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ADUFA/AGDUFA drafts ready for extended comment period

ADUFA and AGDUFA give the FDA the authority to collect user fees that provide supplemental funding to support the new animal drug and generic new animal drug review processes, respectively.

Source: U.S. Food & Drug Administration
Today, the U.S. Food and Drug Administration announced its draft recommendations developed for submission to Congress for the reauthorization of the Animal Drug User Fee Act and the Animal Generic Drug User Fee Act. The agency is also extending the currently open comment periods until Nov. 24 to allow interested persons to submit comments on these draft recommendations.

ADUFA and AGDUFA give the FDA the authority to collect user fees that provide supplemental funding to support the new animal drug and generic new animal drug review processes, respectively. These resources support the FDA’s responsibility to review these drugs for safety and effectiveness and to enhance the timeliness and predictability of application reviews.

The current authorizations for ADUFA and AGDUFA expire on Sept. 30, 2018. Without new legislation reauthorizing these programs, FDA will no longer have the authority to collect user fees to help support the new animal drug and generic new animal drug review processes.

The proposed recommendations for ADUFA and AGDUFA are divided into four categories: Enhancing the Process for Premarket Review; Inflation Adjuster and Workload Adjuster; Offset Provision and Excess Collections; and the impact of the recommended changes on user fee revenue. Details on these recommendations and information on the extension of the comment period are available at:

Animal Drug User Fee Act; Recommendations; Request for comments; Extension of comment period 
Animal Generic Drug User Fee Act; Recommendations; Request for comments; Extension of comment period                                              

As previously announced , the FDA is also holding two public meetings on Nov. 2, one on ADUFA reauthorization and one on AGDUFA reauthorization, to offer opportunity for discussion on the proposed recommendations.

To electronically submit comments to the docket on the ADUFA and AGDUFA reauthorization draft recommendations, visit Regulations.gov and type the relevant docket number in the search box.

ADUFA IV: FDA-2011-N-0656
AGDUFA III: FDA-2011-N-0655

To submit comments to the docket by mail, use the following address. Be sure to include the relevant docket number on each page of your written comments.

Dockets Management Staff
HFA-305
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Comments will be accepted no later than Nov. 24 to ensure that the FDA can consider the comments and revise the recommendations as necessary.

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