Redacted_J&A_PTSD_Samples_Redacted.pdf

Control No: JA-18-185

"For Official Use Only”

Sole Source Justification (SSJ) in accordance with FAR subpart 13.5 using Simplified

Acquisitions Procedures (SAP)

1. Contracting Activity: The Contracting activity for this action is the U.S. Army Medical

Research Acquisition Activity (USAMRAA), 820 Chandler Street, Fort Detrick, MD 21702-

5014.

2. Requiring Activity: The requiring activity for this action is the U.S. Army Center for

Environmental Health Research (USACEHR) BLDG 568 Doughten Drive, Fort Detrick, MD

21702.

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)

** See FAR 12.207(b).

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

* Firm Fixed Price: _______

**Time & Materials: _______

* Cost: _______

Funds:

Fiscal Year of Funds:

Estimated Total Dollar Value including Options:

4. Contractor Name:

Contractor: The Mclean Hospital Corporation

Street Address: 115 Mill Street

City, State, Zip: Belmont, MA, 02478-1041

Phone:

Duns: 046514535

Cage: 1F6D4

5. Description of Supplies: The U.S. Army Center for Environmental Health Research

(USACEHR) has a requirement for the purchase and processing of four hundred (400) genomes samples unique to Dr. Kerry J. Ressler’s laboratory at the Mclean Hospital.

The Minimum Essential Characteristics (MECs) for the samples are as follows:

1. The samples shall be collected from participants in the early morning and the participants shall be instructed to fast overnight. Similar to blood draws for most standard clinical assessments, Post-Traumatic Stress Disorder (PTSD) analytes vary markedly throughout the day and are dependent on the variability of food intake.

2. The participants shall have been tested for PTSD and other confounding co-morbidities using standardized psychological tests.

3. Shall include both male and female participants and have appropriate demographics to compare with the military population (education, age, male/female).

4. Shall have a full spectrum of symptoms of PTSD spanning from no symptoms through fully characterized PTSD.

5. Is willing to provide samples without commercial/institutional/agency (etc.) constraints.

6. Serum and DNA sample aliquots shall be provided to USACEHR after Quality Control checks.

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:

Only one source is reasonably available due to continuity and consistency of results within

USACEHR’s ongoing research efforts. The Surgeon General of the United States Army, Navy, and Air Force instructed the PTSD Systems Biology Consortium to determine an objective signature of PTSD, which could be used as a diagnostic tool. The PTSD Systems Biology

Consortium’s focus is to establish biomarkers for military-acquired PTSD.

Dr. Ressler of the McLean Hospital/Harvard Medical School has the only available collection of samples that can meet USACEHR’s requirement. Dr. Ressler’s laboratory has collected unconstrained samples (funded by NIH) in the precise manner outlined by the consortium from approximately 1200 civilian personnel, both male and female, with samples being clearly classified as PTSD, subthreshold PTSD, or no indication of PTSD (but all exposed to trauma). In the study group over 35% have clinical, DSM-IV-defined PTSD (a standardized psychological assessment tool) and there are traumatized control groups with subclinical PTSD as well as those without any symptoms. Dr. Ressler’s study group contains interpersonal psychotherapy (IPT) which aids in moving the project to advanced development, specifically FDA approval of our diagnostic tools.

For scientific and programmatic consistency, USACEHR will need to complete ongoing multi-year research projects using the same system that was previously developed using Dr. Ressler’s study group.

8. Efforts to obtain Competition: The required samples are unique to Dr. Ressler’s laboratory at the McLean Hospital. Therefore there is no opportunity to allow for increased competition to meet USACEHR’s current requirement. If there are changes in the market in future years and the required samples are available from another source, such vendors would be allowed to compete for future acquisitions of this kind. USACEHR will also continue to reevaluate mission requirements and products that meet those needs in future actions.

a. Effective Competition: No competition is available for the required genomes samples.

b. Subcontracting Competition: Not applicable as this is a supply requirement. The cell cultures being procured are proprietary and therefore no subcontracting opportunities exist for this requirement.

9. Actions to remove or overcome barriers Competition: The Government will continue to survey the market place to determine if there are any other sources capable of providing the specified customized samples required for future research.

10. Market Survey: In preparation for this requirement, USACEHR staff researched other available sample sets through online and industry contacts. However, the required samples are unique to Dr. Ressler’s laboratory at the McLean Hospital Corporation.

11. Interested Sources: A Notice of Intent to award a Sole Source was posted on 11 June 2018 for 15 days on the Federal Business Opportunities website to afford the public an opportunity to respond with a Capability Statement. No responses were received in response to the Notice of

Intent.

12. Procurement History and any other facts:

Previous Contract or Purchase Order Number: N/A

Previously competed: N/A

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.

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.