J&A.pdf

Justification for Other than Full and Open Competition at or Below the Simplified Acquisition Threshold Project Title: Sample Analysis/Purification

I . Identification of the agency and contracting activity

DHHS, NIH, NIAID, Vaccine Research Center (VRC), Virus Persistence and Dynamics Section (VPDS) Requestors name: Dr. Eli Boritz 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 20892

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): Brigham & Women's Hospital

Sequence number, if available: 1780865

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

B. AMBIS Sequence number for this requirement: 1941866

C. Total estimated dollar value of the requirement (including options, if applicable): $44,928.00

D. Period of performance, inclusive of options: December 13, 2018 ‐ December 12, 2019

E. Project Background

The VPDS goal is to help develop antiretroviral therapy or means of targeting virus reservoirs and reducing disease progression in HIV patients. This involves the testing of infected CD4 T cells by PCR‐activated cell sorting (PACS) technology for processing and further testing and analysis. The VPDS lab will use these samples in conjunction with downstream applications such as flow cytometry, quantitative PCR, sequencing, and potentially other techniques to determine how infected CD4 T cells contributing to as a barrier to HIV cure.

With that being stated these rare samples require specialized analysis and purification.

F. Description of Supplies/services to be purchased

Sample Analysis/Purification

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

☒ 41 USC 253(c) (1) a nd FAR Pa r t 6 . 302 ‐ 1 : Only one responsible source ☐ FAR Pa r t 8 . 4 05 ‐ 6 : F ede r a l S upp l y S c hedu l e ( F S S ) , l im i t ed c ompe t i t i o n ☐ 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) a nd FAR Pa r t 6 . 302 ‐ 2 : Unusual & compelling urgency ☐ 41 USC 253(c)(3) a nd FAR Pa r t 6 . 302 ‐ 3 : Industrial mobilization; or engineering, developmental, or research capability; or expert services

☐ 41 USC 253(c)(4) a nd FAR P a r t 6 . 302 ‐ 4 : International agreement

☐ 41 USC 253(c)(5) a nd FAR Pa r t 6 . 302 ‐ 5 : Authorized or required by statute

☐ 41 USC 253(c)(6) a nd FAR P a r t 6 . 302 ‐ 6 : National security

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):

Brigham and Women’s Hospital Ann Romney Center for Neurologic Diseases 60 Fenwood Road, RM 9002 Boston, MA 02115

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

VPDS platforms and data have been established using Brigham and Women’s Hospital model for sample analysis and purification of specimens. Our methods and parameters must be consistent. Any changes during the study are unacceptable and may render years of existing data invalid. Small change in the process, chemicals, protocol, or equipment can have large, adverse effects on analysis/purification and render the research invalid. Salient requirements must be maintained. With that being stated, Brigham and Women’s Hospital has been working with NIAID since 2013 and have the corporate knowledge to ensure the samples will be utilized to the maximum extent possible. These sample are very rare and a misstep in protocols or processes will ruin a sample that cannot readily be replaced. Due to the nature of this project and loss of life aspect, going with an alternative at this time is too much of a risk. 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

Brigham and Women’s Hospital does not share process, technicians, or protocols with outside laboratories.

The only way to ensure the exact same processes, chemicals, and protocols are utilized to maintain salient requirements is to acquire the analysis/purification from Brigham and Women’s Hospital.

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.

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 and CO approval is accurate and complete.