US Congress House Bill 3059 (Prior Session Legislation)

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September 26 2011 - Referred to the Subcommittee on Health.
Pending: House Subcommittee on Health Committee
Text: Latest bill text (Introduced) [PDF]

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

Rep McCaul, Michael T.	Rep Adams, Sandy	Rep Amodei, Mark E.	Rep Andrews, Robert E.
Rep Baca, Joe	Rep Bachus, Spencer	Rep Benishek, Dan	Rep Berg, Rick
Rep Bilbray, Brian P.	Rep Bishop, Timothy H.	Rep Black, Diane	Rep Blackburn, Marsha
Rep Bono Mack, Mary	Rep Boren, Dan	Rep Boustany, Charles W., Jr.	Rep Brady, Robert A.
Rep Braley, Bruce L.	Rep Buchanan, Vern	Rep Buerkle, Ann Marie	Rep Burgess, Michael C.
Rep Burton, Dan	Rep Butterfield, G. K.	Rep Calvert, Ken	Rep Canseco, Francisco "Quico"
Rep Carnahan, Russ	Rep Carney, John	Rep Carter, John R.	Rep Cassidy, Bill
Rep Castor, Kathy	Rep Christensen, Donna M.	Rep Clay, Wm. Lacy	Rep Cohen, Steve
Rep Connolly, Gerald E. "Gerry"	Rep Cooper, Jim	Rep Crenshaw, Ander	Rep Cuellar, Henry
Rep Cummings, Elijah E.	Rep Davis, Danny K.	Rep Davis, Geoff	Rep DeGette, Diana
Rep Dent, Charles W.	Rep Dold, Robert J.	Rep Doyle, Michael F.	Rep Duncan, John J., Jr.
Rep Farenthold, Blake	Rep Filner, Bob	Rep Fitzpatrick, Michael G.	Rep Flores, Bill
Rep Frank, Barney	Rep Frelinghuysen, Rodney P.	Rep Gallegly, Elton	Rep Garamendi, John
Rep Gardner, Cory	Rep Garrett, Scott	Rep Gerlach, Jim	Rep Gingrey, Phil
Rep Gonzalez, Charles A.	Rep Granger, Kay	Rep Green, Al	Rep Griffin, Tim
Rep Griffith, H. Morgan	Rep Grijalva, Raul M.	Rep Guthrie, Brett	Rep Hahn, Janice
Rep Hall, Ralph M.	Rep Hanna, Richard L.	Rep Harper, Gregg	Rep Harris, Andy
Rep Himes, James A.	Rep Hinchey, Maurice D.	Rep Holt, Rush D.	Rep Huizenga, Bill
Rep Hultgren, Randy	Rep Hurt, Robert	Rep Israel, Steve	Rep Jackson-Lee, Sheila
Rep Jackson, Jesse L., Jr.	Rep Jenkins, Lynn	Rep Johnson, Eddie Bernice	Rep Johnson, Henry C. "Hank," Jr.
Rep Jones, Walter B., Jr.	Rep Keating, William R.	Rep Kelly, Mike	Rep King, Peter T.
Rep Kinzinger, Adam	Rep Kissell, Larry	Rep Lance, Leonard	Rep Lankford, James
Rep Larson, John B.	Rep Latta, Robert E.	Rep Loebsack, David	Rep Lowey, Nita M.
Rep Luetkemeyer, Blaine	Rep Lungren, Daniel E.	Rep Lynch, Stephen F.	Rep Maloney, Carolyn B.
Rep Marchant, Kenny	Rep Markey, Edward J.	Rep McCollum, Betty	Rep McCotter, Thaddeus G.
Rep McDermott, Jim	Rep McGovern, James P.	Rep McHenry, Patrick T.	Rep McKinley, David B.
Rep McMorris Rodgers, Cathy	Rep Meehan, Patrick	Rep Meeks, Gregory W.	Rep Michaud, Michael H.
Rep Miller, Candice S.	Rep Miller, Gary G.	Rep Moran, James P.	Rep Mulvaney, Mick
Rep Murphy, Tim	Rep Myrick, Sue Wilkins	Rep Nadler, Jerrold	Rep Napolitano, Grace F.
Rep Norton, Eleanor Holmes	Rep Nunnelee, Alan	Rep Olson, Pete	Rep Pascrell, Bill, Jr.
Rep Paul, Ron	Rep Paulsen, Erik	Rep Pelosi, Nancy	Rep Pierluisi, Pedro R.
Rep Pingree, Chellie	Rep Platts, Todd Russell	Rep Poe, Ted	Rep Polis, Jared
Rep Posey, Bill	Rep Price, David E.	Rep Rangel, Charles B.	Rep Ribble, Reid J.
Rep Richardson, Laura	Rep Roby, Martha	Rep Roe, David P.	Rep Rogers, Mike D.
Rep Rogers, Mike J.	Rep Ros-Lehtinen, Ileana	Rep Roskam, Peter J.	Rep Ross, Dennis
Rep Rothman, Steven R.	Rep Rush, Bobby L.	Rep Sablan, Gregorio Kilili Camacho	Rep Schmidt, Jean
Rep Schock, Aaron	Rep Scott, Austin	Rep Scott, Tim	Rep Sewell, Terri A.
Rep Shuster, Bill	Rep Smith, Adam	Rep Smith, Lamar	Rep Speier, Jackie
Rep Sullivan, John	Rep Terry, Lee	Rep Thompson, Glenn	Rep Tiberi, Patrick J.
Rep Tierney, John F.	Rep Tonko, Paul D.	Rep Towns, Edolphus	Rep Tsongas, Niki
Rep Turner, Robert L.	Rep Van Hollen, Chris	Rep Velazquez, Nydia M.	Rep Walden, Greg
Rep Walz, Timothy J.	Rep Wasserman Schultz, Debbie	Rep Welch, Peter	Rep Westmoreland, Lynn A.
Rep Whitfield, Ed	Rep Wolf, Frank R.	Rep Womack, Steve	Rep Woolsey, Lynn C.
Rep Young, C.W. Bill	Rep Young, Don

Date	Chamber	Action
2011-09-26	House	Referred to the Subcommittee on Health.
2011-09-23	House	Referred to the House Committee on Energy and Commerce.

SB606 (Related) 2011-03-17 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Type	Source
Summary	http://thomas.loc.gov/cgi-bin/bdquery/z?d112:HN03059:@@@L&summ2=m&
Text	http://gpo.gov/fdsys/pkg/BILLS-112hr3059ih/pdf/BILLS-112hr3059ih.pdf