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.

Areas of interest include:

  • Therapeutics or Vaccines
    • Toxicity testing and immunogenicity studies
    • Efforts to produce therapeutic immune sera or immune-globulin—both of which contain antibodies against the disease—under an investigational new drug (“IND”) application from either vaccine-immunized subjects or disease survivors
    • Repurposed therapeutics that have already been approved by the U.S. Food and Drug Administration and broad-spectrum antivirals as long as they demonstrate efficacy for Ebola
    • Preclinical non-Good Laboratory Practices (“GLP”) efficacy studies
    • Manufacturing process development, manufacturing, characterization, and release of current Good Manufacturing Practices (“GMP”) material
    • IND-enabling non-clinical studies
    • Development, submission, and sponsorship of an IND application
    • Clinical studies
  • Diagnostics
  • Social networking, road, estuary, and human mobility, and hospital disease transmission modeling or methods
  • Ebola characterization, including identification of how Ebola survives in nature and the means of its transmission
  • Determination of a quantitative infectious dose
  • Persistence and decay or survival rate studies to facilitate predictions of potential mutations in the virus, as well as studies into molecular determinants for persistence
  • Biohazard personal protective equipment and rapid disinfection processes

The DTRA intends to evaluate proposals in stages over approximately five months, with Phase I expected to be complete within two months of the preliminary submission of a “quad chart” and white paper and Phase II expected to be complete within three months of the submission of a complete proposal.  The BAA will remain in effect for two years, with the potential to award contracts up to three years after its issuance.

Federal entities may not act as prime contractors or furnish principal investigators to offerors, but offerors may identify federal entities as subcontractors.  Offerors that propose to subcontract with a federal laboratory may need to enter into a Cooperative Research and Development Agreement (“CRADA”) with another agency in addition to entering into a contract with the DTRA.  CRADAs are not subject to the FAR and typically have unique intellectual property provisions of which offerors should be aware.

The BAA represents yet another opportunity for contractors to offer novel solutions to a number of issues raised by the recent Ebola outbreak.  However, great risk may be associated with offering a potential solution to the Ebola outbreak.  Contractors should carefully evaluate the scope of their potential liability when responding to solicitations like the BAA.

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Photo of Jennifer Plitsch Jennifer Plitsch

Jennifer Plitsch leads the firm’s Government Contracts Practice Group, where she works with clients on a broad range of issues arising from both defense and civilian contracts including contract proposal, performance, and compliance questions as well as litigation, transactional, and legislative issues.


Jennifer Plitsch leads the firm’s Government Contracts Practice Group, where she works with clients on a broad range of issues arising from both defense and civilian contracts including contract proposal, performance, and compliance questions as well as litigation, transactional, and legislative issues.

She has particular expertise in advising clients on intellectual property and data rights issues under the Federal Acquisition Regulations (FAR) and obligations imposed by the Bayh-Dole Act, including march-in and substantial domestic manufacturing. Jen also has significant experience in negotiation and compliance under non-traditional government agreements including Other Transaction Authority agreements (OTAs), Cooperative Research and Development Agreements (CRADAs), Cooperative Agreements, Grants, and Small Business Innovation Research agreements.

For over 20 years, Jen’s practice has focused on advising clients in the pharmaceutical, biologics and medical device industry on all aspects of both commercial and non-commercial agreements with various government agencies including:

  • the Department of Veterans Affairs (VA);
  • the Department of Health and Human Services (HHS), including the Biomedical Advanced Research and Development Authority (BARDA), the National Institutes of Health (NIH), and the Centers for Disease Control (CDC);
  • the Department of Defense (DoD), including the Defense Threat Reduction Agency (DTRA), the Defense Advanced Research Projects Agency (DARPA), and the Joint Program Executive Office for Chemical Biological Defense (JPEO-CBRN); and
    the U.S. Agency for International Development (USAID).

She regularly advises on the development, production, and supply to the government of vaccines and other medical countermeasures addressing threats such as COVID-19, Ebola, Zika, MERS-CoV, Smallpox, seasonal and pandemic influenza, tropical diseases, botulinum toxin, nerve agents, and radiation events. In addition, for commercial drugs, biologics, and medical devices, Jen advises on Federal Supply Schedule contracts, including the complex pricing requirements imposed on products under the Veterans Health Care Act, as well as on the obligations imposed by participation in the 340B Drug Pricing program.

Jen also has significant experience in domestic sourcing compliance under the Buy American Act (BAA) and the Trade Agreements Act (TAA), including regulatory analysis and comments, certifications, investigations, and disclosures (including under the Acetris decision and Biden Administration Executive Orders). She also advises on prevailing wage requirements, including those imposed through the Davis-Bacon Act and the Service Contract Labor Standards.