S. 606 · 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.
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CaseySponsor11 cosponsors · 6 D, 5 R
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Brown
SB
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Brown
AF
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Franken
JI
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Isakson
KG
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Gillibrand
RB
D
Blumenthal
RB
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Blunt
MC
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Crapo
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Vitter
CS
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Schumer
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Lautenberg4 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 Senate · Mar 17, 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 innovative 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 (Mar 17, 2011): Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Policy area: Health · Origin: Senate · Introduced: Mar 17, 2011
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.