3.0.0 3478 2023-08-07T13:00:25Z 2023-08-07T13:00:25Z Senate S 2022-01-11 117 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2022-01-11T22:24:09Z Food and Drug Amendments of 2022 117 7667 HR 2022-06-09 Received in the Senate. Related bill CRS 2022-01-11 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2022-01-11 Introduced in Senate IntroReferral 10000 9 Library of Congress C001070 Sen. Casey, Robert P., Jr. [D-PA] Bob Casey D PA N C001075 Sen. Cassidy, Bill [R-LA] Bill Cassidy R LA 2022-01-11 True M001169 Sen. Murphy, Christopher [D-CT] Christopher Murphy D CT S. 2022-01-11 True Health Health 00 2022-01-11 Introduced in Senate 2023-08-07T12:47:14Z Generating Antibiotic Incentives Now Through Opening Opportunities to Leverage Science Act of 2022 or the GAIN TOOLS Act of 2022

This bill expands the definition of a qualified infectious disease product (QIDP) to include eligible biological products. Under current law, the first application (or supplement) for a specific product and indication to be designated a QIDP shall receive priority review for market approval by the Food and Drug Administration.

Generally, a biological product designated as a QIDP is one that acts on bacteria or fungi and is intended to treat a serious or life-threatening infection.

However, a biological product with a QIDP designation shall not receive the market exclusivity extension currently available to drugs that receive the designation.

]]> GAIN TOOLS Act of 2022 Display Title GAIN TOOLS Act of 2022 Short Title(s) as Introduced GAIN TOOLS Act of 2022 Introduced in Senate IS Short Title(s) as Introduced Generating Antibiotic Incentives Now Through Opening Opportunities to Leverage Science Act of 2022 Introduced in Senate IS Official Title as Introduced A bill to provide for the designation of biological products as qualified infectious disease products. Introduced in Senate IS Introduced in Senate 2022-01-11T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-117s3478is/xml/BILLS-117s3478is.xml 2022-01-11 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. 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.