Developing humanized mouse models for NNMT and SULT1A1

COMPETITIVE COMBINED SYNOPSIS / SOLICITATION 75N95023Q00612 . TITLE: Developing humanized mouse models for NNMT and SULT1A1 (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 75N95023Q00612 and the solicitation is issued as a request for quotation (RFQ). This acquisition is for a commercial item 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 2023-04, effective June 2, 2023. (iv) The associated NAICS code is 541380 and the Small Business size standard is $19M. This requirement is Full and Open with no set-aside restrictions. (v) This requirement is for the following services: Biochemical testing of inhibitors from the NNMT and SUL1A1 projects have shown lower potency towards the human version of the enzyme vs the mouse version in biochemical and cellular assays. This has forced the use of large amounts of compound in animal studies without a true readout of the therapeutic potential in human. Thus, it is imperative that humanized mouse models are developed for dosing to determine the maximum tolerated dose and subsequent doses for PK/PD and efficacy experiments. The preferable approach to generate such humanized mice will be CRISPR knock in technology. See the attached Statement of Work (SOW) for complete requirement details. (vi) The Government anticipates a period of performance of 12 months from receipt of a general design to CRO from NCATS. NCATS anticipates, but does not guarantee, sending the test article within two (2) weeks after the date of award. A meeting will be scheduled to discuss the project after award. SPECIAL CONTRACT REQUIREMENTS (vii) Contractor Requirements. The services under this contract involves live vertebrate animals. Respondents must have: 1. An active OLAW Animal Welfare Assurance or complete the OLAW certification following NIH procedures after award. Please provide a statement as to your current OLAW Certification Standing. 2. 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. (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. 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: contact@example.gov; Phone: +1 (555) 000-0000). (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: contact@example.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: - The provision at FAR 52.204-7, System for Award Management (Oct 2018) - The provision at FAR 52.204-16, Commercial and Government Entity Code Reporting (Aug 2020) - FAR 52.212-1, Instructions to Offerors-Commercial Products and Commercial Services (Mar 2023) - 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), 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) 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 Products and Commercial Services (Dec 2022) - 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 Confidential Information (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 Items (Mar 2023) - NIH Invoice and Payment Provisions (xxii) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. (xxiii) The provision at FAR clause 52.212-2, Evaluation - Commercial Items (Nov 2021), applies to this acquisition and is included as an attachment. (xxiv) The Offerors to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications'Commercial Products and Commercial Services (Dec 2022), with its offer. If the offeror has completed FAR clause 52.212-3 at www.sam.gov, then the offeror does not need to provide a completed copy with its offer. EVALUATION AND AWARD (xxv) All responses to this RFQ must be received by 1:00pm Eastern Time on September 1, 2023 and must reference Solicitation Number 75N95023Q00612. Responses must be submitted electronically to Michelle Cecilia, Contracting Officer, at contact@example.gov. (xxvi) The Government will evaluate quotations or offers in accordance with FAR 13.106-2 and award a purchase order from this solicitation to the responsible offeror whose quote conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotes: a. Technical capability of the item offered to meet the Government requirement; b. Price; and c. Past performance [see FAR 13.106-2(b)(3)]. (xxvii) 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 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. Fax responses will not be accepted. (xxviii) ATTACHMENTS 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 Products and Commercial Services (Jun 2023) 6. The clause at 52.212-4, Contract Terms and Conditions-Commercial Products and Commercial Services Addendum 7. NIH Invoicing Instructions (March 2023) 8. Contractor Non-Disclosure Agreement