The Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013 (; ) is a bill that was introduced into the

United States Senate The United States Senate is the upper chamber of the United States Congress, with the House of Representatives being the lower chamber. Together they compose the national bicameral legislature of the United States. The composition and pow ...

during the

113th United States Congress The 113th United States Congress was a meeting of the legislative branch of the United States federal government, from January 3, 2013, to January 3, 2015, during the fifth and sixth years of Presidency of Barack Obama, Barack Obama's presiden ...

. The bill would authorize the collection of fees by the

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...

for use to fund activities related to the approval of drugs for animals. The bill would amend the

Federal Food, Drug, and Cosmetic Act The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of f ...

. The bill was signed by President

Barack Obama Barack Hussein Obama II ( ; born August 4, 1961) is an American politician who served as the 44th president of the United States from 2009 to 2017. A member of the Democratic Party, Obama was the first African-American president of the U ...

on June 13, 2013, becoming .

Background

Provisions/Elements of the bill

The Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013 would authorize the collection and spending of fees by the

(FDA) for certain activities to expedite the development and marketing approval of drugs for use in animals. Fees would supplement appropriated funds to cover FDA’s costs associated with reviewing certain applications and investigational submissions for brand and generic animal drugs. Such fees could be collected and made available for obligation only to the extent and in the amounts provided in advance in appropriation acts. The legislation would extend through fiscal year 2018, and make several technical changes to, FDA’s existing fee programs for brand and generic animal drugs, which expire at the end of fiscal year 2013.

Procedural history

Senate

The Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013 () was introduced into the

on March 20, 2013 by Senator Tom Harkin (D-Iowa). On May 8, 2013, the bill passed the Senate by Unanimous consent.

House

The Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013 was received in the

United States House of Representatives The United States House of Representatives, often referred to as the House of Representatives, the U.S. House, or simply the House, is the Lower house, lower chamber of the United States Congress, with the United States Senate, Senate being ...

on May 9, 2013. It passed the House on June 3, 2013 by a vote of 390-12, recorded i
Roll Call Vote 185

Debate and discussion

Notes/References

External links

Library of Congress - Thomas S. 622beta.congress.gov S. 622GovTrack.us S. 622OpenCongress.org S. 622Congressional Budget Office's report on S. 622House Republicans' Report on S. 622
{{US government sources United States federal health legislation Acts of the 113th United States Congress Food and Drug Administration Veterinary medicine in the United States Veterinary drugs