1-MKT RESEARCH - Brand-Name JUSTIFICATION for posting.docx

Justification for Other than Full and Open Competition:

Brand Name at or Below the Simplified Acquisition Threshold

Project Title: NOVA Biomedical consumable standing order request

I. Identification of the agency and contracting activity

DHHS, NIH, NIAID, VRC, VPP

Address of the requesting lab/office: 9 West Watkins Mill Rd, Rm 200, Gaithersburg MD, 20878

A. 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. We are requesting these Cell Line Development and Cell Culture Development supplies in support of the VPP’s 7 Nova Flex 2 Systems under a POP of Jul 23 to Jul24. VPP requests receiving these supplies in 4 shipments. The requested ship dates are listed in the table in section F

II. 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. 302 - 1: Only one responsible source/Brand Name

A. 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 under VPP’s Cell Culture and Cell Line Development SOPs. Additionally, the instrument 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 therapeutics would result in the pilot plant having to retool and then revalidated existing materials at the pilot plant. This would then cause significant (greater than 12 months) delays in the VRC’s program goals.