PREVENT Act of 2020

II 116TH CONGRESS 1ST SESSION S. 3096 To amend the Public Health Service Act to authorize the Director of the Centers for Disease Control and Prevention to develop a program to prevent the use of electronic nicotine delivery systems among students in middle and high schools, to award grants to State and local health agencies to implement such program, and for other purposes. IN THE SENATE OF THE UNITED STATES DECEMBER 18, 2019 Mr. DURBIN introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To amend the Public Health Service Act to authorize the Director of the Centers for Disease Control and Preven- tion to develop a program to prevent the use of electronic nicotine delivery systems among students in middle and high schools, to award grants to State and local health agencies to implement such program, and for other pur- poses. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 VerDate Sep 11 2014 00:22 Dec 28, 2019 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S3096.IS S3096 pamtmann on DSKBC07HB2PROD with BILLS 2 •S 3096 IS SECTION 1. SHORT TITLE. 1 This Act may be cited as the ‘‘Providing Resources 2 to End the Vaping Epidemic Now for Teenagers Act of 3 2020’’ or the ‘‘PREVENT Act of 2020’’. 4 SEC. 2. FINDINGS. 5 Congress finds the following: 6 (1) High school e-cigarette use increased by 7 135 percent between 2017 and 2019. 8 (2) Middle school e-cigarette use increased by 9 approximately 218 percent between 2017 and 2019. 10 (3) Results from the National Youth Tobacco 11 Survey of the Centers for Disease Control and Pre- 12 vention (in this section referred to as ‘‘CDC’’) and 13 the Food and Drug Administration (in this section 14 referred to as ‘‘FDA’’) published in December 2019 15 show that 27.5 percent of high school students and 16 10.5 percent of middle school students reported 17 using an e-cigarette in the previous 30 days, up 18 from 20.8 percent and 4.9 percent, respectively, in 19 2018. 20 (4) In 2019, more than one-third (34.2 percent) 21 of high school e-cigarette users reported using e-cig- 22 arette products frequently, on 20 to 30 days in the 23 past month. 24 (5) The CDC, the FDA, the Department of 25 Health and Human Services, the Surgeon General, 26 VerDate Sep 11 2014 00:22 Dec 28, 2019 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S3096.IS S3096 pamtmann on DSKBC07HB2PROD with BILLS 3 •S 3096 IS and various State and local health authorities have 1 determined the skyrocketing e-cigarette use amongst 2 American youth to be an ‘‘epidemic’’. 3 (6) According to the CDC, the use of nicotine 4 among adolescents can be detrimental to memory 5 making, learning, and behavior, and e-cigarette use 6 has been linked to lung conditions and mysterious 7 illness. 8 (7) According to data from the FDA’s Popu- 9 lation Assessment of Tobacco and Health Study, 10 youth e-cigarette use is associated with more than 11 four times the odds of trying cigarettes and nearly 12 three times the odds of current cigarette use. 13 (8) The CDC and FDA continue to reiterate 14 that the use of any tobacco product, including e- 15 cigarettes, is unsafe for young people. 16 SEC. 3. GRANT PROGRAM TO PREVENT THE USE OF ELEC- 17 TRONIC NICOTINE DELIVERY SYSTEMS IN 18 MIDDLE AND HIGH SCHOOLS. 19 Title III of the Public Health Service Act is amended 20 by inserting after section 317T of such Act (42 U.S.C. 21 247b–22) the following: 22 VerDate Sep 11 2014 00:22 Dec 28, 2019 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S3096.IS S3096 pamtmann on DSKBC07HB2PROD with BILLS 4 •S 3096 IS ‘‘SEC. 317U. GRANT PROGRAM TO PREVENT THE USE OF 1 ELECTRONIC NICOTINE DELIVERY SYSTEMS 2 IN MIDDLE AND HIGH SCHOOLS. 