1942291___J&A.pdf

Justification for Other than Full and Open Competition

Brand-Name at or Below the Simplified Acquisition Threshold Project Title: Life Technologies Biologicals

I . Identification of the agency and contracting activity

DHHS, NIH, NIAID/Vaccine Research Center (VRC) , Virology Core Section (VCS)

Requestors name: Catherine Liu Requestors phone number: 240.627.3459 Requestors email address: cuiping.liu@nih.gov Address of the requesting lab/office: VCS, VRC, 40 Convent Drive, Rm 46014, 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: 1912042 and 1934671 Was the initial and any subsequent awards competed? ☒ Yes ☐ No

B. AMBIS Sequence number for this requirement: 1942291

C. Total estimated dollar value of the requirement (including options, if applicable): $31,500.00

D. Period of performance, inclusive of options: Need as soon as possible

E. Project Background

The VCS of the VRC is developing vaccines for HIV-1 and other viruses. Production of various wild type and mutant viral proteins is critical in vaccine development. These viral proteins need to be expressed in cell lines. Proteins so made will be used in for structural analysis and pre-clinical animal studies. With that being said, part of the process utilized to further this research involves Life Technologies Expifectamine Transfxn Kit. This product is embedded into the research protocols and processes and cannot be changed at this time. This biological/kit 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 Biologicals

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

- Expifectamine Transfxn Kit, Catalog Number: A14525, Quantity of 10

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) a n d F A R P a r t 1 3 . 5 0 1 : Only one responsible source / Brand Name

☐ F A R P a r t 8 . 4 0 5 - 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) a n d F A R P a r t 6 . 3 0 2 - 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 Expifectamine Transfxn Kit, which is currently only produced by Life Technologies.

Furthermore and most importantly, since we have been using this biological/kit 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.