3.0.0 3116 2023-01-11T13:24:11Z 2023-01-11T13:24:11Z House H HR 2013-09-17 113 From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. LANCE:H.R. 3116.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8, Clause 3[Page H5589]]]> hsju00 Judiciary Committee House Standing hsju03 Courts, Intellectual Property, and the Internet Subcommittee Referred to 2014-01-09T18:08:26Z Referred to 2013-09-17T16:00:27Z hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2013-09-20T17:40:34Z Referred to 2013-09-17T16:00:17Z hswm00 Ways and Means Committee House Standing Referred to 2013-09-17T16:00:22Z 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 3091 HR 2013-10-15 Referred to the Subcommittee on Courts, Intellectual Property, and the Internet. Related bill CRS 2014-01-09 hsju03 Courts, Intellectual Property, and the Internet Subcommittee 1 House committee actions Referred to the Subcommittee on Courts, Intellectual Property, and the Internet. Committee 2013-09-20 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2013-09-17 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 2013-09-17 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 2013-09-17 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 2013-09-17 Introduced in House IntroReferral Intro-H 9 Library of Congress 2013-09-17 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 2013-09-17 True G000558 Rep. Guthrie, Brett [R-KY-2] Brett Guthrie R KY 2 2013-09-17 True P000594 Rep. Paulsen, Erik [R-MN-3] Erik Paulsen R MN 3 2013-09-17 True R000053 Rep. Rangel, Charles B. [D-NY-13] CHARLES RANGEL D NY B. 13 2013-09-17 True R000594 Rep. Runyan, Jon [R-NJ-3] Jon Runyan R NJ 3 2013-09-17 True S001162 Rep. Schwartz, Allyson Y. [D-PA-13] Allyson Schwartz D PA Y. 13 2013-09-17 True K000210 Rep. King, Peter T. [R-NY-2] PETER KING R NY T. 2 2013-09-17 True M001157 Rep. McCaul, Michael T. [R-TX-10] Michael McCaul R TX T. 10 2013-09-17 True W000791 Rep. Walden, Greg [R-OR-2] GREG WALDEN R OR 2 2013-09-17 True T000462 Rep. Tiberi, Patrick J. [R-OH-12] PATRICK TIBERI R OH J. 12 2013-09-17 True L000565 Rep. Loebsack, David [D-IA-2] David Loebsack D IA 2 2013-09-17 True L000570 Rep. Lujan, Ben Ray [D-NM-3] Ben Lujan D NM R. 3 2013-09-17 True E000288 Rep. Ellison, Keith [D-MN-5] Keith Ellison D MN 5 2013-09-17 True J000255 Rep. Jones, Walter B., Jr. [R-NC-3] WALTER JONES R NC B. 3 2013-09-17 True L000576 Rep. Long, Billy [R-MO-7] Billy Long R MO 7 2013-09-17 True B001256 Rep. Bachmann, Michele [R-MN-6] Michele Bachmann R MN 6 2013-09-18 False B001275 Rep. Bucshon, Larry [R-IN-8] Larry Bucshon R IN 8 2013-09-18 False C001045 Rep. Crenshaw, Ander [R-FL-4] ANDER CRENSHAW R FL 4 2013-09-18 False L000111 Rep. Latham, Tom [R-IA-3] TOM LATHAM R IA 3 2013-09-30 False B000911 Rep. Brown, Corrine [D-FL-5] CORRINE BROWN D FL 5 2013-09-30 False D000610 Rep. Deutch, Theodore E. [D-FL-21] Theodore Deutch D FL E. 21 2013-10-08 False S001190 Rep. Schneider, Bradley Scott [D-IL-10] Bradley Schneider D IL Scott 10 2013-10-30 False W000798 