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
- 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.