3.0.0 3059 2023-01-11T13:22:20Z 2023-01-11T13:22:20Z House H HR 2011-09-23 112 From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. McCAUL:H.R. 3059.Congress has the power to enact this legislation pursuantto the following:This legislation is authorized by the United StatesConstitution under Article I, Section 8, ``Congress shallhave the power To . . . provide for the common Defense andgeneral Welfare of the United States'' and ``To make all Lawswhich shall be necessary and proper for carrying intoExecution the forgoing Powers.''[Page H6457]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2011-09-26T13:58:19Z Referred to 2011-09-23T13:02:10Z Creating Hope Act of 2011 112 606 S 2011-03-17 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Related bill CRS 2011-09-26 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2011-09-23 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2011-09-23 Introduced in House IntroReferral Intro-H 9 Library of Congress 2011-09-23 Introduced in House IntroReferral 1000 9 Library of Congress M001157 Rep. McCaul, Michael T. [R-TX-10] Michael McCaul R TX T. 10 N B001251 Rep. Butterfield, G. K. [D-NC-1] G. K. Butterfield D NC 1 2011-09-23 True M001134 Rep. Myrick, Sue Wilkins [R-NC-9] SUE MYRICK R NC WILKINS 9 2011-09-23 True V000128 Rep. Van Hollen, Chris [D-MD-8] Chris Van Hollen D MD 8 2011-09-23 True B001248 Rep. Burgess, Michael C. [R-TX-26] Michael Burgess R TX C. 26 2011-09-23 True S001175 Rep. Speier, Jackie [D-CA-12] Jackie Speier D CA 12 2011-09-23 True K000376 Rep. Kelly, Mike [R-PA-3] Mike Kelly R PA 3 2011-09-23 True J000288 Rep. Johnson, Henry C. "Hank," Jr. [D-GA-4] Henry Johnson D GA C. "Hank" 4 2011-09-23 True D000096 Rep. Davis, Danny K. [D-IL-7] DANNY DAVIS D IL K. 7 2011-09-23 True T000326 Rep. Towns, Edolphus [D-NY-10] EDOLPHUS TOWNS D NY 10 2011-09-23 True C000380 Del. Christensen, Donna M. [D-VI-At Large] DONNA CHRISTENSEN D VI M. 0 2011-09-23 True R000515 Rep. Rush, Bobby L. [D-IL-1] BOBBY RUSH D IL L. 1 2011-09-23 True C001063 Rep. Cuellar, Henry [D-TX-28] Henry Cuellar D TX 28 2011-09-23 True B000461 Rep. Bilbray, Brian P. [R-CA-50] BRIAN BILBRAY R CA P. 50 2011-09-23 True W000672 Rep. Wolf, Frank R. [R-VA-10] FRANK WOLF R VA R. 10 2011-09-23 True M001159 Rep. McMorris Rodgers, Cathy [R-WA-5] Cathy McMorris Rodgers R WA 5 2011-09-23 True K000375 Rep. Keating, William R. [D-MA-10] William Keating D MA R. 10 2011-09-23 True O000168 Rep. Olson, Pete [R-TX-22] Pete Olson R TX 22 2011-09-23 True C001082 Rep. Canseco, Francisco "Quico" [R-TX-23] Francisco Canseco R TX Quico 23 2011-09-23 True R000575 Rep. Rogers, Mike D. [R-AL-3] Mike Rogers R AL 3 2011-09-23 True B001255 Rep. Boustany, Charles W., Jr. [R-LA-7] Charles Boustany R LA W. 7 2011-09-23 True D000603 Rep. Davis, Geoff [R-KY-4] Geoff Davis R KY 4 2011-09-23 True R000435 