75F401-22-SSN-112322 Sources Sought Notice.pdf

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) issues this Sources Sought announcement on behalf of the Office of Regulatory Affairs (ORA)’s Arkansas Laboratory (ARKL) in order to determine if there are existing small business sources capable providing an Automated Solid Phase Extraction (SPE) System for per and poly-fluorinated alkyl substances (PFAS) Analysis.

If your firm is considered a small business source under North American Industry Classification System (NAICS) 334516 – Analytical Laboratory Instrument Manufacturing; with a Small Business Size Standard of 1000 employees, and you believe that your firm would be able to provide the FDA with the product described below, please submit an email as instructed below. The vendor shall include information about the company and demonstrate that it can meet all of the minimum technical and performance requirements outlined herein.

Background: The Arkansas Laboratory (ARKL) is the sole servicing Office of Regulatory Affairs (ORA) lab for Persistent Organic Pollutants (POPs) at the Food and Drug Administration (FDA).

The group has been charged with developing and implementing analytical methods for the determination of an emerging class compounds called poly-fluorinated alkyl substances (PFAS). PFAS are synthetic chemicals found in many products, including food packaging, household cleaners and nonstick cookware and are referred to as forever chemicals. ARKL has verified EPA Method 537.1 for use with bottled water samples, is performing collaborative work with Center for Scientific Applied Nutrition (CFSAN) and is developing and validating a method for the determination of PFAS in food.

ARKL will be analyzing a variety of food and feed matrices. This includes the Total Diet Study (TDS) assignments issued by CFSAN and farm assignments under CVM. ARKL will annually be analyzing more than 1,100 TDS samples and various animal feed and feed components.

EPA Method 537.1, the method employed for the collaborative work with CFSAN, and the method under development for the determination of PFAS in food all utilize Solid Phase Extraction (SPE) as part of the sample extraction and cleanup process. Because SPE is a technique common to the PFAS methods used in the group, and due to the number of samples expected to be received, an automated system is desired with the flexibility to accommodate multiple method conditions. Testing for PFAS is a rapidly changing area. In addition to the current work listed, the system will be used for method development work which makes maximum flexibility a priority as analyte suites evolve. Because PFAS are present in many materials commonly utilized in automated SPE systems, the unit must be designed for PFAS cleanup and tested to demonstrate low system background.

Salient physical, functional, or performance characteristics for an automated SPE system:

1. The system must be engineered for use with PFAS testing. Materials used in the construction shall be chosen to eliminate or minimize the addition of PFAS to the sample from the SPE system. The manufacturer shall provide demonstrable proof of low PFAS background during routine use.

2. The system shall have a capacity of at least 24 samples per sequence, and the capability to accommodate sample sizes up to 1 liter in size.

3. The system shall be closed from sample vessel to elution vessel in order to minimize environmental contamination of the samples. In addition, it shall be pressure and liquid tight up to a maximum pressure of 4bar.

4. The system must be compatible with standard polypropylene cartridges from 1 to 15mL in size, from a variety of manufacturers.

5. The system shall be capable of overlapping loading, drying, and elution steps of different samples – systems sequentially processing a sample beginning to end before starting the next sample will not be considered technically acceptable.

6. To maximize throughput, the system shall have the capability to skip samples in the event of a blocked cartridge and continue processing the remaining samples in a sequence.

7. The system must accommodate at least six solvents/solutions for the conditioning, washing, equilibration, and elution of cartridges.

8. Cartridge elution options shall include 1) a single solvent into one vial 2) a single solvent into multiple vials 3) multiple solvents into multiple vials 4) multiple solvents into a single vial.

9. Any Software Requirements: The Contractor (and/or any subcontractor) shall follow secure coding best practice requirements, as directed by the United States Computer Emergency Readiness Team (US-CERT) specified standards and the Open Web Application Security Project (OWASP) that will limit system software vulnerability exploits.

10. The Contractor (and/or any subcontractor) shall ensure IT applications designed and developed for end users (including mobile applications and software licenses) run in the standard user context without requiring elevated administrative privileges.

