U.S. Congress - H.R.3059 Creating Hope Act of 2011
H.R.3059 - Creating Hope Act of 2011
Creating Hope Act of 2011 view all titles (3)
All Bill Titles
- Official: Creating Hope Act of 2011 as introduced.
- Short: Creating Hope Act of 2011 as introduced.
- Official: 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.
This Bill currently has no wiki content. If you would like to create a wiki entry for this bill, please Login, and then select the wiki tab to create it.
Bill's Views
- Today: 6
- Past Seven Days: 35
- All-Time: 922
|
|
|
|
|
|
|
|
Official Summary
9/23/2011--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
9/23/2011--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 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.
...Read the Rest
Recent News Coverage
Congress Will Have to Deal with Much More than Just Elections in 2012
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 co-sponsors in the House and nine ...
Congress Will Have to Deal with Much More than Just Elections in 2012
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 co-sponsors in the House and nine ...
Rep. McCaul Introduces Bill to Improve Priority Review Voucher Incentive ...
Michael McCaul, R-Texas, has introduced legislation (HR 3059) to amend the Federal Food, Drug, and Cosmetic Act to "improve the priority review voucher incentive program relating to tropical and rare pediatric diseases." The bill was introduced
Recent Blog Coverage
View All (72)
|
View Top Rated
PEDIATRIC CANCER: Were are the drugs? Childhood Cancer meet ...
H.R. 3059, the Creating Hope Act of 2011, introduced on the day of the 2nd annual Childhood Cancer Summit, would expand the cost-neutral Food and Drug Administration priority review voucher (PRV)program, allowing ...
More Information On The Creating Hope Act | Armand's Hope
The Senate bill is S. 606, while the House bill is H.R. 3059. More information can be found here. On a related note, in August I sent an email to Sen. Brown thanking him for the support of the bill, and inviting him to ...
Car Insurance Companies Lobbying for Cheap Parts Legislation
Some repair shops and car parts manufacturers are being pitted with auto insurance companies due to a new car legislation in Congress Bill H.R. 3059 is the.
Latest Letters to Congress
See All Letters (2)Vote on This Bill
-
Share This Bill
More Share via Email