Rep. Walberg, Tim [R-MI-7] Tim Walberg R MI 7 2013-10-30 False Y000064 Rep. Young, Todd [R-IN-9] Todd Young R IN C. 9 2013-11-13 False S000250 Rep. Sessions, Pete [R-TX-32] PETE SESSIONS R TX 32 2014-01-29 False M001160 Rep. Moore, Gwen [D-WI-4] Gwen Moore D WI 4 2014-02-03 False L000559 Rep. Langevin, James R. [D-RI-2] JAMES LANGEVIN D RI R. 2 2014-02-03 False B001259 Rep. Braley, Bruce L. [D-IA-1] Bruce Braley D IA L. 1 2014-02-05 False T000472 Rep. Takano, Mark [D-CA-41] Mark Takano D CA 41 2014-02-10 False C001072 Rep. Carson, Andre [D-IN-7] Andre Carson D IN 7 2014-02-25 False C001084 Rep. Cicilline, David N. [D-RI-1] David Cicilline D RI N. 1 2014-02-26 False B001285 Rep. Brownley, Julia [D-CA-26] Julia Brownley D CA 26 2014-02-27 False G000549 Rep. Gerlach, Jim [R-PA-6] Jim Gerlach R PA 6 2014-02-28 False M001143 Rep. McCollum, Betty [D-MN-4] BETTY MCCOLLUM D MN 4 2014-03-04 False W000804 Rep. Wittman, Robert J. [R-VA-1] Robert Wittman R VA J. 1 2014-03-06 False H001068 Rep. Huffman, Jared [D-CA-2] Jared Huffman D CA 2 2014-03-12 False R000409 Rep. Rohrabacher, Dana [R-CA-48] DANA ROHRABACHER R CA 48 2014-03-12 False E000291 Rep. Ellmers, Renee L. [R-NC-2] Renee Ellmers R NC L. 2 2014-03-25 False D000533 Rep. Duncan, John J., Jr. [R-TN-2] JOHN DUNCAN R TN J. 2 2014-03-25 False B001257 Rep. Bilirakis, Gus M. [R-FL-12] Gus Bilirakis R FL M. 12 2014-03-26 False R000587 Rep. Ribble, Reid J. [R-WI-8] Reid Ribble R WI J. 8 2014-04-29 False I000057 Rep. Israel, Steve [D-NY-3] STEVE ISRAEL D NY 3 2014-05-07 False L000569 Rep. Luetkemeyer, Blaine [R-MO-3] Blaine Luetkemeyer R MO 3 2014-05-09 False E000215 Rep. Eshoo, Anna G. [D-CA-18] ANNA ESHOO D CA G. 18 2014-05-09 False S001170 Rep. Shea-Porter, Carol [D-NH-1] Carol Shea-Porter D NH 1 2014-05-09 False M001171 Rep. Maffei, Daniel B. [D-NY-24] Daniel Maffei D NY B. 24 2014-05-09 False M000933 Rep. Moran, James P. [D-VA-8] JAMES MORAN D VA P. 8 2014-05-20 False B000490 Rep. Bishop, Sanford D., Jr. [D-GA-2] SANFORD BISHOP D GA D. 2 2014-05-20 False N000181 Rep. Nunes, Devin [R-CA-22] Devin Nunes R CA 22 2014-05-20 False P000099 Rep. Pastor, Ed [D-AZ-7] ED PASTOR D AZ 7 2014-05-21 False B001251 Rep. Butterfield, G. K. [D-NC-1] G. K. Butterfield D NC 1 2014-05-22 False Y000033 Rep. Young, Don [R-AK-At Large] DON YOUNG R AK E. 0 2014-05-28 False B001281 Rep. Beatty, Joyce [D-OH-3] Joyce Beatty D OH 3 2014-05-28 False P000096 Rep. Pascrell, Bill, Jr. [D-NJ-9] WILLIAM PASCRELL D NJ J. 9 2014-05-30 False T000469 Rep. Tonko, Paul [D-NY-20] Paul Tonko D NY 20 2014-06-09 False P000258 Rep. Peterson, Collin C. [D-MN-7] COLLIN PETERSON D MN C. 7 2014-06-17 False P000604 Rep. Payne, Donald M., Jr. [D-NJ-10] Donald Payne D NJ M. 10 2014-06-23 False G000569 Rep. Grimm, Michael G. [R-NY-11] Michael Grimm R NY G. 11 2014-06-23 False T000467 Rep. Thompson, Glenn [R-PA-5] Glenn Thompson R PA 5 2014-06-26 False L000551 Rep. Lee, Barbara [D-CA-13] BARBARA LEE D CA 13 2014-07-09 False F000451 Rep. Fitzpatrick, Michael G. [R-PA-8] Michael Fitzpatrick R PA