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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) has issued this sources sought announcement on behalf of the National Center for Toxicological Research (NCTR) in order to determine if there are existing small business sources capable of providing an Ion-Trap-based Triple Quadrupole mass spectrometer 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 Warren.Dutter@fda.hhs.gov. The vendor should include information about the company and demonstrate that it can meet all of the minimum performance requirements.

Background: The FDA National Center for Toxicological Research (NCTR) is in need of a specific “Brand Name or Equal” AB-SCIEX Triple Quadrupole 5500+ trap-based mass spectrometer system, that is capable of analyzing a wide range of bioanalytical samples (plasma, urine, tissues). The system is to be applied to the analysis of trace levels of study test articles and their metabolites in bioanalytical samples, such as plasma, tissues, urine and other matrices. A quadrupole ion trap design is required to provide an instrument which has the increased sensitivity provided by the ability to trap target ions in the ion trap. Such sensitivity is required to support pharmacokinetic and toxicology studies from oral, intra-peritoneal and inhalation exposures of test articles over a wide range of administered doses, including studies done at the very low doses of test articles which mimic human exposures to some compounds. In addition, the instrument is also needed to provide qualitative information via the ion trap's ability to conduct multiple stage MS/MS fragmentations (MS to the nth power) experiments to identify unknown metabolites. This capability is needed to identify conjugated metabolites in urine and other matrices, which often require both mass spectrometry (MS)/mass spectrometry (MS) and mass spectrometry (MS)/mass spectrometry/mass spectrometry (MS) experiments to characterize their structure.

To maintain consistency and reproducibility with previously utilized systems, the purchased instrumentation shall be compatible with the AB-Sciex QTRAP line of Ion-Trap based triple quadrupole mass spectrometer systems (e.g. AB-Sciex 3200 QTRAP mass spectrometer systems, which are currently in use in the laboratory. It is important to minimize analytical downtime, staff training, and the development of new method analysis protocols to ensure continuity in data quality and maintain laboratory throughput.

Minimum Technical Requirements:

1. Shall have the ability to operate the mass spectrometer as a QTRAP (QTRAP activated).


2. Shall have the ability to perform both electrospray ionization (both positive and negative modes) and atmospheric pressure chemical ionization (both positive and negative modes).


3. Shall have the ability to analyze for both positive and negative ions in the same acquisition method.


4. Shall be able to obtain the following, but not limited to, types of scans: Q1 (quadrupole 1) MS (mass spectrum), Q3 MS, product ion, precursor ion, neutral loss or gain, MRM (multiple reaction monitoring).


5. Shall have a mass range of at least 5-1200 Da (daltons), and a mass accuracy that is maintained over a linear dynamic range of at least three orders of magnitude.


6. Shall be able to detect analyte concentrations of interest at sub-parts per billion (ppb) concentrations.


7. Shall be able to maintain mass stability and calibration of at least 5 parts per million (ppm) over at least a 1 hour to support long liquid chromatography (LC) runs, and shall be able to maintain a mass accuracy of 10 ppm for the entire workday to satisfy multiple LC injections.


8. Shall have a calibration independent of source conditions to allow for adjustments to the ion source without recalibration.


9. Shall have a built-in syringe pump to infuse analyte solutions directly into the mass spectrometer.


10. Shall have a scan speed of at least 10,000 Da/second.


11. Shall provide computer systems to run instrument control, data acquisition and data quantification.


12. Computer and Software Requirements:
    
    
    
    1. Shall provide a Windows 10 or Windows 11 based computer systems to interface with the instruments.
    
    
    2. Shall provide software that allows for instrument control, data acquisition and data processing (Brand name or equal to Analyst), and in conjunction with the new mass spectrometers (MS) be able to operate previously acquired liquid chromatography (LC) systems (Agilent) each as a single integrated LC-MS system.
    
    
    3. Shall provide all software and firmware updates that become available during the 1-year warranty period.
    
    
    
    


13. Ultra-high performance liquid chromatography (UHPLC) System minimum requirements:
    
    
    
    1. Shall support very fast analytical run times (few minutes to less than 1 hour) to accommodate “next day” turnaround time for sample analysis.
    
