A02-1-Redacted-Amended-JA-Hydrogel-2_Redacted.pdf

Control No: JA-20-06-00119(amended) Contractor:

Program: Hydrogel Embedded Dexamethasone

Version – September 2018 FOR OFFICIAL USE ONLY

JUSTIFICATION REVIEW DOCUMENT

Amendment to FAR PART 6 JUSTIFICATION AND APPROVAL FOR OTHER THAN

FULL AND OPEN COMPETITION

Program/Equipment: Hydrogel Embedded Dexamethasone for Traumatic Brain Injury (TBI)

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:

Prepared by: DSN:

Date: 25-Jun-20

Contracting Officer: Laura Tomitz Contracting Officer Email: laura.a.tomitz.civ@mail.mil

DSN:

Date:25JUN 2020

Technical: DSN:

Date: 25-Jun-20

Requirements: DSN:

Date: 25-Jun-20

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

Program Manager:

Typed Name:

DSN:

.SU

Signature:

Legal Counsel:

Typed Name:

Right-Click "Signature Setup"

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Program: Hydrogel Embedded Dexamethasone

Version – September 2018 FOR OFFICIAL USE ONLY

FAR Part 6 Justification and Approval for Other than Full and Open Competition

1. Contracting Activity: The Contracting Activity is the United States Army Medical Research Acquisition Activity (USAMRAA). The Requiring Activity is the Walter Reed Army Institute ofResearch

(WRAIR).

2. Description of Action: This is a new requirement to conduct research using degradable, synthetic hydrogel. Dexamethasone will be embedded into the hydrogel creating Hydrogel Embedded Dexamethasone, or dexamethasone delivered via PEG-hydrogel. This compound is required for Traumatic Brain Injury (TBI) research for the Brain Trauma Neuroprotection (BTN) Branch at the WRAIR. BTN requests a new, cost reimbursement contract with , located at

. The Government projects award for August 2020 and fiscal year 2020, RDT&E funds will be used.

3. Description of Supplies/Services: The purpose of this requirement is to provide the technical expertise and research services necessary to perform traumatic brain injury and neuroprotection research in support of the BTN Branch at Walter Reed Army Institute of Research (WRAIR). The Contractor shall deliver and determine the pharmacokinetic (PK) profile of dexamethasone delivered via PEG-hydrogel, and conduct studies that specifically evaluate the therapeutic efficacy of dexamethasone-embedded PEG-hydrogel treatment on neurobehavioral (i.e. motor and cognitive) outcome measures. Additionally, the Contractor shall evaluate the acute post-injury dexamethasone-embedded PEG-hydrogel treatment on measures of injury-induced edema, inflammatory cytokine upregulation, and neuroinflammation. These are nonseverable, research and development services.

A potent anti-inflammatory drug, dexamethasone, will be embedded in to the hydrogel. The dexamethasone - biodegradable polyethylene glycol (PEG)-hydrogel scaffold will be used to seal a wound caused by a traumatic brain injury in an animal model. The biodegradable polyethylene glycol (PEG)-hydrogel scaffold will facilitate the controlled, continuous release of drugs directly into the injured brain. This project represents an effort by WRAIR using patented material to evaluate the therapeutic efficacy of dexamethasone-embedded PEG-hydrogel treatment in two different traumatic brain injury animal models.

Three Year Period: 2020 to August 2023 Total Estimated Value:

4. Authority Cited: 10 U.S.C. 2304(c)(1), as implemented by FAR 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements.

5. Reason for Authority Cited: As described at FAR 6.302-1(b)(2), the existence of limited rights in data, patent rights, copyrights, or secret processes; the control of basic raw material; or similar circumstances, make the supplies and services available from only one source.

The use and method of making this degradable hydrogel is patented to under Patent No. US 7,754,241 B1. This requirement is for support necessary to perform traumatic brain injury and neuroprotection research, which requires a degradable, synthetic hydrogel only available through Clemson University.

6. Efforts to Obtain Competition: The Contracting Officer published the notices required by FAR

5.201. No proposals or bids were received in response to the notices.

a. Effective Competition: A sources sought was posted to Federal Business Opportunities (FBO) on 27 May 2020 for ten (10) calendar days in order to determine whether there were any viablecandidates

Contractor: Clemson University Program: Hydrogel Embedded Dexamethasone

Version – September 2018 FOR OFFICIAL USE ONLY with the knowledge, experience and/or capability of providing Hydrogel Embedded Dexamethasone, however, no responses were received.

b. Subcontracting Competition: Not applicable. No subcontracting competition is expected to exist for this requirement.

7. Actions to Increase Competition: No effort was taken; Clemson University is the only vendor capable of meeting the Government’s need.

8. Market Research: 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), Market research was conducted, on 10 March 2020, using historical data and internet research. At this time, only one known source, Clemson University, has been identified that can meet the Government’s needs to provide support for this effort. A sources sought was posted to FEDBizOPS (FBO) on 29 April 2020, no responses were received. A notice of intent to Sole Source was posted to FBO on 4 June 2020 and no responses were received. Based on the market research, Clemson University, is the only sourcethat can provide the required services.

9. Interested Sources: 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. Not applicable.

(2) The competitive status of these actions. Not applicable.

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

(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. Not applicable.

(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. Not applicable.

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys. Not applicable.

(7) If a justification was prepared to support the procurement made before this one, briefly describethe circumstances justifying the procurement and whether there have been any significant changes. Not applicable.

Program: Hydrogel Embedded Dexamethasone

Version – September 2018 FOR OFFICIAL USE ONLY

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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 andbelief.

Typed Name: Date: 25-Jun-20 Title: Signature:

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12. Requirements Certification: I certify that the supporting data under my cognizance whichare included in the justification are accurate and complete to the best of my knowledge and belief.

Typed Name: Date: 25-Jun-20 Title: Signature:

Program: Hydrogel Embedded Dexamethasone

Version – September 2018 FOR OFFICIAL USE ONLY

X Right-Click "Signature Setup"

13. Fair and Reasonable Cost Determination: I hereby determine that the anticipated cost or price tothe Government for this contract action will be fair and reasonable.

This determination will be made usingthe 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.

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

In accordance with FAR 15.403-4(a)(1), the estimated cost of the contract action is less than the threshold ($750,000) for certified cost or pricing data.

Signature: Date:

Typed Name: Laura Tomitz Title: Contracting Officer

14. Contracting Officer Certification: I certify that this justification is accurateand complete to thebest of my knowledge and belief.

Typed Name: Laura Tomitz Date:

Title: Contracting Officer Signature:

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Control No: JA-20-06-00119

Program: Hydrogel Embedded Dexamethasone

Version – September 2018 FOR OFFICIAL USE ONLY

Approval Based on the foregoing justification, I hereby approve the procurement of hydrogel protocol research and development at on a sole source basis pursuant to the authority of the 10 U.S.C.2304(c)(1), subject to availability of funds, and provided that the services or supplies herein described have otherwise been authorized for acquisition.