U.S. Congress - S.606 Creating Hope Act of 2011
S.606 - Creating Hope Act of 2011
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. view all titles (2)
All Bill Titles
- Short: Creating Hope Act of 2011 as introduced.
- Official: 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. as introduced.
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Official Summary
3/17/2011--Introduced.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 sponOfficial Summary
3/17/2011--Introduced.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.
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Organizations Supporting S.606
- Pfizer
- Pablove Foundation
- Curesearch for Children's Cancer
- Aeras Global TB Vaccine Foundation
- Association of Pediatric Oncology Social Workers
- American Society of Clinical Oncology
- ...and 50 more. See all.
Organizations Opposing S.606
- None via MapLight at this time.
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H.R.3059: Creating Hope Act of 2011 - U.S. Congress ...
One such bill, the Creating Hope Act (S.606 and HR 3059) would enable drug developers to receive priority review vouchers that could be sold or transferred more than once. The Creating Hope Act has attracted 104 ...
H.R.3059: Creating Hope Act of 2011 - U.S. Congress ...
One such bill, the Creating Hope Act (S.606 and HR 3059) would enable drug developers to receive priority review vouchers that could be sold or transferred more than once. The Creating Hope Act has attracted 104 ...
H.R.3059: Creating Hope Act of 2011 - U.S. Congress ...
One such bill, the Creating Hope Act (S.606 and HR 3059) would enable drug developers to receive priority review vouchers that could be sold or transferred more than once. The Creating Hope Act has attracted 104 ...
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