3.0.0 3497 2021-04-19T19:18:43Z 2021-04-19T19:18:43Z House H HR 2011-11-18 112 From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. LANCE:H.R. 3497.Congress has the power to enact this legislation pursuantto the following:Article I of the Constitution of the United States.[Page H7892]]]> hsju00 Judiciary Committee House Standing hsju12 Over-Criminalization Task Force Subcommittee Referred to 2011-12-02T21:38:03Z Referred to 2011-11-18T14:04:20Z hswm00 Ways and Means Committee House Standing hswm02 Health Subcommittee Referred to 2011-11-22T22:29:54Z Referred to 2011-11-18T14:04:15Z hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2011-11-18T19:01:34Z Referred to 2011-11-18T14:04:10Z Improving Diagnostic Innovations Act of 2012 112 6446 HR 2012-09-26 Referred to the Subcommittee on Health. Related bill CRS 2011-12-02 hsju12 Over-Criminalization Task Force Subcommittee 1 House committee actions Referred to the Subcommittee on Intellectual Property, Competition and the Internet. Committee 2011-11-22 hswm02 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2011-11-18 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2011-11-18 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 2011-11-18 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 2011-11-18 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 2011-11-18 Introduced in House IntroReferral Intro-H 9 Library of Congress 2011-11-18 Introduced in House IntroReferral 1000 9 Library of Congress L000567 Rep. Lance, Leonard [R-NJ-7] Leonard Lance R NJ 7 N L000111 Rep. Latham, Tom [R-IA-4] TOM LATHAM R IA 4 2011-12-02 False I000026 Rep. Inslee, Jay [D-WA-1] JAY INSLEE D WA 1 2011-12-02 False W000811 Rep. Walsh, Joe [R-IL-8] Joe Walsh R IL 8 2011-12-12 False H001059 Rep. Hultgren, Randy [R-IL-14] Randy Hultgren R IL 14 2011-12-12 False F000339 Rep. Frank, Barney [D-MA-4] BARNEY FRANK D MA 4 2011-12-12 False M000933 Rep. Moran, James P. [D-VA-8] JAMES MORAN D VA P. 8 2012-02-06 False G000558 Rep. Guthrie, Brett [R-KY-2] Brett Guthrie R KY 2 2012-02-14 False R000580 Rep. Roskam, Peter J. [R-IL-6] Peter Roskam R IL J. 6 2012-03-07 False L000551 Rep. Lee, Barbara [D-CA-9] BARBARA LEE D CA 9 2012-04-16 False J000283 Rep. Jackson, Jesse L., Jr. [D-IL-2] JESSE JACKSON D IL L. 2 2012-05-09 False B000911 Rep. Brown, Corrine [D-FL-3] CORRINE BROWN D FL 3 2012-05-16 False J000255 Rep. Jones, Walter B., Jr. [R-NC-3] WALTER JONES R NC B. 3 2012-05-16 False W000791 Rep. Walden, Greg [R-OR-2] GREG WALDEN R OR 2 2012-05-16 False N000147 Del. Norton, Eleanor Holmes [D-DC-At Large] ELEANOR NORTON D DC HOLMES 0 2012-05-16 False N000015 Rep. Neal, Richard E. [D-MA-2] RICHARD NEAL D MA E. 2 2012-05-16 False C001049 Rep. Clay, Wm. Lacy [D-MO-1] WM. CLAY D MO LACY 1 2012-05-16 False K000210 Rep. King, Peter T. [R-NY-3] PETER KING R NY T. 3 2012-05-16 False C001081 Rep. Critz, Mark S. [D-PA-12] Mark Critz D PA S. 12 2012-05-16 False H001045 Rep. Harper, Gregg [R-MS-3] Gregg Harper R MS 3 2012-05-17 False L000569 Rep. Luetkemeyer, Blaine [R-MO-9] Blaine Luetkemeyer R MO 9 2012-05-17 False C001045 Rep. Crenshaw, Ander [R-FL-4] ANDER CRENSHAW R FL 4 2012-05-30 False T000462 Rep. Tiberi, Patrick J. [R-OH-12] PATRICK TIBERI R OH J. 12 2012-05-30 False L000570 Rep. Lujan, Ben Ray [D-NM-3] Ben Lujan D NM R. 3 2012-05-30 False W000672 Rep. Wolf, Frank R. [R-VA-10] FRANK WOLF R VA R. 10 2012-05-30 False P000601 Rep. Palazzo, Steven M. [R-MS-4] Steven Palazzo