SOURCES SOUGHT
A -- Request for Information: Spray Dried Pooled Plasma.
- Notice Date
- 2/7/2011
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- RDECOM Contracting Center - Natick R&D (RDECOM-CC), ATTN: AMSRD-ACC-N, Natick Contracting Division (R and BaseOPS), Building 1, Kansas Street, Natick, MA 01760-5011
- ZIP Code
- 01760-5011
- Solicitation Number
- W911QY-11-R-SDPP
- Response Due
- 2/28/2011
- Archive Date
- 4/29/2011
- Point of Contact
- Shawn Haubner, 508-233-6167
- E-Mail Address
-
RDECOM Contracting Center - Natick R&D (RDECOM-CC)
(shawn.haubner@us.army.mil)
- Small Business Set-Aside
- N/A
- Description
- The Committee on Tactical Combat Casualty Care, on behalf of the Naval Health Research Center (NHRC) is conducting a market survey to determine the availability to obtain solutions for manufacturing an urgently needed FDA-approved, commercial off the shelf (COTS) dried, pooled, pathogen-inactivated plasma product for use in the treatment of patients with severe hemorrhage. Products that may meet this requirement are currently available in the European market however current products are not FDA approved and thus cannot be commercially procured by the Army. In an effort to address the ongoing need of minimizing preventable fatalities in combat, the Committee on Tactical Combat Casualty Care has identified a requirement for a dried plasma product, to reduce logistical constraints associated with currently used frozen plasma products and expand the availability of plasma in military operations. This Request for Information should be considered an open call for any materials, designs and/or concepts of technology, regardless of maturity level, that has the possibility of fulfilling the requirement to obtain solutions for manufacturing this Spray Dried Pooled Plasma. Performance Requirements: The following requirements are consistent with those in use by a related Army development program. Sources for Requirement: 1) Tactical Combat Casualty Care (TC3) ICD approved; 2) SOCOM requirements harmonized; 3) USAMEDD-DCDD developing CDD: AttributeMinimum Performance ThresholdPreferred Performance Objective FDA Licensure (KPPApproval Approval Efficacy80% of normalized plasma activity90% of normalized plasma activity Shelf2 years 3 years Blood TypeABO Type SpecificUniversal Blood Group Final transfusable volume250 ml250 ml Reconstitution Time< 6 minutes< 1 minute Storage Temperature2-8 C20-24 C Operational Temperature0-40 C0-40 C Reconstituted Shelf Life24 hours120 hours Product Packaging< 48 in <48 in Additional Requirements include (1) Ease of Use: Manufactured product must provide maximum ease of use and be easily accessed, re-suspended (Minimal steps to reconstitute) and delivered. (2) Portability: Product packaging must be light weight, durable and able to handle harsh conditions (i.e. remote field usage able to support high heat and low temperature extremes). No glass bottles can be used to store product. (3) Schedule Requirements: The requirement is for a FDA-approved, commercially available dried plasma product within the most immediate time possible. Responses within this area must be inclusive of fully tested and regulatory compliant product to include full and complete FDA approval. Preference is for availability within 18-24 months however alternative timelines will be considered. Please provide a white paper (7-page limit) explaining the capabilities, materials, designs and/or concepts identified above, on company letterhead, either in Microsoft Word or Acrobat Adobe Format in Times New Roman 12-point font or larger. Responses should include patent rights and/or licensure information for any data, product or technology that may be used to accomplish a proposed solution. Please indicate preference as to whether or not any future development rights would be shared with the government if a partnership were to develop. Include additional supporting documentation as applicable. After all proposals have been received and reviewed, additional materials, prototypes and/or information may be solicited for further Government evaluation. Offerors must indicate whether or not they have a DCAA approved accounting system. Please submit responses no later than 5:00 pm on February 28, 2011 to the Contracting Office Point of Contract listed below. This request is for information and planning purposes only and is not to be considered as a commitment by the Government. This document will assist the Government in identifying potential sources. This is not a Request for Proposals, Invitation for Bid, or an announcement of a solicitation. Response to this RFI is strictly voluntary and will not affect future ability to submit an offer if a solicitation is released. The Government does not intend to award a contract on the basis of this RFI, nor will the Government otherwise pay for information submitted in response to this RFI. The Government will not release any information marked with a Proprietary legend received in response to this RFI to any firm, agency, or individual outside the Government without written permission. Program Office Address: U.S. Army Medical Research and Materiel Command, 504 Scott Street, Fort Detrick, MD 21702-5012. Point of Contact: Anthony Pusateri, PHD, (301) 619-9822; e-mail: Anthony.pusateri@amedd.army.mil Contracting Office Address: Army Contracting Command-Aberdeen Proving Ground (Soldier, Chemical, Research & Test) Natick Contracting Division, 100 Medway Rd, Milford, MA 01757 Point of Contact(s): Shawn Haubner, (508) 233-6167; e-mail: shawn.haubner@us.army.mil
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FBO.gov Permalink
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- Record
- SN02374621-W 20110209/110207234351-3a8631aec2239e2ae61d226237bf58bb (fbodaily.com)
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