MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The U.S. Food and Drug Administration (FDA) is conducting market research to support the National Center for Toxicological Research (NCTR), Jefferson, AR requires mass spectrometry analysis of SARS-CoV‑2 antibody repertoire in 145 human plasma samples. The FDA is seeking small business sources to determine the availability and capability of small business providers for the items described herein. Other than small business concerns are also encouraged to submit capability statements. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort. The associated North American Industry Classification System (NAICS) Code is-621511- Medical Laboratories; Small Business Size Standard is $41.5 million. STATEMENT OF WORK The U.S. Food and Drug Administration’s (FDA) National Center for Toxicological Research (NCTR), Jefferson, AR requires mass spectrometry analysis of SARS-CoV‑2 antibody repertoire in 145 human plasma samples (100 µL each). Samples will be shipped by September 15, 2024. The plasma samples are from COVID-19 patients, subjects vaccinated by COVID-19 vaccines, or subjects without the COVID-19 disease. High resolution individual ion mass spectrometry shall be applied to the analysis of heavy and light chains of antibodies. The entire antibody repertoire against SARS-CoV-2 spike protein receptor-binding domain (RBD) shall be captured. Intact antibodies or antibody chains shall be analyzed to measure accurate masses and intensities. Antibody ion titers and clonalities shall be reported. Results shall be delivered within 30 days after the samples are received. Minimum Performance/Technical requirements: 1. Mass spectrometry analysis of SARS-CoV‑2 antibody repertoire in 145 human plasma samples. 2. High resolution individual ion mass spectrometry shall be applied to the analysis of heavy and light chains of antibodies. 3. Accurate charge detection shall be performed on individual ions using STORI plot analysis. 4. The entire antibody repertoire against SARS-CoV-2 spike protein receptor-binding domain (RBD) shall be captured. 5. Intact antibodies or heavy and light antibody chains shall be analyzed to measure accurate masses and intensities in terms of quantitative proteoforms. 6. Accurate charge state, m/z, mass, intensity of each antibody and/or antibody chain shall be reported. 7. Antibody ion titers and clonality degree shall be reported. 8. Data provided shall include study design, experimental conditions, and results, and all data will be provided to NCTR electronically via word, Excel, PDF, and raw mass spectrometry data files. The plasma samples of 100 uL each will be shipped by September 15, 2024. Upon receipt of samples, the contractor shall perform the required analysis which shall be delivered within 30 calendar days from receipt of the government provided human plasma samples. The Contractor does not own the data (i.e., intellectual property). NCTR/FDA is the owner of the data. Confidentiality and Nondisclosure of Information. Any information provided to the contractor (and/or any subcontractor) by FDA or collected by the contractor on behalf of FDA shall be used only for the purpose of carrying out the provisions of this contract and shall not be disclosed or made known in any manner to any persons or entity except as may be necessary in the performance of the contract. The Contractor assumes responsibility for protection of the confidentiality of Government records and shall ensure that all work performed by its employees and subcontractors shall be under the supervision of the Contractor. Each Contractor employee or any of its subcontractors to whom any FDA records may be made available or disclosed shall be notified in writing by the Contractor that information disclosed to such employee or subcontractor can be used only for that purpose and to the extent authorized herein. The information shall not be disclosed to any other entity without prior FDA approval. Sanitization of Government Files and Information. As part of contract closeout and at expiration of the contract, the Contractor (and/or any subcontractor) shall provide all required documentation to the TPOC/COR to certify that, at the government’s direction, all electronic and paper records are appropriately disposed of and all devices and media are sanitized in accordance with NIST SP 800-88, Guidelines for Media Sanitization and FDA IS2P Appendix T: Sanitization of Computer-Related Storage Media. The confidentiality, integrity, and availability of such information shall be protected in accordance with HHS and FDA policies. Unauthorized disclosure of information will be subject to the HHS/FDA sanction policies and/or governed by the following laws and regulations: a. 18 U.S.C. 641 (Criminal Code: Public Money, Property or Records); b. 18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information); and c. 44 U.S.C. Chapter 35, Subchapter I (Paperwork Reduction Act). Shipping Destinations: U.S. Food and Drug Administration 3900 NCTR Rd. Jefferson, AR 72079 POC: to be provided at award. FOB Point Destination. All items shall include shipping, handling and delivery to the destination identified herein. The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services and components meet the technical requirements identified above. Though the target audience is small business manufacturers or small businesses capable of supplying a U.S. made product/service of a small business manufacturer or producer all interested parties may respond. At a minimum, responses shall include the following: • Business name, SAM Unique Entity ID 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 if responding to provide a product manufactured by another firm); • Sufficient descriptive literature that unequivocally demonstrates that offered products and services can meet the above requirements. All descriptive material necessary for the government to determine whether the service/product offered meets the technical requirements including: technical specifications, ISO certifications, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement. • Past performance information within the last three years in which the offeror has provided same or substantially similar solutions and used for same or near-same applications for mass spectrometry analysis for human plasma samples as set forth herein. For each past performance reference include the date of sale, description, dollar value, client name, client address, client point of 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 ID number and size status) if not the respondent. • If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement. Detailed list of items included and not included on the GSA contract to meet this requirement. • 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. • Provide information if any of these specifications are too restrictive. No response will be considered that the listed specifications are adequate in a competitive environment. • If a large business, identify the subcontracting opportunities that would exist for small business concerns; • Standard commercial warranty and payment terms; • Provide place of service performance and any other applicable information to enable review and analysis to place of performance. Provide (1) the place of performance for the services that process Americans’ plasma samples, genome or exome data (stored or transmitted electronically), to include a specification of whether that processing will occur through or in any foreign country or entity, (2) whether the plasma samples, genome or exome will be provided to any other country or entity, or (3) whether any information technology capabilities used to receive, process, or respond to this contract, to include but not limited to servers, data storage, cloud storage, or analytics tools, are located in any foreign country or entity; and • Though this is not a request for quote, informational pricing is required. The government is not responsible for locating or securing any information, not identified in the response. The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation. Interested Parties shall respond with capability statements which are due by email to the point of contact listed below on or before May 23, 2024 by 13:00 hours (Central Time in Jefferson, Arkansas) to
[email protected]. Reference NCTR-2024-123714. Notice of Intent Responses to this sources sought announcement will assist the Government in determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures. 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).