3.0.0 606 2020-02-10T17:03:12Z 2020-02-10T17:03:12Z Senate S S 2011-03-17 112 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2011-03-17T15:15:46Z Creating Hope Act of 2011 112 3059 HR 2011-09-26 Referred to the Subcommittee on Health. Related bill CRS 2011-03-17 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2011-03-17 Introduced in Senate IntroReferral 10000 9 Library of Congress C001070 Sen. Casey, Robert P., Jr. [D-PA] Bob Casey D PA N B001268 Sen. Brown, Scott P. [R-MA] Scott Brown R MA P. 2011-03-17 True B000944 Sen. Brown, Sherrod [D-OH] Sherrod Brown D OH 2011-03-17 True I000055 Sen. Isakson, Johnny [R-GA] Johnny Isakson R GA 2011-03-17 True F000457 Sen. Franken, Al [D-MN] Al Franken D MN 2011-03-17 True G000555 Sen. Gillibrand, Kirsten E. [D-NY] Kirsten Gillibrand D NY E. 2011-05-17 False B001277 Sen. Blumenthal, Richard [D-CT] Richard Blumenthal D CT 2011-06-23 False B000575 Sen. Blunt, Roy [R-MO] Roy Blunt R MO 2011-09-26 False C000880 Sen. Crapo, Mike [R-ID] Mike Crapo R ID 2011-10-03 False V000127 Sen. Vitter, David [R-LA] David Vitter R LA 2011-12-01 False S000148 Sen. Schumer, Charles E. [D-NY] Charles Schumer D NY E. 2012-03-28 False L000123 Sen. Lautenberg, Frank R. [D-NJ] FRANK LAUTENBERG D NJ R. 2012-06-05 False Health Child health Drug safety, medical device, and laboratory regulation Health promotion and preventive care Infectious and parasitic diseases Health 00 2011-03-17 Introduced in Senate 2011-05-03T20:45:57Z 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.

]]> Creating Hope Act of 2011 Short Titles as Introduced Creating Hope Act of 2011 Display Title Creating Hope Act of 2011 Official Title as Introduced A bill 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 Senate 2011-03-17T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-112s606is/xml/BILLS-112s606is.xml 2011-03-17 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. 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.