[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6481 Introduced in House (IH)]

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115th CONGRESS
  2d Session
                                H. R. 6481

 To direct the Secretary of Health and Human Services, for the purpose 
  of addressing public health crises, to require the manufacturers of 
 covered products to develop, maintain, and update a plan to mitigate 
 the effects of such products on public health, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             July 24, 2018

Mr. DeSaulnier introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
 To direct the Secretary of Health and Human Services, for the purpose 
  of addressing public health crises, to require the manufacturers of 
 covered products to develop, maintain, and update a plan to mitigate 
 the effects of such products on public health, 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 ``National Public Health Act of 
2018''.

SEC. 2. ADDRESSING PUBLIC HEALTH CRISES BY REQUIRING PLANS TO MITIGATE 
              THE EFFECTS OF COVERED PRODUCTS ON PUBLIC HEALTH.

    (a) Requirement.--For the purpose of addressing public health 
crises listed pursuant to subsection (b), the Secretary shall require 
the manufacturer of a covered product--
            (1) not later than 180 days after such product is listed 
        pursuant to subsection (c), to develop and begin implementation 
        of a plan to mitigate the effects of such product on public 
        health; and
            (2) so long as the listing remains in effect, to maintain 
        and update such plan.
    (b) List of Public Health Crises.--Subject to the availability of 
appropriations, the Secretary shall seek to enter into a contract, not 
later than 180 days after the date of enactment of this Act, with the 
National Academy of Medicine (or, if the National Academy declines, 
another appropriate entity)--
            (1) to develop and publish a list of public health crises; 
        and
            (2) to update such list continuously.
    (c) List of Covered Products.--The Secretary shall develop, 
publish, and update a list of products (in this Act referred to as 
``covered products'') that--
            (1) are manufactured for human use or consumption; and
            (2) are determined by the Secretary to have a fiscal impact 
        on the United States public health system, taken collectively 
        with other similar products, of $50,000,000 or more per year.
    (d) Civil Penalty.--
            (1) In general.--A manufacturer shall be liable to the 
        United States for a civil penalty if--
                    (A) the manufacturer violates subsection (a); and
                    (B) the Secretary determines that such violation 
                has a negative impact on public health.
            (2) Amount.--The amount of a civil penalty under paragraph 
        (1) shall not to exceed $20,000 for each day on which the 
        violation continues.
    (e) Definition.--For purposes of this Act:
            (1) The term ``public health crisis''--
                    (A) shall be defined by the Secretary; and
                    (B) may include an event or occurrence that--
                            (i) is temporary or permanent;
                            (ii) is manmade or naturally occurring; and
                            (iii) substantially negatively impacts the 
                        public health.
            (2) The term ``Secretary'' means the Secretary of Health 
        and Human Services.
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