Post-Market Bioequivalence of Generic Drug Product

The Food and Drug Administration seeks to award an indefinite delivery/indefinite quantity contract to conduct up to five post-market bioequivalence or pharmacokinetic studies of generic drug products per task order over a five-year period. Studies may involve healthy subjects or patients and cover topics such as formulation complexity, therapeutic inequivalence, or controlled substances. Questions are due by December 22, 2023 and proposals are due by January 12, 2024. Evaluation criteria will consider technical approach, management plan, and past performance.

The solicitation is set aside as an 8(a) competitive opportunity under NAICS code 541715 with a PSC code of R699. Pricing will be provided at the task order level using firm-fixed rates by labor category, with a minimum value of $2 million and maximum of $20 million over five years. Place of performance will be at the contractor's facilities. Studies are to be completed within timeframes ranging from one to thirty-six months from award.