of enactment of this Act, shall apply with respect to fiscal 
years preceding fiscal year 2024. 
SEC. 3. ANNUAL REPORT. 
(a) IN GENERAL.—For fiscal year 2022 and each 
subsequent fiscal year for which fees are collected under 
section 919 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 387s), the Secretary of Health and Human 
Services, acting through the Commissioner of Food and 
Drugs, shall, not later than 180 days after the end of the 
respective fiscal year for which the report is being pre-
pared, submit to the Committee on Health, Education, 
Labor, and Pensions and the Committee on Appropria-
tions of the Senate, and the Committee on Energy and 
Commerce and Committee on Appropriations of the House 
of Representatives, an annual report with respect to such 
fees that contains the information required under sub-
section (b). 
(b) REQUIRED INFORMATION.—Each report sub-
mitted under subsection (a) shall contain the following in-
formation with respect to the fiscal year for which the re-
port is being submitted: 
(1) A breakdown of the amount expended by 
the Food and Drug Administration on each of the 
following activities: 
(A) Compliance and enforcement. 
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(B) Public education campaigns. 
(C) Scientific research and research infra-
structure. 
(D) Communications. 
(E) Leadership, management, oversight, 
and administrative functions. 
(F) Related overhead activities. 
(G) Other activities. 
(2) Details on the amount expended, and the 
purpose of such expenditures, on each of the five 
largest expenditure amounts within each of the cat-
egories described in paragraph (1). 
(3) A breakdown of the amount expended on 
activities related to deemed tobacco products versus 
how much was expended on activities related to com-
bustible tobacco products outlined in the pre-existing 
categories of tobacco products under section 919 of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 387s). 
(4) An explanation for how the Food and Drug 
Administration ensures that the amount of user fees 
allocated to public education campaigns on youth e- 
cigarette use and prevention is sufficient to meet the 
need for education of teens and minors on the dan-
gers of e-cigarettes and other Electronic Nicotine 
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Delivery 
Systems 
(commonly 
referred 
to 
as 
‘‘ENDS’’). 
(5) A list of the status of submitted, pending, 
and approved tobacco product applications for each 
regulatory pathway and class of tobacco product as 
defined by the Family Smoking Prevention and To-
bacco Control Act (Public Law 111–31), including 
subsequent regulations, for the 3-fiscal year period 
preceding the fiscal year for which the report is 
being prepared. 
(6) When applicable, a breakdown of the 
amount or user fees collected under the amendments 
made by this Act from manufacturers of deemed to-
bacco products and the amount collected from man-
ufacturers of each of the original pre-existing cat-
egories of tobacco products under section 919 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
387s). 
Æ 
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