G. 8 2014-07-09 False C001090 Rep. Cartwright, Matt [D-PA-17] Matt Cartwright D PA 17 2014-07-10 False N000147 Del. Norton, Eleanor Holmes [D-DC-At Large] ELEANOR NORTON D DC HOLMES 0 2014-07-15 False T000460 Rep. Thompson, Mike [D-CA-5] MIKE THOMPSON D CA 5 2014-07-17 False R000435 Rep. Ros-Lehtinen, Ileana [R-FL-27] ILEANA ROS-LEHTINEN R FL 27 2014-07-31 False P000608 Rep. Peters, Scott H. [D-CA-52] Scott Peters D CA H. 52 2014-07-31 False W000812 Rep. Wagner, Ann [R-MO-2] Ann Wagner R MO 2 2014-09-09 False G000573 Rep. Garcia, Joe [D-FL-26] Joe Garcia D FL 26 2014-09-09 False T000459 Rep. Terry, Lee [R-NE-2] LEE TERRY R NE 2 2014-09-09 False H001059 Rep. Hultgren, Randy [R-IL-14] Randy Hultgren R IL 14 2014-09-09 False H001065 Rep. Holding, George [R-NC-13] George Holding R NC 13 2014-09-09 False B001260 Rep. Buchanan, Vern [R-FL-16] Vern Buchanan R FL 16 2014-09-09 False W000799 Rep. Walz, Timothy J. [D-MN-1] Timothy Walz D MN J. 1 2014-09-09 False M001142 Rep. Matheson, Jim [D-UT-4] JIM MATHESON D UT 4 2014-09-09 False R000577 Rep. Ryan, Tim [D-OH-13] TIM RYAN D OH 13 2014-09-16 False M001189 Rep. Messer, Luke [R-IN-6] Luke Messer R IN 6 2014-09-18 False K000379 Rep. Kennedy, Joseph P., III [D-MA-4] Joseph Kennedy D MA P. 4 2014-11-12 False K000363 Rep. Kline, John [R-MN-2] John Kline R MN 2 2014-11-13 False S001183 Rep. Schweikert, David [R-AZ-6] David Schweikert R AZ 6 2014-11-18 False H000324 Rep. Hastings, Alcee L. [D-FL-20] ALCEE HASTINGS D FL L. 20 2014-11-20 False W000795 Rep. Wilson, Joe [R-SC-2] Joe Wilson R SC 2 2014-12-01 False S001188 Rep. Stutzman, Marlin A. [R-IN-3] Marlin Stutzman R IN A. 3 2014-12-02 False P000601 Rep. Palazzo, Steven M. [R-MS-4] Steven Palazzo R MS M. 4 2014-12-02 False F000372 Rep. Frelinghuysen, Rodney P. [R-NJ-11] RODNEY FRELINGHUYSEN R NJ 11 2014-12-03 False C001037 Rep. Capuano, Michael E. [D-MA-7] MICHAEL CAPUANO D MA E. 7 2014-12-03 False W000813 Rep. Walorski, Jackie [R-IN-2] Jackie Walorski R IN 2 2014-12-03 False N000015 Rep. Neal, Richard E. [D-MA-1] RICHARD NEAL D MA E. 1 2014-12-08 False C001101 Rep. Clark, Katherine M. [D-MA-5] Katherine Clark D MA M. 5 2014-12-10 False R000582 Rep. Roe, David P. [R-TN-1] David Roe R TN P. 1 2014-12-10 False B001284 Rep. Brooks, Susan W. [R-IN-5] Susan Brooks R IN W. 5 2014-12-10 False C000556 Rep. Coble, Howard [R-NC-6] HOWARD COBLE R NC 6 2014-12-10 False R000576 Rep. Ruppersberger, C. A. Dutch [D-MD-2] C. A. Ruppersberger D MD Dutch 2 2014-12-11 False C001049 Rep. Clay, Wm. Lacy [D-MO-1] WM. CLAY D MO LACY 1 2014-12-11 False B001271 Rep. Benishek, Dan [R-MI-1] Dan Benishek R MI 1 2014-12-12 False T000465 Rep. Tsongas, Niki [D-MA-3] Niki Tsongas D MA 3 2015-01-02 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 2013-09-17 Introduced in House 2013-12-11T22:45:46Z 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 2013-09-17T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-113hr3116ih/xml/BILLS-113hr3116ih.xml 2014-01-09 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.