FDA Extends Fee Programs' Comment Period

The U.S. Food and Drug Administration extended until Jan. 15, 2013, the comment period for the reauthorization of the Animal Drug User Fee Act and the Animal Generic Drug User Fee Act.

The acts give the FDA authority to collect user fees from the animal health industry and use the money to make the drug approval process faster and more predictable.

The FDA originally sought comments when it published a notice of public meeting in September. (Read an earlier story here.) The agency reopened the comment period to allow the public and stakeholder groups to provide comments throughout the process of reauthorizing both acts.

The agency is interested in responses to two questions and welcomes other input:

1. What is your assessment of the overall performance of the Animal Drug User Fee Act (ADUFA) or Animal Generic Drug User Fee Act (AGDUFA) thus far?

2. What aspects of ADUFA or AGDUFA should be retained, changed or discontinued to further strengthen and improve the program?

Background information and a transcript from the November public meeting are available through the FDA website.

Comments can be submitted electronically at www.regulations.gov or mailed to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Include docket number FDA-2011-N-0656 for the Animal Drug User Fee Act and FDA-2011-N-0655 for the Animal Generic Drug User Fee Act.

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