‘‘(K) For fiscal year 2019, $712,000,000. 
‘‘(L) For fiscal year 2020, $812,000,000. 
‘‘(M) For each subsequent fiscal year, the 
amount that was applicable for the previous fis-
cal year, adjusted by the total percentage 
change that occurred in the Consumer Price 
Index for all urban consumers (all items; 
United States city average) for the 12-month 
period ending June 30 preceding the fiscal 
year.’’. 
(b) APPLICATION OF USER FEES TO ALL CLASSES 
OF TOBACCO PRODUCTS.— 
(1) IN GENERAL.—Subparagraph (A) of section 
919(b)(2) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 387s(b)(2)) is amended to read as 
follows: 
‘‘(A) IN GENERAL.— 
‘‘(i) FISCAL YEARS 2020 AND 2021.— 
For fiscal years 2020 and 2021, user fees 
shall be assessed and collected under sub-
section (a) only with respect to the classes 
of tobacco products listed in subparagraph 
(B)(i), and the total such user fees with re-
spect to each such class shall be an 
amount that is equal to the applicable per-
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centage of each such class for the fiscal 
year multiplied by the amount specified in 
paragraph (1) for the fiscal year. 
‘‘(ii) SUBSEQUENT
FISCAL
YEARS.— 
For fiscal year 2022 and each subsequent 
fiscal year, user fees shall be assessed and 
collected under subsection (a) with respect 
to each class of tobacco products to which 
this chapter applies (including tobacco 
products that the Secretary by regulation 
deems to be subject to this chapter), and 
the total user fees with respect to each 
such class shall be— 
‘‘(I) with respect to each class of 
tobacco products listed in subpara-
graph (B)(i), an amount that is cal-
culated in the same way as the 
amounts calculated for fiscal years 
2020 and 2021 under clause (i), ex-
cept that for purposes of fiscal years 
2022 and subsequent fiscal years, in-
stead of multiplying the applicable 
percentage of each such class by ‘the 
amount specified in paragraph (1) for 
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the fiscal year’, the applicable percent-
age shall be multiplied by— 
‘‘(aa) the amount specified 
in paragraph (1) for the fiscal 
year, reduced by 
‘‘(bb) the total user fees as-
sessed and collected pursuant to 
subclause (II) for the fiscal year; 
and 
‘‘(II) with respect to each class of 
tobacco products to which this chapter 
applies but which is not listed in sub-
paragraph (B)(i), an amount deter-
mined pursuant to a formula under 
subparagraph (C).’’. 
(2) 
OTHER
TOBACCO
PRODUCTS.—Section 
919(b)(2) of the Federal Food Drug, and Cosmetic 
Act (21 U.S.C. 387s(b)(2)), as amended by para-
graph (1), is further amended by adding at the end 
the following new subparagraphs: 
‘‘(C) ALLOCATION
FOR
OTHER
TOBACCO 
PRODUCTS.— 
‘‘(i) IN
GENERAL.—Beginning with 
fiscal year 2022, the total user fees as-
sessed and collected under subsection (a) 
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each fiscal year with respect to each class 
of tobacco products not listed in subpara-
graph (B)(i) shall be an amount that is de-
termined pursuant to a formula developed 
by the Secretary by regulation using infor-
mation required to be submitted under 
subparagraph (D). 
‘‘(ii) ALLOCATION
FOR
OTHER
TO-
BACCO PRODUCTS.—For each class of to-
bacco products not listed in subparagraph 
(B)(i), the percentage of fees under the 
formula under clause (i) for the respective 
fiscal year shall be equal to the percentage 
of the gross domestic sales in the previous 
calendar year that is attributable to such 
class of tobacco products in such calendar 
year, as determined by the Secretary. 
‘‘(iii) ALLOCATION
OF
ASSESSMENT 
WITHIN EACH CLASS OF OTHER TOBACCO 
PRODUCTS.—The percentage of the total 
user fee to be paid by each manufacturer 
or importer of tobacco products in a class 
not listed in subparagraph (B)(i) shall be 
determined by the Secretary, based on the 
percentage of the gross domestics sales of 
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all such classes of tobacco products by all 
manufacturers and importers in the pre-
vious calendar year that is attributable to 
such manufacturer or importer. 
