82212 - SSJ_Specific Pathogen Free eggs.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 National Centers for Immunization and Respiratory Diseases Influenza Division/Virology Surveillance and Diagnosis Branch 1600 Clifton Rd., NE Building 17, 5th floor Atlanta, GA 30329

B. Contracting Activity:

Centers for Disease Control and Prevention OFR-Office of Acquisition Services Chamblee Campus Building 102, MS S102-4 Atlanta, GA 30341-3717

C. Identification of Requirement:

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

a. Sole source acquisition of: Specific Pathogen Free (SPF) Fertile Chicken Eggs

b. Procurement Request (PR) Number (if available): 82212

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

a. Proposed Vendor: Name: Avian Vaccine Services LLC Address: 1 Wisconsin Avenue, Suite 100 Norwich, CT 06360

b. Estimated Procurement Amount: $

3. Is the requirement on GSA Schedule? Yes No

If yes, provide schedule number: NA

Rev. 5/14/19

D. Justification:

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

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 WHO recommends that influenza vaccine seed candidates are produced in SPF-embryonated chicken eggs. The vaccine seed candidates must have the antigenic properties of the recommended strain and improved growth properties for more efficient vaccine production. SPF eggs are produced under strictly isolated conditions to guarantee the absence of all disease agents and antibodies against specified agents, which are laid down in the European Pharmacopoeia and by the USDA. SPF eggs are generally used for all live vaccines and also for inactivated vaccines. NCIRD/ID currently participates in two projects to produce vaccine seed candidates. One project involves the production of high-growth vaccine seed candidates using high-growth reassortants, and the other produces seed candidates for live attenuated influenza vaccines (LAIV).

In the ID laboratory, high-growth reassortant influenza virus reagents have been prepared by infecting an embryonated chicken’s egg with high-growth reassortant viruses. The goal has been to generate reassortant viruses that contain internal genes from the A/PR/8/34 virus plus the hemagglutinin (HA) and neuraminidase (NA) gene segments of the newly recommended wild-type strain. For growing the vaccine seed virus, the eggs from closed, specific-pathogen-free, healthy flocks are recommended by WHO. SPF eggs ensure the highest quality of vaccine seeds prepared by the CDC.

As new vaccine candidates are required yearly for seasonal and non-seasonal influenza vaccines, ongoing production of vaccine seeds is required using Good Laboratory Practices (GLP) and Good Manufacturing Processes (GMP) using SPF eggs.

SPF fertile chicken eggs provided by Avian Vaccine Services (company name formerly Charles River) have been used for egg isolation of candidate vaccine viruses in the NCIRD/ID for over ten years. Changing the source of eggs can affect the genetic content and potential quality of resulting isolates. To ensure consistency in the production of candidate vaccine virus quality, the program seeks to continue obtaining SPF eggs from Avian Vaccine Services.

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

The Program considered required Government sources, existing HHS and government-wide strategic sources, category management, OMB-recommended Best-In-Class contracting vehicles, and information collected during market research.

These searches did not produce any additional sources other than the source NCIRD is requesting. NCIRD then conducted an internet search to identify a list of potential sources for supplying SPF chicken eggs to the Influenza Division. Due to the program’s need to retain continuity to the division’s SPF egg supply, none of the two alternate sources of SPF eggs that were founds (VALO BioMedia North America and Hyline North America) were considered.

3. Program Office efforts to seek potential offerors:

Potential suppliers were found through searches of previous CDC contracts and through a search of the GSA e-Library using the category NAICS code 112310 (Chicken Egg Production). A search of previous CDC contracts has shown that there was a limited source list for Contractors who furnish SPF eggs in the quantities and at the schedule needed for this requirement—the initial search through the GSA e-library using NAICS code 112310 which generated 0 results. A search was then conducted using the previous Contractor, Charles River Laboratories, Inc., which did produce a result placing them in the other than small business category. No other potential Contractors were found using this method; thus, NCIRD conducted a CRA search using NAICS code 112310 and an internet search to identify a list of potential Contractors for supplying SPF chicken eggs. The CRA search using NAICS code 112310 did identify one potential commercial small business, Avian Vaccine Services LLC (AVSBio), which is a subsidiary of Charles River Laboratories, Inc. (the recent/previous Contractor). The internet search produced two (2) large commercial businesses.

Charles Rivers Laboratories, Inc. is a commercial Contractors that has provided these services under the recent sole-sourced five-year CDC contract (200-2018-02844 – Specific Pathogen Free Fertile Eggs) and prior CDC contracts (200-2013-F-57035 [period of performance – 9/10/2013 to 9/9/2018]; 200-2012-M-50487 [period of performance – 7/21/2011 to 7/20/2022]; 200-2012-M-52627 [ period of performance – 8/29/2012 to 8/28/2013]); 200-2012-M-50487 [period of performance – 4/3/2012 to 4/2/2013]; and 200-

2011-M-39774 [period of performance – 7/21/2011 to 7/21/2012], all of which were commercially sole-sourced) supplying NCIRD/ID with the required SPF fertile chicken eggs since 2011. Due to the highly specialized Contractors who supply SPF eggs and the availability of few Contractors who can provide these services, it is important to ensure that continuity of high-quality service in regard to the same source of SPF eggs is maintained and recommended for program success. Maintaining consistency in the SPF eggs supplied is recommended for program success.

There is one (1) potential small business found from NCIRD’s search of NAICS code 112310, and two (2) potential large businesses were found from Internet searches. AVSBio, who is a subsidiary of Charles River Laboratories, Inc. (the recent/previous Contractor) is a small commercial business that was found via NCIRD search of NAICS code 112310, and both Hy-Line North America and VALO BioMedia North America are large commercial businesses. Only AVSBio is found to be a potential Contractor since they provide the same services as the recent/previous Contractor, and the two large businesses were found not to satisfy the requirements for maintaining consistency in SPF egg supply for vaccine seed production.

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: NCIRD/ID/VSDB; Wendy Sessions, Biologist

Digitally signed by Wendy M. Sessions -S Date: 2023.12.06 15:20:16 -05'00'

Official signature:

Certification Date: April 30, 2024

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: Marie Bartkevicius

Contracting Officer Signature:

Certification Date:

Wendy M. Sessions -S