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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) is issuing this source sought announcement on behalf of the Center for Biologics Evaluation and Research (CBER)’s Laboratory of Method Development in order to determine if there are existing small business sources capable of providing Preventive Maintenance and Repair Services for an Illumina MiSeq benchtop next-generation sequencer. Other than small business concerns, especially vendors who may be able to offer domestic products, are also encouraged to submit a capability statement that provides company information, as well as information demonstrating that it can meet all of the minimum requirements included below, to include the country of manufacture of products offered. This requirement also includes two (2) option years of preventive maintenance and repair services.

If your firm is considered a small business source under North American Industry Classification System (NAICS) Code 811210 - Electronic and Precision Equipment Repair and Maintenance; Small Business Size Standard is $34 million and you 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.

Background: The Center for Biologics Evaluation and Research (CBER) ’s Laboratory of Method Development has a requirement for a Preventive Maintenance and Repair Services Agreement for an Illumina MiSeq benchtop next-generation sequencer, with 2 (1- year Option periods).

The FDA is engaging in several projects based on the use of the new-generation sequencing (NGS) for various viruses and viral vaccines to perform assessment of their genetic consistency and safety. We are using Illumina MiSeq as benchtop next-generation sequencer that allows us to generate high throughput sequencing data and its analysis. A MiSeq Preventive Maintenance and Repair Services Agreement is needed to support its maximum performance and minimize interruptions.

Equipment Requiring Services:

Illumina MiSeq, Serial Number: M02269

Covered under service contract until 06/18/2024.

Post-Warranty Preventive Maintenance and Repair Services Minimum Performance Requirements:

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   1. The Contractor shall provide one (1) scheduled on-site planned preventive maintenance visit per year.
   
   
   2. The Contractor shall provide unlimited On-Site Corrective Maintenance/Repairs within 2 business days of call for service where problems cannot be resolved remotely after 2 business days.
   
   
   3. The Maintenance and Repair activities shall be performed by service engineers who are trained and certified by the Original Equipment Manufacturer (OEM). The service provider should follow the OEM specifications, manuals, and service bulletins, using OEM-certified replacement parts, components, subassemblies, etc.
   
   
   4. The Contractor shall include software and firmware updates required during on-site instrument repair and instrument’s performance check during preventive maintenance during the coverage period(s).
   
   
   5. The Contractor shall provide factory-certified replacement parts.
   
   
   6. The Contractor shall include unlimited technical support (via phone and email) on software and hardware and troubleshooting with any equipment issues, Monday through Friday (excluding Federal Holidays) 8:00AM – 5:00PM Eastern Time.
   
   
   7. All maintenance/repair pricing shall be inclusive of labor, travel, replacement parts, components, subassemblies, etc. for the system.
   
   
   
   

Deliverables: 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:

Base Year: 06/19/2024 - 06/18/2025

Option Year 1: 06/19/2025 - 06/18/2026

Option Year 2: 06/19/2026 - 06/18/2027

Delivery Location:

FDA/CBER

Building 52, Lab 1142

10903 New Hampshire Avenue

Silver Spring, MD 20993.

Responses to this Sources Sought shall unequivocally demonstrate that the respondent is regularly engaged in the sale of same or substantially similar product/service. 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.

• 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 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 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.

• 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 April 26, 2024 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-123363.

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 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).

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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