3 ‘‘(a) ESTABLISHMENT.—The Secretary, acting 4 through the Director, in coordination with the Commis- 5 sioner of Food and Drugs, shall— 6 ‘‘(1) develop a program to prevent the use of 7 electronic nicotine delivery systems among students 8 in middle and high schools; and 9 ‘‘(2) award grants to eligible entities to imple- 10 ment such program in the geographic area served by 11 such agencies and organizations. 12 ‘‘(b) ELIGIBLE ENTITIES.—To seek a grant under 13 this section, an entity shall be— 14 ‘‘(1) a State or local health agency; 15 ‘‘(2) a nonprofit organization; or 16 ‘‘(3) if the grant is to serve students in a rural 17 area, a partnership of— 18 ‘‘(A) an entity described in paragraph (1) 19 or (2); and 20 ‘‘(B) a local educational agency or a hos- 21 pital. 22 ‘‘(c) PROGRAM REQUIREMENTS.—The program de- 23 veloped under subsection (a)(1) to prevent the use of elec- 24 tronic nicotine delivery systems among students in middle 25 and high schools shall address each of the following: 26 VerDate Sep 11 2014 00:22 Dec 28, 2019 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S3096.IS S3096 pamtmann on DSKBC07HB2PROD with BILLS 5 •S 3096 IS ‘‘(1) Training for school personnel to identify 1 and prevent the use by youth of electronic nicotine 2 delivery systems. 3 ‘‘(2) Creating and distributing educational re- 4 sources for preventing the use of electronic nicotine 5 delivery systems, designed for students, parents, and 6 school personnel. 7 ‘‘(3) Social media and marketing campaigns to 8 educate students on the health risks of the use of 9 electronic nicotine delivery systems and nicotine ad- 10 diction, to be designed by the Centers for Disease 11 Control and Prevention and implemented by grant- 12 ees in partnership with private advertising compa- 13 nies, nonprofit organizations, and advocacy organiza- 14 tions that specialize in youth substance use preven- 15 tion and addiction treatment. 16 ‘‘(4) Resources for students on how to commu- 17 nicate with their peers on the dangers of e-cigarette 18 use. 19 ‘‘(5) Partnering with school counseling per- 20 sonnel to assist students impacted by youth vaping. 21 ‘‘(6) Offering public health resources and coun- 22 seling to help treat youth nicotine addiction and re- 23 covery. 24 VerDate Sep 11 2014 00:22 Dec 28, 2019 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S3096.IS S3096 pamtmann on DSKBC07HB2PROD with BILLS 6 •S 3096 IS ‘‘(d) PRIORITY.—In awarding grants under this sec- 1 tion, the Secretary shall give priority to eligible entities 2 proposing to serve underserved populations with the great- 3 est use of vaping products. 4 ‘‘(e) APPLICATION.—To seek a grant under sub- 5 section (a)(2), an eligible entity shall submit an applica- 6 tion at such time, in such manner, and containing such 7 information as the Director may require. 8 ‘‘(f) GEOGRAPHIC DISTRIBUTION.—In awarding 9 grants under this section, the Secretary shall ensure that 10 such grants are distributed equitably across urban and 11 rural areas. 12 ‘‘(g) CONSULTATION.—As a condition on receipt of 13 a grant under subsection (a)(2), an eligible entity shall 14 agree that, in carrying out its program funded through 15 the grant, the agency will consult with the following: 16 ‘‘(1) Public health, health care, and youth 17 vaping prevention advocacy organizations, and orga- 18 nizations representing educators. 19 ‘‘(2) Organizations that specialize in addiction 20 prevention and treatment. 