The Food and Drug Administration plans to issue a Request for Quote (RFQ) with Req No. 1010487 to provide expert services for risk/benefit evaluation of seafood relating to Methylmercury in commercial fish. This acquisition is set-aside for competition restricted to small business concerns and will be conducted in accordance with FAR Part 13 Simplified Acquisition Procedures. The requirements for this project are as follows: Project Title: Request Expert Services for Risk/Benefit Evaluation of Seafood Relating to Methylmercury in Commercial Fish. Objective: To perform risk/benefit evaluation(s) of commercial seafood that focus on the risk of methylmercury as weighed against nutritional and other health benefits, and provide options, including a preferred option where appropriate, for consideration by the Food and Drug Administration in light of the latest scientific, technical, and economic data and information. These options will be made for consideration by the Food and Drug Administration about actions to be taken, if any, on the basis of this analysis and discussions and input from all stakeholders, giving due consideration to FDA’s broad responsibilities under the FD&C and PHS Acts. Background: Methylmercury is a neurotoxin that can have pronounced adverse effects in humans at very high doses. These effects have been seen in extreme poisoning events as a result of industrial spills in Japan and Iraq. In the United States, the primary exposure to methylmercury is generally regarded to be through the consumption of fish. Almost all fish have at least trace amounts of methylmercury. Historically, the public health questions surrounding methylmercury have involved determining exposure through fish consumption over time that would be necessary to cause an adverse effect. The degree of exposure is dependent on both the type and amount of fish consumed. Public health actions, both in the United States and elsewhere, have focused on the development of “tolerable daily intake” levels for human exposure, regulatory limits, e.g., “action levels,” for the amount of methylmercury that would be allowed in fish, and consumer advisories recommending upper limits on fish consumption both in terms of amounts and types. Fish have always been considered a good source of nutrition, but more recently, questions have been raised about potential health consequences of not consuming, or substantially limiting the consumption of, seafood. Many of these questions derive from data about the beneficial health effects of omega-3 fatty acids in fish and other potentially positive nutritional characteristics of fish. The recently revised consumer advisory on methylmercury emphasized the benefits of consuming fish but did not involve either a quantitative or qualitative assessment of the risks from mercury exposure versus the benefits of eating fish. Scope of Work: In cooperation with the Office of Seafood, and with the assistance of the Office of Nutritional Products, Labeling, and Dietary Supplements, the Chief Medical Officer, FDA staff, EPA, other federal agencies, and other stakeholders, as needed, the contractor shall: 1. Conduct a new risk evaluation that takes into account all data and all previous assessments including the recent assessment by JECFA. 2. Conduct a benefits evaluation of seafood in the diet that includes but is not necessarily limited to: literature search, and analysis to the extent practicable of known and potential nutritional and other health benefits from seafood consumption and estimates of lost benefits and/or public health harm from dietary changes in seafood consumption, if any. 3. Risk and benefit papers will be peer – reviewed under FDA auspices consistent with guidelines to meet FDA and OMB requirements. 4. Coordinate contract work with the NAS/IOM Study on “Nutrient Relationships in Seafood: Selections to Balance Benefits and Risks” – participating in public meetings, make available the peer – reviewed Risk and Benefit papers and any modeling tools developed to the study. 5. Provide options, including a preferred option where appropriate, to FDA for changes, if any, on the basis of the above evaluation(s). Among other things, these options may relate to the consumer advisory, the action level, and consumer education. 6. Conduct meetings with “stakeholders” in other Federal agencies, consumer advocacy organizations, industry, academia/scientific community, etc. on the purposes and scope of the work, the work itself, and gain their views and understanding. 7. Conduct at least two public meetings, announced in the Federal Register, and conducted to share new data and information and to obtain oral and/or written input. One or more of these public meetings may be held with NAS. 8. Meet with agency, HHS, and other federal agency representatives on a regular basis to discuss the status of the project. 9. Prepare briefing materials and provide support to the agency as needed. 10. Provide advice associated with consumer studies by participation in the Technical Advisory Group. There will be deliverables with scheduled due dates. Support to be Provided by FDA: adequate scientific technical support for research, risk and benefit assessment modeling, drafting, etc.; adequate office space, appropriately provisioned, e.g., desk, telephone, computer, in College Park for the duration of the contract. Scientific technical support may be augmented by staff from EPA and other government agencies, where appropriate. Period of performance is one year from date of award. Offerors will be required to submit a technical and price proposal for evaluation by the Government. It is anticipated that a purchase order will be awarded. The applicable NAICS code is 541990 and the small business size standard is $6.5M. The anticipated release date of the RFQ is on or about June 6, 2006. The firm date and time for receipt of offers will be stated in the RFQ. Only written responses will be accepted. Questions may be sent by e-mail to
[email protected] or
[email protected]; or by fax at 301-827-7106. The RFQ will be made available electronically at this website. It is the offeror’s responsibility to monitor this site for the release of the RFQ and any amendments.