Regulatory Review Support Services

The Food and Drug Administration established this Master BPA on September 26, 2019 with a shared ceiling of $100 million, but ordering closed on September 29, 2024, making this vehicle no longer available for new task orders.

The vehicle is inactive. The last task order award occurred on September 16, 2024, approximately 22 months ago. Activity peaked in 2020 with 17 orders, declining to a low of 6 in 2022 before recovering to 8–11 orders annually in 2023–2024. Across the 50 total awards spanning March 2020 through September 2024, contractors obligated $158.8 million against a combined potential value of $174.6 million—91% draw-down of available capacity before ordering closed.

All work is regulatory review support services for FDA's Office of Computational Science and related divisions. Task orders span data management and quality assurance, clinical and nonclinical data analysis, pharmaceutical standards development, statistical programming, training delivery, system maintenance, and support desk operations. Representative recent awards include Data Modernization Phase 2 ($17.6 million, labor hours), CTP OS Customer Service Center ($19.4 million, labor hours), and Office of Computational Science Regulatory Review Support ($5.6 million, labor hours).

IBM dominates the vehicle, holding 45 of 50 task orders and $154.6 million of the $174.6 million combined potential value—88% of all activity by award count and 89% by value. Booz Allen Hamilton holds the remaining 5 orders ($20 million). The customer base is entirely FDA; no other agency placed orders.

Seventy-eight percent of task orders—39 of 50—carried no set-aside designation. The remainder were set-aside awards, though the source does not specify the categories. Pricing across awards mixes labor hours and firm fixed price, with labor-hour orders typically in the $1.2 million to $5.6 million range and FFP orders clustering from $200,000 to $8.4 million.

This vehicle is closed to new competition. Firms not currently on the award list cannot pursue work here. Existing awardees may continue to execute outstanding task orders, many of which carry performance dates through mid-2025.