Rep. Ros-Lehtinen, Ileana [R-FL-18] ILEANA ROS-LEHTINEN R FL 18 2011-09-23 True P000197 Rep. Pelosi, Nancy [D-CA-8] NANCY PELOSI D CA 8 2011-09-23 True R000462 Rep. Rothman, Steven R. [D-NJ-9] STEVEN ROTHMAN D NJ R. 9 2011-09-23 True C001066 Rep. Castor, Kathy [D-FL-11] Kathy Castor D FL 11 2011-10-03 False C001078 Rep. Connolly, Gerald E. [D-VA-11] Gerald Connolly D VA E. 11 2011-10-03 False B001243 Rep. Blackburn, Marsha [R-TN-7] Marsha Blackburn R TN 7 2011-10-03 False B000013 Rep. Bachus, Spencer [R-AL-6] SPENCER BACHUS R AL 6 2011-10-04 False R000591 Rep. Roby, Martha [R-AL-2] Martha Roby R AL 2 2011-10-04 False C001051 Rep. Carter, John R. [R-TX-31] John Carter R TX R. 31 2011-10-04 False K000210 Rep. King, Peter T. [R-NY-3] PETER KING R NY T. 3 2011-10-05 False P000583 Rep. Paul, Ron [R-TX-14] RON PAUL R TX 14 2011-10-05 False M000133 Rep. Markey, Edward J. [D-MA-7] Edward Markey D MA J. 7 2011-10-05 False M000933 Rep. Moran, James P. [D-VA-8] JAMES MORAN D VA P. 8 2011-10-05 False L000575 Rep. Lankford, James [R-OK-5] James Lankford R OK 5 2011-10-06 False L000569 Rep. Luetkemeyer, Blaine [R-MO-9] Blaine Luetkemeyer R MO 9 2011-10-06 False J000032 Rep. Jackson Lee, Sheila [D-TX-18] SHEILA JACKSON LEE D TX 18 2011-10-06 False R000053 Rep. Rangel, Charles B. [D-NY-15] CHARLES RANGEL D NY B. 15 2011-10-11 False C001060 Rep. Carnahan, Russ [D-MO-3] Russ Carnahan D MO 3 2011-10-11 False S001164 Rep. Schmidt, Jean [R-OH-2] Jean Schmidt R OH 2 2011-10-12 False G000021 Rep. Gallegly, Elton [R-CA-24] ELTON GALLEGLY R CA 24 2011-10-12 False R000580 Rep. Roskam, Peter J. [R-IL-6] Peter Roskam R IL J. 6 2011-10-12 False J000255 Rep. Jones, Walter B., Jr. [R-NC-3] WALTER JONES R NC B. 3 2011-10-12 False F000116 Rep. Filner, Bob [D-CA-51] BOB FILNER D CA 51 2011-10-13 False D000197 Rep. DeGette, Diana [D-CO-1] DIANA DEGETTE D CO 1 2011-10-13 False D000482 Rep. Doyle, Michael F. [D-PA-14] MIKE DOYLE D PA 14 2011-10-14 False T000462 Rep. Tiberi, Patrick J. [R-OH-12] PATRICK TIBERI R OH J. 12 2011-10-14 False H001051 Rep. Hanna, Richard L. [R-NY-24] Richard Hanna R NY L. 24 2011-10-18 False P000598 Rep. Polis, Jared [D-CO-2] Jared Polis D CO 2 2011-10-21 False K000369 Rep. Kissell, Larry [D-NC-8] Larry Kissell D NC 8 2011-10-21 False B001276 Rep. Buerkle, Ann Marie [R-NY-25] Ann Buerkle R NY Marie 25 2011-10-21 False W000800 Rep. Welch, Peter [D-VT-At Large] Peter Welch D VT 0 2011-10-21 False F000339 Rep. Frank, Barney [D-MA-4] BARNEY FRANK D MA 4 2011-10-21 False H000627 Rep. Hinchey, Maurice D. [D-NY-22] MAURICE HINCHEY D NY D. 22 2011-10-21 False M001180 Rep. McKinley, David B. [R-WV-1] David McKinley R WV B. 1 2011-10-24 False T000266 Rep. Tierney, John F. [D-MA-6] JOHN TIERNEY D MA F. 6 2011-10-26 False N000186 Rep. Nunnelee, Alan [R-MS-1] Alan Nunnelee R MS 1 2011-10-27 False S000510 