ASSESS INHIBITION ACTIVITY OF 2 TEST ARTICLES (TA) FOR GENERAL EFFLUX AND UPTAKE TRANSPORTERS

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AMMENDMENT 1 - Dated 06/08/2023

The due date for quotes is hereby extended to Thursday June 15, 2023 @ 1:00 PM EST.

ALL OTHER TERMS AND CONDITIONS REMAIN UNCHANGED.

COMPETITIVE

COMBINED SYNOPSIS / SOLICITATION

Title: Assess inhibition activity of 2 test articles (TA) for general Efflux and Uptake Transporters

(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 75N95023Q00357 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 2023-02 with effective date March 16, 2023.

(iv) The associated NAICS code 541380 and the small business size standard $19M. 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.

To support drug development for Mitragynine and its major metabolite 7-hydroxymitragynine, the inhibition and substrate potential of the test article for major human transporters needs to be assessed

(vi) The purpose of this requisition is to assess inhibition activity and substrate potential of 2 test articles (TA) for each human transporter individually, using study designs in compliance with FDA recommendations., 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 anJune 30, 2023 – October 29, 2023. a final deliverable is final report approved by NCATS must be submitted prior to pinvoicing.

PROVISIONS, CLAUSES, AND OTHER TERMS AND CONDITIONS

(vii) The provision at FAR clause 52.212-1, Instructions to Offerors – Commercial Items (Tailored), applies to this acquisition and is attached in full text.

(viii) 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.

(ix) Offerors are to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Items, with offers.

(x) 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 (Nov 2021)

FAR 52.204-26, Covered Telecommunications Equipment or Services-Representation (Oct 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)

NIH Invoice and Payment Provisions

The following provisions and clauses apply to this acquisition and are attached in full text:

(xi) 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.

(xii) The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items, applies to this acquisition and is attached in full text.

SUBMISSION INSTRUCTIONS

(xiii) 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 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 responses must be received by 03:00 PM, Eastern Time on June 8, 2023, and reference Solicitation Number 75N95023Q00357 . Responses must be submitted by email to the Contract Specialist at claudia.ventola@nih.gov.

(xiv) The name and telephone number of the individual to contact for information regarding the solicitation:

Claudia Ventola, Contract Specialist, 301-496-0870, claudia.ventola@nih.gov.

ATTACHMENTS

1. Statement of Work


2. FAR 52.212-4 Addendum


3. FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders–Commercial Items (Mar 2023)


4. Invoice and Payment Provisions

Attachments/Links