Chemical Analysis Services

Sources Sought Notice for FDA-SS-15-1146769 This is a SOURCES SOUGHT NOTICE to determine the availability of potential small businesses (e.g., 8(a), service-disabled veteran owned small business, HUBZone small business, small disadvantaged business, veteran-owned small business, and women-owned small business) in accordance with FAR 7.104(d). The potential small business will need to demonstrate the capability to perform all facets of the work described below. The sole intent of this Sources Sought Notice is to obtain capabilities for set-aside and procurement planning purposes. The North American Industry Classification System (NAICS) code for the proposed acquisition is 541380, Testing Laboratories with a small business size standard of 500 Employees. This is not an invitation for bid, request for proposal, or other solicitation, and in no way obligates the Food and Drug Administration (FDA) to award a contract. The U. S Food & Drug Administration, Office of Acquisitions and Grant Services has a requirement to purchase "Chemical Analysis Services", for a Base Year (12 Months) and Four Option Years Background: Over the past several years, the agency has faced a wide range of issues related to direct and indirect contamination of food that have required information on the levels of specific chemicals. In many cases, the type of information required is a survey of the levels of contaminants in order to provide CFSAN with information necessary to formulate policy and to assess potential risks. In the past, this information has been provided by scientists within CFSAN: i) through small scale in-house surveys; ii) through contracts with outside laboratories and iii) through surveys conducted by the FDA's Office of Regulatory Affairs. The information from these surveys is not used for direct regulatory action, but is instead used to make decisions about scientific issues associated with food safety problems and to guide policy. This information was used to inform the agency about the nature of acrylamide levels in food, and was followed up in 2011-2014 by a larger study, done by a contract laboratory, which established the levels of acrylamide in a larger set of representative types of foods. This information was used to develop guidance about ways to reduce the occurrence of acrylamide in foods. Future studies will examine how guidance and policy have affected the levels of this chemical in foods. In 2011-2014, contract laboratory analysis was used to assess levels of inorganic arsenic in rice and rice products, as well as fruit juices, in order to obtain information used in developing risk assessments. Similar surveys were conducted to assess levels of 4-methylimidazole (4-MEI), potassium bromate, semicarbazide and color additives in various foods, in order to address different programmatic needs within CFSAN. The U.S. Food and Drug Administration (FDA), Center for Food Safety and Applied Nutrition (CFSAN), and its various offices nationwide, including the Office of Regulatory Science (ORS), the Office of Food Safety (OFS), the Office of Food Additive Safety (OFAS), the Office of Compliance (OC), has a need to obtain information about the levels of chemicals in a wide variety of foods, dietary supplements and cosmetics, through the collection of food, dietary supplement and cosmetic samples, and their subsequent analysis by chemical analytical methods to be specified by CFSAN. SCOPE The Contractor shall collect raw, minimally processed (e.g. bagged), and processed/package foods, dietary supplements and cosmetics from local supermarkets and stores in major metropolitan areas in some parts of the United States. The types of samples to be collected for these studies will include food products from across the United States, including fresh fruits and produce, packaged and processed foods of all types, dietary supplements and cosmetics. The analytical targets of these studies will include chemical contaminants in foods (e.g. pesticides, industrial chemicals), direct food additives, indirect food additives (those produced by processing or transfer from packaging), deliberate adulterants, nutrients, naturally occurring chemical components (such as metals), as well as the chemical constituents of dietary supplements, botanical extracts and cosmetics. The analytical methodology for any specified study will be established and provided by CFSAN, and shall include methods based upon state-of-the-art analytical techniques, including many based on instrumental analysis with various types of separation techniques and spectrometers. Sample Collection Cities chosen may include the metropolitan areas of Atlanta, Chicago, Dallas, Denver, Los Angeles, New York, San Francisco, Seattle and Washington, DC. CFSAN will specify the type of commodity, the brand distribution, lot number and manufacturing date distribution, quantity and geographic location of the samples. While the geographic distribution is not expected to be extensive, the ability to obtain samples from major metropolitan areas is required. Quality Assurance/Quality Control plan - The Contractor shall use quality assurance/quality control or something similar that will be specified with each task order. Data reporting The Contractor shall report data from analyses similar to the following procedures: Certificates of Analysis (COA), a Results Spreadsheet (Excel), raw data files, quantitation files and photocopies or photographs of product packaging should be submitted within 10 working days of completion of the analysis of a specified sample set (food type, group, etc, as determined in consultation with CFSAN). All data must be certified, and the raw data and product package photos uploaded to CFSAN. The contractor shall possess an ISO 17025 Accreditation or the equivalent. This is a "Go" or "No Go" requirement. All services, unless otherwise agreed to by the COR (TBD), must occur or shall be performed at the contractor(s) facility. Responses to this sources sought notice shall unequivocally demonstrate that the respondent is regularly engaged in the performance of the same or substantially similar services, tasks or items. At a minimum, responses shall include the following: 1. Three (3) years of past performance information for the firm and/or sale of same or substantially similar services/items to include date of performance/sale, description (should also include drawings and photos), dollar value, client name, client address, client point of contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include DUNS number and size status) if not the respondent; 2. Descriptive literature, brochures, marketing material, etc. detailing the nature of the services/items the responding firm is regularly engaged in manufacturing and/or selling; and 3. Provide verification of ISO 17025 Accreditation or the equivalent. 4. DUNS Number 5. Company Name 6. Company Address. 7. Company Point of Contact, phone number and email address 8. Type of company under NAICS, as validated via the System for Award Management (SAM). Additional information on NAICS codes can be found at www.sba.gov. Any potential government contract shall be registered on the SAM located at http://www.sam.gov/index.asp. 10. Corporate structure (corporation, LLC, sole proprietorship, partnership, limited liability partnership, professional corporation, etc.); 11. Current GSA Schedules appropriate to this Sources Sought 12. Current Government Wide Agency Contracts (GWACs) 13. Point of Contact, phone number and email address of individuals who can verify the demonstrated capabilities identified in the responses. Interested parties having the capabilities necessary to provide the stated requirements may submit capability statements via email or regular mail to: Responses shall be received not later than 12:00 PM EST, July 30, 2015. Information received will not be returned and will not be accepted after the due date. Documentation should be mailed or emailed to: "Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s)."