A03-Sole_Source_Justification_FDP_Redacted.pdf

DEPARTMENT OF THE ARMY

US ARMY MEDICAL RESEARCH ACQUISITION ACTIVITY

820 CHANDLER STREET

FORT DETRICK MD 21702-5014

Control No: JA18212

Sole Source Justification (SSJ) in accordance with FAR subparts 13.106 or 13.5 using Simplified Acquisitions Procedures (SAP)

1. Contracting Activity: United States Army Medical Research Acquisition Activity

(USAMRAA)

2. Requiring Activity: United States Army Medical Materiel Development Activity

(USAMMDA)

3. Nature of Action:

Commercial Item Non-Commercial Item New Requirement Follow-on Requirement Mod to Existing Purchase Order/Contract Number

Pricing: Firm-Fixed Price* Time & Materials** Cost*

* See FAR 12.207(a)

Funds: RDT&E Operations and Maintenance, Army (OMA)

Other Funds:

Fiscal Year of Funds: 2017

Estimated Total Dollar Value including Options: $426,323.73

4. Contractor Name:

Name of Proposed Contractor(s): SP Scientific Street Address: 935 Mearns Road City, State, Zip: Warminster, PA 18974 Phone:

DUNS:

CAGE Code:

5. Description of Supplies/Services: USAMMDA has a requirement to procure validation services and essential equipment required for the validation of Government Furnished Equipment that is being utilized under a CRADA by Vascular Solutions, Inc.

for the manufacturing development and Food and Drug Administration approval of a Freeze-dried Plasma product (FDP) that will be used on the battlefield to save lives of casualties with severe hemmorhage. The Food and Drug Administration has agreed to fast-track the approval process of the DoD's Freeze-dried Plasma product (FDP) which necessitates this action be completed as soon as possible. The Period of Performance (PoP) for this requirement will be one five (5) month base period.

6. Authority Cited: 41 U.S.C. 1901 OR 41 U.S.C. 1903

(a) FAR 13.106-1(b)(1)(i): Only one source reasonably available (e.g., urgency, exclusive licensing agreement, brand name or industrial mobilization); OR

(b) FAR 13.106-1(b)(1)(ii): Only one source can provide a portion of the purchase that is a particular brand-name item; OR

(c) FAR 13.501(a)(1)(i): Only one source reasonably available (including brand name); OR

(d) FAR 13.501(a)(1)(ii): Only one source can provide a portion of the purchase that is a particular brand-name item.

7. Reason for Authority Cited: This authority was cited because SP Scientific is the only source that can meet the Government’s requirement for all necessary System Integration Testing services to ensure USAMMDA owned lyophilizers operate within manufacturing specification. SP Scientific is the manufacturer and the sole maintainer of the following USAMMDA owned lyophilizers:

Additionally, SP Scientific is the only supplier of all necessary replacement/maintenance parts to fully support continued operational maintenance for all USAMMDA owned lyophilizers. Due to their sole ability to meet the outlined Government need, no other entity in the marketplace can meet the System Integration Testing services needed by the Government on the SP Scientific manufactured lyophilizers.

8. Efforts to obtain Competition: The System Integration Testing services are unique to each lyophilizer mentioned above. SP Scientific is the manufacturer of each lyophilizer, and SP Scientific is the only source that can meet the Government’s requirement for all necessary System Integration Testing services and supply of all necessary replacement/maintenance parts. Therefore, there is no opportunity to allow for increased competition to meet USAMMDA’s current requirement.

a. Effective competition. No effective competition is expected for this acquisition.

b. Subcontracting competition. It is not expected that subcontracting opportunities exist for this acquisition.

9. Actions to remove or overcome barriers Competition: No further actions will be taken to overcome barriers to competition. The Government has performed extensive market research and SP Scientific provides the only solution that meets the needs of the Government without extensive cost or schedule overruns.

10. Market Survey: The acquisition exceeds the simplified acquisition threshold (SAT), therefore, it is not set aside for small business.

Market research was performed using the internet as well as communications with the Freeze Dried Plasma (FDP) Cooperative Research and Development Agreement (CRADA) partner. Although there are multiple suppliers for some of the replacement/maintenance parts, there is no other source that can meet the Government’s requirement for all necessary System Integration Testing services and supply of all necessary replacement/maintenance parts.

A notice of intent to sole source was posted to Fedbizops on 01 August 2018 to notify the public of the Government’s intent to award a contract to Labvantage Solutions, Inc.

The notice expires on 17 August 2018 and it is not expected that any further responses will be received.

11. Interested Sources: A Notice of Intent to award a Sole Source award will be posted for 15 days on the Federal Business Opportunities website to afford the public an opportunity to response with a capability statement. It is not expected that any responses will be received.

12. Procurement History and any other facts:

This is a new requirement and there is no previous procurement history for this action.

13. Technical / Requirements Certification: I certify that the support data under my cognizance which are included in this SSJ are accurate and complete to the best of my knowledge and belief.

Submitted by Signature:

Printed name: Andrew J. Atkinson Agency/Position/Title: USAMMDA/Product Manager E-Mail Address:

Date:

14. Contracting Officer Certification and Approval: I certify that this justification is accurate and complete to the best of my knowledge and belief. Based upon the facts described herein, I hereby determine that the anticipated price to the Government will be fair and reasonable, and a determination of price reasonableness will be documented and placed in the contract file.

Contracting Officer Signature:

Printed name: Patrick K. Harris Agency/Position/Title: USAMRAA, Contracting Officer E-Mail Address:

Date: