Synopsis-JA-Ohio-State-Redacted.pdf

Control No: JA-21-01-00247 Contractors: Ohio State University, , Program: FY20 Joint Warfighter Medical Research Program

JUSTIFICATION REVIEW DOCUMENT

FAR PART 6 JUSTIFICATION AND APPROVAL FOR OTHER THAN

FULL AND OPEN COMPETITION

Program: This Justification and Approval (J&A) is for the procurement of four research projects solicited through the FY20 Joint Warfighter Medical Research Program (JWMRP) in support of the Congressionally Directed Medical Research Program

(CDMRP).

Authority: 10 U.S.C. 2304(c)(1) as implemented by FAR Part 6.302-1 -- Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

Amount: $9,227,782

Prepared by: Douglas A. Medcalf Jr. DSN: 301-619-2394 Contract Specialist Date: 10 February 2020 E-Mail: douglas.a.medcalf.civ@mail.mil

Contracting Officer: Patrick K. Harris DSN: 301-619-2779 Contracting Officer Date: 10 February 2020 E-Mail: patrick.k.harris11.civ@mail.mil

Technical: Angel M. Davey DSN: 301-619-7785 Program Manager Date: 10 February 2020 E-Mail: angel.m.davey.civ@mail.mil

Requirements: Angel M. Davey DSN: 301-619-7785 Program Manager Date: 10 February 2020 E-Mail: angel.m.davey.civ@mail.mil

Contractors: Ohio State University, Program: FY20 Joint Warfighter Medical Research Program

Reviews: I have reviewed this justification and find it adequate to support other than full and open competition.

Program Manager:

Typed Name: Angel M. Davey

DSN: 301-619-7785

Signature: ________________________________

Legal Counsel:

Typed Name: R. Seth Higgs

DSN: 301-619-2727

Signature: ________________________________

DAVEY.ANGEL.MARI

E.1461049903

Digitally signed by

DAVEY.ANGEL.MARIE.1461049903

Date: 2021.02.10 06:32:43 -05'00'

HIGGS.ROGER.

SETH.1266104

Digitally signed by

HIGGS.ROGER.SETH.126

6104347 Date: 2021.02.17 14:08:26 -05'00'

FAR Part 6 Class Justification and Approval for Other Than Full and Open Competition

1. Contracting Activity:

U.S. Army Medical Research Acquisition Activity (USAMRAA) 820 Chandler St.

Fort Detrick, MD 21702

2. Description of Action:

This Class Justification and Approval for Other than Full and Open Competition provides for the award of contracts to four (4) specified vendors on a sole source basis under the FY20 Joint Warfighter Medical Research Program (JWMRP). The four vendors are Ohio State University, Approximately $3,444,548 have been allocated to fully fund the contract to Ohio State University, These vendors have completed the prior phase, or are near completion, of a research effort utilizing previously appropriated Department of Defense (DoD) funds.

The current actions will augment and accelerate high priority DoD and Service medical requirements utilizing FY20 Defense Health Program (DHP) Joint Warfighter Medical Research Program (JWMRP) 6.3 Advanced Development Research, Development, Test and Evaluation (RDT&E) funds. Full proposals were solicited and reviewed by an external peer review panel as well as a programmatic review panel. The peer and programmatic reviews, along with past performance and cost evaluation factors, will result in the issuance of four Research and Development (R&D) contracts. Cost type contracts will be awarded to those selected for funding that meet the requirements of an adequate accounting system per FAR 16.301-3(a)(3). Those selected for funding that do not meet the requirements of an adequate accounting system will be awarded firm fixed price contracts. The period of performance for the selected contracts will range from 24 to 36 months. The Government projects contract award in the third quarter of

FY21.

Ohio State University 1960 Kenny Rd.

Columbus, OH 43210

3. Description of Supplies/Services:

The four (4) vendors receiving contracts through the JWMRP mechanism are listed below accompanied with a description of each project, project duration, and estimated cost. The projected project durations and estimated costs below are based on full application submittals.

Project #1:

Ohio State University (JW200164): Project Duration – 36 Months; Estimated Cost – $3,444,548 Description: This project aims to enhance clinical decision-making for rehabilitation of spine disorders by advancing development of a wearable spine health system that utilizes motion-based metrics via motion sensors along with a host of patient reported outcomes to quantify function, track treatment response, predict long-term outcomes and inform optimal personalized treatments. The specific aims of the project are: 1) To advance Spine Health Platform from TRL 6 to TRL 8 to prepare for DoD acquisition; 2) To validate utility of the Spine Health Platform as a decision-support tool in military environments to predict patient outcomes and inform optimal personalized treatments; and 3) To obtain FDA 510(k) clearance to market Spine Health Platform as a medical device.

