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COMBINED SYNOPSIS / SOLICITATION 75N95023Q00644 TITLE: In vivo testing of a lead CoQ10 biosynthesis inhibitor in an SK-BR-3 xenograph mouse model (i) This is a combined synopsis/solicitation for comme... COMBINED SYNOPSIS / SOLICITATION 75N95023Q00644 TITLE: In vivo testing of a lead CoQ10 biosynthesis inhibitor in an SK-BR-3 xenograph mouse model (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; quotations are being requested and a written solicitation will not be issued. (ii) The solicitation number is 75N95023Q00644 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 and FAR Part 12 - Acquisition of Commercial Items, and is not expected to exceed the simplified acquisition threshold. (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2023-4, effective June 2, 2023. (iv) The associated NAICS code is 541380- Testing Laboratories and Services and the Small Business size standard is $19M. This requirement is non-competitive and no set-aside restrictions are applicable. THIS IS A NON-COMPETITIVE (NOTICE OF INTENT) COMBINED SYNOPSIS SOLICITATION TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Institute on Drug Abuse (NIDA), Office of Acquisition (OA), on behalf of The National Center for Advancing Translational Services (NCATS) intends to negotiate and award a Firm Fixed Priced contract without providing for full and open competition (including brand-name) to Oncology Precision Therapeutics and Imaging Core, 1130 St. Nicholas Ave, Room 2016. New York, NY 10032 for a service contract In vivo testing of a lead CoQ10 biosynthesis. This acquisition is conducted as non-competitive for a commercial item or service and is conducted pursuant to FAR 13.106-1(b)(1). DESCRIPTION (v) The in vivo studies consist of a series of 4 studies. Study 1 will assess the PK properties of the lead inhibitor in SK-BR-3 xenografted mice, Study 2 will assess the 14 day toxicology of the lead inhibitor in NCG mice, Study 3 will assess acute efficacy in SKBR3 xenografted mice, and Study 4 will assess 21 day efficacy of lead inhibitor in xenografted mice. Studies 2-4 are listed as optional, and study initiation will be triggered by successful completion and promising results from previous studies. Background: NCATS TDB has been collaborating with a team at Columbia Univ. to develop small molecules inhibitors of CoQ10 biosynthesis for the treatment of cancer. Currently, we have a series of inhibitors that show good potency and selectivity in vitro. We would like to test our lead inhibitor in a mouse model xenografted with SK-BR-3 human breast cancer cells. NCATS does not have in vivo efficacy testing facility nor capacity to run in vivo efficacy models, and therefore must get this service through a contractor. Purpose: NCATS is requesting this service to assess our lead small molecule ColQ10 biosynthesis inhibitor in an SK-BR-3 xenograft mouse model. Project Requirements: Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services,qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work. The salient characteristics: The in vivo studies consist of a series of 4 studies. Study 1 will assess the PK properties of the lead inhibitor in SKBR3 xenografted mice, Study 2 will assess the 14 day toxicology of the lead inhibitor in NCG mice, Study 3 will assess acute efficacy in SKBR3 xenografted mice, and Study 4 will assess 21 day efficacy of lead inhibitor in xenogragted mice. Studies 2-4 are listed as optional, and study initiation will be triggered by successful completion and promising results from previous studies. See the attached Statement of Work for complete requirement details. (vi) The Government anticipates award of a firm fixed-price contract for this acquisition, and the anticipated delivery is: SEE STATEMENT OF WORK SPECIAL CONTRACT REQUIREMENTS (vii) Contractor Requirements. The services under this contract involves live vertebrate animals. Respondents must include with their quotation: Evidence of an active OLAW Animal Welfare Assurance Institutional Animal Care and Use Committee (IACUC) project approval for this work. The date of IACUC approval must not be more than 36 months prior to the anticipated date of award Evidence of AAALAC Accreditation Vertebrate Animal Section (VAS) (see below) (viii) Animal Welfare. All research involving live, vertebrate animals shall be conducted in accordance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy). The PHS Policy can be accessed at: http://grants1.nih.gov/grants/olaw/references/phspol.htm. In addition, the research involving live vertebrate animals shall be conducted in accordance with the description set forth in the Vertebrate Animal Section (VAS) of the contractor’s quotation. (ix) Vertebrate Animals Section (VAS). It is intended that live vertebrate animals will be used during performance of this contract. The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (authority derived from the Health Research Extension Act of 1985) specifies that certain information is required from offerors in contract proposals submitted to the NIH that will use live vertebrate animals. The VAS should be no more than two (2) pages and must address the following criteria: 1. Description of Procedures. Provide a concise description of the proposed procedures to be used that involve vertebrate animals in the work outlined in the Statement of Work. Identify the species, strains, ages, sex and total number of animals by species to be used in the proposed work. 2. Justifications. Provide justification that the species are appropriate for the proposed research. Explain why the research goals cannot be accomplished using an alternative model (e.g., computational, human, invertebrate, in vitro). 