75F40123SSN117784.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), Office of Compliance and Biologics Quality (OCBQ), Division of Biological Standards and Quality Control (DBSQC), Laboratory of Biochemistry, Virology and Immunochemistry (LBVI) in order to determine if there are existing small business sources capable of providing a an automated vial filling and labeling system for storage of influenza virus that will be used as reference reagents for influenza vaccine lot release testing and other CBER regulatory activities. It is critical that the vial filling and labeling system to be a high throughput closed system controlled by software to ensures sterile conditions, to ensure safety of laboratory personnel. The laboratory has found equipment they have determined will meet their needs: an HTI Automated X- TubeProcessor_Smart with Label Applicator and Dispenser, or equal instrument, plus onsite installation and qualification (IQ/OQ) and four (4) years of post-warranty maintenance.

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 products 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.

This Sources Sought is for a Brand Name or Equal solution. Proposed equal needs to meet all the Technical Requirements listed below to be deemed technically acceptable.

Salient physical, functional, or performance characteristics that “equal” products must meet:

1. A fully automated tube handling system that offers configurable solutions.

2. Shall be able to remove cap and also screw cap back into place after filling vials.

3. Shall be able to dispense varied volumes, ranging from 0.1 mL to 2.0 mL into Sarstedt freezer vials.

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4. Labels must be dispensed automatically

5. Ink used for labels must be clear and permanent (alcohol resistant).

6. Shall include/provide software to write labels

7. Instrument shall include software to allow for automated uncapping, filling, capping and labeling.

8. The system must be encased in a box with HEPA filters for operator safety.

9. It would be advantageous to include a mechanism to keep solution to be dispensed and filled tubes, cool.

10. Shall have minimal dead volume of < 20mL between reservoir and dispensing nozzle.

11. Shall have a throughput of at least 48 tubes/ 15 minutes

12. Shall use a peristaltic pump with single use, sterile tubing; any parts that contact material that is being dispensed that is not single use, shall be autoclavable.

13. Main Power Requirements: 110-240 VAC 50/60 Hz 80W (Max)

14. Shall operate at room temperature and 20% to 80% humidity.

15. Physical Dimensions of the system based on laboratory space restrictions: Height: less than 115 cm (without HEPA filter), Width: less than 80 cm width, Depth: less than 110 cm

16. Hopper Capacity: shall have the ability to hold at least 250 Cryovials and place these in racks used by the system in the correct orientation.

17. Shall provide at least 1-year full warranty with purchase of equipment

18. Shall include 4 extended option year warranties

19. Shall include 10 sets of consumables (tubing/parts).

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, inside delivery, unpacking of the equipment in the laboratory and installation. 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.

7. Provide Equipment qualification protocol for FDA review and address any comments / suggestions

8. Execute Equipment qualification based on FDA-approved protocol

9. Prepare qualification report with data and any deviations

10. Provide qualification report for FDA review and address any comments / suggestions, and

11. Installation and Qualification shall be performed within 90 days after the delivery of the instrument

Minimum Performance Requirements for the Preventative Maintenance and Unlimited Repair Service Agreement:

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

2. PM shall include inspection of fuses, lead screws, linear bearings & guides, belts, latches, grippers and rollers, hinges, power cords and plugs, adjustment, replacement, or repair of these parts, as necessary, as well as thorough cleaning and lubrication of rails and axis, functionality testing of sensors, motors, and accessories, performance test.

3. 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 tools and software, and planned maintenance procedures. All PM services and/or repairs shall be performed following Original Equipment Manufacturer (OEM specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc.).

4. The Contractor shall provide one (1) additional on-site service for emergency needs or scheduled

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5. The Contractor shall provide unlimited on-site corrective maintenance/repairs for the instrument which includes all-inclusive parts replacement. The offeror shall provide certified Original Equipment Manufacturer (OEM) parts for all maintenance and/or repairs.

6. Service contract shall include unlimited free OEM system software, firmware and hardware support and updates that are needed for reliability improvements and correction of any defects.

7. The contractor shall provide a 24-hour response time after the initial call for a service response to equipment failure.

8. Where problems cannot be resolved remotely, the contractor shall provide a preliminary plan of action for repairs within 48 hours of initial contact followed by a mutually agreeable estimate for a planned on-site service call by a suitable technician capable of conducting repairs on the failed instrument(s) described in this solicitation. This mutually agreeable estimate should be provided within 72 hours of initial contact.

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

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/Performance: Expected delivery for the equipment is within 90 days of contract award.

This requirement also includes four (4) post warranty options with period of performance dates (based on expected delivery) estimated as:

Warranty Period: 10/30/2023 – 10/29/2024 Option Year 1: 10/30/2024 – 10/29/2025 Option Year 2: 10/30/2025 – 10/29/2026 Option Year 3: 10/30/2026 – 10/29/2027 Option Year 4: 10/30/2027 – 10/29/2028

Place of Delivery The equipment shall be delivered to the Center for Biologics Evaluation and Research (CBER) at the following address:

US FDA/CBER

10903 New Hampshire Ave Federal Research Center Building 52/72, Rm G246 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 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 instrument 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 is required for both the purchase and if a lease option is also available.

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 12:00 Pm (Central Time in Jefferson AR) on May 26, 2023 to Suzanne Martella, email suzanne.martella@fda.hhs.gov. Reference:

75F40123SSN117784.

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