Creating Hope Reauthorization Act

Bill: 116-hr-4439
Sponsor: full_name: Rep. Butterfield, G. K. [D-NC-1]
Introduced: 2019-09-20
Policy area: Health
Subjects: Child health

Drug safety, medical device, and laboratory regulation

Health programs administration and funding

Health promotion and preventive care

Infectious and parasitic diseases
Latest action: action_date: 2020-09-30
text: Received in the Senate.

Summaries:
action_date: 2019-09-20
action_desc: Introduced in House
text: <p><b>Creating Hope Reauthorization Act</b></p> <p>This bill permanently reauthorizes a Food and Drug Administration program that awards priority review vouchers to manufacturers of drugs that treat rare pediatric diseases. (A priority review voucher entitles the voucher holder to priority review of a single human drug application.)</p>

action_date: 2020-09-29
action_desc: Passed House
text: <p><b>Creating Hope Reauthorization Act</b></p> <p>This bill reauthorizes a Food and Drug Administration (FDA) program that awards priority review vouchers to manufacturers of drugs that treat rare pediatric diseases. (A priority review voucher entitles the voucher holder to priority review of a single human drug application.)</p> <p>Specifically, the bill reauthorizes the program through FY2024, but the FDA may award a voucher afterwards in certain instances.</p>

tv_txt: I 116th CONGRESS 1st Session H. R. 4439 IN THE HOUSE OF REPRESENTATIVES September 20, 2019 Mr. Butterfield (for himself, Mr. McCaul , Ms. Speier , Mr. Kelly of Pennsylvania , Mr. Engel , Mr. Bilirakis , Ms. Kelly of Illinois , Mr. Hudson , Mr. Rush , and Mr. Mullin ) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Federal Food, Drug, and Cosmetic Act to make permanent the authority of the Secretary of Health and Human Services to issue priority review vouchers to encourage treatments for rare pediatric diseases.

1. Short title This Act may be cited as the Creating Hope Reauthorization Act . 2. Providing for permanent authority to issue priority review vouchers to encourage treatments for rare pediatric diseases Section 529(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360ff(b) ) is amended by striking paragraph (5).

tv_txt: II 116th CONGRESS 2d Session H. R. 4439 IN THE SENATE OF THE UNITED STATES September 30 (legislative day, September 29), 2020 Received AN ACT To amend the Federal Food, Drug, and Cosmetic Act to extend the authority of the Secretary of Health and Human Services to issue priority review vouchers to encourage treatments for rare pediatric diseases.

1. Short title This Act may be cited as the Creating Hope Reauthorization Act . 2. Extension of authority to issue priority review vouchers to encourage treatments for rare pediatric diseases Section 529(b)(5) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360ff(b)(5) ) is amended— (1) by striking December 11, 2020 each place it appears and inserting September 30, 2024 ; and (2) in subparagraph (B), by striking December 11, 2022 and inserting September 30, 2026 .

Passed the House of Representatives September 29, 2020. Cheryl L. Johnson, Clerk

tv_txt: I 116th CONGRESS 2d Session H. R. 4439 IN THE HOUSE OF REPRESENTATIVES AN ACT To amend the Federal Food, Drug, and Cosmetic Act to extend the authority of the Secretary of Health and Human Services to issue priority review vouchers to encourage treatments for rare pediatric diseases.

1. Short title This Act may be cited as the Creating Hope Reauthorization Act . 2. Extension of authority to issue priority review vouchers to encourage treatments for rare pediatric diseases Section 529(b)(5) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360ff(b)(5) ) is amended— (1) by striking December 11, 2020 each place it appears and inserting September 30, 2024 ; and (2) in subparagraph (B), by striking December 11, 2022 and inserting September 30, 2026 .

Passed the House of Representatives September 29, 2020. Cheryl L. Johnson, Clerk.

tv_txt: IB Union Calendar No. 451 116th CONGRESS 2d Session H. R. 4439 [Report No. 116–551] IN THE HOUSE OF REPRESENTATIVES September 20, 2019 Mr. Butterfield (for himself, Mr. McCaul , Ms. Speier , Mr. Kelly of Pennsylvania , Mr. Engel , Mr. Bilirakis , Ms. Kelly of Illinois , Mr. Hudson , Mr. Rush , and Mr. Mullin ) introduced the following bill; which was referred to the Committee on Energy and Commerce September 29, 2020 Additional sponsors: Mr. Fitzpatrick , Ms. DeGette , Mrs. Rodgers of Washington , Mrs. Luria , Mr. Rutherford , Mr. Carson of Indiana , Mr. Rodney Davis of Illinois , Ms. Clarke of New York , Ms. Blunt Rochester , Ms. Barragán , Mr. Soto , Mr. Cárdenas , Ms. Kuster of New Hampshire , Mr. Griffith , Mr. Carter of Georgia , Mr. Marshall , Mr. Cohen , Mr. Woodall , Mr. DeFazio , Mr. Balderson , Mr. Malinowski , Mr. Brooks of Alabama , Ms. Lofgren , Mr. King of Iowa , Ms. Porter , Mr. Marchant , Mr. McEachin , Mr. DeSaulnier , Mrs. Lesko , Mr. Fortenberry , Ms. Bonamici , Ms. Sherrill , and Mr. Wilson of South Carolina September 29, 2020 Reported with amendments; committed to the Committee of the Whole House on the State of the Union and ordered to be printed Strike out all after the enacting clause and insert the part printed in italic For text of introduced bill, see copy of bill as introduced September 20, 2019 A BILL To amend the Federal Food, Drug, and Cosmetic Act to make permanent the authority of the Secretary of Health and Human Services to issue priority review vouchers to encourage treatments for rare pediatric diseases.

1. Short title This Act may be cited as the Creating Hope Reauthorization Act . 2. Extension of authority to issue priority review vouchers to encourage treatments for rare pediatric diseases Section 529(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360ff(b) ) is amended— (1) by striking September 30, 2020 each place it appears and inserting September 30, 2024 ; and (2) by striking September 30, 2022 and inserting September 30, 2026 .

Amend the title so as to read: A bill to amend the Federal Food, Drug, and Cosmetic Act to extend the authority of the Secretary of Health and Human Services to issue priority review vouchers to encourage treatments for rare pediatric diseases. .

September 29, 2020 Reported with amendments; committed to the Committee of the Whole House on the State of the Union and ordered to be printed