3. Minimization of Pain and Distress. Describe the interventions including analgesia, anesthesia, sedation, palliative care and humane endpoints to minimize discomfort, distress, pain and injury. 4. Euthanasia. State whether the method of euthanasia is consistent with the recommendations of the American Veterinary Medical Association (AVMA) Guidelines for the Euthanasia of Animals. If not, describe the method and provide a scientific justification. For more discussion regarding the VAS, see NIH Guide Notice NOT-OD-16-006 at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-006.html. The VAS Worksheet is provided as an attachment to this solicitation to assist in the preparation of the VAS. EVALUATION AND AWARD (x) The anticipated award date is September 20, 2023. (xi) The Government plans to award a fixed-price purchase order resulting from this solicitation. The resulting award will be made to Columbia University as long as it is technically acceptable and at a fair and reasonable price. If additional quotations are received, the award will be made to the vendor who represents the best value to the Government, price and other factors considered. The Government will use comparative evaluations to determine which quotation is the best value, in consideration of the following evaluation criteria: 1. Technical Capability, which includes: a) Meeting the contractor requirements listed in Paragraph (vii) b) Ability to perform the required PK study c) Acceptability of the Vertebrate Animal Section (VAS) 2. Past Performance, which includes: a) Demonstrated experience conducting PK studies in validated hamster models routinely used by major academic institutions and/or the pharmaceutical industry 3. Price SUMMARY STATEMENT: Responses to this solicitation must include clear and convincing evidence of the offeror’s capability of fulfilling the requirement as it relates to the technical evaluation criteria. The quote must be for a firm-fixed-price total amount inclusive of all costs and fees. SUBMISSION INSTRUCTIONS (xii) All responses to this RFQ must be received by 3:00pm Eastern Time on September 6, 2023 and must reference the solicitation number cited above. Responses must be submitted via email to Claudia Ventola at claudia.ventola@nih.gov. (xiii) This is an RFQ. This request does not commit the Government to pay any costs incurred in the preparation of the submission of this quotation or to contract for supplies or service. Any representations and/or certifications attached to this RFQ must be completed by the quoter. (xiv) Responses to this RFQ must include sufficient information to establish the interested parties’ bona-fide capabilities of providing the product or service. 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. (xv) Responses must also include the UIE, the Taxpayer Identification Number (TIN), the certification of business size, the OLAW Animal Welfare Assurance number, a Vertebrate Animal Section (VAS), Institutional Animal Care and Use Committee (IACUC) project approval, the completed representation in FAR Provisions 52.204-24 and 52.204-26 (attached), and a quotation that includes: The total price (inclusive of all costs, fees, shipping, etc.), Study 1 Study 2 (option) Study 3 (option) Study 4 (option) 2. Individual prices for each listed line item, 3. Prompt payment discount terms, 4. Product or catalog number(s), 5. Product/service description, and 6. Any other information or factors that may be considered in the award decision. Such factors may include: special features required for effective program performance; trade-in considerations; probable life of the item selected as compared with that of a comparable item; warranty considerations; maintenance availability; and environmental and energy efficiency considerations. (xvi) For information about this RFQ, contact Kimberly Espinosa, Contracting Officer, at 301-827-3546 or kimberly.espinosa@nih.gov. (xvii) All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency. TERMS AND CONDITIONS, PROVISIONS, AND REPRESENTATIONS (xviii) The provision at HHSAR 352.270-5a, Notice to Offerors of Requirement for Compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals (December 18, 2015). The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (PHS Policy) establishes a number of requirements for research activities involving animals. Before awarding a contract to an offeror, the organization shall file, with the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), a written Animal Welfare Assurance (Assurance) which commits the organization to comply with the provisions of the PHS Policy, the Animal Welfare Act, and the Guide for the Care and Use of Laboratory Animals (National Academy Press, Washington, DC). In accordance with the PHS Policy, offerors must establish an Institutional Animal Care and Use Committee (IACUC), qualified through the experience and expertise of its members, to oversee the institution’s animal program, facilities, and procedures. Offerors must provide verification of IACUC approval prior to receiving an award involving live vertebrate animals. No award involving the use of animals shall be made unless OLAW approves the Assurance and verification of IACUC approval for the proposed animal activities has been provided to the Contracting Officer. Prior to award, the Contracting Officer will notify Contractor(s) selected for projects involving live vertebrate animals of the Assurance and verification of IACUC approval requirement. The Contracting Officer will request that OLAW negotiate an acceptable Assurance with those Contractor(s) and request verification of IACUC approval. For further information, contact OLAW at NIH, 6705 Rockledge Drive, RKL1, Suite 360, MSC 7982 Bethesda, Maryland 20892-7982 (E-mail: olaw@od.nih.gov; Phone: 301-496-7163). (End of provision) (xix) The