The Naval Medical Logistics Command (NMLC) intends to award a sole source (severable) contract to la Universidad Peruana Cayetano Heredia (UPCH) to support the Department of Defense (DoD) in understanding the true incidence and characterizing the true clinical spectrum of disease in regards to travelers' diarrhea (such as ETEC, Campylobacter, and Shigella species) and respiratory illnesses for the Naval Medical Research Unit Six (NMRU-6), Lima, Peru. This effort is a continuation of the study titled "NAMRU-6.2012.0011- Incidence, etiology, and severity of travelers' diarrhea among students at a Spanish language school in Cusco, Peru" under Contract N3239817P0408 awarded to UPCH. The anticipated period of performance of this requirement is twelve (12) months with three (3) one-year options for extension. If capable sources are not identified through this notice, NMLC intends to award a sole source contract under the authority of 10 U.S.C. 2304(c)(1), (as implemented by FAR 6.302-1) to UPCH, Av. Honorio Delgado 430, San Martin de Porres 15102, Peru for the performance of the described requirement. The primary objective of this study is to develop an effective vaccine against the most common enteropathogens associated with travelers' diarrhea (such as ETEC, Campylobacter, and Shigella species) as well as respiratory illnesses; however, prior to any vaccine clinical trial, a better understanding of the true incidence of disease and better characterization of the true clinical spectrum of disease in regards to etiology is needed. To accomplish this goal, NAMRU-6 has executed a longitudinal prospective study using foreign language schools in Cusco which enrolls students from developed nations upon arrival. The anticipated schools for this study are The Amauta Spanish School and Spanish School San Blass. 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; enrollment of study participants; performing the informed consent process as described in the protocol; collecting study approved information and biological samples; labeling and keeping of stool samples as well as nasal and pharyngeal swabs 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. Stool samples shall be observed macroscopically and characterized by consistence and appearance. Stool shall also be examined microscopically by direct staining methods for parasite detection and the presence of fecal leukocytes. Cultured enteropathogens shall be biochemically identified, and antibiograms shall be performed. Stool samples shall be cultured for bacterial enteropathogens by conventional microbiologic techniques [Gray, 1995; Nachamkin, 1995]. Routinely, five lactose-fermenting colonies morphologically typical of E. coli shall be selected from MacConkey agar (MAC) and tested for the presence of ETEC heat-labile (LT) and heat-stable (ST) enterotoxin gene sequences by polymerase chain reaction [Stacy-Phipps, 1995]. Campylobacter isolates shall be capsular typed using a standardized multiplex PCR assay (Poly, 2011). Shigella isolates shall be serotyped using commercially available typing sera. All non-typeable Campylobacter and Shigella isolates shall have further characterization. Antibiotic sensitivity testing against 17 antibiotics (amoxicillin-clavulanate, ampicillin, azithromycin, ceftriaxone, chloramphenicol, cephalothin, cefepime, ciprofloxacin, rifaximin, amikacin, gentamicin, imepenem, tetracycline, and trimethoprim-sulfamethoxazole, ticarcillin, ticarcillin/clav, furazolidone) shall be performed by disk diffusion testing. 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. The period of performance is expected to be 12 months from the date of contract approval with three annual option extension periods. This 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, as well as cost information, in sufficient detail and with convincing evidence that clearly demonstrates the capability to perform the required work. Capability statements shall not exceed one (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 2:00PM Eastern Time, 13 September 2019. Capability statements shall be submitted by e-mail ONLY as a Microsoft Word or Adobe PDF attachment to the following address: jesse.d.nisley.civ@mail.mil.
