Brand_Name.pdf

Justification for Other than Full and Open Competition

Brand‐Name at or Below the Simplified Acquisition Threshold

Project Title: Life Technologies Medium

I . Identification of the agency and contracting activity

DHHS, NIH, NIAID/Vaccine Research Center (VRC) Requestors name: Baoshan Zhang / Catherine Liu Requestors phone number: 301 761 6911 Requestors email address: baoshan.zhang@nih.gov / cuiping.liu@nih.gov Address of the requesting lab/office: VRC, bldg. 40, 40 Convent Drive, Bethesda, MD 20892

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, if available: 1903267 & 1881672

Was the initial and any subsequent awards competed? ☒ Yes ☐ No

B. AMBIS Sequence number for this requirement: 1962307 / 1961479

C. Total estimated dollar value of the requirement (including options, if applicable): $97,200.00

D. Period of performance, inclusive of options: Delivery schedule on an as‐needed basis. Period of performance is a 12‐monther POP.

E. Project Background

The goal of the VRC is to translate basic research into tangible vaccine products that can be rapidly deployed to protect public health. Development of a vaccine is a multi‐step process such as understanding the basic immunological needs to help protect against infectious disease, developing vaccine candidates and the testing of such candidates in clinical trials. Our work is only one part of such a process. By understanding functional repertoire of antigen‐specific T and B cells and how these differ across vaccine regimens and infections, we attempt to tailor our vaccine designs such that we elicit the proper immune response to protect against infectious disease. With that being said, part of the process utilized to further this research involves Life Technologies 293 Expression Medium. This product is embedded into the research protocols and processes and cannot be changed at this time. This medium must continue to be utilized to ensure data quality/integrity for ongoing research projects. No substitutions can be utilized for this research.

F. Description of the supplies/services to be purchased

Complete common generic identification of the item required.

Laboratory mediums

Applicable model, make, or catalog number for each brand name product referenced and identity of the commercial catalog in which it appears.

‐ EXPI293 Expression Medium, Catalog Number: A1435101, Quantity of 800 ‐ Freestyle 293 Expression Medium, Catalog Number: 12338018, Quantity of 300

Name of manufacturer, producer, or distributor of each brand name product referenced (and address if not well known).

Life Technologies

III. Identification of the statutory authority permitting other than full and open competition (SELECT ONE)

☒ 41 USC 3304(a)(1) and FAR Pa r t 1 3 . 501 : Only one responsible source / Brand Name

☐ FAR Pa r t 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 Pa r t 6 . 302 ‐ 5 : Authorized or required by statute / Brand Name

IV. Demonstration that the proposed brand name product’s salient characteristics (specific features, qualities and/or the nature of the acquisition) requires use of the authority cited.

The goal of the VRC is to translate basic research into concrete vaccine products that can be rapidly deployed to protect public health. We have developed extensive protocols for this expression medium and thus require the continued use of the 293 Expression, which is currently only produced by Life Technologies. Furthermore and most importantly, since we have been using this medium in ongoing research, we must maintain reagent standards to ensure experimental results are not influenced by other variables. Any other source of media will require extensive testing and delay our production of materials for vaccine development and trials. Finally, to have successful research results, methods, and parameters must be consistent. Any changes during the study are unacceptable and may render years of existing data invalid. Salient requirements must be maintained. At this time and considering the human life aspect of this research, any change in research variables are unacceptable, the risk is too high. The project officer and the Contracting Officer have determined that only one brand‐name source and no other brands or services will satisfy agency requirements.

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

Price reasonableness determination will be included 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 and CO approval is accurate and complete.

Official Name & Title Signature Date

Requestor Certification

Contracting Officer Approval