The objective of this sources sought notice is to find qualified and certified Contractors with the capability to provide these name brand or equal services for Proficiency Testing and Inter-Laboratory Evaluation programs based on the ISO Standards.

Purchase of Additional Technical Service from Quo Data (the makers of ProLab Plus software package licensed by FDA) to incorporate ISO Standards and Methods to FDA's Proficiency Testing Program. The estimated cost for this requirement is $249,000 (for the base and four option years). Purpose: The Center for Food Safety and Applied Nutrition's (CFSAN) proficiency testing program purchased ProLab Plus software for analyzing proficiency test and other inter-laboratory studies data to evaluate and approve FDNCFSAN/OFS/DFPST laboratories. Since the purchase of Prolab Plus the license, it has been extensively used by the Proficiency Testing program. However, specific application and interpretation of relevant standards is NOT part of the general technical service provided with software license. It was determined during discussions along the CFSAN, ORA and FCC scientists that the purchase of additional service will tremendously benefit the PT program. The CFSAN's Proficiency Testing program expanded recently, and we are seeking to acquire ISO accreditation and to fulfill our mandate, we need to incorporate advanced statistical techniques. Objective: The objective of this effort is to find qualified and certified Contractors with the capability to provide these name brand or equal services for Proficiency Testing and Inter-Laboratory Evaluation programs based on the ISO Standards. Scope of Work During a performance term of a base and one option period of twelve (12) months each, the Contractor shall independently furnish all of the necessary personnel, equipment, services, and otherwise do all things required, or incident to, to completing the work. Analysis should be performed by means of the Method Validation /PT software package ProLAB Plus A and InterVal Plus. Task Requirements A. To successfully perform, the personnel for this effort: Must have long-term experience in validation and standardization of methods and in the conduct, analysis and interpretation of collaborative studies. Must have Publications in peer-reviewed journals on statistical methods for validation of both quantitative and qualitative methods. Must have expertise in international standards of such as ISO 13528, 16140, 5725, Guide 34 and similar. Shall ensure that personnel for this effort are qualified and trained. B. Scope Tasks: The contractor shall complete t he following tasks: Task 1 - Provide technical guidance regarding understanding various PT & MV statistical principles which are beyond the scope of technical service normally provided with the software license. Task 2 - Advice and assist in implementation, incorporation and use of various quantitative statistical techniques in accordance with ISO 5725-2, NWIP/ISO 5725-3, NWIP/ISO 5725-5, ISO 16140-2, CD/ISO 16140-4, CD/ISO 16140-5, ISO 13528. Also, statistical analysis by means of newest statistical procedures, e.g. Kernel density estimation methods, sample comprehensive analysis and other appropriate for food chemical and microbiological proficiency testing. Task 3 - Advice and assist in Statistical analysis of qualitative data in accordance with ISO 16140-2, CD/ISO 16140-4, CD/ISO 16140-5. Also, statistical analysis by means of newest statistical procedures. Task 4 - Elaborate and develop statistical techniques in assessing equivalence and/or differences among analytical methods based on PT data. Task 5 - Provide statistical consult with respect to calculation of measurement uncertainty and Analysis of components of measurement uncertainty with respect microbiological analysis of foods. Task 6 - Preparation of comprehensive report with charts, reports and interpretation in close cooperation with FDA. Provide detailed explanation/reasoning of statistical methods used with respect to biological, biochemical, chemical and physico-chemical interpretation of results. Task 7 - Assist in design, implementation and analysis of PT and MV schemes utilizing factorial design approach and dealing with binary qualitative tests utilizing advanced statistical methods such as Legit and Probit. Task 8 - Determination of the statistical limits based on the historical and appropriate data (rather than the arbitrary values used presently) and modification of the statistical criteria applied to proficiency testing program. Task 9 - Assist in design, conduct and publish proficiency testing data using statistical techniques for chemical and microbiological agents in foods and feeds matrices. Guidance on the future direction of the proficiency test program (types and composition of the food PT) samples to be used in the proficiency testing program. Task 10 - Assist in developing protocols for evaluation and of analytical methods used in FDA’s milk program as described in Pasteurized Milk Ordinance-Evaluation of Milk Laboratories. Task 11 - Recommendations for the standardization of the methods used in proficiency testing program Tasks 