A13. Sole Source Justification Redacted.pdf

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service

Centers for Disease Control and Prevention (CDC)

Atlanta GA 30333

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 National Centers for Immunization and Respiratory Diseases Lab Task Force: Strain Surveillance and Emerging Variants Team 1600 Clifton Rd., NE Bldg. 24, 7th floor Mailstop A-20 Atlanta, GA 30333

B. Contracting Activity:

Centers for Disease Control and Prevention Procurement and Grants Office Acquisition Branch 2

C. Identification of Requirement:

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

a. Sole source acquisition of: Expression and purification of eight (8) influenza or host proteins, in correct oligomeric state, the determination of six (6) structures of influenza virions or proteins utilizing cryo-EM methodologies, and polyclonal epitope mapping using negative stain-EM (nsEMPEM) of forty (40) influenza samples.

b. Procurement Request (PR) Number (if available): 86231

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

a. Proposed Vendor: Liang Lab, Emory University School of Medicine, Department of Biochemistry, RM G247, Rollins Research Ctr., 1510 Clifton Rd. NE, Atlanta, GA

30322, USA

b. Estimated Procurement Amount:

3. Is the requirement on GSA Schedule? D Yes If yes, provide schedule number: N/A

IZI No

Rev. 1/6/14

D. Justification:

1. The justification for this non-competitive action is:

IZI 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."

D Urgency

D Exclusive licensing agreements/Proprietary data

D Brand name required

D Industrial mobilization

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

D 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."

D Urgency

D Only One Source D Logical Follow Up

2. Other facts supporting sole source procurement:

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

The Liang lab at the Emory University School of Medicine remains the only group publishing influenza nsEMPEM structures and determining influenza glycoprotein polyclonal landscapes as a service. There are other groups that are capable of nsEMPEM, such as Creative Biostructure and Nanolmaging Services, but which are not able nor experienced in the culturing and working with live viruses in general, including influenza virus specifically.

Other companies, such as Cyrus BioTechnology do not have experience with nsEMPEM even though they utilize other electron microscopy techniques, and still their experience and publication with live influenza virus (not recombinant viral proteins alone) is in question. Finally, there is one other known group with experience both in nsEMPEM and influenza viruses, the European Molecular Biology Laboratory, where many of the techniques were pioneered and members of Liang Lab trained, but they are explicitly only accepting samples for research from scientists within the EU, and are not willing to processes samples from the US/for the US Government.

Additionally, entities further from the CDC would lose time in transition (shipping one day in each direction), when plasmids and proteins can be exchanged directly on the same day they are created due to the close proximity of Emory. Couple this with anticipated turn around times (TAT) of 15-days for protein expression and purification, and 4-6 weeks for solving protein structurers, and the Liang lab provides significantly faster service.

Further, the Liang lab has the exact and rare expertise required: experience in rapid viral protein production and purification, cryo-EM, and particularly the use of cryo-EM to solve viral protein structures.

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

Several other vendors were contacted, including Creative Biostructure, Nanolmanging Services, Cyrus Biotechnology, and EMBL. None of them had the capacity to even start on a new project in under 4 months, and all projected significantly longer TAT's at each step, and much higher costs, as they would have develop and validate new procedures at CDC's cost. In essence, they are currently lacking the concurrent facility space for pathogens and nsEMPEM, and CDC would be paying for them to totally setup an offering they do not currently have in place or the capability to conduct.

3. Program Office efforts to seek potential offerers:

CDC contacted several vendors, including Creative Biostructure, Nanolmanging Services, Cyrus Biotechnology, and EMBL, to determine their willingness and capability to handle the requirement. CDC will continue to research possible offerers for future requirements of this nature.

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 CCR/Program Official Name/Title: NCIRD/IDNSDB; Charmaine McKenzie, PHA

Center/Institute/Office CCR/Program Official Signature:

Certification Date: April 30, 2026

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:

Contracting Officer Signature:

William O'Bryan Digitally signed by William

William O'bryan -5 O'bryan-5

Date: 2024.08.05 09:38:48 -04'00'

Certification Date: Click here to enter a date.