Bill113th Congress

H.R. 1408

Animal Generic Drug User Fee Amendments of 2013

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Introduced
Apr 9, 2013
Origin Chamber
House
Policy Area
Health
Latest Action
Apr 12, 2013

Sponsor

Rep. Gardner, Cory [R-CO-4]

Republican·CO-4
Bioguide ID: G000562
First Name: Cory
Last Name: Gardner
By Request: N
8
Cosponsors
1
Committees
4
Actions
0
Amendments
1
Related Bills
7
Subjects
1
Summaries
3
Titles
1
Text Versions

Bill Details

Update Date
Nov 15, 2022
Origin Chamber
House
Bill Type
HR
Bill Number
1,408
Congress
113
Introduced Date
Apr 9, 2013
Policy Area
Health
Is Law
No
Apr 12, 2013Committee

Referred to the Subcommittee on Health.

Source: House committee actions

Apr 9, 2013IntroReferralH11100

Referred to the House Committee on Energy and Commerce.

Source: House floor actions

Apr 9, 2013IntroReferralIntro-H

Introduced in House

Source: Library of Congress

Apr 9, 2013IntroReferral1000

Introduced in House

Source: Library of Congress

Introduced in House· Apr 9, 20130

Animal Generic Drug User Fee Amendments of 2013 - Amends the Federal Food, Drug, and Cosmetic Act to extend for FY2014-FY2018 the authority of the Food and Drug Administration (FDA) to collect generic animal drug user fees, specifically abbreviated application fees for generic new animal drugs, generic new animal drug product fees, and generic new animal drug sponsor fees.

Subjects generic animal drug applications to a fee 50% of the amount of the normal fee if the application is for an animal drug which contains more than one active ingredient, or the labeling of the drug prescribes, recommends, or suggests use of the drug in combination with one or more other animal drugs, and the active ingredients or drugs intended for use in the combination have previously been separately approved.

Revises the due date for annual generic animal drug user fees to the later of January 31 of each year or the first business day after enactment of an appropriations act providing for the collection and obligation of fees for the fiscal year.

Establishes the total amount of revenue each type of generic user fee shall generate.

Authorizes the Secretary of Health and Human Services (HHS) to accept payment of user fees prior to their due date.

Extends requirements for the FDA to report to Congress on achieving goals related to the generic animal drug development and review process and the implementation of the authority to collect generic animal drug fees.

Terminates the authority to collect generic animal drug user fees October 1, 2018.

Energy and Commerce Committee

House· Standing
Animal and plant healthDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationExecutive agency funding and structureFood and Drug Administration (FDA)User charges and feesVeterinary medicine and animal diseases

Introduced in House

Apr 9, 2013

Animal Generic Drug User Fee Amendments of 2013 — Informed