Justification and Approval ECIS -redacted (AMBIS 2131880).pdf

Justification and Approval

“Source Selection Information – see FAR 2.101 and 3.104”

1. Identification of the agency and contracting activity. Provide the following information: (CUSTOMER PROVIDES)

a. Federal agency and contracting activity. HHS/NIH/NIAID. Enter the OPDIV name after “HHS.”

b. Sponsoring organization. Specify the name of the OPDIV’s major subcomponent organization (such as Institute, Center, Office, or Division) and lower-tier organization, if applicable, that is sponsoring the proposed acquisition.

c. Project Officer information. Provide the following information:

2. Nature and/or description of the action being approved. Provide the following information: (CUSTOMER PROVIDES)

a. Acquisition purpose and objectives. This project will assess the responsiveness of the endothelial barrier in regulating the immune response. The objectives are to identify agents that influence permeability and leukocyte diapedesis during an allergic or inflammatory response in hopes of identifying treatment targets that could allow use of existing (or newly developed) drugs for patients with diseases of barrier disfunction that leads to acute and chronic infections. Because we need to evaluate both diapedesis and permeability, we require an instrument that is capable of differentiating between the two in a higher throughput capacity than we currently possess. With the new technology that the ECIS system offers, which assesses not only barrier integrity and cell migration, but also cell invasion, we will be able to assess the responsiveness of the endothelial barrier and determine which type of response is occurring (cell movement vs fluid egress).

b. Project background. Lab projects have included characterizing pathways leading to increased mast cell hyperactivity and anaphylaxis in individuals with hereditary alpha tryptasemia (HaT) – a common genetic trait resulting from increased TPSAB1 copy number. However, recent findings from our lab have demonstrated the potential for tryptase-induced endothelial barrier regulation of bacterial infection through control of permeability, leukocyte diapedesis, and downstream signaling.

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

(CUSTOMER PROVIDES)

Provide the following information:

c. Project title. Endothelial barrier regulation of bacterial infection

3. Project description. This project aims to assess effects of mast cell tryptases on endothelial barrier function in allergy and infection, which may play a larger role in regulating long term effects of the immune response. Quantitating endothelial cell permeability and diapedesis was made unnecessarily protracted due to a lack of an ECIS system in the LCIM/LAD. We already have access to traditional transwell systems, however they are incapable of distinguishing between fluid egress and cellular movement across a monolayer. Therefore, we propose the purchase of the ECIS Z-Theta system. With this system we will be able to detect subtle differences in endothelial cell behavior, following exposure to a variety of agents (tryptase included) that will have significant physiological effects on allergic and inflammatory responses that ultimately regulate disease progression and rate of infection. In addition to the use of this system screening endothelial cell response to mast cell tryptases and bacterial products, the instrument will also be used by the lab of Dr Ian Myles to ………

Finally, the proposed system will benefit the entire Lab of Clinical Immunology and Microbiology (LCIM) and Lab of Allergic Diseases (LAD) by expanding work on blood vessel regulation of pathogenic organisms in allergy and infection.

Provide the following information:

• Requirement type. Check the appropriate box:

Research & development (R&D) R & D support services Support services (non-R&D) Supplies/equipment Information technology (IT) Construction Architect-engineer (A & E) services Design-build Other (specify): ____________________

• Type of action. Check the appropriate box:

X New requirement Follow-on Other (specify): ______________________

• Proposed contract/order type. Check all that apply:

Firm-fixed-price Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________ Cost-plus-fixed-fee Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________ Time and materials Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________ Other (specify): ___________ Completion Form Term form

• Acquisition identification number. Specify the requisition number, proposed solicitation number, or other acquisition identification number, if applicable. (AMOB PROVIDES)

b. Total estimated dollar value and performance/delivery period.

4. Identification of the statutory authority permitting other than full and open competition. Check the applicable block below based on the acquisition circumstance. (AMOB AND CUSTOMER)

This acquisition is conducted under the authority of 41 United

States Code (U.S.C.) 253(c)(__) as set forth in Federal Acquisition Regulation (FAR) 6.302- __. Check this block for an acquisition that is based on the authority used to support the noncompetitive acquisition (see FAR 6.302-1 through 6.302-7). Enter the appropriate U.S.C. exception and FAR citation in the spaces provided.

