SOLICITATION NOTICE
Q -- In vitro transporter assessment for GS-441524. This is a COVID-19 related activity
- Notice Date
- 7/27/2021 12:57:48 PM
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NIDA Bethesda MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- 75N95021Q00332
- Response Due
- 8/3/2021 6:00:00 AM
- Archive Date
- 08/18/2021
- Point of Contact
- Renato Gomes, Phone: 3014512596
- E-Mail Address
-
renato.gomes@nih.gov
(renato.gomes@nih.gov)
- Description
- �(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 75N95021Q00332 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. (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 541380 and the small business size standard $16.5M. This requirement is not set-aside for small business concerns. 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. COVID-19 is caused by a beta coronavirus called Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Remdesivir is a broad-spectrum antiviral medication developed by Gilead Sciences and approved by the FDA for the treatment of COVID-19. It must be administered intravenously which limits its utility, especially in the outpatient population. Other issues that prevent its widespread use as a treatment for COVID-19 include: 1) difficulty on the synthesis, limiting large scale production; 2) efficient metabolism by the liver, which prevents systemic exposure after oral dosing; 3) it is a pro-drug, and the cells that metabolize it into an active drug (e.g., hepatocytes, macrophages) may not be the same as the cell types most susceptible to infection and tied to COVID-19 progression (e.g., pneumocytes). GS-441524, the parent nucleoside of remdesivir, has similar efficacy to remdesivir in vitro. GS-441524 is one of major circulating metabolites of remdesivir, and its plasma levels in human after dosing remdesivir are at or above the efficacious levels determined in vitro. The bioavailability of orally administered GS-441524 across species was determined by Therapeutic Development Branch (TDB), supporting its further development as a potential oral drug. GS-441524 is a stable crystalline compound with good physical properties for formulation. In addition, the 3-step synthesis of GS-441524 makes it suitable for large scale production. Because of these advantages, and to support the drug development for this compound, information on whether GS-441524 is a substrate for reported nucleoside analog transporters needs to be assessed.� Results obtained from this study will help to understand the elimination mechanism for GS-441524. This activity is related to the NIH response to the current COVID-19 pandemic. (vi)������ The purpose of this requisition is to conduct in vitro transporter assessment for GS-441524 with a contract research organization (CRO). The project centers around assessing if GS-441524 is a substrate for reported nucleoside analogs, as per the attached STATEMENT OF WORK. (vii)����� The Government anticipates award of a firm fixed-price purchase order for this acquisition, and the anticipated the period of performance to be three (3) months. The anticipated award date is August 6, 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 (Aug 2020) 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 (Jul 2021) FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Feb 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) 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) (xiii)���� The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. 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 (xiii)���� 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 will compare: Technical capability of the item offered to meet the Government requirement in accordance with the salient characteristics specified in the Purchase Description, 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. 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 (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. 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 3, 2021, and reference Solicitation Number 75N95021Q00332. Responses must be submitted by email to Renato Gomes, Contract Specialist, renato.gomes@nih.gov, tel. (301) 451-2596. (xv)����� 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. Feb 2021)
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/5305ed59e2844f53996b48a0feef8c9d/view)
- Place of Performance
- Address: Rockville, MD 20850, USA
- Zip Code: 20850
- Country: USA
- Zip Code: 20850
- Record
- SN06074627-F 20210729/210728203728 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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