Analytical Studio Software

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 and supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested and a written solicitation will not be issued. This synopsis is to notify contractors that the government intends to issue a Purchase Order on a brand name or equal basis in accordance with FAR Part 13 for the following, under simplified acquisition procedures. The Request for Quotation number is FDA-SOL-15-1151378. Provisions and clauses in effect through Federal Acquisition Circular 2005-83 are incorporated into this request. It is the contractor's responsibility to be familiar with the applicable clauses and provisions. The provisions and clauses may be accessed in full text at www.acquisition.gov/far. The NAICS code is 541511, Custom Computer Programming Services. All qualified business interests are encouraged to submit a quotation. The U.S. Food and Drug Administration requests quotation responses from qualified sources capable of providing the resources mentioned above (brand name or equal to product) within the time frame specified. Statement of Need: Background and Purpose: The Office of Regulatory Science of CFSAN requires data analysis software, Analytical Studio (brand name or equal to), for use in research, development and analysis related to CFSAN's food safety mission. The software will be used to initially process Liquid Chromatography/Mass Spectrometry (LC/MS) data files from the major manufacturers in an automated fashion. The software will search the data files for target contaminants and provide feedback of their presence. In addition, the software will also search for any other potential contaminant and provide a list of potential identities. This is important for allowing FDA scientists to process their analytical data more efficiently and quickly. Because LC/MS plays a major and vital role in the identification of chemical contaminants in foods and in the identification of compounds that can migrate into food from food packaging, automated data analysis strategies will allow for increased analytical throughput by reducing the burden of data processing. Since the inception of LC/MS, it has been a powerful analytical tool at CFSAN and FDA. The ever-increasing uses of the technique and the advances made have resulted in more instruments purchased to meet FDA's mission. With increasing imports and analytical demands on FDA scientists, software solutions to improve analyst efficiency are required. The solution is to use software to automatically process LC/MS data in order to allow scientists to focus on confirmation, thus reducing the time required to manually process a large number of samples. The current version of the software is capable of processing LC/MS data for a list of user-defined target compounds. The modified version of the software can be used to examine the data for chemicals that may exist outside of the target list and, given the proper instrumentation, assist in the identification of this contaminant in conjunction with both internal and external databases. This approach will be used whenever possible to support the identification of contaminants and to identify chemical constituents of complex mixtures, and it will play an important role in the identification of economic adulterants in the near future