JOFOC_(or_Other_than_Full_and_Open_Competition_v.3.1)_changes_9-11-2018_1._sgnd.pdf

Justification for Other than Full and Open Competition

1. Identification of the agency and contracting activity:

a. Federal agency and contracting activity.

Department of Health and Human Services, Food and Drug Administration

b. Sponsoring organization.

Office of the Chief Scientist, Office of Counterterrorism and Emerging Threats

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

i. Name: Tracy MacGill

ii. Mailing address: 10603 New Hampshire Avenue, Silver Spring Maryland, 20993, Building

1, room 4312

iii. E‐mail address: tracy.macgill@fda.hhs.gov

iv. Telephone number: 301‐796‐1366

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

The nature of the action being proposed is to award a follow‐on contract to the existing protocol of

FDA Contract HHSF223201310079C, for additional studies needed to complete objectives of the project

a. Acquisition purpose and objectives.

FDA is seeking a follow‐on technical approach for a funded study that researches the effects of organ‐specific injury mechanisms related to radiation exposure. This study, awarded in 2013, requires modification to address mounting evidence of the impact of gender‐related differences that may impact study outcomes. To that end, a follow‐on contract to incorporate evaluation of gender differences via the additional effort entitled “Modeling Sex‐Specific Radiation and

Chemotherapy Responses in a Bone Marrow Chip”.

The project is part of the extramural research portfolio that provides funding and support to external performers (including industry, academic, and other government agencies) to perform research projects for FDA OCET. Specifically, the research is part of a an OCET major function to coordinate the FDA’s Medical Countermeasures Initiative (MCMi), “to facilitate the development of safe and effective MCMs against chemical, biological, radiological, and nuclear agents and emerging threats, such as pandemic influenza”.

b. Project background.

On September 9, 2013, the FDA awarded a contract to the Wyss Institute at Harvard University to carry out the study entitled Organ‐on‐chips tools for testing radiation countermeasures. The study aims to develop in vitro platform to understand organ‐specific injury mechanism and MCM screening. The period of performance for the study is 9/09/2013‐8/27/2018; total funding awarded to the contract to date is $5,625,079. During a project status call that FDA OCET conducted with the Wyss institute on Marcy 18, 2018, it was determined that the research done to date has direct applications to current critical knowledge gaps aligned to the FDA Office of

Women’s Health (FDA OWH). Specifically, these gaps pertain to mounting evidence that gender differences play a major role in the response of bone marrow to chemo‐ and radio‐therapies.

Furthermore, the discuss highlighted a need to incorporate additional data derived from organ chips sourced from female donors; during the project instantiation, chips were developed based on available donors, and as a result, the data gathered thus far is predominantly male.

After reviewing the status of the base project, it was determined that the outcomes of the study would be greatly enhanced if additional time/effort was devoted to extend the period of performance to include the additional protocol, entitled “Modeling Sex‐Specific Radiation and

Chemotherapy Responses in a Bone Marrow Chip”. The proposed protocol will mitigate any technical risk by incorporating additional data into the study, balancing gender differences. It will also directly address research questions posed by the FDA Office of Women’s Health.

Without completion of the additional effort, government objectives for the project will not be met, as the regulatory science‐related questions that the overall study aims to address will be confounded based on gender‐specific differences.

Programmatically, there is an incentive to the government to award the extension, given that pursuit of this project independent of the existing award will incur significant additional cost and administrative effort, in order to identify sources and/or utilize the Broad Agency Announcement process, and will require significant additional time to submit a new proposal, review, and award.

Given the technical requirements to address the remaining research questions, much of the effort for a new award would be duplicative, and could potentially create technical/contractual issues given the reliance on intellectual property of Harvard Wyss, in order to address residual technical questions. Finally, given potential disparity in outcome data based on gender differences, the proposed effort will be critical to ensure that the deliverables of the project properly address the government need, both for FDA OCET and OWH.

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

Follow‐on market research with the performer has resulted in an approximate cost (as detailed in the

IGCE) of approximately $405,986 (NOTE: Harvard Wyss has submitted a proposal for the work in the amount of $398,677). This includes costs for both scientific salaries (representing level of effort for 4 scientific personnel needed to complete additional work, using negotiated labor rates from the base contract), and materials. Material costs include the additional organ chip technology (i.e. the “chips”) utilized under the base award, which is only available from the performer and remains the intellectual property of the performer. Additional materials costs include estimated costs for cell culture and reagents, both of which are based on the base contract pricing levels. The specific services required are detailed under the follow ‐on requirement statement of work.

a. Project title.

Modeling Sex‐Specific Radiation and Chemotherapy Responses in a Bone Marrow Chip

b. Project Description.

See attached statement of work

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: modification

Proposed contract/order type.

☐ Firm‐fixed‐price

☐ Other fixed‐price:

☐ Cost‐plus‐fixed‐fee

☒ Other cost reimbursement: Cost Reimbursement, No Fee Contract

☐ Time and materials

☐ Indefinite delivery:

☐ Other:

☐ Completion Form

☐ Term Form

Acquisition identification number.

Organ‐on‐Chips Tools for Testing of Radiation Countermeasures

Modeling Sex‐Specific Radiation and Chemotherapy Responses in a Bone Marrow Chip

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

The total estimated dollar value of the contract and complete performance period are as follows:

Period of Performance: 9/18/2013 – 3/31/2019

Total Cost:

a. Base Award: $4,497,969

b. Option Period: $1,127,110

c. Modeling Sex‐Specific Radiation and Chemotherapy Responses in a Bone Marrow Chip:

$398,677

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).

