75F40122R1253299 – Sources Sought – Bench-top MALDI-ToF mass spectrometer system

May 4, 2022 | Sources Sought, Uncategorized

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 bench-top MALDI-ToF mass spectrometer 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 Standard:  1,000 employees

Requirement and Background

The U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) Facility for Biotechnology resources (FBR) requires a Matrix-Assisted Laser Dissociation/Ionization – Time of Flight (MALDI-ToF) mass spectrometer to replace a current, aging system which is no longer produced or supported by the manufacturer. 

A MALDI-ToF mass spectrometer (MS) is an instrument used for accurate determination of molecular weights (MWs) of organic compounds or biomolecules such as proteins, peptides, and oligonucleotides, etc.  Researchers at CBER FBR rely heavily on a MALDI-TOF MS for quality control (QC) to confirm the molecular weights of synthesized peptides and oligonucleotides used in ongoing studies and scientific protocols.  The underlying principle is that when a synthetic peptide or oligonucleotide’s MW is determined to be consistent with the theoretical value (down to the 2nd or the 3rd decimal point), one has little doubt that the product synthesized is the expected or correct one.

Practical applications of this technology include cutting-edge molecular biological research and review products related to pathogen control, disease treatments, vaccine development (e.g., influenza and covid-19 viruses), as well as protocols involving cellular, tissue and gene therapies.  This research often requires DNA cloning, sequencing, and amplification, which frequently relies on oligonucleotide primers synthesized at FBR.  Peptides synthesized at FBR are often used as antigens for vaccine development and for protein-protein or receptor-ligand interaction studies. Successful synthesis of oligonucleotides or peptides is measured by whether the final products have incorporated the expected number of amino acids or nucleotides during multi-step synthetic processes.  To confirm this, any final product should have expected molecular weight equal to the sum of the molecular weights of those building blocks forming its sequence.  The most efficient method to determine molecular weight of a peptide or an oligonucleotide is to use a highly accurate MALDI-ToF mass spectrometer.

This requirement is for a MADI-ToF mass spectrometer and two (2) option years of preventive maintenance-repair service subsequent to the initial warranty period.

Minimum Technical Requirements are as follows for a MALDI-ToF mass spectrometer system:

*Shall be a stand-alone bench-top MALDI-ToF mass spectrometer system to include instrument control, computer workstation, and integrated data acquisition and processing software;

*Shall be capable of oligonucleotide mass analysis; demonstrated evidence of this capability shall be in the form of supporting technical literature and published scientific reports or application notes;

*Computer workstation shall include Windows 10 (or later) 64-bit OS, with a diagonal screen size  of no less than 20”; workstation shall be delivered with pre-installed software programs necessary for top-down and bottom-up data acquisition and routine QC for synthetic peptides or oligonucleotides;

*Shall be a “bench-top” instrument installed within the following physical space limitations: 22”L x 27”W x 55”H;

*Shall be operated using both positive and negative ionization modes, and in linear or reflectron (ion mirror) mode for mass accuracy;

* Shall incorporate a turbo pump vacuum system and oil-free pre-vacuum pump; 

*Required mass range shall be between 100 Da and 500 kDa, and mass accuracies with internal calibrants of < 150 ppm and < 15 ppm in linear and reflectron modes, respectively;

*Resolution for the instrument shall be > 2,000 in linear, positive ion mode for m/z (mass/charge ratio) = ~1,500, and > 15,000 in a reflectron, positive ion mode for m/z =~3,000;

*Sensibility for BSA at S/N (signal to noise ratio) 50:1 shall be ~500 fmol, and ~1 fmol for a ~1,500 peptide at S/N >10:1;

*Instrument laser shall be capable of ion acceleration of -20 to +20 kV (kilo volts) and a repetitive rate of ~60 Hz;

* Shall require 110-120V power source with no special adaptor requirement;

*Shall include on-site installation and qualification service, and a minimum of three (3) days of on-site staff familiarization and training; vendor shall re-install and re-qualify the instrument should it be relocated at any time during the initial warranty period;

*Shall include minimum one-year full manufacturer warranty commencing from date of acceptance and functionality.

