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SOURCES SOUGHT NOTICE # FDA_SSN_1225525 for a Valve-less Automated Dioxin-PCB Sample Purification System Posted Date: March 19, 2020 Response Date: April 3, 2020 by no later than 2:00 pm CDT Classific... SOURCES SOUGHT NOTICE # FDA_SSN_1225525 for a Valve-less Automated Dioxin-PCB Sample Purification System Posted Date: March 19, 2020 Response Date: April 3, 2020 by no later than 2:00 pm CDT Classification: 6640 – Laboratory Equipment and Supplies NAICS Code: 334516 – Analytical Laboratory Instrument Manufacturing MARKET RESEARCH PURPOSES ONLY - NOT A REQUEST FOR PROPOSAL OR SOLICITATION This is a Sources Sought notice to determine the availability of Small Businesses capable of supplying the instrument system described below. This notice is for planning purposes only, and does not constitute an Invitation for Bids, Request for Proposal, Request for Quotation, or an indication the Government intends to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. Your response to the information requested will assist the Government in determining the appropriate acquisition method, including whether a Small Business Set-Aside is possible. The appropriate NAICS code for the acquisition is 334516 – Analytical laboratory Instrument Manufacturing; Small Business Size Standards – 1,000 employees. Requirement and Background The Arkansas Laboratory (ARKL), located at the U. S. Food and Drug Administration (FDA) National Center for Toxicological Research in Jefferson, Arkansas, is the national servicing laboratory for the Persistent Organic Pollutants (POPs) program for the FDA. Under this program, the FDA’s Center for Food Safety and Nutrition (CFSAN) has requested the analysis of 7 polychlorinated dibenzo-para-dioxins (PCDDs), 10 polychlorinated dibenzo-para-furans (PCDFs), 3 non-ortho polychlorinated biphenyls (PCBs), 21 additional PCBs, and 6 polybrominated diphenyl ethers (PBDEs). Currently, the analyses of these and similar compounds at ARKL are conducted using an older sample purification system which includes a very time-consuming sample preparation/extraction and cleanup procedure consisting of multiple transfer steps and very large solvent usage. The current process also produces significant environmental waste and impact. The ongoing challenge with the current solution in presenting research findings is in addressing the potential carryover-contamination which occurs over time due to the required low-level reporting of parts per trillion (ppt). Mitigating this carryover-contamination requires (1) enormous amounts of researcher time and resources, (2) inefficient cleaning steps and (3) large volumes of solvents to minimize background, or “blank,” levels between sample batches. The current systems employed for this clean-up rely on closed valves for channeling the fluids containing the sample extracts. These traditional valves have channels where reagent materials or sample particles (from columns) become “stuck,” resulting in the copious amounts of expensive solvents, researcher time, and carryover contamination mentioned above. However, recent technological advances in this field have resulted in the development of sample preparation systems which are vastly more efficient and less expensive to operate and produce results required by the FDA – specifically, systems which utilize an innovative method of flow switching without the use of valves, essentially a “valve-less” system, that eliminates the inefficiencies and carryover contamination of the current systems. An additional benefit of a valve-less system is a dramatic reduction in environmental waste and impact. ARKL requires a valve-less dioxin/PCB sample preparation system to replace the current valve-based solution. Minimum Technical Requirements The Automated Dioxin-PCB Sample Purification System shall include and meet the following technical requirements: 1. System shall be valve-less, fully-automated, and deliver Dioxin, and PCB/PBDE analyte fractions using surfaces within its columns; 2. Final sample volumes of the separate Dioxin and PCB/PBDE fractions shall be less than 3 mils; 3. System shall require less than 100 ml total of solvent per sample and shall not require Dichloromethane; 4. Include different clean-up columns to maintain sample quality over a broad range of foods matrices; 5. Certificate of Quality shall be provided for each lot of column sets provided; 6. All columns shall be disposable; 7. Include column chambers capable of increasing the temperature of the column station clean-up systems; 8. Include a control module to edit and create new methods; 9. Include a host controller with programmable logic; 10. Include all hardware, firmware, components and software required for installation and operation to meet the FDA’s stated need and intended purpose; 11. Shall meet performance specifications and required results criteria pursuant to EPA Method 1613 for Dioxins and EPA Method 1614 and 1668 for PBDEs/PCBs; 12. Installation and staff familiarization; 13. Minimum 1-yr. full warranty from date of government acceptance of the system; 14. Include all shipping charges FOB Destination. Delivery Address: U.S. Food and Drug Administration National Center for Toxicological Research 3900 NCTR Road Jefferson, AR 72079 Responses to this Sources Sought notice shall unequivocally demonstrate the respondent is currently engaged in providing the required valve-less automated dioxin-PCB sample purification system meeting the technical requirements set forth above. Although the target audience is small businesses or small businesses capable of providing these systems from another small business, all interested parties may respond. At a minimum, responses in the form of a Capability Statement shall include the following: Business name and bio, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address. Provide this same information again if responding with the capability of providing an instrument offered by another firm; Descriptive literature, brochures, marketing material, etc. detailing the instrument and equipment (to include consumables) which the responding firm is regularly engaged in providing; Information on available service/maintenance plans for the identified equipment; If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SIN’s that are applicable to this potential requirement are also requested. If a large business, provide documentation if subcontracting opportunities exist for small business concerns; Though this is not a request for quote, informational pricing is encouraged. The Government is not responsible for locating or securing any information, not identified in the response. Interested parties shall respond with Capability Statements, as described above, in person, by e-mail, fax, mail or other delivery method before 2:00 pm (Central Daylight Time - Local Prevailing Time in Jefferson, Arkansas) on April 3, 2020 to timothy.walbert@fda.hhs.gov, fax (870) 543-7990, or mail to the U. S. Food and Drug Administration, OO/OFBA/OAGS/DAP, Attention of Tim Walbert, 3900 NCTR Road, Building 50, Room 426, Jefferson, AR 72079-9502. Reference the following on the outside packaging: FDA_SSN_1225525. Notice of Intent Responses to this Sources Sought announcement will assist the Government in determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures. 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 and Proprietary Information 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).