SPECIAL NOTICE
A -- T-PAS+ Clinical Trials and Regulatory Support
- Notice Date
- 4/17/2017
- Notice Type
- Special Notice
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of the Army, U.S. 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
- W81XWH-17-R-0046
- Archive Date
- 5/17/2017
- Point of Contact
- Christopher Sult, Phone: 3016191342
- E-Mail Address
-
christopher.m.sult.civ@mail.mil
(christopher.m.sult.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- The United States Army Medical Research Acquisition Activity (USAMRAA) intends to issue a sole source contract under the authority of FAR 6.302-1 (a) (2) - Only One Responsible Source and No Other Services will Satisfy Agency Requirements, on or about 14 July 2017 to Terumo BCT, 10811 West Collins Ave, Lakewood, Colorado 80215-4440 on behalf of the United States Army Medical Materiel Development Activity (USAMMDA). The North American Industrial Classification System (NAICS) code for this acquisition is 541711 and the size standard is 1,000 employees The key objectives of this effort are to conduct clinical trials and provide regulatory management support for the Terumo BCT T-PAS+ (PAS-E) Platelet Additive Solution sufficient for the Food and Drug Administration (FDA) approval. This requirement is to conduct Phase 1 clinical trials consisting of an in vitro platelet quality study and in vivo recovery and survival clinical trial at two separate sites and an optional task for Phase 2 clinical trial of CSP in T- PAS+ in patients undergoing cardiopulmonary bypass surgery. At the completion of the Phase 2 trial, a two stage analysis will be used to analyze the data and if superiority is shown, the data will be presented to the FDA to proceed with a Biologic License Application. Interested contractors may identify their interest and bona fide capability to fulfill the requirement. This notice of intent is not a request for competitive proposals. Interested parties who believe they can meet this requirement shall submit information about their capabilities no later than 4:00 PM EST, 02 May 2017. All information shall be furnished at no cost or obligation to the Government. No solicitation will be made available. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. A determination by the Government not to compete this proposed solicitation based upon responses to this notice is solely within the discretion of the Government. Telephone inquiries will not be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH-17-R-0046/listing.html)
- Record
- SN04474312-W 20170419/170417234313-c616ec69f600fc7e31554d4529c9dcb1 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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