JOFOC-IconeusSignedNienborg - signed 5-29-20.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. HHS.NIH

b. Sponsoring organization. OD

c. Project Officer information.

• Project Officer name. Hendrikje Nienborg

• Mailing address. 49 Convent Dr. Bethesda MD.20892

• E-mail address. hendrikje.nienborg@nih.gov

• Telephone number. 301-496-9377

Nature and/or description of the action being approved.

The requested product is a preclinical equipment based on the latest advances of this technology and is expected to bring novel insights in basic and translational neuroscience as it enables real-time large-field functional ultrasound imaging in a large variety of subject states including awake, behaving- or resting-state and asleep conditions, compatible with other techniques (electrophysiology etc.) using a “Plug and Scan” hardware and software without time-consuming post-processing. Focused on the imaging of large areas of microvasculature and the assessment of subtle changes in blood volume, this equipment will confer substantial added value in many basic research projects compared to other brain imaging modalities.

Acquisition purpose and objectives. This product is required to develop portable functional imaging that can be readily used in combination with electrophysiological recordings in non-human primates within existing recording setups, to guide and complement these recordings. Recently, the use of ultrasonic plane waves transmitted at ultrafast frame rates was shown to highly increase Doppler ultrasound sensitivity to blood flows in small vessels in rodents. This ultrafast Doppler ultrasound can map brain vessels with a high resolution and is highly sensitive to measure blood variations due to the neurovascular coupling giving access to brain activation. By identifying regions of brain activation, Ultrafast Doppler was entering into the world of preclinical neuroimaging.

This new technique is called functional ultrasound (fUS). The combination of many advantages, including unprecedented high spatio-temporal resolution, deep penetration, high sensitivity and portability provide unique information about brain function.

Project background

N/A

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

a. Project title. ICONEUS-ONE - full pre-clinical package offer

b. Project description. The requested product is a preclinical equipment based on the latest advances of this technology and is expected to bring novel insights in basic and translational neuroscience as it enables real-time large-field functional ultrasound imaging in a large variety of subject states including awake, behaving- or resting-state and asleep conditions, compatible with other techniques

• Requirement type.

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

❑ Support services (non-R&D)

◼ Supplies/equipment

❑ Information technology (IT)

❑ Construction

❑ Architect-engineer (A & E) services

❑ Design-build

❑ Other (specify): ____________________

• Type of action.

◼ New requirement ❑ Follow-on

❑ Other (specify): ______________________

• Proposed contract/order type.

• 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. N/A

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

$341,609 and a delivery time of 30 days after down payment.

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

❑ This acquisition is conducted under the authority of 41 United States Code (U.S.C.) 253(c)(__) as set forth in Federal Acquisition Regulation (FAR) 6.302- __. .

❑ This acquisition is conducted under the authority of section 4202 of the Clinger-Cohen Act of 1996.

❑ This acquisition is conducted under the authority of the Services Acquisition Reform Act of 2003 (41 U.S.C. 428a).

4. 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).

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

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

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

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

N/A

8. Any other facts supporting the use of other than full and open competition. N/A

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

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. N/A

12. Program office certification. N/A.

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.

Official Name & Title Signature Date

Project Officer Hendrikje Nienborg, Section Chief

5/28/20

Project Officer’s

Immediate Supervisor

Bruce Cumming, Chief

5/28/20

Head of the Sponsoring

Program Office

13. Contracting Officer Certification.

This is to certify 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.

Official Name & Title Signature Date

Contracting Officer

14. Chief of the Contracting Office and Head of the Contracting Activity signature(s). N/A https://na2.documents.adobe.com/verifier?tx=CBJCHBCAABAAudBMKL4Z6G4zYrGgJAh6haCbHbPL4Si5

Official Name & Title Signature Date

Chief of the

Office

Head of the

Activity

15. Competition Advocate signature N/A

Competition Advocate

16. HHS Senior Procurement Executive signature. N/A

HHS Senior Procurement

Executive

JOFOC-IconeusSignedNienborg Final Audit Report 2020-05-28

Created: 2020-05-28

By: Hendrikje Nienborg (nienborgh2@nei.nih.gov)

Status: Signed

Transaction ID: CBJCHBCAABAAudBMKL4Z6G4zYrGgJAh6haCbHbPL4Si5

"JOFOC-IconeusSignedNienborg" History Document created by Hendrikje Nienborg (nienborgh2@nei.nih.gov) 2020-05-28 - 2:34:05 PM GMT- IP address: 73.250.90.208

Document emailed to Bruce Cumming (bgc@nei.nih.gov) for signature

2020-05-28 - 2:34:50 PM GMT

Document e-signed by Bruce Cumming (bgc@nei.nih.gov) Signature Date: 2020-05-28 - 2:53:58 PM GMT - Time Source: server- IP address: 104.63.227.103

Signed document emailed to Hendrikje Nienborg (nienborgh2@nei.nih.gov) and Bruce Cumming (bgc@nei.nih.gov)

2020-05-28 - 2:53:58 PM GMT