3.0.0 2455 2022-02-08T23:19:36Z 2022-02-08T23:19:36Z House HR 2019-05-01 116 [Congressional Record Volume 165, Number 71 (Wednesday, May 1, 2019)][House]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. JOYCE of Pennsylvania:H.R. 2455.Congress has the power to enact this legislation pursuantto the following:Article I Section 8 Clause 3--Congress has the ability toregulate Commerce with foreign Nations, and among the severalStates, and with the Indian Tribes.[Page H3406]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2019-05-02T14:20:20Z Referred to 2019-05-01T14:04:30Z Ensuring Timely Access to Generics Act of 2019 116 1169 S 2019-04-11 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Identical bill CRS Lowering Prescription Drug Prices for America’s Seniors and Families Act of 2020 116 3384 S 2020-03-03 Read twice and referred to the Committee on Finance. Related bill CRS 2019-05-02 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2019-05-01 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2019-05-01 Introduced in House IntroReferral Intro-H 9 Library of Congress 2019-05-01 Introduced in House IntroReferral 1000 9 Library of Congress J000302 Rep. Joyce, John [R-PA-13] John Joyce R PA 13 N B001308 Rep. Brindisi, Anthony [D-NY-22] Anthony Brindisi D NY 22 2019-05-01 True W000827 Rep. Wright, Ron [R-TX-6] Ron Wright R TX 6 2019-05-28 False C001121 Rep. Crow, Jason [D-CO-6] Jason Crow D CO 6 2019-05-28 False W000823 Rep. Waltz, Michael [R-FL-6] Michael Waltz R FL 6 2019-05-28 False F000466 Rep. Fitzpatrick, Brian K. [R-PA-1] Brian Fitzpatrick R PA K. 1 2019-06-05 False S001199 Rep. Smucker, Lloyd [R-PA-11] Lloyd Smucker R PA 11 2019-06-13 False Health Administrative remedies Department of Health and Human Services Drug safety, medical device, and laboratory regulation Food and Drug Administration (FDA) Government information and archives Prescription drugs Health 00 2019-05-01 Introduced in House 2021-09-12T19:05:33Z Ensuring Timely Access to Generics Act of 2019

This bill requires the Food and Drug Administration (FDA) to consider certain factors in determining whether a petition is submitted for the primary purpose of delaying the approval of a drug application.

The FDA must (1) publish a list of petitions that were submitted with an intent to delay, and (2) establish procedures to refer such petitions to the Federal Trade Commission.

The FDA may establish a timeline for submitting petitions.

]]> Ensuring Timely Access to Generics Act of 2019 Display Title Ensuring Timely Access to Generics Act of 2019 Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Introduced in House IH Short Title(s) as Introduced Ensuring Timely Access to Generics Act of 2019 Introduced in House IH Introduced in House 2019-05-01T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116hr2455ih/xml/BILLS-116hr2455ih.xml 2019-05-02 Referred to the Subcommittee on Health. 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.