H.R. 6433 · 110th Congress
Animal Generic Drug User Fee Act of 2008
Key: what the circles and colors mean
Each circle is a bill. The ring fills as it moves through Congress:
Under the number: the Yea · Nay count of its final (or latest) recorded vote. On a member's page, the small badge is how that member voted: Y Yea / Aye, N Nay / No, P Present, – Not voting.
Gold and violet are only for Yea and Nay; they never mean a party. A member's party is the letter on their photo.
Never voted on. It didn't reach a floor vote before the 110th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
D
PalloneSponsor5 cosponsors · 3 D, 2 R
4 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
Animal Generic Drug User Fee Act of 2008 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to assess and collect fees for an abbreviated application for a generic new animal drug, including application fees, product fees, and sponsor fees.
What it does: CRS summary · Reported to House with amendment(s) · Jul 30, 2008
Animal Generic Drug User Fee Act of 2008 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to assess and collect fees for an abbreviated application for a generic new animal drug, including application fees, product fees, and sponsor fees.
Sets forth total revenue to be collected for each type of fee for FY2009-FY2013.
Provides for fee adjustments. Requires the Secretary to establish such fees each fiscal year.
Provides for fee waivers where the Secretary finds that the generic new animal drug is intended solely to provide for a minor use or minor species indication.
Authorizes appropriations for FY2009-FY2013.
Requires the Secretary to report to Congress and make publicly available information on: (1) progress toward the goal of expediting the generic new animal drug development process and the review of abbreviated applications for such drugs; and (2) the implementation of the authority for and use of generic new animal drug fees.
Sets forth the process for developing recommendations to present to Congress for the review of abbreviated applications for generic new animal drugs after FY2013.
Terminates the authority to assess and use generic new animal drug fees on October 1, 2013. Terminates reporting requirements on January 31, 2014.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Animal Generic Drug User Fee Act of 2008
Latest action (Jul 30, 2008): Placed on the Union Calendar, Calendar No. 521.
Policy area: Health · Origin: House · Introduced: Jul 8, 2008
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.