President and Fellows of Harvard College

Harvard College, President & Fellow

25 Shattuck Street

Boston MA 021156027

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

The proposed work leverages the equipment, expertise, and technical capabilities provided and developed under the existing contract. The technical approach detailed under the follow‐on requirement statement of work (entitled Modeling Sex‐Specific Radiation and Chemotherapy

Responses in a Bone Marrow Chip) directly addresses a knowledge gap that will directly impact the body of work completed under the existing contract. Without completion of the additional effort, government objectives for the project will not be met, as the regulatory science‐related questions that the overall study aims to address will be confounded based on gender‐specific differences. In order to address this residual, gender‐related knowledge gap, the methodology must remain consistent with the work done to date (i.e. using the same equipment, capabilities, and technical approach for the study hypotheses). In terms of equipment, the objectives of the overall study are predicated on technically (the Organs on Chips) which are the intellectual property of the performer. Unique technical features of the chips, including (but not limited to the formulation of polymers used in the design of the chip, as well as patented, tubeless technology to reduce air bubble generation) are pivotal to the technical approach, and cannot be provided or reproduced by another performer. As such, no other potential performer could be identified that has the capability to complete the study to sufficiently align to the work completed in the base/option periods of the existing contract. As a result, the only way to suitably complete this work (in consideration of scientific methodology, and in a manner that is technically suitable for FDA review and acceptance) is to utilize the existing performer to complete the additional effort. This will also ensure that all deliverables are completed in a timely manner, and presented concurrently via final reporting.

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. .

Discussion with the COR for the contract and market research online have been conducted to confirm that the existing performer is the sole‐source of the current technology needed to complete the additional study. Furthermore, evaluation of existing in‐silico organ chip models currently under development by other performers has enabled the identification of significant differences in technical approach/design which would unreasonably add a high degree of variability to the technical approach; these designs are at an earlier phase in technical development relative to the Wyss technology and would yet results that are incomparable to the work done under the existing contract. No other performers currently work with and/or could provide the organ on chip technology which FDA has funded through the existing contract. Additionally, FDA will issue a public notice (via Fedbizops.gov) to elaborate on the intent to award a new sole source follow‐on contract.

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

Prior to the award of the proposed contract/order, pricing information was obtained from the proposed contractor via the BAA submission process. Negotiated costs for the additional work, including labor rates, equipment‐related costs, and indirects were then used for the development of an independent government cost estimate, which was later utilized to analyze the cost proposed by the performer. The comparison determined that the proposed costs are fair and reasonable, and technically in alignment with the proposed approach.

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.

N/A as stated above

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

The use of in silico models in scientific research (including for both regulatory science advancement and for the development of medical countermeasures) remains an enterprise that is on the “cutting edge” of scientific product development. While other approaches for the design of such models have been conceived, proposed, and in some cases tested, the technology developed at Wyss has achieved a significantly higher degree of technical development, which was made possible in part due to previous FDA funding via the BAA. If other sources were utilized to complete this work, there would be significant technical risk for the overall project, given that the work would not be done in a manner consistent with the base/option work completed to date.

Furthermore, the additional work described under the follow‐on requirement is designed to be incorporated into the current body of results from 5 years of study over the course of the project.

The follow‐on requirement is a logical addition within the existing scope of work, which addresses research questions (specifically gender‐based differences) that are directly relevant to the results of the overall study. These factors could not be identified when the BAA proposal was originally submitted, as the variability of gender‐based differences for in vitro testing of this type was not well understood; it was only over the course of the study that the potential impacts of these factors were identified. As a result, the proposed new follow‐on contract will adjust for these factors, and ensures that the deliverables of the overall study meet the government’s requirements.

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

Not applicable

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.

The protocol requiring follow‐on requirements was initially identified via a proposal submission to the

2013 FDA Broad Agency Announcement (BAA). The performer has subsequently indicated that a new submission to the next iteration of the BAA (in FY2019) is possible, but specific timepoints for submission and the scope/cost of the new effort cannot be confirmed at this time. It is likely that further awarded research to this performer will be to further develop technical approaches and research tools that could be commercialized in the future; however, at present the materials which are vital to the current follow‐on requirements remain solely available from the performer.

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:____________________________________

Robert Orr COR/Requiring Activity POC

[Enter date here.]

Tracy MacGill

COR/POC Immediate Supervisor

Estella Jones

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.

Regina R. Williams Contracting Officer

14. Competition Advocate signature.

The designated OPDIV Competition Advocate (CA), upon acceptance of the rationale provided in the

J&A, shall complete the information required below and sign in the block provided as the approving official for any J&A over $700,000 but not exceeding $13 million. [FAR 6.304(a)(2) and FAR

13.501(a)(2)(ii)]

[Enter name here.] Competition Advocate

15. Division Director and Head of the Contracting Activity signature(s).

The Division Director, if applicable, and the HCA shall indicate review of, and concurrence with, any

J&A over $13 million, but not exceeding $68 million by providing the information required below and signing in the applicable block. [FAR 6.304(a)(3) and FAR 13.501(a)(2)(iii)]

Division Director

Head of the Contracting Activity

16. HHS Senior Procurement Executive signature.

The HHS SPE, upon acceptance of the rationale provided in the J&A, shall complete the information required below and sign in the block provided as the approving official for any J&A over $68 million.

[FAR 6.304(a)(4) and FAR 13.501(a)(2)(iv)]

HHS Senior Procurement Executive