Rep. Smith, Adam [D-WA-9] ADAM SMITH D WA 9 2011-10-27 False C000059 Rep. Calvert, Ken [R-CA-44] KEN CALVERT R CA 44 2011-10-31 False D000604 Rep. Dent, Charles W. [R-PA-15] Charles Dent R PA W. 15 2011-10-31 False M000087 Rep. Maloney, Carolyn B. [D-NY-14] CAROLYN MALONEY D NY B. 14 2011-11-02 False P000585 Rep. Platts, Todd Russell [R-PA-19] TODD PLATTS R PA RUSSELL 19 2011-11-02 False R000572 Rep. Rogers, Mike J. [R-MI-8] Mike Rogers R MI 8 2011-11-02 False B001271 Rep. Benishek, Dan [R-MI-1] Dan Benishek R MI 1 2011-11-03 False S001189 Rep. Scott, Austin [R-GA-8] Austin Scott R GA 8 2011-11-04 False F000451 Rep. Fitzpatrick, Michael G. [R-PA-8] Michael Fitzpatrick R PA G. 8 2011-11-04 False R000587 Rep. Ribble, Reid J. [R-WI-8] Reid Ribble R WI J. 8 2011-11-10 False G000550 Rep. Gingrey, Phil [R-GA-11] Phil Gingrey R GA 11 2011-11-10 False C001045 Rep. Crenshaw, Ander [R-FL-4] ANDER CRENSHAW R FL 4 2011-11-10 False R000582 Rep. Roe, David P. [R-TN-1] David Roe R TN P. 1 2011-11-10 False H001047 Rep. Himes, James A. [D-CT-4] James Himes D CT A. 4 2011-11-10 False P000596 Resident Commissioner Pierluisi, Pedro R. [D-PR-At Large] Pedro Pierluisi D PR R. 0 2011-11-14 False J000290 Rep. Jenkins, Lynn [R-KS-2] Lynn Jenkins R KS 2 2011-11-15 False W000738 Rep. Woolsey, Lynn C. [D-CA-6] LYNN WOOLSEY D CA 6 2011-11-15 False N000147 Del. Norton, Eleanor Holmes [D-DC-At Large] ELEANOR NORTON D DC HOLMES 0 2011-11-15 False J000283 Rep. Jackson, Jesse L., Jr. [D-IL-2] JESSE JACKSON D IL L. 2 2011-11-15 False L000480 Rep. Lowey, Nita M. [D-NY-18] NITA LOWEY D NY M. 18 2011-11-15 False P000594 Rep. Paulsen, Erik [R-MN-3] Erik Paulsen R MN 3 2011-11-16 False C001068 Rep. Cohen, Steve [D-TN-9] Steve Cohen D TN 9 2011-11-17 False P000599 Rep. Posey, Bill [R-FL-15] Bill Posey R FL 15 2011-11-18 False M001151 Rep. Murphy, Tim [R-PA-18] Tim Murphy R PA 18 2011-11-18 False G000553 Rep. Green, Al [D-TX-9] Al Green D TX 9 2011-11-29 False G000544 Rep. Gonzalez, Charles A. [D-TX-20] CHARLES GONZALEZ D TX A. 20 2011-11-29 False H001032 Rep. Holt, Rush [D-NJ-12] RUSH HOLT D NJ D. 12 2011-11-29 False G000559 Rep. Garamendi, John [D-CA-10] John Garamendi D CA 10 2011-11-29 False W000799 Rep. Walz, Timothy J. [D-MN-1] Timothy Walz D MN J. 1 2011-11-29 False M001147 Rep. McCotter, Thaddeus G. [R-MI-11] Thaddeus McCotter R MI G. 11 2011-11-29 False P000592 Rep. Poe, Ted [R-TX-2] Ted Poe R TX 2 2011-12-01 False L000567 Rep. Lance, Leonard [R-NJ-7] Leonard Lance R NJ 7 2011-12-01 False Y000033 Rep. Young, Don [R-AK-At Large] DON YOUNG R AK E. 0 2011-12-02 False M001143 Rep. McCollum, Betty [D-MN-4] BETTY MCCOLLUM D MN 4 2011-12-06 False B001149 Rep. Burton, Dan [R-IN-5] DAN BURTON R IN 5 2011-12-06 False M001182 Rep. Mulvaney, Mick [R-SC-5] Mick Mulvaney R SC 5 2011-12-06 False B001273 Rep. Black, Diane [R-TN-6] Diane Black