SSN 75F40126SSN134073.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 Notice (SSN) on behalf of the Center for Biologics Evaluation and Research (CBER) in order to determine if there are existing small business sources capable of providing uniquely identifiable magnetic carboxylated microsphere beads for use in fluorescent magnetic immunoassays (FMIA) to support the viral research and review program. The laboratory has identified a product that meets their needs: those produced by Luminex. Accordingly, this requirement is for the Luminex MagPlex, or equivalent microsphere beads which meet or exceed the requirements listed below.

If your firm is considered a small business source under North American Industry Classification System (NAICS) 325413 – In-Vitro Diagnostic Substance Manufacturing; with a Small Business Size Standard of 1,250 employees, and you believe that your firm would be able to provide the FDA with the product described below, please submit an email to suzanne.martella@fda.hhs.gov.

Other than small business concerns 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 specifications included below—to include the country of manufacture of products offered.

Minimum Requirements/Specifications for the magnetic carboxylated microsphere beads:

Physical and Chemical Properties:

1. Surface Chemistry: Carboxylated (COOH functional groups)

2. Magnetic Properties: Superparamagnetic or paramagnetic properties suitable for magnetic separation

Functional Requirements

1. Conjugation Capability: Suitable for amine coupling chemistry (EDC/NHS or equivalent)

2. Unique Identification: Each bead set must have distinct fluorescent signatures identifiable by flow cytometry mailto:suzanne.martella@fda.hhs.gov

3. Variety: Minimum of 20 distinct bead regions/sets available for multiplex applications

4. Flow Cytometry Compatibility: Functional in multi-laser flow cytometry systems (minimum 2-laser systems)

5. Stability: Minimum 6-month shelf life from date of delivery when stored per manufacturer’s recommendations

6. Must not be expired.

Quality Standards

1. Lot-to-lot consistency in fluorescent intensity and magnetic properties

2. Free from microbial contamination

3. Free from aggregation or clumping

Required Beads, or equivalent, and required quantities of each:

Item Volume Cat# Qty Avidin MagPlex Bead 16 1 ml MA-C016-01 4 Avidin MagPlex Bead 17 1 ml MA-C017-01 4 Carboxylated MagPlex Bead 12 1 ml MC10012-01 4 Carboxylated MagPlex Bead 13 1 ml MC10013-01 2 Carboxylated MagPlex Bead 18 1 ml MC1-0018-01 1 Carboxylated MagPlex Bead 19 1 ml MC10019-1 4 Carboxylated MagPlex Bead 20 1 ml MC1-0020-01 1 Carboxylated MagPlex Bead 21 1 ml MC10021-01 4 Carboxylated MagPlex Bead 22 1 ml MC10022-01 4 Carboxylated MagPlex Bead 23 1 ml MC10023-01 4 Carboxylated MagPlex Bead 24 1 ml MC10024-01 4 Carboxylated MagPlex Bead 25 1 ml MC1-0025-01 1 Carboxylated MagPlex Bead 26 1 ml MC1-0026-01 1 Carboxylated MagPlex Bead 27 1 ml MC1-0027-01 1 Carboxylated MagPlex Bead 28 1 ml MC1-0028-01 1 Carboxylated MagPlex Bead 29 1 ml MC1-0029-01 1 Carboxylated MagPlex Bead 30 1 ml MC10030-01 2 Carboxylated MagPlex Bead 31 1 ml MC10031-01 4 Carboxylated MagPlex Bead 32 1 ml MC10032-01 4 Carboxylated MagPlex Bead 33 1 ml MC1-0033-01 1 Carboxylated MagPlex Bead 34 1 ml MC1-0034-01 1 Carboxylated MagPlex Bead 35 1 ml MC1-0035-01 1 Carboxylated MagPlex Bead 36 1 ml MC1-0036-01 1 Carboxylated MagPlex Bead 37 1 ml MC1-0037-01 1 Carboxylated MagPlex Bead 38 1 ml MC10038-01 2 Carboxylated MagPlex Bead 40 1 ml MC10040-01 4 Carboxylated MagPlex Bead 41 1 ml MC10041-01 4 Carboxylated MagPlex Bead 42 1 ml MC1-0042-01 1

Carboxylated MagPlex Bead 43 1 ml MC1-0043-01 1 Carboxylated MagPlex Bead 44 1 ml MC1-0044-01 1 Carboxylated MagPlex Bead 45 1 ml MC1-0045-01 1 Carboxylated MagPlex Bead 46 1 ml MC1-0046-01 1 Carboxylated MagPlex Bead 51 1 ml MC1-0051-01 1 Carboxylated MagPlex Bead 52 1 ml MC1-0052-01 1 Carboxylated MagPlex Bead 53 1 ml MC1-0053-01 1 Carboxylated MagPlex Bead 54 1 ml MC1-0054-01 1 Carboxylated MagPlex Bead 55 1 ml MC1-0055-01 1 Carboxylated MagPlex Bead 61 1 ml MC10061-01 2 Carboxylated MagPlex Bead 62 1 ml MC1-0062-01 1 Carboxylated MagPlex Bead 63 1 ml MC1-0063-01 1 Carboxylated MagPlex Bead 64 1 ml MC1-0064-01 1 Carboxylated MagPlex Bead 65 1 ml MC1-0065-01 1

Delivery Terms: Delivery is expected within 60 days of contract award at the below address:

US FDA/CBER

10903 New Hampshire Ave.

Bldg 52/72, Room 1230 Silver Spring MD 20993

POC: will be appointed and contact information will be given upon contract award.

Responses to this Sources Sought shall unequivocally demonstrate that the respondent is regularly engaged in the sale of same or substantially similar products. 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 to include date of sale, description of services provided, 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/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 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 3:00 pm (Central Time in Jefferson AR) on May 6, 2026 to Suzanne Martella, email suzanne.martella@fda.hhs.gov. Reference:

75F40126SSN134073.

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.

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 mailto:suzanne.martella@fda.hhs.gov 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. 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.