21 ‘‘(3) Mental health and medical specialists, in- 22 cluding professionals who specialize in child develop- 23 ment. 24 VerDate Sep 11 2014 00:22 Dec 28, 2019 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S3096.IS S3096 pamtmann on DSKBC07HB2PROD with BILLS 7 •S 3096 IS ‘‘(4) School principals and other school admin- 1 istrators. 2 ‘‘(h) REPORTING.— 3 ‘‘(1) BY GRANTEES.—As a condition on the re- 4 ceipt of a grant under subsection (a)(2), an eligible 5 entity shall agree to submit to the Director a report 6 annually over the grant period. Each such report 7 shall address the following: 8 ‘‘(A) The greatest obstacles in imple- 9 menting the program developed under sub- 10 section (a)(1). 11 ‘‘(B) The greatest obstacles in preventing 12 the use by youth of electronic nicotine delivery 13 systems. 14 ‘‘(C) Additional resources are needed to 15 address the popularity of electronic delivery sys- 16 tems and youth vaping culture. 17 ‘‘(2) REPORTING BY CDC.—Not later than 2 18 years after the program is developed pursuant to 19 subsection (a)(1), and annually thereafter, the Di- 20 rector shall submit to Congress a report on the fol- 21 lowing: 22 ‘‘(A) How the funds made available for 23 carrying out this section were used in devel- 24 oping a program under subsection (a)(1) and 25 VerDate Sep 11 2014 00:22 Dec 28, 2019 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S3096.IS S3096 pamtmann on DSKBC07HB2PROD with BILLS 8 •S 3096 IS implementing such program through grants 1 under subsection (a)(2). 2 ‘‘(B) Which strategies or resources were 3 effective in preventing the use by youth of elec- 4 tronic nicotine delivery systems. 5 ‘‘(C) Which strategies or resources were 6 not effective in preventing the use by youth of 7 electronic nicotine delivery systems. 8 ‘‘(3) POSTING OF REPORTS AND COMPILED 9 FINDINGS.—The Director shall— 10 ‘‘(A) not later than 60 days after receiving 11 a report submitted by a grantee pursuant to 12 paragraph (1), summarize the key findings of 13 such report and post such summary on the pub- 14 lic internet website of the Centers for Disease 15 Control and Prevention; and 16 ‘‘(B) not later than 60 days after submit- 17 ting a report to Congress under paragraph (2), 18 summarize the key findings of the report and 19 post such summary on such public internet 20 website. 21 ‘‘(i) DEFINITIONS.—In this section: 22 ‘‘(1) The term ‘Director’ means the Director of 23 the Centers for Disease Control and Prevention. 24 VerDate Sep 11 2014 00:22 Dec 28, 2019 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S3096.IS S3096 pamtmann on DSKBC07HB2PROD with BILLS 9 •S 3096 IS ‘‘(2) The term ‘electronic nicotine delivery sys- 1 tem’ has the meaning given to such term in section 2 919A of the Federal Food, Drug, and Cosmetic Act. 3 ‘‘(j) FUNDING.—Out of amounts collected as fees 4 under section 919A of the Federal Food, Drug, and Cos- 5 metic Act, there are authorized to be appropriated to carry 6 out this section the following: 7 ‘‘(1) For fiscal year 2021, $200,000,000. 8 ‘‘(2) For each of fiscal years 2022 and 2023, 9 the amount described in paragraph (1), adjusted by 10 the percentage change in the Consumer Price Index 11 for all urban consumers (all items; United States 12 city average) between 2021 and the applicable 13 year.’’. 14 SEC. 4. USER FEES RELATING TO ELECTRONIC NICOTINE 15 DELIVERY SYSTEMS. 16 (a) IN GENERAL.—Chapter IX of the Federal Food, 17 Drug, and Cosmetic Act (21 U.S.C. 387 et seq.) is amend- 18 ed by inserting after section 919 the following: 19 ‘‘SEC. 919A. USER FEES RELATING TO ELECTRONIC NICO- 20 TINE DELIVERY SYSTEMS. 21 ‘‘(a) ESTABLISHMENT OF QUARTERLY FEE.