Testing of NCGC00846044 Compound in the SUGEN-Hypoxia Model of Pulmonary Hypertension
TITLE: Testing of NCGC00846044 Compound in the SUGEN-Hypoxia Model of Pulmonary Hypertension (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 75N95022Q00532 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 teshold. The Government anticipates award of a firm fixed-price purchase order for this acquisition, and the anticipated award date is on or around August 31, 2022. (iii) The solicitation document and incorporated provisions and clauses are those in effect tough Federal Acquisition Circular (FAC) Number 2022-07 dated August 10, 2022. (iv) This acquisition is full and open with no set-aside restrictions. The associated NAICS code is 541380 and the small business size standard is $16.5 million. DESCRIPTION (v) This acquisition is for the following list of contract line item numbers (CLINs) and items, quantities, and units of measure (including option(s), if applicable): CLIN 01: Testing of NCGC00846044 Compound in the SUGEN-Hypoxia Model of Pulmonary Hypertension (vi) The statement of work with a description of the services to be performed is included as Attachment 1 to this Solicitation. (vii) The period of performance will be twelve (12) months. PROVISIONS, CLAUSES, AND OTHER TERMS AND CONDITIONS (viii) The provision at FAR clause 52.212-1, Instructions to Offerors – Commercial Products and Commercial Services applies to this acquisition. (ix) The Government will perform a comparative evaluation of responses in accordance with FAR 13.106-2(b)(3) and award a purchase order from this solicitation to the responsible offeror whose response meets the solicitation’s requirements and, as a whole, will be most advantageous to the Government, price and other factors considered. The evaluation will compare: Technical Capability of the service to meet the Government requirement, Price, and 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. (x) Offerors are to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Products and Commercial Services, with offers. Offerors are also to complete the attached provision at FAR 52.204-26, and FAR 52.204-24 if applicable, with their offers. Alternatively, these representations and certifications must be completed within Offerors’ active SAM.gov registrations at the time of the Government’s receipt of a response to this Solicitation, and they shall apply to their response and be relied upon by the Government. (xi) 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) 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 52.204-21, Basic Safeguarding of Covered Contractor Information Systems (Nov 2021) 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 352.223-70, Safety and Health (December 18, 2015) The following provisions and clauses apply to this acquisition and are attached in full text: 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) Invoice and Payment Provisions (Vendor Has Transitioned to IPP). Addendum to these invoicing instructions applies to this acquisition as follows: the Contractor will invoice for payment upon completed deliveries. (xii) The clause at FAR 52.212-4, Contract Terms and Conditions-Commercial Products and Commercial Services, applies to this acquisition and an addendum is attached in full text. (xiii) The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Products and Commercial Services, applies to this acquisition and is attached in full text. (xiv) 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 tough 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) (xv) 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 tough 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) tough (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) (xvi) The services under this acquisition are subject to Free Trade Agreements. SPECIAL CONTRACT REQUIREMENTS (xvii) Contractor Requirements: The services under this contract involves live vertebrate animals. Offerors must have: An active Animal Welfare Assurance (Assurance) from the NIH Office of Laboratory Animal Welfare 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. (xviii) Animal Welfare: All work 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 work 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. (xix) Vertebrate Animals Section (VAS): The VAS should be no more than two (2) pages and must address the following criteria: 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. 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). Minimization of Pain and Distress. Describe the interventions including analgesia, anesthesia, sedation, palliative care and humane endpoints to minimize discomfort, distress, pain and injury. 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. SUBMISSION INSTRUCTIONS (xx) Responses to this solicitation must include clear and convincing evidence of the offeror’s capability of providing the service. The quote must be for a firm-fixed-price total amount inclusive of all costs and fees. The Unique Entity Identifier (UEI), 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 responses must be received by 05:00 PM, EDT on August 25, 2022, and reference Solicitation Number 75N95022Q00532 Responses must be submitted by email to the Contracting Officer at mark.mcnally@nih.gov. All Offerors must include a Vertebrate Animal Section (VAS) with their quotation. (xxi) The name and telephone number of the individual to contact for information regarding the solicitation: Mark McNally, Contracting Officer, 301-827-5869, mark.mcnally@nih.gov.
