SOURCES SOUGHT
A -- Sources Sought for a Biologics Developer to Complete Development Activities in Support of FDA Licensure of Freeze-dried Plasma (FDP) for Use in Battlefield Treatment of Severe Hemorrhage
- Notice Date
- 8/10/2010
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWHRFI10222
- Response Due
- 9/13/2010
- Archive Date
- 11/12/2010
- Point of Contact
- Shannyn Scassero, 301-619-2640
- E-Mail Address
-
US Army Medical Research Acquisition Activity
(shannyn.scassero@amedd.army.mil)
- Small Business Set-Aside
- N/A
- Description
- THIS IS A REQUEST FOR INFORMATION (RFI) AS DEFINED IN FAR 15.201 (e). THE PURPOSE OF THIS RFI IS TO GAIN KNOWLEDGE OF POTENTIAL QUALIFIED SOURCES FOR PLANNING PURPOSES ONLY FOR THE U.S. ARMY MEDICAL MATERIEL DEVELOPMENT ACTIVITY (USAMMDA), FORT DETRICK, MARYLAND. USAMMDAs mission is to protect and preserve the lives of America's sons and daughters by providing new drugs, vaccines, blood products, and medical devices that enhance readiness, ensure the provision of the highest quality medical care to DoD, and maximize the survival rate for medical casualties on the battlefield. USAMMDA is seeking a biologics developer to complete development activities in support of FDA licensure of freeze-dried plasma (FDP) for use in battlefield treatment of severe hemorrhage. Specifically sought is a biologics developer with FDP that demonstrates a level of product development maturity equivalent to Biomedical Technology Readiness Level 5 (TRL5), specifically: "Single-donor, donor tested, freeze-dried plasma "Demonstration of levels of clotting factors and other plasma proteins within generally accepted ranges for at least 20 units of product manufactured in a stable manufacturing line and process "Completion of Pre-clinical studies, including GLP animal safety & toxicity, sufficient to support IND application "Stable product formulation "Final product package including a binary system for product and reconstitution fluid, preferably a hardened package for battlefield use. "Active IND for clinical testing "Clinical study(ies) begun in support of FDA licensure "Well defined clinical and regulatory development plan to FDA licensure "Well-defined manufacturing development plan, including definition of manufacturing capacity to meet market needs "Market analysis and well-defined business and marketing plan, including product pricing "Well-defined development funding plan to licensure "Well-defined development schedule to licensure A short fact sheet (no more than 1 page for each criterion, total 12 pages, single-space, font size 12, Times New Roman) is requested that documents satisfaction of criteria outlined above. Potential Offerors should not submit a fact sheet if they cannot provide thorough documentary and physical evidence of each criterion outlined. However, this announcement is not a formal solicitation and is not a request for proposal. No contract will be awarded from this announcement. No reimbursement will be made of any costs to provide information in response to this announcement or any follow up information requests. Availability of any formal solicitation will be announced under a separate announcement. This synopsis is for information and planning purposes only and is not to be construed as a commitment by the Government. Each response must reference the sources sought title. All information received in response to this RFI will be treated as business confidential information, and exempted from disclosure under the Freedom of Information Act. Nonetheless, submitters should properly mark their responses if the information is confidential. All proprietary information should be marked as such. Response to this solicitation will not be returned. In accordance with FAR 15.201 (e), responses to this RFI are not offers and cannot be acepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. Please submit your fact sheet by e-mail to shannyn.scassero@amedd.army.mil. Responses must be received no later than 13 SEP 10, by 2:00 P.M. Eastern Daylight Savings Time.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWHRFI10222/listing.html)
- Place of Performance
- Address: US Army Medical Research Acquisition Activity ATTN: MCMR-AAA, 820 Chandler Street Frederick MD
- Zip Code: 21702-5014
- Zip Code: 21702-5014
- Record
- SN02235388-W 20100812/100810235851-89c14e94a7d162587f66ee04ce5c434c (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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