I 

116TH CONGRESS 

2D SESSION H. R. 5721 

To apply user fees with respect to tobacco products deemed subject to the 

requirements of chapter IX of the Federal Food, Drug, and Cosmetic Act. 

IN THE HOUSE OF REPRESENTATIVES 

JANUARY 30, 2020 

Mrs. BUSTOS introduced the following bill; which was referred to the 

Committee on Energy and Commerce 

A BILL 

To apply user fees with respect to tobacco products deemed 

subject to the requirements of chapter IX of the Federal 

Food, Drug, and Cosmetic Act. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Resources to Prevent 

5 Youth Vaping Act’’. 

6 SEC. 2. USER FEES. 

7 (a) INCREASE IN TOTAL AMOUNT.—Section 

8 919(b)(1) of the Federal Food, Drug, and Cosmetic Act 

9 (21 U.S.C. 387s(b)(1)) is amended by striking subpara10 graph (K) and inserting the following subparagraphs: 


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1 ‘‘(K) For fiscal year 2019, $712,000,000. 

2 ‘‘(L) For fiscal year 2020, $812,000,000. 

3 ‘‘(M) For each subsequent fiscal year, the 

4 amount that was applicable for the previous fis5 cal year, adjusted by the total percentage 

6 change that occurred in the Consumer Price 

7 Index for all urban consumers (all items; 

8 United States city average) for the 12-month 

9 period ending June 30 preceding the fiscal 

10 year.’’. 

11 (b) APPLICATION OF USER FEES TO ALL CLASSES

12 OF TOBACCO PRODUCTS.— 

13 (1) IN GENERAL.—Subparagraph (A) of section 

14 919(b)(2) of the Federal Food, Drug, and Cosmetic 

15 Act (21 U.S.C. 387s(b)(2)) is amended to read as 

16 follows: 

17 ‘‘(A) IN GENERAL.— 

18 ‘‘(i) FISCAL YEARS 2020 AND 2021.— 

19 For fiscal years 2020 and 2021, user fees 

20 shall be assessed and collected under sub21 section (a) only with respect to the classes 

22 of tobacco products listed in subparagraph 

23 (B)(i), and the total such user fees with re24 spect to each such class shall be an 

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1 centage of each such class for the fiscal 

2 year multiplied by the amount specified in 

3 paragraph (1) for the fiscal year. 

4 ‘‘(ii) SUBSEQUENT FISCAL YEARS.— 

5 For fiscal year 2022 and each subsequent 

6 fiscal year, user fees shall be assessed and 

7 collected under subsection (a) with respect 

8 to each class of tobacco products to which 

9 this chapter applies (including tobacco 

10 products that the Secretary by regulation 

11 deems to be subject to this chapter), and 

12 the total user fees with respect to each 

13 such class shall be— 

14 ‘‘(I) with respect to each class of 

15 tobacco products listed in subpara16 graph (B)(i), an amount that is cal17 culated in the same way as the 

18 amounts calculated for fiscal years 

19 2020 and 2021 under clause (i), ex20 cept that for purposes of fiscal years 

21 2022 and subsequent fiscal years, in22 stead of multiplying the applicable 

23 percentage of each such class by ‘the 

24 amount specified in paragraph (1) for 


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1 the fiscal year’, the applicable percent2 age shall be multiplied by— 

3 ‘‘(aa) the amount specified 

4 in paragraph (1) for the fiscal 

5 year, reduced by 

6 ‘‘(bb) the total user fees as7 sessed and collected pursuant to 

8 subclause (II) for the fiscal year; 

9 and 

10 ‘‘(II) with respect to each class of 

11 tobacco products to which this chapter 

12 applies but which is not listed in sub13 paragraph (B)(i), an amount deter14 mined pursuant to a formula under 

15 subparagraph (C).’’. 

16 (2) OTHER TOBACCO PRODUCTS.—Section 

17 919(b)(2) of the Federal Food Drug, and Cosmetic 

18 Act (21 U.S.C. 387s(b)(2)), as amended by para19 graph (1), is further amended by adding at the end 

20 the following new subparagraphs: 

21 ‘‘(C) ALLOCATION FOR OTHER TOBACCO

22 PRODUCTS.— 

23 ‘‘(i) IN GENERAL.—Beginning with 

24 fiscal year 2022, the total user fees as25 sessed and collected under subsection (a) 


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1 each fiscal year with respect to each class 

2 of tobacco products not listed in subpara3 graph (B)(i) shall be an amount that is de4 termined pursuant to a formula developed 

5 by the Secretary by regulation using infor6 mation required to be submitted under 

7 subparagraph (D). 

