3.0.0 971 2023-01-11T13:28:28Z 2023-01-11T13:28:28Z House HR 2015-02-13 114 [Congressional Record Volume 161, Number 25 (Friday, February 13, 2015)]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. GRIJALVA:H.R. 963.Congress has the power to enact this legislation pursuantto the following:Article IV, Section 3[Page H1070]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2015-02-20T14:54:58Z Referred to 2015-02-13T14:02:35Z Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 114 1421 S 2015-05-21 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Related bill CRS 2015-02-20 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2015-02-13 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2015-02-13 Introduced in House IntroReferral Intro-H 9 Library of Congress 2015-02-13 Introduced in House IntroReferral 1000 9 Library of Congress B001257 Rep. Bilirakis, Gus M. [R-FL-12] Gus Bilirakis R FL M. 12 N M001157 Rep. McCaul, Michael T. [R-TX-10] Michael McCaul R TX T. 10 2015-02-13 True B001251 Rep. Butterfield, G. K. [D-NC-1] G. K. Butterfield D NC 1 2015-02-13 True P000611 Rep. Poliquin, Bruce [R-ME-2] Bruce Poliquin R ME 2 2015-03-03 False G000546 Rep. Graves, Sam [R-MO-6] SAM GRAVES R MO 6 2015-03-03 False G000576 Rep. Grothman, Glenn [R-WI-6] Glenn Grothman R WI 6 2015-03-03 False F000449 Rep. Fortenberry, Jeff [R-NE-1] Jeff Fortenberry R NE 1 2015-03-17 False M001159 Rep. McMorris Rodgers, Cathy [R-WA-5] Cathy McMorris Rodgers R WA 5 2015-03-17 False H000324 Rep. Hastings, Alcee L. [D-FL-20] ALCEE HASTINGS D FL L. 20 2015-04-13 False D000619 Rep. Davis, Rodney [R-IL-13] Rodney Davis R IL 13 2015-04-13 False Q000023 Rep. Quigley, Mike [D-IL-5] Mike Quigley D IL 5 2015-04-15 False N000185 Rep. Nugent, Richard B. [R-FL-11] Richard Nugent R FL B. 11 2015-04-21 False G000564 Rep. Gibson, Christopher P. [R-NY-19] Christopher Gibson R NY P. 19 2015-04-21 False P000594 Rep. Paulsen, Erik [R-MN-3] Erik Paulsen R MN 3 2015-04-28 False S001176 Rep. Scalise, Steve [R-LA-1] Steve Scalise R LA 1 2015-05-13 False H001068 Rep. Huffman, Jared [D-CA-2] Jared Huffman D CA 2 2015-06-02 False R000409 Rep. Rohrabacher, Dana [R-CA-48] DANA ROHRABACHER R CA 48 2016-03-07 False A000373 Rep. Ashford, Brad [D-NE-2] Brad Ashford D NE 2 2016-03-07 False F000372 Rep. Frelinghuysen, Rodney P. [R-NJ-11] RODNEY FRELINGHUYSEN R NJ 11 2016-03-17 False S000522 Rep. Smith, Christopher H. [R-NJ-4] CHRISTOPHER SMITH R NJ H. 4 2016-05-13 False F000451 Rep. Fitzpatrick, Michael G. [R-PA-8] Michael Fitzpatrick R PA G. 8 2016-09-07 False L000567 Rep. Lance, Leonard [R-NJ-7] Leonard Lance R NJ 7 2016-09-08 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 2015-02-13 Introduced in House 2015-07-07T18:28:16Z Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015

Amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to extend by six months the exclusivity period for an approved drug or biological product 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 FDA to revoke an extension if the application for the new indication contained an untrue material statement.

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

Requires the FDA to notify the public of products that receive this extension and patents related to those products.

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 2015 Display Title Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 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 2015 Introduced in House 2015-02-13T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114hr971ih/xml/BILLS-114hr971ih.xml 2015-02-20 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.