3.0.0 3030 2024-07-24T15:22:24Z 2024-07-24T15:22:24Z House H HR 2023-04-28 118 [Congressional Record Volume 169, Number 72 (Friday, April 28, 2023)][House]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. SORENSEN:H.R. 3030.Congress has the power to enact this legislation pursuantto the following:Article 1, Section 8 of the Commerce ClauseThe single subject of this legislation is:FDA Citizen Petitions[Page H2120]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2023-05-05T15:45:56Z Referred to 2023-04-28T13:07:45Z 2023-05-05 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2023-04-28 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2023-04-28 Introduced in House IntroReferral Intro-H 9 Library of Congress 2023-04-28 Introduced in House IntroReferral 1000 9 Library of Congress S001225 Rep. Sorensen, Eric [D-IL-17] Eric Sorensen D IL 17 N K000382 Rep. Kuster, Ann M. [D-NH-2] Ann Kuster D NH M. 2 2023-06-01 False Health Administrative remedies 2023-07-07T19:30:27Z Congressional oversight 2023-07-07T19:30:27Z Food and Drug Administration (FDA) 2023-07-07T19:30:27Z Government information and archives 2023-07-07T19:30:27Z Prescription drugs 2023-07-07T19:30:27Z Health 2023-05-17T16:15:53Z 00 2023-04-28 Introduced in House 2024-01-05T20:09:02Z Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2023 or the STOP GAMES Act of 2023

This bill specifies factors that the Food and Drug Administration (FDA)must use in determining if a petition is submitted with the primary purpose of delaying the approval of a pending new or generic drug application. (Current law allows third parties, including interested parties, to file petitions asking the FDA to take various actions, such as to consider certain issues pertaining to an application for market approval for a drug; current law also allows the FDA to deny a petition that is submitted with the primary purpose of delaying approval of an application.)

The factors include (1) whether the petitioner filed serial petitions raising issues that could have been known to the petitioner when an earlier petition was filed, and (2) whether the petition has any data or information to support its scientific positions.

If the FDA finds that delay is the primary purpose of the petition, it must refer the matter to the Federal Trade Commission.

A party filing a petition must do so within 60 days of when the party first learned of the information on which the petition is based.

]]> STOP GAMES Act of 2023 Display Title 45 STOP GAMES Act of 2023 2024-07-24T15:22:24Z Short Title(s) as Introduced 101 STOP GAMES Act of 2023 2024-05-24T13:40:23Z Introduced in House IH Short Title(s) as Introduced 101 Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2023 2024-05-24T13:40:23Z Introduced in House IH Official Title as Introduced 6 To amend subsection (q) of section 505 of the Federal Food, Drug, and Cosmetic Act to clarify the process for denying certain petitions whose primary purpose is to delay the approval of an application submitted under subsection (b)(2) or (j) of such section 505, and for other purposes. 2024-03-18T20:42:15Z Introduced in House IH Introduced in House 2023-04-28T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-118hr3030ih/xml/BILLS-118hr3030ih.xml 2023-05-05 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.