R TN 6 2011-12-07 False G000567 Rep. Griffin, Tim [R-AR-2] Tim Griffin R AR 2 2011-12-07 False T000467 Rep. Thompson, Glenn [R-PA-5] Glenn Thompson R PA 5 2011-12-08 False W000791 Rep. Walden, Greg [R-OR-2] GREG WALDEN R OR 2 2011-12-08 False B001228 Rep. Bono Mack, Mary [R-CA-45] MARY BONO MACK R CA 45 2011-12-08 False F000460 Rep. Farenthold, Blake [R-TX-27] Blake Farenthold R TX 27 2011-12-08 False M001149 Rep. Michaud, Michael H. [D-ME-2] Michael Michaud D ME H. 2 2011-12-12 False D000533 Rep. Duncan, John J., Jr. [R-TN-2] JOHN DUNCAN R TN J. 2 2011-12-12 False M000312 Rep. McGovern, James P. [D-MA-3] JAMES MCGOVERN D MA P. 3 2011-12-12 False Y000031 Rep. Young, C. W. Bill [R-FL-10] C. W. Young R FL Bill 10 2011-12-14 False D000613 Rep. Dold, Robert J. [R-IL-10] Robert Dold R IL J. 10 2011-12-16 False S001177 Del. Sablan, Gregorio Kilili Camacho [D-MP-At Large] Gregorio Sablan D MP Kilili Camacho 0 2012-01-13 False B001242 Rep. Bishop, Timothy H. [D-NY-1] Timothy Bishop D NY H. 1 2012-01-13 False J000126 Rep. Johnson, Eddie Bernice [D-TX-30] EDDIE JOHNSON D TX BERNICE 30 2012-01-17 False T000459 Rep. Terry, Lee [R-NE-2] LEE TERRY R NE 2 2012-01-23 False M001181 Rep. Meehan, Patrick [R-PA-7] Patrick Meehan R PA 7 2012-01-24 False R000581 Rep. Richardson, Laura [D-CA-37] Laura Richardson D CA 37 2012-01-24 False B001272 Rep. Berg, Rick [R-ND-At Large] Rick Berg R ND 0 2012-01-24 False M001137 Rep. Meeks, Gregory W. [D-NY-6] GREGORY MEEKS D NY W. 6 2012-01-24 False P000523 Rep. Price, David E. [D-NC-4] DAVID PRICE D NC E. 4 2012-01-25 False S000583 Rep. Smith, Lamar [R-TX-21] LAMAR SMITH R TX 21 2012-01-31 False R000593 Rep. Ross, Dennis A. [R-FL-12] Dennis Ross R FL A. 12 2012-01-31 False S001185 Rep. Sewell, Terri A. [D-AL-7] Terri Sewell D AL A. 7 2012-01-31 False W000809 Rep. Womack, Steve [R-AR-3] Steve Womack R AR 3 2012-01-31 False G000377 Rep. Granger, Kay [R-TX-12] KAY GRANGER R TX 12 2012-02-01 False L000565 Rep. Loebsack, David [D-IA-2] David Loebsack D IA 2 2012-02-01 False A000369 Rep. Amodei, Mark E. [R-NV-2] Mark Amodei R NV E. 2 2012-02-01 False C001049 Rep. Clay, Wm. Lacy [D-MO-1] WM. CLAY D MO LACY 1 2012-02-02 False G000548 Rep. Garrett, Scott [R-NJ-5] Scott Garrett R NJ 5 2012-02-03 False B001227 Rep. Brady, Robert A. [D-PA-1] ROBERT BRADY D PA A. 1 2012-02-06 False L000566 Rep. Latta, Robert E. [R-OH-5] Robert Latta R OH E. 5 2012-02-07 False B001259 Rep. Braley, Bruce L. [D-IA-1] Bruce Braley D IA L. 1 2012-02-09 False G000551 Rep. Grijalva, Raúl M. [D-AZ-7] Raúl Grijalva D AZ M. 7 2012-02-09 False F000372 Rep. Frelinghuysen, Rodney P. [R-NJ-11] RODNEY FRELINGHUYSEN R NJ 11 2012-02-14 False B001234 Rep. Baca, Joe [D-CA-43] JOE BACA D CA 43 2012-02-14 False P000597 Rep. Pingree, Chellie [D-ME-1] Chellie Pingree D ME 1 2012-02-15 False T000469 Rep. Tonko, Paul [D-NY-21] Paul