THIS IS A SOURCES SOUGHT ANNOUNCEMENT, A MARKET SURVEY FOR WRITTEN INFORMATION ONLY. THIS IS NOT A SOLICITATION ANNOUNCEMENT FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED FROM THIS ANNOUNCEMENT. NO REIMBURSEMENT WILL BE MADE FOR ANY COSTS ASSOCIATED WITH PROVIDING INFORMATION IN RESPONSE TO THIS ANNOUNCEMENT OR ANY FOLLOW-UP INFORMATION REQUESTS. NO TELEPHONE CALLS WILL BE ACCEPTED REQUESTING AN RFQ PACKAGE OR SOLICITATION. THERE IS NO RFQ PACKAGE OR SOLICITATION. IN ORDER TO PROTECT THE PROCUREMENT INTEGRITY OF ANY FUTURE PROCUREMENT, IF ANY, THAT MAY ARISE FROM THIS ANNOUNCEMENT, INFORMATION REGARDING THE TECHNICAL POINT OF CONTACT WILL NOT BE GIVEN AND NO APPOINTMENTS FOR PRESENTATIONS WILL BE MADE.

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) is issuing this sources sought announcement on behalf of the Office of Regulatory Affairs (ORA), in order to determine if there are existing small business sources and other than small business sources capable of providing an Automated Dioxin/PCB/BDE Liquid Handling Purification System, meeting the requirements below.

If your firm is considered a small business source under North American Industry Classification System (NAICS) Code 334516- Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 1000 employees and believe that your firm would be able to provide the FDA with the supplies/services described below, please submit an email to [email protected]. The vendor should include information about the company and demonstrate that it can meet all the minimum performance requirements.

Background: The U.S Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Office of Regulatory Science (ORS), Office of Human and Animal Foods Laboratory Operations (OHAFLO), Arkansas Human and Animal Food Laboratory (ARLHAF) is the national servicing lab for the Persistent Organic Pollutants (POPs) program for the FDA. As part of this program Center for Food Safety and Applied 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). The analysis of these compounds starts with a very time-consuming sample preparation/extraction and cleanup procedure including multiple transfer steps requiring a very large solvent usage.

The ARLHAF workgroup requires efficient and less costly means for critical sample cleanup. ARLHAF has been using automated sample purification systems to purify samples for the persistent organic pollutants, Dioxins, PCBs, and PBDEs for years but they are not 'green' systems. Current automated sample purification systems use very large volumes of solvents, especially Dichloromethane which translates to a definite adverse environmental impact and high cost against our yearly budgets. Currently, the ARLHAF work group is phasing out the use of Dichloromethane due to a current recommendation by the U.S. Environmental Protection Agency to reduce or ban the use of Dichloromethane in the US due to toxicity concerns.  

Regarding automated fluid handling purification systems, 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.  The FDA requires a valve-less dioxin/PCB sample preparation system to replace the previous valve-based version.

Minimum Technical Requirements:

The Automated Dioxin-PCB Sample Purification System shall include and meet the following technical requirements:

1. Shall be capable of full automation with efficient delivery of Dioxin, and PCB/PBDE analyte fractions using special surfaces within its columns.
2. The system shall allow the cleanup of six (6) samples per test run.
3. Final sample volumes of the separate Dioxin and PCB/PBDE fractions shall be less than 3 milliliters.
4. System shall allow the attachment of 2.0 ml volume, 9-425 type screw top, 41 mm x 11.6 mm dimension glass vials.
5. System shall require less than 140 ml total of solvent per sample and shall not require Dichloromethane.
6. Include different clean-up columns to maintain sample quality over a broad range of foods matrices.
7. Certificate of Quality shall be provided for each lot of different column sets provided.
8. Shall be a valve-less or pinch disposable tubing system to avoid sample contamination.
9. System shall include 400 sets of disposable columns.
10. Shall require column chambers that increase the temperature of the column station cleanup systems within a range of 45 deg C up to 90 deg C. This increases the flow efficiency of the analytes and the chemical reactions.
11. Include a control module in order to edit or create new methods.
12. Shall include a Benchtop Concentrator/Evaporator that includes 12mm x 32 mm vial positions in a rotor that can hold 2 ml vials. –
13. Shall include a Diaphragm Membrane vacuum - 20 liters/min pump.
14. Shall include a host controller with programmable logic.
15. Shall meet performance specifications and required results criteria pursuant to EPA Method 1613 for Dioxins and EPA Method 1614 and 1668 for PBDEs/PCBs.

Installation, Training and Warranty:

• Upon delivery and installation, the Contractor shall coordinate with the Technical Point of Contact (TPOC) to demonstrate functionality and schedule a training session with program office points of contacts to conduct the training. The training shall be detailed and capture full functionality of the machine. At the end of the training, the vendor shall transition over training aids, materials and technical guides to support utilization/maintenance of the machine.

• Offered systems shall be a turn-key solution i.e. the contractor shall be responsible for providing all hardware, components, instruments, computers, software, and that otherwise required to meet these specifications and the FDA’s stated need. The systems shall be delivered with all necessary supplies and accessories required for installation and start-up.

• Systems shall be warranted for not less than one (1) year from FDA acceptance of the system(s). 

• The FDA will conduct onsite acceptance testing in accordance with the SOP protocol to confirm test results pass the required parameters.

Period of Performance:

Delivery, Installation and Training shall occur within 90 calendar days from date of award.

Warranty shall commence upon acceptance of the Automated Dioxin-PCB Sample Purification System.

Delivery Location:

FDA-NCTR

3900 NCTR Rd.

Bldg 26Jefferson, AR 72079

Though the target audience is small business vendors or small businesses capable of supplying a U.S. service of a small business vendor or producer all interested parties may respond. At a minimum, responses shall include the following:

• Business name and bio, unique entity identification (UEI) 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 to provide a service offered by another firm.

• Past Performance information for the manufacturer and/or sale of same or substantially similar product and service or similar brand instruments to include date of sale, description, dollar value, client name, client address, client 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 UEI number and size status) if not the respondent.

• Descriptive literature, brochures, marketing material, etc. detailing the nature of the product and service the responding firm is regularly engaged in manufacturing and/or selling.

• The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered services meet the technical requirements identified above.

• The offeror shall advise if the product and/or service is on a Best in Class contract.

• If applicable, the offeror shall clearly identify where the offered product is made.

• If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement are also requested.

• If a large business, provide if subcontracting opportunities exist for small business concerns.

• Standard commercial warranty and payment terms.

• Provide place of product manufacture or service performance and any other applicable information to enable review and analysis pertaining to the Buy American statute and requirements relating to Made in America in the event a nonavailability waiver request through the MIAO Digital Waiver Portal is needed.

• Informational pricing is desired.

• The Government is not responsible for locating or securing any information, not identified in the response.

Interested Contractors must respond with capability statements which are due by email to the point of contact listed below on or before May 19, 2023 by 1:00 PM Central Time at the Food and Drug Administration, Field Operations Branch, FDA|OO|OFBA|OAGS|DAP, Attn: Warren Dutter, email [email protected]. Reference: FDA-SSN-118591.

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 sam.gov. 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).

Additional Notes:

If the stated requirements appear restrictive, please submit comments detailing the concern. Though this is not a request for quote, informational pricing for the service would be helpful.