Independent Attestation Report: Food and Drug Administration Budget Formulation Compliance Report and Detailed Accounting Submission for Fiscal Year 2021 National Drug Control Activities, and Accompanying Required Assertions

This report provides the results of our review of the Food and Drug Administration (FDA) Office of National Drug Control Policy (ONDCP) Budget Formulation Compliance Report, which includes budget formulation information for the fiscal year ending September 30, 2023, and the Chief Financial Officer's or accountable senior executive's assertions relating to the budget formulation information. We performed this review as required by 21 U.S.C. section 1704(d)(1) and as authorized by 21 U.S.C. section 1703(d)(7) and in compliance with the ONDCP Circular National Drug Control Program Agency Compliance Reviews, dated September 9, 2021 (ONDCP Compliance Reviews Circular).

We also received FDA's ONDCP Detailed Accounting Report and management's assertions for the fiscal year ended September 30, 2021. FDA did not provide this report in sufficient time for the Office of Inspector General to review and authenticate the report. Accordingly, we do not express a conclusion about the reliability of management's assertions.

Based on our review, FDA did not conform in all material respects to the ONDCP Compliance Reviews Circular. Specifically, FDA did not provide a timely ONDCP Detailed Accounting Report for the fiscal year ended September 30, 2021. Except for this deficiency, we are not aware of any material modifications that FDA should make to be in accordance with the ONDCP Compliance Reviews Circular.