READACTED JOFOC 2177961.pdf

Justification for Other than Full and Open Competition:

Brand-Name at or Below the Simplified Acquisition Threshold

Project Title: Procurement of DynaPro III Dynamic Light Scattering Platereader

I . Identification of the agency and contracting activity

DHHS, NIH, NIAID, VRC

Requestor’s name:

Requestor’s phone number:

Requestors email address:

Address of the requesting lab/office: VPP, 9W Watkins Mill Rd, Gaithersburg, MD 20878

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):

Sequence number, if available:

Was the initial and any subsequent awards competed? Yes No

B. AMBIS Sequence number for this requirement:

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

D. Period of performance, inclusive of options:

E. Project Background:

Formulation development for all VRC vaccine products requires analysis by dynamic light scattering, for both development experiments and qualification of assays used for clinical product manufacture. It is especially critical for use in mRNA-LNP, nanoparticle and VLP projects, where particle size and population homogeneity are key stability indicating attributes.

The Formulation group currently uses two DynaPro Plate Readers, Model II and Model III. The Model III unit is currently 10 years old and has outmoded hardware and software. As such, the data quality generated on the instrument is in question and the procedures required to use the instrument do not align with those used with Model II< resulting in difficulties in equivalence of data generated with each instrument. This has resulted in a resources restriction within the Formulation group, affecting productivity and achievement of VRC project objectives.

Acquisition of a Model III Platereader to replace the Model II will relieve the resource restriction, improve data quality, and align with current dynamic light scattering practices across the VPP and other VRC laboratories where this instrument is in use.

F. Description of the supplies to be purchased.

a. General Description: DynaPro Platereader III, High throughput Dynamic Lights Scattering

Platereader with 384 well plate capability.

b. Specific items (see quote # WTCQ 0046979):

i. WPR3 - DynaPro Plate Reader III

ii. CK3800 - DYNAMICS 8 Software (required for operation of DynaPro Plate Reader III)

iii. 900175 - 50 nm (radius) Batch DLS Size Standard, Lot Certified (required for calibration of instrument)

iv. Y-TECHSUPP - Instrument Technical Support (provided no charge)

v. Y-LSUDA - Instrument Training (provided no charge)

vi. Y-INSTALL1 – Instrument Installation

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 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 DynaPro Platereader III system and predecessors have been in use at the VPP for 10+ years, and the high quality of instrumentation and performance has been empirically verified. These instruments possess the following technical specifications which are required for high quality analysis of VRC vaccines and biotherapeutics.

a. Automated, high throughput measurements of size, molar mass, aggregation and conformational stability indicators using dynamic and static light scattering technology in standard microwell plates.

b. Imaging capability for each well using built-in, high-resolution camera

c. Capability for analysis using standard 96, 384, or 1536 well plates

d. Advanced data processing software.

Maintenance of vendor (Wyatt) for this system is critical. Change of vendor will result in the need to develop new assays for more than 10 ongoing projects, due to the inherent differences in instrument and data processing algorithms between vendors. This would result in delays of up to 6 months to planned clinical trials and loss of support to ongoing clinical trials.

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

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