J A_Redacted_(Covance).pdf

J&A Number: 10168-14

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), Fort Detrick, MD, on behalf of the requesting agency, Naval Medical Research Unit

San Antonio (NAMRU-SA), 3650 Chambers Pass, Building 3610, JBSA Fort Sam Houston, TX

78234.

2. Description of the Action Being Approved.

Award of a firm fixed price indefinite delivery indefinite quantity (IDIQ) contract on a sole source basis for male Rhesus Non-human Primates (NHP) of Chinese and Indian Origin (up to

80 total) in support of NAMRU-SA’s research for hemorrhagic shock-resuscitation projects, Navy protocol numbers 14-03 and 14-04, funded by the DoD Hemorrhage and Resuscitation

Research and Development Program Combat Casualty Care (JPC-6). The proposed source is

Covance Research Products (Covance), 310 Swamp Bridge Rd, Denver, PA, 17517-8723.

3. Description of Supplies/Services.

The purpose of this acquisition is to procure a minimum of 8 and a maximum of 80 healthy male

Imported Rhesus non-human primates (NHP) of Chinese origin and male Domestic Rhesus

NHPs of Indian origin. The contract requires NHPs with known blood types A, B, or AB to carry out individual procedures in order to match with experimental agents. The facility requires

NHPs to be TB negative and have a clean fecal reading. In addition, incoming NHP to the vivarium must have Tetanus Toxoid vaccine, Hepatitis A vaccine, B Virus Testing, Simian

Retrovirus testing, testing for Measles titers, SIV, and STLV-1.

Since the Navy protocol study builds off existing study, it is imperative to use the same vendor that was used for the initial study. 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. In addition, Covance is listed on the Institute of Animal Care and Use

Committee (IACUC) approved list for animal vendors.

The period of performance for this contract is anticipated to be a base period of 12-months, followed by one 12-month option period for a total of 24-months. The type of funding which shall be utilized in the base period for each delivery order is FY2014 Research, Development, Test and Evaluation (RDT&E). The estimated value of the base period is $408,176 and the estimated value of the option period is $408,176, for a total estimated value of $816,352 (base and options included).

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

10 USC 2304(c)(1) (as implemented by FAR 6.302-1); Only one responsible source and no other supplies or services will satisfy agency requirements.

5. Rationale Justifying Use of Cited Statutory Authority.

The identified vendor was utilized by the Naval Medical Research Center (NMRC) under protocol number KO04-09, “Control of Severe Intra-abdominal Hemorrhage with Infusible

Platelet-Derived Hemostatic Agents in a Non-Human Primate (Macaca mulatta) Model.” The current approved protocols (#’s 14-03 and 14-04) are a continuation of NMRC’s research and it is incumbent upon NAMRU-SA to make every effort to duplicate NMRC’s processes.

A critical linchpin to the overall integrity of the NAMRU-SA study will be the ability to maintain uniformity in the processes and the supplies that were used in the NMRC project. Slight variations from the NMRC 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. Uniformity is the key toward obtaining valid and reliable data and this is attained through standardization and duplication of the processes and materials used in previous studies. This identified source and the material requested is commensurate with one of the parameters used in the NMRC research project and will assist in establishing the required controls to maintain overall integrity of the NAMRU-SA research effort. Use of another vendor would result in inconsistent results and could negatively impact the integrity of the entire study. The research conducted at NAMRU-SA under Navy protocol numbers 14-03 and 14-04 builds on the research at NMRC therefore it is imperative that the NHPs come from the same vendor as those obtained by NMRC.

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

This requirement will be synopsized on Federal Business Opportunities (FEDBIZOPPS).

Currently no other sources will be solicited. If another company submits a written interest in this requirement as a result of the announcement, the company's information will be evaluated before the contract is signed with Covance.

7. Determination of Fair and Reasonable Cost.

The contracting officer will perform a price analysis in order to determine that the anticipated price of the product procured by the Government under 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 type of product covered by this document. If another potential source emerges, NMLC will assess whether competition for future requirements is feasible.

9. Contracting Point Of Contact.

The point of contact at NMLC is Ms. Amber O’Bryan, Code 02, at DSN 343-8892, commercial

(301) 619-8892 or by e-mail at amber.o’bryan@med.navy.mil.

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TECHNICAL AND REQUIREMENTS CERTIFICATION

I certify that the facts and representations under my cognizance which are included in this Justification and its supporting acquisition planning documents, except as noted herein, are complete and accurate to the best of my knowledge and belief.

Technical Cognizance

LTJG Robert A. Stubbs MSC, USN Date

Contracts and Agreements Officer

Naval Medical Research Unit San Antonio

Requirements Cognizance

CAPT Rita G. Simmons, MSC, USN Date

Commanding Officer

Naval Medical Research Unit San Antonio

LEGAL SUFFICIENCY REVIEW AND CONCURRENCE

I have determined this Justification is legally sufficient.

Julia P. Hatch Code 00L (301) 619-7491 Date

Office of Counsel

CONTRACTING OFFICER’S CERTIFICATION

I certify that this Justification is accurate and complete to the best of my knowledge and belief. To the extent that the J&A value is between $150K and $650K, the Contracting Officer’s signature below also represents approval of the J&A.

Emily K. O’Hara Code 02 (301) 619-9242 Date

Contracting Officer

COMPETITION ADVOCATE REVIEW

To the extent that the J&A value is between $650K and $12.5M, the Competition Advocate’s signature below also represents approval of the J&A/LSJ.

Darin L. Callahan Code 00 (301) 619-3095 Date

Competition Advocate