    
    2. Shall be able to support binary pump maximum operating pressures of at least 15,000 pounds per square inch (PSI) under a flow of at least 1 milliliters (mL)/minute, have a total delay volume under 100 microliters (μL)
    
    
    3. Shall be able to inject 10 μL samples with an accuracy of at least ±0.2 μL with an injection linearity over 0.999 and a carryover under 0.004%. A flow-through needle design is required to reduce carryover.
    
    
    4. The system shall include a temperature-controlled column compartment and autosampler to increase sample stability.
    
    
    5. The autosampler shall be able to accommodate at least two 96-well plates, two plates capable of housing 48 standard autosampler vials, or a combination of one 96-well plate and one plate capable of housing 48 standard autosampler vials. This will enable samples to be assayed from a number of existing or future protocols.
    
    
    6. An automated electronic means of tracking each column usage and operational parameters (eg. number of injections, maximum pressure attained in the column) to enable proper maintenance of the UHPLC columns utilized in the system.
    
    
    7. The recording of instrument diagnostic data, such as pump flow, pressure levels, column and autosampler temperatures, etc.) and environmental parameters (eg. room temperature) are desirable in order to better enable Good Laboratory Practice (GLP) record maintenance and troubleshooting.
    
    
    
    


14. Contractor shall provide the installation of the unit and ensure they meet or exceed original equipment manufacturer (OEM) operating standards.


15. Contractor shall provide training describing the instruments routine maintenance, operations, applications, and include access to online learning resources.

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).

Post-Warranty Service Minimum Performance Requirements:

1. 
   
   
   
   1. The Contractor shall provide one (1) scheduled on-site planned preventive maintenance visits per year.
   
   
   2. The Contractor shall provide unlimited On-Site Corrective Maintenance/Repairs within 3 business days of call for service where problems cannot be resolved remotely after 2 business days.
   
   
   3. All Preventive Maintenance and repairs shall be performed on-site by formally trained and certified technicians/engineers, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc.
   
   
   4. The Contractor shall include software and firmware updates as required.
   
   
   5. The Contractor shall include unlimited technical support (via phone and email) on software and hardware and troubleshooting with the equipment issues, Monday through Friday (excluding Federal Holidays) 8:00AM – 4:00PM Central Time.
   
   
   6. All maintenance/repair pricing shall be inclusive of labor, travel, replacement parts, components, subassemblies, etc for the system.
   
   
   
   

Service Records and Reports - the Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), 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/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/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 and repair activities (including warranty work) each time service and/or repair is performed.

Period of Performance:

Delivery, Installation and Training shall occur within 120 calendar days from date of award.

4 (1-year Post-Warranty Maintenance and Repair Option periods):

Option Year 1: 12 consecutive months commencing upon expiration of initial warranty;

Option Year 2: 12 consecutive months commencing upon expiration of Option Year 1;

Option Year 3: 12 consecutive months commencing upon expiration of Option Year 2;

Option Year 4: 12 consecutive months commencing upon expiration of Option Year 3.

Warranty shall commence upon acceptance of the Ion-Trap-based Triple Quadrupole mass spectrometer system. Post-warranty Preventative maintenance and repair service, if exercised, shall commence, upon expiration of the warranty period and continue for a year, which may be extended in annual increments. If/when Option Period 1 is exercised; the periods of performance for all options will be firmed via bilateral modification.

The period of performance for the option periods in any resultant award will be estimated based on the date of award, required delivery of the system (inclusive of inside delivery, installation, and training), and the offered warranty period.

Delivery Location:

FDA/NCTR

3900 NCTR Rd

Jefferson, Arkansas 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 December 13, 2022 by 1:00 PM Central Time at the Food and Drug Administration, Field Operations Branch, FDA|OO|OFBA|OAGS|DAP, Attn: Warren Dutter, email warren.dutter@fda.hhs.gov. Reference: FDA-SSN-115568.

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.

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