1940051_J&A.pdf

Justification for Other than Full and Open Competition at or Below the Simplified Acquisition Threshold Project Title: Covaris System/Equipment Expansion

I . Identification of the agency and contracting activity

DHHS, NIH, National Institute of Allergy and Infectious Diseases (NIAID), Vaccine Research Center (VRC) Requestors name: Drs. Eli A Boritz, Si Young Lee Requestors phone number: 301‐443‐5398 Requestors email address: boritze@niaid.nih.gov Address of the requesting lab/office: Bldg 40, Rm 2512, 40 Convent Dr. Bethesda, MD 20814

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): Covaris, Inc.

Sequence number, if available: 1789185

Was the initial and any subsequent awards competed? ☒ Yes ☐ No B. AMBIS Sequence number for this requirement: 1940051 C. Total estimated dollar value of the requirement (including options, if applicable): $54,858.40 D. Period of performance, inclusive of options: Need by November 26, 2018

E. Project Background

One of the areas of VRC research is into is HIV‐infected CD4 T cell pool. During antiretroviral therapy (ART) in vivo represents a major barrier to HIV cure, and may be enabled in part by transcriptional quiescence of the HIV proviruses within these cells. Repressive chromatin structure (ex., facultative heterochromatin formation) may contribute to this quiescence. To examine the chromatin states of the HIV provirus within infected cells and to profile structural changes associated with HIV expression, we will check repressive chromatin markers (ex., H3K9me3 and H3K9me3) as well as RNA polymerase accessibility in HIV‐infected cells. Understanding epigenetic regulation of HIV‐1 latency in primary cells may elucidate mechanisms of provirus silencing, potentially enabling the design of novel therapeutic strategies. With that being stated, this research requires high performance/precision DNA fragmentation for many applications including Chip‐seq, DNA‐seq and some RNA‐seq applications. To meet this ongoing/expanding research additional Corvaris Ultrasoncator is required to support high‐ throughput library prep. This expansion can only be accomplished by the purchase an additional Covaris Ultrasonicator.

F. Description of Supplies/services to be purchased

This request is for Covaris System/Equipment Expansion.

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

☒ 41 USC 253(c) (1) and FAR Pa r t 6 . 302 ‐1 : Only one responsible source

☐ FAR Pa r t 8 . 405 ‐6 : Fede r a l Supp l y S chedu l e ( F S S ) , l im i t ed compe t i t i on ☐ An urgent and compelling need exists, and following the procedures would result in unacceptable delays ☒ Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized and must be maintained by the original manufacturer.

☐ In the interest of economy and efficiency, the new work is a logical follow‐on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order or BPA must not have been previously issued under sole‐source or limited‐sources procedures.

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) and FAR Pa r t 6 . 3 02 ‐2 : Unusual & compelling urgency ☐ 41 USC 253(c)(3) and FAR Pa r t 6 . 3 02 ‐3 : Industrial mobilization; or engineering, developmental, or research capability; or expert services

☐ 41 USC 253(c)(4) and FAR Pa r t 6 . 3 02 ‐4 : International agreement

☐ 41 USC 253(c)(5) and FAR Pa r t 6 . 3 02 ‐5 : Authorized or required by statute

☐ 41 USC 253(c)(6) and FAR Pa r t 6 . 3 02 ‐6 : National security

☐ 41 USC 253(c) (7) and FAR Pa r t 6 . 302 ‐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):

Covaris Inc., 14 Gill Street, Unit H, Woburn, MA 01801

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

The Covaris system and laboratory protocols have been utilized/in place since 2016. The Covaris expansion into VRC must utilize the same equipment, software, and research protocols being utilized in sister laboratories. The Virus Persistence and Dynamics Section (VPDS) under VRC must continue to utilize the same equipment, consumables, and research protocols to ensure data integrity. An alternate system at this time, is not possible. To have successful research results, methods and parameters must be consistent. Any changes during the study are unacceptable and may render years of existing data invalid. Salient requirements must be maintained. At this time and considering the human life aspect of this research, any change in research variables are unacceptable, the risk is too high. Project manager and the Contracting Officer have determined that only one source and no other source will satisfy agency requirements.

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

ME220 Focused‐ultrasonicator can only be obtained directly from the manufacturer. The manufacture does not have any licensed third party resellers.

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

Price reasonableness determination will be included in the acquisition file.