SSN 75F40124Q124188.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 Food Safety and Nutrition (CFSAN) in order to determine if there are existing small business sources or domestic sources capable of providing an instrument for automated Most-Probable-Number (MPN)-based enumeration of selected microbial cells for the analysis of food quality indicators. The laboratory has found an instrument that will meet their needs: the Biomerieux TEMPO, or equal instrument that must meet the minimum specifications listed below.

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 products described below, please submit a capability statement via email to suzanne.martella@fda.hhs.gov.

Other than small business concerns, especially vendors who may be able to offer domestic products, are also encouraged to submit a capability statement that provides company information, as well as information demonstrating that it can meet all of the minimum requirements included below, to include the country of manufacture of products offered.

Minimum Specifications: The instrument shall:

• Be fully automated.

• Use the “Most Probable Number (MPN)” method for quantification and enumeration.

• Be officially validated (acknowledged by AOAC international and AFNOR standard organizations)(tests are specific to the microbes being enumerated)

• Be able to automatically enumerate Aerobic mesophilic total flora, Bacillus cereus, Campylobacter, Coliforms, Escherichia coli (“e-coli”), Enterobacteriaceae, Lactic acid bacteria, Staphylococcus (coag+), yeast and mold from food or environmental samples.

Delivery Terms: The instrument shall be delivered within 30 days from award to the address listed below.

mailto:suzanne.martella@fda.hhs.gov

Place of Performance: Instrument shall be delivered to the following address:

DHHS-FDA-CFSAN

5001 Campus Drive.

CPK#1 Wiley Harvey BLDG, Rm 3E-024 College Park MD, 20740

Responses to this Sources Sought shall unequivocally demonstrate that the respondent is regularly engaged in the sale of same or substantially similar products/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 product 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, contract 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 what 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 meet the 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, identify any Best in Class (BIC) contract information or other Government-wide or HHS-wide contracts that the product is available on.

• If your firm is a large business, provide whether subcontracting opportunities exist for small business concerns.

• Standard commercial warranty and payment terms.

• Provide place of manufacture or 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 products 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 10:00 am (Central Time in Jefferson AR) on Aug 6, 2024 to Suzanne Martella, email suzanne.martella@fda.hhs.gov. Reference:

75F40124Q124188.

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