75N95022Q00532 Department of Health and Human Services National Institutes of Health National Institute on Drug Abuse
8/18/22, 5:40 PM Testing of NCGC00846044 Compound in the SUGEN-Hypoxia Model of Pulmonary Hypertension
This is a Small Business 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 small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition; and Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. Background: The National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) focuses on getting more treatments to more patients more quickly. Several thousand genetic diseases affect humans, of which only about 500 have any treatment. A novel drug, device or other intervention can take about 14 years and $2 billion to develop, with a failure rate exceeding 95 percent. NCATS is directly addressing this problem by discovering new technologies and other approaches that could greatly accelerate the process of developing and deploying solutions that can be used by all translational researchers. The NCATS Early Translation Branch (ETB) is tasked with identifying and developing novel small molecule leads against a wide spectrum of human disease targets, which it accomplishes by screening thousands of small molecules in collaboration with both intra-and extramural researchers. In pursuit of this goal, the Center has a strong internal transdisciplinary team of scientists who continually discover novel small molecules for application against a wide range of human diseases. As an ongoing high priority project for ETB we are in need of testing NCGC00846044 in the mouse SUGEN-Hypoxia model of pulmonary hypertension. NCGC00846044 was developed tough NIH Molecular Libraries Program that set out to discover, optimize, and assess biological activity of small molecules agonists of human relaxin receptor 1 (RXFP1). The natural peptide hormone relaxin targets the class B G-protein coupled receptor RXFP1 but has limited utility clinically because of a short half-life in vivo. Optimized compounds from this series are potent and highly selective RXFP1 agonists with similar efficacy as the natural hormone in functional assays. To further understand the effect of NCGC00846044 ETB is in need of studying NCGC00846044 in a hypertensive mouse model to assess RXFP1 agonist effects on fibrosis, heart compliance, and pulmonary function. The SUGEN-Hypoxia model of pulmonary hypertension is the established standard animal model for this biology and is predictive of human efficacy. Purpose and Objectives: Testing services to assess NCGC00846044 in a SUGEN-Hypoxia model of pulmonary hypertension to assess fibrosis, heart compliance, and pulmonary function in mice, using humanized-RXFP1 mice. Project requirements: Possess a Public Health Service (PHS) Animal Welfare Assurance (Assurance) on file with the NIH Office of Laboratory Animal Welfare (OLAW) Procure and have access to 72 knock-in human-RXFP1 mice and source breeding mice Be able to house mice for 90 days in 15 cages (21 days quarantine and 69 days mouse model) Do echocardiography in 36 mice Data analysis to assess fibrosis, heart compliance, and pulmonary function Provide invasive hemodynamic measurements for pulmonary hypertension in 72 mice Conduct histology, gene, and protein expression studies and provide data Provide 72 mice, by procuring breeding knock-in human-RXFP1 mice; house and administer NCGC00846044 to mice; study effects of NCGC00846044 on fibrosis, heart compliance, and pulmonary function using echocardiography, invasive hemodynamic measurements, and histology, gene, and protein expression studies. Anticipated period of performance: Twelve (12) months. Other important considerations: Interested companies must demonstrate they have a Public Health Service (PHS) Animal Welfare Assurance (Assurance) on file with the NIH Office of Laboratory Animal Welfare (OLAW). In case domestic sources are available and capable of fulfilling the Government’s need, and a future solicitation is published, the Government will use evaluation preferences in accordance with FAR 25. Capability statement /information sought. Companies that believe they possess the capabilities to provide the required services should submit documentation of their ability to meet each of the project requirements to the Contracting Officer. The capability statement must specifically address each of the project 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. One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2” x 11” paper size, with 1” top, bottom, left and right margins, and with single or double spacing. The information submitted must be in and outline format that addresses each of the elements of the project requirement and in the capability statement /information sought paragraphs stated herein. A cover page and an executive summary may be included but is not required. The response is limited to ten (10) page limit. The 10-page limit does not include the cover page, executive summary, or references, if requested. All responses to this notice must be submitted electronically to the Contract Specialist and Contracting Officer. Facsimile responses are NOT accepted. The response must be submitted to Mark McNally, Contracting Officer, at e-mail address mark.mcnally@nih.gov. The response must be received on or before 03:00 PM EDT, July 25, 2022. “Disclaimer and Important Notes: 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 presolicitation synopsis and solicitation may be published in www.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).”
75N95022Q00451 Department of Health and Human Services National Institutes of Health National Institute on Drug Abuse
7/18/22, 3:03 PM