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W911SR-23-S-IMPRT

REQUEST FOR INFORMATION

Importation and Distribuiton of a U.S. Food and Drug Administration (FDA) Approved Schedule IV Controlled Product

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 Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical) and the Joint Program Executive Office for Chemical, biological, Radiological, and Nuclear Defense (JPEO-CBRND) is seeking information on the available capabilities and willingness of private entities (academic, non-profit, and commercial) to collaborate with the Government in the areas listed below.

Background:

JPM CBRN Medical is interested in meeting the operational need for supporting fielded systems. As such, the Department of Defense (DoD) has a need for importing medical products. JPEO-CBRND is responsible for the development, procurement, fielding, and sustaining of medical treatment and prophylactic capabilities against CBRN threats.

Requirements:

The Government is seeking white papers outlining approaches for the importation of a controlled substance. The purpose of this RFI is to solicit information on the availability of U.S. based companies capable of importing and distributing an FDA approved Schedule IV product. The ability for immediate import is required. The product will be transportable by standard air, ground, and water systems, and is designed to survive transportation in military combat, tactical air, ground, and sea systems. Custodian supervision is required for shipment.

Performance Objectives:

1. Performer must have a U.S. Drug Enforcement Administration (DEA) import license and the ability to import a Schedule IV product immediately.


2. Performer must have an existing DEA Importer Registration.


3. Performer must have initial storage capacity with an existing DEA Registration.


4. Performer must have capability to further distribute to product to up to eight locations within the U.S. and Outside the Contiguous United States (OCONUS).


5. Custodian supervision is required for shipment.

The Respondents shall provide the following in reply to this RFI, not to exceed 7 pages in total:

1. Company Description (2 page maximum).

• Provide a brief description of company history, alliances and funding emphasizing experience in importing an FDA approved Schedule IV product.

1. Import Plan (5 page maximum)

• Description and discussion of any innovative approaches that address the overarching program goals that do not precisely match the above Performance Objectives can be included.


• Provide a supply chain plan that would support the import, and distribution a controlled product. Must have the immediate ability to meet all DEA licensing and registration requirements.


• Provide a Rough Order of Magnitude cost.

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 15 May 2023. Responses should be sent by e-mail to: usarmy.detrick.jpeo-cbd.mbx.mcs-rfi@mail.mil, and usarmy.detrick.dod-jpeo-cbrnd.mbx.baa@army.mil, with Subject Line of Responding Organization and RFI Title. Material that is advertisement only in nature is not desired. If a solicitation is subsequently released based on the responses to this RFI, it will be posted on Sam.gov. For questions related to this RFI, please e-mail to: usarmy.detrick.jpeo-cbd.mbx.mcs-rfi@mail.mil, and usarmy.detrick.dod-jpeo-cbrnd.mbx.baa@army.mil. The Point of Contact for this RFI is Richard Totten at Richard.w.totten2.civ@army.mil.

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