JA_BioSurety_Redactedx.pdf

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Justification and Approval For other Than Full and Open Competition

1. CONTRACTING ACTIVITY

Army Contracting Command-Aberdeen Proving Ground, Natick Contracting Division, ATTN: CCAP-SCN, Kansas Street, Natick, MA 01760

2. DESCRIPTION OF ACTION

Approval is requested to solicit on the basis of other than full and open competition for a new contract.

The contract is in support of:

Continuation of the MCS-JVAP Biological Surety Agents and Toxins (BSAT) Program in compliance with Army Regulation 50.1 at IIT Research Institute (IITRI).

Type of contract contemplated: Cost Plus Fixed Fee.

Reason for type of contract:

The contract will support the maintenance of the BSAT program. The services can be clearly defined and priced.

Funding information:

This effort will be funded with Plague Vaccine BA5 RDT&E funding.

Fiscal Year: 17 Type of Money to be used:

Research Development Test and Evaluation.

3. DESCRIPTION OF SUPPLIES/SERVICES

The service provided under this contract is for the sustainment/maintenance of a Biological Surety Program that is compliant with DoD Biological Select Agents and Toxins Regulations to support the ongoing mission of the Joint Vaccine Acquisition Program (JVAP). This Biological Surety Program will include a Biological Personnel Reliability Program (BPRP) and is subject to routine Department of the Army Inspector General (DAIG) rated inspections and Surety Management Reviews. Activities to be conducted to support maintenance of the BPRP Program include: training, annual and ongoing medical evaluations, BSAT inventory, Badging, Hosting Audits, BSAT Security equipment maintenance, Emergency Response Drills, and annual vulnerability assessments.

The Period of Performance for this Requirement will be a Base Year Plus Four (4) Option Years for a total of , and shall not exceed Sixty (60) Months.

4. AUTHORITY CITED

The statutory authority permitting other than full and open competition is 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:

In accordance with FAR 6.302-1(a)(2)(iii), only one responsible source exists as using another source would result in a substantial duplication of costs to the Government and unacceptable delays in fulfilling the agency's requirement. This is a follow-on contract for the continued provision of highly specialized services.

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The requested services are needed to support the Plague vaccine program.

. The FDA also requires that these testing procedures be validated. The Government funded IITRI under a separate contract action to develop and validate these assays (i.e., potency). Transferring these assays to another BSAT complaint facility would be considered a duplication of effort and would significantly impact the program schedule, delaying FDA approval resulting in a delay in delivering a needed capability to the Warfighter. There would be a significant cost increase associated with transferring this effort to another facility as IITRI is the only entity that is BSAT complaint and has the validated assays to support FDA licensure of the Plague vaccine. If the subject contract were delayed, an unacceptable program delay of approximately Six (6) Months and duplication of cost estimated at to re-perform and validate plague assays and to become BSAT Compliant would be incurred.

6. EFFORTS TO OBTAIN COMPETITION:

No efforts will be made to obtain competition for this action at this time. Only two companies, and IITRI, currently meet the Army's BSAT requirements. However, IITRI is the only company that has the necessary, validated, plague assays needed for the current Biological Surety Program. Making a direct award to IITRI will result in a cost saving to the Government of about $3M as IITRI is the only facility that has the validated mouse potency assay needed to release the plague vaccine final drug product.

A notice of intent to sole source this action will be synopsized for Fifteen (15) Days via FedBizOpps prior to award to allow opportunity

7. ACTIONS TO INCREASE COMPETITION:

The - Team will continue to conduct market research to the maximum extent practicable to compete future acquisitions. Establishing additional sources will require inspection and approval by the Department of the Army Inspector General (DAIG) to demonstrate that the Offerer is compliant with Army Regulation 50.1; Biological Surety Agents and Toxins (BSAT). The Government will further assess alternate test facilities and conduct a business case analysis to determine if technology transfer of the validated assays is in the best interest of the Government.

8. MARKET RESEARCH

The market research effort was conduct in two phases:

1) Facilities that are BSAT complaint: MCS-JVAP identified Five (5) facilities that are BSAT compliant based on United States Army Inspector General Technical Inspections Division (DAIG) inspections. Three (3) of those facilities are Government labs and two (2) that are contractor owned and operated ( and IITRI).

2) Facilities that have a validated mouse potency assay to support the release of plague vaccine final drug product: The Government facilities do not have any validated assays to support the testing of the plague vaccine. does not have experience working with the plague vaccine nor does it have a validated mouse plague assay. IITRI is the only facility that has a validated

Page 5 of 720120507 mouse potency assay and can support the release of the plague vaccine under the BSAT Program.

9. INTERESTED SOURCES:

To date, no other sources have written to express an interest. A notice of intent to sole source this action will be synopsized via FedBizOpps Fifteen (15) Days before award to allow interested parties the opportunity to propose, if applicable.

10. OTHER FACTS:

Discuss any other facts supporting use of other than full and open competition, such as the following:

a. Procurement History When BSAT regulations were established, - worked with the prime contractor at the time, , to implement BSAT requirements with Subcontractors. This testing required the use of Biological Select Agent and Toxins (BSAT). Since IITRI was already BSAT Compliant, they were contracted directly to handle these biological select agents and toxins.

b. Acquisition Data Availability The current SOO requires the vendor to operate under the same guidance as originally determined. Given the need to procure continued services from the current incumbent, no documents will be prepared for open competition at this time.

c. Unusual and Compelling Urgency

Not Applicable

d. Subcontracting Competition There are no subcontracting efforts anticipated, however, should they arise, the contractor will be required to comply with the FAR requirements for competition in subcontracting.

e. Follow-on Contracts The original Contract for these BSAT Sustainment Services was a Sole Source Award. Due to the proprietary nature of the validated mouse plague potency assay for FDA licensure, this capability only exists at IITRI. In order to compete this requirement, the Government would have to establish a new BSAT Facility, Tech Transfer the assay from IITRI to a new Contractor, and then validate the mouse plague potency assay at the new facility. The cost to implement a new BSAT requirement is $3.5M and the cost to technology transfer and re-validate the mouse potency assays is about $4.0M. The cost of $7.5M is considered to be a substantial duplication of cost that could not be recovered through competition.

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.

Typed Name:

Date: 29 August 2016

Title:

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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.

Typed Name:

Date: 29 August 2016

Title:

Signature:

13. FAIR AND REASONABLE COST DETERMINATION:

I hearby determine that the anticipated cost to the Government for this contract action will be fair and reasonable.

The techniques to be used to determine fair and reasonable prices are:

price analysis.

As Part of the basis, certified cost or pricing data will be required.

If one of the exceptions in FAR 15.401 applies, please indicate.

Typed Name:

Date: 29 August 2016

Title:

Signature:

14. CONTRACTING OFFICER CERTIFICATION:

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

Typed Name:

Date: 29 August 2016

Title:

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APPROVAL

Based on the foregoing justification, I hereby approve the procurement of:

MCS-JVAP Biosurety Program in support of Plague vaccine on an other than full and open competition basis pursuant to the authority of 10 U.S.C. 2304(c)(1), subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

Date: