SOURCES SOUGHT
A -- Academic Institution in the city of Peru with a large trajectory of research in Leishmaniasis for the continuation study of the evaluation of CL Detect™
- Notice Date
- 1/31/2018
- Notice Type
- Sources Sought
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- Department of the Navy, Bureau of Medicine and Surgery, Naval Medical Logistics Command, 693 Neiman Street, FT Detrick, Maryland, 21702-9203, United States
- ZIP Code
- 21702-9203
- Solicitation Number
- ADVFY18RD00013
- Archive Date
- 3/2/2018
- Point of Contact
- Cheryl Vendemia, Phone: 3016196004, Thomas L. Hood, Phone: 3016199236
- E-Mail Address
-
cheryl.r.vendemia.civ@mail.mil, thomas.l.hood26.civ@mail.mil
(cheryl.r.vendemia.civ@mail.mil, thomas.l.hood26.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- Sources Sought Notice The Naval Medical Logistics Command (NMLC) is seeking sources to perform a collaborative research effort to execute the study titled "Evaluation of a Diagnostic Device, CL Detect TM Rapid Test, for the Diagnosis of Cutaneous Leishmaniasis in Peru" in support of Naval Medical Research Unit Six (NAMRU-6), Parasitology Department, Ave. Venezuela Cdra 36 s/n, Bellavista - Callao - Peru. NAMRU-6 is in need of an academic institution in the city of Lima, Peru with a large trajectory of research in Leishmaniasis, for a collaborative research effort to execute in Lima, Peru the study titled "Evaluation of a Diagnostic Device, CL Detect TM Rapid Test, for the Diagnosis of Cutaneous Leishmaniasis in Peru" (LRDD-PERU-02- NAMRU6.2015.0009). The primary objective of the study is to determine the sensitivity and specificity of the FDA-cleared CL Detect TM Rapid Test in Peru, using a test procedure that was modified from that described in the device instructions to optimize these parameters for the detection of Leishmania species identified in Peru. The CL Detect TM Rapid Test is the trade name for the Cutaneous Leishmaniasis Rapid Diagnostic Device (LRDD). This acquisition requires the research project to carry out coordination and obtainment of study authorization from local health facilities to perform the study in Peru; obtainment of local IRB approval; recruitment and training of personnel for performing the study; screening of at least 200 potential study participants; performing the informed consent process as described in the protocol; collecting study approved information and biological samples; labeling and keeping of samples in adequate cold-chain conditions; maintenance of all forms with identifiers in a locked office; preparation of biological samples for shipments to NAMRU-6 in adequate cold-chain conditions; shipment of samples to NAMRU-6; delivery to NAMRU-6 of all samples collected as part of the study, consent/assent documents, and all clinical report forms. All activities must be carried out with the utmost adherence to all ethical and quality control standards, in order to minimize risk of performance slips and maintain compliance with appropriation of funds and expectations of the sponsor. This institution is the only one with the required local approvals in place, the appropriate financial, human and technical resources, and experience and organizational controls needed to accomplish the study's goals. The period of performance is expected to be 12 months from the date of contract approval. If capable sources are not identified through this notice, NMLC intends to award a sole source contract under the authority of FAR 6.302-1 to la Universidad Peruana Cayetano Heredia (UPCH), Av. Honorio Delgado 430, San Martin de Porres 15102, Peru. This sources sought notice is not a request for competitive proposals and no solicitation document exists for the requirement. Sources interested in responding to this notice are required to submit a capability statement that includes management and technical data and cost information, in sufficient detail and with convincing evidence that clearly demonstrates the capability to perform the required work. Capability statements shall not exceed 1 (8.5 x 11 inch) page using a font size no smaller than 10-point. All capability statements received by the due date of this notice will be considered by the Government. A request for documentation or additional information will not be considered as an affirmative response. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement or to proceed with a sole source contract. Capability statements are due by noon Local Time, 5 February 2018. Capability statements shall be submitted by e-mail ONLY as a Microsoft Word or Adobe PDF attachment to the following address: cheryl.r.vendemia.civ@mail.mil AND thomas.l.hood26.civ@mail.mil.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/DON/BUMED/N62645/ADVFY18RD00013/listing.html)
- Place of Performance
- Address: Naval Medical Research Unit Six (NAMRU-6), Parasitology Department, Ave. Venezuela Cdra 36 s/n, Bellavista - Callao - Peru., Peru
- Record
- SN04805738-W 20180202/180131231437-449455b35f569f10c20e11e8282414f4 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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