C JEFO_Redacted.pdf

JUSTIFICATION FOR AN EXCEPTION TO FAIR OPPORTUNITY

1. Identification of the Agency and Contracting Activity.

a. Federal Agency and Contracting Activity.

Department of Health and Human Services National Institute of Health National Institute on Drug Abuse

b. Sponsoring Organization.

Department of Health and Human Services National Institute of Health National Center for Advancing Translational Sciences

c. Project Officer Information.

Dr. Craig Thomas, Leader of Chemistry Technologies, NCATS

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

a. Acquisition purpose and objectives. The purpose of this acquisition is to obtain extended Chemistry, Manufacturing, and Controls (CMC) studies for the development of 2R,6R-Hydroxynorketamine (2R,6R-HNK) as a therapy for treatment resistant depression.

b. Project background. Major Depressive Disorder (MDD) is a widespread medical condition with nearly 300 million worldwide patients and is a leading cause of disease burden in North America. Currently, over a dozen pharmaceuticals which target monoaminergic systems are utilized as the leading pharmaceutical treatment for MDD. However, most patients require weeks of treatment in order to see improvement in their symptoms. Moreover, up to 40% of patients do not respond to conventional pharmaceutical treatment. Due to these concerns, there is a large unmet medical need for MDD and especially for treatment-resistance MDD. Recently, the well-known sedative ketamine has generated significant interest as an effective and rapid acting antidepressant.

Ketamine has been used safely and effectively as an anesthetic for the last 50 years. Recently, several clinical trials have shown that the use of subanesthestic intravenous ketamine yields an antidepressant effect in patients with MDD. This antidepressant action is unique in that it is fast-acting (antidepressant effects within hours, not weeks), and long-lasting (one IV injection lasts up to a week).

To date, we have conducted extensive CMC studies as part of our efforts to develop 2R,6R-HNK.

Additional research and manufacturing are now needed to continue this work;

3. Description of the Requirement.

a. Project title. Extended CMC studies for the development of 2R,6R-HNK as a therapy for treatment resistant depression.

b. Project description. This requirement extends and expands this existing work around 2R,6R-HNK as a therapy for treatment resistant depression and includes the completion of six (6) key studies:

1) Investigation into the particle size alterations in different batches of the drug substance

2) Capsule compatibility testing and dissolution analysis

3) Additional CMC work

4) Demonstration batch of 2R,6R-HNK

5) Production of a new Good Manufacturing Practice (GMP) batch of 2R,6R-HNK

6) Stability studies

c. Requirement type.

Support services (non-research & development) Supplies/equipment Information technology (IT)

X Research and Development (R&D) Other (specify): ____________________

d. Type of action.

New requirement X Follow-on to HHSN271201700008I / HHSN27100001. Task Order HHSN27100001 has a period of performance of September 24, 2018 through October 31, 2020 and has a total award amount of $734,162.00.

Other (specify): ______________________

e. Proposed order type.

Firm-fixed-price Time and materials Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________ X Cost Reimbursement: ___________

Other (specify): ________________

f. Acquisition identification number.

The solicitation and resulting task order reference number will be N01TR-17- 2001-05.

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

The total estimated dollar value is The period of performance is expected to be 36 months, but the Offeror may propose an alternate period of performance. A 36-month period of performance was identified as a reasonable amount of time to complete the required activities based on the Program Official’s knowledge of the activities. However, the Offeror will be allowed to request a longer period of performance; there may be organizational factors that require more than 36 months, or residual effects from the COVID-19 quarantine may slow the pace of certain activities, or other factors. It is not critical that the activities be completed by a specific date and NCATS wants to allow the Offeror an opportunity to propose an alternate period of performance if needed. As such, the solicitation will specify that the anticipated period of performance is 36 months and state that the Offeror may propose an alternative period of performance.

The ultimate period of performance may be longer than 36 months but will not exceed 60 months. This task order is for non-severable services and the period of performance may not exceed 60 months. If the Offeror proposes a price in excess of the originally-anticipated and the price is determined to be fair and reasonable, it will be confirmed that adequate funding is available to cover the price of this task order.

