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Justification for Other than Full and Open Competition:

Brand Name at/or Below the Simplified Acquisition Threshold

Project Title: p24 ELISA assay HIV-1

I. Identification of the agency and contracting activity

II. Description of the project, and supplies or services required to meet the agency’s needs (including the estimated value) A. Type of action. Check the appropriate box:

☐ New requirement ☒ Follow-on

· Name of the previous contractor(s) Life Technologies

· Sequence number: 1781656

· Was the initial and any subsequent awards competed? ☐ Yes ☒ No B. AMBIS Sequence number for this requirement: 1800243 C. Total estimated dollar value of the requirement (including options, if applicable): $61,082.00 D. Period of performance, inclusive of options: not a POP E. Project Background: Among individuals infected with HIV, a unique subset have the innate ability to durably restrict HIV replication d thus halt disease progression. Over the past two decades, HIV-Specific Immunity Section (HSIS) and other labs have identified that differences in the functionality of HIV-Specific T-cells correlate with disease outcomes and likely hold the key to understanding the mechanisms responsible for enabling immunologic restriction of HIV. As a result of these observations, new vaccine designs, such as those that employ Adenovirus vector, have been geared towards eliciting a strong T-cell response.

F. Description of the supplies/services to be purchased:

The p24 ELISA assay HIV-1 is needed to perform quantification of samples within the study of T-cell responses. p24 ELISA assay HIV-1 is specifically formulated for use with PE Inspire plate reading machine currently being used within the lab.

III. Identification of the statutory authority permitting other than full and open competition (SELECT ONE) ☒ 41 USC 3304(a)(1) and FAR Part 6.302-1: Only one responsible source/Brand Name

☐ FAR Part 8.405-6: Federal Supply Schedule (FSS), limited competition/Brand Name Important Note: The statutory authority listed below will rarely ever be used in NIH. Before selecting this authority, please ensure that you have read and understood the citation and discussed it with the cognizant Contracting Officer.

☐ 41 USC 3304(a)(5) and FAR Part 6.302-2: Authorized or required by statute/Brand Name

IV. 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)

B. Describe why only the requested brand or brand name feature of the supply/service will meet the government’s needs: The required p24 ELISA assay HIV-1 has been used previously in ongoing HIV trials and experiments. These specific assay will affect the outcome of the quantification process. Changing the type of assays used in this process would be costly to the government as this could result in different results in ongoing clinical trials and experiments. Thus, making previously collected data worthless for comparison sake. This assay has been designed to be used with on-site plate reader PE Inspire.

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

Price reasonableness is based on market research, previous purchases, and quotes; see under “Price Determination” tab in the acquisition file.

VI. 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 my request (for the requestor) and approval (for the CO) of is accurate and complete.