3.0.0 2030 2023-01-11T13:29:46Z 2023-01-11T13:29:46Z Senate S 2015-09-15 114 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Reported by 2016-04-05T20:31:05Z Markup by 2016-02-09T15:08:34Z Referred to 2015-09-15T18:46:51Z 114 34 HR 2016-12-13 Became Public Law No: 114-255. Related bill CRS 2016-04-05 Senate Placed on Senate Legislative Calendar under General Orders. Calendar No. 416. Calendars 2016-04-05 sshr00 Health, Education, Labor, and Pensions Committee Senate Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report. Committee 2016-04-05 Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report. Committee 14000 9 Library of Congress sshr00 Health, Education, Labor, and Pensions Committee 2016-02-09 sshr00 Health, Education, Labor, and Pensions Committee Senate Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably. Committee 2015-09-15 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2015-09-15 Introduced in Senate IntroReferral 10000 9 Library of Congress B001267 Sen. Bennet, Michael F. [D-CO] Michael Bennet D CO N B001135 Sen. Burr, Richard [R-NC] Richard Burr R NC Mauze 2015-09-15 True W000817 Sen. Warren, Elizabeth [D-MA] Elizabeth Warren D MA A. 2015-09-15 True H000338 Sen. Hatch, Orrin G. [R-UT] ORRIN HATCH R UT GRANT 2015-09-15 True E000285 Sen. Enzi, Michael B. [R-WY] MICHAEL ENZI R WY B. 2016-02-23 False R000595 Sen. Rubio, Marco [R-FL] Marco Rubio R FL 2016-04-20 False Health Drug safety, medical device, and laboratory regulation Drug therapy Genetics Health

00 2015-09-15 Introduced in Senate 2016-04-15T15:15:56Z Advancing Targeted Therapies for Rare Diseases Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to permit the Food and Drug Administration to allow the sponsor of a new drug or biological product for the treatment of a rare, serious condition to rely upon information submitted for an approved medication that uses the same technology. For a sponsor to be eligible to rely upon submitted information: (1) the sponsor must have developed, or have a right of reference to, the relied upon information; and (2) the new medication must use nucleic acids (e.g., DNA) or similar chemicals, or must affect a disease-causing protein variant (e.g., the protein that causes cystic fibrosis).]]>

01 2016-04-05 Reported to Senate with amendment(s) 2016-07-08T15:36:13Z Advancing Targeted Therapies for Rare Diseases Act of 2016

(Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act to permit the Food and Drug Administration to allow the sponsor of a new drug or biological product for the treatment of a rare, serious condition to rely upon information submitted for an approved medication that uses the same technology. For a sponsor to be eligible to rely upon submitted information: (1) the sponsor must have developed, or have a right of reference to, the relied upon information; and (2) the new medication must use nucleic acids (e.g., DNA) or similar chemicals, or must affect a disease-causing product of a mutated gene (e.g., the protein that causes cystic fibrosis).]]>

Display Title Official Title as Introduced Introduced in Senate IS Short Titles as Introduced Short Titles as Reported to Senate S Senate Reported to Senate 2016-04-05T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114s2030rs/xml/BILLS-114s2030rs.xml Introduced in Senate 2015-09-15T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114s2030is/xml/BILLS-114s2030is.xml 2016-04-05 Placed on Senate Legislative Calendar under General Orders. Calendar No. 416. 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.