SSJ_Redacted MLG.pdf SL signed 9 May 25.pdf

JUSTIFICATION FOR SOLE SOURCE PROCUREMENT (OPEN MARKET OR GSA)

UNDER $250,000

Sole source acquisitions may be used on a limited basis and only when the Contracting Officer’s Representative (COR)/Program Official has provided sufficient justification and the Contracting Officer has determined that the circumstances warrant such action. The content for a justification must contain detailed facts and rationale to justify the sole source acquisition. Soliciting from a single source must be done in accordance with FAR 13.106-1(b) or 8.405-6. At a minimum, the following information must be included:

Identification of Program Office, Contracting Activity, and Proposed Requirement, Justification and Program Office Certification:

A. Program Office:

Centers for Disease Control and Prevention (CDC) Dengue Branch 1324 Canada St.

San Juan, PR 00920

B. Contracting Activity:

Centers for Disease Control and Prevention Office of Financial Resources Acquisition Branch

C. Identification of Requirement:

1. Nature of Action to be Approved by Contracting Officer:

a. Sole source acquisition of: Reagents and laboratory supplies

b. Procurement Request (PR) Number (if available):

2. Proposed Vendor and Estimated Procurement Amount (if available):

a. Proposed Vendor: Bioanalytical Instruments // 1828 Calle Reina de las Flores Suite

203, Bo Monacillos San Juan, Puerto Rico 00927-0021

b. Estimated Procurement Amount:

3. Is the requirement on GSA Schedule? ☐ Yes ☒ No

If yes, provide schedule number: Click here to enter text.

Rev. 5/14/19

D. Justification:

1. The justification for this non-competitive action is: (NOTE: Must select only ONE of the listed justifications for other than full and open competition and fully support the justification in the following paragraphs. Please delete this note prior to submitting the justification.)

☒ In accordance with FAR 13.106-1(b)(1), “only one source [is] reasonably available” which states that, “For purchases not exceeding the simplified acquisition threshold. (i) Contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name or industrial mobilization). (ii) Where a single source is identified to provide a portion of a purchase because that portion of the purchase specifies a particular brand-name item, the documentation in paragraph (b)(1)(i) of this section only applies to the portion of the purchase requiring brand-name item. The documentation should state it is covering only the portion of the acquisition which is brand- name.”

☐ Urgency

☐ Exclusive licensing agreements/Proprietary data

☒ Brand name required

☐ Industrial mobilization

☐ Other (e.g., compatibility, space issues, continuity, compatibility, etc.)

☐ In accordance with FAR 8.405-6 “Limiting Sources” which states that, “the only circumstances that may justify the action are – (A) An urgent and compelling need exists, and following the procedures would result in unacceptable delays; (B) 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; or (C) In the interest of economy and efficiency, the new work is a logical follow-up 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 BPA must not have been previously issued under sole-source or limited-sources procedures.”

☐ Urgency

☐ Only One Source

☐ Logical Follow Up

☐ Brand name required

2. Other facts supporting sole source procurement:

a. What can this product/service do that other products/services cannot do?

The requested reagents and supplies are necessary for cell and tissue culture research activities at the Dengue Branch Laboratory. Cells in culture are extremely fragile and require specific conditions for growth and survival. BioAnalytical is the only authorized local supplier of Gibco and Invitrogen products. We have validated Gibco and Invitrogen products for our cell and tissue culture activities with great result for their stability, maintenance, and growth. Given the vulnerability of cells in culture, using different products could greatly disrupt our workflow and impinge in the quality of the experiments.

BioAnalytical is the sole authorized distributor for Thermo Fisher Scientific reagents and supplies in Puerto Rico. FDA approved tests performed at the Dengue Branch Diagnostics Laboratory required the use of specific enzymes sold exclusively by Themo Fisher Scientific and distributed by BioAnalytical in Puerto Rico. The enzymes are:

SuperScriptTM III PlatinumTM CDC Triplex RT-PCR IDV EUA

Rev. 5/14/19

SuperScriptTM III PlatinumTM CDC DENV-1-4 RT-PCR IDV 510K TaPathTM CDC COVID-19 RT-PCR IDV 510K

TaPathTM CDC Influenza RT PCR IDV 510K

b. What other products/services were considered and why did they not meet the need?

BioAnalytical is the only Gibco and Invitrogen supplier in Puerto Rico, therefore, alternative products were not considered to maintain quality assurance and ensure the reproducibility of our results. No other products were considered for this request because only reagents and supplies approved for the tests by FDA can be used to perform the tests.

3. Program Office efforts to seek potential offerors:

The Program is not required to identify additional vendors due to the limitations in reagents product manufacturing and specifications needed to comply with Federal and Market standard quality controls related to our laboratory projects.

E. Program Office Certification:

I have reviewed this sole source justification and certify the justification is true and accurate to the best of my knowledge and adequate to support other than full and open competition.

Center/Institute/Office COR/Program Official Name/Title: Mara L. Garcia, Business Support Specialist, COR I

Center/Institute/Office COR/Program Official Signature: _____________________________________

Certification Date: Click here to enter a date.

F. Contracting Office Certification:

I have fully relied on the information provided herein and hereby certify that this justification is accurate and complete to the best of my knowledge and belief:

Contracting Officer Name: Click here to enter text.

Contracting Officer Signature:

Certification Date: Click here to enter a date.