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 lymphoid tissue specimens for a research study. 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 FDA/NCTR anticipates only one source available therefore the FDA intends to award a sole source, firm fixed price purchase order to University of Tennessee Health Science Center (UTHSC) under the authority of FAR 13.106-1(b)(1), Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements; depending on the results of this sources sought/market research notice if no other capable sources are found. The associated North American Industry Classification System (NAICS) Code is-621511- Medical Laboratories; Small Business Size Standard is $41.5 million. Statement of Work 1.0 INTRODUCTION 1.1 Background Montelukast is a cysteinyl leukotriene type-1 receptor (CYSLTR1) antagonist approved for chronic daily administration for adults and pediatrics with persistent concerns regarding reports of adverse neuropsychiatric events associated with the use of montelukast, which resulted in a boxed warning for montelukast products. However, additional and increasing concerns remain regarding potential accumulation of drug in the brain and other tissues. A pharmacokinetic (PK) animal model with clinically relevant plasma exposure levels has been established at NCTR; however, clinical tissues are needed to establish the translatability from rodents to humans for tissue: plasma drug exposure levels, tissue clearance rates, and tissue accumulation. Furthermore, there is an increased concern for accumulation in pediatrics in particular. 1.2 Objectives In order to assess clinical drug exposure levels, clinical specimens are needed from pediatric patients who have been treated with montelukast. Since montelukast is often administered with corticosteroids, it is important to obtain tissues from patients also receiving combination treatment with montelukast + corticosteroid. Control specimens are also needed from patients without treatment by either drug and with treatment of corticosteroids only. 2.0 Constraints The UTHSC already has a separate IRB-approved clinical study from pediatric patients, as part of their ongoing clinical programs and the Choosing Healthy Activities and Lifestyle Management through Portal Support (CHAMPS). A new contractor will need to have IRB approval prior to the performance period start in Section 6.0. 3.0 SCOPE Clinical specimens will be shipped to NCTR. All evaluations of drug exposure levels in the clinical specimens will be conducted by NCTR investigators at the Jefferson labs. 4.0 TASKS Clinical lymphoid tissues will be collected from patients undergoing tonsillectomy and/or adenoidectomy procedures under the Contractor’s facility will archive and ship the specimens to NCTR. University of Tennessee Health Science Center (UTHSC) ongoing clinical study Choosing Healthy Activities and Lifestyle Management through Portal Support (CHAMPS). Dr. Heather Smallwood at the (UTHSC) will archive and ship the specimens to NCTR. 5.0 DELIVERABLES • 6 lymphoid tissue specimens from patients treated with montelukast. • 6 lymphoid tissue specimens from patients treated with montelukast + corticosteroids • 6 lymphoid tissue specimens from control patients treated with corticosteroids only • 6 lymphoid tissue specimens from control patients not treated with montelukast or corticosteroids 6.0 PERIOD OF PERFORMANCE 9/25/2024 through 9/24/2025. 7.0 PLACE OF PERFORMANCE Specimens will be collected by the Contractor at the Contractor’s facility. 8.0 GOVERNMENT FURNISHED EQUIPMENT (GFE)/GOVERNMENT FURNISHED INFORMATION No government-furnished property or government-furnished information will be provided in the scope of this acquisition. 9.0 SECURITY REQUIREMENTS There are no IT needs or IT-related security requirements for this acquisition. Specimens will be shipped and received in accordance with recommendations from safety and IRB personnel at both the shipping and receiving locations. 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 June 5, 2024 by 13:00 hours (Central Time in Jefferson, Arkansas) to
[email protected]. Reference NCTR-2024-123621. 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).