Tonko D NY 21 2012-02-16 False L000562 Rep. Lynch, Stephen F. [D-MA-9] Stephen Lynch D MA F. 9 2012-02-16 False H000067 Rep. Hall, Ralph M. [R-TX-4] RALPH HALL R TX M. 4 2012-02-16 False B001254 Rep. Boren, Dan [D-OK-2] Dan Boren D OK 2 2012-02-21 False N000179 Rep. Napolitano, Grace F. [D-CA-38] GRACE NAPOLITANO D CA F. 38 2012-02-27 False C001075 Rep. Cassidy, Bill [R-LA-6] Bill Cassidy R LA 6 2012-02-28 False N000002 Rep. Nadler, Jerrold [D-NY-8] JERROLD NADLER D NY 8 2012-02-28 False T000471 Rep. Turner, Robert L. [R-NY-9] Robert Turner R NY L. 9 2012-02-28 False M001139 Rep. Miller, Gary G. [R-CA-42] GARY MILLER R CA 42 2012-03-01 False H001060 Rep. Hurt, Robert [R-VA-5] Robert Hurt R VA 5 2012-03-05 False S001184 Rep. Scott, Tim [R-SC-1] Tim Scott R SC 1 2012-03-05 False C000984 Rep. Cummings, Elijah E. [D-MD-7] ELIJAH CUMMINGS D MD E. 7 2012-03-06 False H001063 Rep. Hahn, Janice [D-CA-36] Janice Hahn D CA 36 2012-03-06 False A000366 Rep. Adams, Sandy [R-FL-24] Sandy Adams R FL 24 2012-03-07 False T000465 Rep. Tsongas, Niki [D-MA-5] Niki Tsongas D MA 5 2012-03-08 False A000210 Rep. Andrews, Robert E. [D-NJ-1] ROBERT ANDREWS D NJ E. 1 2012-03-08 False L000517 Rep. Lungren, Daniel E. [R-CA-3] DANIEL LUNGREN R CA EDWARD 3 2012-03-13 False G000558 Rep. Guthrie, Brett [R-KY-2] Brett Guthrie R KY 2 2012-03-13 False I000057 Rep. Israel, Steve [D-NY-2] STEVE ISRAEL D NY 2 2012-03-13 False G000549 Rep. Gerlach, Jim [R-PA-6] Jim Gerlach R PA 6 2012-03-19 False P000096 Rep. Pascrell, Bill, Jr. [D-NJ-8] WILLIAM PASCRELL D NJ J. 8 2012-03-19 False S001179 Rep. Schock, Aaron [R-IL-18] Aaron Schock R IL 18 2012-03-19 False S001155 Rep. Sullivan, John [R-OK-1] John Sullivan R OK 1 2012-03-21 False W000796 Rep. Westmoreland, Lynn A. [R-GA-3] Lynn Westmoreland R GA A. 3 2012-03-21 False L000557 Rep. Larson, John B. [D-CT-1] JOHN LARSON D CT B. 1 2012-03-21 False S001154 Rep. Shuster, Bill [R-PA-9] Bill Shuster R PA 9 2012-03-22 False M001158 Rep. Marchant, Kenny [R-TX-24] Kenny Marchant R TX 24 2012-03-22 False B001260 Rep. Buchanan, Vern [R-FL-13] Vern Buchanan R FL 13 2012-03-22 False H001045 Rep. Harper, Gregg [R-MS-3] Gregg Harper R MS 3 2012-03-26 False W000797 Rep. Wasserman Schultz, Debbie [D-FL-20] Debbie Wasserman Schultz D FL 20 2012-04-16 False M001150 Rep. Miller, Candice S. [R-MI-10] Candice Miller R MI S. 10 2012-04-16 False G000562 Rep. Gardner, Cory [R-CO-4] Cory Gardner R CO 4 2012-04-18 False G000568 Rep. Griffith, H. Morgan [R-VA-9] H. Griffith R VA Morgan 9 2012-04-18 False W000413 Rep. Whitfield, Ed [R-KY-1] EDWARD WHITFIELD R KY 1 2012-04-19 False C001083 Rep. Carney, John C., Jr. [D-DE-At Large] John Carney D DE C. 0 2012-04-24 False K000378 Rep. Kinzinger, Adam [R-IL-11] Adam Kinzinger R IL 11 2012-04-24 False F000461 Rep. Flores, Bill [R-TX-17] Bill Flores R TX 17 