—Begin- 22 ning with fiscal year 2021, the Secretary, acting through 23 the Commissioner of Food and Drugs, shall assess user 24 fees on, and collect such fees from, each manufacturer and 25 VerDate Sep 11 2014 00:22 Dec 28, 2019 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S3096.IS S3096 pamtmann on DSKBC07HB2PROD with BILLS 10 •S 3096 IS importer of electronic nicotine delivery systems. The fees 1 shall be assessed and collected with respect to each quarter 2 of each fiscal year, and the total amount assessed and col- 3 lected for a fiscal year shall be the amount specified in 4 subsection (b)(1) for such year, subject to subsection (c). 5 ‘‘(b) ASSESSMENT OF USER FEE.— 6 ‘‘(1) AMOUNT OF ASSESSMENT.—The total 7 amount of user fees authorized to be assessed and 8 collected under subsection (a) for a fiscal year is the 9 following, as applicable to the fiscal year involved: 10 ‘‘(A) For fiscal year 2021, $200,000,000. 11 ‘‘(B) For fiscal year 2022 and fiscal year 12 2023, the amount described in subparagraph 13 (A), adjusted by the percentage change in the 14 Consumer Price Index for all urban consumers 15 (all items; United States city average) between 16 2021 and the applicable year. 17 ‘‘(2) DETERMINATION OF USER FEE BY COM- 18 PANY.—The total user fee to be paid by each manu- 19 facturer or importer of electronic nicotine delivery 20 systems shall be determined for each quarter pursu- 21 ant to a formula developed by the Secretary. 22 ‘‘(3) TIMING OF ASSESSMENT.—The Secretary 23 shall notify each manufacturer and importer of elec- 24 tronic nicotine delivery systems subject to this sec- 25 VerDate Sep 11 2014 00:22 Dec 28, 2019 Jkt 099200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S3096.IS S3096 pamtmann on DSKBC07HB2PROD with BILLS 11 •S 3096 IS tion of the amount of the quarterly assessment im- 1 posed on such manufacturer or importer under this 2 subsection for each quarter of each fiscal year. Such 3 notifications shall occur not later than 30 days prior 4 to the end of the quarter for which such assessment 5 is made, and payments of all assessments shall be 6 made by the last day of the quarter involved. 7 ‘‘(4) CALCULATION OF MARKET SHARE.—Be- 8 ginning not later than fiscal year 2020, and for each 9 subsequent fiscal year, the Secretary shall ensure 10 that the Food and Drug Administration is able to 11 determine— 12 ‘‘(A) the annual amount of total sales in 13 the electronic nicotine delivery system market of 14 the United States; and 15 ‘‘(B) the applicable percentage shares 16 under paragraph (2). 17 ‘‘(c) CREDITING AND AVAILABILITY OF FEES.— 18 ‘‘(1) IN GENERAL.—Fees authorized under sub- 19 section (a) shall be collected and available for obliga- 20 tion only to the extent and in the amount provided 21 in advance in appropriations Acts. Such fees are au- 22 thorized to remain available until expended. Such 23 sums as may be necessary may be transferred from 24 the ‘Food and Drug Administration—Salaries and 25 VerDate Sep 11 2014 00:22 Dec 28, 2019 Jkt 099200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S3096.IS S3096 pamtmann on DSKBC07HB2PROD with BILLS 12 •S 3096 IS Expenses’ account without fiscal year limitation to 1 such appropriation account for salaries and expenses 2 with such fiscal year limitation. 3 ‘‘(2) AVAILABILITY.—Fees appropriated under 4 paragraph (3) shall be— 5 ‘‘(A) transferred to the Centers for Disease 6 Control and Prevention; and 7 ‘‘(B) available only for the purpose of pay- 8 ing the costs of carrying out section 317U of 9 the Public Health Service Act. 10 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 11 For fiscal year 2021 and each subsequent fiscal 12 year, there is authorized to be appropriated for fees 13 under this [Text truncated for display. Full text available on Congress.gov.]