Soman Nerve Agent Pre-Treatment Pyridostigmine Bromide (SNAPP) Shelf-life Modernization
W911QY-19-S-0010
REQUEST FOR INFORMATION
Soman Nerve Agent Pre-Treatment Pyridostigmine Bromide (SNAPP) Shelf-life Modernization
Objective: This is a Request for Information (RFI) for planning purposes only. It is not to be construed as a commitment by the Government nor will the Government pay for the information solicited. No solicitation document exists or is guaranteed to be issued as a result of this RFI. The Joint Program Executive Office for Chemical and Biological Defense (Medical Countermeasures Systems) are seeking information on the capabilities and willingness of private entities (academic, non-profit and commercial) in the areas listed below.
Background:
The Joint Program Executive Office for Chemical and Biological Defense (Medical Countermeasures Systems) Chemical Defense Pharmaceutical Division is seeking information on the capabilities and willingness of private entities (academic, non-profit and commercial) to conduct FDA compliant studies on the stability of Soman Nerve Agent Pre-Treatment Pyridostigmine Bromide tablets (SNAPP), NSN 6505-01-178-7903 and NSN 6505-01-676-2174 to support modernization efforts. 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.
Requirements:
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 according to The U.S. Pharmacopeia (USP) <659> "Packaging and Storage Requirements."
Performance Objectives:
1. Demonstrate ability to complete stability studies for SNAPP under the following conditions:
a. Ambient temperature (Temperature range 0oC and 35oC)
b. Extended Controlled room temperature (Temperature range 20°C to 25°C)
c. Operational Temperature (Temperature range 0°C, 40oC, and 50°C)
d. Change from Refrigeration to Controlled Room Temperature (Temperature range 5°C to 25°C)
e. Temperature excursions
2. Experience and ability to conduct Good Manufacturing Practices (GMP) compliant stability studies
3. Experience producing and reporting stability data for FDA submissions
4. Synopsis of any relevant experience with the FDA
5. Maximum 3-5 pages
RFI Format: Provide a description of what specifically the respondents should provide and in what format the information is organized. Example:
The Respondents shall provide the following in response to this this RFI:
1. Company Description
• Provide a brief company description and history, emphasizing experience developing similar studies including other products approved by FDA
• Description of resources / equipment available to complete stability studies
• Experience in executing FDA-approved protocols and collecting data for FDA submissions
• Do you anticipate any foreign nationals working on the project?
2. System Description
• A brief description of proposed methodology to complete the studies
3. Cost
• Provide the Rough Order of Magnitude (ROM) cost estimate of the proposal to acquire the stability data
4. Schedule
• Proposed timeline/schedule to complete the studies
Administration: The Government will retain comments and information received in response to this RFI. Proprietary information should be identified as Company Proprietary. Do not use Government security classification markings. All written responses must be received by COB on 20 June 2019. Responses should be sent by e-mail to: usarmy.detrick.jpeo-cbd.mbx.mcs-rfi@mail.mil, with Subject Line of Responding Organization and RFI Title. Material that is advertisement only in nature is not desired. A release of a solicitation under FBO or a competitive release against the Medical CBRN Defense Consortium (MCDC) OTA will be determined based on assessment of responses and review of program requirements. Respondents not already members of the consortium are encouraged to join at www.medcbrn.org. Respondents may also inquire about the MCDC at mcdc@ati.org.
Richard Totten, Contract Specialist, Phone 3016192446, Email richard.w.totten2.civ@mail.mil
