75F40124SSN122894.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 MiniSeq DNA RNA Next Generation Sequencer (NGS) device, or equal product for the Microbiology Surveillance Program, which shall include four (4) years of post-warranty maintenance.

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.

The NGS device will be used to identify and quantify the potential pathogens in lab animals, biological samples, feeds, waters, environment, bedding, and feeds. Genome sequencing has played a critical role in maintaining pathogen-free lab animals to prevent any compromise in research findings by principal investigators and researchers at NCTR. Whole genome sequencing is a fast and affordable test method to obtain detailed information about microorganisms. a new MiniSeq, or equal NGS would help provide additional applications such as gene expression, small RNA profiling, targeted DNA amplification and small genome sequencing.This requirement for the aforementioned instrument will also include four (4) option years of post-warranty maintenance to occur after the initial manufacturer’s warranty.

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 for the MiniSeq Next Generation Sequencer (NGS):

1) Total output: minimum of 7.5 Gigabytes

2) Reads per run: up to 25 million.

mailto:suzanne.martella@fda.hhs.gov

3) Minimum quality scores: > 80% bases higher than Q30

4) Sequencing type: cluster generation, paired-end sequencing, sequencing by synthesis

5) Nucleic acid type: DNA, RNA

6) Multiple applications: Targeted DNA amplicon sequencing, targeted expression profiling, enrichment panel, viral pathogen panel, microRNA sequencing, small whole genome sequencing

7) Equipment will not be on the FDA network and does not have a separate workstation, all information is self-contained.

8) The system shall be installed by a contracted representative from the company and shall include familiarization of the system, optimization of basic functions for sample analysis and analysis training.

9) The system shall be warranted for parts and labor for a minimum of 12 months from the date of installation. All warranty work shall be performed on-site at NCTR.

10) The system must be accompanied by four (4) one-year maintenance/service agreement options, in addition to the 12-month manufacturer’s warranty.

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 and 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 and repairs within 3 business days of call for service where problems cannot be resolved remotely after 2 business days.

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

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

7) 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.

8) All maintenance/repair pricing shall be inclusive of labor, travel, replacement parts, components, subassemblies, etc. for the MiniSeq NGS (or equal).

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 ____ (??) 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: 09/30/2024 – 09/29/2025 Option Year 1 Service: 09/30/2025 – 09/29/2026 Option Year 2 Service: 09/30/2026 – 09/29/2027

Option Year 3 Service: 09/30/2027 – 09/29/2028 Option Year 4 Service: 09/30/2028 – 09/29/2029

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(s) will be firmed via bilateral modification.

Each year of post-warranty maintenance shall be funded at the time the option year is exercised;

options will be exercised based on funds availability and the needs of the Federal Government. The initial Service period shall be for one year and each subsequent period of performance may be renewed at the government’s option for the period between 12-24 months, 24-36 months, 36-48 months, and 48-60 months beyond the initial contract service period.

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 3:00pm (Central Time in Jefferson AR) on April 11, 2024 to Suzanne Martella, email suzanne.martella@fda.hhs.gov. Reference:

75F40124SSN122894.

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.

mailto:suzanne.martella@fda.hhs.gov

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.