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MARKET SURVEY REQUEST - MEDICAL COUNTERMEASURES TO TREAT/PROTECT AGAINST OPIOID POISONING IN NON-OPIOID DEPENDENT CASUALTIES


Massachusetts, United States
Government : Military
RFI
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MARKET SURVEY REQUEST - MEDICAL COUNTERMEASURE PLATFORM TECHNOLOGIES:

THIS IS A REQUEST FOR INFORMATION (RFI) ONLY for market research and planning purposes only, as defined in FAR 15.201(e). This is not a solicitation or request for competitive proposals. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. 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 Notice. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted, and the Government will not reimburse respondents for preparation of the response. Response to this Notice is strictly voluntary and will not affect future ability to submit an offer if a solicitation is released. There is no bid package or solicitation document associated with this announcement.


The U.S. Army Contracting Command - Aberdeen Proving Ground (ACC-APG), Natick Contracting Division is conducting market research to obtain information regarding the capability of companies with technologies that can counter the effects of opioids, across a wide window of intervention opportunities.


MEDICAL COUNTERMEASURES TO TREAT/PROTECT AGAINST OPIOID POISONING IN NON-OPIOID DEPENDENT CASUALTIES


Background. The high availability of synthetic opioids, such as fentanyl and its derivatives, is a concern to both the civilian and military communities. The onset of severe respiratory depression creates critical needs for 1) rapid administration of adequate doses of medical countermeasures (MCM) to reverse adverse effects, 2) MCM with sustained efficacy profiles to allow time for evacuation of casualty to definitive care within 1 to 2 hours, and 3) pre-exposure (i.e., prophylactic) MCMs to reduce or eliminate the need for post-exposure MCM while sustaining the casualty during transport to definitive care. A suite of MCM is envisioned to adequately address the desire to maintain freedom of action on a battlefield where opioids may be present. The long duration of action of many opioids, to include re-narcotization, makes it desirable to have MCM with comparable, or longer, durations of action.


Requirements. The DoD is seeking technologies that can counter the effects of opioids, across a wide window of intervention opportunities.
The Government requests potential performers provide up to a Five (5) page response containing the following information regarding medical countermeasures to protect against or treat opioid intoxication in a non-opioid dependent population:


1. Description of the technology, to include delivery mechanism (e.g., pill, injection, patch);


2. Conformance with the critical attributes (Table 1) to include duration of action;


3. Stage of product development; Non-clinical safety data; Clinical safety/efficacy data;


4. Relevant experience with US FDA-regulated products (e.g., formulation development,
combination products, novel devices, tableting, clinical trials, non-clinical studies);


5. Proposed regulatory path to licensure;


6. Intellectual Property associated with the technology (e.g., API, FDP, and device).


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 Close of Business (C.O.B.) on 11 October 2017. The Government Contracting Officer for this notice is Ms. Jessica Ely. Responses should be sent by e-mail to: jessica.l.ely.civ@mail.mil. Material that is advertisement only in nature is not desired.


SUBMITTALS:
Interested parties shall respond by specifying if they have a capability that expressly meets the parameters listed above.


Interested Parties shall submit a short summary (no more than 5 pages total) describing their products' capabilities in each of these areas. Interested Parties shall provide business size status based upon NAICS code 541711, Small Business Size Standard of 1,000 Employees, and CAGE code as registered at SAM.gov. Interested Parties may include item brochure information with the summary package by the Government's requested date of submittal of October 11th, 2017. Interested parties shall submit information in response to this RFI to: Jessica.l.ely.civ@mail.mil.


Responses shall be submitted and received via Email no later than 5:00pm EST October 26th, 2017. Documents shall be electronic in Microsoft Word, Excel, Power Point, and/or Adobe Portable Document Format (PDF) and provided as attachments to the Email. No telephonic responses to this RFI will be considered. Questions concerning this RFI may be addressed by contacting: Jessica.l.ely.civ@mail.mil.


All information received in response to this RFI that is marked proprietary will be handled accordingly. Responses to the RFI will not be returned. Responses to this RFI are not offers for contract and will not be used by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. Vendors having capabilities that they believe would be suitable for military operations as described herein shall submit all supporting documentation requested by this RFI to the POC noted above.


Please provide information on your organization in the following areas:


1. Company Name, Address and Single Point of Contact with Name, Title, Telephone Number and E-mail Address.


2. DUNS Number and Cage Code


3. Confirmation of Current Active Registration in System for Award Management (SAM)


4. Primary NAICS Code(s) and Business Size (i.e., small/large)


5. GSA Schedule, If Available


6. Commercial Price List, if GSA schedule is Not Available


7. Product Specific Brochures Literature



PROVISIONS AND CLAUSES:


52.215-3 -- Request for Information or Solicitation for Planning Purposes.


Request for Information or Solicitation for Planning Purposes (Oct 1997)


(a) The Government does not intend to award a contract on the basis of this solicitation or to otherwise pay for the information solicited except as an allowable cost under other contracts as provided in subsection 31.205-18, Bid and proposal costs, of the Federal Acquisition Regulation.


(b) Although "Proposal" and "Offeror" are used in this Request for Information, your response will be treated as information only. It shall not be used as a proposal.


(c) This solicitation is issued for the purpose of: [state purpose].


(End of Provision)


Jessica L. Ely, Contracting Officer, Phone 3016198457, Email jessica.l.ely.civ@mail.mil

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