Animal Generic Drug User Fee Act of 2008

Bill: 110-hr-6433
Sponsor: Rep. Pallone, Frank, Jr. [D-NJ-6]
Introduced: 2008-07-08 in the House
Policy area: Health
Subjects: Administrative fees
Administrative procedure
Animals
Appropriations
Authorization
Commerce
Congress
Congressional reporting requirements
Department of Health and Human Services
Drug approvals
Drug industry
Economics and Public Finance
Electronic government information
Food and Drug Administration (FDA)
Generic drugs
Government Operations and Politics
Government publicity
Law
Pharmaceutical research
Science, Technology, Communications
Sunset legislation
Veterinary medicine

Summary:
action_date: 2008-07-08
text: 
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 collect: (1) an application fee from persons who submit an abbreviated application for a generic new animal drug on or after July 1, 2008; (2) an annual product fee from applicants named in an abbreviated application or supplemental abbreviated application for a generic new animal drug product that has been submitted for listing for commercial distribution who have such an application pending before the Secretary after September 1, 2008; and (3) an annual sponsor fee from generic new animal drug sponsors who have such an application or an investigational submission pending after such date. 

Sets forth the total revenues to be collected from each of such fees in each of FY2009-FY2013. Provides for revenue adjustments based on application review workloads. Requires the Secretary to establish such fees before each fiscal year based on such revenue amounts and adjustments and total review costs.

Deems such an application or investigational submission to be incomplete until all such fees have been paid. Authorizes the Secretary to waive or reduce such fees where the drug is intended solely to provide for a minor use or minor species indication.

Conditions fee assessment and obligation on appropriation funding levels.

Requires the Secretary to report annually on: (1) the Food and Drug Administration's (FDA's) progress in expediting the development process and the review of abbreviated applications and investigational submissions for generic new animal drugs; and (2) implementation of the fee authority and FDA's use of the fees. 

Sets forth consultation requirements regarding the process for the review of such abbreviated applications for the five years after FY2013.

action_date: 2008-07-30
text: 
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.
 


Legislative actions:
action_date: 2008-07-30
text: Placed on the Union Calendar, Calendar No. 521.
action_date: 2008-07-30
text: Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 110-805.
action_date: 2008-07-30
text: Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 110-805.
action_date: 2008-07-16
text: Ordered to be Reported (Amended) by Voice Vote.
action_date: 2008-07-16
text: Committee Consideration and Mark-up Session Held.
action_date: 2008-07-09
text: Forwarded by Subcommittee to Full Committee by Voice Vote .
action_date: 2008-07-09
text: Subcommittee Consideration and Mark-up Session Held.
action_date: 2008-07-08
text: Referred to the Subcommittee on Health.
action_date: 2008-07-08
text: Referred to the House Committee on Energy and Commerce.
action_date: 2008-07-08
text: Introduced in House
action_date: 2008-07-08
text: Introduced in House