Inactive

COMBINED SYNOPSIS / SOLICITATION 75N95023Q00536 TITLE: Maximally tolerated dose (MTD) and 14-Day Dose Range-Finding (DRF) Toxicity Study in Male and female rats for NCATS ETB. (i) This is a combined s... COMBINED SYNOPSIS / SOLICITATION 75N95023Q00536 TITLE: Maximally tolerated dose (MTD) and 14-Day Dose Range-Finding (DRF) Toxicity Study in Male and female rats for NCATS ETB. (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 75N95023Q00536 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 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 Sciences (NCATS), intends to negotiate and award a purchase order without providing for full and open competition (including brand-name) to Pharmaron, Inc., 201 E Jefferson St., Louisville, KY 40202-1246. To ensure consistency among data, the current study must be conducted by the same vendor that conducted prior studies. Therefore, to ensure the continuity of science, this acquisition is restricted to Pharmaron, Inc. DESCRIPTION (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. The National Center for Advancing Translational Sciences (NCATS) is a part of the National Institutes of Health (NIH), which mission it 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. The Early Translational Branch (ETB) is tasked with identifying and developing novel small molecule leads for improving human health. In pursuit of this goal, the Center has a strong internal trans-disciplinary team of scientists who continually discover novel small molecules to modulate molecular targets to identify novel treatment strategies. As such, discovering lead molecules that could serve as starting points for therapeutic development for patients is a key part of discovery. At ETB we have developed a small molecule inhibitor to combine with immunotherapy for treating advanced hepatocellular carcinoma. It is essential to identify possible toxicity in an earlier stage before filing IND enabling studies. Therefore, we would like to analyze one compound in a 14-day tox study and determine the Maximum tolerability dose in rats. See the attached Statement of Work (SOW) for complete requirement details. (vi) The Government anticipates a period of performance of eight (8) weeks from receipt of test article compounds from NCATS. NCATS anticipates, but does not guarantee, sending the test article within two (2) weeks after the date of 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 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. EVALUATION AND AWARD (x) The anticipated award date is September 1, 2023. (xi) The Government plans to award a fixed-price purchase order resulting from this solicitation. The resulting award will be made to Pharmaron, Inc. 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) Technical response to the SOW b) Meeting the contractor requirements listed in Paragraph (vii) c) Acceptability of the Vertebrate Animal Section (VAS) 2. Past Performance 3. Price SUBMISSION INSTRUCTIONS (xii) All responses to this RFQ must be received by 3:00pm Eastern Time on August 9 ,2023 and must reference the solicitation number cited above. Responses must be submitted via email to Samson Shifaraw at samson.shifaraw@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 Dun & Bradstreet Number (DUNS), 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: 1. The total price (inclusive of all costs, fees, shipping, etc.), 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 Samson Shifaraw, Contracts Specialist, at 301-480-7153 or samson.shifaraw@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 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 HHSAR 352.223-70, Safety and Health (December 18, 2015) The clause at HHSAR 352.224-71 Confidential Information (December 18, 2015) (xxii) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. (xxiii) 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 (Mar 2023)