Project #2:

Project #3:

Project #4:

4. Authority Cited: The statutory authority permitting other than full and open competition is 10 U.S.C. 2304(c)(1). The FAR citation is 6.302-1 Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements with application at 6.302-1(a)(2).

5. Reason for Authority Cited:

a. As described at FAR 6.302-1(a)(2), when the supplies or services required by the agency are available only from one responsible source, or for DoD, NASA and the

Coast Guard, from only one or a limited number of responsible sources, and no other types of supplies or services will satisfy agency requirements, full and open competition need not be provided for.

b. Congress appropriated $40M for this program in the “Consolidated Appropriations Act, 2020”, Public Law 116-93. Page 237 of Senate Report 116-103 states that the funds “shall be used to augment and accelerate high priority Department of Defense (DoD) and Service medical requirements and to continue both core and congressionally-directed prior year initiatives that are close to achieving their objectives and yielding a benefit to military medicine. These funds shall not be used for new projects or basic research, and they shall be awarded at the discretion of the Secretary of Defense following a review of medical research and development gaps, as well as unfinanced medical requirements of the Services.” For this reason, the undersigned determines that the cited statutory authority permitting other than full and open competition is supported and required.

This Bill limits the competition to contractors that have previous/existing Core or Congressional Special Interest (CSI) research projects (contracts or assistance agreements) which benefit military medicine. The Bill also states that funds shall be awarded at the discretion of the Secretary of Defense following a review of medical research and development gaps. The strategy in executing the JWMRP was to find highly valued research efforts on research assistance agreements or contracts that could meet critical service requirements and that were not being continued through other appropriations. Based on a comparative analysis by the scientific and programmatic reviewers from the U.S. Army Medical Research and Development Command (USAMRDC) and Joint Program Committees, the four JWMRP research projects discussed above were selected for contracts to complete follow-on efforts to the previous efforts.

The aforementioned projects in Section 3 are the only sources for the proposed work.

No other contractors have received Core or CSI funding for the proposed research projects nor possess the specific intellectual property to push this research through advanced development.

6. Efforts to Obtain Competition:

A sources sought notice was posted to beta.sam.gov on 15 December 2020. The Government received three responses to this public notice. Two vendors, provided capability statements in response to Project #4. submitted a response regarding Project #3. However, it was confirmed that these vendors do not have the intellectual property to complete the respective requirements without a duplication of effort. No responses were received for Projects #1 or #2. No other efforts were made to obtain competition for this requirement because Ohio State University, are the only contractors capable of providing the highly specialized research services associated with their respective projects while also meeting the requirements of the

JWMRP.

a. Effective Competition:

Because this is a sole source action, effective competition is not applicable.

b. Subcontracting Competition:

The four projects discussed were selected for award through a peer and programmatic review process which evaluated full proposals from each vendor.

By selecting these vendors, the Government has effectively accepted each vendor’s subcontracting strategy as shown in their proposals. The strategies are discussed below.

Ohio State University is subcontracting to the Uniformed Services University, Switchbox, and Priority Designs. No other subcontracting opportunities exist.

Based on these facts, no further competition will occur for subcontracting.

7. Actions to Increase Competition:

Future actions are dependent upon statutory requirements. At this time, no additional actions were taken to increase competition due to the language in the “Consolidated Appropriations Act, 2020”, Public Law 116-93.

8. Market Research:

Based on the reasons cited above under Section 5, Reasons for Authority Cited, market research was conducted through the process of soliciting project nominations from the Services, U.S. Army Medical Materiel Development Activity (USAMMDA), the Congressionally Directed Medical Research Program (CDMRP), and the Chairs for the Joint Program Committees. In addition, in accordance with Defense Federal Acquisition Regulation Supplement (DFARS) 205.205-71, DFARS 206.302-1(d), and DFARS Procedures, Guidance and Information (PGI) 206.302-1(d), a sources sought notice was posted to posted to beta.sam.gov on 15 December 2020 for seven (7) days. The Government received three responses to this public notice, as discussed in Section 6.

The Government posted a request for information (RFI) to beta.sam.gov in January 2020 to inform the general public of the JWMRP opportunity. Respondents were instructed to submit a brief letter of interest to verify that they met all requirements of the program. Pre-applications were requested from all qualified vendors and were reviewed in accordance with the JWMRP appropriation which specifically states that the funding “shall be awarded at the discretion of the Secretary of Defense following a review of medical research and development gaps, as well as unfinanced medical requirements of the Services.” Full proposals were requested from those determined to be close to achieving their objectives and considered to be an advanced development programmatic priority for the military. A peer and programmatic review process resulted in a list of projects for funding. The full applications were segregated into those for advanced development (6.4 funded) and those for basic/applied research (6.3 funded).

