Attachment_No._05-Sole_Source_Justification-Promega_P450-Glo.pdf

Revised10/31/2016

FAR Subpart 13.106-1(b)

SOLE-SINGLE SOURCE (including Brand-Name) JUSTIFICATION

1. Identification of the Agency and Contracting Activity.

a. Federal Agency and Contracting Activity.

Department of Health and Human Services (DHHS) National Institute of Health (NIH) National Center for Advancing Translational Sciences (NCATS)

b. Sponsoring Organization.

National Center for Advancing Translational Sciences (NCATS) Division of Preclinical Innovation (DPI) Tox21 group

c. Project Officer Information.

Project Officer Name- Anna Rossoshek Mailing Address- 9800 Medical Center Dr, Building B, Rockville, MD 20850 E-mail Address- asirota@mail.nih.gov Telephone Number- 301-312-3156

2. Project Description.

a. Name of Item or Project Title.

P450-Glo™ assay systems

b. Description of the Item or Service.

Tox21, an inter-federal collaboration is mainly aimed to develop better toxicity assessment methods by running in vitro assay screenings against 10,000 compound collection in a high throughput format in order to eliminate the traditional animal toxicology studies. Currently Tox21 group seeks to purchase P450-Glo™ assay systems from Promega Corporation. These assays can be used for testing the effects of Tox21 chemical entities on cytochrome P450 enzyme activities.

3. Market Research (see FAR Part 1 0).

Market Research was conducted and the results of market research are detailed in the attached market research document.

4. Acquisition Type.

This acquisition exceeds $3,500 and is not expected to exceed $250,000, and is conducted in accordance with FAR Part 13—Simplified Acquisition Procedures.

Solicitation No. NIHDA201800410

FAR Subpart 13.106-1(b)

5. Acquisition Authority. This acquisition is conducted under the authority of the Federal Acquisition Regulations (FAR) Subpart 13.106-1 (b) Soliciting from a single source. (1) For purchases not exceeding the simplified acquisition threshold, contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, or industrial mobilization).

6. Justification Rationale.

Only one source is available:

I hereby determine that the assay kits listed herein is available from only one source, and competition is precluded for the reasons indicated below. There are no substitutes available.

This acquisition is restricted to:

Promega Corporation 2800 Woods Hollow Rd Madison, WI 53711-5399 www.promega.com Custom Order Phone: 800-356-9526

Charlie Sheen Phone: +1 608 274 1181 ext. 1780 charlie.sheen@promega.com

Brand-name or Items peculiar to one manufacturer:

The essential characteristics of the P450-Glo™ assay systems that limit the availability to a sole source are the only luminescent methods for measuring cytochrome P450 CYP3A4, CYP2D6, and CYP1A2 activities. These luminescent assays exhibit exquisite sensitivity, low background signals and broad dynamic range. The P450-Glo™ Assays generate a "glow-type" luminescent signal, produced using derivatized luciferins as P450 substrates and a recombinant stabilized luciferase (Ultra-Glo™ Luciferase) coupled with a proprietary buffer system. The half-life of the luminescent output is greater than two hours, eliminating the need for luminometers with injectors and allowing batch plate processing. The formulation also minimizes the incidence of false positives due to inhibition of luciferase by analytes when screening for cytochrome P450 inhibitors.

DMSO, a common solvent used to solubilize chemical compounds, can significantly inhibit the activity of the 3A4 isoform of cytochrome P450, even at low concentrations (<0.1%).The P450-Glo™ CYP3A4 System (Luciferin-PPXE) DMSO-Tolerant Assay is specifically designed to tolerate DMSO in the 3A4 reaction. The assay exhibits little to no

FAR Subpart 13.106-1(b) change in the signal-to-background ratio in the presence of 0.2% DMSO compared to a no-DMSO control. Assays are complete systems that include a membrane preparation containing recombinant human cytochrome P450 enzyme, a luminogenic cytochrome P450 substrate appropriate for the enzyme, an NADPH regeneration system, reaction buffer, Luciferin Detection Reagent and Luciferin-Free Water.

7. Any other facts supporting the justification.

Since its Since its inception, Tox21 group ran several screenings using these Promega’s assay systems. So far all these assays which involved in quantification of luciferase reporter gene activity resulted in excellent performance statistics in terms of low variations and high Z values.

Promega’s assay systems are very stable and can withstand several freeze-thaw cycles without dropping in fold. Also these assay systems are homogenous which does not involve any washing steps. All these three luminogenic P450-Glo™ assay systems are exclusive to Promega Corporation.

8. Project Officer Certification. The undersigned program official(s) certifies that the information in support of this justification for the proposed acquisition has been reviewed, is completed and correct to the best of my knowledge and belief and recommends approval.

Project Officer Date

9. Contracting Officer Certification. The Contracting Officer certifies that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete and in accordance with FAR 13.106-1(b)(1), the facts of this acquisition preclude the use of full and open competition.

Contracting Officer Date

Menghang Xia Aug 1, 2018 Menghan g Xia -S

Digitally signed by Menghang Xia -S DN: c=US, o=U.S. Government, ou=HHS, ou=NIH, ou=People, cn=Menghang Xia -S, 0.9.2342.19200300.100.1.1=0012050 Date: 2018.08.01 17:29:56 -04'00'

Jeffrey R. Schmidt -S Digitally signed by Jeffrey R. Schmidt -S Date: 2018.08.01 17:43:25 -04'00'