11. The Contractor (and/or any subcontractor) shall ensure that computer software developed on behalf of HHS/FDA or tailored from an open-source product, is fully functional and operates correctly on systems configured in accordance with government policy and federal configuration standards. The contractor shall test applicable products and versions with all relevant and current updates and patches updated prior to installing in the HHS/FDA environment. No sensitive data shall be used during software testing.

12. The Contractor (and/or any subcontractor) shall protect information that is deemed sensitive from unauthorized disclosure to persons, organizations, or subcontractors who do not have a need to know the information. Information which, either alone or when compared with other reasonably available information, is deemed sensitive or proprietary by HHS/FDA shall be protected as instructed in accordance with the magnitude of the loss or harm that could result from inadvertent or deliberate disclosure, alteration, or destruction of the data. This language also applies to all subcontractors that are performing under this contract.

Trade and Service Specifications:

1. The instrument must be a newly manufactured unit, not used and refurbished or previously used for demonstration.

2. The system shall be delivered with all necessary supplies and accessories required for installation and start-up.

3. FOB Point destination to include inside delivery and clean-up of area after installation.

4. The instrument and its associated accessories shall include operations and maintenance manuals covering proper operation, routine maintenance, and troubleshooting for the instrument and controlling software. All manuals and documentation on the instrument shall be provided in hard copy and/or electronic format.

5. The entire system must be warranted for parts and labor for at least12 months from the date of formal government acceptance. The vendor must also be capable of servicing the instrument through the covered warranty period. The system must include at least a one (1) year warranty and shall include at a minimum: coverage on all non-consumable items and parts supplied including base instrument, factory-certified replacement parts, engineer labor and travel costs.

Any equipment repair and maintenance work shall be performed by an OEM-trained engineer.

This factory-trained engineer shall have (verified by the OEM) the following: 1) access to OEM factory telephone support; 2) access to the most current OEM factory training for both hardware and software components; and 3) access to all current OEM factory parts, not build-to-order parts. The OEM-trained service engineer shall not use salvaged parts from other instruments for performing maintenance and repairs. All parts used in PM and repairs must be guaranteed, factory-tested, OEM quality parts.

6. During the warranty period, instrument operators shall have access to a technical representative call center at no additional charge, for technical assistance and troubleshooting, which is staffed by qualified experienced scientist or application specialists to provide a high level of expertise for troubleshooting the instrument.

7. Sufficient familiarization training for 3-5 users per delivery onsite location will be provided at time of installation or shortly thereafter (within 30 days), such that operators may independently operate the instrument and with increased familiarity and proficiency. The training shall include manuals (user, operator, maintenance, etc.) and any consumables to be used during training.

Service Records and Reports: The Contractor shall, commensurate with the completion of each preventive maintenance service visit, provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced, a detailed description of the work performed, the test instruments or other equipment used to perform the service, the name(s) and contact information of the technician who performed the service, and for information purposes, the on-site hours expended, and parts/components replaced. In addition, the Contractor shall provide a written report to the FDA COR and Contract Specialist, summarizing all maintenance activities (including warranty work) each time service is performed.

Delivery: Instrument is expected to be delivered to the address below no later than 30 days after award. Installation and training shall occur no later than 2 weeks after instrument delivery.

Delivery Location

US FDA/ARKL

3900 NCTR Rd. Building 26 Jefferson AR 72079

Responses to this Sources Sought shall unequivocally demonstrate that the respondent is regularly engaged in the sale of same or substantially similar service. Though the target audience is small business vendors or small businesses capable of supplying a U.S. product/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 Identity ID (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 (within the last 3 years) information for the sale of same or substantially similar product/service on the brand name instrument to include date of sale, description of service provided, equipment serviced, 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/service the responding firm is regularly engaged in manufacturing or selling.

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

• If applicable, identification of Best in Class (BIC) contract information or other Government-wide or HHS-wide contracts that the equipment/service is available on.

• If a large business, provide whether 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.

• Though this is not a request for quote, informational pricing for the equipment/service would be helpful for market research purposes.

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 to be submitted by email only to the point of contact listed below on or before 2:00 pm (Central Time in Jefferson AR) on June 1, 2022 to Suzanne Martella, email suzanne.martella@fda.hhs.gov. Reference: 75F401-22-

SSN-112322.

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 – Contracting 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).

mailto:suzanne.martella@fda.hhs.gov

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 product and/or service would be helpful.