SS13D0030.pdf

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JUSTIFICATION AND APPROVAL FOR OTHER THAN

FULL AND OPEN COMPETITION

Becton, Dickinson and Company (BD & CO)

J&A Control Number: 13-281

1. CONTRACTING ACTIVITY: The contracting activity for this action is the US Army

Medical Research Acquisition Activity (USAMRAA) in support of the US Army

Medical Research Institute of Chemical Defense (MRICD).

2. DESCRIPTION OF ACTION: This approval is being requested for a firm-fixed price, IDIQ requirements-type commercial contract award to Becton, Dickinson and Company, Franklin

Lakes, NJ 07417. The cost for these supplies is approximately $130,000.00 for the base year; and approximately $130,000.00 for each of the three option year.

3. DESCRIPTION OF SUPPLIES/SERVICES: MRICD has a requirement for procuring reliable tissue fractions (human liver microsomes – HLM), cDNA-expressed enzymes (BD

SupersomesTM) and P450 High Throughput Inhibitor Screening Kits for phase I drug development ADME assays. BD UltraPool HLM from BD Biosciences is equal male to female ratio with low lot-to-lot variability and represents the average patient in population. Each vial contains a protein content of 20 mg/ml in sucrose and quality is assured via catalytic assays conducted prior to shipping. P450 High Throughput Inhibitor Screening kits are designed to rapidly screen for potential inhibitors of cytochrome P450 catalytic activity by using a fluorescence substrate. The activity is catalyzed by the specific cytochrome which is expressed from human cDNA using a baculovirus expression system (BD SupersomesTM ). Microsomal stability studies have been conducted using these microsomes and supersomes, and for continuity purposes we need to continue to use these preparations. Moreover, each fluorescent substrate to be used is designed for use with a specific expressed P450 isozyme, making it necessary to purchase both enzyme and substrate from a single source.

4. AUTHORITY CITED: This procurement is being conducted under the authority of Federal

Acquisition Regulation (FAR) 13.106-1(b).

5. REASONS FOR AUTHORITY CITED: The establishment of an ADME Center of Excellence is a high priority for DTRA-JSTO. Key to success is the timely delivery of high quality and consistent data. All previous studies, in this laboratory have utilized these specific microsomes and supersomes. All assays have been developed and optimized using these microsomes and supersomes. A large data base has been developed using these particular items and changing the protein source would completely nullify all previous research conducted. Any changes in protein source would not only compromise the quality of the data but also significantly impact the ability to reach critical milestones, and potentially compromise future funding in this area.

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6. EFFORTS TO OBTAIN COMPETITION: For continuity purposes, we need to continue to use the BD Supersomes cDNA-expressed drug metabolizing enzymes which are also part of the

Screening Kits. These reagents are necessary in order to fully accomplish the DTRA-funded

ADME Center project.

7. ACTIONS TO INCREASE COMPETITION: It is the policy of USAMRAA to promote the use of competitive procedures whenever and wherever possible. However, this is a unique item which makes efforts to increase competition very difficult. Market research with future procurements of this nature will include a search for competitive manufacturers. Furthermore, competing this requirement will not benefit the Government since all scientific experiments would have to be redone and revalidated. This additional cost would not benefit the Government or enhance scientific research.

8. MARKET RESEARCH: No market research has been conducted because we cannot use any other enzyme expression systems besides the BD Biosciences microsomes and supersomes.

9. INTERESTED SOURCES: While there are other sources known, because of the on-going nature of these studies, other similar products cannot be substituted without compromising the historical protocols, data gathered and previous research using BD & CO products.

10. OTHER FACTS: This on-going research is being funded by DTRA for the establishment of an

ADME Center of Excellence which is a high priority for DTRA-JTSO. Meeting the time-line research protocols is imperative so that this collaborative study is not negatively impacted.

Prices have been negotiated with the vendor, BD & CO, so that the quoted prices for the base year remain valid through 31 DEC 2017, which will include the three option years.

11. TECHNICAL CERTIFICATION AND REQUIREMENTS CERTIFICATION: I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

12. FAIR AND REASONABLE COST DETERMINATION: I hereby determine that anticipated cost to the Government for this award was fair and reasonable. The resulting award was

3 | P a g e negotiated with Becton, Dickinson Biosciences. Cost and pricing data are not required per the

13. CONTRACTING OFFICER CERTIFICATION AND APPROVAL: I certify that this justification is accurate and complete to the best of my knowledge and belief. Additionally, based on the foregoing justification, I hereby approve the sole source acquisition to Becton, Dickinson Biosciences, on an other than full and open basis. Approval is pursuant to the authority of the FAR Subpart 13.1061(b), considering no other vendor will satisfy Agency requirements, subject to availability of funds, and provided that the items herein described have otherwise been authorized for acquisition.

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