GovTrack’s Bill Summary
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S. stands for Senate bill.
This bill was enacted after being signed by the President on June 13, 2013.
20% chance of being enacted.
The following factors determined this bill’s prognosis:
The sponsor is the chairman of a committee to which the bill has been referred. ▲
The sponsor is on a committee to which the bill has been referred, and the sponsor is a member of the majority party. ▲
The bill was introduced in the first year of the Congress. ▼
6+ cosponsors serve on a committee to which the bill has been referred. ▼
The bill was referred to Senate Health, Education, Labor, and Pensions. ▼
Key: ▲ Correlated with successful bills. ▼ Correlated with unsuccessful bills. Correlation may not indicate causation.
Last updated Jun 05, 2013.
|Reported by Committee|
|Signed by the President|
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.
No summaries available.
Click a format for a citation suggestion:
S. 622--113th Congress: Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013. (2013). In www.GovTrack.us. Retrieved March 14, 2014, from http://www.govtrack.us/congress/bills/113/s622
“S. 622--113th Congress: Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013.” www.GovTrack.us. 2013. March 14, 2014 <http://www.govtrack.us/congress/bills/113/s622>
|title=S. 622 (113th)
|accessdate=March 14, 2014
|author=113th Congress (2013)
|date=March 20, 2013
|quote=Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013
We don’t have a summary available yet.
The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress.
The summary below was written by the House Republican Conference, which is the caucus of Republicans in the House of Representatives.
This summary can be found at http://www.gop.gov/bill/113/1/s622.
In 2003, Congress first enacted the Animal Drug User Fee Act (ADUFA) (P.L. 108-130, passed the House by voice vote), which established a user fee program to help improve the Food and Drug Administration’s (FDA) review of new animal drugs. Under the program, FDA collected fees to expedite the approval process, reduce the application backlog, and improve communication with drug sponsors. The program was reauthorized for an additional five years in 2008 (P.L. 110-316, passed by voice vote in the House).
As part of the reauthorization of ADUFA in 2008, Congress also enacted a new program to help improve FDA review of generic drugs, called the Animal Generic Drug User Fee Act (AGDUFA). AGDUFA helps to ensure that customers have access to safe, lower cost alternatives to brand name animal drugs.
Both of these programs expire on October 1, 2013. S. 622 reauthorizes these programs for an additional five years and is the result of negotiation between the FDA and stakeholders, as stipulated in the statute. According to testimony from the Director of the Center for Veterinary Medicine at the FDA, “[given] the current success of the program, FDA and industry agreed that only minor refinements were necessary.”
 Animal Drug User Fee Agreements: Advancing Animal Health for the Public Health: Hearing on S. 622 Before the Senate Committee on Health, Education, Labor, and Pensions, 113th Cong. 5 (2013) (Statement of Bernadette M. Dunham, D.V.M., Ph.D., Dir. of Center for Veterinary Services, FDA)
S. 622 reauthorizes two programs providing for the collection and spending of fees by the Food and Drug Administration (FDA) in order to expedite the review and approval of drugs for use in animals. Under the programs, FDA may assess different types of fees, the amounts, proportion, and annual adjustments of which are fixed in the bill and have been negotiated between the FDA and stakeholders, as required by current law. The fees collected may not be spent or obligated without future appropriation. This authority will expire October 1, 2018.
Also included in the legislation, as in previous authorizations, are provisions requiring annual performance and financial reports from the Secretary of Health and Human Services concerning the progress of achieving the program’s statutory goals and the use of the fees. Further, the law establishes a process of consultation with stakeholders for proposing changes in future reauthorization bills.
“CBO estimates that implementing S. 622 would reduce discretionary outlays, on net, by $7 million over the 2014-2018 period, assuming appropriation actions consistent with the bill.”
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The bill contains the following citations to other parts of U.S. law:
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