SPECIAL NOTICE
65 -- Notice of Intent to Sole Source Teleflex
- Notice Date
- 7/7/2021 12:55:11 PM
- Notice Type
- Special Notice
- NAICS
- 325414
— Biological Product (except Diagnostic) Manufacturing
- Contracting Office
- W4PZ USA MED RSCH ACQUIS ACT FORT DETRICK MD 21702-5014 USA
- ZIP Code
- 21702-5014
- Response Due
- 7/22/2021 1:00:00 PM
- Archive Date
- 08/06/2021
- Point of Contact
- James Cheng, Phone: 3016191012
- E-Mail Address
-
james.cheng1.civ@mail.mil
(james.cheng1.civ@mail.mil)
- Description
- This notice announces the intent by the U.S. Army Medical Research Acquisition Activity (USAMRAA) in support of the Defense Health Agency (DHA) to procure Freeze Dried Plasma (FDP) without competition as prescribed in FAR 6.302-1(a)(2). Specifically, the Government will procure the FDP from Teleflex Incorporated. As described at FAR 6.302-1(a)(2), when the supplies or services required by the agency are available only from one responsible source, or for DoD, NASA and the Coast Guard, from only one or a limited number of responsible sources, and no other types of supplies or services will satisfy agency requirements, full and open competition need not be provided for. There are no known suppliers for FDP in the United States at this time. As a result the U.S. FDA granted on July 10, 2018, to the Department of Defense (DoD) an emergency use authorization (EUA) under �564 of the Food, Drug and Cosmetic Act (FDCA) to enable the emergency use of Pathogen-Reduced Leukocyte-Depleted Freeze-Dried Plasma manufactured by the French military (referred to in the EUA as French FDP). The FDA�s EUA confirmed a commitment to partner with U.S. military agencies to develop an expedited path for development of medical products to treat the unique needs of military personnel. Medical product developers within DoD (USAMRDC and USAMMDA) have committed considerable funding (approximately $56M fully burdened) to support the research and development of a US sourced FDP product that has variable temperature stability, durable-packaging that can be easily stored, transported, and�administered in remote conditions. Under the terms of Cooperative Research and Development Agreement (CRADA) 14-0420-CRA between USAMMDA and Teleflex Incorporated formerly known as Vascular Solutions, Teleflex Incorporated is responsible for product development and establishing manufacturing operations, including chemistry, manufacturing, and controls information to support the submission of the Investigational New Drug (IND) application, which was made in October 2016 ((IND) #17154 and Utility Patent Application Serial Number: US 15/399,643). USAMMDA has since sponsored, managed and funded all preclinical and clinical studies required to support a Biologic License Application (BLA) for commercialization. FDA approval is anticipated to be in early Fiscal Year (FY) 22 and once that is received, Teleflex will be entitled to market EZPLAS Freeze-Dried Plasma, including sales to branches of the military and private sector medical providers. Teleflex has developed a FDP product that is waiting for FDA-licensure. There are no other FDP products available. It has taken an estimated $17M and five years to get to this level of development since the project began. It is estimated that it would take up to 7 years and $21M to develop a competing product that would meet the Government's requirement. This duplicate investment of $21M would not be recovered through competition. Due to the unique nature and lengthy development time for the FDP, no other entity can meet the Government's requirements for both the simulated and FDA licensed FDP by the required timeframe. This announcement fulfills the synopsis requirements under FAR 5.102(a)(6) and 5.203(a). USAMRAA intends to publish a solicitation no sooner than 15 days after publishing this synopsis. This Special Notice of Intent is not a request for competitive quotes. Information received in response to this notice will be considered solely for the purpose of determining whether a competitive procurement is in the best interest of the Government. If no written responses are received by the date listed below, which reflects at least fifteen (15) days after the publication of this notice, the solicitation will be issued as sole source requirement. All questions and responses concerning this notice shall be emailed to James Cheng at james.cheng1.civ@mail.mil. Interested concerns must identify their capability in writing to the above email address listed above no later than 4:00 PM ET,�22 July 2021.
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/ca6817e89cc8483f8fda7282b0140e67/view)
- Place of Performance
- Address: USA
- Country: USA
- Country: USA
- Record
- SN06053084-F 20210709/210707230112 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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