S 3697 · 111th Congress 2009–2011, ended

Creating Hope Act of 2010

Fact sheet

Latest action · Aug 4, 2010 Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Progress

Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.

  1. IntroducedAug 4, 2010
  2. Passed SenateNot reached
  3. Passed HouseNot reached
  4. To the PresidentNot reached
  5. Became lawNot reached

Summary

Creating Hope Act of 2010 - 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 produce and distribute the product.

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.

Cosponsors 2

Members who signed on, in the order they did. All signed on Aug 4, 2010.

SeatCosponsorSigned on
D-MNAl FrankenOriginalAug 4, 2010
D-OHSherrod BrownOriginalAug 4, 2010

Actions 2

Everything that happened, newest first.

  1. Aug 4, 2010Introduced in Senate
  2. Aug 4, 2010Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Subjects

Assigned by the Library of Congress. Policy area: Health.

Text 1

Each version as it was printed, newest first.

  1. Aug 4, 2010Introduced in Senate

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Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov.