This amendment is to correct the response date to August 27, 2019 and change the classification to AN11. The Veteran s Administration (VA) Office of Research and Development, Regional Procurement Office East in Pittsburgh, PA intends to negotiate on a sole source basis with the Center for Infection and Immunity at the Columbia University Mailman School of Public Health, on behalf of the Madison, WI VA Healthcare System. The requirement is to provide Blood and plasma sample analyses and consultation on the interpretation of resulting data for a multisite research project. The planned study is a research project titled Post-Exertion Malaise in Gulf War Illness: Brain, Autonomic and Behavioral Interaction, and the proposed extension of this project, require lab services for the purpose of conducting genetic, epigenetic, transcriptomic, proteomic, metabolomic, microbiologic, and serologic analyses of previously, and to be collected, blood and plasma samples. In order to optimize results and minimize inconsistencies, the plan is to incorporate TruCulture blood collection and processing procedures. Thus, study personnel at the Madison VA and our collaborative site, the War Related Illness and Injury Study Center at the East Orange campus of the VA New Jersey Health Care System, responsible for blood sample collection and processing will require training on the necessary equipment and procedures. The specific work to be performed includes: The contractor, Center for Infection and Immunity at the Columbia University Mailman School of Public Health, train project personnel at the Madison VA and New Jersey WRIISC in TruCulture blood collection and processing procedures, conduct genetic, epigenetic, metabolomic, transcriptomic, proteomic, microbiologic, and serologic analyses of plasma and blood samples collected at the Madison and New Jersey sites, provide expert scientific consultation on the results of the analyses, and aid in the preparation of presentations and manuscripts to disseminate the study findings. This work is to proceed over the course of 3 years. Specific Tasks. Task 1. The contractor shall provide results from comprehensive metabolomic analyses of previously and to be collected blood plasma samples from participants of the parent project and its extension 1.1 Duplicate testing of as many as three (3) plasma samples, each representing a different time point, shall be analyzed for each of the 180 anticipated participants 1.2 For optimal resolution, the contractor shall perform three untargeted metabolomic assays and one targeted assay for 5,122 metabolites representing primary metabolites, biogenic amines, complex lipids, and bioactive oxylipins, while filtering for possible confounding factors (e.g., medication) 1.3 For each participant at each of the three timepoints, results for primary metabolites, biogenic amines, and complex lipids shall be normalized by the sum intensity of all annotated metabolites 1.4 For each participant at each of the three timepoints, results for bioactive oxylipins shall be reported in absolute concentrations (e.g., nanomoles/L) Task 2. The contractor shall provide results from comprehensive proteomic analyses of previously and to be collected blood plasma samples from participants of the parent project and its extension 2.1 As many as three (3) tissue samples, each representing a different time point, shall be analyzed for each of the 180 anticipated participants 2.2 The results of the proteomic analyses shall provide the investigators with protein expression profile information for all usable samples Task 3. The contractor shall provide training to project personnel at the Madison VA and New Jersey WRIISC on TruCulture blood collection and processing procedures 3.1 The training provided shall be comprehensive and standardized between sites to ensure the accuracy and integrity of the resulting analyses of samples collected using the TruCulture methodology 3.2 Training on the TruCulture methodology must be completed for personnel at both sites within the first 6 months of this contracted arrangement 3.3 The contractor shall advise personnel at both sites on all necessary equipment for the TruCulture sample collection and processing procedures 3.4 The contractor shall verify tissue sample quality from each site using the TruCulture methodology and shall work to address any suspected deviations from the prescribed procedures for the duration of the contract 3.5 The contractor shall also provide support to the Madison VA and New Jersey WRIISC personnel for the duration of the contract in order to maintain sample quality and integrity Task 4. The contractor shall provide results from comprehensive epigenetic analyses of blood samples to be collected using the TruCulture methodology from participants of the parent project and its extension 4.1 Samples shall be analyzed for each on the 100 anticipated participants providing TruCulture collected tissue 4.2 The contractor shall sequence bisulphite-treated DNA libraries for all usable samples in order to establish DNA methylation status, permitting the investigators to test for differential DNA methylation between our participant groups Task 5. The contractor shall provide results from transcriptomtic analyses (i.e., RNA sequencing) of blood samples to be collected using the TruCulture methodology from participants of the parent project and its extension 5.1 Samples shall be analyzed for each on the 100 anticipated participants providing TruCulture collected tissue 5.2 The contractor shall complete a quantitative trait analysis with a centered focus on immune cell dysfunction and altered metabolic properties of peripheral blood cells permitting the investigators to test for differences between our participant groups Task 6. The contractor shall provide results from microbiologic analyses (i.e., Luminex) of blood samples to be collected using the TruCulture methodology from participants of the parent project and its extension 6.1 Duplicate testing of samples shall be analyzed for each on the 100 anticipated participants 6.2 The results of the analyses shall provide data on the expression of soluble immune factors in response to stimulation with mimics of bacterial, viral and fungal infection Task 7. The contractor shall provide results from serologic analyses of previously and to be collected plasma samples from participants of the parent project and its extension 7.1 Enterovirus peptide array analyses shall be conducted for each of the 180 anticipated participants providing tissue samples 7.2 The results of the analyses shall provide data on the enterovirus exposure and permit investigators to evaluate differences in exposure between groups Task 8. The contractor shall purchase all necessary supplies and equipment for use at their site in order to complete the lab services requested (i.e., Tasks 1-6) 8.1 The contractor shall purchase all supplies necessary for the conduction of the contracted analyses as they are needed 8.2 The contractor shall purchase and maintain a -80 freezer on site for the purpose of short-term storage of tissue samples while they await processing 8.3 The contractor shall invoice the Madison VA for costs associated with the supplies and equipment used in the completion of the lab services requested Task 9. The contractor shall provide expert scientific consultation on the interpretation of the resulting data and statistical analysis of these data 9.1 The contractor shall work with project staff to develop a comprehensive evaluation of the resulting data 9.2 This consultation shall include guidance on statistical analyses, in particular, topological data analysis of the integrated results 9.3 The contractor shall provide reference data from similar patient populations for the purpose of informing the interpretation of the findings from the present project and its extension Task 10 The contractor shall aid in and contribute to preparations of presentations and manuscripts intended to disseminate the results of the project and its extension to the public 10.1 Consultation on results interpretation and statistical analyses shall extend to the preparations of formal scientific presentations and peer-reviewed publications The requirement shall take place at a VA facility Madison, Wisconsin. The sole source is pursuant to FAR 6.302-1 Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. This notice of intent is not a request for competitive proposals, however; any responsible source who believes it is capable of meeting the requirement may submit a capability statement and supporting documentation to the contracting office no later than August 27, 2019, (10:00 AM, EST). Interest/capability statements may be sent to Michael Haydo at [email protected]. No telephone responses will be accepted. A determination not to compete the proposed requirement based upon the responses to this notice is solely within the discretion of the Government.