SSN 75F40124SSN123407.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 National Center for Toxicological Research (NCTR) in order to determine if there are existing small business sources capable providing an Illumina NextSeq 2000 Sequencing System, or equal instrument, plus one option year of post warranty maintenance as there are multiple projects within the DGMT and collaborating Divisions that require sequencing across all available methods (RNA-Seq, Whole Genome Sequencing, Metagenomics, Duplex Sequencing, Target Amplicon Sequencing etc.).

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.

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 equipment described herein, please submit an email with the aforementioned information to suzanne.martella@fda.hhs.gov.

Minimum Requirements: The sequencer shall:

1) Have Q30 reads for over 80% of the bases at the largest amplicon size.

2) Have amplicon and genomic DNA ranges from 50 to 600 bp, single and pair-end reads.

3) Produce a minimum of 40 GB of data in 13 hours for 50 bp amplicons and 180 GB of data in 44 hours for 300 bp amplicons.

4) Mutliplexed, high throughput with options that allow for more sequencing depth and coverage with newer kits.

5) Has a simplified workflow that is fast and reliable, and well published.

mailto:suzanne.martella@fda.hhs.gov

6) Has bioinformatics workflows that are reliable and validated in the literature.

7) Instrument must be a self-contained, dry instrument with integrated DRAGEN Bio-IT field-programmable gate array (FPGA) secondary analysis (or equal) software.

8) Be a desktop sequencer due to space requirements.

9) Be established in the literature for refining long-read sequencing technologies.

10) The manufacturer shall provide compatible reagent kits for flexible run formats (whole genome sequencing, amplicon sequencing, library sequencing, Ribonucleic Acid (RNA) sequencing, transcriptomics, metagenomics) and multiple configurations for choice of read lengths and total data generated (i.e., 100-600 cycles and 30-540 Gb data).

Installation, Training and Additional System Requirements

1) The components and equipment shall be newly manufactured, not used or refurbished, or previously used for demonstration.

2) 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.

3) The systems shall be delivered with all necessary supplies and accessories required for installation and start-up.

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

5) The Contractor shall provide all labor, travel, and tools to install the equipment at the address provided below, to include shipping. The contractor shall demonstrate upon installation that the item meets or exceeds all performance specifications. Upon acceptance of the system, the contractor shall provide on-site operator training/familiarization for at least two (2) attendees.

Such familiarization shall include system operations, calibration, optimization, troubleshooting and basic operational maintenance procedures.

6) Systems shall be warranted for not less than one (1) year from FDA acceptance of the system(s) to include on-site training. Warranty service shall include troubleshooting capabilities based on complete knowledge of the entire system, immediate access to replacement parts, and immediate access to system improvements and updates. Phone and email technical support shall be included for a minimum of one (1) year.

Minimum Performance Requirements for the Preventative Maintenance an Unlimited Repairs Post Warranty Maintenance contract

1) The Contractor shall provide one (1) scheduled on-site planned preventive maintenance visit per year which shall include all labor, travel, and OEM factory-certified replacement parts, components, subassemblies, etc., as well as consumables.

2) The Contractor shall provide unlimited On-Site Corrective Maintenance/Repairs.

3) The offeror shall provide certified Original Equipment Manufacturer (OEM) parts for all repairs and maintenance.

4) All maintenance and repair activities shall be performed by service technicians/engineers who are formally trained and certified by the original manufacturer. Engineers shall have access to the manufacturer’s latest technical developments, repair procedures, application updates, diagnostic software, and planned maintenance procedures. All repairs and PM services shall be performed following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc.

5) The contractor shall provide reagent replacement due to instrument failures.

6) The contractor shall provide a 24-hour priority response time after the initial call for service and have a plan of action for repairs within 48 hours of initial contact where problems cannot be resolved remotely after the first 48 hours.

7) Contractor shall guarantee a mutually agreeable schedule for on-site repairs to be initiated within 72 hours of initial contact where repairs require on-site service.

8) Service contract shall include unlimited free OEM system software, firmware and hardware support and updates.

9) The Contractor shall include unlimited technical support Monday through Friday (excluding Federal Holidays) 8:00AM - 5:00PM Central Time.

10) The contract shall enable the FDA Technical Point of Contact (TPOC) and system operator personnel to have access to the manufacturer's call center for technical assistance, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument.

11) All maintenance/repair pricing shall be inclusive of labor, travel, replacement parts, components, subassemblies, etc. for the instrument.

Deliverables: 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/TPOC and Contract Specialist, summarizing all maintenance activities (including warranty work) each time service is performed.

Delivery: Expected delivery, installation and training on the equipment is within four (4) months of contract award.

Anticipated Dates for the Option year based on the date of the actual award and actual warranty date: anticipated dates are as follows:

Warranty Period: 10/15/2024 – 10/14/2025 Option Year 1 Service: 10/15/2025 – 10/14/2026

The period of performance for the option period 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. If/when Option Year 1 Post-Warranty Service/maintenance is exercised; the period of performance for the post-warranty option will be firmed via bilateral modification.

Place of Delivery/Service Address

The equipment shall be delivered to the National Center for Toxicological Research (NCTR) and post warranty maintenance service shall be performed at the following address:

US FDA/NCTR

3900 NCTR Rd.

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

• Descriptive literature, brochures, marketing material, etc. detailing the nature of the 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.

• The offeror’s estimated historical on-site response time for the brand name and model of product in this requirement.

• 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 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 3:00 pm (Central Time in Jefferson AR) on May 20, 2024 to Suzanne Martella, email suzanne.martella@fda.hhs.gov. Reference:

75F40124SSN123407.

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 or combined synopsis/ 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).

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.

mailto:suzanne.martella@fda.hhs.gov