SPECIAL NOTICE
65 -- Notice of Intent to Sole Source Freeze Dried Plasma
- Notice Date
- 11/1/2019
- Notice Type
- Special Notice
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- Department of the Army, US Army Medical Research Acquisition Activity, U.S. Army Medical Research Acquisition Activity, Attn: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014, Maryland, 21702-5014, United States
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH20R0010
- Archive Date
- 12/1/2019
- Point of Contact
- James Cheng, Phone: 3016191012
- E-Mail Address
-
james.cheng1.civ@mail.mil
(james.cheng1.civ@mail.mil)
- Small Business Set-Aside
- N/A
- 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. Specifically, the Government will procure FDP from Teleflex, Inc. 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. Medical product developers within DoD (USAMRDC and USAMMDA) have committed considerable support to 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 Fiscal Year (FY) 20 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 five years to get to this level of development since the project began. It is estimated that it would take up to another 7 years to develop a competing product that would meet the Government's requirement. This duplicate investment 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 brand name only. 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 4:30 PM ET, 16 November 2019.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH20R0010/listing.html)
- Place of Performance
- Address: 7700 Arlington Blvd, Falls Church, Virginia, 22042, United States
- Zip Code: 22042
- Zip Code: 22042
- Record
- SN05488264-W 20191103/191101231044-4e088bbcf8900f9c7794af234952c938 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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