3.0.0 3091 2023-01-11T13:24:12Z 2023-01-11T13:24:12Z House H HR 2013-09-12 113 From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. LANCE:H.R. 3091.Congress has the power to enact this legislation pursuantto the following:Article I, Section 2, Clause 3[Page H5547]]]> hsju00 Judiciary Committee House Standing hsju03 Courts, Intellectual Property, and the Internet Subcommittee Referred to 2013-10-15T13:54:23Z Referred to 2013-09-12T13:01:30Z hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2013-09-13T18:12:45Z Referred to 2013-09-12T13:01:20Z hswm00 Ways and Means Committee House Standing Referred to 2013-09-12T13:01:25Z Diagnostic Innovation Testing and Knowledge Advancement Act of 2013 113 2085 HR 2013-06-03 Referred to the Subcommittee on Health. Related bill CRS MODDERN Cures Act of 2013 113 3116 HR 2014-01-09 Referred to the Subcommittee on Courts, Intellectual Property, and the Internet. Related bill CRS 2013-10-15 hsju03 Courts, Intellectual Property, and the Internet Subcommittee 1 House committee actions Referred to the Subcommittee on Courts, Intellectual Property, and the Internet. Committee 2013-09-13 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2013-09-12 Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. IntroReferral H11100 2 House floor actions hsju00 Judiciary Committee 2013-09-12 Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. IntroReferral H11100 2 House floor actions hswm00 Ways and Means Committee 2013-09-12 Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2013-09-12 Introduced in House IntroReferral Intro-H 9 Library of Congress 2013-09-12 Introduced in House IntroReferral 1000 9 Library of Congress L000567 Rep. Lance, Leonard [R-NJ-7] Leonard Lance R NJ 7 N R000580 Rep. Roskam, Peter J. [R-IL-6] Peter Roskam R IL J. 6 2013-09-12 True G000558 Rep. Guthrie, Brett [R-KY-2] Brett Guthrie R KY 2 2013-09-12 True P000594 Rep. Paulsen, Erik [R-MN-3] Erik Paulsen R MN 3 2013-09-12 True R000053 Rep. Rangel, Charles B. [D-NY-13] CHARLES RANGEL D NY B. 13 2013-09-12 True R000594 Rep. Runyan, Jon [R-NJ-3] Jon Runyan R NJ 3 2013-09-12 True S001162 Rep. Schwartz, Allyson Y. [D-PA-13] Allyson Schwartz D PA Y. 13 2013-09-12 True K000210 Rep. King, Peter T. [R-NY-2] PETER KING R NY T. 2 2013-09-12 True M001157 Rep. McCaul, Michael T. [R-TX-10] Michael McCaul R TX T. 10 2013-09-12 True W000791 Rep. Walden, Greg [R-OR-2] GREG WALDEN R OR 2 2013-09-12 True T000462 Rep. Tiberi, Patrick J. [R-OH-12] PATRICK TIBERI R OH J. 12 2013-09-12 True L000565 Rep. Loebsack, David [D-IA-2] David Loebsack D IA 2 2013-09-12 True L000570 Rep. Lujan, Ben Ray [D-NM-3] Ben Lujan D NM R. 3 2013-09-12 True E000288 Rep. Ellison, Keith [D-MN-5] Keith Ellison D MN 5 2013-09-12 True J000255 Rep. Jones, Walter B., Jr. [R-NC-3] WALTER JONES R NC B. 3 2013-09-12 True L000576 Rep. Long, Billy [R-MO-7] Billy Long R MO 7 2013-09-12 True B001260 Rep. Buchanan, Vern [R-FL-16] Vern Buchanan R FL 16 2013-10-02 False Health Administrative law and regulatory procedures Administrative remedies Advisory bodies Department of Health and Human Services Drug safety, medical device, and laboratory regulation Drug therapy Executive agency funding and structure Food and Drug Administration (FDA) Government studies and investigations Intellectual property Medical research Medical tests and diagnostic methods Medicare Prescription drugs Health 00 2013-09-12 Introduced in House 2013-12-11T22:45:22Z Modernizing Our Drug & Diagnostics Evaluation and Regulatory Network Cures Act of 2013 or MODDERN Cures Act of 2013 - Requires the Secretary of Health and Human Services (HHS) to: (1) establish the Advanced Diagnostics Education Council to recommend standard terms and definitions related to innovative diagnostics for use by patients, physicians, health care providers, payers, and policy makers; and (2) publish a guide regarding such terms and definitions.

Sets forth additional factors for the Secretary to consider in determining the payment amount for new clinical diagnostic laboratory tests under gap filling procedures which are used when no comparable existing test is available.

Extends the exclusivity period for a medicine if the diagnostic test related to such drug has been determined by the Secretary to have been developed by, or with the participation of, the manufacturer or sponsor of the medicine, and use of the diagnostic tests provides for or improves: (1) the identification of a patient population for the medicine; or (2) the determination of the most appropriate treatment option for a patient population with the medicine.

Establishes a dormant therapy designation for medicine that addresses unmet medical needs. Gives such medicine 15 years of data exclusivity under which no drug can be approved by relying on the approval or licensure of the dormant therapy.

Directs the Secretary to arrange with the Institute of Medicine (or, if it declines, another appropriate entity) to study intellectual property laws and their impact on therapy and diagnostic development in order to formulate recommendations on how to facilitate the clinical evaluation and development of therapies currently available on the market for new potential indications.]]>

MODDERN Cures Act of 2013 Display Title MODDERN Cures Act of 2013 Official Title as Introduced To promote the development of meaningful treatments for patients. Introduced in House IH Short Titles as Introduced MODDERN Cures Act of 2013 Short Titles as Introduced Modernizing Our Drug & Diagnostics Evaluation and Regulatory Network Cures Act of 2013 Introduced in House 2013-09-12T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-113hr3091ih/xml/BILLS-113hr3091ih.xml 2013-10-15 Referred to the Subcommittee on Courts, Intellectual Property, and the Internet. 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.