SSJ _SAP rOCHE c4800_c6800-PE.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 & Prevention (CGH/DGHT/ILB) Roybal Campus 1600 Clifton Rd Centers for Disease Control and Prevention Atlanta, GA 30333

B. Contracting Activity:

Centers for Disease Control and Prevention Office of Financial Resources Acquisition Branch 4

C. Identification of Requirement:

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

a. Sole source acquisition of: Reagents and consumables for use on the Roche cobas 6800 by Roche Diagnostics (see provided quote for pricing), classic service for cobas 4800 and cobas 6800 Systems.

b. Procurement Request (PR) Number (if available): 000HCWBB-2026-98331

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

a. Proposed Vendor: Roche Diagnostics, 9115 Hague Rd, Indianapolis, IN 46256

b. Estimated Procurement Amount: $130,151.30

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

If yes, provide schedule number: V797D-70105

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?

Only Roche Diagnostics can provide reagents compatible with the Roche cobas 6800 system. These supplies are proprietary to the manufacturer and there are no authorized resellers. The Roche cobas 6800 and cobas 4800 instruments are necessary to provide HIV-1 viral load and early infant diagnosis testing support, guidance, and training to the many PEPFAR-supported field laboratories with these Roche instruments. If another product is sourced the International Laboratory Branch will be unable to support our international PEPFAR-supported laboratories that use these testing platforms for HIV viral load testing and early infant diagnosis testing of HIV. The cost of sourcing another testing platform and validating a new testing platform would be prohibitive and would not enable the International Laboratory Branch to perform its function of supporting the field staff with the technology used in the field. Time delays in support to the field would also be an issue due to validation of the new testing platforms and the platform would not be the same as that used by our laboratories in the field. The following items and corresponding quantities are

Rev. 5/14/19 required: cobas 58/68/8800 HIV 192 test Kit, 5 each; cobas 58/68/8800 HIV-1/HIV-2 QUAL 192 test IVD Kit, 5 each; cobas omni processing plate, 2 each; cobas omni pipette tips, 3 each; cobas omni amplification plate, 1 each; KIT COBAS 58/68/8800 WASH IVD, 7 each; KIT COBAS 58/68/8800 SPEC DIL RGNT IVD, 2 each; KIT COBAS 58/68/8800 LYS RGNT IVD, 2 each; KIT COBAS 58/68/8800 MGP IVD, 4 each; KIT COBAS 58/68/8800 HBV/HCV/HIV RMC IVD, 2 each; KIT COBAS 58/68/8800 NHP NEG RMC, 2 each; KIT COBAS 58/68/8800 HIV-1/2 RMC IVD, 2 each; cobas 6800 classic service, 1 each; cobas 4800 classic service, 1 each

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

No other products were considered as only Roche reagents and consumables are compatible with the Roche cobas 6800 system. Roche is the sole manufacturer, distributor, and service provider of the Roche cobas 4800 System and the Roche cobas 6800 system. These supplies are proprietary to the manufacturer and there are no authorized resellers. Fisher Scientific, Invitrogen, Sigma were among the vendors researched to source these supplies.

3. Program Office efforts to seek potential offerors:

Roche consumables and reagents are only available through Roche Diagnostics. Roche is the sole manufacturer, distributor, and service provider of the Roche cobas 6800 and cobas 4800 real time PCR Systems. These supplies are proprietary to the manufacturer and there are no authorized resellers. Please see attached supporting documentation from the manufacturer, Roche. These items are on GSA: V797D-70105. Our previous award numbers for Roche orders such as this include: 75D30124F00073, 75D30123P18272, 200-2017-M- 94153, 75D30118P02219, 75D30121P12414, 75D30122P13919, 75D30124P19350 and 75D30125F20626.

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: CDC/GHC/DGHT/ILB, COR TEAGAN

YISRAEL,PHA

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.

04.27.2026