HHS Colony Stimulating Factor 2013-2018

The Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response established this Master IDIQ on September 19, 2013, to acquire Colony Stimulating Factor (G-CSF or GM-CSF) as a medical countermeasure for neutropenia arising from exposure to ionizing radiation in national medical emergencies. The vehicle's ordering period closed on September 28, 2018, and remains inactive; no new orders can be placed against it.

Seven task orders totaling $401.7 million in combined potential value were issued under the vehicle between September 2013 and September 2018, with all $401.6 million obligated. The customer base was confined to HHS ASPR; no other agencies participated. All awards were firm fixed price, unrestricted competitive procurements with no set-aside designations.

Amgen USA Inc. dominated the vehicle, winning four orders for a combined potential value of $350.1 million—approximately 87 percent of the total. Partner Therapeutics, Inc. won two orders worth $51.6 million, while Sanofi-Aventis U.S. LLC received one order with zero potential value (likely a maintenance or administrative action). The two largest orders were both awarded to Amgen in September 2018: one with a $154.4 million ceiling and another with a $708,420 ceiling. Earlier tranches in 2016 and 2013 ranged from approximately $14 million to $157.3 million in ceiling value. Ordering activity clustered in the vehicle's first and final years, with minimal middle-period flow.

Since the ordering period closed seven years ago and all available potential value has been obligated, this vehicle is not available for new task orders. Existing task-order completions extended into 2024, but no new work can be pursued under this vehicle. Any CSF medical countermeasure requirements from HHS ASPR would require a successor vehicle or alternative contracting mechanism if one exists.

The Department of Health and Human Services (HHS) has the responsibility of maintaining a definitive supply of medical countermeasures - or the forward deployment of same - for use in national medical emergencies declared by the Secretary of HHS.HHS has a requirement to acquire, hold, and distribute medical countermeasures that will mitigate injuries caused by exposure to chemical threat agents, biological threat agents, and physical radiologic and nuclear exposures. In the case of exposure to radiologic or nuclear ionizing energy, the integrity and homeostasis of neutrophil number and function (i.e., neutropenia) is an early pathology that must be clinically addressed due to increased risk of infection and sepsis. The most common clinical treatment to address neutropenia is the use of Colony Stimulating Factor (CSF) as either Granulocyte (G) or Granulocyte-Macrophage (GM), also known as G-CSF or GM-CSF.