D.CSS_75N95023Q00520.pdf

COMPETITIVE

COMBINED SYNOPSIS / SOLICITATION

Title: Assess Cytochrome P450 (CYP450) enzymes induction potential of 2 test articles (TA)

(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 75N95023Q00520 and the solicitation is issued as a request for quotation.

This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplif ied Acquisition Procedures;

FAR Subpart 13.5—Simplif ied Procedures for Certain Commercial Items; and FAR Part 12—Acquisition of Commercial Items, and is not expected to exceed the simplif ied acquisition threshold.

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2023-04, with effective date June 2023.

(iv) The associated NAICS code 541714- Research and Development in Biotechnology (except Nanobiotechnology) and the small business size standard is 1000 employees.

There are no set-aside restrictions for this requirement.

(v) This requirement is for the following commercial services: Assess Cytochrome P450 (CYP450) enzymes induction potential of 2 test articles (TA)

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 CYP450 induction potential of the test articles for major human CYP450 needs to be assessed

NCATS is looking to Assess CYP450 induction potential using study designs in compliance with FDA recommendations of 2 test articles (TA) for: CYP1A2 (AhR mediated), CYP2B6 (CAR mediated) and CYP3A4 (PXR mediated). CYP2C may be evaluated as a follow-up assay upon positive results for CYP3A4.

(vi) SPECIFIC REQUIREMENTS

LEVEL OF EFFORT:

Scientist who are capable to run the human CYP450 induction studies. The effort includes to conduct in vitro cell based assays, data analysis and report writing.

GOVERNMENT RESPONSIBILITIES

NCATS will review study protocol, provide the test article, review experiment data, and review/approve study report.

(vii) The Government anticipates award of a firm fixed-price purchase order for this acquisition, and the anticipated period of performance of 12 months after contractor receipt of order (ARO). Performance shall be FOB Destination and shall be delivered to 9800 Medical Center Drive, Rockville, MD, 20850 between the hours of 8:00 am and 5:00 pm, Eastern Standard Time, Monday through Friday (except on Federal

(viii)

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 identif ier 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 52.212-1, Instructions to Offerors-Commercial Items (Oct 2018)

• FAR 52.212-3, Offeror Representations and Certif ications-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:

(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.

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

• FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders--Commercial Items (Oct 2018)

• NIH Invoice and Payment Provisions (2/2014)

(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;

b. Price; and

c. Past performance [see FAR 13.106-2(b)(3)].

The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

(x) The Offerors to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certif ications-Commercial Items, with its offer.

(xi) The clause at FAR 52.212-4, Contract Terms and Conditions-Commercial Items, applies to this acquisition. Addendum to this FAR clause applies to this acquisition and is attached.

(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.

(xiii) 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.

DELIVERY OR DELIVERABLES

1. CYP450 induction studies protocol and experiment results

2. Final study reports

REPORTING REQUIREMENTS

Final report should include experiment protocol, study date and site, materials used, CYP450 induction results, data interpretations, and conclusions.

KEY PERSONNEL

Cell biologist, CYP450 induction study expert

INFORMATION SYSTEM SECURITY PLAN

Vendor’s SOP on information system security

DATA RIGHTS

NCATS owns the right on the study data for mitragynine and 7-OH-mitragynine.

Section 508—ELECTRONIC AND INFORMATION TECHNOLOGY STANDARDS Vendor’s SOP on the electronic and information technology standards.

PUBLICATIONS AND PUBLICITY

No publication on this study is allowed without the permission from NCATS.

CONFIDENTIALITY AND INFORMATION

All data generated from this study by the awarded vendor should not be released, disclosed, or published without the permission from NCATS.

(xiv) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement.

(xv) Responses to this solicitation must include clear and convincing evidence of the offeror’s capability of fulf illing 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 Identif ication Number (TIN), and the certif ication 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 questions must be received by 12:00PM., Eastern Daylight/Standard Time, on August 14, 2023, and reference Solicitation Number 75N95023Q00520 Questions may be submitted electronically to Chandani Hangilipola, Contract Specialist, at chandani.hangilipola@nih.gov

All quotations must be received by 3:00 PM, Eastern Daylight/ Standard Time, on August 16, 2023.and reference Solicitation Number 75N95023Q00520.

Responses must be submitted electronically to Chandani Hangilipola, Contract Specialist at chandani.hangilipola@nih.gov

Fax responses will not be accepted.

http://www.sam.gov/