SOLICITATION NOTICE
B -- Expert Services for Risk and Benefit Evaluation of Seafood Relating to Methylmercury in Commercial Fish
- Notice Date
- 8/21/2006
- Notice Type
- Solicitation Notice
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, MD, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- Reference-Number-FDA-SOL-06-00349
- Response Due
- 9/1/2006
- Archive Date
- 9/16/2006
- Small Business Set-Aside
- Total Small Business
- Description
- This is a Combine Synopsis/Solicitation for commercial items prepared in accordance with the format under Simplified Acquisition Procedures in accordance with FAR Part 13, as supplemented with additional information included in this notice. This Combine Synopsis/Solicitation replaces a previous announcement REQ101487 posted on May 22, 2006 in its entirety. This solicitation document incorporates provisions and clauses that are in effect through August 2006 Federal Acquisition Regulation revision, which includes the consolidation of all Federal Acquisition Circulars through 2005-12. This acquisition is 100% a small business set-aside and the North American Industry Classification System (NAICS) code is 541990 with a small business size standard of $6.5 million. Objective: To perform risk and benefit evaluation of commercial seafood that focuses on the risk of methylmercury. The evaluation will assess the extent to which nutritional and other health benefits from eating fish may be relevant to risk from methylmercury. The evaluation will provide risk management options 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 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 daily or weekly levels of exposure that are deemed to be safe, ?action levels,? for the amount of methylmercury that would be allowed in fish in order to keep exposures from exceeding the level deemed to be safe, 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. Scope of Work: In cooperation with the Office of Seafood, Center for Food Safety and Applied Nutrition, and with the assistance of the Office of Nutritional Products, Labeling, and Dietary Supplements, CFSAN?s Chief Medical Officer, FDA staff, EPA, other federal agencies, and other stakeholders, as needed, the contractor shall: 1.Conduct a new risk evaluation for commercial fish that takes into account all data and all previous assessments. The risk evaluation shall focus on the sufficiency of data available to FDA to carry out its mission of determining whether a reasonable possibility of injury exists for all or some portion(s) of U.S. consumers. 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. Obtain peer review per FDA and OMB requirements. 4. Provide risk management options to FDA on the basis of the above evaluation(s). 5. Conduct at least two public meetings, announced in the Federal Register, to share new data and information and to obtain oral and/or written input. 6. Meet with agency, HHS, and other federal agency representatives to discuss the status of the project. 7. Prepare briefing materials and provide support to the agency as needed. 8.Provide advice associated with consumer studies by participation in the Technical Advisory Group. Deliverables: The contractor shall submit the following reports/deliverables in the timeframes indicated: 1. A document that has been peer reviewed and that contains: A risk evaluation update. A benefits evaluation update. Options where appropriate. Due: End of calendar year 2006. This document may be a single document or more than one document at the discretion of the contractor. Conduct at least two public meetings. Due: End of calendar year 2006. The Food and Drug Administration (FDA) will provide adequate scientific and technical support for research, risk and benefit assessment modeling, drafting, peer review, etc.; adequate office space, appropriately provisioned, e.g., desk, telephone, computer, in College Park for the duration of the contract. 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. EVALUATION CRITERIA: Primary consideration for all quotation received shall first be evaluated from a technical standpoint without regard to proposed Cost or Price. However, in the event that the technical evaluation reveals that two or more offerors are approximately equal in the technical ability, then cost may become a significant factor in determining award. In any event, the government reserves the right to make an award based on a best value determination, cost and other factors considered. Technical Evaluation. a. Proposed Type of Personnel: 50%: Offeror shall demonstrate that it has the personnel requisite to: Understand seafood hazards and spectrum of controls that are available for those hazards in order to evaluate the hazard of methyl mercury and potential controls for that hazard in the context of overall risk management strategy for seafood. Understand and evaluate the existing national and international risk management framework for methyl mercury, including: The ?safety assessment? model, including its strengths and weaknesses as these apply to assessing risk for environmental contaminants and for methyl mercury in particular; The ?risk assessment? model, including its strengths and weaknesses as these would apply to assessing risk for environmental contaminants and for methyl mercury in particular; Understand and evaluate existing and emerging epidemiological data on methyl mercury as they may adversely affect various health endpoints. Understand and evaluate existing and emerging scientific data on potential health and nutritional benefits from the consumption of fish. Understand and provide guidance to a team of experts on options to model methyl mercury risks against health benefits from fish consumption in order to conduct a risk/benefit evaluation of this food/hazard combination. b. Organizational Experience: 30%: Offeror shall demonstrate past experience in: Managing teams of experts in the conduct of highly innovative and technical projects to a successful conclusion. Risk management in food safety and seafood safety in particular. Evaluating and understanding methyl mercury as a potential food safety hazard in fish. The drafting of complex scientific or technical papers. The conduct of public meetings designed to receive public comment and engage in a dialog with the public on complex scientific or technical deliberations or policies. c. Technical Approach: 20%: Offerors shall indicate how they would approach: The development of scientific/technical papers on methyl mercury risk; potential or established nutritional or other health benefits from consuming fish; risk/benefit modeling that combines both risk and benefit data; The conduct of public meetings and peer review in general for these papers once they are developed. The purchase order term will be September 8, 2006 through September 7, 2007 with option for one (1) successive one-year period(s). The FAR provisions and clauses sited herein are incorporated by reference into this solicitation. Offerors are advised to propose in accordance with the provision of FAR 52.212 1, Instructions to Offerors Commercial Items. Offerors are advised to provide with their offer a completed copy of the following provisions: FAR 52.212 3, Offeror Representations and Certifications Commercial Items (http://www.arnet.gov/far/). The following FAR clauses apply to this acquisition: FAR 52.212 4, Contract Terms and Conditions Commercial Items; FAR 52.212 5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items. All questions must be submitted by close of business August 28, 2006 at 12:01pm EST. This is a Request for Quotations (RFQ) and no other document will be issued. Sources interested in responding to this notice must submit a response via e-mail or mail within ten (10) business days from the publication date of this notice. All responsive sources may submit a proposal which will be considered by the FDA. All questions must be submitted by close of business September 25, 2006 at 12:01pm EST. via e-mail. The response date for this RFQ is September 1, 2006 at 12:01pm Eastern Standard Time (EST). Responses must be sent via e-mail to: patricia.pemberton@fda.hhs.gov or hand delivered to 5630 Fisher Lane HFA-500, Room 2081, Rockville, Maryland 20857 by the closing. Strict adherence to all response dates will be enforced. Facsimiles WILL NOT BE ACCEPTABLE. Only written responses will be accepted. See notes 22.
- Place of Performance
- Address: 5100 Paint Branch Parkway, College Park, Maryland
- Zip Code: 20740
- Country: UNITED STATES
- Zip Code: 20740
- Record
- SN01120829-W 20060823/060821220258 (fbodaily.com)
- Source
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