JOFOC__rev_red.pdf

Justification for Other than Full and Open Competition

Brand Name at or Below the Simplified Acquisition Threshold

Project Title: McDermott CAVD eOD-GT8 – G001 Clinical Trial

I . Identification of the agency and contracting activity DHHS, NIH, NIAID, Vaccine Research Center Requestors name: David Leggat Requestors phone number: 301 761 6940

Requestors email address: david.leggat@nih.gov Address of the requesting lab/office: 40 Convent Drive, Building 40, room 3613B

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(s), if available:

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

B. AMBIS Sequence number for this requirement: 1921382 C. Total estimated dollar value of the requirement (including options, if applicable): $44940.00 D. Period of performance, inclusive of options: One Year After Receipt of Award E. Project Background

Human lymphocytes are involved in maintenance of immune responses against human immunodeficiency virus (HIV) and other infectious illnesses will be characterized in extensive detail by polymerase chain reaction assays and the unique pathogen receptors they express. These investigations help define how key immune cells are expanded and thus contribute to the pathogenesis and the immunologic control of these important infectious diseases.

F. Description of the supplies or services to be purchased

The requested item is a high-sensitivity thermal cycling RNA polymerase that is used in a novel assay that the VRC has developed and used to detect and sequence B cell receptor DNA from cells of infected individuals. Key specifications are as follows:

• Processivity sufficient for amplification of single cell level transcript

• High fidelity base incorporation

• Compatible with other components of the assay

• Efficiency level appropriate for up and down stream processing

III. Identification of the statutory authority permitting other than full and open competition (SELECT ONE)

☒ 41 USC 253(c)(1) a n d F A R P a r t 6 . 3 0 2 - 1 : Only one responsible source/Brand Name

☐ 41 USC 501 a n d F A R P a r t 8 . 4 0 5 - 6 : Federal Supply Schedule (FSS), limited competition Important Note: The statutory authorities listed below will rarely ever be used in NIH. Before selecting one of these authorities, please ensure that you have read and understood the citation and discussed it with the cognizant Contracting Officer.

☐ 41 USC 253(c)(2) a n d F A R P a r t 6 . 3 0 2 - 2 : Unusual & compelling urgency mailto:david.leggat@nih.gov

☐ 41 USC 253(c)(3) a n d F A R P a r t 6 . 3 0 2 - 3 : Industrial mobilization; or engineering, developmental, or research capability; or expert services

☐ 41 USC 253(c)(4) a n d F A R P a r t 6 . 3 0 2 - 4 : International agreement

☐ 41 USC 253(c)(5) a n d F A R P a r t 6 . 3 0 2 - 5 : Authorized or required by statute

☐ 41 USC 253(c)(6) a n d F A R P a r t 6 . 3 0 2 - 6 : National security

☐ 41 USC 253(c)(7) a n d F A R P a r t 6 . 3 0 2 - 7 : Public interest

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)

New England Biolabs, 240 Country Road, Ipswich, MA 01938-2723

B. Describe why only the requested supply/service will meet the government’s needs

This product is a high sensitivity enzyme that has been thoroughly tested and proven to amplify DNA from single cell sources in a custom assay or ensure the integrity of the rare donor material. Other products were unable to reliably produce high quality results in this format. This is essential to the trial that researchers plan to use it for. These high-quality results from extremely low initial levels of nucleic acid are necessary as it is an important factor in determining the trial success and because failure will result in the loss of highly precious materials from this clinical trial. These reagents are also being used by VRC collaborative sites and must be identical to allow cross site comparisons. Any deviation in the formulation of these reactions will confound the results and reduce the power of the data below statistical levels of any value. This product has been shown to yield required results where others have failed.

C. Describe why only the proposed contractor is capable of providing the requested supply/service

This is the only contractor which produces this exact proprietary product. They are capable of coordinating with the clinical trials other site and ensuring standardized and harmonized lots between both sites. They have the capacity to produce the quantities required in the time frame needed. No other suitable contractor has been identified.

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

The price is determined to be fair and reasonable based on: Price reasonableness determination will be included in the acquisition file.

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

Requestor Certification

David Leggat, PhD, Scientist, Vaccine Immunology Program, Vaccine Research Center

Contracting Officer Approval