United States Code
USC most recently checked for updates: Oct 04, 2023
For fiscal year 2022 and each subsequent fiscal year for which fees are collected under section 387s of this title, the Secretary of Health and Human Services shall, not later than 180 days after the end of the fiscal year, prepare and submit to the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate, an annual report that contains the information required under subsection (b).
The Secretary of Health and Human Services shall make the reports required under this section available to the public on the website of the Food and Drug Administration.
Reporting under this section shall include best estimates for any reporting category for which the Food and Drug Administration does not have precise calculations. Such best estimates shall be accompanied with an explanatory statement for why the Food and Drug Administration does not have access to, or cannot calculate, the exact figure and a date by which the Food and Drug Administration will update its internal accounting procedures to allow for such reporting. If a category is successfully reported by the Food and Drug Administration with regard to another type of user fee but is provided a best estimate by the Center for Tobacco Products, the explanatory statement shall include information regarding how the Food and Drug Administration will align systems and apply learning across the agency to allow for accurate reporting.