JEFO_Drodex_IBMSC_Redacted.pdf

JUSTIFICATION FOR AN EXCEPTION TO FAIR OPPORTUNITY

1.

Agency: Department of Health and Human Services (HHS)

Requiring Activity: Administration for Strategic Preparedness and Response (ASPR), Center for Industrial Base Management and Supply Chain (IBMSC)

2.

New Requirement Sole Source Order against Contract Number 75A50121D00011/75A50525F65015

Firm- (FFP)

3.

(DPA) – to and program requirements.

options, is: with a 3 month option period at .

4.

RFO 16.507-

-on by March 30, 2026, to ensure ASPR’s Center for Industrial Base

Management and Supply Chain (IBMSC) Defense Production Act (DPA) – Due to a series of unforeseen federal and Departmental actions, a new competitive was not awarded as originally planned.

-scale reductions in contracts resulting in increased terminate for convenience and close out the eliminated contracts, , and two federal government shutdowns.

timeline and, consequently, limited competition, please refer to the timeline outlined below:

On June 3-7, 2024, a team of ASPR Representatives (CORs) and Project Managers (PMs) for a new competitive professional and

-IDIQ) for ASPR -long ) Civilian Services

MA- gh March 29, 2025. -IDIQs included FAR clause 52.216- prior the MA-IDIQ to have a period of performance up to one year beyond the MA- MA-completed October 2, 2024, with the goal to continue competitively award employees was reduced from full-time equivalents. Amid these reductions, the ursuant to Departmental guidance and in coordination with ( ), ASPR was directed to review and reduce, via negotiated terminations for convenience, agreements for assisted acquisitions.

Additionally, the March 27, 2025 reo announcement indicated that the number of HHS divisions would be reduced from , core administrative functions would be regarding ASPR’s future structure and mission MA-IDIQ contract, as requirements could

Furthermore, as a result of the April 1, 2025 Reduction in Force (RIFs)

-8 to the capabilities while providing time to assess ASPR’s long-enduring requirements. At that time, the

Shortly thereafter, the federal government shut down from October 1 through November 12, 2025, the longest shutdown in American history. Contracting and program personnel during this period. -

Once the continuing resolution to fund the government through January 30, 2026 was passed and the language indicated in the draft FY2026 appropriations bill indicated that the the acquisition and the reorga .

In parallel, HHS implemented a Department-wide procurement consolidation. OMAS, 20, 2026.

A second, shorter government shutdown from January 31, 2026 through February 3, 2026, again disrupted procurement activities.

On February 3, 2026, H.R. 7148, the Consolidated Appropriations Act, 2026, was enacted vices (e.g., requirements endured.

multi- Program. DPA-ritical materials and goods

HHS is onshoring domestic manufacturing of essential medicines currently produced in whole or in part outside of the US and they constitute a vulnerability in national security.

DPA-

three (3) current contracts for the production of Active Pharmaceutical Ingredients (APIs)/Key Starting Materials (KSMs) and three (3) active contracts for alternative time, and at feasibility of projects, the associated costs, timeline for completion, and funding and cost-sharing options providing recommendations for leadership. A lapse in qual

-year investment contracts and then to add the required steps to issue

Failure to continue with the current vendor will result in unacceptable delays which will in the capability to meet the government’s requirements and source contractors with appropriate sole source bridge without any transition period. By contrast, awarding this requirement to a oarding and vetting new personnel, obtaining completely new, but necessary badges and system accesses, and

29, 2026. As a result, attempting to compete this requirement now would itself cause the very lapse in mission-critical services that this bridge action is intended to avoid.

-month bridge is a reduction in administrative and physical security costs and time to on-board new contractor personnel, 5.

I hereby determine that the anticipated price/cost for this contract action will be fair and reasonable. contract.

labor category price lists for each company have been established through the over-arching

However, HHS reserves the right to further negotiate price reductions as allowable by the FAR.

In addition, under this sole source, reasonableness by comparing the proposed labor categories, hours, and rates to (1) the rates