75F40126SSN134302 Luminometer.pdf

This is a Sources Sought Notice (SSN) - a market survey designed to collect 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. There is no RFQ, or other iteration of a solicitation associated with this Notice, and no telephone calls will be accepted requesting an RFQ package or solicitation. To protect the procurement integrity of any future acquisition that may arise from this announcement, information regarding a government technical point of contact will not be given and no appointments for presentations will be made.

The U.S. Food and Drug Administration (FDA), Center for Biologics and Review (CBER), Office of Vaccine Research and Review (OVRR), Laboratory of Hepatitis Viruses (LHV) requires a luminometer to read luminescence from luciferase as it relates to cell expression and hepatitis C studies. This instrument will replace an existing luminometer which is no longer operational.

LHV performs many studies that require the measurement of luminescence from infected or transfected cells.

This luminescence expression is induced through the transfection of cells with plasmids expressing various forms of luciferase or infection of cells with viruses expressing various forms of luciferase. The quantification of the luciferase expression is required in order to scientifically assess the level of expression or infection.

If your firm is considered a small business source under North American Industry Classification System (NAICS) Code 334516 – Analytical Laboratory Instrument Manufacturing, with a Small Business Size Standard of 1,00 employees, and you believe that your firm would be able to provide the FDA with the equipment and/or services described below, please submit an email containing capability statement(s) to timothy.walbert@fda.hhs.gov.

Other than small (large) business concerns are also encouraged to submit capability statements. An interested supplier shall include information about the company and demonstrate that it can meet all the following minimum performance requirements.

The minimum technical requirements that a luminometer shall meet are as follows:

*Shall have a reasonable laboratory footprint suitable for standard laboratory benchtop installation;

*Capable of reading 96-well plates;

*Includes an injection system for the delivery of luciferase reagent with variable volume;

*Minimum of 2 injectors with selectable volume;

*Spectral range of 340-630nm;

*Shall be capable of sensitivity readings of less than 5 amol ATP per well;

*Shall be capable of sensitivity that can detect less than 2 Zeptomoles of firefly luciferase;

*Greater than 6 orders of magnitude dynamic range;

*Shall include computer software for running the instrument on PC computer, plate set-up and data analysis;

*Minimum of one-year full manufacturer’s warranty;

*Include installation and staff training.

Delivery Point

U.S. FDA CBER-OVRR-LHV

Attn: TBD mailto:timothy.walbert@fda.hhs.gov

Bldg. 52/72, Room 1256 10903 New Hampshire Avenue Silver Spring, MD 20993-0002

Responses to this Sources Sought Notice shall unequivocally demonstrate that the respondent is regularly engaged in the sale of same or substantially similar equipment and/or services. 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 SAM Unique Entity Identifier (UEI) and size status) if not the respondent;

• Descriptive literature, brochures, marketing material, etc. detailing the nature of the equipment and/or services 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, the offeror’s capability to initiate service within 5 business days of original notification, to include 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 under;

• If a large business, provide whether subcontracting opportunities exist for small business concerns;

• Standard commercial warranty and payment terms;

• Provide place of product manufacture (Country of Origin) 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 required.

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 submitted ONLY by email on or before 2:00 pm (Central Time in Jefferson AR) on June 1, 2026 to Tim Walbert at timothy.walbert@fda.hhs.gov. Please reference 75F40126SSN1334302 in the Subject line of the e-mail.

Disclaimer and Important Notes This notice does not obligate the Government to award a contract or 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.

Responses with weblinks will not be opened or viewed. Responses must demonstrate capability, not merely affirm the respondent’s capability (i.e. the response must go beyond the statement that, “XYZ company can provide the instrument, technical support etc.”).

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 on 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. Failure to provide information indicating that the listed specifications are too restrictive will be interpreted as confirmation that the specifications are adequate for a competitive environment.

mailto:timothy.walbert@fda.hhs.gov