Inactive

(i) This is a combined synopsis/solicitation for commercial supplies prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6 as supplemented with additional informa... (i) This is a combined synopsis/solicitation for commercial supplies prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. (ii) The solicitation number is 75N95024Q00499 and the solicitation is issued as a Request for Quotation (RFQ). This acquisition is for a commercial item or service and is conducted under the authority of the FAR part 13—Simplified Acquisition Procedures; and FAR Part 12—Acquisition of Commercial Products and Commercial Services, and is not expected to exceed the Simplified Acquisition Threshold (SAT). A fixed-price type of purchase order is contemplated for this requirement. (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2024-06, dated July 30, 2024. (iv) The North American Industry Classification System (NAICS) code for this procurement is 325414 - Biological Product (except Diagnostic) Manufacturing, and the small business size standard is 1,250 employees or less. This requirement shall be solicited using full and open competitive procedures. (v) DESCRIPTION The Government requires primary human hepatocytes. It shall consist of the following items: 1. Hepatocyte-Adult-Pltabl-Mid Term 2. Hep-Ad-Plt-MT 3. Availability of a minimum of 100 different donors 4. Specific donor types required: (1) Female donor aged 35, Asian, with a BMI between 19-32, fibrosis score of 0, NAS of 0 (2) Female donor aged 25, Caucasian, with a BMI between 19-32, fibrosis score of 0, NAS of 0 (3) Male donor aged 50, Asian, with a BMI between 19-32, fibrosis score of 0, NAS of 0 (4) Male donor aged 51, Caucasian, with a BMI between 19-32, fibrosis score of 0, NAS of 0 (5) Female donor aged 63, Black, with a BMI between 19-32, fibrosis score of 0, NAS of 0 (6) Male donor aged 44, Black, with a BMI between 19-32, fibrosis score of 0, NAS of 0 (7) Female donor aged 41, Hispanic, with a BMI between 19-32, fibrosis score of 0, NAS of 0 (8) Male donor aged 52, Hispanic, with a BMI between 19-32, fibrosis score of 0, NAS of 0The Government requires the following brand name or equal services: (vi) Please refer to Attachment 1 – Purchase Description for details and information describing the salient characteristics and requirements. (vii) The Government anticipates award of a firm fixed-price purchase order for this acquisition, with delivery occurring within 30 days after issuance of the purchase order. (viii) The provision at FAR Clause 52.212-1 Instructions to Offerors—Commercial Products and Commercial Services (SEP 2023) is applicable and incorporated by reference into this solicitation. (ix) The provision at FAR Clause 52.212-2, Evaluation-Commercial Products and Commercial Services (NOV 2021) is applicable and incorporated by reference into this solicitation. The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. Each quote will be evaluated in strict conformity with the evaluation factors, utilizing quantitative scores and written critiques. The evaluation will be based upon the demonstrated capabilities of the prospective Contractor in relation to the needs of the project as set forth in the solicitation. The quote will also be evaluated taking into consideration any price reductions for the requirement being ordered. A price reasonableness determination will be made and a best value analysis will be performed. The best value analysis will take into consideration the results of the technical evaluation, price evaluation, and the ability to complete the work within the Government's required schedule. The analysis will document that the award represents the best value to the Government (considering technical evaluation factors, past performance, and price) to meet the Government’s needs. The Government reserves the right to issue an order to the best advantage of the Government, technical merit, price, and other factors considered. All aspects of a quote are subject to discussion, including price, technical approach and terms and conditions. At the completion of discussions, the Contractor will ensure the technical and price quote reflects the mutual understandings of the requirement and if requested, submit a revised technical and price quote to the Contracting Officer. The Government may request clarifying information from the Contractor, as it relates to its quote. If an award will be made without conducting discussions, Contractors may be given the opportunity to clarify certain aspects of their quote (e.g., the relevance of the contract, the Contractor's past performance information, and adverse past performance information to which the Contractor has not previously had an opportunity to respond) or to resolve minor or clerical errors. Discussions will not be held with any Offeror determined to be technically unacceptable. The Government reserves the right to make a single award, multiple awards, or no award at all as a result of the solicitation. In addition, the solicitation may be amended or canceled as necessary to meet the Government’s requirements. A tradeoff process shall be used for this acquisition because it has been determined to be in the best interest of the Government to consider award to other than the lowest priced Offeror or other than the highest technically rated offeror. All evaluation factors other than cost or price, when combined, are more important than cost or price. For this acquisition, the following considerations will be part of the trade-off process: Technical Evaluation Factors including Past Performance, and Price. The evaluation factors are used by the technical evaluation committee when reviewing the technical quotes. The factors below are listed in order of its relative importance for evaluation purposes. 1. Technical Capability and Functionality NCATS shall evaluate the offeror’s technical approach for overall capability and functionality in relation to the General Requirement, Salient Characteristics, Quantity and Deliverables as described in the Purchase Description. 