The Joint Program Executive Office for Chemical and Biological Defense (Medical Countermeasures Systems) Chemical Defense Pharmaceutical Division is seeking information on the capabilities of private entities (academic, non-profit and commercial) to conduct FDA compliant studies on the stability of Soman Nerve Agent Pre-Treatment Pyridostigmine Bromide (PB) tablets.
Pyridostigmine bromide (PB) is approved by the Food and Drug Administration (FDA) to be used as a pretreatment for exposure to the chemical nerve agent, soman.
SNAPP is packaged in an immediate container containing twenty-one (21) tablets individually sealed in a blister strip package supplied in a protective sleeve. The FDA-approved storage conditions for SNAPP is under refrigeration between 2oC and 8oC (36oF to 46oF) for a period of 10 years or at controlled room temperature at 20°C to 25°C (68°F to 77°F) for a period of five (5) years. Personnel are advised not to dispense the content of the unit packages (10 blister packs) and shipping containers (10 packages of 10 each blister packs) after removal from refrigeration or controlled room temperature for more than a total of 3 months. Military personnel are advised to discard the contents of the individual unit packages of SNAPP three (3) months after issue.
SNAPP is for Military Use only and is manufactured by Bausch Health Companies, Inc, Laval, Quebec, Canada and is distributed by the Defense Supply Center, Philadelphia, PA, U.S.A. The sponsor is the U.S. Army.
The purpose of this RFI is to solicit information on the availability of industry to conduct stability studies of SNAPP under a variety of storage conditions (temperature, humidity) to support shelf-life extension. The respondent should address extended stability studies over a period of 0 months to 132 months across a range of temperature, humidity, and storage conditions.
Additional requirements are detailed on FBO.gov under Solicitation Number: W911QY-19-S-0010.