A03-JA-17031_FINAL_12-12-2016__REDACTED.pdf

Control No.: JA17031

PROCUREMENT SENSITIVE INFORMATION: Ref: FAR 3.104-3, Statutory & Releated Prohibitions, Restrictions & Requirements FAR 3.104-4, Disclosure, Protection & Marking of Contractor Bid or Proposal Information & Source Selection Information.

Justification and Approval for Other Than Full and Open Competition

1. CONTRACTING ACTIVITY:

The Contracting Activity responsible for this action is the U.S. Army Medical Research Acquisition Activity (USAMRAA)

2. DESCRIPTION OF ACTION:

The approval is being requested for a new 36 month pre-clinical study for a Cost Reimbursable Contract with the Safar Center for Resuscitation Research, at the University of Pittsburgh (Pitt) in support of the Brain Trauma Neuroprotection and Neurorestoration (BTNN) Branch at the Walter Reed Army Institute of Research (WRAIR).

This is an intramural Army Core funded project through the Program Area Directorates (PAD 2) - Combat Casualty Care Research Program (CCCRP). These services will focus on the evaluation of neurotherapeutic resuscitation strategies in polytrauma associated with traumatic brain injury. The estimated cost of this contract is $600,000.00 using FY 17 Research, Development, Test & Evaluation (RDT&E). A purchase request for $200,000.00 has been approved.

3. DESCRIPTION OF SUPPLIES/SERVICES:

The study is being performed as part of the CCCRP with WRAIR as the sponsor and the Pitt as the funder. As the sponsor, WRAIR is in control of the contractor performing the study.

Scope of work will include:

(a) Conducting animal experiments using a mouse model of controlled cortical impact (CCI) combined with hemorrhagic shock, to identify the optimal combination of resuscitation fluid and neurotherapeutic drugs for restoring systemic/cerebral perfusion and reducing cerebral edema. Specific tasks including, but not limited to:

i. Collecting the physiological data such as mean arterial pressure, brain tissue oxygen tension, intracranial pressure, and blood gases;

ii. Collecting edema data at specified time point using wet/dry method;

iii. Collecting proteomics/molecular data using Western blotting/ELISA/immunohistochemistry;

(b) Completion of data processing and analyses.

4. AUTHORITY CITED:

10 United States Code 2304(c)(1) as implemented in Federal Acquisition Regulation (FAR) 6.302- 1(a)(2)(iii) services may be deemed to be available only from the original source in the case of follow-on contracts for continued provision of highly specialized services.

5. REASON FOR AUTHORITY CITED:

An award to any other source would result in substantial duplication of costs (which could not be recovered through competition) and unacceptable delays in fulfilling the agency requirements.

PROCUREMENT SENSITIVE INFORMATION: Ref: FAR 3.104-3, Statutory & Releated Prohibitions, Restrictions & Requirements FAR 3.104-4, Disclosure, Protection & Marking of Contractor Bid or Proposal Information & Source Selection Information.

Duplication of Cost

Pitt demonstrates a unique and innovative capability, specifically with its controlled cortical impact (CCI) mouse model. The CCI was invented by the scientists at the Pitt and is used by many scientists studying brain injury.

Unique to the Safar Institute, is the added paradigm of hemorrhagic shock associated with polytrauma. Efforts to replicate the (CCI) along with the added paradigm would entail additional costs to produce an unverified equivalent; CCI has been utilized, assessed, and proven to be effective. Pitt would eliminate the substantial duplication of costs due to its expertise, familiarity, and process of the CCI in conjunction with the introduction of the hemorrhagic shock.

Unacceptable delays in fulfilling the agency’s requirement:

The combination of TBI and hemorrhagic shock is highly lethal, and the optimal resuscitation strategy for this combined insult has not been studied by other institutions/investigators. The addition of hemorrhagic shock in order to study polytrauma is a difficult and lethal procedure to perform; even in the hands of experienced technician the lethality rate is 10% for the animals being studied. Scientists at the Safar institute have developed a protocol that reduces the lethality and is highly reproducible. Going outside the Safar institute for a polytrauma model would increase the risk that the proposal would not be successful in identifying an optimal resuscitation strategy following a combined TBI and hemorrhagic shock. Training technicians to follow the established protocol and meet a low lethality rate would result in unacceptable delays.

Furthermore, the objective of this research is to support a pre-existing, approved project funded in support of the Combat Casualty Care Research Program (CCCRP). Unacceptable delays to the use of the CCI model would impact the larger project that is dependent on the results of the mouse model.

6. EFFORTS TO OBTAIN COMPETITION:

a. Effective competition. Current Market research has identified that no competition exists for

University of Pittsburgh with their unique expertise and technology in resuscitation and traumatic brain injury.

b. Subcontracting competition. Subcontracting any part of this requirement is not deemed beneficial to the Government as it increases the cost of the contract and increases risk of successful clinical trial.

7. ACTIONS TO INCREASE COMPETITION:

It is not possible to compete the current acquisition. There is no plan to continue this work after this research ends. No efforts to increase competition will be made.

8. MARKET RESEARCH:

Market research has been conducted using internet search (google.com, Pubmed database, Web of Science, and colleagues). No other research groups provide the expertise required by the current study.

9. INTERESTED SOURCES:

A Request for Information (RFI) was posted on FedBizOpps from 25 October 2016 to 8 November 2016. The RFI resulted in only one response from the University of Pittsburgh. The University of Pittsburgh provided a capability statement that was evaluated and determined acceptable by WRAIR.

10. OTHER FACTS: NONE

PROCUREMENT SENSITIVE INFORMATION: Ref: FAR 3.104-3, Statutory & Releated Prohibitions, Restrictions & Requirements FAR 3.104-4, Disclosure, Protection & Marking of Contractor Bid or Proposal Information & Source Selection Information.

a. Procurement history:

(1) Contract numbers and dates of the last several contracts for these same requirements: N/A

(2) Competitive status of these actions: N/A

(3) Authority previously used for less than full and open competition: N/A

(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:

N/A

(5) If any prior award was accomplished by full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources: N/A

(6) An explanation of any unusual patterns which may be revealed by the history, e.g., several consecutive, urgent buys: N/A

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

b. Other facts. N/A

PROCUREMENT SENSITIVE INFORMATION: Ref: FAR 3.104-3, Statutory & Releated Prohibitions, Restrictions & Requirements FAR 3.104-4, Disclosure, Protection & Marking of Contractor Bid or Proposal Information & Source Selection Information.

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.

signed

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.

Signed

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.

This will be a Cost Reimbursable Contract. Comparison of labor rates of other preclinical research contracts will be used to assess the rates. No certified cost and pricing indices will be used.

14. CONTRACTING OFFICER CERTIFICATION:

This certification shall be made by the contracting officer who will sign the contract resulting from this justification and approval. Include the following statement:

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