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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.


I

116th CONGRESS

1st Session

H. R. 2095

IN THE HOUSE OF REPRESENTATIVES

April 4, 2019

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.

1.

Short title

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

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 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.