Sources Sought CBER-2025-129805.pdf

MARKET RESEARCH PURPOSES ONLY

NOT A REQUEST FOR PROPOSAL OR SOLICITATION

Service Contract for a Bruker Microflex Mass Spectrometer (SN: 825696910109) and Accessories

CBER-2025-129805

The U.S. Food and Drug Administration (FDA) is conducting market research to support the Facility for Biotechnology Resources (FBR) within the Center for Biologics Evaluation and Research (CBER) which provides an array of services, including peptide synthesis/ characterization and MS-based protein identification, quantification, and post-translational analysis.

FBR uses a Bruker Microflex mass spectrometer (MS) to ensure high quality peptides are accurately synthesized. The MS is also used for proteomic services to support the research endeavors of FDA scientists. The MS is utilized daily, thus maintaining the system at a good working condition is critical for our operation.

This requirement is for a service contract for maintenance and/or repairs of the MS and accessories.

The FDA is seeking small business sources to determine the availability and capability of small businesses capable of providing the required service/product. Other Than Small Business (OTSB) concerns are also encouraged to submit capability statements. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort.

The associated North American Industry Classification System (NAICS) Code is - 811210 – Electronic and Precision Equipment Repair and Maintenance; the applicable Small Business Size Standard is $34 million.

Statement of Work

See below.

Alternative Solutions

Alternative solutions will be considered insofar as any such alternate system and/or system components meet the minimum intended use of the system and brand name or equal technical requirements.

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

Response Instructions

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

Section 1: Respondent Overview

- Business name, SAM Unique Entity ID 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.

Section 2: Descriptive Information

- Sufficient descriptive literature that unequivocally demonstrates that offered products and services can meet the above requirements. All descriptive material necessary for the government to determine whether the service/product offered meets the technical requirements including technical specifications, ISO certifications, descriptive material, literature, brochures, and other information, which demonstrates the capabilities of the contractor to meet the requirement.

Section 3: Past Performance

- Three (3) years of past performance service information, if not the manufacturer of the equipment identified herein, where the respondent has provided same or substantially similar service solutions on the same or near-same brand name equipment.

- 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 (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 SAM Unique Entity ID number and size status) if not the respondent.

Section 4: Capabilities and Delivery

- The offeror’s capability to meet the delivery requirements within the time specified above.

- Offeror shall provide estimated historical on-site response time from the initial call for service until a service technician was on-site for the brand name and model of instrument in this solicitation or a standard target time for onsite performance from initiation of service call.

- If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement. Detailed list of items included and not included on the GSA contract to meet this requirement.

- 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.

- Capability and understanding of accessibility testing and customization to conform with the applicable Section 508 standards identified herein.

Provide information if the respondent has an Accessibility Conformance Report (ACR) for the products offered for the Revised 508 Standards.

The ACR should be based on the Voluntary Product Accessibility Template Version 2.0 (MS Word) provided by the Industry Technology Industry Council (ITIC).

- Provide information if any of these specifications are too restrictive. No response will be considered that the listed specifications are adequate in a competitive environment.

- If a large business, identify the subcontracting opportunities that would 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; and

- Though this is not a request for quote, informational pricing is encouraged for both the purchase of the instrument and a lease of the instrument.

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

The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation.

Interested Parties shall respond with capability statements which are due by email to the point of contact listed below on or before July 16, 2025 by 13:00 hours (Central Time in Jefferson, Arkansas) to david.kramer@fda.hhs.gov.

Reference CBER-2025-129805

Notice of Intent

Responses to this Sources Sought announcement will assist the Government in determining whether 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 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).

Statement of Work

Service Contract for a Bruker Microflex Mass Spectrometer (SN: 825696910109) and Accessories

CBER-2025-129805

1. Background:

The Facility for Biotechnology Resources (FBR) of the Center for Biologics Evaluation and Research (CBER) provides an array of services, including peptide synthesis/ characterization and MS-based protein identification, quantification, and post-translational analysis.

FBR uses a Bruker Microflex mass spectrometer (MS) to ensure high quality peptides are accurately synthesized. The MS is also used for proteomic services to support the research endeavors of FDA scientists. The MS is utilized daily, thus maintaining the system at a good working condition is critical for our operation.

This requirement is for a service contract for maintenance and/or repairs of the MS and accessories.

2. Objectives:

Scientists at FDA conduct cutting-edge molecular biological research and review products related to pathogen identification, disease mechanisms, vaccine development (e.g., influenza and covid 19 viruses), or protocols involving cellular, tissue and gene therapies. Often these studies require synthetic peptides for characterization or for antibody production. Frequently, one needs to identify proteins present in biological samples.

