SOLICITATION NOTICE
R -- Dietary Supplement Safety Evaluation
- Notice Date
- 7/31/2006
- Notice Type
- Solicitation Notice
- NAICS
- 541618
— Other Management Consulting 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
- FDA-SOL-1018590gh
- Response Due
- 8/10/2006
- Archive Date
- 8/30/2006
- Description
- This is a combined synopsis/solicitation for commercial services in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation, FDA-SOL-1018590gh, is issued as a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 05-10. The acquisition is set a-side for small businesses. The NAICS code is 541618. This acquisition will be acquired using Simplified Acquisition procedures. TITLE: Dietary Supplement Safety Evaluation: Product Consistency and Adverse Events Project. BACKGROUND: The mission of the Center for Food Safety and Applied Nutrition (CFSAN) of the U.S. Food and Drug Administration (FDA) is to assure the safety and wholesomeness of the nation?s food supply, including dietary supplements in accordance with the regulations established by the Dietary Supplement Health and Education Act of 1994. Among CFSAN?s priority activities in supporting this mission is performing post market surveillance of adverse events and using other information from academic or regulatory bodies to detect signals of possible safety concerns associated with the use of dietary supplements. In November 2004 FDA announced a ?Regulatory Strategy for the Further Implementation and Enforcement of the Dietary Supplement Health and Education Act of 1994?. Included in this announcement were several specific initiatives, including: (1) plans to improve the evidentiary base for safety and enforcement decision making through external collaborations and internal resource priority-setting. (2) FDA?s intention to implement a transparent and systematic process for evaluating safety concerns about dietary ingredients and dietary supplements. To assist FDA in its efforts to identify the safety issues affecting dietary supplement use, FDA is announcing this research proposal to identify variations in the level of stimulant-like ingredients associated with dietary supplement adverse event reports that are relevant to the safety of dietary supplement products. OBJECTIVE: To link with an existing adverse event reporting system capable of identifying adverse events associated with the use of dietary supplement products claiming stimulant or sympathomimetic properties and to sample these products for variation in the level of ingredients that may contribute to the reported adverse events. Critical to the successful implementation of this project will be the linkage with medical toxicologists trained in the investigation, assessment and testing for the causality of exposures. The purpose of utilizing expertise in medical toxicology in investigation and follow up (appropriate case review, analysis of products, and clinical testing) is to provide the best available science to support the regulatory process. Furthermore, identification of specific examples where product variation of ingredient content may have contributed to the reported adverse event and its seriousness may provide beneficial information to consumers and in the implementation of regulatory guidelines or requirements that improve product safety and consistency. SCOPE OF WORK: The Contractor shall link with a dietary supplement health effects surveillance program for investigating reports of adverse health events in individuals using dietary supplements. This program will operate independently in a consistent and transparent manner to identify adverse events associated with products making stimulant or sympathomimetic claims, obtain product for sampling, and test for variation in the level of combination of ingredients with stimulant or sympathomimetic properties that may have contributed to the adverse event or its seriousness. The goal is to apply a consistent, objective approach and validated testing method to identify variation in ingredient quantity or combination that may contribute to the incidence of adverse events reported for dietary supplements making stimulant or sympathomimetic claims. The proposal meeting this need will: REQUIREMENTS: (1) Utilize an existing adverse effect reporting system(s) (i.e. Poison Control System, Hospital Emergency Call Center) that monitor calls involving dietary supplements and collect cases that involve symptoms for prompt follow-up and investigation. (2) Identify adverse events reported for products with claims associated with stimulant of sympathomimetic properties (i.e. weight loss, performance enhancing). (3) Utilize medical toxicology expertise to assess the strength of association between reported exposure to dietary supplement products and the reported events, including expertise in: A. Mechanisms of toxicity : (1) Biochemistry, (2) Pathophysiology, (3) Pharmacology, (4) Toxicokinetics, (5) Adverse Drug Events/Drug interactions, (6) Teratogens/carcinogens; B. Analytical Toxicology Laboratory; C. Forensic toxicology; D. Statistics. 1. Carry out comprehensive clinical and laboratory investigation of reported events to obtain reliable and accurate data in a timely manner, including product analysis and biological fluid testing by a reliable and reproducible laboratory system. 