Redacted_JA.pdf

Control No: J

"For Official Use Only”

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

Small Laboratory Research Animals from Charles River Laboratories, Inc.

1. Contracting Activity: The Contracting Activity responsible for this action is the U.S. Army Medical Research Acquisition Activity (USAMRAA), 820 Chandler Street, Fort Detrick, MD.

2. Requiring Activity: The U.S. Army Medical Research Institute of Chemical Defense (USAMRICD), 2900 Ricketts Point Road, Aberdeen Proving Ground, MD 21010.

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:

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

Fiscal Year of Funds: _ FY2017/2018

Estimated Total Dollar Value including Options:

4. Contractor Name:

Name of Proposed: Contractor(s): Charles River Laboratories, Inc.

Street Address: 251 Ballardvale Street City, State, Zip: Wilmington, MA 01887-1096 Phone: 1-800-522-7287

DUNS: 019716729

Cage Code: 5A148

Control No:

"For Official Use Only”

5. Description of Supplies/Services: The U.S. Army Medical Research Institute of Chemical Defense (USAMRICD) requires various strains/models of small laboratory research animals to support on-going research protocols. In total, USAMRICD requires 3,350 rats, 1,420 mice, and 96 rabbits for a total quantity of 5,0666 small laboratory research animals. This requirement can be fulfilled using the Blanket Purchase Agreement (BPA) W81XWH-15-A-0008. Multiple delivery dates are required to accommodate the research results.

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: The USAMRICD research studies require various strains/models of small animals. The various strains/models of require replication and low variability, with one of the largest sources of variability in the study being the biological system itself (i.e. the animal). Small animals ordered for research studies at the onset of the research from a certain vendor the same vendor must be used to obtain any future small animals. By doing so, ensures the animals are from the same production site (and if possible, the same barrier). Animals of the same strain differ genetically between vendors. This is a known problem purchasing small animals from different vendors. It is a result of the intensive inbreeding schemes that occur within each vendor's production colonies. This intense inbreeding leads to slight genetic drift over time within these colonies, which have been in production for decades. These genetic differences can impact animal responses to research manipulations, thus potentially impacting the validity of data. Therefore, to ensure the scientific validity and integrity, the Government must obtain animals from the same source throughout the life of a study, and for all subsequent studies based off that original study. The genetic differences between animals may be even more pronounced between vendors if we are speaking about genetically modified animals, since the constructs and methods used to create these special animals are also vendor-specific.

Using animals from different vendors compromises the integrity of the research and USAMRICD would be unable to compare the research results over time, resulting in a total failure of the research study and causing USAMRICD to be in breach of contract with the Government agencies funding the research.

8. Efforts to obtain Competition: As the results of the on-going research study depend upon purchasing animals from the original source, these animals will be purchased directly from Charles River Laboratories, Inc. as the animals included in the original study were purchased from this vendor.

a. Effective competition. As previously stated, to maintain the integrity of the research, animals must be purchased from the same vendor. As a result, no competition is expected.

b. Subcontracting competition. Not applicable; as this is a supply-type requirement, the Government does not anticipate subcontracting competition opportunities. Note, however, that a small business subcontracting plan is included in the contract file for the base BPA (W81XWH-15-A-0008).

9. Actions to remove or overcome barriers Competition: Multiple Blanket Purchase Agreements (BPAs) were awarded in Fiscal Year 2015 for small laboratory research animals. As research objectives change, USAMRICD researchers can compete future animal needs for new studies among these BPA holders or in the open market among all vendors that supply the types of animals that will be needed for future studies. Additionally, the Government may post a Request for Information (RFI) for any future procurement to FedBizOpps to determine if there are sources available in the market place that can meet the Government’s need. If responses from an RFI posting show that there are competitors in the market place, future acquisitions may be competed.

10. Market Survey: Direct correspondence on 19 August 2014 with Charles River Laboratories, Inc. during the pre-award phase of the above referenced BPAs confirmed that the vendor does not subcontract any of its animal production or maintenance services. This is due to animal health and welfare laws as well as rules and regulations governing the industry. This includes the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC), which is a requirement for vendors that provide these animals to USAMRCID and other laboratories within the DoD Medical community. Therefore, as no other vendors can provide the small laboratory research animals bred by Charles River, this requirement will be a Call Order awarded on a sole source basis to Charles River Laboratories, Inc. against the master BPA W81XWH-15-A-0008 for small laboratory research animals.

11. Interested Sources: As the exception at FAR 5.202(a)(11) applies to this requirement, there will be no special notice posted to FedBizOpps.

12. Procurement History and any other facts:

• A sole source contract, W81XWH-14-D-0019 in the amount of $1,350,000.00 was awarded to Charles River Laboratory, Inc. on 11 August 2014 under the authority of FAR 6.302-1(a)(2)(i), Only One Responsible Source and No Other Supplies or Services will Satisfy Agency Requirements.

Control No: JA18-332

• Multiple five (5) year Blanket Purchase Agreements (BPAs) were awarded by USAMRAA on 8 July 2015 to the following contractors: Charles River Laboratories (W81XWH-15-A-0008), Covance Research Products, Inc.

(W81XWH-15-A-0009), Envigo RMS, Inc., formerly Harlan Laboratories, Inc.

(W81XWH-15-A-0010), and The Jackson Laboratories, Inc. (W81XWH-15-A- 0011). The scope of these BPAs include the purchase of the following six (6) species: Mice, Rats, Rabbits, Guinea Pigs, Hamsters, and Gerbils.

• Previous Call Orders for various small animals have been awarded to Charles River Laboratories under BPA W81XWH-15-A-0008. This includes three Call Orders for mice, rats, and rabbits which is the current requirement.

• Sole source Call Order W81XWH-15-A-0008-0003, effective 24 September 2016, in the amount of $134,723.44, and Call Orders W81XWH-15-A-0006 in the amount of $138,252.51, and Call Order W81XWH-15-A-0007 in the amount of $25,121.68 both effective on 25 September 2017, were awarded to Charles River Laboratories under the authority of FAR 13.106-1(b)(1)(i), only one source reasonably available. The scope of these Call Order included various small laboratory animals including mice, rats, and rabbits.

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:

Agency/Position/Title:

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:

Agency/Position/Title: USAMRAA, Contracting Officer

E-Mail Address:

Date