I 

116TH CONGRESS 

1ST SESSION H. R. 2095 

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 

APRIL 4, 2019 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘National Public Health 

5 Act of 2019’’. 


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1 SEC. 2. ADDRESSING PUBLIC HEALTH CRISES BY REQUIR2 ING PLANS TO MITIGATE THE EFFECTS OF 

3 COVERED PRODUCTS ON PUBLIC HEALTH. 

4 (a) REQUIREMENT.—For the purpose of addressing 

5 public health crises listed pursuant to subsection (b), the 

6 Secretary shall require the manufacturer of a covered 

7 product— 

8 (1) not later than 180 days after such product 

9 is listed pursuant to subsection (c), to develop and 

10 begin implementation of a plan to mitigate the ef11 fects of such product on public health; and 

12 (2) so long as the listing remains in effect, to 

13 maintain and update such plan. 

14 (b) LIST OF PUBLIC HEALTH CRISES.—Subject to 

15 the availability of appropriations, the Secretary shall seek 

16 to enter into a contract, not later than 180 days after the 

17 date of enactment of this Act, with the National Academy 

18 of Medicine (or, if the National Academy declines, another 

19 appropriate entity)— 

20 (1) to develop and publish a list of public health 

21 crises; and 

22 (2) to update such list continuously. 

23 (c) LIST OF COVERED PRODUCTS.—The Secretary 

24 shall develop, publish, and update a list of products (in 

25 this Act referred to as ‘‘covered products’’) that— 


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1 (1) are manufactured for human use or con2 sumption; and 

3 (2) are determined by the Secretary to have a 

4 fiscal impact on the United States public health sys5 tem, taken collectively with other similar products, 

6 of $50,000,000 or more per year. 

7 (d) CIVIL PENALTY.— 

8 (1) IN GENERAL.—A manufacturer shall be lia9 ble to the United States for a civil penalty if— 

10 (A) the manufacturer violates subsection 

11 (a); and 

12 (B) the Secretary determines that such 

13 violation has a negative impact on public 

14 health. 

15 (2) AMOUNT.—The amount of a civil penalty 

16 under paragraph (1) shall not exceed $20,000 for 

17 each day on which the violation continues. 

18 (e) DEFINITION.—For purposes of this Act: 

19 (1) The term ‘‘public health crisis’’— 

20 (A) shall be defined by the Secretary; and 

21 (B) may include an event or occurrence 

22 that— 

23 (i) is temporary or permanent; 

24 (ii) is manmade or naturally occur25 ring; and 


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1 (iii) substantially negatively impacts 

2 the public health. 

3 (2) The term ‘‘Secretary’’ means the Secretary 

4 of Health and Human Services. 

Æ 


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