Justification consolidated - redacted.pdf

Justification for Other than Full and Open Competition:

Brand Name at or Below the Simplified Acquisition Threshold

Project Title: PerkinElmer consumable standing order request

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): ______________

• Sequence number, if available: __________________________

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

B. AMBIS Sequence number for this requirement: ________ 2133763 _______ C. Total estimated dollar value of the requirement (including options, if applicable):

D. Period of performance, inclusive of options: from JUL2022 to JUL2023 E. Project Background

The National Institute of Allergy and Infectious Diseases (NIAID) conducts and supports basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. For more than 50 years, NIAID research has led to new therapies, vaccines, diagnostic tests, and other technologies that have improved the health of millions of people in the United States and around the world.

The Vaccine Research Center (VRC) is an intramural research center within NIAID dedicated to discovery and translational science for infectious disease indications. The VRC has full bench-to-bedside capabilities that enable rapid clinical evaluation of VRC discoveries. The VRC’s Vaccine Production Program Laboratory has process, formulation, and analytical development groups and oversees cGMP manufacturing at the VRC’s pilot plant.

Since the VRC/Vaccine Production Program (VPP) group is responsible for developing a scale able GMP process the items requested need to be standardized with what will be utilized in the VRC’s pilot plant and applicable to a GMP process and analytical standards that are used to characterize and release therapeutic and vaccine candidates to treat diseases including Covid-19 (SARS2-CoV), HIV, Influenza, Malaria, and Ebola.

Understanding these attributes are required for moving forward with a candidate to GMP manufacturing and clinical trials. We are requesting these Analtyical Development consumable supplies in support of the VPP’s therapeutic and vaccine candidates using the VPP’s GXII instrument for July 2022 to July 2023. VPP requests receiving these supplies in 4 shipments. The requested ship dates are listed in the table in section F

F. Description of the supplies/services to be purchased

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 - 2 : A u t h o r i z e d o r r e q u i r e d b y s t a t u t e / B r a n d N a m e

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)

PerkinElmer Health Sciences Inc 710 Bridgeport Avenue Shelton, CT 06484-4794 Phone: 1-800-762-4000 Fax: (203) 944-4904 Andrew Newton Sr. Sales Specialist | Life Science Solutions

B. Describe why only the requested brand or brand name feature of the supply/service will meet the government’s needs

The items ordered herein fall into two categories: 1) They are specific to an instrument that require the specific items listed in section F to be from this manufactured by the requested manufacturer and/or 2) these items have historical applications and have already proven to be effective with our specific biological candidates, are currently

ITEM Description Part # Quantity

Quantity Per

Shipmen t

HT PICO PROTEIN REAGENT KIT 760498 12 3

Protein Express Reagent Kit CLS960008 24 6

Protein Express LabChip Economy 4 Pack 760528 24 6

Category

Shipment 1 Shipment 2 Shipment 3 Shipment 4 under VPP’s Analytical Development SOPs. Additionally, the instruments for which these supplies are being requested are currently in use at the GMP Pilot plant and are currently validated in their process. Attempts to modify the items the VPP utilizies in the development of the next generation vaccine and or theriapeutics would result in the pilot plant having to re tool and then re validated existing materials at the pilot plant. This would then cause significant (greater than 12 months) delays in the VRC’s program goals.

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

Official Name & Title Signature Date

These PerkinElmer reagents and assay kits have two categories of compatibility requirements:

1) These items are specific to an existing instrument that has requirements on which types of reagents and kits can be used. The existing instruments’ compatibility requirements requires the reagents and assay to be manufactured from PerkinElmer.

2) These PerkinElmer branded reagents and kits have historical applications and have already proven to be effective with Program’s specific biological candidates. They are currently under Program’s Vaccine Production Program (VPP) Analytical Development SOPs. Since the VPP group is responsible for developing a “scalable” GMP process, the items requested need to be standardized with what will be utilized in the VRC’s pilot plant and applicable to a GMP process and analytical standards. Furthermore, the instruments for which these supplies are being requested are currently in use at Program’s GMP Pilot plant and are currently validated in their process. Attempts to modify or substitute the items that Program uses in the development of the next generation vaccine and/or therapeutics would result in Program’s pilot plant having to re-tool and then re-validate existing materials at the pilot plant. This would cause not only additional costs to Program, but also cause significant time delays (greater than 12 months) that would greatly inhibit Program’s research.