Loren Data's SAM Daily™

FBO DAILY ISSUE OF JULY 14, 2004 FBO #0961
SOURCES SOUGHT

A -- Contract Research Organization (CRO) to take Real-time Leishmania PCR research assays forward for FDA clearance

Notice Date

7/12/2004
 

Notice Type

Sources Sought
 

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-SOURCESSOUGHT-USAMMDA
 

Response Due

10/29/2004
 

Archive Date

12/28/2004
 

Point of Contact

Cheryl Miles, 301-619-7148
 

E-Mail Address

Email your questions to US Army Medical Research Acquisition Activity
(cheryl.miles@det.amedd.army.mil)
 

Small Business Set-Aside

N/A
 

Description

The point-of-contact for this Sources Sought Announcement is MAJ David Shoemaker at david.shoemaker@det.amedd.army.mil. THIS IS NOT A SOLICITATION ANNOUNCEMENT. THIS IS A SOURCES SOUGHT SYNOPSIS ONLY. THE PURPOSE OF THIS SOURCES SOUGHT SYNOPSIS IS T O GAIN KNOWLEDGE OF POTENTIAL QUALIFIED SOURCES FOR PLANNING PURPOSES ONLY FOR THE U.S. ARMY MEDICAL MATERIEL DEVELOPMENT ACTIVITY (USAMMDA), FORT DETRICK, MARYLAND. Its mission is to protect and preserve the lives of America's sons and daughters by provid ing new drugs, vaccines, 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 Contract Research Organization (CRO) to take 'Real-Time Leishmania PCR' research assays developed by the U.S. military forward for FDA clearance for use on clinical specimens, and ensure that they remain commercially available for use by the U.S. military for a minimum of 5 years. The Leishmania real-time PCR assays developed by the U.S. military consist of a Leishmania sp. assay, a Leishmania major assay, and a PCR internal control assay for use on the Cepheid SmartCycler????. The CR O would be responsible for producing or subcontracting the production of the assay under the appropriate quality system regulations, to include production of the PCR chemistries, killed Leishmania parasite positive extraction controls, and purified DNA pos itive PCR controls. This work would also require the growth of the Leishmania parasites (specifically, L. major and L. braziliensis) to produce the extraction controls and positive PCR controls. Collaborations with USAMMDA would be required for the test and evaluation of these assays to ensure that they meet military requirements. The FDA-cleared assays must be capable of being used in a CAP/CLIA-certified clinical laboratory. The CRO would be responsible for conducting or subcontracting the assay valid ation and for preparing a 510(k) application for submission to the FDA. The CRO must ensure that the FDA-cleared assays remain available for purchase by the U.S. military for at least 5 years once cleared by the FDA. USAMMDA can envision an approach wher eby the CRO would subcontract various portions of the work, but would remain responsible for the overall management and success of the effort. USAMMDA would coordinate with the CRO to obtain the appropriate clinical and other critical specimens necessary to conduct the validation studies and to serve as source material to produce the extraction and PCR controls. Ideally the FDA-cleared 510(k) application would be held and managed by the CRO, although consideration could be given to the U.S. Army Medical Re search and Materiel Command holding the application and the CRO managing it. The CRO should be able to demonstrate that they have the ability and experience to successfully develop an FDA-cleared or approved diagnostic assay. A short fact sheet (less than 3 pages) is requested that summarizes capabilities of the CRO in completing the requirements identified above. It is requested the CRO identify what facilities, personnel, and equipment they may have available 'in house' for this effort, and what resources they would have to subcontract for, to include identifying if possible the potential subcontractors and what portion of the work each subcontractor would be responsible for. It is requested the CRO provide an estimated cost of any facilities, personnel, and equipment to meet the requirements above. 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 plan ning purposes only and is not to be construed as a commitment by the Government. Each response must reference the sources sought title. All proprietary information should be marked as such. Responses will be held confidential if requested. Please submit f act sheets to the attention of: USAMMDA, ATTN: MCMR-UMP, 622 Neiman Street, Fort Detrick, MD 21702-5009. Fact sheets may be emailed to: david.shoemaker@det.amedd.army.mil. Responses must be received no later than October 29, 2004, by 4:00 P.M. Eastern Day light Time.
 

Place of Performance

Address: US Army Medical Research Acquisition Activity ATTN: MCMR-AAA, 820 Chandler Street Frederick MD

Zip Code: 21702-5014

Country: US
 

Record

SN00619262-W 20040714/040712212354 (fbodaily.com)
 

Source

FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)

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