SPECIAL NOTICE
65 -- Justification and Approval (J&A)
- Notice Date
- 5/6/2014
- Notice Type
- Special Notice
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH14T0191
- Archive Date
- 5/6/2015
- Point of Contact
- Hugo Robinson, 301-619-7811
- E-Mail Address
-
US Army Medical Research Acquisition Activity
(hugo.m.robinson.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- The United States Army Medical Research Acquisition Activity (USAMRAA), Fort Detrick, MD intends to issue a sole source award utilizing Simplified Acquisition Procedures to Terumo BCT, Inc. for the Trima Blood Collection System Version 5. The US Army Medical Materiel Development Activity (USAMMDA) requires the Trima Blood Collection System Version 5. The Food and Drug Administration has approved a supplement to the Army Blood Program biologics license application for Whole Blood and blood components to include the manufacture of single Fresh Frozen Plasma collected by automated plasmapheresis using the GAMBRO Trima Automated Blood Collection System Version 4 under U.S. License Number 611. The Food and Drug Administration approves not only the process for the manufacture of single Fresh Frozen Plasma but also the equipment that is used in the process. This ensures the safety and efficacy of the product when it is used. Any deviation of the biologics license could result in revocation (21 CFR 601.5) or suspension (21 CFR 601.6) of the existing license. The proposed contractor for this requirement is Terumobct and is the only known source to distribute the GAMBRO Trima Automated Blood Collection System. The Trima Blood Collection System Version 5 is uniquely capable of meeting the requirements listed above. This notice of intent is for information purposes only, therefore, no solicitation will result from this announcement. All sources eligible to provide this service must respond in writing. Responses must be supported with clear and convincing evidence to clearly be able to provide services outlined above. A request for documentation will not be considered as an affirmative response. If no responses are received, within 15 days, 21 May 2014, after publication of this notice, to the effect that comparable supplies and services are available, and that it is more advantageous to the Government than obtaining these services through a sole-source contract, then a sole source acquisition award will be made. Response to this award is to be sent to hugo.m.robinson.civ@mail.mil.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH14T0191/listing.html)
- Record
- SN03358393-W 20140508/140506234901-ae1ecbf20daf40951f3381c35ef6a65a (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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