidity and mortality rates comparable with historically severe pandemics such as 1918, 1957, and 1968. This ongoing threat underscores the compelling need to optimize current medical countermeasures and develop entirely new modalities for prevention and treatment of influenza disease. Vaccines, therapeutics and diagnostics are essential to protect all segments of the civilian population. This BAA will support advanced development activities to improve candidate products and diagnostic tools and incorporate considerations of the challenging lifecycle requirements of these products before and during a pandemic (e.g. shelf life, storage, distribution, and dispensing). The Pandemic and All Hazard Preparedness Act directs 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. The priorities of the BARDA Division of Influenza and Emerging Infectious Diseases are closely aligned with the National Strategy for Pandemic Influenza and the HHS Pandemic Influenza Implementation Plan. In addition, the recently released HHS Public Health Emergency Medical Countermeasures Enterprise Review emphasizes the need to improve medical countermeasure technologies and move towards - nimble, flexible capacity to produce medical countermeasures rapidly in the face of any attack or threat. The purpose of this BAA is to solicit proposals that focus on one or more of the following Research Areas of Interest: - Vaccines - Antiviral Therapeutics for Treatment and/or Prophylaxis - Mitigation of Severe Respiratory Disease Resulting from Influenza Infection - Clinical Influenza Test Systems and Diagnostic Tools 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 is anticipated on March 28, 2011. The Government expects to make 1 or more awards, subject to the availability of funds, on or about September 17, 2011. Point of Contact: Comments to this announcement, referencing synopsis BAA BARDA 11-100-SOL-00013 may be submitted to FLU-BAA@hhs.gov Note: Offerors are encouraged to attend one or both of the conferences. Pre-proposal Conference #1: April 12, 2011 for all research areas of interest. Hubert H. Humphrey Building 1st Floor Auditorium 200 Independence Avenue S.W. Washington, DC 20201 Please note the following regarding the pre-proposal conference: 1. Attendance is limited to a maximum of two (2) people per company. Email the names of your attendees and Research Area of Interest to FLU-BAA@hhs.gov by April 5, 2011. To ensure an equal distribution of attendees in each Research Area of Interest, registration for each section will be controlled and a wait-list established. 2. Enter the Humphrey Building at the Independence Avenue Street entrance. 3. Arrive 30 minutes early to allow time to clear security 4. Bring your identification 5. The closest metro stop is Federal Center SW 6. Tape recorders and videos are prohibited. 7. Presentation material from the conference will be posted on FedBizOpps in an amendment to the BAA following the pre-proposal conference Pre-proposal Conference #2: A second pre-proposal conference may be announced in a subsequent FedBizOps amendment to this BAA. Questions from may be emailed to FLU-BAA@hhs.gov no later than April 5th, 2011. A selection of submitted questions will be addressed during the April 12th, 2011 Pre-Proposal Conference NOTE: For those who are unable to attend, please use the following dial-in information: (866)880-0098 Passcode: 3458287#. Dial-in attendees will be muted.