1 – 11 shall be completed during the base and option years. Place of Performanc e: The work involved in the execution of this contract shall be performed at the government site primarily at the Moffett Center in Summit-Argo, Illinois. Appropriate workspace will be provided at the government site. Some limited work may be performed at the Contractor’s site. Responses Requested : The FDA/CFSAN requires all of the following questions answered in this RFI: Questions that are not responded to shall be considered non-responsive to the Request for Information and the Contractor shall not be considered as part of the market research. A. Contractors shall provide their point(s) of contact name, address, telephone number, and email address; and the company’s business size, and Data Universal Numbering System (DUNS) Number. B. Is your company a small business, SDBs, HUBZone, or 8(a) concern? Please provide proof of qualifications. C. Is your company considered small under the NAICS code XXXXXX? D. Provide in your capability statement: (1) Demonstrated ability to meet all of the requirement/salient characteristics listed if other than brand name product is being offered; (2) a list of active contracts for commercial, federal, state, and local governments. Listed contracts shall provide communication on the Government requirement illustrating the capability for comparison. E. Is your company available under any; Government Wide Agency Contract (GWAC) General Services Administration Schedules (GSA) Indefinite Delivery Indefinite Quantity (IDIQ) Blanket Purchase Agreement (BPA) If so, please list the contract number and a brief summary of the products and services provide. Provide a short summary of your potential approach to this type of contract and meeting the specific requirements and your experience managing similar contracts with similar requirement for the FDA. F. Are you the manufacturer or distributor of the services being research above? G. If you are a small business and you are an authorized distributor/reseller for the services identified above, do you alter or modify the services request in any way? H. Are you an authorized distributor/reseller? Provide evidence from original service provider. I. What is your schedule for providing the services after receipt of the order? J. What is your estimated pricing for the services being requested? The estimated pricing is not considered the final price, it is only budgetary information purpose for the Government. Opportunity: The FDA/CFSAN, is seeking information from potential Contractors on their ability to provide these services. THIS IS A REQUEST FOR INFORMATION (RFI) ONLY. Small Business Concerns are encouraged to provide responses to this RFI in order to assist the FDA/CFSAN in determining potential levels of competition available in the industry. Contractor shall possess the capability to meet all requirements and objectives. Instructions and Response Guidelines : RFI responses are due by August 27, 2021 at 10:00 a.m. (EST); size is limited to 8.5 x 11 inches, 12-point font, with 1-inch margins in Microsoft Word format via email to [email protected]. All questions shall be submitted by August 23, 2021 at 10:00 a.m. (EST) via email to [email protected]. Telephone requests or inquiries will not be accepted. Public Information is available and will not be provided. This is not a new requirement. The subject line shall read: RFI #1243313 -- Technical Service from Quo Data (the makers of ProLab Plus software package licensed by FDA) to incorporate ISO Standards and Methods to FDA's Proficiency Testing Program. NO SOLICITATION EXISTS AT THIS TIME. There is no page limitation on subparagraphs 5(A) – 5(L). Please provide the information you deem relevant in order to respond to the specific inquiries of the RFI. Information provided will be used solely by FDA/CFSAN/OAGS as “market research” and will not be released outside of the FDA/CFSAN/OAGS Purchasing and Contract Team. This RFI does not constitute a Request for Proposal (RFP), Invitation for Bid (IFB), or Request for Quotation (RFQ), and it is not to be construed as a commitment by the Government to enter into a contract, nor will the Government pay for the information submitted in response to this request. All information contained in the RFI is preliminary as well as subject to modification and is in no way binding on the Government. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the U.S. Government to form a binding contract. If a solicitation is released, it will be synopsized in the Beta.Sam.Gov website or GSA. It is the responsibility of the interested parties to monitor these sites for additional information pertaining to this RFI, or future RFP/RFQ. Contact Information: Contract Specialist/Contracting Officer: [email protected] Your responses to this notice are appreciated. THIS NOTICE IS NOT A REQUEST FOR COMPETITIVE QUOTES/PROPOSALS; however, any firm that believes it can meet the requirements may given written notification prior to the response due date and time. Supporting evidence must be furnished in sufficient detail to demonstrate the ability to perform the requirement.