Redacted_J&A.pdf

Control No: JA-19-11-020

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

1. Contracting Activity: United States Army Medical Research Acquisition Activity (USAMRAA), 1504 Porter Street, Fort Detrick, Maryland 21702

2. Requiring Activity: Walter Reed Army Institute of Research, 503 Robert Grant Avenue Silver Spring, Maryland 20910

3. Nature of Action:

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

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

* See FAR 12.207(a) ** See FAR 12.207(b)

For Hybrid Contracts, list percentage of each type of pricing:

* Firm Fixed Price: N/A ** Time & Materials: N/A

* Cost: N/A

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

Other Funds:

Fiscal Year of Funds: FY18/19

Estimated Total Dollar Value including Options: $6,300,000.00

4. Contractor Name:

Name of Proposed Contractor: Fisher Bioservices, Inc.

Street Address: 14665 Rothgeb Drive City, State, Zip Code: Rockville, MD 20850 Phone: 240-618-1423 DUNS No: 161157953 Cage Code: 0M6N4

MCMR-AAA-A

SUBJECT: Justification and Approval for Consultation for Oversight and Management of Biorepository and Chemical Information Systems

5. Description of Supplies/Services:

The Walter Reed Army Institute of Research (WRAIR) conducts biomedical research that is responsive to Department of Defense and U.S. Army requirements and delivers life-saving products including knowledge, technology and medical material that sustain the combat effectiveness of the Warfighter.

The Experimental Therapeutics (ET) Branch is part of the WRAIR. The mission of the ET Branch is to discover and develop new pharmaceutical agents to protect military members from death, disease, and injury. The ET Branch is the nation’s primary developer of new drugs to prevent and/or treat malaria and leishmaniasis. Collectively, ET engages in drug discovery, drug efficacy and mechanism evaluation, and formal preclinical and clinical development.

This is a non-personal requirement is for the oversight and management of biorepository and chemical information systems. This effort requires the contractor to meet all security and regulatory compliance requirements and to provide all qualified personnel, facilities, equipment, materials, and services to operate a chemical biorepository. This includes the receipt, storage, and maintenance of approximately one million samples of approximately 800,000 different compounds, chemicals, and drugs with an additional average of approximately 5,000-6,000 new samples entering the program annually from the Experimental Therapeutics (ET) branch at WRAIR along with its collaborators and partners. The contractor shall also prepare and ship approximately 15,000 compounds, chemical, and drug samples to various CONUS and OCONUS locations.

The contractor shall store, administer, and maintain manual, digital, and imaged chemical information and inventory systems for the storage and retrieval of chemical sample data sheets, investigational new drugs (INDs), clinical protocols, and other documents. The contractor shall also provide administration and maintenance of the relational database system (RDS) and associated third-party commercial-off-the-shelf (COTS) software Laboratory Information Management System (LIMS).

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 reasonable available

(including brand name) OR

(c) 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:

Fisher Bioservices, Inc. currently manages the receipt, storage, and maintenance of over one million WRAIR samples of approximately 800,000 different chemical compounds, including chemical elements, drugs, formulations, pharmaceuticals, natural products, radioisotopes, and radioactive samples. Relocating WRAIR’s quantity of samples to a different biorepository facility would pose substantial duplication of cost to the Government in the amount of $XXXXX - $XXXXX (i.e.

$XXXXX per sample), which equates to the cost of one year of service/performance under this contract.

Loss or mishandling of delicate research samples which require specific storage conditions (temperature, radiological, or GMP requirements) could jeopardize years of progress on these projects to include ongoing research projects in anti-malarial drug development (e.g., triazine, pyrimidinylguanidine, and 8-aminoquinoline) as well as the Presidential initiative for Combating Antibiotic Resistant Bacteria (CARB). These projects, which total more than $XXXX in active grant funding, rely on ready access to samples in the biorepository for ongoing pre-clinical and clinical testing protocols.

8. Efforts to obtain Competition:

a. Effective competition. Not applicable. No effective competition is anticipated as there is no other source available to perform these required services.

b. Subcontracting competition. Pursuant to Federal Acquisition Regulation (FAR) 19.702, a small business subcontracting plan will be a requirement set forth in the solicitation package. This will ensure the prime contractor obtains as much competition as possible in its subcontracting obligations.

9. Actions to remove or overcome barriers Competition: Not applicable. No effort will be made to remove or overcome barriers to competition as there is only one source capable of performing the required services. However, the Government will assess the market place at the end of the performance period in an effort to promote competition, if applicable.

10. Market Survey: Market Research was conducted on FBO.gov website through a Request for Information (RFI) (i.e. W81XWH19R0002RFI) which was posted on 03 October 2018 for thirteen (13) calendar days with only one (1) response received which was from CAMRIS International. Their capabilities statement was evaluated by the Government and determined the Respondent was unable to meet the requirements of the PWS, since their Nuclear Regulatory Commission (NRC) material license only permits storage up to 30 millicuries of H3 (tritium, a radioactive isotope of hydrogen) and this effort requires over 429 millicuries. Modifications to these licenses typically require at least 45 days or longer. Additionally CAMRIS International’s NRC material license does reflect the capability of storing Ba133 or Cs137 isotopes, which is also needed. The Notice of Government Intent to Sole Source was posted on FBO.gov on 19 October 2018 for fifteen (15) calendar days with one (1) response received from Bracane Company. Their capabilities statement was evaluated by the Government and determined the Respondent was unable to meet the requirements of the PWS since their qualifications indicate management of clinical trials, site selection and monitoring through study design and interpretation and included nothing to indicate they have logistical or storage capability. Based on results of the RFI, the Government determined that the only viable vendor with the capabilities able to meet the requirements set forth in the Performance Work Statement (PWS) is the incumbent, Fisher Bioservices, Inc.

11. Interested Sources: Respondents included two(2):

Both are unable to meet the requirements of the PWS.

CAMRIS International, 3 Bethesda Metro Center Floor 16 Bethesda, MD 20814 and

Bracane Company 1201 East 15th Street Plano, TX 75074

12. Procurement History and any other facts:

Previous Contract Number:W81XWH-14-C-0055

Previously competed: Yes. This requirement is a follow-on to W81XWH-14-C- 0055, which was previously competed full and open. The previous solicitation was posted for thirty-four (34) calendar days with only two (2) proposals received, one from the incumbent, Fisher Bioservices, Inc. and the other from Srisai Biopharmaceutical Solutions, LLC. Proposals were evaluated on a best value “tradeoff process” basis. The incumbent, Fisher Bioservices, Inc. received an overall rating of “Outstanding” while the competitor received a rating of “Marginal.”

Previous authority for less than Full & Open Competition: N/A

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:XXXXXX Agency/Position/Title: XXXXXX Email Address: XXXXXXX Date: 11/19/2018

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/cost 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 Printed Name: XXXXXX Agency/Position/Title: USAMRAA Contracting Officer Email Address: XXXXXX Signature:

15. I hereby determine this SSJ to be legally sufficient.

Type Name: XXXXXXX CPT, JA Date:

XXXXXX

Title: Acquisition Attorney Signature: XXXXXX

Approval Command Advocate for Competition

Based on the foregoing justification, I hereby approve the procurement of “Oversight and Management of Biorepository and Chemical Information Systems” on an other than full and open competition basis pursuant to the authority of 41 U.S.C. 1903, as implemented by FAR subpart FAR 13.501(a)(1)(ii), subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

Date: Signature: XXXXXXXXXXXXXXXXXXX Command Advocate for Competition