SOLICITATION NOTICE
B -- Survey of Cosmetic Products for Phthalate Esters
- Notice Date
- 7/21/2008
- Notice Type
- Presolicitation
- NAICS
- 541690
— Other Scientific and Technical 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, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA1045448
- Archive Date
- 8/20/2008
- Point of Contact
- David - Kordel,
- E-Mail Address
-
david.kordel@fda.hhs.gov
- Small Business Set-Aside
- Total Small Business
- Description
- FDA1045448 The Food and Drug Administration (FDA) is seeking small business competition for vendors to conduct a survey of cosmetic products for phthalate esters. BACKGROUND Phthalate esters are present in many consumer products, including food wrappings, medical devices (e.g., blood bags), children's toys, wood finishes, paints, upholstery, plastic products and cosmetics. In cosmetic products, phthalate esters are used as solvents for fragrances, suspension agents for solids in aerosols, lubricants for aerosol valves, antifoaming agents, skin emollients, and plasticizers in nail care products. As a result of their extensive use in this wide variety of applications, phthalate esters are almost ubiquitous in the human environment and have been found in food, water, and other sources. Phthalate esters are of potential concern because of reproductive and other toxic effects reported for phthalate esters in animal models. Tests with rats have shown that some phthalate esters can damage the male reproductive system of offspring and cause other developmental abnormalities. The relevance of human exposure to phthalate esters is difficult to assess because the effects observed in animals resulted from exposure to relatively high doses, and more importantly, rats may metabolize phthalate esters differently than humans. Metabolites of phthalate esters have been found in human urine, but the levels are highly variable from person to person and between different demographic groups. Because of the common use of phthalates in consumer products it is difficult to pin point any specific product as the source of phthalate esters in human urine. FDA initiated limited surveys of cosmetic products for phthalate esters in 2002. A more extensive survey of cosmetic products will help FDA determine to what extent cosmetic products contribute to the total human exposure to phthalates. DESCRIPTION OF WORK The Contractor shall work closely with the FDA Project Officer throughout this project. The Contractor shall conduct a laboratory survey of cosmetic products for the phthalate esters that have been most typically found in cosmetics: dimethylphthalate (DMP), diethylphthalate (DE), dibutylphthalate (DBP) and, for certain product types, butylbenzylphthalate (BBP). General product categories to be analyzed include: body lotion, face lotion, hairspray, deodorant, fragrance, hair gel, hair mousse, body wash, shampoo, hand cream, and nail enamel. Between 5 and 35 specific products per product category (depending on the category) shall be analyzed. A total of 200 cosmetic products shall be analyzed and the levels of phthalate esters found reported. Specifically, 1. The Contractor shall identify appropriate laboratory analytical methods and consult with the project officer in making the final selection of method(s) to be used in the survey. 2. The Contractor shall demonstrate the ability to perform the necessary analyses by performing recovery studies on a variety of cosmetic matrices identified by the Project Officer. Results of the recovery studies must be reviewed and approved by the Project Officer before the rest of the work may proceed. 3. The Contractor shall consult with the Project Officer to refine the list of product categories and the specific products to include in the survey. The Project Officer must approve the final list. 4. The Contractor shall purchase the specific cosmetic products on the final list described above. 5. The Contractor shall analyze the specific cosmetic products on the final list for the phthalate esters identified above. 6. The Contractor shall provide reports as described under “Deliverables,” below. DELIVERABLES The Contractor shall provide a report of recovery studies described under #2, above. (One electronic copy and one paper copy, in a format specified by the Project Officer.) The Contractor shall provide interim reports, at 3 month intervals, on the results of the analysis of cosmetic products for phthalate esters. The Contractor shall provide a final report that includes the results of all analyses of cosmetic product for phthalate esters, a full description of the methods used, the results of the initial recovery studies, a description of problems encountered (if any) and their solution, and other issues relevant to the study. The Contractor shall ship all unused product to the FDA project team at the end of the study using an FDA FedEx or UPS account, which would involve no additional cost to the Contractor. EVALUATION OF VENDORS Personnel (40 points) Offeror shall demonstrate that it employs the personnel required to perform high quality quantitative analysis of cosmetics for phthalate esters. The offeror shall name the participating personnel, identify their qualifications and experience, and for each person, indicate the percentage of time that would be devoted to this contract. Overall Price (30 points) The offeror shall provide the best overall value for the FDA in terms of cost, relevant experience and approach. Organizational Experience (25 points) Offeror shall demonstrate experience in analytical chemical analysis. Project Management (5 points) Offer shall provide information on the administration of the project. This should include management plans, methods for implementing, and quality control and cost control procedures. Period of Performance The performance period will be one year from the time of award. ***Responses to this solicitation should not exceed 20 pages.*** This is a REQUEST FOR QUOTATION (RFQ). This announcement constitutes the only solicitation and a written solicitation will not be issued. QUESTIONS DEADLINE: all questions must be received by email (david.kordel@fda.hhs.gov) before 10:00 AM (1000) EST on 28 July 2008. All responsible sources must be registered in the Central Contractor Registry System (CCR) at www.ccr.gov to be considered. FDA intends to make an award soon after the response date of this notice and all bids must be submitted via email and be received by 10:00 AM (1000) EST on 5 August 2008 to the attention of David Kordel, david.kordel@fda.hhs.gov. Evaluation/Award will be based on the technically acceptable quote that offers the best value to the Government. The award will be made in accordance with FAR Part 13, Simplified Acquisition Procedures as a purchase order noted in FAR part 13.003(b)(1).
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