Egg Supply J and A_Redacted.pdf
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- Solicitation number
- 75A50125C00002
About this file
This is a Justification and Approval (J&A) document for other than full and open competition for maintaining embryonated egg supply for non-seasonal production of pandemic vaccine in fiscal year 2025. The contract will be awarded to a sole source contractor under FAR 6.302-1 authority (only one responsible source) to maintain a dynamic raw material supply chain of embryonated hen eggs for manufacturing pandemic influenza vaccine.
The contractor must provide a domestic network of incubation facilities and flocks to ensure year-round supply of embryonated eggs specifically for an FDA-licensed seasonal and pandemic influenza vaccine, with capability to produce minimum 10 million monovalent influenza vaccine final finished containers per week during public health emergencies. The contract will use a hybrid pricing structure (FFP, CPFF, Cost) and is a follow-on to contract #75A50122C00018. A Special Notice was published on SAM.gov from November 24-December 10, 2024 with no interested parties responding. The contracting agency is the Department of Health and Human Services' Assistant Secretary for Preparedness and Response (ASPR).
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The total estimated value of the proposed action, including all options is $
Identify the statutory authority, FAR title and FAR citation permitting other than full and open competition. It may be one of the following most commonly used citations by the operating divisions of the Department of Health and Human Services (HHS), but other exceptions may apply per FAR Subpart 6.3.
: Only one responsible source and no other supplies or services will satisfy agency requirements, 41 U.S.C.
3304(a)(1)
: Authorized or Required by Statute, 41 U.S.C. 3304(a)(5)
Other (See FAR Subpart 6.3 for additional authority)
Provide a full explanation to justify use of the exception.
Describe the actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration prior to any subsequent acquisition for the supplies of services is made. If no such actions have been taken, explain why.
: Unusual and compelling urgency, 41 U.S.C. 3304(a)(2)
Purchase order or contract number:
Was action competed?
If action was not competed, state the cited authority, summarize rationale, and describe the actions that were supposed to be taken to increase competition and the results thereof:
By my signature below, I certify that the supporting data included in this J&A is accurate and complete.
As Contracting Officer, by my signature below, I hereby determine that the anticipated price/cost to the Government for this contract action will be fair and reasonable.
I hereby certify that this justification is accurate and complete to the best of my knowledge. I approve this justification subject to availability of funds, and provided that the services and supplies herin describe have otherwise been authorized for acquisition.
I have reviewed this justification and find that it adequately supports other than full and open competition.
I have reviewed this justification and find that it adequately supports other than full and open competition.
Non-Concur:
Based on the foregoing justification, I hereby approve other than full and open competition for the above stated procurement, subject to the availability of funds, and provided that the services herein described have otherwise been authorized for acquisition.
Use of noncompetitive procedures, 41 U.S.C. 3304 (a)(1) and FAR 6.302-1 Only one responsible source and no other supplies or services will satisfy agency requirements.
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