[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 3096 Introduced in Senate (IS)]

<DOC>






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 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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Providing Resources to End the 
Vaping Epidemic Now for Teenagers Act of 2020'' or the ``PREVENT Act of 
2020''.

SEC. 2. FINDINGS.

    Congress finds the following:
            (1) High school e-cigarette use increased by 135 percent 
        between 2017 and 2019.
            (2) Middle school e-cigarette use increased by 
        approximately 218 percent between 2017 and 2019.
            (3) Results from the National Youth Tobacco Survey of the 
        Centers for Disease Control and Prevention (in this section 
        referred to as ``CDC'') and the Food and Drug Administration 
        (in this section referred to as ``FDA'') published in December 
        2019 show that 27.5 percent of high school students and 10.5 
        percent of middle school students reported using an e-cigarette 
        in the previous 30 days, up from 20.8 percent and 4.9 percent, 
        respectively, in 2018.
            (4) In 2019, more than one-third (34.2 percent) of high 
        school e-cigarette users reported using e-cigarette products 
        frequently, on 20 to 30 days in the past month.
            (5) The CDC, the FDA, the Department of Health and Human 
        Services, the Surgeon General, and various State and local 
        health authorities have determined the skyrocketing e-cigarette 
        use amongst American youth to be an ``epidemic''.
            (6) According to the CDC, the use of nicotine among 
        adolescents can be detrimental to memory making, learning, and 
        behavior, and e-cigarette use has been linked to lung 
        conditions and mysterious illness.
            (7) According to data from the FDA's Population Assessment 
        of Tobacco and Health Study, youth e-cigarette use is 
        associated with more than four times the odds of trying 
        cigarettes and nearly three times the odds of current cigarette 
        use.
            (8) The CDC and FDA continue to reiterate that the use of 
        any tobacco product, including e-cigarettes, is unsafe for 
        young people.

SEC. 3. GRANT PROGRAM TO PREVENT THE USE OF ELECTRONIC NICOTINE 
              DELIVERY SYSTEMS IN MIDDLE AND HIGH SCHOOLS.

    Title III of the Public Health Service Act is amended by inserting 
after section 317T of such Act (42 U.S.C. 247b-22) the following:

``SEC. 317U. GRANT PROGRAM TO PREVENT THE USE OF ELECTRONIC NICOTINE 
              DELIVERY SYSTEMS IN MIDDLE AND HIGH SCHOOLS.

