3.0.0 2985 2023-01-11T13:24:18Z 2023-01-11T13:24:18Z House H HR 2013-08-02 113 From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. CHAFFETZ:H.R. 2985.Congress has the power to enact this legislation pursuantto the following:Clause 3 of Section 8 of Article I of the Constitution: Toregulate Commerce with foreign Nations, and among the severalStates, and with the Indian Tribes;Clause 18 of Section 8 of Article I of the Constitution: Tomake all Laws which shall be necessary and proper forcarrying into Execution the foregoing Powers, and all otherPowers vested by this Constitution in the Government of theUnited States, or in any Department or Officer thereof.[Page H5400]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2013-08-02T14:22:15Z Referred to 2013-08-02T13:10:10Z 2013-08-02 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2013-08-02 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2013-08-02 Introduced in House IntroReferral Intro-H 9 Library of Congress 2013-08-02 Introduced in House IntroReferral 1000 9 Library of Congress C001076 Rep. Chaffetz, Jason [R-UT-3] Jason Chaffetz R UT 3 N C000556 Rep. Coble, Howard [R-NC-6] HOWARD COBLE R NC 6 2013-08-02 True S000018 Rep. Salmon, Matt [R-AZ-5] MATT SALMON R AZ 5 2013-08-02 True M001179 Rep. Marino, Tom [R-PA-10] Tom Marino R PA 10 2014-02-11 False M001142 Rep. Matheson, Jim [D-UT-4] JIM MATHESON D UT 4 2014-09-17 False Health Drug safety, medical device, and laboratory regulation Prescription drugs Product development and innovation Health 00 2013-08-02 Introduced in House 2013-12-03T15:37:29Z Combination Drug Development Incentive Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act with respect to the five-year bar on a new drug application (or abbreviated drug application) by anyone that has not obtained a right of reference or use from the original and approved drug approval applicant by or for whom investigations under the original, subsequently approved application were conducted.

Applies this five-year bar, and the requirement of a grant of a right of reference or use, with respect to an approved drug application (or abbreviated drug application) if: (1) the application contains reports of new clinical investigations (other than bioavailability studies) essential to the approval of the application and conducted or sponsored by the applicant, (2) the application is for a drug which contains a combination of active ingredients (combination drug), and (3) no such combination of active ingredients has been approved in any other application.

]]> Combination Drug Development Incentive Act of 2013 Display Title Combination Drug Development Incentive Act of 2013 Official Title as Introduced To amend section 505 of the Federal Food, Drug, and Cosmetic Act to provide incentives for the development of new combination drugs. Introduced in House IH Short Titles as Introduced Combination Drug Development Incentive Act of 2013 Introduced in House 2013-08-02T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-113hr2985ih/xml/BILLS-113hr2985ih.xml 2013-08-02 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.