Minimum Technical Requirements are as follows for preventive maintenance-repair service for a MALDI-ToF mass spectrometer system:

*The preventive maintenance plan shall include at least one (1) planned on-site visits for routine certification of the instrument per year; PM plan shall include all periodic maintenance services as described and required for annual system health checks;

*All preventive maintenance (PM) and repair activities shall be performed by formally trained and manufacturer-certified technicians/engineers. All PM services shall be performed following Original Equipment Manufacturer (OEM specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc.;

*Corrective or repair visits shall occur within 3-5 business days of call for service (for issues that can’t be resolved remotely via phone or Internet); troubleshooting activities shall include spare parts replacement where required and allowed;  service plan shall also include FDA Technical Representative access to OEM technical developments as required;

*Shall include software and firmware updates, where applicable;

*Unlimited technical support Mondays – Fridays (excluding Federal Holidays) between the hours of 7:00 AM – 5:00 PM Eastern Time, and shall begin working on a solution to the problem within 8 business hours of contact for assistance;

*Proposed pricing shall provide Preventive Maintenance service(s) inclusive of shipping, labor, travel, replacement parts, components, subassemblies, etc.

Deliverables: Service Records and Reports:

The Contractor shall, commensurate with the completion of each service call or preventive maintenance visit, provide the end-user of the equipment and the Contracting Officer 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.

Preventive maintenance or repair visits shall not be scheduled during Federal Holidays or Federal Closures as determined by Executive Orders or opm.gov. Federal Holidays are as follows:

New Year’s Day

Martin Luther King, Jr.’s Birthday

Washington’s Birthday

Memorial Day

Juneteenth Day

Independence Day

Labor Day

Columbus Day

Veterans Day

Thanksgiving Day

Christmas Day

Contract Type:  Commercial Item-Firm Fixed Price

Period(s) of Performance (Estimated)

Warranty Period:         12 consecutive months from date of system acceptance;

Option Year 1:             12 consecutive months commencing from expiration of warranty period;

Option Year 2:            12 consecutive months from expiration of Option Year 1;

Delivery Address:

U.S. Food and Drug Administration

Center for Biologics Evaluation and Research

Bldg 52, Rm 1152

10903 New Hampshire Ave.

Silver Spring, MD  20993-0002

Responses to this Sources Sought notice shall unequivocally demonstrate the respondent is currently engaged in supplying the MALDI-ToF mass spectrometer systems and preventive maintenance-repair services described herein.   Although the target audience for this Notice are small businesses or small businesses capable of providing these stocks from another small business, all interested parties may respond. At a minimum, responses in the form of a Capability Statement shall include the following:

  1. Business name and bio, SAM Unique Entity Identifier (UEI), 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 virus stocks offered by another firm;
  2. Descriptive literature, brochures, marketing material, etc. detailing the MALDI-ToF mass spectrometer systems and preventive maintenance-repair services the responding firm is regularly engaged in providing. Capability statements must provide sufficient information that unequivocally demonstrates that the technical requirements identified above can be met;
  3. Provide recent (within the last three years) and relevant past performance information where the offeror has provided same or substantially similar instrument systems. For each past performance reference include the date of sale, description, dollar value, client name, client address, client point of contact name, client point of contact mailing address and phone number, and e-mail address (if different from that provided for client);
  4. If applicable, standard commercial warranty and payment terms;
  5. 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;
  6. If a large business, provide documentation of any subcontracting opportunities which exist for small business concerns;
  7. Though this is not a request for quote, informational pricing is encouraged;
  8. The Government is not responsible for locating or securing any information, not identified in the response;
  9. Respondent shall advise if the services required is currently available on a “Best in Class” or other Government-wide or HHS-wide contract.
  10. If applicable, respondent shall provide place (country) of product/service manufacture or performance and any other applicable information to enable review and analysis pertaining to the requirements under the Buy American Act and requirements relating to Executive Order 14005 Ensuring the Future is Made in All of America by All of America’s Workers, in the event that a nonavailability waiver request submitted through the Made in America Office (MIAO)  Digital Waiver Portal is required.

Interested parties shall respond with Capability Statements as described above by e-mail only, before 2:00 pm (Central Daylight Time – Local Prevailing Time in Jefferson, Arkansas) on May 13, 2022, to Tim Walbert, Contract Specialist, at the following address:  timothy.walbert@fda.hhs.gov.

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/or combined synopsis-solicitation may be published on SAM/Federal Contract Opportunities (formerly FBO) at https://sam.gov/content/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). 

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