2. Contract Management and Customer Support NCATS shall evaluate the offeror’s ability to provide a high level of customer service, particularly in the area of initial responsiveness and resolution of device and service problems. Specifically, the Government will evaluate the Offeror’s capability based on its description of any applicable warranty, customer support process. 3. Speed of Delivery NCATS shall evaluate the offeror’s technical approach for completeness, feasibility, soundness and practicality of the proposed approach and work plan for accomplishing the requirements of the Purchase Description PAST PERFORMANCE The Offeror shall provide past performance information. Past performance information shall cover a minimum of 1 year in relevant services and deliveries of comparable systems. The Offeror shall provide at least one reference for any project identified under the experience factor that has a performance period within the past three years. For each reference, the offeror shall provide: (1) organization/contracting partner's name; (2) point of contact's (POC) name and contact information, including current phone numbers and valid email addresses; and (3) description that precisely explains both the general scope and specific requirements of the contract. Offerors will be evaluated based on information obtained from references provided by the offeror, other relevant past performance information obtained from other sources known to the Government, and any information supplied by the offeror concerning problems encountered on the identified contracts and corrective action taken. Furthermore, the Government will assess the relative risks associated with each offeror. Performance risks are those associated with an offeror's likelihood of success in performing the acquisition requirements as indicated by that offeror's record of past performance. The assessment of performance risk is not intended to be the product of a mechanical or mathematical analysis of an offeror's performance on a list of contracts but rather the product of subjective judgment by the Government after it considers all available and relevant information. PRICE EVALUATION Offerors price quote will be evaluated for reasonableness. For a price to be reasonable, it must represent a price to the government that a prudent person would pay when consideration is given to prices in the market. Normally, price reasonableness is established through adequate price competition, but may also be determined through cost and price analysis techniques. Price evaluation will not be conducted on any Offeror determined to be technically unacceptable. (x) The provision at FAR Clause 52.212-3, Offeror Representations and Certifications - Commercial Products and Commercial Services (MAY 2024), is applicable and incorporated by reference into this solicitation. (xi) The provision at FAR Clause 52.212-4, Contract Terms and Conditions—Commercial Products and Commercial Services (NOV 2023), applies to this acquisition. See Attachment 2. (xii) The provision of FAR Clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Products and Commercial Services (MAY 2024), applies to this acquisition. See Attachment 3. (xiii) There are no additional contract requirement(s) or terms and conditions applicable to this acquisition. (xiv) The Defense Priorities and Allocations System (DPAS) is not applicable to this requirement. (xv) Responses to this solicitation must include sufficient information to establish the interested parties’ bona-fide capabilities of providing the product or service. Responses to this solicitation must include clear and convincing evidence of the Offeror’s capability of fulfilling the requirement as it relates to the government requirements stated in this solicitation. Basic cost and price information in the Offeror’s proposal must contain sufficient information to allow the Government to perform a basic analysis of the reasonableness of the Offeror to supply the required goods/services. Any other information or factors that may be considered in the award decision may include such factors as: past performance; special features required for effective service coverage; trade-in considerations; warranty considerations; maintenance and service coverage availability; serial, product or catalog number(s); product description; delivery terms, and prompt payment discount terms. The Contractor shall submit its quote electronically. Offerors MUST verify the valid certifications, registrations, and Representation and Certifications from the System of Award Management (SAM) applications at www.SAM.gov, which may be indicated on the Offeror’s cover sheet. In addition, the vendor Unique Entity Identifier (UEI) and the certification of business size must be included in the response. All Offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. All responses must be received no later than August 28, 2024, 4:00 PM EST. Late responses may not be accepted. All responses must reference solicitation number 75N95024Q00499. Responses must be submitted electronically to rob.bailey@nih.gov. For information regarding this solicitation, please contact Rob Bailey by email at rob.bailey@nih.gov or by phone at 301-451-7586. (xvi) DATE QUESTIONS DUE: Questions and requests for clarification must be submitted electronically to the Contract Specialist, Rob Bailey, at rob.bailey@nih.gov on or before 4:00 PM EST, August 26, 2024. Fax responses will NOT be accepted. ATTACHMENTS Attachment 1 - Statement of Work (SOW) Attachment 2 - FAR 52.212-4, Contract Terms and Conditions - Commercial Products and Commercial Services (NOV 2023) Attachment 3 - FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Products and Commercial Services (MAY 2024) Attachment 4 – Invoice and Payment Instructions

Inactive