Ohio State University, were selected to receive 6.3 funded contracts.

9. Interested Sources:

A Notice of the Government’s intent to award four sole source contracts to Ohio State University, was posted on 22 December 2020 and remained open until 08 January 2021. In accordance with 5.207(c)(16)(ii), inquiries from any interested offerors would have been evaluated accordingly by the contracting officer prior to issuance of the sole source contracts; however, the Government did not receive any responses to this notice. To date, no other sources have written to express interest in the acquisition.

10. Other Facts:

a. Procurement history:

(1) Contract numbers and dates of the last several contracts for these same requirements.

Ohio State University (JW200164) HU00012020008 – “Predicting and Preventing Low Back Pain in MARSOC Raider Trainees, Marine Raiders and Marine Aviators at Camp Lejeune”; the previous award is a cooperative agreement which was awarded to the Henry M. Jackson Foundation. Ohio State University served as a subawardee on the previous award.

Period of Performance: 15 November 2019 – 14 November 2022

(2) Competitive status of these actions.

Ohio State University (JW200164) HU00012020008 – “Predicting and Preventing Low Back Pain in MARSOC Raider Trainees, Marine Raiders and Marine Aviators at Camp Lejeune” The previous cooperative agreement was awarded on a competitive basis to the Henry M. Jackson Foundation.

(3) Authority previously cited if less than full and open competition was used.

This section does not apply to Ohio State University,

(4) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results.

(5) If any prior contract for this requirement was accomplished using full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources.

The previous acquisitions for Ohio State University, described above were accomplished through full and open competition. Section 5, above, explains the circumstances which require that these new contracts be on a sole source basis.

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys.

No unusual patterns have been found.

(7) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the procurement and whether there have been any significant changes.

b. Other facts

N/A

11. Technical Certification:

I certify that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Angel M. Davey Date:

Program Manager Signature:

12. Requirements Certification:

I certify that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Angel M. Davey Date:

Program Manager Signature:

13. Fair and Reasonable Cost Determination:

I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable. A cost analysis will be conducted to determine if the proposed budget is fair and reasonable. Certified cost or pricing data will be required in accordance with FAR 15.403.

This determination will be made using the following: cost analysis price analysis should cost IGE audit: other:

As a part of this basis, certified cost or pricing data:

will be required.

will not be required and the following exception applies (FAR 15.403):

Prices that will be agreed upon are based on adequate price competition.

Prices that will be agreed upon are based on prices set by law or regulation.

A commercial item is being acquired.

A waiver has been granted by the head of the contracting activity (HCA) in accordance with DFARS PGI 215.403-1.

DAVEY.ANGEL.M

ARIE.1461049903

Digitally signed by

DAVEY.ANGEL.MARIE.1461049903

Date: 2021.02.10 06:33:23 -05'00'

DAVEY.ANGEL.M

ARIE.1461049903

Digitally signed by

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Date: 2021.02.10 06:33:44 -05'00'

The contract action is a modification to a contract or subcontract for commercial item(s).

The estimated cost of the contract action is less than the threshold for certified cost or pricing data.

Patrick K. Harris Date:

Contracting Officer Signature:

14. Contracting Officer Certification:

I certify that this justification is accurate and complete to the best of my knowledge and belief.

Patrick K. Harris Date:

Contracting Officer Signature:

HARRIS.PATRIC

K.K.1395451320

Digitally signed by

HARRIS.PATRICK.K.1395451320

Date: 2021.02.10 07:42:41 -05'00'

HARRIS.PATRICK.K.

1395451320

Digitally signed by

HARRIS.PATRICK.K.1395451320

Date: 2021.02.10 07:42:59 -05'00'

Approval Command Advocate for Competition

Based on the foregoing justification, I hereby approve this procurement of the above mentioned services from Ohio State University, in the amount of $9,227,782 on an other than full and open competition basis pursuant to the authority of 10 U.S.C.2304(c)(1) and FAR 6.302-1(a)(2), subject to availability of funds, and provided that the services or property herein described have otherwise been authorized for acquisition.

CHRISTOPHER E. SHERMAN Date:

Command Advocate for Competition Signature:

SHERMAN.CH

RISTOPHER.E.

1230688741

Digitally signed by

SHERMAN.CHRISTOP

HER.E.1230688741

Date: 2021.02.19 07:23:16 -05'00'