Sole_Source_J&A_Redacted.pdf

J&A Number: NMLC-18-10017

JUSTIFICATION AND APPROVAL FOR USE OF OTHER THAN FULL AND OPEN

COMPETITION

1. Contracting Activity.

This Justification and Approval (J&A) is executed by the Naval Medical Logistics Command (NMLC) on behalf of the requesting agency: Naval Medical Research Unit-Dayton (NAMRU-D, located in Dayton, OH).

2. Description of the Action Being Approved.

The contract action being proposed is the award of an indefinite delivery, indefinite quantity (IDIQ) contract with Firm Fixed Price (FFP) task orders to provide NAMRU-D up to 11,500 rodents of various strains at varying weights/ages. This is in support of research that focuses on the protection, resuscitation, and stabilization of combat casualties at echelon 1 and 2 points of care in the combat theater. The proposed source is Charles River Laboratories, Inc. (Charles River), 251 Ballardvale Street, Wilmington, MA 01887-7329.

3. Description of Supplies/Services.

Rodents to be provided under this IDIQ contract include: up to 200 Golden Syrian Hamsters, up to 200 Guinea Pigs, up to 200 Mongolian Gerbils and 100 White New Zealand Rabbits. Rodents are categorized based of weight or age depending on the strain of rodent.

The rodents provided must be of the same genetic makeup as the rodents used in the earlier research to provide genetic consistency and as to not invalidate earlier study results.

The ordering period for this IDIQ contract is divided into a base and four option periods, each consisting of 12 months, for a total of 60 months (if all options are exercised).

4. Statutory Authority Permitting Other Than Full and Open Competition.

The statutory exception permitting other than full and open competition for this acquisition is 41 U.S.C. 1901, as implemented by FAR 13.501; only one responsible source and no other supplies or services will satisfy agency requirements.

5. Rationale Justifying Use of Cited Statutory Authority.

Market research was conducted to ascertain what rodents are available in the commercial marketplace that will meet the requirements of the Government, as outlined in section 3.

Upon completion of this research, it was determined that although rodents are available from multiple suppliers, only Charles River provides animals with a genetic makeup that is consistent with the genetic makeup of the rodents used in earlier research studies. The rodents being procured are used in studies that build on and advance the research conducted in previous studies.

A critical linchpin to the overall integrity of the studies will be the ability to maintain uniformity in the processes and the supplies that have been used to date. Slight variations from the current controls and markers will make it impossible to validate this critical data and withstand any creditable peer review. This consistency is paramount toward ensuring the scientific data generated is reliable, which is critical when testing different vendor devices under that same research environment. Use of another vendor will result in inconsistent results and negatively impact the integrity of the entire study.

No rodents except those with a genetic makeup consistent with those utilized in earlier studies will meet the Governments requirement. As Charles River provided all of the rodents used in the earlier studies, they are the only source that can meet the Governments requirement. Any other supplier’s rodents are incompatible with the historical data and would require all of the previous research to be re-conducted in order to establish a body of historical data compatible with non- Charles River rodents.

6. Description of Efforts Made to Solicit Offers from as Many Offerors as Practicable.

To date, no other sources have written to express and interest in this requirement. A notice of intent sole source was issued on the FBO website on 03 January 2018 for 15 days and no additional sources expressed an interest. No additional market research was conducted because it is not practicable for the reasons discussed in paragraph 5 above, for any company other than Charles River to provide the required services.

7. Determination of Fair and Reasonable Cost.

The Contracting Officer will perform a price analysis in order to determine whether the anticipated quotes received by the Government for services covered by this J&A will be fair and reasonable.

8. Actions to Remove Barriers to Future Competition.

For the reasons set forth in Paragraph 5, NMLC has no plans at this time to compete future contracts for the types of services covered by this document. If another potential source emerges, NMLC will assess whether competition for future requirements is feasible.

JUSTIFICATION AND APPROVAL FOR USE OF OTHER THAN FULL AND OPEN COMPETITION