SOLICITATION NOTICE
B -- Expert Services for Risk/Benefit Evaluation of Seafood Relating to Methylmercury
- Notice Date
- 8/3/2004
- 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
- F6103804
- Response Due
- 8/11/2004
- Archive Date
- 8/26/2004
- Point of Contact
- Sharon Savage, Management Analyst, Phone 301-827-1509, Fax 301-827-6854, - Susan Pearlman, Contract Specialist, Phone (301) 827-7046, Fax (301) 827-7101,
- E-Mail Address
-
SES@CDRH.FDA.GOV, spearlma@oc.fda.gov
- Description
- This is a combined synopsis/solicitation for commercial items or services IAW with the format in FAR Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a written solicitation will not be issued. This solicitation is issued as a Request for Quote (RFQ) No. F61038. The solicitation clauses and provisions are those in effect through Federal Acquisition Circular 97-27. The NAICS Code is 541990. The FDA intends to issue a purchase order on a sole source basis to Thomas J. Billy, 4802 Chevy Chase Boulevard, Chevy Chase, Maryland. The contractor shall have expertise in evaluating and managing food safety issues. The expertise must include a detailed knowledge of seafood hazards and controls and the issue of methylmercury in particular; food safety risk assessment and analysis; and food safety risk management and communication strategies from both a national and international perspective. The contractor will need to perform the Scope of Work, which is to include: Project Title: Request Expert Services for Risk/Benefit Evaluation of Seafood Relating to Methylmercury 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 and recommendations for consideration by the Food and Drug Administration in light of the latest scientific, technical, and economic data and information. These options and recommendations 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 and others 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, impact assessment of the consumer advisory, 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. Provide options and recommendations to FDA for changes, if any, on the basis of the above evaluation(s). Among other things, these options and recommendations may relate to the consumer advisory, the action level, and consumer education. 4. Conduct meetings with ?stakeholders? within the Administration, 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. 5. 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. 6. Meet with agency, HHS, and Administration representatives on a regular basis to discuss the status of the project. 7. Prepare briefing materials and provide support to the agency as needed. Deliverables: The contractor shall submit the following reports/deliverables: 1. Risk Evaluation Update Document 2. Benefits Evaluation Document (The Risk Evaluation & Benefits Evaluation may be separate documents or combined, at the discretion of the contractor). 3. Option/Recommendations 4. Meetings with Stakeholders 5. Public Meetings The Food and Drug Administration (FDA) will provide adequate scientific technical support for research, risk and benefit assessment modeling, drafting, etc.; results of consumer impact studies; adequate office space, appropriately provisioned, e.g., desk, telephone, computer, in College Park for the duration of the contract. The FDA intends to make an award immediately following this notice. The anticipated period of performance will be approximately August 16, 2004 through August 15, 2005. The following FAR clauses shall apply to the solicitation: 52.212 Instructions of Offerors-Commercial; 52.214-4 Contract Terms and Conditions-Commercial Items; and 52.232-33 Electronic Funds Transfers. All responsible sources that can provide and meet the above requirements shall submit written quotations by the due date referenced above. All questions should be submitted in writing via email to sharon.savage@fda.hhs.gov or fax to (301) 827-7039. FAR provisions can be found at the following website: http://www.arnet.gov.
- Place of Performance
- Address: CFSAN/Office of Seafood, 5100 Paint Branch Parkway, HFS-415, College Park, MD
- Zip Code: 20740
- Country: US
- Zip Code: 20740
- Record
- SN00635576-W 20040805/040803211949 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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