At FBR, we performed macromolecular synthesis to provide scientists with needed peptides. In addition, we offer proteomic services to help identification and characterization of proteins based on mass spectrometric analyses. We achieve these tasks using either a MALDI-TOF or LC-MS. Bruker Microflex MS is particularly useful for assessing the quality of synthetic peptides as data of multiple samples could be acquired in very short time.

To ensure uninterrupted services, the Microflex MS needs professional preventive services or repairing. The instrument’s current service contract is due to expire on September 28, 2025, thus this requisition is to initiate a service contract.

3. Required Maintenance and Repair Services:

The scope of the desired contract is preventive maintenance and repairs of a Bruker’s Microflex MS, plus the essential instrument-controlling computer and software programs.

1. The service provider shall provide complete system maintenance which encompasses maintenance of the mass spectrometer system (including the computer, plate-loading/retrieval station, and other accessories) in a functional state by providing one (1) preventive maintenance (PM) visit per year and required repairs.

2. The service engineer dispatched to the FDA site shall be certified by Bruker Scientific, LLC and familiar with Microflex MS.

3. Replacement and repair parts shall be new or refurbished replacement parts that are certified to manufacturer’s specifications. The new and/or replacement parts must be of specific quality standard and must be able to support the function of the mass spectrometer.

4. The service provider shall provide certified service engineer(s) who are familiar with Microflex instrument and have experience in troubleshooting. The service engineers shall have the knowledge of repair procedures, software applications, and planned maintenance procedures. The service provider shall follow the Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins.

5. The contractor shall include unlimited technical support (via phone and email) on software and hardware related issues and trouble-shooting capabilities, Monday through Friday (excluding Federal Holidays). Access by the FDA Technical Point of Contact (TPOC) and system operator personnel to the manufacturer’s call center for technical assistance including software, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument.

6. All costs for labor, travel, and parts required for preventative maintenance and repairs shall be included. No additional charges will be allowed.

7. The service provider shall include unlimited software updates during the entire coverage period(s).

8. Service provider shall provide unlimited on-site corrective maintenance and repairs within three (3) business days of call for service where problems cannot be resolved remotely after two (2) business days. All costs for labor, travel, and parts shall be included.

9. Deliverables / Service Records and Reports: The contractor shall provide service reports clearly identifying the work performed in contractor format distributed by email to the designated TPOC.

4. Original Equipment Manufacturer:

The instrument is originally manufactured by Bruker Scientific, LLC. Microflex MS uses patented technologies licensed to Bruker Scientific.

5. Government-Furnished Property, Material, Equipment, or Information (GFP, GFM, GFE, or GFI)

N/A

6. Contractor Provided Special Material Requirements

N/A

7. Security

The work described in this Statement of Work is non-sensitive.

Contractor engineers shall be accompanied by FDA staff during service visits. Contractor shall receive training on general laboratory security and safety prior to performing services.

8. Travel

Service contract shall include all travel by the contractor to the stated Place of Performance.

9. Place of Performance

On-site services under this contract shall be provided at:

FBR/CBER

Rm 1152, Building 52 10903 New Hampshire Ave.

Silver Spring, MD 20993

10. Holidays and Government Closures

The Contractor is not required to provide on-site services on the following days that are Federal Holidays or on any other day designated as a Federal holiday for the Washington, DC area:

New Year’s Day Martin Luther King Day President’s Day Memorial Day Juneteenth Independence Day Independence Day Labor Day Columbus Day Veteran’s Day Thanksgiving Day Christmas Day

In the event of inclement weather when the Federal government is closed, the Contractor is not required to provide on-site service. The Contractor is required to follow, as a minimum, other directives issued by the U.S. Office of Personnel Management or other such official for late arrivals due to inclement weather (unless otherwise specified in the Contract).

In the event the Federal Government is closed by order of the President of the United States or the U.S. Office of Personnel Management for any reason, or the agency, the center or the building is closed for administrative or safety reasons, the Contractor shall follow directives issued by responsible officials concerning reporting for work.

11. Period of Performance

Base: 09/28/2025 - 09/27/2026

Option Period One (1): 09/28/2026 - 09/27/2027

Option Period Two (2): 09/28/2027 - 09/27/2028

Option Period Three (3): 09/28/2028 - 09/27/2029

12. Contract Administration

Technical Point of Contact (TPOC):

To be provided at time of award.