    ``(a) Establishment.--The Secretary, acting through the Director, 
in coordination with the Commissioner of Food and Drugs, shall--
            ``(1) develop a program to prevent the use of electronic 
        nicotine delivery systems among students in middle and high 
        schools; and
            ``(2) award grants to eligible entities to implement such 
        program in the geographic area served by such agencies and 
        organizations.
    ``(b) Eligible Entities.--To seek a grant under this section, an 
entity shall be--
            ``(1) a State or local health agency;
            ``(2) a nonprofit organization; or
            ``(3) if the grant is to serve students in a rural area, a 
        partnership of--
                    ``(A) an entity described in paragraph (1) or (2); 
                and
                    ``(B) a local educational agency or a hospital.
    ``(c) Program Requirements.--The program developed under subsection 
(a)(1) to prevent the use of electronic nicotine delivery systems among 
students in middle and high schools shall address each of the 
following:
            ``(1) Training for school personnel to identify and prevent 
        the use by youth of electronic nicotine delivery systems.
            ``(2) Creating and distributing educational resources for 
        preventing the use of electronic nicotine delivery systems, 
        designed for students, parents, and school personnel.
            ``(3) Social media and marketing campaigns to educate 
        students on the health risks of the use of electronic nicotine 
        delivery systems and nicotine addiction, to be designed by the 
        Centers for Disease Control and Prevention and implemented by 
        grantees in partnership with private advertising companies, 
        nonprofit organizations, and advocacy organizations that 
        specialize in youth substance use prevention and addiction 
        treatment.
            ``(4) Resources for students on how to communicate with 
        their peers on the dangers of e-cigarette use.
            ``(5) Partnering with school counseling personnel to assist 
        students impacted by youth vaping.
            ``(6) Offering public health resources and counseling to 
        help treat youth nicotine addiction and recovery.
    ``(d) Priority.--In awarding grants under this section, the 
Secretary shall give priority to eligible entities proposing to serve 
underserved populations with the greatest use of vaping products.
    ``(e) Application.--To seek a grant under subsection (a)(2), an 
eligible entity shall submit an application at such time, in such 
manner, and containing such information as the Director may require.
    ``(f) Geographic Distribution.--In awarding grants under this 
section, the Secretary shall ensure that such grants are distributed 
equitably across urban and rural areas.
    ``(g) Consultation.--As a condition on receipt of a grant under 
subsection (a)(2), an eligible entity shall agree that, in carrying out 
its program funded through the grant, the agency will consult with the 
following:
            ``(1) Public health, health care, and youth vaping 
        prevention advocacy organizations, and organizations 
        representing educators.
            ``(2) Organizations that specialize in addiction prevention 
        and treatment.
            ``(3) Mental health and medical specialists, including 
        professionals who specialize in child development.
            ``(4) School principals and other school administrators.
    ``(h) Reporting.--
            ``(1) By grantees.--As a condition on the receipt of a 
        grant under subsection (a)(2), an eligible entity shall agree 
        to submit to the Director a report annually over the grant 
        period. Each such report shall address the following:
                    ``(A) The greatest obstacles in implementing the 
                program developed under subsection (a)(1).
                    ``(B) The greatest obstacles in preventing the use 
                by youth of electronic nicotine delivery systems.
                    ``(C) Additional resources are needed to address 
                the popularity of electronic delivery systems and youth 
                vaping culture.
            ``(2) Reporting by cdc.--Not later than 2 years after the 
        program is developed pursuant to subsection (a)(1), and 
        annually thereafter, the Director shall submit to Congress a 
        report on the following:
                    ``(A) How the funds made available for carrying out 
                this section were used in developing a program under 
                subsection (a)(1) and implementing such program through 
                grants under subsection (a)(2).
                    ``(B) Which strategies or resources were effective 
                in preventing the use by youth of electronic nicotine 
                delivery systems.
                    ``(C) Which strategies or resources were not 
                effective in preventing the use by youth of electronic 
                nicotine delivery systems.
            ``(3) Posting of reports and compiled findings.--The 
        Director shall--
                    ``(A) not later than 60 days after receiving a 
                report submitted by a grantee pursuant to paragraph 
                (1), summarize the key findings of such report and post 
                such summary on the public internet website of the 
                Centers for Disease Control and Prevention; and
                    ``(B) not later than 60 days after submitting a 
                report to Congress under paragraph (2), summarize the 
                key findings of the report and post such summary on 
                such public internet website.
    ``(i) Definitions.--In this section:
            ``(1) The term `Director' means the Director of the Centers 
        for Disease Control and Prevention.
            ``(2) The term `electronic nicotine delivery system' has 
        the meaning given to such term in section 919A of the Federal 
        Food, Drug, and Cosmetic Act.
    ``(j) Funding.--Out of amounts collected as fees under section 919A 
of the Federal Food, Drug, and Cosmetic Act, there are authorized to be 
appropriated to carry out this section the following:
            ``(1) For fiscal year 2021, $200,000,000.
            ``(2) For each of fiscal years 2022 and 2023, the amount 
        described in paragraph (1), adjusted by the percentage change 
        in the Consumer Price Index for all urban consumers (all items; 
        United States city average) between 2021 and the applicable 
        year.''.

SEC. 4. USER FEES RELATING TO ELECTRONIC NICOTINE DELIVERY SYSTEMS.

    (a) In General.--Chapter IX of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 387 et seq.) is amended by inserting after section 919 
the following:

``SEC. 919A. USER FEES RELATING TO ELECTRONIC NICOTINE DELIVERY 
              SYSTEMS.

