SOLICITATION NOTICE
A -- Expert Services for Risk/Benefit Evaluation of Seafood Relating to Methylmercury in Commercial Fish
- Notice Date
- 11/8/2005
- Notice Type
- Solicitation Notice
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- 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-1010487
- Response Due
- 11/23/2005
- Point of Contact
- Lori Forgosh, Contract Specialist, Phone (301) 827-7044, Fax (301) 827-7106, - Patricia Calhoun, Contract Specialist, Phone (301) 827-1022, Fax (301) 827-1018,
- E-Mail Address
-
lforgosh@oc.fda.gov, pcalhoun@oc.fda.gov
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in 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 synopsis, identified as No. 1010487, is to notify contractors of the government’s intent to award a purchase order to Thomas Billy of International Food Safety Consulting LLC under the simplified acquisition procedures. The FDA intends to issue a simplified acquisition on a sole source basis to Food Safety Consulting LLC4802 Chevy Chase Blvd, Chevy Chase, MD 20815-5340. There is only one responsible source and no other supplies or services will satisfy agency requirements due to the following reasons: Due to uncontrollable circumstances the contractor was not able to complete the work. Continuing the services of Mr. Billy under this contract enables FDA to have ready access to an individual who is widely recognized as an expert in Food Safety and, more importantly methylmercury. The potential health affects of methymercury in children and pregnant women is of great concern, and a high priority issue with members of Congress and the American people. FDA needs the consistency of interaction between Mr. Billy and the stakeholders to ensure completion and any subsequent revision to reports. Tom Billy is an internationally recognized leader in evaluating and managing food safety issues. This expertise includes 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. His knowledge of, and experience in, these matters covers a broad spectrum that is important to this contract, in that he possesses a special understanding of all components of the food safety community both within and outside of the U.S. Federal government, including the international community, and has earned their respect. Mr. Billy began his Federal career in fisheries research. From 1974 to 1991 he served first as the Director of the Seafood Safety and Inspection Division of the National Marine Fisheries Service of the U.S. Department of Commerce, then as that agency’s Director of Utilization Research and Inspection, and finally as the Deputy Director of the Office of Trade and Industry Services. During this period he led efforts to conduct a comprehensive risk assessment on methylmercury in seafood and submit a petition to modify the FDA action level based upon this scientific analysis. In 1991 he was recruited to serve as the first director of FDA’s Office of Seafood. A recognized seafood expert, he led efforts to develop an innovative HACCP program to improve seafood safety and served as the U.S. delegate to the Codex Alimentarius Committee on Fish and Fishery Products. From 1994-1996, Mr. Billy served as Associate Administrator for USDA’s Food Safety and Inspection Service (FSIS). He led the design and development of innovative program changes needed to improve the safety of meat and poultry products. From 1996 to 2001, Mr. Billy served as Administrator for FSIS. In this position he was leader of USDA’s food safety activities and managed an agency of 10,000 employees with an $800 million budget. Mr. Billy’s efforts resulted in his receiving the 1997 Presidential Rank Award for Distinguished Federal Executives. He has also received two FDA Commissioner’s Special Citations. Mr. Billy also was elected to serve two two-year terms as the Chairman of Codex Alimentarius. As Chairman, Mr. Billy developed and gained support from the 168 members of the Codex Commission for strategies to strengthen the scientific basis for its work and to improve the efficiency and effectiveness of Codex, thus positioning it to address emerging food safety issues in the 21st century. To the best of our knowledge, Mr. Billy is the only person qualified to lead the evaluations and develop the options called for in this contract in such a short time frame. During his 39 year Federal career, Mr. Billy has gained leadership, policy, analytical, and communication skills that are needed to carry out this difficult task. His particular knowledge of seafood safety and methylmercury in particular further strengthens his value in this effort. His historical perspective on national and international issues related to this contract makes him uniquely qualified to accomplish the task required. Also, Mr. Billy’s reputation and stature in the food safety community, both domestic and international, provide a degree of credibility and reassurance to stakeholders that would be difficult to duplicate and might not otherwise be readily obtainable for this project. These reasons, considered in their entirety, are why FDA anticipates a sole source award to Tom Billy of International Food Safety Consulting LLC, however, other sources may submit descriptive literature that fully demonstrates their capabilities and they will be reviewed to determine if they are considered qualified. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2001-27. The associated NAICS code is 541710 –Research and Development in the Physical, Engineering, and Life Sciences and the small business size standard is 500 employees. The following are objectives and tasks International Food Safety Consulting LLC will be requested to provide: 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. The provision at FAR 52.212-1, Instructions to Offerors—Commercial Items applies to this solicitation. The following agenda have been attached to this provision: None. Offerors shall include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications—Commercial Items. The clause at FAR 52.212-4, Contract Terms and Conditions—Commercial Items applies to this acquisition. The following agenda have been attached to the clause: None. The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items applies to this acquisition. The following FAR clauses cited are applicable: FAR 52.222-26, FAR 52.222-35, FAR 52.222-36, FAR 52.225-3, FAR 52.225-15, FAR 52.232-33. Clauses and provisions are incorporated by reference and apply to this acquisition. The FDA intends to make award immediately following the response date on this notice. All responsible sources that intend to submit descriptive literature shall submit it by COB on the due date referenced above to the following address or e-mail: Food and Drug Administration, 5630 Fishers Lane, Room 2083, HFA-500, Rockville, Maryland 20857-0001 or Lforgosh@oc.fda.gov. The Government will award a firm-fixed-price purchase order using Simplified Acquisition procedures in accordance with FAR 13.5. For information regarding this solicitation, please contact Lori Forgosh at 301-827-7044, fax 301-827-7106 or e-mail Lforgosh@oc.fda.gov. NOTE: THIS NOTICE MAY HAVE POSTED ON FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (08-NOV-2005). IT ACTUALLY APPEARED OR REAPPEARED ON THE FEDBIZOPPS SYSTEM ON 01-AUG-2006, BUT REAPPEARED IN THE FTP FEED FOR THIS POSTING DATE. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link to FedBizOpps document.
(http://www.fbo.gov/spg/HHS/FDA/DCASC/Reference-Number-1010487/listing.html)
- Place of Performance
- Address: Food and Drug Administration 5100 Paint Branch Parkway College Park, MD
- Zip Code: 20740
- Country: usa
- Zip Code: 20740
- Record
- SN01103794-F 20060803/060801223351 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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