Redacted JOFOC 2005593 DynaPro Plate Reader.pdf

Justification for Other than Full and Open Competition:

Project Title: Procurement of DynaPro Plate Reader III

I . Identification of the agency and contracting activity

DHHS, NIH, NIAID, VRC/VPPL

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 B. Project Background

The vaccine Production Program Laboratory (VPPL) advances candidate products from the laboratory to the clinic;

develops manufacturing processes and tests that provide material for Phase I/II clinical trials, with emphasis on techniques suitable for large-scale manufacture of vaccines; produces vaccine components at VRC facilities and through contract agreements and a cGMP pilot plant. and ensures the timelines of vaccine projects selected for clinical trial evaluation, prepares regulatory submissions, and develops appropriate pre-clinical testing for all vaccine products.

The VPP Formulation laboratory executes Dynamic Light Scattering (DLS) analyses as part of all vaccine development projects executed at the VPP. This analysis is necessary for development of vaccine Formulations, support of other development functions within the VPP, and development of an FDA required submicron particle assay for all antibody products manufactured at the VCMP (required for all antibody clinical trials).

C. Description of the supplies/services to be purchased

a. Product general description: Dynamic Light Scattering PlateReader

b. Specific Items

• DynaPro PlateReader III, Part Number: WPR3

• Dynamics 7 Software, Part Number CK3000

• Instrument and Software Installation, Part Number Y-INSTALL1

• Instrument and Software Technical Support, Part Number Y-TECHSUPP

• Instruments and Software Training, Part Number Y-LSUDA

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 6 . 3 0 2 - 1 : Only one responsible source/Brand Name

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

The purchase of the DynaPro Plate Reader III is needed to continue to execute Dynamic Light Scattering (DLS) analyses as part of all vaccine development projects. This analysis is necessary for development of vaccine Formulations.

An alternate manufactured instrument is not acceptable as the project uses DynaPro Plate Reader II currently and would require changing the experimental platform, delaying of 6-9 months to multiple ongoing vaccine development projects.

The DynaPro Plate Reader III is manufactured and distributed by Wyatt Technology. They do not have a reseller for this product.

Vendor Information:

Wyatt Technology Corporation 6330 Hollister Ave Goleta, CA 93117-3115

Kueltzo, Lisa (NIH/VRC) [C] Not sure if this is the right option. If this is a follow-on, the previous instrumentation is the DynaPro Plate Reader 1, which this instrument is replacing, and was purchased through AMBIS (I think) in 2010/2011.