National Public Health Act of 2019

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 cov- ered 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. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘National Public Health 4 Act of 2019’’. 5 VerDate Sep 11 2014 19:50 Apr 17, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H2095.IH H2095 pbinns on DSK79D2C42PROD with BILLS 2 •HR 2095 IH SEC. 2. ADDRESSING PUBLIC HEALTH CRISES BY REQUIR- 1 ING PLANS TO MITIGATE THE EFFECTS OF 2 COVERED PRODUCTS ON PUBLIC HEALTH. 3 (a) REQUIREMENT.—For the purpose of addressing 4 public health crises listed pursuant to subsection (b), the 5 Secretary shall require the manufacturer of a covered 6 product— 7 (1) not later than 180 days after such product 8 is listed pursuant to subsection (c), to develop and 9 begin implementation of a plan to mitigate the ef- 10 fects of such product on public health; and 11 (2) so long as the listing remains in effect, to 12 maintain and update such plan. 13 (b) LIST OF PUBLIC HEALTH CRISES.—Subject to 14 the availability of appropriations, the Secretary shall seek 15 to enter into a contract, not later than 180 days after the 16 date of enactment of this Act, with the National Academy 17 of Medicine (or, if the National Academy declines, another 18 appropriate entity)— 19 (1) to develop and publish a list of public health 20 crises; and 21 (2) to update such list continuously. 22 (c) LIST OF COVERED PRODUCTS.—The Secretary 23 shall develop, publish, and update a list of products (in 24 this Act referred to as ‘‘covered products’’) that— 25 VerDate Sep 11 2014 19:50 Apr 17, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H2095.IH H2095 pbinns on DSK79D2C42PROD with BILLS 3 •HR 2095 IH (1) are manufactured for human use or con- 1 sumption; and 2 (2) are determined by the Secretary to have a 3 fiscal impact on the United States public health sys- 4 tem, taken collectively with other similar products, 5 of $50,000,000 or more per year. 6 (d) CIVIL PENALTY.— 7 (1) IN GENERAL.—A manufacturer shall be lia- 8 ble to the United States for a civil penalty if— 9 (A) the manufacturer violates subsection 10 (a); and 11 (B) the Secretary determines that such 12 violation has a negative impact on public 13 health. 14 (2) AMOUNT.—The amount of a civil penalty 15 under paragraph (1) shall not exceed $20,000 for 16 each day on which the violation continues. 17 (e) DEFINITION.—For purposes of this Act: 18 (1) The term ‘‘public health crisis’’— 19 (A) shall be defined by the Secretary; and 20 (B) may include an event or occurrence 21 that— 22 (i) is temporary or permanent; 23 (ii) is manmade or naturally occur- 24 ring; and 25 VerDate Sep 11 2014 19:50 Apr 17, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H2095.IH H2095 pbinns on DSK79D2C42PROD with BILLS 4 •HR 2095 IH (iii) substantially negatively impacts 1 the public health. 2 (2) The term ‘‘Secretary’’ means the Secretary 3 of Health and Human Services. 4 Æ VerDate Sep 11 2014 19:50 Apr 17, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6301 E:\BILLS\H2095.IH H2095 pbinns on DSK79D2C42PROD with BILLS