JOFOC_Computational_Whole_Heart_r.pdf

Justification for Other than Full and Open Competition

1. Identification of the agency and contracting activity:

a. Federal agency and contracting activity.

U.S. Food and Drug Administration, Office of Operations, Office of Finance, Budget, & Acquisitions, Office of Acquisitions and Grants Services (OAGS)

b. Sponsoring organization.

Office of Medical, Products and Tobacco (OMPT) / Center for Device and Radiological Health (CDRH) / Office of Science and Engineering Laboratories (OSEL) / Division of Applied Mechanics (DAM)

c. Contracting Officer’s Representative (COR)/Requiring Activity Point of Contact (POC) information.

i. Name: Tina Morrison

ii. Mailing address: 10903 New Hampshire Avenue, Silver Spring, MD

iii. E-mail address: Tina.Morrison@fda.hhs.gov

iv. Telephone number: 301-796-6310

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

a. Acquisition purpose and objectives.

In accordance with FAR 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements, the action being proposed for approval is a justification for sole source award to Dassault Systemes Americas Corp., DUNS 020878042.

b. Project background.

CDRH/OSEL/DAM has a critical path project to demonstrate to the FDA and industry how to more fully harness computational human heart modeling to reduce the size of prospective clinical trials for human heart medical devices. This will include extending methodologies developed by CDRH in conjunction with stakeholders to employ the “virtual patient model”. See this link for additional background: https://mdic.org/project/virtual-patient-vp-model/

In support of these efforts, CDRH established a Research Collaboration Agreement (RCA) with Dassault Systemes Simulia Corp., an affiliate of Dassault Systemes Americas Corp., in pursuit of this critical path project; the agreement was put in place outside the purview of the FDA Office of Acquisitions and Grants Services (OAGS) and therefore does not have a contract number. The RCA was established in March of 2018 and continues as of this justification; an amendment to the agreement effective June 24, 2019 was established to expand the research activities from the original agreement.

The purpose of the RCA is to leverage simulation and heart models to develop testing paradigms for the insertion, placement, performance of pacemaker leads and other cardiovascular devices used to treat cardiovascular disease.

Thru the RCA, CDRH and Dassault developed a Project Plan for the critical path project; the Project Plan is not available to the public based on the terms and conditions of the RCA. The collaboration’s research results will be made public through publications and presentations.

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

a. Project title.

Computational Whole Heart Modeling

b. Project Description.

A service contract as issued by FDA OAGS is now required to complete a component of the of the Project Plan. The Project Plan developed under the RCA for an “in silico clinical trial” of a generic medical device as part of a digital regulatory mock submission and review. The Project has a defined scope under which these services fit as part of the Project Plan. Critical to achieving the Project is the computational analysis of the generic medical device simulated within a library of virtual patients who will represent a population with the condition the device is intended to treat.

The scope of services required shall include performing computational analyses using this library of whole heart models with, and as appropriate without, a virtually implanted generic medical device. The model library must: 1) comprise the whole human heart including all relevant anatomical features (such as ventricles, atria and vessels) and be physics-based capturing all of the critical functionality of the heart: electrophysiology, solid mechanics, and fluid dynamics; 2) characterize relevant disease states that the generic medical device is intended to treat so a population of virtual patients is represented in the in silico clinical trial and can be virtually treated with the generic medical device; and 3) be accessible to FDA and relevant third parties as determined by FDA in order to reproduce the work or create derivations.

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:

Type of action.

New requirement

Follow-on

Other:

Proposed contract/order type.

Firm-fixed-price

Other fixed-price:

Cost-plus-fixed-fee

Other cost reimbursement:

Time and materials

Indefinite delivery:

Other:

Completion Form

Term Form

Acquisition identification number.

19-FDA-SOL-1211586

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

The total estimated dollar value of this acquisition is $130,000.00.

4. Identification of the statutory authority permitting other than full and open competition. Check the applicable block below based on the acquisition circumstance.

Federal Acquisition Regulation (FAR):

6.302-1 Only one responsible source and no other supplies or services will satisfy agency requirements. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(1) or 41 U.S.C. 3304(a)(1).

6.302-2 Unusual and compelling urgency. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(2) or 41 U.S.C. 3304(a)(2).

6.302-3 Industrial mobilization; engineering, developmental, or research capability; or expert services. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(3) or 41 U.S.C. 3304(a)(3).

6.302-4 International agreement. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(4) or 41 U.S.C. 3304(a)(4).

6.302-5 Authorized or required by statute. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(5) or 41 U.S.C. 3304(a)(5).

6.302-6 National security. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(6) or 41 U.S.C. 3304(a)(6).

6.302-7 Public interest. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(7) or 41 U.S.C. 3304(a)(7).

13.501(a)(1)(ii) Sole source, including brand name, under Simplified Procedures for Certain Commercial Items. This acquisition is using this justification format, modified to reflect that the procedures in FAR subpart 13.5 were used in accordance with 41 U.S.C. 1901 or the authority of 41 U.S.C. 1903.

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).

Dassault Systemes Americas Corp.

175 Wyman St.

Waltham, MA 02451-1223

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

The services required for this contract action are a component of the Project Plan that was developed between FDA CDRH and Dassault. As the Project Plan is not available to the public, the services required must be performed by Dassault.

6. Description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by subpart 5.2 and, if not, which exception under 5.202 applies.

The combined synopsis/solicitation for sole source award Dassault will be posted on FedBizOpps;

while the intent is sole source, provides opportunities for potential offerors to submit a quote.

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

The Contracting Officer will utilize the independent government estimate, available market prices, and comparison of established labor rates for proposed labor categories to determine price fair and reasonableness.

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.

No additional market research was conducted for this requirement due to the confidential nature of the Project Plan developed between FDA CDRH and Dassault. No other vendors would be able to perform the scope of services required.

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

None

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.

No subsequent acquisitions are anticipated beyond this contract action at this time based on the established Project Plan. However, the research results from the Project Plan could lead to additional amendments to the RCA which may impact the need for similar services from Dassault in the future.

As the research results are generated out of the RCA, it is unlikely that the FDA can overcome barriers to competition for future acquisitions.

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.

Signature:

Tina Morrison

COR/Requiring Activity POC

Date

Signature:

Anton Dmitriev

COR/POC Immediate Supervisor

Date

Signature:__ Angela Clingerman

Head of the Sponsoring Program Office

Date

09/27/2019

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.

Signature:

Phillip Frame

Contracting Officer

Date