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H.R. 3059 · 112th Congress

Creating Hope Act of 2011

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Never voted on. It didn't reach a floor vote before the 112th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.

MMR McCaulSponsor
173 cosponsors · 76 D, 97 R
BBR Bilbray MBR Burgess GKD Butterfield CBR Boustany DCD Christensen HCD Cuellar QCR Canseco DDD Davis GDR Davis HJD Johnson WKD Keating MKR Kelly SMR Myrick CMR McMorris Rodgers POR Olson NPD Pelosi IRR Ros-Lehtinen SRD Rothman BRD Rush MRR Rogers JSD Speier ETD Towns CVD Van Hollen FWR Wolf MBR Blackburn KCD Castor GCD Connolly SBR Bachus JCR Carter MRR Roby PKR King EMD Markey JMD Moran RPR Paul SJD Jackson Lee BLR Luetkemeyer JLR Lankford RCD Carnahan CRD Rangel EGR Gallegly WJR Jones PRR Roskam JSR Schmidt DDD DeGette BFD Filner MDD Doyle PTR Tiberi RHR Hanna AMR Marie Buerkle BFD Frank MHD Hinchey LKD Kissell JPD Polis PWD Welch DMR McKinley JTD Tierney ANR Nunnelee ASD Smith KCR Calvert CDR Dent CMD Maloney TPR Platts MRR Rogers DBR Benishek MFR Fitzpatrick ASR Scott ACR Crenshaw PGR Gingrey JHD Himes PRR Roe RRR Ribble PPD Pierluisi JJD Jackson LJR Jenkins NLD Lowey END Norton LWD Woolsey EPR Paulsen SCD Cohen TMR Murphy BPR Posey CGD Gonzalez AGD Green JGD Garamendi RHD Holt TMR McCotter TWD Walz LLR Lance TPR Poe DYR Young DBR Burton BMD McCollum MMR Mulvaney DBR Black TGR Griffin MBR Bono Mack BFR Farenthold GTR Thompson GWR Walden JDR Duncan JMD McGovern MMD Michaud CYR Young BDR Dold TBD Bishop GSD Sablan EJD Johnson LTR Terry RBR Berg GMD Meeks PMR Meehan LRD Richardson DPD Price DRR Ross LSR Smith TSD Sewell SWR Womack MAR Amodei KGR Granger DLD Loebsack WCD Clay SGR Garrett RBD Brady RLR Latta BBD Braley RGD Grijalva JBD Baca RFR Frelinghuysen CPD Pingree RHR Hall SLD Lynch PTD Tonko DBD Boren GND Napolitano BCR Cassidy JND Nadler RTR Turner GMR Miller RHR Hurt TSR Scott ECD Cummings JHD Hahn SAR Adams RAD Andrews NTD Tsongas BGR Guthrie SID Israel DLR Lungren JGR Gerlach BPD Pascrell ASR Schock JLD Larson JSR Sullivan LWR Westmoreland VBR Buchanan KMR Marchant BSR Shuster GHR Harper CMR Miller DWD Wasserman Schultz CGR Gardner HGR Griffith EWR Whitfield JCD Carney AKR Kinzinger BFR Flores NVD Velázquez BHR Huizenga JMD McDermott PMR McHenry JCD Cooper AHR Harris RHR Hultgren

24 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.

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)…

What it does: CRS summary · Introduced in House · Sep 23, 2011

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.

Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov

About this bill and sources

Official title: Creating Hope Act of 2011

Latest action (Sep 26, 2011): Referred to the Subcommittee on Health.

Policy area: Health · Origin: House · Introduced: Sep 23, 2011

Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)

No recorded floor vote found.