1-BSM JOFOC redacted.docx

Justification for Other than Full and Open Competition:

Brand Name at or Below the Simplified Acquisition Threshold Project Title:

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:

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

D. Period of performance, inclusive of options: from _ to E. Project Background The VRC/Vaccine production program/Analytical Development group is responsible for developing assays that are used to characterize and release therapeutic and vaccine candidates for Toxicology studies as well as reference standards to treat diseases includinc HIV, Influenza, Malaria, and Ebola. Being able to understand and monitor these attributes are required for moving forward a candidate to GMP manufacturing and clinical trials.

F. Description of the supplies/services to be purchased

1) Acquity UPLC plus BSM, product # 186015082, quantity: 2

2) HPLC module installation, product # 741000100, quantity: 2

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

· F A R P a r t 8 . 405 - 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. 302 - 2: A u t ho r i z e d o r r e qui r e d by 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) Waters Corporation CEMED Enterprises 34 Maple St.

Milford, MA 01757 Contact name: Donna Martin, Sr Sales Support Coordinator, Phone: 1800-252-4752 Email: Donna_Martin@waters.com

B. Describe why only the requested brand or brand name feature of the supply/service will meet the government’s needs This specific instrument is specified in the SOP for Characterization and Release assays for projects at the VPP/VRC. Any changes to these may cause the assays and results coming from these assays to be void. It is required to quantity impurities and monitor quality in order to demonstrate safety and efficacy of the therapeutic and vaccine candidates for 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 (for the requestor) and approval (for the CO) of is accurate and complete.

Digitally signed Yile Li -S (Affiliate) (Affiliate) Date: 2020.03.1 by Yile Li -S

2 15:05:35 -04'00'

Contracting Officer Approval