Ebola

Yesterday, President Barack Obama signed into law a $1.1 trillion appropriations act that allocates approximately $5.4 billion in emergency funding to support the U.S. Government’s response to the Ebola outbreak in West Africa.  Although this funding falls short of the Administration’s initial $6.18 billion request—approximately $1.54 billion of which was to be allocated to a contingency fund similar to appropriations made in response to pandemic influenza—all emergency funding for Ebola provided by the act is available for immediate use.  The funding is split between the Department of Health and Human Services (“HHS”), the Department of Defense (“DoD”), the Department of State, and the Agency for International Development (“AID”).  Government contractors and grant recipients can expect these agencies to use their respective shares of the funding to create a number of opportunities in the coming months.
Continue Reading President Signs Act Authorizing $5.4 Billion in Emergency Funding to Combat Ebola

The U.S. Department of Health and Human Services (“HHS”) published a declaration today under the Public Readiness and Emergency Preparedness (“PREP”) Act covering activities relating to three Ebola vaccine candidates that are currently in development.  The declaration went into effect on December 3, 2014 and extends liability protection to manufacturers, distributors, program planners, and qualified persons who prescribe, administer, or dispense the vaccine candidates identified in the declaration when distributed in connection with a federal contract, grant, or other agreement, or as directed in a public health emergency.  The declaration represents another significant step in the federal government’s response to the Ebola outbreak in West Africa, following recent actions taken by HHS and the Defense Threat Reduction Agency to fund the development of Ebola countermeasures and related products and services.
Continue Reading HHS Issues PREP Act Declaration Covering Ebola Vaccines

The Defense Threat Reduction Agency (“DTRA”) issued a broad agency announcement (“BAA”) at the end of last week seeking “near-term” solutions that can be developed in time to assist with the current (Zaire) Ebola virus outbreak in West Africa.  Expanding on the BAA under which the U.S. Department of Health and Human Services (“HHS”) is seeking solutions to Ebola, which we covered in a recent post, the BAA issued by the DTRA covers a significantly wider array of potential technologies, products, and services, including protective equipment and rapid disinfection processes.  In addition, unlike the BAA issued by HHS, the BAA issued by the DTRA is primarily seeking solutions with almost immediate results—with a number of suggested timeframes calling for a solution’s development in less than six months.

Contracts can be awarded on a fixed price, cost reimbursement, or cost plus fixed fee basis.  The BAA contemplates the potential award of a number of contract types, including indefinite delivery, indefinite quantity (“IDIQ”) contracts, task orders issued under existing IDIQ contracts, and Other Transaction Agreements (“OTAs”).  Other than OTAs, contracts awarded under the BAA will be subject to FAR and DFARS requirements.Continue Reading Defense Threat Reduction Agency Seeks “Near-Term” Solutions to Ebola Outbreak

As the U.S. government works to address the threat posed by the Ebola virus, one tool available to the Department of Health and Human Services (HHS) in this effort is a broad agency announcement (BAA) originally issued in 2009 as a means of accelerating the development of vaccines, therapeutics, and diagnostics to prevent and treat the disease. On October 16, for instance, the agency highlighted that BAA in announcing the award of an $8.6 million contract for the development of an experimental Ebola vaccine. That announcement came on the heels of another HHS award in September 2014 — this one worth $42.3 million — for the development of a separate drug to treat Ebola infections, ZMapp. Additionally, HHS recently issued a task order under its Centers for Innovation in Advanced Development and Manufacturing (CIADM) program inviting three qualified laboratories to submit proposals for the acceleration of production of experimental ZMapp doses. HHS officials have signaled a readiness to look to the BAA in order to identify other qualified technologies for additional awards to combat Ebola.

In a recent press release announcing that HHS is “seeking additional proposals” for the advanced development of Ebola treatments, Robin Robinson, the Director of HHS’s Biomedical Advanced Research and Development Authority (BARDA), vowed that the agency would “push[] hard to advance the development of multiple products as quickly as possible for clinical evaluation and future use in preventing or treating this deadly disease.” For companies with an interest in assisting the government in its Ebola prevention and treatment efforts, a strong working understanding of the above-referenced BAA and its requirements is vital.Continue Reading Government Looking to Existing Procurement Vehicles to Stem Ebola Threat