The anticipated period of performance for the proposed task order is August 21, 2020 through August 21, 2023. The exact start date will be determined based on the pace of the acquisition process and the ultimate award date.

4. Market Research. The market research conducted includes a scientific evaluation of work and a review of other potential awardees. The Program Official at NCATS evaluated the status of work under the current task order and the work to be completed under this proposed task order. The Program Official reviewed the proposals and capabilities of the other contractors with an IDIQ under this technical area that proposed on the current task order. The results of these evaluations conclude that a follow-on task order to the incumbent contractor, the University of Minnesota, is the most appropriate acquisition approach.

The other contractors with an IDIQ under this technical area are capable of performing the required activities but have no extraordinary expertise or experience that outweighs the additional time and expense of transitioning this work to another vendor. None of the other vendors have exceptional knowledge or recent experience with this exact compound to enable them to perform the activities under the new task order without first performing the foundational work that’s already been completed by the University of Minnesota. Any other vendor would need to re-perform this foundational work at a substantial investment of additional time and resources (see Section 5.a below). The additional investment would produce no benefit to this work or to the project as a whole and would outweigh the benefit of competition.

5. Identification of the justification rationale [see 16.505(b)(2)] for exceptions to the fair opportunity process.

a. Interest of Economy and Efficiency. FAR Subpart 16.505(b)(2)(i)(C) – The order must be issued on a sole-source basis in the interest of economy and efficiency because it is a logical follow-on to an order already issued under the contract. All IDIQ holders under this technical area were provided fair opportunity to be considered for the original task order.

Award of this task order to any other contractor would require the duplication of much work that the University of Minnesota has already completed under Task Order HHSN27100001.

This work has been performed by the University of Minnesota over the past 18 months since Task Order HHSN27100001 was awarded in September 2018; it would take another contractor almost as much time to duplicate this work.

This duplicative work would also require additional re-investment. Task Order HHSN27100001 is funded at $734,162.00 and the Government estimates that the duplicative work would cost NCATS an additional

Award of this task order to any other vendor would result in significant loss of time and investment to the NIH and ultimately to taxpayers. It would disrupt the clinical examination of 2R,6R-HNK and delay the examination of a potentially transformative therapy for Major Depressive Disorder and the 300 million people who suffer from it.

6. Determination by the Contracting Officer that the anticipated cost to be fair and reasonable. The Contracting Officer will ensure the proposed price is fair and reasonable before task order award by performing a cost realism analysis and price analysis on the Offeror’s proposal.

7. Any other facts supporting the justification. N/A

8. Statement of the actions, if any, the agency may take to remove or overcome any barriers that led to the exception to fair opportunity before any subsequent acquisition for the supplies or services is made.

a. Removal of barriers to competition. The Government has no plans to take additional action to remove barriers to competition in regard to this requirement.

The incumbent contractor’s IDIQ contains a requirement to prepare a Transition Plan in advance of task order expiration, to facilitate the transition to a successor contractor. However, the experience gained and data developed by a contractor during the performance of a task order, which may reasonably result in a logical follow-on order such as this, is difficult and often not reasonable to mitigate.

b. Listing of sources, if any, that expressed an interest, in writing, in the acquisition. None.

9. Program office certification.

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 or requirements, or other rationale for an exception to fair opportunity, are accurate and complete.

Official Name & Title Signature and Date

Project Officer

Project Officer’s Immediate Supervisor

Head of the Sponsoring Program Office*

*The Head of the Sponsoring program is the individual at least one level above the Project Officer’s Immediate Supervisor

10. Contracting Officer Certification and Approval Signature(s).

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.

Action Official Name & Title Signature and Date

Review Contracting Officer

Concur Chief of the Contracting Office

Concur Head of the Contracting Activity

Certify & Approve

Competition Advocate

Revised 08-01-2016

Craig Thomas

Kimberly Espinosa

Kimberly A.

Espinosa -S

Digitally signed by Kimberly A. Espinosa -S Date: 2020.06.09 06:45:37 -04'00'