Rector_UVA_2018_07_05_14_34_04.doc

NMRC (template)

JUSTIFICATION AND APPROVAL OTHER THAN FULL AND OPEN COMPETITION

Identification of the agency and the contracting activity.

This justification is executed by the Naval Medical Research Center (NMRC), Silver Spring, MD, on behalf of the Navy to meet Naval Medical Research and Development mission.

Nature and/or description of the action.

The proposed action is for the design, procurement and quality-control of 160 custom-developed Enteric TaqMan Array Cards (TAC) along with provision of the relevant positive and internal controls for the characterization of moderate to severe traveler's diarrhea in archived samples from developed and developing countries. Three hundred and sixty-three nucleic specimens will be tested using sixty (60) of the TaqMan Array Cards. A TAC run template and relevant Standard Operating Procedures (SOPs) will be provided to support standardization. The Government intends on awarding a Firm Fixed Price contract. The proposed source is the University of Virginia, PO Box 801340, Charlottesville, VA 22908.

Description of Supplies or Services:

The Naval Medical Research Center is leading a multi-site epidemiology study to characterize the epidemiology of ETEC-and Shigella-associated moderate-severe travelers' diarrhea from archived, de-identified samples from the developed and developing world. NMRC has a need for a standard laboratory procedure to genotypically characterize ETEC strains for LT/ST toxin and relevant colonization factors, as well as Shigella presence from bacterial isolates or frozen stool. The TaqMan Array Card provides simultaneous detection of 19 diarrhea-causing enteropathogens and will be used on an estimated 1,050 unique samples. The 160 custom developed cards will need to be designed and quality-controlled and provided to NMRC along with the relevant positive and internal controls. Provision of the cards will also include a run template and Standard Operation Procedures to ensure proper testing of the samples. CRADA funds (NCRADA-NMRC-15-9673 in the amount of$ will be used to procure the cards and testing services.

Identification of the statutory exceptions permitting other than full and open competition.

The statutory exception permitting other than full and open competition for this acquisition is I 0 U.S.C. 2304(c)(l) and FAR 13.106-l(b)(l) soliciting from a single source.

Market research was not performed for this work. This contractor developed the needed technology and is the proprietor of this technology and recognized among the field as such [Liu, J., Gratz, J., Amour, C., Kibiki, G., Becker, S., Janaki, L., Houpt, E. R. (2013). A Laboratory Developed TaqMan Array Card for Simultaneous Detection of 19 Enteropathogens. Journal of Clinical Microbiology, 51(2), 472-480. http://doi.org/10.1128/JCM.02658-12]. Although the cards can be purchased through the manufacturer, all card customizations, validation/QC, internal controls and standard operating procedures for extracting samples come from this contractor as the developer of the technology.

Other facts supporting the use of other than full and open competition.

This contractor is the proprietor of this technology and recognized among the field as such. Although the cards can be purchased through the manufacturer, all card customizations, validation/QC, internal controls and standard operating procedures for extracting samples come from this contractor as the developer of the technology.

Listing of Sources, if any, which expressed, in writing, an interest in the acquisition.

To date, no other sources have written to express an interest. Any sources expressing interest in response to the synopsis will receive consideration.'

Statement of actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

Future requirements will be synopsized in accordance with FAR 5.203.

For the reasons set forth in Paragraph 5, (contracting activity) has no plans at this time to compete future contacts for the types of supplies/services covered by this document. If another potential source emerges, (NMRC) will assess whether competition for future requirements is feasible. This is a one-time buy to support work under CRADA 15-9673.

The Government (or Program Office) expects to obtain a technical data package that will support competition for future acquisitions of the same or similar items.)

Point of Contact.

The point of contact at the Naval Medical Research Center, Silver Spring, MD, regarding the contents of the sole source justification is, Mrs. Nichole Giller, who may be reached at (240) 429-8454 or LCDR Michael Prouty 301-319-7679.

S. Demonstration that the proposed contractor's unique qualifications or the nature of the acquisition requires use of the authority cited.

The TaqMan Array Card is the only diagnostic tool available to provide genotypic results for enteric pathogen samples and this contractor is the developer of custom TaqMan Array Cards [Liu, J., Gratz, J., Amour, C., Kibiki, G., Becker, S., Janaki, L., Houpt, E. R. (2013). A Laboratory-Developed TaqMan Array Card for Simultaneous Detection of 19 Enteropathogens. Journal of Clinical Microbiology, 51(2), 472-480. http://doi.org/10.l 128/JCM.02658-12].

Use of this proprietary technology requires this contractor to design and validate the cards for individual organizations as well as provide a standard operating procedure and sample run template developed by the contractor. Currently, this is the only genotypic diagnostic tool for enteric pathogens used among the overseas labs involved in this effort.

Description of efforts made to ensure that offers are solicited from as many potential sources as practicable.

Market research was not performed for this work. This contractor developed the needed technology and is the proprietor of this technology and recognized among the field as such [Liu, J., Gratz, J., Amour, C., Kibiki, G., Becker, S., Janaki, L., Houpt, E. R. (2013). A Laboratory Developed TaqMan Array ard for Simultaneous Detection of 19 Enteropathogens. /ournal of Clinical Microbiology, 51(2), 472-480. http://doi.org/10.l 128/JCM.02658-12]. Although the cards can be purchased through the manufacturer, all card customizations, validation/QC, internal controls and standard operating procedures for extracting samples come from this contractor as the developer of the technology.

Determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

The Contracting Officer shall determine the anticipated cost to the Government of the supplies/services covered by this Justification and Approval will be fair and reasonable by conducting a price analysis before an award is made. In addition, the Government anticipates that the negotiated contract price will reflect a discount from the University of Virginia's commercial price list and will be determined fair and reasonable.

Description of the market survey conducted and the results, or a statement of the reasons a market survey was not conducted.

TECHNICAL AND REQUIREMENTS CERTIFICATION REQUIRED BY NAVSUP 4200.83 series file_0.jpg file_1.jpg outy Phone: 30 l-319-7679 Date I certify that the facts and representations under my cognizance which are included in this justification and approval and which form a basis for this just ification are complete and accurate.

Title: Principle In vestigato r Departmen t/Command: Enteric Diseases/NMRC file_2.jpg file_3.jpg

. --_::;? Name: LCD R Micl{a Prouty Title: Department Head Depa rtment /Co mmand: Enteric D iseases /NMRC Phone: 30 l -319 - 7679 Date

CONTR I\CTI NG OFFICER CERTIFICATION

I ce rtify that thi s justification is accurate and complete to the best of my knowledge.

file_4.jpg file_5.jpg file_6.jpg e Phone Date

Contracting Officer file_7.bin

Edilberto P. Calma Contracting Officer Phone Date