    ``(a) Establishment of Quarterly Fee.--Beginning with fiscal year 
2021, the Secretary, acting through the Commissioner of Food and Drugs, 
shall assess user fees on, and collect such fees from, each 
manufacturer and importer of electronic nicotine delivery systems. The 
fees shall be assessed and collected with respect to each quarter of 
each fiscal year, and the total amount assessed and collected for a 
fiscal year shall be the amount specified in subsection (b)(1) for such 
year, subject to subsection (c).
    ``(b) Assessment of User Fee.--
            ``(1) Amount of assessment.--The total amount of user fees 
        authorized to be assessed and collected under subsection (a) 
        for a fiscal year is the following, as applicable to the fiscal 
        year involved:
                    ``(A) For fiscal year 2021, $200,000,000.
                    ``(B) For fiscal year 2022 and fiscal year 2023, 
                the amount described in subparagraph (A), adjusted by 
                the percentage change in the Consumer Price Index for 
                all urban consumers (all items; United States city 
                average) between 2021 and the applicable year.
            ``(2) Determination of user fee by company.--The total user 
        fee to be paid by each manufacturer or importer of electronic 
        nicotine delivery systems shall be determined for each quarter 
        pursuant to a formula developed by the Secretary.
            ``(3) Timing of assessment.--The Secretary shall notify 
        each manufacturer and importer of electronic nicotine delivery 
        systems subject to this section of the amount of the quarterly 
        assessment imposed on such manufacturer or importer under this 
        subsection for each quarter of each fiscal year. Such 
        notifications shall occur not later than 30 days prior to the 
        end of the quarter for which such assessment is made, and 
        payments of all assessments shall be made by the last day of 
        the quarter involved.
            ``(4) Calculation of market share.--Beginning not later 
        than fiscal year 2020, and for each subsequent fiscal year, the 
        Secretary shall ensure that the Food and Drug Administration is 
        able to determine--
                    ``(A) the annual amount of total sales in the 
                electronic nicotine delivery system market of the 
                United States; and
                    ``(B) the applicable percentage shares under 
                paragraph (2).
    ``(c) Crediting and Availability of Fees.--
            ``(1) In general.--Fees authorized under subsection (a) 
        shall be collected and available for obligation only to the 
        extent and in the amount provided in advance in appropriations 
        Acts. Such fees are authorized to remain available until 
        expended. Such sums as may be necessary may be transferred from 
        the `Food and Drug Administration--Salaries and Expenses' 
        account without fiscal year limitation to such appropriation 
        account for salaries and expenses with such fiscal year 
        limitation.
            ``(2) Availability.--Fees appropriated under paragraph (3) 
        shall be--
                    ``(A) transferred to the Centers for Disease 
                Control and Prevention; and
                    ``(B) available only for the purpose of paying the 
                costs of carrying out section 317U of the Public Health 
                Service Act.
            ``(3) Authorization of appropriations.--For fiscal year 
        2021 and each subsequent fiscal year, there is authorized to be 
        appropriated for fees under this section an amount equal to the 
        amount specified in subsection (b)(1) for the fiscal year.
    ``(d) Applicability to Fiscal Year 2020.--If the date of enactment 
of the Providing Resources to End the Vaping Epidemic Now for Teenagers 
Act of 2020 occurs during fiscal year 2021, the following applies:
            ``(1) The Secretary shall determine the fees that would 
        apply for a single quarter of such fiscal year according to the 
        application of subsection (b) to the amount specified in 
        paragraph (1)(A) of such subsection (referred to in this 
        subsection as the `quarterly fee amount').
            ``(2) For the quarter in which such date of enactment 
        occurs and any preceding quarter of fiscal year 2021, fees 
        shall not be assessed or collected under this section.
            ``(3) The amount specified in subsection (b)(1)(A) is 
        deemed to be reduced by the quarterly amount for each quarter 
        for which fees are not assessed or collected by operation of 
        paragraph (3).
            ``(4) For any quarter in fiscal year 2021 following the 
        quarter in which the date of enactment of the Providing 
        Resources to End the Vaping Epidemic Now for Teenagers Act of 
        2020 occurs, the full quarterly fee amount shall be assessed 
        and collected.''.
    (b) Enforcement.--
            (1) In general.--Section 902(4) of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 387b(4)) is amended by inserting 
        ``, or the manufacturer or importer of electronic nicotine 
        delivery systems fails to pay a user fee assessed to such 
        manufacturer or importer pursuant to section 919A by the date 
        specified in section 919A or by the 30th day after final agency 
        action on a resolution of any dispute as to the amount of such 
        fee'' before the semicolon.
            (2) Effective date.--The amendment made by paragraph (1) 
        shall take effect on the later of October 1, 2021, or the date 
        of enactment of this Act.
    (c) Definition.--Section 900 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 387) is amended--
            (1) by redesignating paragraphs (8) through (22) as 
        paragraphs (9) through (23), respectively; and
            (2) by inserting after paragraph (7) the following:
            ``(8) Electronic nicotine delivery system.--The term 
        `electronic nicotine delivery system'--
                    ``(A) means a tobacco product that is an electronic 
                device that delivers nicotine, flavor, or another 
                substance via an aerosolized solution to the user 
                inhaling from the device (including e-cigarettes, e-
                hookah, e-cigars, vape pens, advanced refillable 
                personal vaporizers, and electronic pipes) and any 
                component, liquid, part, or accessory of such a device, 
                whether or not sold separately; and
                    ``(B) does not include a product that is approved 
                by the Food and Drug Administration for sale as a 
                tobacco cessation product or for another therapeutic 
                purpose.''.
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