3.0.0 5750 2023-01-11T13:25:20Z 2023-01-11T13:25:20Z House H HR 2014-11-20 113 From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]Mr. BILIRAKIS:H.R. 5750.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8, Clause 1, which gives the Congressthe authority to provide for the general welfare of theUnited States. Additionally, under Article I, Section 8,Clause 8 which gives Congress the power to promote theprogress of science and useful arts by securing for limitedtimes to authors and inventors the exclusive right to theirrespective writings and discoveries.[Page H8170]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2014-11-21T21:04:25Z Referred to 2014-11-20T14:02:05Z 2014-12-10 Sponsor introductory remarks on measure. (CR H8938) IntroReferral B00100 9 Library of Congress 2014-11-21 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2014-11-20 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2014-11-20 Introduced in House IntroReferral Intro-H 9 Library of Congress 2014-11-20 Introduced in House IntroReferral 1000 9 Library of Congress B001257 Rep. Bilirakis, Gus M. [R-FL-12] Gus Bilirakis R FL M. 12 N B001251 Rep. Butterfield, G. K. [D-NC-1] G. K. Butterfield D NC 1 2014-11-20 True M001157 Rep. McCaul, Michael T. [R-TX-10] Michael McCaul R TX T. 10 2014-11-20 True H000324 Rep. Hastings, Alcee L. [D-FL-20] ALCEE HASTINGS D FL L. 20 2014-11-20 True Q000023 Rep. Quigley, Mike [D-IL-5] Mike Quigley D IL 5 2014-12-10 False Health Administrative law and regulatory procedures Administrative remedies Department of Health and Human Services Drug safety, medical device, and laboratory regulation Drug therapy Food and Drug Administration (FDA) Government information and archives Intellectual property Prescription drugs Health 00 2014-11-20 Introduced in House 2015-02-24T22:20:21Z Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2014 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to extend by six months the exclusivity period for a drug or biological product approved by the Food and Drug Administration (FDA) when the product is additionally approved to prevent, diagnose, or treat a new indication that is a rare disease or condition (also known as an “orphan disease”).

Allows the Secretary to revoke an extension if the application submitted to the FDA for the new indication contained an untrue material statement.

Requires the sponsor of a product receiving an extension to notify HHS one year prior to discontinuing production for commercial reasons.

Requires the Secretary to notify the public of products that receive this extension.

Limits a product to one extension under this Act. Sets forth that extensions under this Act are in addition to other extensions.

Applies only to products approved after enactment of this Act for a new indication that is a rare disease or condition.]]> Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2014 Display Title Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2014 Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act to authorize a 6-month extension of certain exclusivity periods in the case of approved drugs that are subsequently approved for a new indication to prevent, diagnose, or treat a rare disease or condition, and for other purposes. Introduced in House IH Short Titles as Introduced Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2014 Introduced in House 2014-11-20T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-113hr5750ih/xml/BILLS-113hr5750ih.xml 2014-12-10 Sponsor introductory remarks on measure. (CR H8938) 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.