4-Award_J&A.docx

Sole Source Justification

“Source Selection Information – see FAR 2.101 and 3.104”

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity. DHHS/National Institutes of Health [NIH]/National Institute of Allergy & Infectious Diseases [NIAID]/Acquisitions Management Operations Branch [AMOB]

b. Sponsoring organization. DHHS/NIH/NIAID/ Division of Intramural Research [DIR]/Rocky Mountain Laboratories/Laboratory of Bacteriology (LB) Immunity to Pulmonary Pathogens Section (IPP)

2. Nature and/or description of the action being approved

a. Acquisition purpose and objectives.

The Rocky Mountain Laboratory (RML) Laboratory of Bacteriology (LB) Immunity to Pulmonary Pathogens Section elucidates the mechanism by which highly virulent pathogens, including the intracellular bacterium Francisella tularensis, evades and suppresses host immune responses to cause disease. This works utilizes in vitro cell culture of primary human and murine cells as well as an in vivo mouse model to define the molecular mechanisms by which F. tularensis and other pathogens manipulate the host immune system to cause disease and death.

b. IPP performs tissue culture and in vivo experiments to identify the mechanism by which pathogens manipulate host cell processes to cause disease. The in vivo environment consists of a wide array of cells that (even when not infected) to contribute to either resolution or exacerbation of infection. It is critical to understand on both a genetic and molecular level how each of these cell types are behaving following infection.

c. Project background. In order to understand how these cell types behave, one must sort cell populations of interest to be applied in downstream applications. To date, this has been very difficult and expensive to execute in the BSL-3 setting, typically requiring expensive equipment that must be housed in a custom-built biological safety cabinet to enable its use.

· Miltenyi-Biotec has developed new technology (the MACSQuant Tyto) that will allow one to sort cells quickly, gently and without the need for housing the machine in a biological safety cabinet. The Tyto allows one to collect specific cell populations of interest from a single cell suspension. Importantly, unlike traditional fluorescence-activated cell sorting (FACS), the Tyto collects all cells as either positive or negative for a flurochrome of interest. Thus, there is no cell loss and one can sort for additional populations from the same preparation. Finally, as stated above, the Tyto is a completely closed system which does not generate aerosols or droplets vastly improving the safety of sorting cells at BSL-3. The purpose of this acquisition is to purchase the MACSQuant Tyto system from Miltenyi Biotech. This is a powerful technology that will greatly improve our understanding of the interface of pathogen, infected cell and uninfected by-stander cells.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

a. Project title. MACSQuant Tyto Cell Sorter

b. Project description.

· Requirement type.

Research & development (R&D) R & D support services Support services (non-R&D) Supplies/equipment Information technology (IT)

· Type of action.

New requirement Follow-on Other (specify): ______________________

· Proposed contract/order type.

Firm-fixed-price

· Acquisition identification number.

AMBIS # 1978101, NIAID solicitation ID # NOI-RML-C- 1978101

c. Total estimated dollar value and performance/delivery period. $ 280,675.00. Estimated delivery period: 60-90 days ARO.

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

This acquisition is conducted under the authority of 41 United States Code (U.S.C.) (3304(a)(1) as set forth in Federal Acquisition Regulation (FAR) 13.106-1(b) and FAR 13.501(a). Sole Source acquisition under FAR Subpart 13.5 Simplified Procedures for Certain Commercial Items

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

Miltenyi Biotec Inc.

2303 Lindberg St Auburn, CA 95602-8562

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

Miltenyi Biotec Inc is the manufacturer of the MACSQuant Tyto Cell Sorter system and does not distribute through other vendors.

The MACSQuant® Tyto® is a next generation, benchtop cell sorter equipped with 3 lasers, which allows for 10-parameter cell sorting. A unique feature of the instrument is the fact that the actual sorting process takes place exclusively within the MACSQuant Tyto Cartridge. The cartridge provides a single-use, disposable and fully closed system, eliminating the risk of sample contamination and carry-over.

The MACSQuant® Tyto® Cartridge provides a completely closed and sterile system, in which samples are fully protected from environmental contamination. In contrast to conventional droplet sorters, the MACSQuant Tyto Cell Sorter does not use droplets to separate cells, eliminating biohazardous aerosol formation. The air used to pressurize the input chamber and control the sorting flow within the cartridge is prefiltered. In addition, pressure outlets on the positive and negative chambers are sealed with 0.1 µm filters that allow for sterile ventilation of your sample.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

As required by FAR Subpart 5.2, a Notice of Intent (NOI) to award a sole source contract will be publicized on FedBizOpps (www.fbo.gov) for the required 10 days, announcing the Government’s intent to acquire the MACSQuant Tyto from Miltenyi Biotec Inc. on a non-competitive basis. However, if any vendor feels they can provide this unit in which the government is unaware, they will have the opportunity to submit a quote and capabilities statement.

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

The techniques identified at FAR 13.106-3(a)(2) will be used to ensure award will be at fair and reasonable prices. An independent government estimate has been conducted of industry prices for similar equipment; and comparison of proposed prices were found to be reasonable. Based on the aforementioned, there is no reason to believe that the proposed price will not be fair and reasonable to the government. A final determination by the Contracting Officer will be conducted prior to award of this contract.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

Market research was conducted in accordance with FAR Part 10. I. The Purchasing Agent reviewed in accordance with FAR Subpart 8.002(a)(1) Priorities for Use of Government Supply Sources, and determined that none of the mandatory Government sources could satisfy this requirement. The Purchasing Agent also reviewed previous purchases for similar requirements as well as similar or same purchases listed on GovSpend.com. A search was conducted on the Dynamic Small Business Search, using several keywords, and revealed no profiles. Market research was also conducted on GSA Advantage and revealed no results for the search criteria. Miltenyi-Biotec is the sole manufacturer and distributor of this MACSQuant Tyto System in the United States and the system is only available through the Open Market.

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

The field in which pathogens manipulate host cell processes to cause disease is rapidly expanding, pushing the boundaries of resolution and speed. If the RML scientific community is to continue to produce work at the forefront of infectious disease discovery, we need to be able to provide up-to-date, cutting edge technologies and tools that will facilitate this research. The MACSQuant Tyto, will be used to collect specific cell populations of interest from a single cell suspension using powerful technology that will greatly improve our understanding of the interface of pathogen, infected cell and uninfected by-stander cells.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

Any responses received from the Notice of Intent posting will be considered.

**No other responses were received other than from Miltenyi Biotech

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

It is the policy of NIAID to promote the use of competitive procedures whenever and wherever possible. In an effort to remove or overcome barriers to competition in the future, the market will be scanned frequently for new companies and products that could satisfy the Government’s requirement.