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 2024, the total user fees as-
sessed and collected under subsection (a) 
VerDate Sep 11 2014 
00:06 Aug 06, 2021
Jkt 019200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H4629.IH
H4629
pbinns on DSKJLVW7X2PROD with BILLS
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 
VerDate Sep 11 2014 
00:06 Aug 06, 2021
Jkt 019200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H4629.IH
H4629
pbinns on DSKJLVW7X2PROD with BILLS
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 2024 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 
VerDate Sep 11 2014 
00:06 Aug 06, 2021
Jkt 019200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6201
E:\BILLS\H4629.IH
H4629
pbinns on DSKJLVW7X2PROD with BILLS
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, 2023, for calendar year 
2022, by April 1, 2023, for the period of Janu-
ary 1, 2023, through March 30, 2023, and 
monthly thereafter. Such information shall in-
clude— 
‘‘(i) the identification of the manufac-
turer or importer; 
VerDate Sep 11 2014 
00:06 Aug 06, 2021
Jkt 019200
PO 00000
Frm 00007
Fmt 6652
Sfmt 6201
E:\BILLS\H4629.IH
H4629
pbinns on DSKJLVW7X2PROD with BILLS
‘‘(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’’. 
VerDate Sep 11 2014 
00:06 Aug 06, 2021
Jkt 019200
PO 00000
Frm 00008
Fmt 6652
Sfmt 6201
E:\BILLS\H4629.IH
H4629
pbinns on DSKJLVW7X2PROD with BILLS
(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 
2024. 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 
VerDate Sep 11 2014 
00:06 Aug 06, 2021
Jkt 019200
PO 00000
Frm 00009
Fmt 6652
Sfmt 6201
E:\BILLS\H4629.IH
H4629
pbinns on DSKJLVW7X2PROD with BILLS