8 ‘‘(ii) ALLOCATION FOR OTHER TO9 BACCO PRODUCTS.—For each class of to10 bacco products not listed in subparagraph 

11 (B)(i), the percentage of fees under the 

12 formula under clause (i) for the respective 

13 fiscal year shall be equal to the percentage 

14 of the gross domestic sales in the previous 

15 calendar year that is attributable to such 

16 class of tobacco products in such calendar 

17 year, as determined by the Secretary. 

18 ‘‘(iii) ALLOCATION OF ASSESSMENT

19 WITHIN EACH CLASS OF OTHER TOBACCO

20 PRODUCTS.—The percentage of the total 

21 user fee to be paid by each manufacturer 

22 or importer of tobacco products in a class 

23 not listed in subparagraph (B)(i) shall be 

24 determined by the Secretary, based on the 

25 percentage of the gross domestics sales of 


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1 all such classes of tobacco products by all 

2 manufacturers and importers in the pre3 vious calendar year that is attributable to 

4 such manufacturer or importer. 

5 ‘‘(iv) EFFECT OF FAILURE TO FINAL6 IZE FORMULA ON TIME.—If the Secretary 

7 for any reason fails to finalize by fiscal 

8 year 2022 the formula required by this 

9 subparagraph for the assessment and col10 lection of user fees for classes of tobacco 

11 products not listed in subparagraph 

12 (B)(i)— 

13 ‘‘(I) the Secretary shall continue 

14 to assess and collect fees under sub15 section (a) with respect to each class 

16 of tobacco products listed in subpara17 graph (B)(i); and 

18 ‘‘(II) until the first fiscal year 

19 commencing after the finalization of 

20 such formula, the exception described 

21 in subparagraph (A)(ii)(I) shall not 

22 apply. 

23 ‘‘(v) REVISIONS BY REGULATION.— 

24 Any revisions to the formula promulgated 


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1 pursuant to this subparagraph shall be by 

2 regulation. 

3 ‘‘(vi) DEFINITION.—In this subpara4 graph, the term ‘gross domestic sales’ 

5 means the total value in dollars of the sale 

6 or distribution by manufacturers and im7 porters of tobacco products in the United 

8 States in classes not listed in subpara9 graph (B)(i), as determined based on the 

10 aggregation of sales data from every man11 ufacturer and importer of tobacco products 

12 that submits sales data to the Secretary. 

13 ‘‘(D) INFORMATION REQUIRED TO BE SUB14 MITTED.—Each manufacturer or importer of 

15 any tobacco product shall submit to the Sec16 retary the information required under this sub17 paragraph by March 1, 2021, for calendar year 

18 2020, by April 1, 2021, for the period of Janu19 ary 1, 2021, through March 30, 2021, and 

20 monthly thereafter. Such information shall in21 clude— 

22 ‘‘(i) the identification of the manufac23 turer or importer; 


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1 ‘‘(ii) the class or classes of tobacco 

2 products sold by the manufacturer or im3 porter; 

4 ‘‘(iii) the full listing of the finished to5 bacco products in a class not listed in sub6 paragraph (B)(i) sold or distributed by the 

7 manufacturer or importer in the United 

8 States; and 

9 ‘‘(iv) the gross domestic sales data for 

10 each class of finished tobacco products sold 

11 or distributed by the manufacturer or im12 porter in the United States.’’. 

13 (3) PROHIBITED ACT.—Section 301(q)(1)(B) of 

14 the Federal Food, Drug, and Cosmetic Act (21 

15 U.S.C. 331(q)(1)(B)) is amended by inserting 

16 ‘‘919(b)(2)(D),’’ before ‘‘or 920’’. 

17 (c) ALLOCATION OF ASSESSMENT WITHIN EACH

18 CLASS OF TOBACCO PRODUCT.—Section 919(b)(4) of the 

19 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

20 387s(b)(4)) is amended by striking ‘‘shall be the percent21 age determined for purposes of allocations under sub22 sections (e) through (h) of section 625 of Public Law 108– 

23 357’’ and inserting ‘‘shall be the percentage determined 

24 by the Secretary’’. 


