SOURCES SOUGHT
Q -- Request for information (RFI) for stability testing on Intravenous Artesunate (IVAS) and Phosphate Solution using already established protocols and validated procedures.
- Notice Date
- 3/25/2015
- 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
- W81XWH-15-S-1002
- Response Due
- 4/30/2015
- Archive Date
- 5/30/2015
- Point of Contact
- Michael Ursone, 301-619-9525
- E-Mail Address
-
US Army Medical Research Acquisition Activity
(michael.a.ursone.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- THIS IS NOT A REQUEST FOR PROPOSALS (RFP) OR A REQUEST FOR QUOTATIONS; IT IS STRICTLY A REQUEST FOR INFORMATION (RFI). NEITHER UNSOLICITED PROPOSALS NOR ANY OTHER KINDS OF OFFERS WILL BE CONSIDERED IN RESPONSE TO THIS RFI. NO CONTRACT WILL BE AWARDED PURSUANT TO THIS ANNOUNCEMENT. 1.0 SUBJECT: In support of the U.S. Army Medical Materiel Development Activity's (USAMMDA) mission is to develop and manage medical materiel to protect and sustain the Warfighter, this request for information is seeking entities interested in performing the stability testing on Intravenous Artesunate (IVAS) and Phosphate Solution using already established protocols and validated procedures. 2.0 DISCLAIMER: This RFI is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any other kind of offers will be considered in response to this RFI. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. All information received in response to this RFI that is marked Proprietary will be handled accordingly. Responses to the RFI will not be returned. At this time, questions concerning the composition and requirements for a future RFP will not be entertained. 3.0 DESCRIPTION: The Government is seeking to find company/ies with established/successful experience in the non-clincial testing of IVAS/Phosphate Solution, who are interested in performing two stability test timepoints on a 12 month interval. These points will represent the time points 60 and 72 for both the Artesunate (AA241-1-10-01), and the Phosphate Solution (Lot 1023-09), each of which have been tested with approved protocols and validated analytical procedures in accordance with cGMP regulations (Title 21 CFR Part 211), as well as Good Laboratory Practice for Nonclinical Studies (Title 21 CFR Part 58). The stability testing supports the ongoing clinical use of the product under the U.S. Army Office of The Surgeon General (USAOTSG) sponsored Investigational New Drug (IND) application. 4.0 SUBMISSION INSTRUCTIONS: Entities interested in submitting a response must furnish in writing, a 2-3 page (not including cover page, index or list of references) synopsis of their capability to perform stability testing of the IVAS product for a US Government sponsored IND. Companies responding to this notice must provide complete contact information (telephone, address, email address). Responders must identify their company's business size (based on the NAICS size standard), and business status (i.e. small business, disadvantaged, HUB zone, woman owned, service disabled veteran owned). Please also include information regarding any prior experience with U.S. Government contracts and favorable experience working with the FDA. 5.0 SUBMISSION CONTACT INFORMATION: Interested entities shall forward submissions to Mr. Michael Ursone, at michael.a.ursone.civ@mail.mil no later than the close of business 30 April 2015. Telephonic communication will not be considered as submission or receive response.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH-15-S-1002/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
- SN03678404-W 20150327/150325234851-c1a8c025b4063f14687952281d8690f9 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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