Inactive Total Small Business Set-Aside (FAR 19.5)

AMENDMENT No.: 01 from September 7, 2022. QUOTATION DUE DATE: 9 a.m. (EDT) on September 14, 2022 (changed) This amendment No.: 01 is to Amend the Combined Synopsis/Solicitation (RFQ) in order to modif... AMENDMENT No.: 01 from September 7, 2022. QUOTATION DUE DATE: 9 a.m. (EDT) on September 14, 2022 (changed) This amendment No.: 01 is to Amend the Combined Synopsis/Solicitation (RFQ) in order to modify the NAICS code and extend the date and time to for responses to the solicitation. This amendment No.: 01 is attached in full (D CSS-C RFQ 75N95022Q00559_Mod1) END OF AMENDMENT No.: 01 (i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in 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 75N95022Q00559 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 Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures; FAR Subpart 13.5— Simplified Procedures for Certain Commercial Items; and FAR Part 12—Acquisition of Commercial Items, and is expected to exceed the simplified acquisition threshold. (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2022-07, with effective date August 10, 2022. (iv) The associated NAICS codes and the small business size standard are as follows: 541990 - All Other Professional, Scientific, and Technical Services and the small business size standard is $16.5M. 541714 Research and Technology in Biotechnology (except Nanobiotechnology) and the small business size standard is 1000 employees 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) and the small business size standard is 1000 employees. This requirement is a total small business set-aside (v) The National Institutes of Health (NIH) is the nation’s leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people’s health and save lives. NCATS is one of 27 Institutes and Centers at the NIH and its mission is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. Experts in NCATS DPI develop system approaches that improve the efficiency and effectiveness of the translation process. Examples include advancing new technologies to make preclinical research more predictive and efficient or de-risking potential drug targets or research projects to make them more attractive for commercial investment. Using state-of-the-art resources to enable the ongoing operation of all NCATS translational research activities within Automation, Compound Management (CM), Analytical Chemistry, and Informatics. The NCATS DPI CM staff operate in partnership with the automation team. Using numerous types of sophisticated and automated sample management and liquid-handling instrumentation, these experts provide follow-up and dose-response library-plating services for NCATS screening activities. NCATS has become a key partner in the Antiviral Program for Pandemics (APP), a multi-agency initiative that includes National Institute of Allergy and Infectious Diseases (NIAID) and Biomedical Advanced Research and Development Authority (BARDA), to accelerate antiviral development through early discovery and preclinical development of safe and effective oral antivirals. The initial priority for the APP is to develop treatments for SARS-CoV-2 and other coronaviruses, with the program expanding to address other virus families with pandemic potential. NCATS will apply its proficiency in drug discovery and development and its cutting-edge technologies to fill critical needs of the APP, such as (i) target validation, (ii) high-throughput screening (HTS) for drug starting points, (iii) medicinal chemistry for lead optimization, and (iv) preclinical, investigational new drug (IND)-enabling development. NCATS DPI CM has the capacity for large scale development of anti-viral biological assays and screening them against the APP Antiviral Library of small molecule, with the aim of identifying compounds that can serve as starting points for medicinal chemistry optimization and preclinical to IND drug candidate development. Thus, this Statement of Work seeks to obtain the professional services to design and produce a large-scale APP Antiviral Library. The services shall include designing the library and obtaining the small molecules for delivery to NCATS. (vi) The Statement of Work (SOW) with a description of the services to be performed is included as an attachment to this Solicitation, as per the following schedule of services: Line 0001: Phase 1. LIBRARY DESIGN - Firm-Fixed Price (FFP) Line 0002: Phase 2. COMPOUND ACQUISITION – Time and Material (T&M) The National Center for Advancing Translational Sciences (NCATS), Division of Preclinical Innovation (DPI), Compound Management (CM) seeks obtain the professional services to design and produce a large-scale APP Antiviral Library composed of individual small molecules to support the NCATS DPI CM and the APP with the capability for large scale development of anti-viral biological assays based on screening against small molecule of the library. (vii) The Government anticipates award of a mixed Firm-Fixed Price (FFP) and Time & Material (T&M) for this acquisition, and the anticipated period of performance is September 23, 2022 through September 22, 2023 (12-months) or 12-months from date of award. (viii) The provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference (Feb 1998), applies to this acquisition. This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at these addresses: https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html (End of provision) The following provisions apply to this acquisition and are incorporated by reference: FAR 52.204-7, System for Award Management (Oct 2018) FAR 52.204-16, Commercial and Government Entity Code Reporting (Aug 2020) FAR 52.212-1, Instructions to Offerors-Commercial Items (Nov 2021) FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Nov 2021) FAR 52.216-31 Time-and-Materials/Labor-Hour Proposal Requirements—Commercial Acquisition (Nov 2021) HHSAR 352.239-73, Electronic and Information Technology Accessibility Notice (December 18, 2015) The clause at FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998), applies to this acquisition. This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at these addresses: https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html (End of clause) The following clauses apply to this acquisition and are incorporated by reference: FAR 52.204-13, System for Award Management Maintenance (Oct 2018) FAR 52.204-18, Commercial and Government Entity Code Maintenance (Aug 2020) FAR 52.212-4, Contract Terms and Conditions--Commercial Items (Nov 2021). Addendum to this FAR clause applies to this acquisition and is attached. FAR 52.227-14, Rights in Data-General (May 2014). Pursuant to paragraph (d), the Contractor may not assert copyright, make use of, release to others, reproduce, distribute, or publish any data first produced or specifically used by the Contractor in the performance of this contract without prior approval of the contracting officer. HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015) HHSAR 352.237-75, Key Personnel (December 18, 2015). HHSAR 352.239-74, Electronic and Information Technology Accessibility (December 18, 2015) The following provisions and clauses apply to this acquisition and are attached in full text. Offerors MUST complete the provisions at 52.204-24 