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1 (d) CONFORMING AMENDMENTS.—Section 919(b) of 

2 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

3 387s(b)) is amended— 

4 (1) by striking paragraph (5); 

5 (2) by redesignating paragraphs (6) and (7) as 

6 paragraphs (5) and (6), respectively; and 

7 (3) by amending paragraph (6), as redesig8 nated, to read as follows: 

9 ‘‘(6) MEMORANDUM OF UNDERSTANDING.—The 

10 Secretary shall request the appropriate Federal 

11 agency to enter into a memorandum of under12 standing that provides for the regular and timely 

13 transfer from the head of such agency to the Sec14 retary of all necessary information regarding all to15 bacco product manufacturers and importers required 

16 to pay user fees. The Secretary shall maintain all 

17 disclosure restrictions established by the head of 

18 such agency regarding the information provided 

19 under the memorandum of understanding.’’. 

20 (e) APPLICABILITY.—The amendments made by sub21 sections (b), (c), and (d) apply beginning with fiscal year 

22 2022. Subject to the amendment made by subsection (a), 

23 section 919 of the Federal Food, Drug, and Cosmetic Act 

24 (21 U.S.C. 387s), as in effect on the day before the date 


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1 of enactment of this Act, shall apply with respect to fiscal 

2 years preceding fiscal year 2022. 

3 SEC. 3. ANNUAL REPORT. 

4 (a) IN GENERAL.—For fiscal year 2020 and each 

5 subsequent fiscal year for which fees are collected under 

6 section 919 of the Federal Food, Drug, and Cosmetic Act 

7 (21 U.S.C. 387s), the Secretary of Health and Human 

8 Services, acting through the Commissioner of Food and 

9 Drugs, shall, not later than 180 days after the end of the 

10 respective fiscal year for which the report is being pre11 pared, submit to the Committee on Health, Education, 

12 Labor, and Pensions and the Committee on Appropria13 tions of the Senate, and the Committee on Energy and 

14 Commerce and Committee on Appropriations of the House 

15 of Representatives, an annual report with respect to such 

16 fees that contains the information required under sub17 section (b). 

18 (b) REQUIRED INFORMATION.—Each report sub19 mitted under subsection (a) shall contain the following in20 formation with respect to the fiscal year for which the re21 port is being submitted: 

22 (1) A breakdown of the amount expended by 

23 the Food and Drug Administration on each of the 

24 following activities: 

25 (A) Compliance and enforcement. 


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1 (B) Public education campaigns. 

2 (C) Scientific research and research infra3 structure. 

4 (D) Communications. 

5 (E) Leadership, management, oversight, 

6 and administrative functions. 

7 (F) Related overhead activities. 

8 (G) Other activities. 

9 (2) Details on the amount expended, and the 

10 purpose of such expenditures, on each of the five 

11 largest expenditure amounts within each of the cat12 egories described in paragraph (1). 

13 (3) A breakdown of the amount expended on 

14 activities related to deemed tobacco products versus 

15 how much was expended on activities related to com16 bustible tobacco products outlined in the pre-existing 

17 categories of tobacco products under section 919 of 

18 the Federal Food, Drug, and Cosmetic Act (21 

19 U.S.C. 387s). 

20 (4) An explanation for how the Food and Drug 

21 Administration ensures that the amount of user fees 

22 allocated to public education campaigns on youth e23 cigarette use and prevention is sufficient to meet the 

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1 gers of e-cigarettes and other Electronic Nicotine 

2 Delivery Systems (ENDS). 

3 (5) A list of the status of submitted, pending, 

4 and approved tobacco product applications for each 

5 regulatory pathway and class of tobacco product as 

6 defined by the Family Smoking Prevention and To7 bacco Control Act (Public Law 111–31), including 

8 subsequent regulations, for the 3-fiscal year period 

9 preceding the fiscal year for which the report is 

10 being prepared. 

11 (6) When applicable, a breakdown of the 

12 amount or user fees collected under the amendments 

13 made by this Act from manufacturers of deemed to14 bacco products and the amount collected from man15 ufacturers of each of the original pre-existing cat16 egories of tobacco products under section 919 of the 

17 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

18 387s). 

Æ 


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