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H.R. 2095 (116th): National Public Health Act of 2019

The text of the bill below is as of Apr 4, 2019 (Introduced). The bill was not enacted into law.



1st Session

H. R. 2095


April 4, 2019

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


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.


Short title

This Act may be cited as the National Public Health Act of 2019.


Addressing public health crises by requiring plans to mitigate the effects of covered products on public health



For the purpose of addressing public health crises listed pursuant to subsection (b), the Secretary shall require the manufacturer of a covered product—


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


so long as the listing remains in effect, to maintain and update such plan.


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)—


to develop and publish a list of public health crises; and


to update such list continuously.


List of covered products

The Secretary shall develop, publish, and update a list of products (in this Act referred to as covered products) that—


are manufactured for human use or consumption; and


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.


Civil penalty


In general

A manufacturer shall be liable to the United States for a civil penalty if—


the manufacturer violates subsection (a); and


the Secretary determines that such violation has a negative impact on public health.



The amount of a civil penalty under paragraph (1) shall not exceed $20,000 for each day on which the violation continues.



For purposes of this Act:


The term public health crisis


shall be defined by the Secretary; and


may include an event or occurrence that—


is temporary or permanent;


is manmade or naturally occurring; and


substantially negatively impacts the public health.


The term Secretary means the Secretary of Health and Human Services.