75F401-22-SSN-1254221 (SSN for epMotion 5075tc).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 Center for Biologics Evaluation and Research (CBER)’s Facility for Biotechnology Resources (FBR) in order to determine if there are existing small business sources capable of providing a high throughput automatic Next Generation Sequencing (NGS) library preparation device system plus 4 option years of a preventative maintenance and unlimited repair agreement that meets their needs in order to prepare libraries suitable for using in Illumina sequencers (e.g., MiSeq, Next-Seq, and NovaSeq).

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 1,000 employees, and you believe that your firm would be able to provide the FDA with the system described below, please submit an email to suzanne.martella@fda.hhs.gov. Other than small business concerns are also encouraged to submit capability statements. The vendor shall include information about the company and demonstrate that it can meet all of the minimum performance requirements.

Background: The U.S. Food and Drug Administration’s (FDA), Center for Biologics Evaluation and Research (CBER)’s Facility for Biotechnology Resources (FBR), the Next Generation Sequencing (NGS) team—in supporting CBER’s mission of fighting COVID-19 viruses—helps researchers to sequence SARS-CoV2 genomes, identify variants, evaluate vaccines, and dissect cellular mechanisms responding to SAR-CoV2 infection. All these efforts not only facilitate COVID-19 research at FDA but also assist its regulatory tasks. While the NGS team is heavily involved in COVID-19 research, the team is also responsible for a wide range of other sequencing efforts requested by investigators.

Their service throughput and consistency are affected by the manual library preparation processes prior to sequencing. Thus, library preparation is a very critical step for reliable NGS outcomes because sample DNA needs to be made sequencing-ready before accurate sequence could be determined in a sequencer. Library preparation involves multi-step procedures which call for skillful, manual operations. For instance, preparing an mRNA library for transcriptome analysis takes 138 steps in a protocol. As the team often receives 20-40 samples for each NGS project, it could be overwhelmed mailto:suzanne.martella@fda.hhs.gov to have to manually prepare the sequencing libraries. The complicated handling processes also limit the throughput and could lead to inconsistent results due to unavoidable manual errors. To better support the increasing NGS demands from FDA scientists, it is necessary to improve the throughput, efficacy, and quality of sequencing library preparation.

For this reason, the team needs a high throughput automated NGS sequencing library preparation system and has found one that meets their needs: the Eppendorf EpMotion 5075tc or equal instrument. The system is designed to carry out different types of sequencing library preparations automatically, including but not limit to, genomic DNA, total RNA, mRNA, small RNA, and Chromatin Immuno-precipitation DNA libraries. The system can effectively transform library preparation processes from manual operation to robotically processing of up to 96 samples, which will significantly improve our service quality as well as sequencing throughput.

Instrument Salient Characteristics/General Requirements that “or equal” instruments must include.

1. The system shall be qualified to perform library preparation protocols, using specialized sample preparation kits manufactured by Illumina Inc. such as those kits for Stranded Total RNA, Stranded mRNA, RNA Prep with Enrichment, DNA Prep, Nextera XT DNA, TruSight Tumor 15, various TruSeq DNA/RNA kits, etc.

2. The instrument shall be an integrated system, does not require further hardware or software programs.

3. Due to space constraints, the system shall be a compact bench model and the goal is that the system will fit in the available bench space, which measures 45”x25”x32” (WxDxH).

4. The automatic system shall be integrated with devices for heating, cooling, and mixing of samples. UV light and HEPA filters should be included for decontamination and keeping a clean working environment.

5. The automatic system shall have at least 12 workable positions for loading devices, reagents, and supplies. It allows for a pipetting range from 250nL to 1000μL and could perform library preparation for 1 to 96 samples simultaneously.

6. The system shall have the capability to monitor liquid levels, supplies consumption, and tools condition; and has a safety feature to pause if the platform door is opened.

7. The system shall have at least one module to facilitate heating, cooling, and mixing of samples in one place.

8. Pipette tools and gripper shall be automatically operated by system programs to avoid manual intervention. The tools are able for contact-free dispensing to reduce cross-contamination.

9. If the reagent volume is below 1μl, the tools can be switched to the contact mode.

10. The performance of pipette tools shall be able to be optimized based on the liquid’s physical properties (surface tension, viscosity, and vapor pressure).

11. The system shall be equipped with a touch screen computer for running the operation software and controlling the system functions.

12. The vendor shall install the system, provide necessary training on instrument operations, and render free technical assistance for troubleshooting.

Installation, Training and Additional System Requirements:

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

2. System shall be warranted for not less than one (1) year from FDA acceptance, 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.

3. The system 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 guidance on pre-installation site requirements.

6. 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, trouble-shooting and basic operational maintenance procedures.

Post Warranty Maintenance Agreement Requirements:

1. The Contractor shall provide one (1) scheduled on-site planned preventive maintenance visit per year which is inclusive of labor, travel, replacement parts, components, subassemblies, etc.

2. The Contractor shall provide access to the Original Equipment Manufacturer (OEM) technical developments, repair procedure bulletins, hardware and software application updates and revisions.

3. The maintenance and/or repair activities shall be performed by formally trained and certified technicians/engineers. 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.

4. The Contractor shall include unlimited priority access to software and firmware updates during the coverage period(s).

5. The Contractor shall provide unlimited technical support Mondays - Fridays (excluding Federal Holidays) between the hours of 8:00 AM - 5:00 PM Central Time and shall begin working on a solution to the problem within 8 business hours of contact for assistance. (e.g., telephone-based, email-based, website-based, etc.)

6. The Contractor shall guarantee unlimited onsite service for repairs and maintenance within 5 business days from original notification.

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

Delivery Period:

Expected delivery for the equipment is within 60 days of contract award.

Place of Delivery

US FDA/CBER

10903 New Hampshire Ave.

WO Bldg 52/72, Room 1106 Silver Spring MD 20993

Period(s) of Performance for Service/Maintenance Plan: The periods of performance for the post-warranty maintenance service options are estimated to be:

Warranty Period: 8/30/2022 - 8/29/2023 Post Warranty Maintenance Option Year 1: 8/30/2023 - 8/29/2024 Post Warranty Maintenance Option Year 2: 8/30/2024 - 8/29/2025 Post Warranty Maintenance Option Year 3: 8/30/2025 - 8/29/2026 Post Warranty Maintenance Option Year 3: 8/30/2025 - 8/29/2026

The period of performance for the Option years 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 periods of performance for all post-warranty Options will be firmed via bilateral modification.

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

• 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 11:30 am (Central Time in Jefferson AR) on June 27, 2022 to Suzanne Martella at email suzanne.martella@fda.hhs.gov. Reference: 75F401-22-

SSN-1254221.

mailto:suzanne.martella@fda.hhs.gov

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 – 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.