This acquisition is conducted under the authority of section 4202 of the Clinger-Cohen Act of 1996. Check this block for an acquisition that is based on the authority of the test program for commercial items – specifically section 4202 of the Clinger-Cohen Act of 1996 [see FAR 13.501(a)(1)(ii)].

This acquisition is conducted under the authority of the Services

Acquisition Reform Act of 2003 (41 U.S.C. 428a). Check this block for an acquisition that is based on the authority of the test program for commercial items – specifically the Services Acquisition Reform Act of 2003 [see FAR 13.500(e) and 13.501(a)(1)(ii)]. {NOTE: This authority may only be used when acquiring items in support of a contingency operation or to facilitate the defense against or recovery from nuclear, biological, chemical, or radiological attack [see FAR 13.500(e)(1)]}.

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited. Provide the following information, as applicable: (CUSTOMER PROVIDES)

a. Name and address of the proposed contractor(s). Applied BioPhysics, 185 Jordan Road, Troy NY 12180

b. Nature of the acquisition and proposed unique qualifications of the contractor(s). Applied BioPhysics is the only company that make the ECIS ZTheta system. It is the most advanced all-in-one instrument with a distinct method of accurately measuring cellular behaviors including proliferation, migration, barrier function, attachment, inflammation, etc.

Not only is the ECIS Z-Theta capable of a multitude of assays, it’s all done in real time, giving it the edge in impedance-based assays. ECIS is capableof detecting and quantifying morphology changes in the sub-nanometer to micrometer range. In ECIS a small alternating current is applied across the electrode pattern at the bottom of the ECIS arrays (direct current cannot be used). This results in a potential across the electrodes which is measured by the ECIS instrument. The impedance is determined by Ohm’s law Z = V/I. When cells are added to the ECIS® Arrays and attach to the electrodes, they act as insulators increasing the impedance. As cells grow and cover the electrodes, the current is impeded in a manner related to the number of cells covering the electrode, the morphology of the cells and the nature of the cell attachment. When cells are stimulated to change their function, the accompanying changes in cell morphology alter the impedance. The data generated is impedance versus time.

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. (AMOB PROVIDES) Explain the efforts taken (or to be taken) to solicit as many potential offerors as possible, particularly if the basis of the JOFOC is the authority cited in FAR 6.302-2 (i.e., unusual and compelling urgency) or 6.302-6 (i.e., national security.) (NOTE:

Proposed acquisitions for other than full and open that are expected to exceed $25,000 must be announced in Federal Business Opportunities (FedBizOpps), whether or not a sources sought notice or other presolicitation notice was issued previously.) Indicate whether a FedBizOpps notice will be published as required by FAR Subpart 5.2 and, if not, state the exception in FAR 5.202 that applies.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable. (AMOB PROVIDES) Provide a statement, based on the specific circumstances and type of acquisition proposed, that reflects the steps the CO will take (including documentation) regarding the fairness and reasonableness of the cost/price of the contract/order prior to its award. The determination shall cite, at a minimum: (a) the type of cost or pricing information that will be obtained from the proposed contractor(s) and whether it will be certified – see FAR 15.406-2; (b) the type and extent of cost or price analysis anticipated; and (c) whether an audit will be performed.

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

(CUSTOMER AND AMOB PROVIDE)

8. This system is sole source

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

No other system can provide all the needed requirements of fully understanding the endothelial cell behavior at this level. Transwell system can be used, but do not distinguish between cellular movement, invasion, fluid egress and thus cannot truly assess barrier function.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition. (AMOB AND CUSTOMER) N/A

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. (AMOB AND CUSTOMER) This will be a one-time purchase. A major advantage of this device is its ability to accurately assess blood vessel behavior that will assist in determining future direction for the lab.

12. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

13. Contracting Officer certification.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.