Inactive

NON-COMPETITIVE COMBINED SYNOPSIS / SOLICITATION Title: In vitro and in vivo study of ROC-325 and its analogs in live SARS-CoV-2 models in support of COVID 19 research. (i) This is a combined synopsis... NON-COMPETITIVE COMBINED SYNOPSIS / SOLICITATION Title: In vitro and in vivo study of ROC-325 and its analogs in live SARS-CoV-2 models in support of COVID 19 research. (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 75N95022Q00477 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. 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 Texas Biomedical Research Institute, P.O. Box 760549, San Antonio, TX 78245-0549 for testing of ROC-325 or its analogs in in vitro and in vivo models of live SARS-CoV-2. This acquisition is conducted as non-competitive for a commercial item or service and is conducted pursuant to FAR 13.106-1(b)(1). The rationale for the brand-name justification is that no other vendor has the specific characteristics necessary for this service, including: 1) BSL-3 facilities and methods for handling of SARS-CoV-2 2) Expertise using the k18-hACE2 transgenic mouse model 3) Expertise handling and infection animals with SARS-CoV-2 4) Harvesting and cryopreservation of tissues for MS analysis 5) Ability to conduct live virus study under treatment with small molecules 6) Knowledge of virology and SARS-CoV-2 entry mechanisms 7) Access to SARS-CoV-2 WA1, Delta and Omicron strains 8) Expertise in using IVIS technology to image animals infected with rSARS-CoV-2-mCherry-Nluc or an equivalent tagged virus 9) Expertise in in vitro methods to analyze SARS-CoV-2 infection such as viral protein AlphaLISA, HTRF, imaging or RT-qPCR. (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2022-06, with effective date May 26, 2022. (iv) The associated NAICS code 541714 and the small business size standard 1,000 employees. This requirement is full and open with no set-aside restrictions. (v) This requirement is for the following services: In vitro and in vivo study of ROC-325 and its analogs in live SARS-CoV-2 models. Live viral titers of the following: SARS-CoV-2 WA-1, Delta, Omicron and rSARS-CoV-2mCherry-Nluc tagged virus. (vi) SARS-CoV-2 has presented a major ongoing public health challenge to the entire world. Although effective therapeutics to treat the virus have finally begun to emerge it is unclear how long their efficacy will last. Historically single agent virus targeted therapeutics have quickly lost their efficacy due to mutation acquired resistance. Therefore, it is important that the Government continues the development of other types of SARSCoV-2 inhibitors. One option is to target the entry mechanism of the virus. Previous work done by NCATS has demonstrated the compounds that effect lysosomal function, such as ROC-325, are able to block viral entry in vitro. A pilot in vivo study conducted in collaboration with the Texas Biomedical Research Institute (TBRI) also showed promising efficacy in vivo using the k18-hACE2 mouse model. The objective of this study is to determine the efficacy of ROC325 and its analogs against live SARS- CoV-2 in vitro and in vivo. Additionally, ROC-325 or an active analog will be paired with other approved and clinically promising therapeutic agents in order to develop combination therapies that could better address the emergence of mutation acquired resistant strains of the SARS-CoV-2 virus. This study will be divided into two phases: in vitro and in vivo. The in vitro study will: 1) Determine which analogs of ROC-325 have improved efficacy against SARS-CoV-2 using a live virus homogeneous time resolved fluorescent (HTRF) assay that was previously developed by NCATS in partnership with TBRI 2) Use matrix screening to determine which therapeutics demonstrate synergy with ROC-325 against SARSCoV-2 3) Validate efficacy using orthogonal experiments such as RT-qPCR, AlphaLISA and immunofluorescence The in vivo study will: 1) Determine the efficacy of ROC-325 single and combination treatments in the live virus k18-hACE2 mouse model 2) Confirm efficacy in the golden Syrian hamster model 3) Evaluate the phenotype presented in infected animals and how this phenotype is resolved by treatment (vii) The Government anticipates award of a firm fixed-price purchase order for this acquisition, and the anticipated period of performance is 12 months. The in vitro phase will be performed over a period of 3-6 months after the PO and the second in vivo phase will be performed for 3-6 months after the in vitro phase is completed. The Government will provide TBRI with: 1) Compound plates for ROC-325, derivatives and other compounds 2) HTRF assay reagents 3) AlphaLISA assay reagents 4) ATP Lite reagents 5) 384 well white solid bottom plates 6) Consumables for auto-pipettors 7) Compound vehicle for in vivo study Reporting Requirements: TBRI will deliver to Government a complete data package including spreadsheets of any raw data and analysis in the specific format requested by Government staff. TBRI will provide summaries and documentation of protocols to Government staff as necessary. Meetings will be conducted on a regular basis to go over generated data and adjust protocols and conditions of the study. Additional meetings may be held as requested by either Government or TBRI. Data Rights All data used and analyzed is the sole property of the government. (viii) The additional instructions to offerors are as follows: 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) 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) 52.212-4 Contract Terms and Conditions—Commercial Products and Commercial Services. (Nov 2021) Addendum to this FAR clause applies to this acquisition and is attached. 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) NIH Invoice and Payment Provisions (Feb 2021) (ix) 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; and b. Price (x) The Offerors to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Items (Nov 2021), 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. (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) There are no additional contract requirement(s) or terms and conditions applicable to this acquisition. (xiii) 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. (xiv) Responses to this solicitation must include sufficient information to establish the interested parties’ bona-fide capabilities of providing the product or service. The price quote shall include: unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s), product description, and any other information or factors that may be considered in the award decision. Such factors may include: past performance, 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. Respondents that believe that they are manufacturers or authorized resellers of the brand-name product specified in this announcement must provide, as part of their response: (a) product, catalog, model, and/or part number(s); (b) product description; (c) all relevant information and documentation that the item(s) offered meets the salient physical, functional, or performance characteristics as specified in the purchase description; quantity; estimated price or cost; shipping, handling, and/or installation charges; and delivery date after receipt of order. 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 price proposal must include the labor categories, an estimate of the number of hours required for each labor category, fully loaded fixed hourly rate or each labor category, breakdown and rationale for other direct costs or materials, and the total amount. 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 quotations must be received by 4:00 p.m., Eastern Standard Time, on August 11, 2022, and reference Solicitation Number 75N95022Q00477. Responses must be submitted electronically to Samson Shifaraw, Contract Specialist, at samson.shifaraw@nih.gov. Fax responses will not be accepted.