and 52.204-26 and submit completed copies as separate documents with their proposal. FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021) FAR 52.204-26 Covered Telecommunications Equipment or Services-Representation (Oct 2020) FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Products and Commercial Services (May 2022) Invoice and Payment Provisions with and without IPP (Apr 2022) (ix) The Government will perform a comparative evaluation of responses in accordance with FAR 13.106-2(b) to award a purchase order from this solicitation to the responsible offeror whose response meets the solicitation’s requirements and, as a whole, provides the best value, considering price and other factors in this solicitation. The evaluation will compare: (a) Technical capability of the service offered to meet the Government requirement; (b) Price; and (c) Past Performance as defined under FAR 13.106-2(b)(3). If only one quotation is received it will be evaluated on the preceding basis. Quoters are encouraged to provide Specific Technical Capability and Past Performance on services related to Translational Science and Small Molecule Library design, for evaluation purposes. Key personnel proposed must include at a minimum a Program Manager and a Sr. Scientist. For each proposed key person, a resume is required. The quoter shall provide a resume for each person proposed for the project. All staff for which resumes are submitted will be considered key staff and dedicated to this project if a purchase order is awarded. A description of all corresponding commercial job titles, experience, functional responsibility and education for those types of employees who will perform services shall be provided. Responses may exceed capability or performance characteristics of the solicitation’s requirements. The Government reserves the right, but is not required, to award to a response that exceeds capability or performance characteristics of the solicitation’s requirements if it provides a benefit to the Government and the Government is not requesting or accepting alternate proposal(s). (x) The Offerors are to include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Products and Commercial Services (May 2022), with offers. If the offeror has completed FAR provision 52.212-3 at www.sam.gov, then the offeror does not need to provide a completed copy with its offer. (xi) The clause at FAR 52.212-4, Contract Terms and Conditions-Commercial Items (Nov 2021), applies to this acquisition. Addendum to this FAR clause applies to this acquisition and is attached. (xii) Additional contract requirement(s) or terms and conditions applicable to this acquisition: This COVID-19 requirement will be funded with COVID-19 funds at time of award. The following language is applicable and shall be included in the resultant COVID-19 award. “HHS reserves the right to exercise priorities and allocations authority with respect to this contract, to include rating this order in accordance with 45 CFR Part 101, Subpart A— Health Resources Priorities and Allocations System.” CONTRACTING OFFICER'S REPRESENTATIVE (COR) The following Contracting Officer's Representative (COR) and Alternate COR will represent the Government for the purpose of this contract: [to be specified prior to award] The COR and Alternate COR are responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance. The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of the purchase order; or (6) sign written licensing agreements. The Government may unilaterally change its COR designation. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE Contractor Performance Evaluations Interim and Final evaluations of Contractor performance will be prepared on this purchase order in accordance with FAR Subpart 42.15. The Final performance evaluation will be prepared at the time of completion of work. In addition to the Final evaluation, Interim evaluation(s) may be prepared periodically as determined by the Contracting Officer. Interim and Final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final. Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions. Electronic Access to Contractor Performance Evaluations Contractors may access evaluations through a secure Web site for review and comment at the following address: http://www.cpars.gov (xiii) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. (xiv) Responses to this solicitation must include sufficient information to establish the interested parties’ bona-fide capabilities of providing the service. The quote, utilizing the Pricing Form attached, must be for a mix of Firm-Fixed Price (FFP) and Time & Material (T&M). For the LIBRARY DESIGN, Phase 1, the quote must be for a firm-fixed-price, as listed in the attached pricing spreadsheet, with the total amount inclusive of all costs and fees and include any other information or factors that may be considered in the award decision. For COMPOUND ACQUISITION, phase 2, the quoter must submit fully burdened labor rates for the T&M line item listed in the attached pricing spreadsheet. The applicable ceiling price(s) and/or quantities used to generate the evaluated price are detailed on the attached pricing spreadsheet. The T&M labor mix and level of effort specified are for estimation purposes. The contractor may reallocate, without prior written approval, the number of hours by labor category within the labor CLIN as needed to effectively manage the project, provided the total funded labor cost is not exceeded. Any additional labor categories or increases to ceilings or labor rates required during performance must be approved by the Contracting Officer and added to the purchase order by modification. The Government will not be liable for any costs exceeding the ceiling price of requirements detailed on the pricing spreadsheet. To assist in the preparation of your quote, the Government estimates that material costs will total $2,000,000.00 for this period of performance to accomplish the requirements identified in COMPOUND ACQUISITION, phase 2 of the Statement of Work. This is only an estimate and does not constitute a commitment, implied or otherwise, that the Government will expend the entire amount indicated below during the performance of the purchase order. The Unique Entity ID from SAM.gov, the Taxpayer Identification Number (TIN), 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 questions must be received by 9 a.m., Eastern Time, on September 7, 2022, and reference Solicitation Number 75N95022Q00559. Questions may be submitted electronically to Renato Gomes at renato.gomes@nih.gov. All quotations must be received by 9 a.m., Eastern Time, on September 14, 2022, and reference Solicitation Number 75N95022Q00559. Responses must be submitted electronically to Renato Gomes at renato.gomes@nih.gov. Fax responses will not be accepted. Attachments: Statement of Work FAR 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021) FAR 52.204-26, Covered Telecommunications Equipment or Services-Representation (Oct 2020) Addendum to FAR 52.212-4 Contract Terms and Conditions—Commercial Products and Commercial Services. FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders–Commercial Products and Commercial Services (May 2022) Invoice and Payment Provisions with and without IPP (Apr 2022) Pricing Form (template)