Summary: H.R.4955 — 107th Congress (2001-2002)All Information (Except Text)

There is one summary for H.R.4955. Bill summaries are authored by CRS.

Shown Here:
Introduced in House (06/18/2002)

Animal Drug User Fee Act of 2002 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services to assess and collect fees for an animal drug or a supplemental animal drug application (if it requires safety or effectiveness data). Requires payment upon submission or the application will be considered incomplete and not accepted. Excepts from payment applications which were previously filed but withdrawn or not approved without a waiver or refund.

Assesses annual fees on animal drug products, establishments, and sponsors.

Establishes a fee schedule for FY 2003 through 2007, including total fee revenues for animal drug products, establishments, and sponsors. Adjusts fees to reflect inflation, review workload, operating reserves of carryover user fees (in the final year), and to maintain an equal balance of revenue from applications, products, establishments, and sponsors. Reduces or waives fees: (1) in excess of administrative costs; (2) that present a significant barrier to innovation; (3) to promote availability for minor uses or use in minor species; or (4) for first applications by a small business.

Makes fees available for obligation only to the extent provided in advance in appropriations Acts. Offsets any excess fees against subsequent appropriations.