‘‘(iv) EFFECT OF FAILURE TO FINAL-
IZE FORMULA ON TIME.—If the Secretary 
for any reason fails to finalize by fiscal 
year 2022 the formula required by this 
subparagraph for the assessment and col-
lection of user fees for classes of tobacco 
products 
not 
listed 
in 
subparagraph 
(B)(i)— 
‘‘(I) the Secretary shall continue 
to assess and collect fees under sub-
section (a) with respect to each class 
of tobacco products listed in subpara-
graph (B)(i); and 
‘‘(II) until the first fiscal year 
commencing after the finalization of 
such formula, the exception described 
in subparagraph (A)(ii)(I) shall not 
apply. 
‘‘(v) REVISIONS
BY
REGULATION.— 
Any revisions to the formula promulgated 
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pursuant to this subparagraph shall be by 
regulation. 
‘‘(vi) DEFINITION.—In this subpara-
graph, the term ‘gross domestic sales’ 
means the total value in dollars of the sale 
or distribution by manufacturers and im-
porters of tobacco products in the United 
States in classes not listed in subpara-
graph (B)(i), as determined based on the 
aggregation of sales data from every man-
ufacturer and importer of tobacco products 
that submits sales data to the Secretary. 
‘‘(D) INFORMATION REQUIRED TO BE SUB-
MITTED.—Each manufacturer or importer of 
any tobacco product shall submit to the Sec-
retary the information required under this sub-
paragraph by March 1, 2021, for calendar year 
2020, by April 1, 2021, for the period of Janu-
ary 1, 2021, through March 30, 2021, and 
monthly thereafter. Such information shall in-
clude— 
‘‘(i) the identification of the manufac-
turer or importer; 
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‘‘(ii) the class or classes of tobacco 
products sold by the manufacturer or im-
porter; 
‘‘(iii) the full listing of the finished to-
bacco products in a class not listed in sub-
paragraph (B)(i) sold or distributed by the 
manufacturer or importer in the United 
States; and 
‘‘(iv) the gross domestic sales data for 
each class of finished tobacco products sold 
or distributed by the manufacturer or im-
porter in the United States.’’. 
(3) PROHIBITED ACT.—Section 301(q)(1)(B) of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 331(q)(1)(B)) is amended by inserting 
‘‘919(b)(2)(D),’’ before ‘‘or 920’’. 
(c) ALLOCATION
OF ASSESSMENT WITHIN EACH 
CLASS OF TOBACCO PRODUCT.—Section 919(b)(4) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
387s(b)(4)) is amended by striking ‘‘shall be the percent-
age determined for purposes of allocations under sub-
sections (e) through (h) of section 625 of Public Law 108– 
357’’ and inserting ‘‘shall be the percentage determined 
by the Secretary’’. 
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(d) CONFORMING AMENDMENTS.—Section 919(b) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
387s(b)) is amended— 
(1) by striking paragraph (5); 
(2) by redesignating paragraphs (6) and (7) as 
paragraphs (5) and (6), respectively; and 
(3) by amending paragraph (6), as redesig-
nated, to read as follows: 
‘‘(6) MEMORANDUM OF UNDERSTANDING.—The 
Secretary shall request the appropriate Federal 
agency to enter into a memorandum of under-
standing that provides for the regular and timely 
transfer from the head of such agency to the Sec-
retary of all necessary information regarding all to-
bacco product manufacturers and importers required 
to pay user fees. The Secretary shall maintain all 
disclosure restrictions established by the head of 
such agency regarding the information provided 
under the memorandum of understanding.’’. 
(e) APPLICABILITY.—The amendments made by sub-
sections (b), (c), and (d) apply beginning with fiscal year 
2022. Subject to the amendment made by subsection (a), 
section 919 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 387s), as in effect on the day before the date 
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of enactment of this Act, shall apply with respect to fiscal 
years preceding fiscal year 2022. 
SEC. 3. ANNUAL REPORT. 
(a) IN GENERAL.—For fiscal year 2020 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-
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gers of e-cigarettes and other Electronic Nicotine 
Delivery Systems (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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