The U.S. Department of Health and Human Services (HHS) has published a change in federal grants regulations. What is changing? Before October 1, 2024, HHS used primarily the regulations stated in 45 CFR 75. On October 1, 2024, HHS adopted a few provisions contained in 2 CFR 200 in lieu of the similar provisions in 45 CFR 75. The goal was to provide some added flexibility for recipients. As of October 1, 2025, HHS will use the government-wide regulations of 2 CFR 200, with some modifications, which are found in 2 CFR 300.
For more details, please refer to the following links:
HHS Regulation Changes Overview
Code of Federal Regulations: Title 2 / Subtitle B / Chapter III / Part 300
HHS MODIFICATIONS
Recipients of HHS funding must assess the codified requirements under 2 CFR Part 300 to ensure internal policies, cost practices, conflict of interest standards, and approval processes align with the updated regulatory structure. Early alignment is critical to maintaining compliance, audit readiness, and continued eligibility for HHS awards.
Key Changes address conflict of interest standards, recipient-specific award requirements, nondiscrimination provisions, prior approval for research patient care costs, and indirect cost limitations, among other areas.
Why it matters?
The transition to 2 CFR Part 300 represents more than a regulatory reorganization—it formalizes HHS policy expectations into enforceable compliance requirements. Enhanced conflict of interest standards, special rules for for-profit recipients, indirect cost caps, and prior approval thresholds increase compliance risk for organizations that do not update internal controls, cost structures, and governance frameworks in advance of the October 1, 2025 effective date.
For more details, please refer to the following link: Grant Policy Bulletin