2. Work in conjunction with the Project Officer to publish novel findings of dietary supplement related illnesses. Specifically, the Contractor shall: 1. Identify reported adverse events associated with dietary supplement products marketed with stimulant claims and labeled with stimulant or sympathomimetic ingredients. 2. Obtain samples of the product, including the actual lot or package when possible, for qualitative and quantitative evaluation of the ingredients of concern. 3. Report to the project officer the testing findings and relationship of these findings to the incidence and type of adverse events reported for these types of products. The monitoring and testing program shall include: 1. Demonstration of the process for receiving, collecting and reviewing adverse event information and identification of the products of interest. 2. Establishment of guidelines for the handling, processing and redacted distribution of any privileged information which may be shared with FDA or other parties during the performance of the contract in accordance with Privacy Act requirements; 3. Description and demonstration of the validation methods used in the qualitative and quantitative assessment of product sampling, addressing product and operative consistency and reliability. INSPECTION AND ACCEPTANCE: Schedule: 1. Initial meeting to discuss work plan, 2. Regular monthly conferences to review and discuss progress, 3. Final meeting after delivery of the final report to respond to agency questions. DELIVERIES/PERFORMANCE: The contractor shall: 1. Provide a final report that: (a) Summarizes all adverse event reports received during the period of work performance. (b) Summarizes the characteristics of the adverse event reports identified for product testing. (c) Summarizes the qualitative and quantitative findings of the testing for ingredients in the products that were tested. (d) Summarizes issues and challenges encountered during the performance of this contract for product testing and validation. 2. Describe the testing and validation methods for quantitative and qualitative assessment. 3. Provide results for testing and validation of all products and equipment utilized for this projects on request of the Project Officer. Delivery Instructions for Reports: Unless otherwise specified, all reports or copies of reports shall be delivered to the Project Officer. EVALUATION CRITERIA Primary consideration for all proposals received shall first be evaluated from a technical standpoint without regard to proposed Cost or Price. Technical Evaluation: A. Proposed Type of Personnel 50percentOfferor shall demonstrate that it has the personnel requisite to: 1. Understand medical toxicology to assess the strength of association between reported exposure to dietary supplement products and the reported events, including expertise in (a) Pharmacology(b) Toxicokinetics (c) Forensic toxicology. 2. Understand and evaluate existing frameworks for causality association of adverse events. 3. Understand and evaluate existing and emerging epidemiological data on the use of dietary supplements with stimulant ingredients for various health outcomes. 4. Understand and evaluate existing and emerging scientific data on risk review and communication. 5. Understand and provide guidance to a team of experts on options to model adverse event reporting and evaluation of risks of dietary supplement use against health benefits in order to conduct a risk/benefit evaluation. b. Organizational Experience 30percent, Offeror shall demonstrate past experience in: (1) Managing teams of experts in the conduct of innovative and technical projects to a successful conclusion. (2) The evaluation of adverse event information from existing reporting systems. (3) Evaluating and understanding dietary supplements as a potential food with health risks. (4)The drafting of complex scientific or technical papers.(5) The publication of case reports or series of adverse events associated with the use of dietary supplement products. c. Technical Approach 20 percent Offerors shall indicate how they would approach: (1) The clinical and laboratory investigation of reported events to obtain reliable and accurate date in a timely manner, including product analysis and biological fluid testing by a reliable and reproducible laboratory system. (2) Developing a process for providing relevant summary reports for public distribution on adverse events associated with dietary supplement use while maintaining the security of individual privacy information. PERIOD OF PERFORMANCE: August 15, 2006 ? December 31, 2006. Quoters are required to submit completed copies of the provisions at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items, with their quotes. FAR clause 52.212-4, Contract Terms and Conditions-Commercial Items, applies to this acquisition and does not include an addendum. FAR clause 52.212-5, contract Terms and Conditions Required to Implement Statutes or Executive Orders, Commercial Items applies to this acquisition. The following clauses within 52.212-5(b) are applicable to this acquisition: 52.222-3, 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37, and 52.232-33. All questions should be sent via fax on (301)827-7106 or email, no later than 2:00 p.m., EST, August 4, 2006. All quotes are due by 2:00 p.m. EST., August 10, 2006.
- Record
- SN01101954-W 20060802/060731220324 (fbodaily.com)
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