D JandA Redacted.pdf

Justification and Approval for Sole Source

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 (HHS) National Institute of Health (NIH) National Institute on Drug Abuse (NIDA)

b. Sponsoring organization.

National Center for Advancing Translational Sciences (NCATS) Division of Preclinical Innovation (DPI) Stem Cell Translational Laboratory (SCTL)

c. Project Officer information.

2. Nature and/or description of the action being approved.

a. Acquisition purpose and objectives.

The National Center for Advancing Translational Sciences (NCATS) Division of Preclinical Innovation (DPI) requires a service agreement for Axion Biosystems instruments. The prior agreements on these instruments will have all ended by August 31, 2023 and a new agreement is needed to ensure the instruments are covered. These instruments must remain covered to ensure the instruments receive the necessary service and/or preventative maintenance as needed.

b. Project background.

The mission of the National Center for Advancing Translational Sciences (NCATS) is to develop new therapeutics for treatments of rare diseases by using small molecule screening to identify lead compounds, study their mechanisms of action, and identify molecular targets. The Therapeutic Development Branch (TDB) and Stem Cell Translation Laboratory (SCTL) within DPI in the NCATS require the use of microelectrode array (MEA) assays for use in neuronal toxicity screening in pursuit of this mission.

In order to obtain reliable, reproducible, high-quality data, the equipment must remain in operable working condition. The equipment must receive preventative maintenance (when available for that instrument) to maintain peak operability and must receive service and repairs when not working properly. A service contract, with preventative maintenance where possible, is therefore required.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

a. Project title: Service Agreement for Axion Biosystems Instruments

b. Project description.

Requirement type. Check the appropriate box:

Research & development (R&D) R & D support services

X Support services (non-R&D) Supplies/equipment Information technology (IT) Construction Architect-engineer (A & E) services Design-build Other (specify): ____________________

Type of action. Check the appropriate box:

New requirement X Follow-on

Other (specify): ______________________

Proposed contract/order type. Check all that apply:

X Firm-fixed-price Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________ Cost-plus-fixed-fee Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________ Time and materials Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________ Other (specify): ___________ Completion Form Term form

Acquisition identification number.

75N95023Q00650

c. Total estimated dollar value and performance/delivery period.

The total estimated value is over the following anticipated performance periods:

BASE PERIOD (

OPTION PERIOD 1 (

OPTION PERIOD 2 (

4. Identification of the statutory authority permitting other than full and open competition.

X This acquisition is conducted using the procedures of FAR subpart 13.5 in accordance with 41 U.S.C. 1901.

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

Axion BioSystems 1819 Peachtree Road NE, Suite 350 Atlanta, GA 30309. .

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

Axion BioSystems is the sole manufacturer and North American distributor of the Maestro Multielectrode Array (MEA) system and APEX system that NCATS currently own. The equipment must be maintained under a maintenance agreement with the manufacturer, as only factory-authorized and trained technicians can work on this equipment without the risk of damaging sensitive electronics. These are very sensitive pieces of equipment and require technicians with training and experience with these exact makes and models. Knowledge of other brands in general will not suffice as it may result in improper repairs that invalidate data, delay projects, and cost additional funds to fix. Additionally, any spare parts utilized must be original equipment manufacturer (OEM) parts to ensure compatibility and maximum instrument performance. The risks of third-party technicians and non-OEM parts outweigh any benefits of competition.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a notice was or will be publicized on the governmentwide point of entry as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

This acquisition will be synopsized on the governmentwide point of entry (SAM.gov). Any interested party may submit a capability statement, proposal, or quotation, which shall be considered by the agency.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

9. Any other facts supporting the use of other than full and open competition.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

No other sources have expressed an interest, in writing, in the proposed acquisition.

11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

12. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.