R MS M. 4 2012-05-30 False S000250 Rep. Sessions, Pete [R-TX-32] PETE SESSIONS R TX 32 2012-05-30 False P000096 Rep. Pascrell, Bill, Jr. [D-NJ-8] WILLIAM PASCRELL D NJ J. 8 2012-05-30 False F000116 Rep. Filner, Bob [D-CA-51] BOB FILNER D CA 51 2012-05-30 False L000565 Rep. Loebsack, David [D-IA-2] David Loebsack D IA 2 2012-06-08 False P000587 Rep. Pence, Mike [R-IN-6] MIKE PENCE R IN 6 2012-06-26 False S001174 Rep. Sutton, Betty [D-OH-13] Betty Sutton D OH 13 2012-06-26 False P000594 Rep. Paulsen, Erik [R-MN-3] Erik Paulsen R MN 3 2012-07-10 False C001072 Rep. Carson, Andre [D-IN-7] Andre Carson D IN 7 2012-07-10 False R000576 Rep. Ruppersberger, C. A. Dutch [D-MD-2] C. A. Ruppersberger D MD Dutch 2 2012-07-24 False R000053 Rep. Rangel, Charles B. [D-NY-15] CHARLES RANGEL D NY B. 15 2012-07-24 False B000461 Rep. Bilbray, Brian P. [R-CA-50] BRIAN BILBRAY R CA P. 50 2012-07-24 False B001234 Rep. Baca, Joe [D-CA-43] JOE BACA D CA 43 2012-08-02 False D000607 Rep. Donnelly, Joe [D-IN-2] Joe Donnelly D IN 2 2012-08-02 False R000592 Rep. Rokita, Todd [R-IN-4] Todd Rokita R IN 4 2012-08-02 False E000288 Rep. Ellison, Keith [D-MN-5] Keith Ellison D MN 5 2012-08-02 False W000738 Rep. Woolsey, Lynn C. [D-CA-6] LYNN WOOLSEY D CA 6 2012-08-02 False S001162 Rep. Schwartz, Allyson Y. [D-PA-13] Allyson Schwartz D PA Y. 13 2012-09-10 False B001275 Rep. Bucshon, Larry [R-IN-8] Larry Bucshon R IN 8 2012-09-20 False M001143 Rep. McCollum, Betty [D-MN-4] BETTY MCCOLLUM D MN 4 2012-09-20 False R000594 Rep. Runyan, Jon [R-NJ-3] Jon Runyan R NJ 3 2012-09-20 False D000613 Rep. Dold, Robert J. [R-IL-10] Robert Dold R IL J. 10 2012-09-20 False B001149 Rep. Burton, Dan [R-IN-5] DAN BURTON R IN 5 2012-09-21 False T000460 Rep. Thompson, Mike [D-CA-1] MIKE THOMPSON D CA 1 2012-11-29 False Health Administrative law and regulatory procedures Advisory bodies Department of Health and Human Services Drug safety, medical device, and laboratory regulation Drug therapy Executive agency funding and structure Government information and archives Health information and medical records Intellectual property Medical research Medical tests and diagnostic methods Medicare Research and development Health 00 2011-11-18 Introduced in House 2012-05-14T15:27:37Z Modernizing Our Drug & Diagnostics Evaluation and Regulatory Network Cures Act of 2011 or the MODDERN Cures Act of 2011 - 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 drug or biological product 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 drug or biological product, and use of the diagnostic tests provides for or improves: (1) the identification of a patient population for the drug or biological product; or (2) the determination of the most appropriate treatment option for a patient population with the drug or biological product.

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

]]> MODDERN Cures Act of 2011 Short Titles as Introduced MODDERN Cures Act of 2011 Short Titles as Introduced Modernizing Our Drug & Diagnostics Evaluation and Regulatory Network Cures Act of 2011 Display Title MODDERN Cures Act of 2011 Official Title as Introduced To promote the development of meaningful treatments for patients. Introduced in House 2011-11-18T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-112hr3497ih/xml/BILLS-112hr3497ih.xml 2011-12-02 Referred to the Subcommittee on Intellectual Property, Competition 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.