clause at HHSAR 352.270-5b, Care of Live Vertebrate Animals (December 18, 2015). (a) Before undertaking performance of any contract involving animal-related activities where the species is regulated by the United Sates Department of Agriculture (USDA), the Contractor shall register with the Secretary of Agriculture of the United States in accordance with 7 U.S.C. 2136 and 9 CFR sections 2.25 through 2.28. The Contractor shall furnish evidence of the registration to the Contracting Officer. (b) The Contractor shall acquire vertebrate animals used in research from a dealer licensed by the Secretary of Agriculture under 7 U.S.C. 2133 and 9 CFR sections 2.1-2.11, or from a source that is exempt from licensing under those sections. (c) The Contractor agrees that the care, use, and intended use of any live vertebrate animals in the performance of this contract shall conform with the Public Health Service (PHS) Policy on Humane Care of Use of Laboratory Animals (PHS Policy), the current Animal Welfare Assurance (Assurance), the Guide for the Care and Use of Laboratory Animals (National Academy Press, Washington, DC) and the pertinent laws and regulations of the United States Department of Agriculture (see 7 U.S.C. 2131 et seq. and 9 CFR subchapter A, Parts 1-4). In case of conflict between standards, the more stringent standard shall govern. (d) If at any time during performance of this contract, the Contracting Officer determines, in consultation with the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), that the Contractor is not in compliance with any of the requirements and standards stated in paragraphs (a) through (c) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. Notice of the suspension may be communicated by telephone and confirmed in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer’s written notice of suspension, the Contracting Officer may, in consultation with OLAW, NIH, terminate this contract in whole or in part, and the Contractor’s name may be removed from the list of those contractors with Animal Welfare Assurances. Note: The Contractor may request registration of its facility and a current listing of licensed dealers from the Regional Office of the Animal and Plant Health Inspection Service (APHIS), USDA, for the region in which its research facility is located. The location of the appropriate APHIS Regional Office, as well as information concerning this program may be obtained by contacting the Animal Care Staff, USDA/APHIS, 4700 River Road, Riverdale, Maryland 20737 (E-mail: ace@aphis.usda.gov; website: http://www.aphis.usda.gov/wps/portal/aphis/ourfocus/animalwelfare). (End of clause) (xx) The provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference (Feb 1998). 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 www.acquisition.gov. The following provisions apply to this acquisition and are incorporated by reference: 1. The provision at FAR 52.204-7, System for Award Management (Oct 2018) 2. The provision at FAR 52.204-16, Commercial and Government Entity Code Reporting (Aug 2020) 3. The provision at 52.212-3, Offeror Representations and Certifications—Commercial Items (Nov 2020) (xxi) The clause at FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998). 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 www.acquisition.gov. In addition to the clauses checked in FAR 52.212-5 (attached), the following clauses also apply to this acquisition and are incorporated by reference: The clause at FAR 52.204-13, System for Award Management Maintenance (Oct 2018) The clause at FAR 52.204-18, Commercial and Government Entity Code Maintenance (Aug 2020) The clause at FAR 52.212-4, Contract Terms and Conditions – Commercial Items (Oct 2018) The clause at FAR 52.227-14, Rights in Data-General (May 2014). Under 52.227-14(c)(1), the contractor must obtain approval from the contracting officer to assert copyright in any data first produced in performance of this contract and published in academic, technical or professional journals, symposia proceedings, or similar works. Under 52.227-14(d)(2), the contractor must obtain approval from the contracting officer to use, release to others, reproduce, distribute, or publish any data first produced or specifically used by the contractor in the performance of this contract. The clause at HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015) The clause at HHSAR 352.223-70, Safety and Health (December 18, 2015) The clause at HHSAR 352.224-71 Confidential Information (December 18, 2015) (c)(2)(i) The publication or dissemination of the following types of information are restricted under this contract: 1) Information about the test article, including but not limited to, its structure, and 2) Results of the PK study. (c)(2)(ii) The reasons for restricting the types of information identified in subparagraph (i) are: 1) The test article is the proprietary intellectual property of the Government, and 2) Results of the PK study are commercial confidential information and may be used in the development of a future commercial therapeutic (xxii) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. 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. ATTACHMENTS (xxiii) The following are attached in full text: 1. Statement of Work 2. VAS Worksheet 3. The provision at FAR 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021) 4. The provision at FAR 52.204-26, Covered Telecommunications Equipment or Services- Representation (Oct 2020) 5. The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders–Commercial Items (Jun 2023) 6. The provision at FAR 52.212-1, Instructions to Offerors – Commercial Items (Mar 2023) 7. NIH Invoicing Instructions with IPP (Mar 2023) 8. FAR 52.217-7 - Option for Increased Quantity-Separately Priced Line Item