The National Center for Advancing Translational Sciences (NCATS) Division of Preclinical Innovation (DPI) Early Translation Branch (ETB) is seeking Capability Statements from Other Than Small Business... The National Center for Advancing Translational Sciences (NCATS) Division of Preclinical Innovation (DPI) Early Translation Branch (ETB) is seeking Capability Statements from Other Than Small Business organizations under the North American Industry Classification System (NAICS) code 325414, that are manufacturers of Primary Human Hepatocytes vials to be used in the evaluation of the impact of patient variability on the development of drug induced liver injury. This Primary Human Hepatocytes vials are necessary to build an accurate in vitro model of the liver for evaluation a panel of drugs for drug induced liver injury. This is a Sources Sought Notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified business sources; and (2) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. The established NAICS code is 325414, Biological Product (except Diagnostic) Manufacturing. The U.S. Small Business Administration establishes a size standard for 325414 as 1,250 employees or less. BACKGROUND INFORMATION AND OBJECTIVE: NCATS mission is to turn research observations into health solutions through translational science. The DPI plans and conducts collaborative research projects across the preclinical phases of the translational science spectrum. The specific mission of NCATS DPI ETB is to uncover small-molecule probes for disease targets and advance the process of therapeutic development through a collaborative research model. To support this mission, NCATS seeks to harness 3D tissue engineered models to evaluate a 240-drug panel for toxicity in the form of drug induced liver injury. Current in vitro models are failing to predict injury in a clinical setting. Therefore, NCATS aims to harness spheroid models formed from a wide variety of donors, male and female of different ethnic backgrounds, to increase model accuracy. As the primary functional cell type of the liver, human hepatocytes must be procured to form this model. REQUIREMENT: Sixteen primary human hepatocytes. It shall consist of the following items: Hepatocyte-Adult-Pltabl-Mid Term Hep-Ad-Plt-MT Availability of a minimum of 100 different donors Specific donor types required: Female donor aged 35, Asian, with a BMI between 19-32, fibrosis score of 0, NAS of 0 Female donor aged 25, Caucasian, with a BMI between 19-32, fibrosis score of 0, NAS of 0 Male donor aged 50, Asian, with a BMI between 19-32, fibrosis score of 0, NAS of 0 Male donor aged 51, Caucasian, with a BMI between 19-32, fibrosis score of 0, NAS of 0 Female donor aged 63, Black, with a BMI between 19-32, fibrosis score of 0, NAS of 0 Male donor aged 44, Black, with a BMI between 19-32, fibrosis score of 0, NAS of 0 Female donor aged 41, Hispanic, with a BMI between 19-32, fibrosis score of 0, NAS of 0 Male donor aged 52, Hispanic, with a BMI between 19-32, fibrosis score of 0, NAS of 0 This product shall include shipping. Salient Characteristics: The following features/characteristics are required for this requirement: The hepatocyte inventory list must have a minimum of 100 available donors with over 30 available vials per donor; There must be a viability of at least 80% upon thaw; The hepatocyte inventory must have a minimum of four different racial backgrounds, with both male and female availability; Hepatocyte inventory must have variability with regards to BMI, age, and drug/alcohol history; and Specific donor types set forth in the Purchase Description are required. Anticipated Delivery Date: Within 30 days after contractor receipt of Purchase Order. INSTRUCTIONS: Companies that believe they possess the capabilities to provide the required product should submit documentation of their ability to meet each of the requirements to the Contracting Officer. The capability statement must specifically address each of the requirements separately. Additionally, the capability statement should include 1) the total number of employees, 2) the professional qualifications of personnel as it relates to the requirements outlined, 3) any contractor GSA Schedule contracts and/or other government-wide acquisition contracts (GWACs) by which all of the requirements may be met, if applicable, and 4) any other information considered relevant to this program. Capability statements must also include the Company Name, Unique Entity ID from SAM.gov, Physical Address, and Point of Contact Information. The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. Interested companies are required to identify their type of business, applicable North American Industry Classification System (NAICS) Code, and size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. The established NAICS code is 325414. Respondents must provide clear and convincing documentation of their capability of providing the products and support services specified in this notice. Also, information must be provided in sufficient details of the respondents’ (a) staff expertise, including their availability, experience, formal and other training; (b) capability to perform the work; (c) prior completed projects of similar nature; (d) compliance with requirements: Vendors must identify and demonstrate specifically how they will meet the requirements listed above. Any other specific and relevant information about this particular area of procurement that would improve our consideration and evaluation of the information presented is desirable. Documentation may include, but not be limited to, contracts both Government and commercial the organization performed, references, i.e., names, titles, telephone numbers and any other information serving to document the organizations capability, e.g., awards, commendations, etc. The information submitted must be in an outline format that addresses each of the elements of the requirement and in the capability statement paragraphs stated herein. A cover page and an executive summary may be included but is not required. Any business concerns that believe they possess the capability necessary to successfully undertake the work described above must SUBMIT CAPABILITY STATEMENTS ELECTRONICALLY to the Contract Specialist, Rob Bailey at Rob.Bailey@nih.gov, NO LATER THAN 4:00 p.m. EST on August 19, 2024. The Subject line for the submission should include this Sources Sought Number and organization name. NIDA will not accept paper or faxed capability statements. THIS NOTICE IS NOT A REQUEST FOR PROPOSALS. This notice is for information and planning purposes only and does not commit the Government to any contractual agreement. 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 on 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).