S. 622: Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013

Introduced:
Mar 20, 2013 (113th Congress, 2013–2015)
Status:
Signed by the President on Jun 13, 2013
Prognosis
20% chance of being enacted
Slip Law:
This bill became Pub.L. 113-14.

This bill was enacted after being signed by the President on June 13, 2013.

Introduced
Mar 20, 2013
Reported by Committee
Mar 20, 2013
Passed Senate
May 08, 2013
Passed House
Jun 03, 2013
Signed by the President
Jun 13, 2013
 
Sponsor
Thomas “Tom” Harkin
Junior Senator from Iowa
Party
Democrat
Text
Read Text »
Last Updated
Jun 05, 2013
Length
25 pages
Related Bills
H.R. 1407 (Related)
Animal Drug User Fee Amendments of 2013

Reported by Committee
Last Action: May 15, 2013

H.R. 1408 (Related)
Animal Generic Drug User Fee Amendments of 2013

Referred to Committee
Last Action: Apr 09, 2013

 
Full Title

An original bill to amend the Federal Food, Drug, and Cosmetic Act to reauthorize user fee programs relating to new animal drugs and generic new animal drugs.

Summary

No summaries available.

 
Prognosis

20% chance of being enacted.

Only about 23% of bills that made it past committee in 2011–2013 were enacted. [show factors | methodology]

Votes
On Motion to Suspend the Rules and Pass
Jun 03, 2013 7:02 p.m.
Passed 390/12

Cosponsors
none
Committees

Senate Health, Education, Labor, and Pensions

The committee chair determines whether a bill will move past the committee stage.

 
Primary Source

THOMAS.gov (The Library of Congress)

GovTrack gets most information from THOMAS, which is updated generally one day after events occur. Activity since the last update may not be reflected here. Data comes via the congress project.

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Notes

S. stands for Senate bill.

A bill must be passed by both the House and Senate in identical form and then be signed by the president to become law.

GovTrack’s Bill Summary

We don’t have a summary available yet.

Library of Congress Summary

The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress.


6/13/2013--Public Law.
(This measure has not been amended since it was introduced. The expanded summary of the Senate reported version is repeated here.)
Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013 -
TitleI - Fees Relating to Animal Drugs
Animal Drug User Fee Amendments of 2013 -
Section103 -
Amends the Federal Food, Drug, and Cosmetic Act to extend for FY2014-FY2018 the authority of the Food and Drug Administration (FDA) to collect animal drug user fees, specifically new animal drug application or supplemental animal drug application fees, animal drug product fees, animal drug establishment fees, and animal drug sponsor fees.
Revises the due date for annual 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 amount of revenue such fees can generate. Specifies percentages of the total revenue that shall be derived from each type of user fee.
Requires the Secretary of Health and Human Services (HHS) to adjust the total revenue amounts for FY2015 and subsequent fiscal years for inflation.
Authorizes the Secretary to accept payment of user fees prior to their due date.
Requires the total fees collected for FY2016-FY2018 to be increased by the cumulative amount, if any, by which the amount of user fees collected and appropriated for prior fiscal year falls below the cumulative amount of fees authorized.
Section104 -
Extends requirements for the FDA to report to Congress on achieving goals related to animal drug development and review processes and implementation of authority to collect animal drug user fees.
Section107 -
Terminates the authority to collect user fees October 1, 2018.
TitleII - Fees Relating to Generic Animal Drugs
Animal Generic Drug User Fee Amendments of 2013 -
Section202 -
Extends for FY2014-FY2018 the authority of the 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 to accept payment of user fees prior to their due date.
Section203 -
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.
Section206 -
Terminates the authority to collect generic animal drug user fees October 1, 2018.

House Republican Conference Summary

The summary below was written by the House Republican Conference, which is the caucus of Republicans in the House of Representatives.


No summary available.

House Democratic Caucus Summary

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