RFI_Atachment_-_3.pdf

Request for Information (RFI)

Malaria Prophylactic Drug Tafenoquine brand name Arakoda

General Information:

This is an RFI as defined in FAR 15.201(e) to ascertain whether a commercial item exists that provides the capabilities described herein.

This RFI is issued solely for information and planning purposes and does not constitute a solicitation. All information received in response to this RFI will be treated as business confidential information. Nonetheless, submitters should properly mark their responses if the information is confidential. Responses to the RFI will not be returned. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expense associated with responding to this RFI.

RFI Response and due date: 3:00 PM EST on 20 May 2019;

Instructions to Responders:

Responses from all capable and qualified sources are encouraged to respond to this request.

White papers should adhere to the following formatting and outline instructions:

1. All submissions shall be made electronically and be in one of the following formats: Microsoft Word or Adobe

PDF.

2. Cover Page (1page)

Title

Organization

Responders technical and administrative points of contact (names, addresses, phone, fax number and email addresses)

Topic area(s) addressed

3. Completed Attachment 1, and Attachment 2. Please note that the response shall provide sufficient technical data to determine how you fully meet the requirements as specified in Attachment 2.

Please note that responses are due no later than 3:00 PM EST on 20 May 2019. The preferred method of submission is via email. The point of contact for this action is Maribel C. Fratina, maribel.c.fratina.civ@mail.mil, Contract Specialist, Email. Only electronic responses are requested. No evaluation letters and/or results will be issued to the respondents. At this time no solicitation exists; therefore, please do not request a copy of the solicitation. NO PHONE CALLS PLEASE. It is the responsibility of any potential offeror to monitor this site for the release of any solicitation or synopsis.

Background/Overview: The U.S. Army Medical Research and Materiel Command (USAMRMC) manages and executes research in five basic areas: military infectious diseases, combat casualty care, military operational medicine, chemical biological defense, and clinical and rehabilitative medicine. The USAMRMC is program coordinator for Department of Defense (DoD) medical research programs focused on the prevention, mitigation and treatment of blast injuries as well as the manager for the Joint Trauma Analysis and Prevention of Injury in Combat

(JTAPIC) program which informs solutions that prevent or mitigate injury during the full range of military operations, by collaborative collection, integration, analysis and storage of data from operations, intelligence, materiel and medical sources.

mailto:maribel.c.fratina.civ@mail.mil

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The U.S. Army Medical Materiel Development Activity (USAMMDA) is an USAMRMC tenant agency. Within the USAMMDA is the Combat Trauma and Acute Rehabilitation (CTAR). The Combat Trauma and Acute

Rehabilitation, Project Management Office (PMO) were formed in July 2018, with the end goal of fielding U.S.

Food and Drug Administration-cleared or approved medical devices, drugs, and biologics that fulfill the unmet requirements identified by the Service end user. This is accomplished either through the development of a new capability or by improving upon existing capabilities.

STATEMENT OF NEED

Title: Malaria Prophylactic Drug Tafenoquine brand name Arakoda

Requiring Activity/Agency Name: U.S. Army Medical Materiel Development Activity (USAMMDA), Pharmaceutical Systems, Project Management Office (PMO)

Program Name: Malaria Prophylactic Drug Tafenoquine brand name Arakoda

1. PURPOSE

The USAMMDA PMO requires Tafenoquine brand name Arakoda in order to accomplish User Acceptance (Initial

Operational) Testing for the malaria prophylactic drug (Tafenoquine). The goal of this testing is to gain information regarding user compliance of a weekly dosing schedule versus a daily schedule; the suitability of packaging; its ability to be used in multiple operational environments; and a single dose post deployment instead of the current standard of care (SOC) 14 day treatment course. The operational testing will look at the drug‘s performance attributes and usability. User feedback will evaluate U.S. Service Members’ preference for a weekly medication, positive or negative side effects compared to the current standard of care prophylactic malaria medications, and general comments on ease of use of the packaging.

2. SCOPE OF WORK

The contractor shall provide USAMMDA Pharmaceutical Systems Project Management Office with Tafenoquine brand name Arakoda.

Contractor shall provide delivery of the malaria prophylactic drug Tafenoquine brand name Arakoda that meets the minimum essential characteristics (MECs) listed below.

Quantity: The Government intends to procure one commercial lot of ~120,000 tablets (7,500 packages) immediately, with base Contract Line Item Number (CLIN) and three (3) optional CLINs to procure up to 3,750 packages per CLIN.

Place of Performance: Delivery of the Tafenoquine:

Shipping Instructions:

SriSai Biopharmaceutical Solutions LLC

320 Montevue Lane

Frederick, MD 21702

3. PERIOD OF PERFORMANCE/DELIVERY DATE:

Base Year Quantity: 7,500 packages (1 Commercial Lot)/TBD

Option 1 Quantity: 3,750 packages/ TBD

Option 2 Quantity: 3,750 packages/ TBD

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Option 3 Quantity: 3,750 packages/ TBD

MINIMUM ESSENTIAL CHARACTERISTICS (MECs)

USAMMDA, PMO requires a minimum of one commercial lot (~120,000 tablets or 7,500 packages) of Tafenoquine brand name Arakoda in order to carry out its mission essential work in fielding of a new U.S. Food and Drug

Administration (FDA) approved drug. The Tafenoquine brand name Arakoda shall meet all of the following requirements.

The Tafenoquine shall be brand name Arakoda (National Stock Number (NSN) 6505-01-675-5542).

The Tafenoquine shall have the following essential characteristics:

a. FDA approved Tafenoquine succinate tablets for oral use, indicated for the prevention of malaria in adults for up to 6 months of continuous dosing.

b. Each tablet contains 100 mg of tafenoquine free base for oral use only.

c. The dosing regimen for tafenoquine consists of a loading dose of 2 x 100 mg tablets once daily for 3 days before travel to a malarious area, followed by weekly 2 x 100 mg maintenance doses while in the malarious area, followed by one dose of 2 x 100 mg in the week following exit from the malarious area.

d. Tafenoquine tablets can be taken with or without food.

e. Tafenoquine 100 mg tablets packed in blister packs of 8 tablets per blister card. A package of Tafenoquine contains 16 tablets (two blister cards).

f. Tafenoquine tablets can be stored at 20°C to 25°C (68°F to 77°F); with excursions permitted to 15-30°C (59-

86°F).