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MARKET RESEARCH PURPOSES ONLY

NOT A REQUEST FOR PROPOSAL OR SOLICITATION

The U.S. Food and Drug Administration (FDA) is conducting market research to support the National Center for Toxicological Research (NCTR) requirement for a sensitive long fragment sequencing device.

The FDA is seeking small business sources to determine the availability and capability of small business manufacturers or small businesses capable of supplying, and subsequently maintaining, a U.S. made product of a small business manufacturer or producer for the items described herein. Other than small business 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-334516- Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 1,000 employees.

Statement of Work – GridION Sequencing Instrument (brand name or equal)

1.0 Background

NCTR needs a fast, reliable, specific, and sensitive long fragment sequencing device in the Microbiology Surveillance Program to identify and quantify the potential pathogens in lab animals, biological samples, water, environment, bedding, and feed. Genome sequencing has played a critical role to maintain pathogen-free lab animals to prevent any compromise in research findings by principal investigators and researchers at NCTR.

(GridION MAT#: RN00027650 would fulfill this requirement)

2.0 Objectives

Requisition of GridION will enhance Microbiology Surveillance Program capability to provide services for research scientists at NCTR.

3.0 Scope

The contractor:

• shall lease one unit of GridION to NCTR.


• shall provide consumables during the initial one-year as included in the Mk1 Starter pack.


• shall provide a remote installation support call to set up the device correctly.


• All standard information on the equipment, including but not limited to User Manuals, Operation and Maintenance (O&M) Manuals, Material and Safety Data Sheets (MSDS), troubleshooting guides and any other applicable documentation, shall be provided upon installation of the system. Upon acceptance of the system, training shall be provided to a minimum of two (2) attendees/users by the Contractor’s trained and certified personnel.


• shall maintain a warranty for the device during the lease period, renewable options annually.

4.0 Requirements

The GridION System shall be as described as below:

• Long fragment sequencing of DNA or RNA up to 4 Mb


• High throughput up to 250 Gb with 50 Gb per MinION flow cell


• Capable of Next Generation sequencing of whole bacterial genomes, 16S rRNA and metagenomes with multiplexing


• Integrated capability of sequence data processing and analysis


• 64 Gb Ram/4 Tb SSD storage


• Compact bench top device: approximate available space is: W 15”x H 9”x D 15”. Larger sizes would have to confirm if the device would fit.


• Flexible design to run up to 5 independent flow cells


• Power requirement: 110 Volts, 60 Hz

5.0 Deliverables or Delivery Schedule

• Delivered by: 9/29/2023


• Number of Unit needed: 1

6.0 Government-Furnished Equipment and Government-Furnished Information

• No Government-furnished equipment and information needed

7.0 Delivery (for equipment purchases) Place of Performance (for services)

Micro Surveillance/Diagnostic Lab

Building 60/Room 108

National Center for Toxicological Research

3900 NCTR Rd.

Jefferson, AR 72079

Contact Person: to be completed at time of award

8.0 Period of Performance (for leasing)

1st Year 9/30/2024 through 9/29/2025

2nd Year 9/30/2025 through 9/29/2026

3rd Year 9/30/2026 through 9/29/2027

4th Year 9/30/2027 through 9/29/2028

FOB Point Destination. All items shall include shipping, handling and in-side delivery to the destination identified herein.

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

• 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 (Provide this same information if responding to provide a product manufactured by another firm);


• 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.


• Past performance information within the last three years for the manufacture and/or sale in which the offeror has provided same or substantially similar solutions and used for same or near-same applications as set forth herein. 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.


• 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 May 18, 2023 by 13:00 hours (Central Time in Jefferson, Arkansas) to nick.sartain@fda.hhs.gov. Reference NCTR-2023-117696.

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 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).

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