3.0.0 8987 2023-01-11T13:43:58Z 2023-01-11T13:43:58Z House HR 2020-12-16 116 [Congressional Record Volume 166, Number 213 (Wednesday, December 16, 2020)][House]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. JOYCE of Pennsylvania:H.R. 8987.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8 of the Constitution of the UnitedStates.[Page H7229]]]> hswm00 Ways and Means Committee House Standing Referred to 2020-12-16T17:00:31Z hsif00 Energy and Commerce Committee House Standing Referred to 2020-12-16T17:00:26Z 2020-12-16 Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. IntroReferral H11100 2 House floor actions hswm00 Ways and Means Committee 2020-12-16 Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2020-12-16 Introduced in House IntroReferral Intro-H 9 Library of Congress 2020-12-16 Introduced in House IntroReferral 1000 9 Library of Congress J000302 Rep. Joyce, John [R-PA-13] John Joyce R PA 13 N Health Business expenses Department of Health and Human Services Drug safety, medical device, and laboratory regulation Emergency medical services and trauma care Executive agency funding and structure Health promotion and preventive care Income tax credits Infectious and parasitic diseases Manufacturing Medical tests and diagnostic methods Public contracts and procurement Health 00 2020-12-16 Introduced in House 2021-03-11T21:24:06Z Enhancing the Security of the U.S. Pharmaceutical Supply Chain Act of 2020

This bill provides tax credits for manufacturing certain priority medicines and establishes an expedited review procedure for drug manufacturers seeking to transition from foreign manufacturing to domestic manufacturing.

The Department of Health and Human Services (HHS) must publish annually a list of priority drugs and active pharmaceutical ingredients that (1) are necessary for use in a public health emergency, (2) are at high risk of becoming in short supply, and (3) have a vulnerable global supply chain. The bill provides a tax credit for 50% of a manufacturer's direct and indirect costs incurred in a taxable year for the production of a drug or active ingredient that was on this list in any of the five preceding years.

Furthermore, the Food and Drug Administration (FDA) must expedite the review and approval of a supplemental application that seeks to transfer manufacturing of an already-approved drug or active pharmaceutical ingredient to a domestic establishment. (A supplemental application generally involves a change, such as a manufacturing change, to an existing application for FDA market approval.) The bill imposes various requirements for this expedited review, including a deadline for the FDA to take action on such a supplemental application within six months of submission.

HHS shall also establish the Facility Transfer Working Group to assist with evaluating such applications and provide advice and feedback to applicants upon request.

]]> Enhancing the Security of the U.S. Pharmaceutical Supply Chain Act of 2020 Display Title Enhancing the Security of the U.S. Pharmaceutical Supply Chain Act of 2020 Short Title(s) as Introduced Enhancing the Security of the U.S. Pharmaceutical Supply Chain Act of 2020 Introduced in House IH Official Title as Introduced To amend the Public Health Service Act to incentivize the manufacture of certain medicines in the United States and to enhance the security of the United States pharmaceutical supply chain, and for other purposes. Introduced in House IH Introduced in House 2020-12-16T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116hr8987ih/xml/BILLS-116hr8987ih.xml 2020-12-16 Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.