SOLICITATION NOTICE
R -- Assay of sample to determine the Absolute Quantification of Metabolic Phenotyping for Discovery of Predictive Blood Biomarkers of Alzheimer's Disease and Brain Markers of Resilience to Alzheimer's pathology
- Notice Date
- 8/15/2014
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, Station Support/Simplified Acquisitions, 31 Center Drive, Room 1B59, Bethesda, Maryland, 20892
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA-SSSA-CSS-14-599
- Archive Date
- 9/9/2014
- Point of Contact
- Hunter A. Tjugum, Phone: 301 435 8780, ,
- E-Mail Address
-
hunter.tjugum@nih.gov, NIDASSSAPurchaseRequ@mail.nih.gov
(hunter.tjugum@nih.gov, NIDASSSAPurchaseRequ@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation number is HHS-NIH-NIDA-SSSA-CSS-14-599 and the solicitation is issued as a Request For Quotation (RFQ). This acquisition is for a commercial service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures and FAR Part 12-Acquisition of Commercial Items, and is not expected to exceed the Simplified Acquisition Threshold (SAT). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-76, dated 25 JULY 2014. The associated NAICS code is 541990 All Other Professional, Scientific, and Technical Services with associated small business size standard $14.0 million. This requirement is released on an unrestricted basis. PROJECT DESCRIPTION Background, purpose and objectives: The National Institute on Aging (NIA), one of the 27 Institutes and Centers of NIH, leads a broad scientific effort to understand the nature of aging and to extend the healthy, active years of life. The Laboratory of Behavioral Neuroscience (LBN) is driven by the purpose to enhance the understanding of age associated physical and biological changes in health and disease. The mission of the LBN is: (1) to conduct basic and clinical research on individual differences in brain structure, function and cognitive abilities; (2) to investigate the influence of age on these variables, using both cross-sectional and longitudinal designs; and (3) to identify predictors of cognitive decline and Alzheimer's Disease, including both risk and protective factors for cognitive and brain aging. In this field, there is a pressing need to identify predictive blood-based biomarkers of Alzheimer's disease (AD), and to facilitate the emerging paradigm shift in Alzheimer's research calling for disease-modifying treatments to be initiated in older individuals who are in preclinical stages of disease prior to the onset of overt cognitive decline. Using mass spectrometry-based proteomic analyses in combination with multi-modal neuroimaging, studies have revealed a robust peripheral signal from the plasma proteome that appears to be associated with AD pathology. This requirement focuses on blood-based biomarkers of AD that accurately reflect well-established endophenotypes of AD pathology such as brain atrophy, and "in vivo" fibrillar Ap deposition. This requirement aims to utilize a targeted quantitative metabolomics approach, which will identify: a) small metabolites in serum that may be useful as predictive blood biomarkers of incident AD and b) metabolite markers in brain associated with resilience to AD pathology. Small metabolites are the end result of all regulatory complexity present in the cell, tissue, or organism, including transcriptional regulation, translational regulation, and post-translational modification, and metabolic changes are thus the most proximal reporters of alterations in the body in response to a disease process. The main objective to complete is accurate quantification of endogenous metabolites of various biochemical classes in human serum, CSF and brain tissue samples from a study on Alzheimer's disease (AD). General Scope of Work: Contractor shall utilize a method called quantitative targeted metabolomics for measuring the absolute concentrations of 180 metabolites in serum and post-mortem brain samples to discover predictive blood biomarkers of Alzheimer's disease (AD) and markers of resilience to AD pathology. Absolute quantification is a novel methodological approach distinct from traditional and most widely used metabolomics methodology where only relative quantification of metabolites can be determined between different samples. Absolute quantification provides more robust information as it is not limited to only allowing comparative differences (i.e. lower or higher) between samples analyzed. The number and type of samples that assays shall be performed on by the contractor for metabolite quantification are approximated as follows to also include tissue homogenization: Human serum - 800 Human brain tissue - 130 Human CSF - 120 Serum for CV calculation - 80 Contractor requirements and tasks to be performed: Contractor shall provide an accurate estimation of absolute metabolite concentrations in human serum, CSF and brain tissue samples from AD study. Contractor shall identify specific sample preparation procedures and analytical techniques for targeted classes of metabolites. Contractor shall indicate method of resolution for subject project, Metabolic Phenotyping for Alzheimer's disease study, of metabolite classes needing to be analyzed. Classes include: amino acids, biogenic amines, acylcarnitines, phosphatidylcholines, sphingomyleins, and hexoses. Tasks performed by the contractor shall aim to predict the onset of AD before clinical symptoms occur. Therefore, accurate and absolute quantification of metabolites is a critical requirement. The ultimate goal of this biomarker study is the development of a blood-test for the prediction of AD that could one day be used in clinical practice settings. The period of performance shall be effective on or around September 30, 2014. Deliverables and Reporting requirements: Data analysis and final reporting will be provided by the contractor on assay procedures carried out under this requirement. Data and final report will be required for delivery no later than 6 months after receipt of samples to be analyzed. Government's responsibilities: NIA will provide the various biochemical classes in human serum, CSF and brain tissue samples from a study on Alzheimer's disease for analysis and quantification of endogenous metabolites by contractor. The Contracting Officer's Representative (COR) will be responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance. Technical Evaluation criteria: Offerors may respond with a proposal indicating their ability to provide the technical requirements stated in this solicitation. Pricing proposals shall indicate the unit price of metabolomics profiling sample analysis and price for data analysis and sample preparation and data acquisition, as applicable. Responses from Offerors will be evaluated on showing an Understanding of the Requirements. The Offeror's technical approach shall indicate compliance with Contractor Requirements, and describe an essential understanding of the requirements involved in accomplishing the work. Offerors will be evaluated on their ability to meet the essential government requirements listed in this solicitation. Offerors will be evaluated on past performance for work on government and commercial contracts for similar requirements in the past two (2) years. Responses to this RFQ must not exceed 25 pages in length and be submitted in Microsoft Word or searchable PDF format in a font size of 11 or 12 point and font type of Arial or Times New Romans. Margins must be 1-inch wide (top, bottom, left, and right). Responses must references this solicitation number and include the name of the contractor. Pages in excess of the specified page limit will not be considered or evaluated. The following FAR provisions shall apply to this solicitation: 52.212-1, Instructions to Offerors--Commercial Items, 52.212-2, Evaluation--Commercial Items. Evaluation factors that will be used to evaluate the offer most advantageous to the Government, price and other factors considered, include ability to meet the technical requirements stated in this pre-solicitation and on basis of best value to the government. Offerors must include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications Commercial Items, with their offer. The Clause at 52.212-4, Contract Terms and Conditions Commercial Items, applies to this acquisition and the Clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items applies to this acquisition. The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. In addition the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All Offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." All responses must be received no later than the response deadline indicated on August 25, 2014, 12:00 pm Eastern time. Late responses will not be accepted. All responses must reference solicitation number HHS-NIH-NIDA-SSSA-CSS-14-599. Responses may be submitted electronically to Hunter.Tjugum@nih.gov and to NIDASSSAPurchaseRequ@mail.nih.gov. Fax responses will be accepted at (301) 480-1358. For information regarding this solicitation, contact Hunter Tjugum by email at hunter.tjugum@nih.gov or by phone at (301) 435-8780.
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