Notice of Intent: Assessing Changes in the Human Gut Microbiome in Relation to Foodborne Illness

This synopsis is hereby issued in accordance with FAR Part 5.203 and FAR 13.501(a) in response to the mandatory requirement for a 15-day notification. The purpose of this synopsis is to announce the Food and Drug Administration's intent to negotiate a Firm Fixed Price sole source contract with the University of Massachusetts, located at Commonwealth Ave, Amherst, MA, 01003 to conduct in-depth, comprehensive assessment, literature reviews, analysis of (1) foods and dietary supplements that claim to modify the human gut microbiome, and (2) the impact of microbiome- altering ingredients in food and dietary supplement products.

The Government intends to negotiate solely with the University of Massachusetts, as no other source of supplies will satisfy agency requirements. This procurement is a continuation of work started under award HHSF223201710435P. This project requires in-depth knowledge and expertise in both the microbiome and nutrition fields to be successful. The FDA has identified Dr. David A. Sela, Professor in the Department of Food Science and the Department of Microbiology at the University of Massachusetts Amherst and his laboratory group as uniquely qualified to properly conduct this project. Dr. Sela is a pioneer and leader in host-microbial (i.e. microbiome) research with an emphasis on dietary influences on beneficial microbial communities, including both probiotics and the microbes that naturally colonize the human gut. Dr. Sela's work on the genomics of milk oligosaccharide utilization by Bifidobacterium has been seminal in the field and has garnered several awards in recognition of these accomplishments. He has also published 35 scientific articles and book chapters. Dr. Sela's expertise is widely respected; he has been awarded competitive research awards from federal sources (USDA and NIH), commodity interests (Center for Produce Safety), and industrial partners (Ocean Spray, Inc.). Dr. Sela has been invited to give several high-profile presentations related to his microbiome research. The Sela Lab's mission is to enhance human health and mitigate disease through judicious interventions in an individual's microbiome. The lab has been responsible for several impactful scientific breakthroughs, act including nutritional interventions based on microbiome-active molecules secreted in breast milk and plant polysaccharides, the engineering of microencapsulated vehicles to orally deliver microbiome-active particles (probiotics and others) to the gut, and the development of bacteriophage-based biosensors to quantify targeted species within microbial communities that may contaminate food systems. The Sela lab consists of several researchers and a research assistant professor who work on diverse projects related to the human gut microbiome and interactions with dietary components. This lab is particularly unique in academia because of its two senior researchers, who provide significant leadership in the field.

The anticipated task areas under this order will be as follows:
1. The Contractor shall conduct an in-depth, systematic literature review covering the impact of probiotic foods and dietary supplements. The Contractor shall synthesize findings, which shall be discussed with subject matter experts within the Epidemiology Branch, as well as with other relevant collaborators.
2. The Contractor shall conduct an in-depth, systematic literature review covering multiple aspects related to microbiome-altering ingredients. The Contractor shall synthesize findings, which shall be discussed with subject matter experts within the Epidemiology Branch, as well as with other relevant collaborators.
3. The Contractor shall co-author summaries/publications/presentations on findings from analyses for publication after appropriate clearance.

The anticipated period of performance for this work is for a one (1) year.

The estimated total value of these services is $112,492.96

THIS NOTICE IS NOT A REQUEST FOR COMPETITIVE PROPOSALS, however, interested firms may submit a capability statement in response to the above requirement with pricing information by April 4th, 2019@ 3:00 PM Eastern Time to Christopher McGucken, Contract Specialist, Phone: (240) 402-7566, Email: Christopher.McGucken@fda.hhs.gov. A determination not to open competition based responses to this notice is solely within the discretion of the Government.

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