HR 1408 · 113th Congress 2013–2015, ended

Animal Generic Drug User Fee Amendments of 2013

Fact sheet

Latest action · Apr 12, 2013 Referred to the Subcommittee on Health.

Progress

Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.

  1. IntroducedApr 9, 2013
  2. Passed HouseNot reached
  3. Passed SenateNot reached
  4. To the PresidentNot reached
  5. Became lawNot reached

Summary

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.

Cosponsors 8

Members who signed on, in the order they did. All signed on Apr 9, 2013.

SeatCosponsorSigned on
R-ILAdam KinzingerOriginalApr 9, 2013
R-KYBrett GuthrieOriginalApr 9, 2013
D-NJFrank Pallone, Jr.OriginalApr 9, 2013
R-MIFred UptonOriginalApr 9, 2013
D-CAHenry A. WaxmanOriginalApr 9, 2013
R-ILJohn ShimkusOriginalApr 9, 2013
R-PAJoseph R. PittsOriginalApr 9, 2013
R-TXMichael C. BurgessOriginalApr 9, 2013

Actions 3

Everything that happened, newest first.

  1. Apr 12, 2013Referred to the Subcommittee on Health.
  2. Apr 9, 2013Introduced in House
  3. Apr 9, 2013Referred to the House Committee on Energy and Commerce.

Related bills 1

Companion bills and other measures the record links to this one.

BillTitleRelationshipLatest action
S 622Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013Related billJun 13, 2013

Subjects

Assigned by the Library of Congress. Policy area: Health.

Text 1

Each version as it was printed, newest first.

  1. Apr 9, 2013Introduced in House

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Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov.