B SSJ_FS_FINAL.pdf

Revised10/31/2016

FAR Subpart 13.106-1(b)

“Source Selection Information – see FAR 2.101 and 3.104”

1. Identification of the Agency and Contracting Activity.

a. Federal Agency and Contracting Activity.

Department of Health and Human Services National Institutes of Health National Institute on Drug Abuse

b. Sponsoring Organization.

National Center for Advancing Translational Sciences (NCATS) Division of Pre-Clinical Innovation (DPI) Early Translation Branch (ETB)

c. Project Officer Information.

Samarjit Patnaik, Ph.D.

9800 Medical Center Drive Rockville, MD 20850 301-827-1772 patnaiks@mail.nih.gov

2. Project Description.

a. Name of Item or Project Title.

Synthesis and bioanalytical analysis of small molecules from MTase projects

b. Description of the Item or Service.

Custom synthesis of small molecule inhibitors and intermediates from a project that seeks to develop methyltransferase inhibitors from a prior project with CRO. Evaluate a fixed set of compounds in dose reponse in a mass spec assay that monitors the enzyme product at the CRO site where compounds are being synthesized.

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 $10,000 and not expected to exceed $250,000, and conducted in accordance with FAR Part 13—Simplified Acquisition Procedures.

SOLE-SINGLE SOURCE (including Brand-Name) JUSTIFICATION

Revised10/31/2016

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. Brand name or items peculiar to one manufacturer

Only one source is available:

The essential characteristics of the item or service that limit the availability to a sole source are:

This acquisition requires previous experience in the making of methyltransferase inhibitors. The service provided by this contractort will allow for continuity of research, consistency of data/results which is imperative in this project. Previous similar work was done under PO # 75N98022D00019/75N98022F00005/P00003

This acquisition is restricted to ChemoGenics BioPharma 3325 Durham Chapel Hill Blvd Suite 250 Durham, NC 27707 Tel: 919-308-1341 Francis Tavares francis@cgbiopharma.com

The estimated cost of the required item is $230,000.00 and is required to be performed within 12 months ARO.

7. Any other facts supporting the justification.

The vendor has developed methods and procedures to synthesize these compounds following what NCATS needs. The protocol they use to make these compounds are not readily available in the commercial marketplace. NCATS provided the vendor with novel chemical compound structures, and the vendor came up with the steps/protocol to make these compounds.

Furthermore, the vendor has the capability to run pharmacokinetics and drug metabolism (PKDM) assessment studies on the compounds they made for NCATS.