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) has issued this sources sought announcement on behalf of the National Center for Toxicological Research (NCTR) in order to determine if there are existing small business sources capable of providing Multiplex Assays.

If your firm is considered a small business source under North American Industry Classification System (NAICS) Code 325414 – Biological Product (except Diagnostic) Manufacturing; with a Small Business Size Standard of 1,250 employees, and believe that your firm would be able to provide the FDA with the supplies/services described below, please submit an email to [email protected]. The vendor should include information about the company and demonstrate that it can meet all of the minimum performance requirements.

Background: The FDA/NCTR/Division of Neurotoxicology at NCTR is in need of specific custom “Brand Name or Equal” Bio-Plex multiplex assays. The Division of Neurotoxicology uses a Bio-Plex 200 system to support numerous protocols requiring analysis of multiple neurodegeneration markers and cell signaling pathways in small samples. This system is currently used to measure metabolites in brain tissue as well as serum and plasma samples.  Sample analysis of specific signaling molecules and neuroinflammation markers in serum, plasma, urine, CSF, and tissues will be done using these kits.

Minimum Requirements for Multiplex Assays:

• Shall delivery in a single shipment 2 of each type of requested Bio-Plex kit for a total of 10 kits.

• Shall provide two (2) Bio-Plex Pro Rat Cytokine 23-Plex Assay 1 x 96-well that includes the following: coupled beads, detection antibodies, standards, buffers, diluents, streptavidin-PE, flat bottom plate, and sealing tape for detecting 23 rat cytokines all in a single well. Analytes are mixed by user.
• Shall provide two (2) Bio-Plex Pro TGF- 3-plex Assay 1 x 96-well that includes the following: coupled magnetic beads, detection antibodies, standards, buffers, diluents, streptavidin-PE, filter plate, and sealing tape for the detection of TGF-β1, TGF-β2, TGF-β3 all in one kit. Analytes are mixed by user.
• Shall provide two (2) Bio-Plex Pro Rat Cytokine Th1/Th2 Assay 1 x 96-well that includes the following: coupled magnetic beads, detection antibodies, standards, buffers, diluents, streptavidin-PE, filter and flat bottom plate, and sealing tape for the detection 12 rat cytokines all in one kit. Analytes are mixed by user. 
• Shall provide two (2) Bio-Plex Pro Cell Signaling MAPK Panel, 9-plex 1 x 96-well plate that includes the following: coupled magnetic beads and detection antibodies, buffers, lysis factor QG, diluent, streptavidin-PE, 96-well flat bottom plate, and plate seals for the detection of 9 MAPK pathway markers. Analytes are mixed by user.
• Shall provide two (2) Bio-Plex Pro Cell Signaling Akt Panel, 8-plex 1 x 96-well plate that includes the following: coupled magnetic beads and detection antibodies, buffers, lysis factor QG, diluent, streptavidin-PE, 96-well flat bottom plate, and plate seals for the detection of 8 Akt pathway markers. Analytes are mixed by users.
• Shall include packaging and freight charges.

Estimated Delivery Date: The contractor shall ship the kits within 60 days of contract award.

Delivery Location:

Food and Drug Administration

National Center for Toxicological Research

3900 NCTR Road

Jefferson, AR  72079

Though the target audience is small business vendors or small businesses capable of supplying a U.S. 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 identification (UEI) 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 information for the manufacturer and/or sale of same or substantially similar product and service or similar brand instruments 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 UEI number and size status) if not the respondent.

• Descriptive literature, brochures, marketing material, etc. detailing the nature of the product and service the responding firm is regularly engaged in manufacturing and/or selling.

• The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered services meet the technical requirements identified above.

• The offeror shall advise if the product and/or service is on a Best in Class contract.

• If applicable, the offeror shall clearly identify where the offered product is made.

• 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 a large business, provide if 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.

• Informational pricing is desired.

• 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 due  by email to the point of contact listed below on or before May 5, 2022 by 1:00 PM Central Time at the Food and Drug Administration, Field Operations Branch, FDA|OO|OFBA|OAGS|DAP, Attn: Warren Dutter, email [email protected]. Reference: FDA-SSN-112333.

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. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality

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.