75F40122I1253516 (SSN for HPLC).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 Laboratory of Respiratory and Special Pathogens in order to determine if there are existing small business sources capable of providing an HPLC system that meets their needs.

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 Laboratory of Respiratory and Special Pathogens focuses on understanding metal-regulated proteins and metal binding and transport systems in Corynebacterium diphtheriae, with the goal of providing information for better potential vaccine targets. To do this, the lab does regular analysis of the size, aggregation, and protein-protein binding capabilities of purified surface proteins. An HPLC system will allow the lab to visualize and capture these aspects of the proteins with high sensitivity and accuracy.

Visualization of the size of purified proteins and aggregates through size exclusion chromatography (SEC) is critical to understanding and documenting the research being done in the lab on protein binding and interaction in C. diphtheriae as it relates to metal acquisition and use by the bacterium.

Having a reliable and sensitive way to acquire and document experimental results is key to proceeding with research. Currently the lab must borrow use of a less-sensitive FPLC from an adjacent lab to run samples by SEC. Any interruption in functionality of this borrowed instrument (or conflicts due to multiple users needing the instrument simultaneously) results in delays or potentially loss of mailto:suzanne.martella@fda.hhs.gov experimental data. Running these samples is time-consuming due to manual injection of individual samples, and any interruptions/column changes for other applications can impact the comparability of sample-to-sample results. In addition, the lower sensitivity of the FPLC instrument increases the amount and concentration of sample required and the lab’s ability to assess some proteins and aggregates accurately. Having a dedicated HPLC instrument will increase the sensitivity of the lab’s results and the reliability of experiments.

The laboratory has identified an instrument that meets its requirements: the Waters Arc HPLC, or equal instrument.

Instrument Salient Characteristics/General Requirements:

1. The HPLC system shall be able to separate, detect, and visualize, small volume purified protein samples

2. The system shall have an operating flow range as low as 0.001mL/min.

3. The system shall have a programable integrated autosampler/sample manager for running multiple samples without user intervention, with injectable sample volumes from 0.1 to 50μL.

4. The system shall have the capability to cool samples to 4C in the sample compartment during programmed runs.

5. The system shall be capable of unattended operation, including leak sensing and recording/displaying of diagnostic data in the event of malfunction during unattended operation.

6. The system shall include a UV/Visible detector capable of dual-wavelength absorbance detection from 190 to 700nm.

7. The system shall include all computer and software components necessary for programming and operation and be able to document and export the results of sample runs.

8. The system shall be able to operate at room temperature (20-25C) or refrigerated (4-8C).

9. The system shall have the capability to be upgraded in the future with a fraction collection module.

10. The contractor shall include all parts, travel and labor to complete installation and training.

Installation and training shall be performed during normal business hours (Monday thru Friday, 8 am to 4:30 pm, CT, excluding federal holidays).

11. The Government is offering the following trade-in equipment:

• Waters UPLC 2535 Quaternary Gradient module - Serial Number: D1235Q153M

• Waters UPLC 2707 AutoSampler - Serial Number: L11707020Z

• Waters UPLC Degasser - Serial Number: E12PD1293M

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.

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 3356 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.

• 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 2:00 pm (Central Time in Jefferson AR) on March 25, 2022 to Suzanne Martella at email suzanne.martella@fda.hhs.gov. Reference:

75F40122I1253516.

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.

mailto:suzanne.martella@fda.hhs.gov