Inactive

AMENDMENT No.: 01, from August 17, 2021 QUOTATION DUE DATE: 09:00 a.m., Eastern Time, on August 20, 2021 (Remains Unchanged) This amendment No.: 01 is to revise the title of project on the Combined Sy... AMENDMENT No.: 01, from August 17, 2021 QUOTATION DUE DATE: 09:00 a.m., Eastern Time, on August 20, 2021 (Remains Unchanged) This amendment No.: 01 is to revise the title of project on the Combined Synopsis/Solicitation and Statement of Work (SOW). This amendment No.: 01 is attached in full (G Mod_1_75N95021Q00319) END OF AMENDMENT No.: 01, from August 17, 2021 (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 75N95021Q00319 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 CBR International Corp (CBRI) , 2905 Wilderness Place, Suite 202, Boulder, CO 80301 for Regulatory Support for FDA IND Meeting: QGRFT for the Prevention of SARS-CoV-2 Infection. 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 based on the vendor’s intimate working knowledge of QGRFT and the relevant FDA feedback to date. NCATS engaged CBRI on a previous competitive requirement to support the earlier pre-IND activities. CBRI then submitted the full IND package to enable the collaborators at ULRF to begin clinical trials. CBRI have an intimate working knowledge of QGRFT and the relevant FDA feedback to date. The requested support for this IND conversion will allow the NCATS collaborators at UPitt to begin trials, and is a logical follow-on to the prior regulatory support that NCATS has acquired from CBRI. They are uniquely positioned to support the ongoing development of QGRFT for treatment of SARS-CoV-2 with no need for additional preparation time or background research. (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2021-06, with effective date July 12, 2021. (iv) The associated NAICS code 541990 and the small business size standard $16.5M. There are no set-aside restrictions for this requirement. DESCRIPTION (v) The National Center for Advancing Translational Sciences (NCATS) is a part of the National Institutes of Health (NIH), with a mission 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 NCATS Therapeutic Development Branch (TDB) forms collaborative research partnerships with external investigators with the goal of “de-risking” therapeutic candidates and novel technologies to speed their development toward clinical evaluation. TDB is collaborating with research partners from the University of Louisville Research Foundation (ULRF) and the University of Pittsburgh (UPitt) to develop QGRFT as a preventative therapeutic against SARS-CoV-2 Infection in humans. This requirement represents the continuity of the work from the pre-IND meeting with the FDA, which informed the further pre-clinical development of QGRFT to combat the novel coronavirus (COVID-19) pandemic. The objective of this acquisition is to provide regulatory expertise and operational support for the conversion of an existing IND package from ULRF to enable further trials at UPitt. (vi) The NCATS Therapeutic Development Branch (TDB) collaborates with external research partners (collaborators) to develop novel treatments for diverse medical conditions. The purpose of this acquisition is to provide regulatory and operational support for the development of Q-Griffithsin (Q-GRFT), which may have therapeutic value as a preventative against SARS-CoV-2, the causative agent of the current COVID-19 pandemic. The QGRFT project requires preparation and submission of a revised Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) to obtain clearance to extend clinical trials. Because TDB does not have in-house regulatory expertise to support the technical requirements of IND application activities, a contractor with this experience is required, as per the attached STATEMENT OF WORK. (vii) The Government anticipates award of a firm fixed-price purchase order for this requirement, and the anticipated period of performance is twelve (12) months from the date of contract award. The anticipated award date is August 23, 2021. TERMS AND CONDITIONS, PROVISIONS, AND REPRESENTATIONS (viii) The provision at FAR clause 52.212-1, Instructions to Offerors – Commercial Items (Jul 2021), applies to this acquisition. (ix) The Quoters are to include a completed copy of the attached provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Feb 2021), with its quote. If applicable, the following FAR Provision Representations and Certifications must be completed, signed, and returned by the quoters with its quote pursuant to FAR 4.2103 Procedures. FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (OCT 2020) FAR 52.204-26 Covered Telecommunications Equipment or Services-Representation (OCT 2020) (x) The clause at FAR 52.212-4, Contract Terms and Conditions-Commercial Items (Oct 2018) applies to this acquisition. Addendum to this FAR clause applies to this acquisition and is attached. The additional contract terms and conditions are as follows. FAR 52.212-4 Addendum – Supplier License Agreements, attached. FAR 52.212-4(g), Invoice, is supplemented by: NIH Invoice and Payment Instructions (Rev. Feb 2021) (xi) The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (Jul 2021) applies to this acquisition and is attached in full text. (xii) The following additional contract requirement(s) or terms and conditions as determined by the contracting officer are necessary for this acquisition and consistent with customary commercial practices. 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 (Jul 2016) FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Oct 2020) FAR 52.204-26 Covered Telecommunications Equipment or Services-Representation (Oct 2020) FAR 52.212-1, Instructions to Offerors-Commercial Items (Oct 2018) FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Oct 2018) 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 (Jul 2016) FAR 52.212-4, Contract Terms and Conditions-Commercial Items (Oct 2018). Addendum to this FAR clause applies to this acquisition and is attached. HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015) HHSAR 352.224-71, Confidential Information (December 18, 2015) (xiii) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. This is a COVID-19 action and any resultant award shall include the following language: Health and Human Services (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 EVALUATION (xiv) The Government plans to award a fixed-price purchase order resulting from this solicitation. The resulting award will be made to CBR International Corp, provided it is technically acceptable and at a fair and reasonable price. If multiple quotations are received, the Government may perform a comparative evaluation of responses in accordance with FAR 13.106-2(b) to select the contractor that is best suited and provides the best value, considering the evaluation factors in this solicitation. The evaluation shall compare: Technical capability of the item offered to meet the Government requirement in accordance with the salient characteristics specified in the Statement of Work, Price, and Past Performance as defined under FAR 13.106-2(b)(3). An award will be made to the vendor whose quotation is most advantageous to the Government. The government reserves the right to select a response that provides benefit to the government that exceeds the minimum; the government is not required to select a response that exceeds the minimum; responses may exceed the requirements; each response must meet the solicitation requirement statement at a minimum; and the government is not requesting or accepting alternate proposal(s). SUBMISSION INSTRUCTIONS (xv) This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. 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. 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. All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency. The Dun & Bradstreet Number (DUNS), 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 responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency. All responses must be received by 9:00 a.m., Eastern Time, on August 20, 2021 and reference Solicitation Number 75N95021Q00319. Responses must be submitted by email to Renato Gomes, Contract Specialist, renato.gomes@nih.gov, tel. (301) 451-2596. (xvi) The name and telephone number of the individual to contact for information regarding the solicitation: Renato Gomes Contract Specialist Phone: (301) 451-2596 Email: renato.gomes@nih.gov ATTACHMENTS (xvi) Attachments: Statement of Work (SOW) FAR 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Oct 2020) FAR 52.204-26, Covered Telecommunications Equipment or Services-Representation (Oct 2020) FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Feb 2021) FAR 52.212-4, Addendum – Supplier License Agreements FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders–Commercial Items (Jul 2021) NIH Invoice and Payment Provisions (Rev. February 10, 2021)