3.0.0 2415 2023-01-11T13:31:22Z 2023-01-11T13:31:22Z House HR 2015-05-19 114 [Congressional Record Volume 161, Number 77 (Tuesday, May 19, 2015)]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. BURGESS:H.R. 2415.Congress has the power to enact this legislation pursuantto the following:Per Section 8, Clause 1 of the Constitution, Congress shallhave the power to lay and collect taxes. Per the Section 8,Clause 3 of the Constitution, Congress shall have the powerregulate Commerce with foreign Nations and among the severalStates.[Page H3389]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2015-05-22T19:48:45Z Referred to 2015-05-19T14:03:15Z 21st Century Cures Act 114 6 HR 2015-07-13 Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Related bill CRS 2015-05-22 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2015-05-19 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2015-05-19 Introduced in House IntroReferral Intro-H 9 Library of Congress 2015-05-19 Introduced in House IntroReferral 1000 9 Library of Congress B001248 Rep. Burgess, Michael C. [R-TX-26] Michael Burgess R TX C. 26 N E000179 Rep. Engel, Eliot L. [D-NY-16] ELIOT ENGEL D NY L. 16 2015-05-19 True Health Drug safety, medical device, and laboratory regulation Government information and archives Health information and medical records Licensing and registrations Health 00 2015-05-19 Introduced in House 2015-11-09T19:30:29Z This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to establish a streamlined data review program under which the holder of an approved application for a drug or biological product may submit a summary of clinical data to support approval of the drug for the treatment of cancer or another indication subject to the program.

For a drug to be eligible for the streamlined data review program there must be a database regarding the safety of the drug and the full data sets used to develop the data summaries must be submitted, unless the FDA determines that the full data sets are not required.

The FDA must annually publish: (1) the number of applications reviewed under the streamlined data review program, (2) the average time for completion of review under the streamlined data review program compared to review of other applications for new indications, and (3) the number of applications reviewed under the streamlined data review program for which the FDA made use of full data sets.]]> To amend the Federal Food, Drug, and Cosmetic Act to provide for establishment of a streamlined data review program. Display Title To amend the Federal Food, Drug, and Cosmetic Act to provide for establishment of a streamlined data review program. Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act to provide for establishment of a streamlined data review program. Introduced in House IH Introduced in House 2015-05-19T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114hr2415ih/xml/BILLS-114hr2415ih.xml 2015-05-22 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.