2012-05-07 False V000081 Rep. Velazquez, Nydia M. [D-NY-12] NYDIA VELAZQUEZ D NY M. 12 2012-05-07 False H001058 Rep. Huizenga, Bill [R-MI-2] Bill Huizenga R MI 2 2012-05-08 False M000404 Rep. McDermott, Jim [D-WA-7] JIM MCDERMOTT D WA 7 2012-06-06 False M001156 Rep. McHenry, Patrick T. [R-NC-10] Patrick McHenry R NC 10 2012-06-12 False C000754 Rep. Cooper, Jim [D-TN-5] JAMES COOPER D TN H. 5 2012-06-20 False H001052 Rep. Harris, Andy [R-MD-1] Andy Harris R MD 1 2012-09-10 False H001059 Rep. Hultgren, Randy [R-IL-14] Randy Hultgren R IL 14 2012-09-19 False Health Child health Drug safety, medical device, and laboratory regulation Health promotion and preventive care Infectious and parasitic diseases Health 00 2011-09-23 Introduced in House 2011-12-09T16:21:51Z Creating Hope Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to revise the priority review voucher program for tropical diseases to: (1) include rare pediatric diseases; (2) allow unlimited transfers of vouchers under the program; and (3) require a sponsor intending to use a voucher to notify the Secretary of Health and Human Services (HHS) at least 90 days (currently, 365 days) before submission of the application.

Revises provisions regarding the priority review user fee, including to make it payable upon notification of the Secretary of intent to use the voucher.

Authorizes the Secretary, upon request of the manufacturer or sponsor of a new drug, to designate that a new drug is: (1) for a rare pediatric disease, and (2) an eligible treatment.

Requires the Secretary to deem a rare pediatric disease product application to be incomplete if it does not contain a description of the sponsor's plan to market the product in the United States. Authorizes the Secretary to refuse to issue a priority review voucher upon the approval of a rare pediatric disease application if the Secretary finds that the sponsor lacks a good faith intention to market the product in the United States. Directs the Secretary to issue a guidance document setting forth the evidentiary support necessary to demonstrate such a good faith intention.

Requires sponsors of applications under the priority review voucher program to report to the Secretary within five years after the approval of the application on the demand and distribution of the product within the United States.

]]> Creating Hope Act of 2011 Display Title Creating Hope Act of 2011 Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act to improve the priority review voucher incentive program relating to tropical and rare pediatric diseases. Introduced in House IH Short Titles as Introduced Creating Hope Act of 2011 Introduced in House 2011-09-23T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-112hr3059ih/xml/BILLS-112hr3059ih.xml 2011-09-26 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.